diff --git a/build_search_index.py b/build_search_index.py new file mode 100644 index 0000000..fc0d1a8 --- /dev/null +++ b/build_search_index.py @@ -0,0 +1,172 @@ +#!/usr/bin/env python3 +""" +Build searchIndex.json for AlcHepNet website search functionality. +Indexes all active HTML pages (excludes backups, templates, and components). +""" + +import os +import re +import json +from pathlib import Path + +SRC_DIR = Path(__file__).parent / "src" +OUTPUT_FILE = SRC_DIR / "searchIndex.json" +PUBLICATIONS_JSON = SRC_DIR / "Publishing" / "doc" / "all_publications.json" +PUBLICATIONS_URL = "Publishing/publications.html" + +# Pages to exclude from index +EXCLUDE_PATTERNS = [ + r"\.backup", + r"-backup\.html$", + r"\.bk\.html$", + r"-bk\.html$", + r"navbar\.html$", + r"footer\.html$", + r"search-modal\.html$", + r"template", + r"page-template", +] + + +def should_exclude(filepath: Path) -> bool: + """Check if file should be excluded from index.""" + name = filepath.name + for pattern in EXCLUDE_PATTERNS: + if re.search(pattern, name, re.IGNORECASE): + return True + return False + + +def strip_html(html: str) -> str: + """Remove HTML tags and decode entities.""" + # Remove script and style blocks + text = re.sub(r"]*>.*?", " ", html, flags=re.DOTALL | re.IGNORECASE) + text = re.sub(r"]*>.*?", " ", text, flags=re.DOTALL | re.IGNORECASE) + # Remove all HTML tags + text = re.sub(r"<[^>]+>", " ", text) + # Collapse whitespace + text = re.sub(r"\s+", " ", text) + return text.strip() + + +def extract_title(html: str, filepath: Path) -> str: + """Extract page title from HTML.""" + match = re.search(r"(.*?)", html, re.IGNORECASE | re.DOTALL) + if match: + return strip_html(match.group(1)) + # Fallback: use filename + return filepath.stem.replace("-", " ").title() + + +def extract_content(html: str) -> str: + """Extract main content from HTML for indexing.""" + # Prefer main tag content + match = re.search(r"]*>(.*?)", html, re.DOTALL | re.IGNORECASE) + if match: + return strip_html(match.group(1)) + # Fallback: body content + match = re.search(r"]*>(.*?)", html, re.DOTALL | re.IGNORECASE) + if match: + body = match.group(1) + body = re.sub(r"]*>.*?", " ", body, flags=re.DOTALL | re.IGNORECASE) + return strip_html(body) + return "" + + +def get_relative_url(filepath: Path) -> str: + """Get URL relative to src directory.""" + rel = filepath.relative_to(SRC_DIR) + return str(rel).replace("\\", "/") + + +def load_publications_index_entries(): + """Create search entries from the publications JSON data.""" + if not PUBLICATIONS_JSON.exists(): + return [] + + try: + with open(PUBLICATIONS_JSON, "r", encoding="utf-8") as f: + publications_data = json.load(f) + except Exception as e: + print(f"Warning: Could not read publications JSON {PUBLICATIONS_JSON}: {e}") + return [] + + publications_by_year = publications_data.get("publicationsByYear", {}) + entries = [] + + for year in sorted(publications_by_year.keys(), reverse=True): + publications = publications_by_year.get(year, []) + if not publications: + continue + + publication_texts = [ + pub.get("content", "").strip() + for pub in publications + if pub.get("content", "").strip() + ] + if not publication_texts: + continue + + content = f"AlcHepNet Publications {year}. " + " ".join(publication_texts) + snippet = " ".join(publication_texts[:2]) + if len(snippet) > 250: + snippet = snippet[:250] + "..." + + entries.append({ + "title": f"AlcHepNet Publications ({year})", + "url": PUBLICATIONS_URL, + "snippet": snippet, + "content": content, + }) + + return entries + + +def build_index(): + """Build search index from all HTML files.""" + index = [] + + for html_file in sorted(SRC_DIR.rglob("*.html")): + if should_exclude(html_file): + continue + + try: + with open(html_file, "r", encoding="utf-8", errors="ignore") as f: + html = f.read() + except Exception as e: + print(f"Warning: Could not read {html_file}: {e}") + continue + + title = extract_title(html, html_file) + content = extract_content(html) + + if not content: + content = title # Ensure something to search + + snippet = content[:250] + "..." if len(content) > 250 else content + + index.append({ + "title": title, + "url": get_relative_url(html_file), + "snippet": snippet, + "content": content, + }) + + index.extend(load_publications_index_entries()) + + return index + + +def main(): + print("Building search index...") + index = build_index() + print(f"Indexed {len(index)} pages") + + with open(OUTPUT_FILE, "w", encoding="utf-8") as f: + json.dump(index, f, ensure_ascii=False, indent=2) + + print(f"Written to {OUTPUT_FILE}") + + +if __name__ == "__main__": + main() diff --git a/src/Biorepo/biorepository.html b/src/Biorepo/biorepository.html index 91d4f00..1e54a03 100644 --- a/src/Biorepo/biorepository.html +++ b/src/Biorepo/biorepository.html @@ -25,7 +25,7 @@

Biorepository

- The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the biorepository in partnership with the Indiana Biobank (IB), which is a state-of-the-art facility for biospecimen storage, tracking, and distribution. The biorepository team uses a comprehensive, searchable database to manage all biospecimens and the associated metadata. The DCC provides a link between stored biospecimen data to facilitate research. + The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the biorepository in partnership with the Indiana Biobank (IB), which is a state-of-the-art facility for biospecimen storage, tracking, and distribution. The biorepository team uses a comprehensive, searchable database to manage all biospecimens and the associated metadata. The DCC provides access to stored biospecimens, and the linkage between biospecimens and clinical data to facilitate research.

diff --git a/src/Clinical/itaald-trial.html b/src/Clinical/itaald-trial.html index 68b835e..202a40c 100644 --- a/src/Clinical/itaald-trial.html +++ b/src/Clinical/itaald-trial.html @@ -29,7 +29,7 @@

Integrated Therapies for Alcohol

- The primary objective of the study is to determine whether subjects receiving F-652 followed by enhanced AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to those receiving prednisone plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling, while those assigned to the AUD usual care will receive brief advice and referral to a 12-step program. + The primary objective of the study is to determine whether subjects receiving F-652 (recombinant IL-22) followed by enhanced AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to those receiving prednisone plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling, while those assigned to the AUD usual care will receive brief advice and referral to a 12-step program.

diff --git a/src/Data_Access/design.html b/src/Data_Access/design.html index 399c5be..1215118 100644 --- a/src/Data_Access/design.html +++ b/src/Data_Access/design.html @@ -31,7 +31,7 @@

Design of ARDaC

1. The ARDaC Data Warehouse

- The heterogeneous clinical data, biosample information, and omics data information will be extracted from the randomized clinical trial, the observational study, and all other alcohol-associated hepatitis (AH) research projects, standardized according to the ARDaC Data Standard, harmonized according to the ARDaC Common Data Model, and hosted in a central ARDaC Data Warehouse. Specifically, the novel ARDaC Common Data Model is derived from and compatible with the Genomics Data Common (GDC) Data Model and is compliant with the FAIR Principles so that AlcHepNet multimodal data will be findable, accessible, interoperable, and reusable. The ARDaC Data Warehouse is the data source for the ARDaC web application, which is open to the public, as well as for regular reporting and customized services within the AlcHepNet consortium. A graph-based provenance model is used for comprehensive data dependency and version control. The ARDaC digital entities, including the standards, data model, data, metadata, scripts, and codes, are attributable, trackable, and reproducible. + The heterogeneous clinical data, biosample information, and omics data information will be extracted from the randomized clinical trial and all other alcohol-associated hepatitis (AH) research projects, standardized according to the ARDaC Data Standard, harmonized according to the ARDaC Common Data Model, and hosted in a central ARDaC Data Warehouse. Specifically, the novel ARDaC Common Data Model is derived from and compatible with the Genomics Data Common (GDC) Data Model and is compliant with the FAIR Principles so that AlcHepNet multimodal data will be findable, accessible, interoperable, and reusable. The ARDaC Data Warehouse is the data source for the ARDaC web application, which is open to the public, as well as for regular reporting and customized services within the AlcHepNet consortium. A graph-based provenance model is used for comprehensive data dependency and version control. The ARDaC digital entities, including the standards, data model, data, metadata, scripts, and codes, are attributable, trackable, and reproducible.

2. The ARDaC web application

diff --git a/src/Data_Access/policy.html b/src/Data_Access/policy.html index 8e0700d..b86ed11 100644 --- a/src/Data_Access/policy.html +++ b/src/Data_Access/policy.html @@ -35,50 +35,58 @@

Data Request Policy

    -
  1. Funding should be available
  2. -
  3. Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to apply
  4. -
  5. Non-AlcHepNet affiliates can apply accompanied by the SC PI as their sponsor
  6. -
  7. Must have prior approval from the AlcHepNet publications and ancillary study committee - (PAC)
  8. -
  9. IU DCC will only offer data within the scope of SC PI's proposal. Additional data requests will be - reviewed by PAC for amended approval. If original data (e.g, omics or genotyping, or cytokines) are - generated on AHN samples at the investigator's site, those data must be first deposited with the DCC prior - to DCC transferring the associated phenotyping data to the investigator. The investigator agrees not to - share the phenotype data to a third party without written approval from the AHN DCC or - Publications/Ancillary Studies or Steering Committees.
  10. -
  11. If using genomic data, SC PI must follow NIH's genomic data sharing policy and procedures.
  12. -
      -
    1. Please reference policies at the following link, agree to the following, and sign below: https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html -
        -
      1. Using the data only for the approved research.
      2. -
      3. Protecting data confidentiality.
      4. -
      5. Following, as appropriate, all applicable national, tribal, and state laws and regulations, as well as - relevant institutional policies and procedures for handling genomic data.
      6. -
      7. Not attempting to identify individual participants from whom the data were obtained.
      8. -
      9. Not selling any of the data obtained from NIH-designated data repositories.
      10. -
      11. Not sharing any of the data obtained from controlled-access NIH-designated data repositories with - individuals other than those listed in the data access request.
      12. -
      13. Institutional Certifications are expected for the submission of large-scale human genomic data.
      14. -
      15. Agreeing to the listing of a summary of approved research uses in dbGaP along with the investigator's - name and organizational affiliation.
      16. -
      17. Agreeing to report any violation of the GDS Policy to the appropriate DAC(s) as soon as it is - discovered.
      18. -
      19. Reporting research progress using controlled-access datasets through annual access renewal requests or - project close-out reports.
      20. -
      -
    2. -
    3. Acknowledging in all oral or written presentations, disclosures, or publications the contributing - investigator(s) who conducted the original study, the funding organization(s) that supported the work, the - specific dataset(s) and applicable accession number(s), and the NIH-designated data repositories through - which the investigator accessed any data.
    4. +
    5. Should have sufficient funds available to support the proposed work
    6. +
    7. Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to apply
    8. +
    9. Non-AlcHepNet affiliates can apply accompanied by the SC PI as their sponsor
    10. +
    11. Must have prior approval from the AlcHepNet publications and ancillary study committee + (PAC)
    12. +
    13. IU DCC will only offer data within the scope of SC PI's proposal. Additional data requests will be + reviewed by PAC for amended approval. If an investigator generates original data (e.g., omics or + genotyping, or cytokines) using the AHN biosamples and later requests clinical data, the DCC will + require the investigator to deposit the omics data with the DCC before the clinical data are released. + The investigator agrees not to share the phenotype data with a third party without written approval from + the AHN DCC or to Publications/Ancillary Studies or Steering Committees.
    14. +
    15. If using genomic data, SC PI must follow NIH's genomic data sharing policy and procedures.
    16. +
        +
      1. Please reference policies at the following link, agree to the following, and sign below: https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html +
          +
        1. Using the data only for the approved research.
        2. +
        3. Protecting data confidentiality.
        4. +
        5. Following, as appropriate, all applicable national, tribal, and state laws and regulations, as + well as + relevant institutional policies and procedures for handling genomic data.
        6. +
        7. Not attempting to identify individual participants from whom the data were obtained.
        8. +
        9. Not selling any of the data obtained from NIH-designated data repositories.
        10. +
        11. Not sharing any of the data obtained from controlled-access NIH-designated data repositories + with + individuals other than those listed in the data access request.
        12. +
        13. Institutional Certifications are expected for the submission of large-scale human genomic data. +
        14. +
        15. Agreeing to the listing of a summary of approved research uses in dbGaP along with the + investigator's + name and organizational affiliation.
        16. +
        17. Agreeing to report any violation of the GDS Policy to the appropriate DAC(s) as soon as it is + discovered.
        18. +
        19. Reporting research progress using controlled-access datasets through annual access renewal + requests or + project close-out reports.
        20. +
        +
      2. +
      3. Acknowledging in all oral or written presentations, disclosures, or publications the + contributing + investigator(s) who conducted the original study, the funding organization(s) that supported the work, + the + specific dataset(s) and applicable accession number(s), and the NIH-designated data repositories + through + which the investigator accessed any data.
      4. +
      +
      +
      +
      Printed Name/Signature of PI
      +
    -
    -
    -
    Printed Name/Signature of PI
    -
    -
@@ -87,27 +95,32 @@

Data Request Policy

Data Request Process

-

- Data request can be submitted by the PIs of the AlcHepNet consortium. Internal - and external collaborators are encouraged, but the actual request must be submitted by one of the PIs. Data - requests by the PI automatically imply he/she is responsible for completing the study in a timely and rigorous - fashion, avoids "mission creep" and abides by other AlcHepNet policies. -

+

+ Data request can be submitted by the PIs of the AlcHepNet consortium. + Internal + and external collaborators are encouraged, but the actual request must be submitted by one of the PIs. + Data + requests by the PI automatically imply he/she is responsible for completing the study in a timely and + rigorous + fashion, avoids "mission creep" and abides by other AlcHepNet policies. +

-

- Request process -

    -
  1. Savannah will send approval from ancillary study/publication proposal. With this approval, she will send the data dictionary for PI to review
  2. -
  3. PI will create a table of data for request. Table should include:
  4. -
      -
    1. Subjects to include (i.e., healthy controls, those with 90-day mortality, RCT, etc.)
    2. -
    3. Time points
    4. -
    5. Specific data points such as those with liver transplant, AKI, PT/INR. Not "outcome related clinical data"
    6. +

      + Request process +

        +
      1. Savannah will send approval from ancillary study/publication proposal. With this approval, she will + send the data dictionary for PI to review
      2. +
      3. PI will create a table of data for request. Table should include:
      4. +
          +
        1. Subjects to include (i.e., healthy controls, those with 90-day mortality, RCT, etc.)
        2. +
        3. Time points
        4. +
        5. Specific data points such as those with liver transplant, AKI, PT/INR. Not "outcome related + clinical data"
        6. +
        +
      5. Savannah will subsequently send to IU DCC for review
      6. +
      7. IU DCC will prioritize requests as they come in. Requests can take 1-4 weeks depending on queue
      -
    7. Savannah will subsequently send to IU DCC for review
    8. -
    9. IU DCC will prioritize requests as they come in. Requests can take 1-4 weeks depending on queue
    10. -
    -

    +

diff --git a/src/Data_Access/query-system.html b/src/Data_Access/query-system.html deleted file mode 100644 index 389013b..0000000 --- a/src/Data_Access/query-system.html +++ /dev/null @@ -1,67 +0,0 @@ - - - - - - - - - Query System - AlcHepNet - - - - - - - -
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Query System

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This page is under construction. Content will be added soon.

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- - - - - - - - - \ No newline at end of file diff --git a/src/News_Training/new-publications.html b/src/News_Training/new-publications.html index 5bf2c58..3f5deb8 100644 --- a/src/News_Training/new-publications.html +++ b/src/News_Training/new-publications.html @@ -15,12 +15,10 @@ .page-header { margin-bottom: 2rem; } - .page-header h1 { - font-size: 2.5rem; - font-weight: 700; + .page-header .section-title { margin-bottom: 0.5rem; } - .section-title { + .subsection-title { font-size: 1.8rem; font-weight: 700; color: #333; @@ -167,6 +165,54 @@ background: var(--btn-primary-bg, #80abc1); color: white; } + .year-section { + margin-bottom: 1.5rem; + border: 1px solid #ddd; + border-radius: 8px; + background: #fff; + box-shadow: 0 1px 3px rgba(0, 0, 0, 0.08); + } + .year-section[open] { + border-color: #2e3b92; + } + .year-header { + font-size: 1.3rem; + font-weight: 700; + color: #2e3b92; + cursor: pointer; + padding: 1rem 1.5rem; + list-style: none; + display: flex; + align-items: center; + gap: 0.5rem; + user-select: none; + } + .year-header::-webkit-details-marker { + display: none; + } + .year-header::before { + content: "▶"; + font-size: 0.9rem; + transition: transform 0.2s; + margin-right: 0.5rem; + } + .year-section[open] .year-header::before { + transform: rotate(90deg); + } + .year-header:hover { + background-color: #f8f9fa; + } + .year-count { + font-size: 0.85rem; + font-weight: normal; + color: #666; + background: #f0f0f0; + padding: 0.2rem 0.5rem; + border-radius: 4px; + } + .year-content { + padding: 0 1.5rem 1.5rem 1.5rem; + } .empty-state { text-align: center; @@ -204,27 +250,36 @@
-

Latest News & Announcements

- -
- -

xxxx

+

Latest News & Announcements

+ +
+
+ Jan + 2026 + News +
+
+
ITAALD Trial Enrollment Began
+
Clinical Trial
+

The ITAALD trial started enrollment in January 2026. The first two patients were enrolled at the Cleveland Clinic. Congratulations to the Cleveland Clinic team!

+
-

Recent Publications

- -
- -

xxxx

+

Recent Publications

+
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+ +

Loading recent publications...

+
@@ -237,7 +292,123 @@

Recent Publications - - - -
- -
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- - - - - -
- - - - - - -
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About AlcHepNet

-

The Alcohol-associated Hepatitis Network project, AlcHepNet, comprised of ten leading partner institutions in the field, will collect and organize patient information, associated data, and samples that can help shed greater light on this disease. Combined, these approaches will improve treatment and how we care for patients with this devastating liver condition.

- - - -

Alcohol-associated hepatitis (AH) is a leading cause of liver-related morbidity and mortality. This network represents a coordinated submission of several NIAAA-funded consortia that have come together as the Alcohol-associated Hepatitis Network (AlcHepNet). Collectively, the network will synergize efforts and expertise to better understand AH. The network aims to: -

-

- Develop a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). -

-

- The primary purpose study is to determine whether subjects receiving AUD treatments combined with sAH therapies will improve alcohol and liver-related events at 6 months compared to usual care for AUD. Patients will receive either integrated treatment with acamprosate and counseling or standard care with brief advice and referral to a 12-step program. -

-

- The secondary purpose of the study is to determine if F-652 is safe and effective in treating severe alcohol-associated hepatitis when compared to prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days. -

- -

- - ARDaC Logo - -

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AlcHepNet Organizations

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- -
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AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH.

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© 2017-2025 Alcohol-associated Hepatitis Network

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- - - - - - - - - \ No newline at end of file diff --git a/src/index-maintenance.html b/src/index-maintenance.html deleted file mode 100644 index 63134c3..0000000 --- a/src/index-maintenance.html +++ /dev/null @@ -1,18 +0,0 @@ - - - - - - - - - - AlcHepNet - Alcohol-associated Hepatitis Network - - - - - -

Down for updates.

- - diff --git a/src/obs.html b/src/obs.html deleted file mode 100644 index ffb7574..0000000 --- a/src/obs.html +++ /dev/null @@ -1,49 +0,0 @@ - - - - - - - - - Observational Study - AlcHepNet - - - - - - - -
- -
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Observational Study (OBS)

-

This page is under construction. Content will be added soon.

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- - - - - - - - - \ No newline at end of file diff --git a/src/page-template.html b/src/page-template.html deleted file mode 100644 index 66cc8b0..0000000 --- a/src/page-template.html +++ /dev/null @@ -1,42 +0,0 @@ - - - - - - - - - PAGE_TITLE - AlcHepNet - - - - - - - -
- -
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- - - - - - - - - \ No newline at end of file diff --git a/src/quickstart.html b/src/quickstart.html deleted file mode 100644 index b1416b2..0000000 --- a/src/quickstart.html +++ /dev/null @@ -1,23 +0,0 @@ - - - - alchepnet.org is almost here! - - - - - -
-

alchepnet.org is almost here!

- -

Upload your website to get started.

- - - - -
- - diff --git a/src/rct.html b/src/rct.html deleted file mode 100644 index 474d814..0000000 --- a/src/rct.html +++ /dev/null @@ -1,49 +0,0 @@ - - - - - - - - - Randomized Controlled Trial - AlcHepNet - - - - - - - -
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Randomized Controlled Trial (RCT)

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This page is under construction. Content will be added soon.

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- - - - - - - - - \ No newline at end of file diff --git a/src/searchIndex.json b/src/searchIndex.json index dab97c0..5ede6bc 100644 --- a/src/searchIndex.json +++ b/src/searchIndex.json @@ -2,235 +2,277 @@ { "title": "AlcHepNet - Biorepository", "url": "Biorepo/biorepository.html", - "snippet": "Biorepository The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the biorepository in partnership with the Indiana University Geneti", - "content": "Biorepository The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the biorepository in partnership with the Indiana University Genetics Biobank (IUGB), which is a state-of-the-art facility for biospecimen storage, tracking, and distribution. The biorepository team uses a comprehensive, searchable database to manage all biospecimens and the associated metadata. The DCC provides a link between stored biospecimen data to facilitate research. Team I suggest you list Linus first, followed by Whitney and then others. Give the contact info only if you let users contact them. In this case, maybe just the contact info for Linus and Whitney. IUGB: (make sure we use names consistently: IUGB is formerly known as the Indiana Biobank. If that is the official name, we should use that name to minimize confusion. We don't need to repeat the info from the Indiana Biobank website. We just need to create a link https://indianabiobank.org) About Indiana Biobank The Indiana Biobank, also known as the Indiana University Genetic Biobank, is a statewide initiative, co-developed by Indiana University School of Medicine and IU Health, to collect blood specimens through the Indiana Biobank for genomic sequencing. The specimens and information can be used in research to develop better treatments for diseases today and in the future. The Indiana Biobank is partnering with AlcHepNet to manage the specimens collected from AlcHepNet studies. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Biorepository --> The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the bioreposi...", + "content": "Biorepository --> The AlcHepNet Biorepository is a part of the Indiana University Data Coordinating Center (DCC). Its primary function is to support biospecimen collection for ongoing AlcHepNet studies. The DCC oversees the operation of the biorepository in partnership with the Indiana Biobank (IB) , which is a state-of-the-art facility for biospecimen storage, tracking, and distribution. The biorepository team uses a comprehensive, searchable database to manage all biospecimens and the associated metadata. The DCC provides access to stored biospecimens, and the linkage between biospecimens and clinical data to facilitate research." }, { "title": "IUGB - AlcHepNet", "url": "Biorepo/iugb.html", - "snippet": "Indiana University Genetics Biobank Note: Add Tu’s IUGB paragraph and link to IUGB resources, please visit the Indiana Biobank website. Mission Statement The goal of the Indiana Biobank is to aid researchers in discovery research that may lead to better ways to treat and prevent diseases. The Indian", - "content": "Indiana University Genetics Biobank Note: Add Tu’s IUGB paragraph and link to IUGB resources, please visit the Indiana Biobank website. Mission Statement The goal of the Indiana Biobank is to aid researchers in discovery research that may lead to better ways to treat and prevent diseases. The Indiana Biobank works towards this goal by providing researchers with the tools and resources they need to advance their research. About the Indiana Biobank The Indiana Biobank was established in 2010 and is intended to be a resource to promote discovery research. We offer a variety of services to meet this aim. Each year, we provide researchers over 4000 sample collection kits, bank samples for over 30 biobanks, support over 15 targeted collections, distribute thousands of specimens and omics data, and collect over 10,000 specimens for broad sharing. Currently, over 50,000 patients have consented to be a part of the Indiana Biobank. The Indiana Biobank is a part of the Indiana Clinical and Translational Sciences Institute (CTSI). The CTSI is a statewide collaboration of scientists at Indiana University, Purdue University, and the University of Notre Dame, as well as public and private partnerships. Who is using our services? Since 2010, the Indiana Biobank has supported hundreds of academic and commercial researchers through services and distributed thousands of specimens to aid in discovery research in a variety of therapeutic areas. Erin Conboy, MD Assistant Professor of Clinical Medical and Molecular Genetics, Department of Medical and Molecular Genetics and PediatricsIndiana University School of Medicine \"The Indiana Biobank provides sample collection kits, sample processing, and distribution services for our Undiagnosed and Rare Disease Clinic. They also work with us to make sure our samples are distributed quickly and efficiently, helping our comprehensive genetic and metabolic testing and analysis run smoothly as our researchers work together to look for answers for families in Indiana.\" David Haas, MD Robert A. Munsick Professor of Obstetrics & Gynecology, Department of Obstetrics and GynecologyIndiana University School of Medicine \"I appreciate how flexible the Indiana Biobank team is. Our project is a multi-year, multi-site, and multi-visit study focused on pregnant mothers and their babies. As we continue to develop and design the most efficient workflow, the Indiana Biobank team works with us to support our project's evolving needs.\" Melissa Kacena, PhD Professor of Orthopaedic Surgery, Department of Orthopaedic SurgeryIndiana University School of Medicine \"The Indiana Biobank worked quickly to provide me with high quality samples and clinical data for my COVID-19 research. They have been incredibly accommodating and efficient as we work through the pandemic. I would encourage other investigators to use them as a resource.\" Nabil Adra, MD Assistant Professor of Clinical Medicine, Assistant Professor of Urology, Director, Genitourinary OncologyIndiana University Simon Comprehensive Cancer Center \"The Indiana Biobank supports my research by providing kits, sample processing, storage, and sample distribution services for my biobanks. They also share their biobanking expertise with me, allowing me to sharpen the focus of my research. The Indiana Biobank is a great partner!\" Sharon Moe, MD Co-director Indiana CTSI, Director, Division of Nephrology, Stuart A. Kleit Professor of MedicineIndiana University School of Medicine, Scientific Director, Indiana Biobank \"The Indiana Biobank has been a key partner of the Indiana Center for Musculoskeletal Health since the inception of the Center. The Indiana Biobank staff worked with us to design several blood and tissue sample collections. They have also worked with us to develop an online sample catalog to help our collaborators determine which samples meet their research needs. We look forward to our continued partnership with the Indiana Biobank to accelerate discoveries and understanding in musculoskeletal health.\" Dongbing Lai, PhD Assistant Research Professor of Medical & Molecular Genetics, Department of Medical and Molecular GeneticsIndiana University School of Medicine \"The Indiana Biobank provided me with over 3,600 DNA samples for my collaboration with the National Institute on Drug Abuse (NIDA). The Biobank team worked with me to design a query to identify cases and controls of interest for my research. They also provided me with health information for each sample. In addition to samples, I have also received GWAS data from the Indiana Biobank to support my research looking at the genetics factor of substance use disorders and related diseases. Their team has been great to work with, and I would highly recommend working with them.\" Indiana Biobank The Indiana Biobank is a statewide initiative, co-developed by Indiana University School of Medicine and IU Health to collect blood specimens through the Indiana Biobank for genomic sequencing. The specimens and information can be used in research to find better treatments for diseases of today and the future. IU Health patients can participate in this effort by donating blood samples. Patients who are already in the lab for a scheduled blood draw can consent in-person or may consent remotely for a future draw. The Indiana Biobank can also use blood specimens left over from other procedures. Patients who participate are automatically enrolled in the All IN for Health program initiative and will receive a newsletter that provides resources for good health and opportunities to participate in more health research and clinical studies. The goal of the project is to enroll 300,000 IU Health patients over the next five years. Here are some frequently asked questions about the Indiana Biobank. For more information, visit the Indiana Biobank website or contact them at inbiobnk@iu.edu or call 317-278-0880. $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function () { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function () { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "Indiana Biobank --> The Indiana Biobank, also known as the Indiana University Genetic Biobank, is a statewide initiative, co-developed by Indiana University School of Medicine and IU Health to collect blood specimens through the Indiana Biobank for g...", + "content": "Indiana Biobank --> The Indiana Biobank, also known as the Indiana University Genetic Biobank, is a statewide initiative, co-developed by Indiana University School of Medicine and IU Health to collect blood specimens through the Indiana Biobank for genomic sequencing. The specimens and information can be used in research to develop better treatments for diseases today and in the future. The Indiana Biobank is partnering with AlcHepNet to manage the specimens collected from AlcHepNet studies. For more information about the Indiana Biobank, please visit https://indianabiobank.org" }, { "title": "AlcHepNet Biosample Summary", "url": "Biorepo/samples-collected.html", - "snippet": "Samples Collected Summary of AlcHepNet biospecimen aliquots by specimen type, study arm, and visit. Table 1. Aliquots by specimen type and study arm Specimen Type AH Case HDC Healthy Control RCT Total CPT plasma 72759531383304712658 HCl acidified plasma 252747155461 Lysed RBC 21442224614733300 NEAT ", - "content": "Samples Collected Summary of AlcHepNet biospecimen aliquots by specimen type, study arm, and visit. Table 1. Aliquots by specimen type and study arm Specimen Type AH Case HDC Healthy Control RCT Total CPT plasma 72759531383304712658 HCl acidified plasma 252747155461 Lysed RBC 21442224614733300 NEAT plasma 2771355159504 PBMC 497347956731299148 Platelet-poor plasma 56374531281278110152 Platelet-rich plasma 22291181834662996 Serum 304122144810534763 Whole blood 52397152143915 Serum for Anakinra trough level ------3333 Stool 718218 Urine 290430588212175308 Saliva 8211021 Liver biopsy 121812 Table 2. Observational aliquots by study visit Specimen Type Week 0 Week 4 Week 12 Week 24 Total CPT plasma5996155492511369611 HCl acidified plasma202391847306 Lysed RBC16225233103722827 NEAT plasma233411853345 PBMC332011046699266019 Platelet-poor plasma4479117370210177371 Platelet-rich plasma15564902722122530 Serum21386413765553710 Whole blood659523724772 Stool1410116 Urine22996274647014091 Saliva341311 Liver biopsy40004 Table 3. RCT aliquots by study visit Specimen Type Day 0 Day 3 Day 7 Day 14 Day 28 Day 60 Day 90 Day 180 Total CPT plasma645135974474123442922973047 HCl acidified plasma312282423161615155 Lysed RBC1239358641574640473 NEAT plasma352272423161715159 PBMC68866004484033742993113129 Platelet-poor plasma566184863983483942752962781 Platelet-rich plasma1510809460442017466 Serum27043751437146301141053 Whole blood824330252087143 Serum for Anakinra trough level8965410033 Stool200000002 Urine24602251511381661161751217 Saliva7020001010 Liver biopsy600200008 Table 4. Number of participants with each sample type Specimen Type OBS RCT Total CPT plasma9501361086 HCl acidified plasma22854282 Lysed RBC66882750 NEAT plasma24956305 PBMC9141361050 Platelet-poor plasma10171381155 Platelet-rich plasma42546471 Serum10491471196 Whole blood68144725 Serum for Anakinra trough level02626 Stool11213 Urine791121912 Saliva111021 Liver biopsy4711 $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Samples Collected Summary of AlcHepNet biospecimen aliquots by specimen type, study arm, and visit. Table 1. Aliquots by specimen type and study arm Specimen Type AH Case HDC Healthy Control RCT Total CPT plasma 7275 953 1383 3047 12658 HCl acidified...", + "content": "Samples Collected Summary of AlcHepNet biospecimen aliquots by specimen type, study arm, and visit. Table 1. Aliquots by specimen type and study arm Specimen Type AH Case HDC Healthy Control RCT Total CPT plasma 7275 953 1383 3047 12658 HCl acidified plasma 252 7 47 155 461 Lysed RBC 2144 222 461 473 3300 NEAT plasma 277 13 55 159 504 PBMC 4973 479 567 3129 9148 Platelet-poor plasma 5637 453 1281 2781 10152 Platelet-rich plasma 2229 118 183 466 2996 Serum 3041 221 448 1053 4763 Whole blood 523 97 152 143 915 Serum for Anakinra trough level -- -- -- 33 33 Stool 7 1 8 2 18 Urine 2904 305 882 1217 5308 Saliva 8 2 1 10 21 Liver biopsy 1 2 1 8 12 Table 2. Observational aliquots by study visit Specimen Type Week 0 Week 4 Week 12 Week 24 Total CPT plasma 5996 1554 925 1136 9611 HCl acidified plasma 202 39 18 47 306 Lysed RBC 1622 523 310 372 2827 NEAT plasma 233 41 18 53 345 PBMC 3320 1104 669 926 6019 Platelet-poor plasma 4479 1173 702 1017 7371 Platelet-rich plasma 1556 490 272 212 2530 Serum 2138 641 376 555 3710 Whole blood 659 52 37 24 772 Stool 14 1 0 1 16 Urine 2299 627 464 701 4091 Saliva 3 4 1 3 11 Liver biopsy 4 0 0 0 4 Table 3. RCT aliquots by study visit Specimen Type Day 0 Day 3 Day 7 Day 14 Day 28 Day 60 Day 90 Day 180 Total CPT plasma 645 13 597 447 412 344 292 297 3047 HCl acidified plasma 31 2 28 24 23 16 16 15 155 Lysed RBC 12 3 93 58 64 157 46 40 473 NEAT plasma 35 2 27 24 23 16 17 15 159 PBMC 688 6 600 448 403 374 299 311 3129 Platelet-poor plasma 566 18 486 398 348 394 275 296 2781 Platelet-rich plasma 151 0 80 94 60 44 20 17 466 Serum 270 4 375 143 71 46 30 114 1053 Whole blood 8 2 43 30 25 20 8 7 143 Serum for Anakinra trough level 8 9 6 5 4 1 0 0 33 Stool 2 0 0 0 0 0 0 0 2 Urine 246 0 225 151 138 166 116 175 1217 Saliva 7 0 2 0 0 0 1 0 10 Liver biopsy 6 0 0 2 0 0 0 0 8 Table 4. Number of participants with each sample type Specimen Type OBS RCT Total CPT plasma 950 136 1086 HCl acidified plasma 228 54 282 Lysed RBC 668 82 750 NEAT plasma 249 56 305 PBMC 914 136 1050 Platelet-poor plasma 1017 138 1155 Platelet-rich plasma 425 46 471 Serum 1049 147 1196 Whole blood 681 44 725 Serum for Anakinra trough level 0 26 26 Stool 11 2 13 Urine 791 121 912 Saliva 11 10 21 Liver biopsy 4 7 11" }, { "title": "Team - AlcHepNet", "url": "Biorepo/team.html", - "snippet": "AHN Biobank Team The core team managing biospecimen collection, processing, and distribution for the AlcHepNet research network. Whitney Jaunzemis, BS, CCRP She/Her Project Manager wjaunzem@iu.edu Tae-Hwi Linus Schwantes-An, PhD He/Him Assistant Professor of Medical & Molecular Genetics at IUSM, Dir", - "content": "AHN Biobank Team The core team managing biospecimen collection, processing, and distribution for the AlcHepNet research network. Whitney Jaunzemis, BS, CCRP She/Her Project Manager wjaunzem@iu.edu Tae-Hwi Linus Schwantes-An, PhD He/Him Assistant Professor of Medical & Molecular Genetics at IUSM, Director of Genetics at Indiana Biobank tlschwan@iu.edu Jacob Lee, BS He/Him Clinical Research Coordinator jacoblee@iu.edu Becky Long, BS She/Her Clinical Research Coordinator rlong@iu.edu Michael Aikin, BS He/Him Clinical Research Specialist maikin@iu.edu Erin Koehler, R.T.(R)M She/Her Clinical Research Specialist ekoehler@iu.edu $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "AHN Biobank Team The core team managing biospecimen collection, processing, and distribution for the AlcHepNet research network. Tae-Hwi Linus Schwantes-An, PhD Assistant Professor of Medical & Molecular Genetics at IUSM, Director of Genetics at Indi...", + "content": "AHN Biobank Team The core team managing biospecimen collection, processing, and distribution for the AlcHepNet research network. Tae-Hwi Linus Schwantes-An, PhD Assistant Professor of Medical & Molecular Genetics at IUSM, Director of Genetics at Indiana Biobank tlschwan@iu.edu Whitney Jaunzemis, BS, CCRP Project Manager wjaunzem@iu.edu Jacob Lee, BS Clinical Research Coordinator Becky Long, BS Clinical Research Coordinator Michael Aikin, BS Clinical Research Specialist Erin Koehler, R.T.(R)M Clinical Research Specialist" }, { "title": "AlcHepNet - Observational Study Eligibility and Enrollment", "url": "Clinical/eligibility.html", - "snippet": "AlcHepNet Observational Study Eligibility and Enrollment Eligibility information Ages Eligible for Study: 21 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Sampling Method: Probability Sample Study Population Any subject with Alcohol-associated hep", - "content": "AlcHepNet Observational Study Eligibility and Enrollment Eligibility information Ages Eligible for Study: 21 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Sampling Method: Probability Sample Study Population Any subject with Alcohol-associated hepatitis, Heavy healthy drinkers, and Healthy controls Criteria CASES: Heavy drinkers with alcohol-associated hepatitis Inclusion criteria A clinical diagnosis of alcohol-associated hepatitis Serum total bilirubin >3 mg/dL Subject or guardian ability to understand and willingness to provide written consent Age greater or equal to 21 years Re-enrolment of an alcohol-associated hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcohol-associated hepatitis 24 weeks or longer after the most recent enrolment in the study Exclusion criteria Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) Pregnant or breast feeding Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements. CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. Subject or guardian ability to understand and willingness to provide written consent Age greater or equal to 21 years Exclusion criteria Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past). Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa. Pregnant or breast feeding Any of the following laboratory abnormalities within 90 days prior to signing the consent. Total bilirubin: >ULN* INR: > 1.4 5 *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation. Healthy Controls Inclusion criteria AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse) Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment Ability to understand and willingness to provide written consent. Exclusion criteria Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcohol-associated hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. Presence of diabetes (requiring treatment with oral agents or insulin). Significant heart disease (prior history of heart disease, other than hypertension) Chronic lung disease (requiring chronic treatment) Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.) Known infection with HIV Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days BMI>35 Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment Pregnant or breast feeding Any of the following laboratory abnormalities within 90 days prior to signing the consent. Hemoglobin: <10 g/dL Conjugated bilirubin: > ULN INR: > 1.4 AST: >40 IU/mL ALT: >40 IU/mL Based on the judgment of the investigator, subject is not capable of complying with the study requirements AlcHepNet Clinical Trial Eligibility and Enrollment Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/l AST:ALT > 1.5 and both values < 400 IU/l and/or histological evidence of AH* * In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/mL or > 400 IU/mL, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a liver biopsy will be performed to confirm AH and exclude competing etiologies MELD 20-35 on day of randomization. Exclusion Criteria MELD SCORE <20 or> 35 Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion Pneumonia as evidenced by radiological exam Multi-organ failure Renal failure defined by GFR <50 mL/min. Clinically active C. diff infection History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \\hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI) History of HIV infection (positive HIV RNA or on treatment for HIV infection) History or presence of cancer (including hepatocellular carcinoma) other than nonmelanoma skin cancer History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments Pregnancy or breastfeeding Prior exposure to experimental therapies in last 3 months Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan Total WBC count > 30000/mm3 Known allergy or intolerance to therapeutic agents to be tested Inability to voluntarily obtain informed consent from participant or guardian Perceived inability to follow study procedures and comply with protocol Platelet count < 50,000. The participants for this study will be recruited from a hospitalized population of participants meeting the eligibility criteria outlined above who live within one day travel from one of the participating clinical centers and who have provided informed consent to participate in this clinical trial and who are willing to continue their participation for the anticipated follow-up period of the trial. Although the primary endpoint is survival at 90 days, follow-up visits will be continued up to 6 months. $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "AlcHepNet Observational Study Eligibility and Enrollment Eligibility information Ages Eligible for Study:   21 Years and older   (Adult, Older Adult) Sexes Eligible for Study:   All Accepts Healthy Volunteers:   Yes Sampling Metho...", + "content": "AlcHepNet Observational Study Eligibility and Enrollment Eligibility information Ages Eligible for Study:   21 Years and older   (Adult, Older Adult) Sexes Eligible for Study:   All Accepts Healthy Volunteers:   Yes Sampling Method:   Probability Sample Study Population Any subject with Alcohol-associated hepatitis, Heavy healthy drinkers, and Healthy controls Criteria CASES: Heavy drinkers with alcohol-associated hepatitis Inclusion criteria A clinical diagnosis of alcohol-associated hepatitis Serum total bilirubin >3 mg/dL Subject or guardian ability to understand and willingness to provide written consent Age greater or equal to 21 years Re-enrolment of an alcohol-associated hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcohol-associated hepatitis 24 weeks or longer after the most recent enrolment in the study Exclusion criteria Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) Pregnant or breast feeding Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements. CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. Subject or guardian ability to understand and willingness to provide written consent Age greater or equal to 21 years Exclusion criteria Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past). Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa. Pregnant or breast feeding Any of the following laboratory abnormalities within 90 days prior to signing the consent. Total bilirubin: >ULN* INR: > 1.4 5 *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation. Healthy Controls Inclusion criteria AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse) Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment Ability to understand and willingness to provide written consent. Exclusion criteria Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcohol-associated hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. Presence of diabetes (requiring treatment with oral agents or insulin). Significant heart disease (prior history of heart disease, other than hypertension) Chronic lung disease (requiring chronic treatment) Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.) Known infection with HIV Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days BMI>35 Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment Pregnant or breast feeding Any of the following laboratory abnormalities within 90 days prior to signing the consent. Hemoglobin: <10 g/dL Conjugated bilirubin: > ULN INR: > 1.4 AST: >40 IU/mL ALT: >40 IU/mL Based on the judgment of the investigator, subject is not capable of complying with the study requirements --> AlcHepNet Clinical Trial Eligibility and Enrollment Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/l AST:ALT > 1.5 and both values < 400 IU/l and/or histological evidence of AH* * In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/mL or > 400 IU/mL, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a liver biopsy will be performed to confirm AH and exclude competing etiologies MELD 20-35 on day of randomization. Exclusion Criteria MELD SCORE 35 Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion Pneumonia as evidenced by radiological exam Multi-organ failure Renal failure defined by GFR <50 mL/min. Clinically active C. diff infection History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \\hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI) History of HIV infection (positive HIV RNA or on treatment for HIV infection) History or presence of cancer (including hepatocellular carcinoma) other than nonmelanoma skin cancer History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments Pregnancy or breastfeeding Prior exposure to experimental therapies in last 3 months Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan Total WBC count > 30000/mm3 Known allergy or intolerance to therapeutic agents to be tested Inability to voluntarily obtain informed consent from participant or guardian Perceived inability to follow study procedures and comply with protocol Platelet count < 50,000. The participants for this study will be recruited from a hospitalized population of participants meeting the eligibility criteria outlined above who live within one day travel from one of the participating clinical centers and who have provided informed consent to participate in this clinical trial and who are willing to continue their participation for the anticipated follow-up period of the trial. Although the primary endpoint is survival at 90 days, follow-up visits will be continued up to 6 months. --> AlcHepNet Organizations --> --> AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. --> -->" }, { "title": "AlcHepNet - Observational Study - Executive Summary", "url": "Clinical/executive-summary.html", - "snippet": "Executive Summary ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in ", - "content": "Executive Summary ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcohol-associated hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcohol-associated hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A \"biological sample\" is usually blood, but can be any body fluid. \"Personal Health Information\" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits. Study Type Prospective, observational study Investigational Sites Indiana University; University of Louisville affiliated hospitals in Kentucky; University of Massachusetts Medical Center in Massachusetts; Mayo Clinic in Rochester, Minnesota; Cleveland Clinic Foundation, Ohio; University of Pittsburgh Medical Center in Pennsylvania; University of Texas at Southwestern in Dallas, Texas; and Virginia Commonwealth University in Richmond, Virginia Planned Number of Patients Approximately 1260 (720 subjects with alcohol-associated hepatitis (AH), 360 heavy drinkers without AH, and 180 healthy donors) will be enrolled. Objectives PRIMARY OBJECTIVE: To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcohol-associated hepatitis. SECONDARY OBJECTIVE: To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcohol-associated hepatitis, heavy drinkers without clinical liver disease, and healthy subjects to support translational research in the pathophysiology of alcohol-associated hepatitis Methodology Screening phase: Subjects will be assessed for the eligibility criteria and a written informed consent will be obtained from the eligible subjects. Study phase: Subjects will undergo history taking, physical examination, questionnaire administration, and laboratory tests. Biosamples including serum/plasma, peripheral mononuclear cells (at select sites), genomic DNA, stool samples (when available), urine, and liver tissue (where available) will be obtained. Follow up phase: Alcohol-associated hepatitis subjects will be followed for 360 days, Heavy drinking controls for 180 days, and healthy controls subjects for 1 day (at initial meeting for baseline). $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "Executive Summary ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) a...", + "content": "Executive Summary ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcohol-associated hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcohol-associated hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A \"biological sample\" is usually blood, but can be any body fluid. \"Personal Health Information\" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits. Study Type Prospective, observational study Investigational Sites Indiana University; University of Louisville affiliated hospitals in Kentucky; University of Massachusetts Medical Center in Massachusetts; Mayo Clinic in Rochester, Minnesota; Cleveland Clinic Foundation, Ohio; University of Pittsburgh Medical Center in Pennsylvania; University of Texas at Southwestern in Dallas, Texas; and Virginia Commonwealth University in Richmond, Virginia Planned Number of Patients Approximately 1260 (720 subjects with alcohol-associated hepatitis (AH), 360 heavy drinkers without AH, and 180 healthy donors) will be enrolled. Objectives PRIMARY OBJECTIVE: To collect and store clinical data to facilitate investigations of the epidemiology, diagnosis, pathophysiology, natural history, and treatment of alcohol-associated hepatitis. SECONDARY OBJECTIVE: To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcohol-associated hepatitis, heavy drinkers without clinical liver disease, and healthy subjects to support translational research in the pathophysiology of alcohol-associated hepatitis Methodology Screening phase: Subjects will be assessed for the eligibility criteria and a written informed consent will be obtained from the eligible subjects. Study phase: Subjects will undergo history taking, physical examination, questionnaire administration, and laboratory tests. Biosamples including serum/plasma, peripheral mononuclear cells (at select sites), genomic DNA, stool samples (when available), urine, and liver tissue (where available) will be obtained. Follow up phase: Alcohol-associated hepatitis subjects will be followed for 360 days, Heavy drinking controls for 180 days, and healthy controls subjects for 1 day (at initial meeting for baseline). AlcHepNet Organizations --> AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. --> -->" }, { "title": "AlcHepNet - Interventional Study Eligibility and Enrollment", "url": "Clinical/interventional-eligibility.html", - "snippet": "AlcHepNet Clinical Trial Eligibility and Enrollment Please note that recruitment is closed. Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit Regular consumption of alcohol wi", - "content": "AlcHepNet Clinical Trial Eligibility and Enrollment Please note that recruitment is closed. Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/l AST:ALT > 1.5 and both values < 400 IU/l and/or histological evidence of AH* * In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/mL or> 400 IU/mL, AST/ALT ratio < 1.5), antinuclear antibody> 1:160 or SMA > 1:80, a liver biopsy will be performed to confirm AH and exclude competing etiologies MELD 20-35 on day of randomization. Age ≥ 21 Exclusion Criteria MELD SCORE <20 or> 35 Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion Pneumonia as evidenced by radiological exam Multi-organ failure Renal failure defined by GFR < 35 mL/min. Clinically active C. diff infection History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \\hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI). Previously treated hepatitis C that was cured (sustained virological response with negative RNA ≥24 weeks following treatment) is not an exclusion. History of HIV infection (positive HIV RNA or on treatment for HIV infection) History or presence of cancer (including hepatocellular carcinoma) other than non-melanoma skin cancer History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments Pregnancy or breastfeeding Prior exposure to experimental therapies in last 3 months Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan Total WBC count > 30,000/mm3 Known allergy or intolerance to therapeutic agents to be tested Inability to voluntarily obtain informed consent from participant or guardian Perceived inability to follow study procedures and comply with protocol Platelet count < 40,000 k/cumm. Positive PCR test for COVID-19 within 7 days prior to baseline day 0 visit* *Positive PCR test for COVID-19 is exclusionary only during the screening period. If a patient tests positive any time after baseline randomization, a positive PCR test for COVID-19 will be considered as a SAE. Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hrs. Due to gastrointestinal bleeding, or with a decrease in mean arterial BP to < 65 mmHg The participants for this study will be recruited from a hospitalized population of participants meeting the eligibility criteria outlined above who live within one day travel from one of the participating clinical centers and who have provided informed consent to participate in this clinical trial and who are willing to continue their participation for the anticipated follow-up period of the trial. Although the primary endpoint is survival at 90 days, follow-up visits will be continued up to 6 months. $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "AlcHepNet Clinical Trial Eligibility and Enrollment Please note that recruitment is closed. Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to...", + "content": "AlcHepNet Clinical Trial Eligibility and Enrollment Please note that recruitment is closed. Inclusion Criteria AH, as defined by the NIAAA pan-consortia for AH: Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/l AST:ALT > 1.5 and both values and/or histological evidence of AH* * In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST 400 IU/mL, AST/ALT ratio 1:160 or SMA > 1:80, a liver biopsy will be performed to confirm AH and exclude competing etiologies MELD 20-35 on day of randomization. Age ≥ 21 Exclusion Criteria MELD SCORE 35 Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion Pneumonia as evidenced by radiological exam Multi-organ failure Renal failure defined by GFR Clinically active C. diff infection History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \\hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI). Previously treated hepatitis C that was cured (sustained virological response with negative RNA ≥24 weeks following treatment) is not an exclusion. History of HIV infection (positive HIV RNA or on treatment for HIV infection) History or presence of cancer (including hepatocellular carcinoma) other than non-melanoma skin cancer History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments Pregnancy or breastfeeding Prior exposure to experimental therapies in last 3 months Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan Total WBC count > 30,000/mm3 Known allergy or intolerance to therapeutic agents to be tested Inability to voluntarily obtain informed consent from participant or guardian Perceived inability to follow study procedures and comply with protocol Platelet count Positive PCR test for COVID-19 within 7 days prior to baseline day 0 visit* *Positive PCR test for COVID-19 is exclusionary only during the screening period. If a patient tests positive any time after baseline randomization, a positive PCR test for COVID-19 will be considered as a SAE. Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hrs. Due to gastrointestinal bleeding, or with a decrease in mean arterial BP to The participants for this study will be recruited from a hospitalized population of participants meeting the eligibility criteria outlined above who live within one day travel from one of the participating clinical centers and who have provided informed consent to participate in this clinical trial and who are willing to continue their participation for the anticipated follow-up period of the trial. Although the primary endpoint is survival at 90 days, follow-up visits will be continued up to 6 months. AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. --> -->" }, { "title": "AlcHepNet - Interventional Study Executive Summary", "url": "Clinical/interventional-executive-summary.html", - "snippet": "Executive Summary ALCOHOLIC HEPATITIS NETWORK INTERVENTIONAL STUDY Title of Trial A multicenter, randomized, double blinded, placebo-controlled clinical trial of Anakinra (plus zinc) or prednisone in participants with severe alcoholic hepatitis by the AlcHepNet Consortium. Name of Active Ingredient(", - "content": "Executive Summary ALCOHOLIC HEPATITIS NETWORK INTERVENTIONAL STUDY Title of Trial A multicenter, randomized, double blinded, placebo-controlled clinical trial of Anakinra (plus zinc) or prednisone in participants with severe alcoholic hepatitis by the AlcHepNet Consortium. Name of Active Ingredient(s) Anakinra Prednisone Zinc-Sulfate Pharmacological Class of the Drugs Anakinra is immunological agent, an inhibitor of the Interleukin-1 receptor (IL-1). Prednisone is an adrenal glucocorticoid. Zinc-sulfate is a nutritional supplement. Indication Severe alcoholic hepatitis. Study Type Phase 2B multicenter randomized, 2-arm, double blinded, placebo controlled clinical trial. Investigational Sites Indiana University, Mayo Clinic, Virginia Commonwealth University, Cleveland Clinic Foundation, University of Louisville, Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, and University of Texas Southwestern Medical Center Planned Number of Participants Approximately 258 participants will be randomized in a 1:1 ratio into 1 of 2 treatment arms (129 participants per arm): (1) Prednisone + Placebo for Anakinra/Zinc (2) Anakinra + Zinc + Placebo for Prednisone. Objectives This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH. Overview of Study Design and Conduct The proposed study is a Phase 2b, multicenter, prospective, randomized, 2-arm, double blinded, placebo-controlled clinical trial to assess the efficacy of Anakinra, an interleukin (IL)-1 receptor antagonist plus zinc compared to prednisone for the treatment of severe AH (Model for End Stage Liver Disease (MELD) score ≥ 20). All participants will receive standard care for treatment of severe AH as described in recent guidelines endorsed by American Association for the Study of Liver Diseases (AASLD) and American Gastroenterological Association (AGA). The study will be conducted at 8 clinical sites across the United Stated selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and will be supported by a Data Coordinating Center at Indiana University (DCC-IU). The biorepository will be managed by University of Massachusetts. The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state and federal regulatory requirements. Adverse events during the course of the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, we will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events. This study will be approved by an appropriately convened single IRB, Western Institutional Review Board (WIRB), and will be monitored by an NIAAA appointed Data and Safety Monitoring Board (DSMB). We will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA). It is anticipated that a centrally located investigational pharmacy located at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC-IU. Anakinra plus zinc, prednisone and matching placebos will be provided by the study to the participants. Interventions to be tested Concomitant treatments in this trial include standard care for severe AH for all participants as recommended in recent guidelines 1. The standard of care for severe AH includes attention to early diagnosis and treatment of bacterial and fungal infections, portal hypertension and its complications including acute kidney injury, gastrointestinal bleeding, fluid overload (ascites and edema) and hepatic encephalopathy. In addition, all participants will be offered as part of the standard of care, non-pharmacologic intervention for treatment of alcohol use disorders, such as cognitive behavioral therapy and 12-step programs intervention as aligned with the best practices at the participating study site. Participants with severe AH are very sick and often have multiple active medical problems requiring intervention. The use of specific interventions during this time has the potential to modify treatment response. Ideally, these interventions would be completely standardized. However, the standard of care varies by region, institution and the specialties involved in the care of the participant. The decision regarding treatments for these complications will be delegated to the primary physicians caring for the participants during hospitalizations and to the investigators during the ambulatory follow-up of the participants. Other than the general guidelines noted, no specific treatments for specific complications such as those noted are required. However, such treatments might include, but are not limited to the administration of IV fluids, intravenous human serum albumin, antibiotics including antifungal medications, renal replacement therapy, supplemental oxygen, assisted ventilation and intravenous pressors. Diagnostic procedures such as paracentesis, upper endoscopy, colonoscopy, endoscopic ultrasound and liver biopsy will be permitted as required to provide standard care. During the initial six months of trial, the investigators will develop a \"manual of clinical operations\" that will include best practices on the use of vasopressors, albumin, ICU care, mechanical ventilation and renal replacement therapy using Surviving Sepsis Campaign, International Guidelines for Management of Severe Sepsis and Septic Shock. The investigators will also provide best practices for management of nutrition and alcohol counseling and minimization of recidivism. Although the management of these complications will not be mandated by protocol, the care provided will be recorded to develop novel designs for future trials and for practice guidance and quality improvement programs. After informed consent has been obtained and all of the inclusion are met and none of the exclusion, participants will be randomized to receive one of the following interventions in addition to standard care. Group 1: Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90). Group 2: Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30). Figure 1. Distribution of study drug and placebo Participants or guardian will be instructed in subcutaneous injection technique to continue self-administration of these experimental treatments after discharge from the hospital. Study personnel will ensure participants and guardian are proficient in the technique before the end of study visit and an instructional document will be provided. Primary and Important Secondary Endpoints Primary Endpoints Survival at 90 days Secondary Endpoints Changes in score(s): Changes in Lille score, change in MELD score, development of AKI, multi-organ failure, SIRS, transfer to ICU, changes in liver function will all be evaluated at 7, 30 and 90 days. Organ dysfunction: Measure of changes in Sequential Organ Failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation. The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH. Infections and Sepsis: The endpoints and case definitions related to sepsis may vary depending on what will be used (clinical care, research, surveillance or quality improvement). Given the central role of sepsis as a driver of outcomes, measuring the types of infection will occur but also identify the proportions of those with sepsis, septic shock or quick-SOFA (qSOFA) criteria based on SEPSIS-3 guidance 2, 3 . Key parameters will be captured and needed for various sepsis related endpoint construction aligned by the recent guidance from the European Drug Development Hub (http://eddh-cro.wixsite.com/fdtsfv). Renal dysfunction: In alignment with guidance from the acute disease quality initiative, the AKI development will be quantified and its progression through persistent AKI, acute kidney disease to chronic kidney disease. Need for care escalation: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT. Indicators of gut permeability: (endotoxin and bacterial 18S DNA) and pro-inflammatory cytokine/chemokines (TNFa, MCP1, IL-6, IL-1ß) will be assessed in serum/plasma samples. Survival at 30 days and 180 days Limitations of mortality as an endpoint in AH and plans to overcome these All-cause mortality is most relevant when mortality is substantial and attributable to a single mechanism in a homogeneous population. Participants with severe AH are highly heterogeneous with respect to disease severity, end organ involvement and the care they receive. Moreover, as in sepsis and heart failure, death involves failure of multiple organs (liver, heart, kidney, lungs) making it difficult to ascertain which one is the primary cause of death. This has led to development and regulatory acceptance of composite endpoints including mortality and key parameters driving mortality for acute heart failure trials. These guiding principles to construct a novel and innovative key secondary composite endpoint which will include death or worsening of the modified SOFA score 4, 5 by ≥2 points and worsening of MELD score by ≥2 points. These are associated with mortality and capture the organ recruitment that marks progression of AH towards death. This endpoint will also be validated with respect to reliability, construct-, criterion- and content validity to establish this as a primary endpoint in future trials. Model changes in SOFA scores and MELD scores against mortality to further optimize this endpoint and cross-validate it in the observation cohort will occur. Novel (experimental) endpoints to overcome limitations of conventional endpoints Efficacy endpoints must capture \"clinically meaningful benefit\". While traditional endpoints such as mortality are meaningful, they also have multiple shortcomings in the context of AH as noted below. Innovation will be used to construct, measure and validate novel additional endpoints to overcome the limitations of currently used endpoints and cross-validate them in the observational cohort. The combined expertise in endpoint development and the use of harmonized measurements will make this feasible. These will provide novel assessments in AH and provide the scientific evidence-base to use these as primary endpoints in future trials. View Inclusion and Exclusion criteria. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Executive Summary ALCOHOLIC HEPATITIS NETWORK INTERVENTIONAL STUDY Title of Trial A multicenter, randomized, double blinded, placebo-controlled clinical trial of Anakinra (plus zinc) or prednisone in participants with severe alcoholic hepatitis by th...", + "content": "Executive Summary ALCOHOLIC HEPATITIS NETWORK INTERVENTIONAL STUDY Title of Trial A multicenter, randomized, double blinded, placebo-controlled clinical trial of Anakinra (plus zinc) or prednisone in participants with severe alcoholic hepatitis by the AlcHepNet Consortium. Name of Active Ingredient(s) Anakinra Prednisone Zinc-Sulfate Pharmacological Class of the Drugs Anakinra is immunological agent, an inhibitor of the Interleukin-1 receptor (IL-1). Prednisone is an adrenal glucocorticoid. Zinc-sulfate is a nutritional supplement. Indication Severe alcoholic hepatitis. Study Type Phase 2B multicenter randomized, 2-arm, double blinded, placebo controlled clinical trial. Investigational Sites Indiana University, Mayo Clinic, Virginia Commonwealth University, Cleveland Clinic Foundation, University of Louisville, Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, and University of Texas Southwestern Medical Center Planned Number of Participants Approximately 258 participants will be randomized in a 1:1 ratio into 1 of 2 treatment arms (129 participants per arm): (1) Prednisone + Placebo for Anakinra/Zinc (2) Anakinra + Zinc + Placebo for Prednisone. Objectives This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH. Overview of Study Design and Conduct The proposed study is a Phase 2b, multicenter, prospective, randomized, 2-arm, double blinded, placebo-controlled clinical trial to assess the efficacy of Anakinra, an interleukin (IL)-1 receptor antagonist plus zinc compared to prednisone for the treatment of severe AH (Model for End Stage Liver Disease (MELD) score ≥ 20). All participants will receive standard care for treatment of severe AH as described in recent guidelines endorsed by American Association for the Study of Liver Diseases (AASLD) and American Gastroenterological Association (AGA). The study will be conducted at 8 clinical sites across the United Stated selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and will be supported by a Data Coordinating Center at Indiana University (DCC-IU). The biorepository will be managed by University of Massachusetts. The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state and federal regulatory requirements. Adverse events during the course of the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, we will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events. This study will be approved by an appropriately convened single IRB, Western Institutional Review Board (WIRB), and will be monitored by an NIAAA appointed Data and Safety Monitoring Board (DSMB). We will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA). It is anticipated that a centrally located investigational pharmacy located at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC-IU. Anakinra plus zinc, prednisone and matching placebos will be provided by the study to the participants. Interventions to be tested Concomitant treatments in this trial include standard care for severe AH for all participants as recommended in recent guidelines Hepatology</i>. 2010;51(1):307-328.\">1 . The standard of care for severe AH includes attention to early diagnosis and treatment of bacterial and fungal infections, portal hypertension and its complications including acute kidney injury, gastrointestinal bleeding, fluid overload (ascites and edema) and hepatic encephalopathy. In addition, all participants will be offered as part of the standard of care, non-pharmacologic intervention for treatment of alcohol use disorders, such as cognitive behavioral therapy and 12-step programs intervention as aligned with the best practices at the participating study site. Participants with severe AH are very sick and often have multiple active medical problems requiring intervention. The use of specific interventions during this time has the potential to modify treatment response. Ideally, these interventions would be completely standardized. However, the standard of care varies by region, institution and the specialties involved in the care of the participant. The decision regarding treatments for these complications will be delegated to the primary physicians caring for the participants during hospitalizations and to the investigators during the ambulatory follow-up of the participants. Other than the general guidelines noted, no specific treatments for specific complications such as those noted are required. However, such treatments might include, but are not limited to the administration of IV fluids, intravenous human serum albumin, antibiotics including antifungal medications, renal replacement therapy, supplemental oxygen, assisted ventilation and intravenous pressors. Diagnostic procedures such as paracentesis, upper endoscopy, colonoscopy, endoscopic ultrasound and liver biopsy will be permitted as required to provide standard care. During the initial six months of trial, the investigators will develop a \"manual of clinical operations\" that will include best practices on the use of vasopressors, albumin, ICU care, mechanical ventilation and renal replacement therapy using Surviving Sepsis Campaign, International Guidelines for Management of Severe Sepsis and Septic Shock. The investigators will also provide best practices for management of nutrition and alcohol counseling and minimization of recidivism. Although the management of these complications will not be mandated by protocol, the care provided will be recorded to develop novel designs for future trials and for practice guidance and quality improvement programs. After informed consent has been obtained and all of the inclusion are met and none of the exclusion, participants will be randomized to receive one of the following interventions in addition to standard care. Group 1: Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90). Group 2: Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30). Figure 1. Distribution of study drug and placebo Participants or guardian will be instructed in subcutaneous injection technique to continue self-administration of these experimental treatments after discharge from the hospital. Study personnel will ensure participants and guardian are proficient in the technique before the end of study visit and an instructional document will be provided. Primary and Important Secondary Endpoints Primary Endpoints Survival at 90 days Secondary Endpoints Changes in score(s): Changes in Lille score, change in MELD score, development of AKI, multi-organ failure, SIRS, transfer to ICU, changes in liver function will all be evaluated at 7, 30 and 90 days. Organ dysfunction: Measure of changes in Sequential Organ Failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation. The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH. Infections and Sepsis: The endpoints and case definitions related to sepsis may vary depending on what will be used (clinical care, research, surveillance or quality improvement). Given the central role of sepsis as a driver of outcomes, measuring the types of infection will occur but also identify the proportions of those with sepsis, septic shock or quick-SOFA (qSOFA) criteria based on SEPSIS-3 guidance JAMA</i>. 2016;315(8):762- 774.\">2 , Clin Microbiol Infect</i>.2017;23(2):104-109.\">3 . Key parameters will be captured and needed for various sepsis related endpoint construction aligned by the recent guidance from the European Drug Development Hub ( http://eddh-cro.wixsite.com/fdtsfv ). Renal dysfunction: In alignment with guidance from the acute disease quality initiative, the AKI development will be quantified and its progression through persistent AKI, acute kidney disease to chronic kidney disease. Need for care escalation: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT. Indicators of gut permeability: (endotoxin and bacterial 18S DNA) and pro-inflammatory cytokine/chemokines (TNFa, MCP1, IL-6, IL-1ß) will be assessed in serum/plasma samples. Survival at 30 days and 180 days Limitations of mortality as an endpoint in AH and plans to overcome these All-cause mortality is most relevant when mortality is substantial and attributable to a single mechanism in a homogeneous population. Participants with severe AH are highly heterogeneous with respect to disease severity, end organ involvement and the care they receive. Moreover, as in sepsis and heart failure, death involves failure of multiple organs (liver, heart, kidney, lungs) making it difficult to ascertain which one is the primary cause of death. This has led to development and regulatory acceptance of composite endpoints including mortality and key parameters driving mortality for acute heart failure trials. These guiding principles to construct a novel and innovative key secondary composite endpoint which will include death or worsening of the modified SOFA score J Dig Dis</i>. 2013;14(9):484-490.\">4 , World journal of gastroenterology</i>. 2016;22(41):9205-9213.\">5 by ≥2 points and worsening of MELD score by ≥2 points. These are associated with mortality and capture the organ recruitment that marks progression of AH towards death. This endpoint will also be validated with respect to reliability, construct-, criterion- and content validity to establish this as a primary endpoint in future trials. Model changes in SOFA scores and MELD scores against mortality to further optimize this endpoint and cross-validate it in the observation cohort will occur. Novel (experimental) endpoints to overcome limitations of conventional endpoints Efficacy endpoints must capture \"clinically meaningful benefit\". While traditional endpoints such as mortality are meaningful, they also have multiple shortcomings in the context of AH as noted below. Innovation will be used to construct, measure and validate novel additional endpoints to overcome the limitations of currently used endpoints and cross-validate them in the observational cohort. The combined expertise in endpoint development and the use of harmonized measurements will make this feasible. These will provide novel assessments in AH and provide the scientific evidence-base to use these as primary endpoints in future trials. View Inclusion and Exclusion criteria. AlcHepNet Organizations --> AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. --> -->" }, { "title": "AlcHepNet - ITAALD Trial - Eligibility", "url": "Clinical/itaald-eligibility.html", - "snippet": "ITAALD Clinical trial Eligibility and Enrollment Status: Trial is not yet recruiting Inclusion Criteria Age ≥18, <70 MELD 20-35 on day of randomization Definitive or probable diagnosis as defined by the NIAAA criteria4, 5 Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior", - "content": "ITAALD Clinical trial Eligibility and Enrollment Status: Trial is not yet recruiting Inclusion Criteria Age ≥18, <70 MELD 20-35 on day of randomization Definitive or probable diagnosis as defined by the NIAAA criteria4, 5 Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks Ongoing consumption of > 40 gm (for females) and > 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/L, AST: ALT > 1.5 ALT and AST values < 400 IU/L and/or histological evidence of AH* *In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies. Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. Exclusion Criteria Active listing for liver transplantation before screening MELD score <20 or > 35 Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy) Progressive hemodynamic compromise requiring intravenous pressors Pneumonia as evidenced by clinical and radiological examination Renal failure defined by estimated GFR <35 mL/min. Clinically active C. diff infection Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease) History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 2 days within the previous 30 days Current use of naltrexone or acamprosate. Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to < 65 mmHg Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator Uncontrolled mental illness as determined by the study investigator Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR one year prior to enrollment Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days. Uncontrolled diabetes mellitus with A1c > 9 Pregnancy or breastfeeding Known allergy or intolerance to therapeutic agents to be tested Unwillingness to stop alcohol use and to undergo AUD treatment Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam/gel/film/cream/suppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation. Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant's participation in the study. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "ITAALD Clinical trial Eligibility and Enrollment Status: Trial is not yet recruiting Inclusion Criteria Age ≥18, <70 MELD 20-35 on day of randomization Definitive or probable diagnosis as defined by the NIAAA criteria4, 5 Onset of jaundice (define...", + "content": "ITAALD Clinical trial Eligibility and Enrollment Status: Trial is not yet recruiting Inclusion Criteria Age ≥18, <70 MELD 20-35 on day of randomization Definitive or probable diagnosis as defined by the NIAAA criteria4, 5 Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks Ongoing consumption of > 40 gm (for females) and > 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice AST > 50 IU/L, AST: ALT > 1.5 ALT and AST values and/or histological evidence of AH* *In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST 400 IU/L, AST/ALT ratio 1:160 or SMA > 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies. Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. Exclusion Criteria Active listing for liver transplantation before screening MELD score 35 Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy) Progressive hemodynamic compromise requiring intravenous pressors Pneumonia as evidenced by clinical and radiological examination Renal failure defined by estimated GFR Clinically active C. diff infection Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease) History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 2 days within the previous 30 days Current use of naltrexone or acamprosate. Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator Uncontrolled mental illness as determined by the study investigator Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR one year prior to enrollment Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days. Uncontrolled diabetes mellitus with A1c > 9 Pregnancy or breastfeeding Known allergy or intolerance to therapeutic agents to be tested Unwillingness to stop alcohol use and to undergo AUD treatment Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam/gel/film/cream/suppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation. Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant's participation in the study. -->" }, { "title": "AlcHepNet - ITAALD Trial - Executive Summary", "url": "Clinical/itaald-executive-summary.html", - "snippet": "Executive Summary For more information, please visit the official ITAALD trial registration on ClinicalTrials.gov (NCT07060638) . Title of trial Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) Name of Active Ingredient F-652 (IL-22) Prednisone Acamprosate Pharmacolo", - "content": "Executive Summary For more information, please visit the official ITAALD trial registration on ClinicalTrials.gov (NCT07060638) . Title of trial Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) Name of Active Ingredient F-652 (IL-22) Prednisone Acamprosate Pharmacological Class of the Drugs F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects Prednisone is an adrenal glucocorticoid with anti-inflammatory effects Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects Indication Severe alcohol-associated hepatitis (sAH), steroid-eligible Study Type Phase 2B, multicenter, sequentially randomized controlled trial for integrated treatments. Investigational Sites Indiana University, Mayo Clinic, Virginia Commonwealth University, Cleveland Clinic Foundation, University of Louisville, and University of Texas Southwestern Medical Center Planned number of Participants A total of 216 participants with sAH will be enrolled sequentially randomized into four treatment groups Objectives: To determine whether interventions directed to treat AUD integrated with sAH therapies will improve a composite endpoint of alcohol and liver-related events at 6 months compared to usual care for AUD (primary endpoint). To compare 90-day survival in patients receiving F-652 with those receiving up to 28 days of prednisone using the Day-7 Lille score as a stopping rule (secondary endpoint). To compare one-year overall survival in patients receiving either IL-22 or prednisone with or without acamprosate (secondary endpoint). Trial design and conduct We will conduct a prospective, multicenter, sequentially randomized trial in 216 patients with sAH using a sequentially randomized design for proof of concept. The trial will assess whether integrated treatment of sAH and alcohol use disorder (AUD) reduces alcohol- and liver-related events and mortality. The trial design resembles a 2X2 factorial study, but the AUD treatment assignment [acamprosate + motivational interviewing (MI) + motivational enhancement therapy (MET)] versus usual care (UC), defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program, is done on Day 7 after the start of the sAH treatment. Only survivors of the first 7 days will be randomized to receive the AUD intervention or UC. Figure 1. Diagram of trial design Abbreviations: R: randomization, AUD: alcohol use disorder, MI: motivational interviewing, MET: motivational enhancement therapy. The study will be conducted at six clinical sites in the United States selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and supported by a Data Coordinating Center at Indiana University (DCC). The DCC will also manage the biorepository. The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state, and federal regulatory requirements. Adverse events during the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, we will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events. This study will be approved by an appropriately convened single IRB, Advarra, and will be monitored by an NIAAA-appointed Data and Safety Monitoring Board (DSMB). We will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA). It is anticipated that a centrally located investigational pharmacy at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC. The study will provide the participants with F-652, prednisone, matching placebos, and acamprosate. Duration of Trial by Phase Treatment phase: up to 6 months Follow-up phase: up to two years Interventions to be tested F-652 vs. prednisone as treatment for sAH. AUD interventions (acamprosate + MI + MET) versus usual care for AUD treatment. Group assignment: We will sequentially randomize the study participants into four treatment groups. On day 1, participants will be randomized to receive either F-652 or prednisone at a 1-to-1 ratio. Those randomized to receive F-652 will also receive a prednisone placebo; those randomized to receive prednisone will receive the F-652 placebo. Prednisone or prednisone placebo will be stopped if the Day-7 Lille score is >0.45. On day 7, survivors will be randomized to receive either the AUD intervention (acamprosate + MI + MET) or usual care at a 1-to-1 ratio. Block randomization will be used to ensure balanced group sizes in randomization. So, there will be four treatment combinations: ARM 1: F-652 on days 1 and 7 and matching placebos for prednisone for 28 days and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months. ARM 2: F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD. ARM 3: Prednisone for 28 days and matching placebos for F-652 on days 1 and 7 and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months. ARM 4: Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD. $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "Executive Summary For more information, please visit the official ITAALD trial registration on ClinicalTrials.gov (NCT07060638) . Title of trial I ntegrated T herapies for A lcohol use in A lcohol-associated L iver D isease (ITAALD) Name of Active In...", + "content": "Executive Summary For more information, please visit the official ITAALD trial registration on ClinicalTrials.gov (NCT07060638) . Title of trial I ntegrated T herapies for A lcohol use in A lcohol-associated L iver D isease (ITAALD) Name of Active Ingredient F-652 (IL-22) Prednisone Acamprosate Pharmacological Class of the Drugs F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects Prednisone is an adrenal glucocorticoid with anti-inflammatory effects Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects Indication Severe alcohol-associated hepatitis (sAH), steroid-eligible Study Type Phase 2B, multicenter, sequentially randomized controlled trial for integrated treatments. Investigational Sites Indiana University, Mayo Clinic, Virginia Commonwealth University, Cleveland Clinic Foundation, University of Louisville, and University of Texas Southwestern Medical Center Planned number of Participants A total of 216 participants with sAH will be enrolled sequentially randomized into four treatment groups Objectives: To determine whether interventions directed to treat AUD integrated with sAH therapies will improve a composite endpoint of alcohol and liver-related events at 6 months compared to usual care for AUD (primary endpoint). To compare 90-day survival in patients receiving F-652 with those receiving up to 28 days of prednisone using the Day-7 Lille score as a stopping rule (secondary endpoint). To compare one-year overall survival in patients receiving either IL-22 or prednisone with or without acamprosate (secondary endpoint). Trial design and conduct We will conduct a prospective, multicenter, sequentially randomized trial in 216 patients with sAH using a sequentially randomized design for proof of concept. The trial will assess whether integrated treatment of sAH and alcohol use disorder (AUD) reduces alcohol- and liver-related events and mortality. The trial design resembles a 2X2 factorial study, but the AUD treatment assignment [acamprosate + motivational interviewing (MI) + motivational enhancement therapy (MET)] versus usual care (UC), defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program, is done on Day 7 after the start of the sAH treatment. Only survivors of the first 7 days will be randomized to receive the AUD intervention or UC. Figure 1. Diagram of trial design Abbreviations: R: randomization, AUD: alcohol use disorder, MI: motivational interviewing, MET: motivational enhancement therapy. The study will be conducted at six clinical sites in the United States selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and supported by a Data Coordinating Center at Indiana University (DCC). The DCC will also manage the biorepository. The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state, and federal regulatory requirements. Adverse events during the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, we will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events. This study will be approved by an appropriately convened single IRB, Advarra, and will be monitored by an NIAAA-appointed Data and Safety Monitoring Board (DSMB). We will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA). It is anticipated that a centrally located investigational pharmacy at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC. The study will provide the participants with F-652, prednisone, matching placebos, and acamprosate. Duration of Trial by Phase Treatment phase: up to 6 months Follow-up phase: up to two years Interventions to be tested F-652 vs. prednisone as treatment for sAH. AUD interventions (acamprosate + MI + MET) versus usual care for AUD treatment. Group assignment: We will sequentially randomize the study participants into four treatment groups. On day 1, participants will be randomized to receive either F-652 or prednisone at a 1-to-1 ratio. Those randomized to receive F-652 will also receive a prednisone placebo; those randomized to receive prednisone will receive the F-652 placebo. Prednisone or prednisone placebo will be stopped if the Day-7 Lille score is >0.45. On day 7, survivors will be randomized to receive either the AUD intervention (acamprosate + MI + MET) or usual care at a 1-to-1 ratio. Block randomization will be used to ensure balanced group sizes in randomization. So, there will be four treatment combinations: ARM 1: F-652 on days 1 and 7 and matching placebos for prednisone for 28 days and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months. ARM 2: F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD. ARM 3: Prednisone for 28 days and matching placebos for F-652 on days 1 and 7 and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months. ARM 4: Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD. -->" }, { "title": "AlcHepNet - ITAALD Trial", "url": "Clinical/itaald-trial.html", - "snippet": "Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) trial ITAALD is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The primary purpose of the study", - "content": "Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) trial ITAALD is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling, whereas those assigned to AUD standard care will receive brief advice and referral to a 12-step program. The secondary purpose of the study is to determine whether F-652 is safe and effective in treating sAH compared with prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days. More information about ITAALD $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "I ntegrated T herapies for A lcohol use in A lcohol-associated L iver D isease (ITAALD) trial --> ITAALD is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and ...", + "content": "I ntegrated T herapies for A lcohol use in A lcohol-associated L iver D isease (ITAALD) trial --> ITAALD is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The primary objective of the study is to determine whether subjects receiving F-652 (recombinant IL-22) followed by enhanced AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to those receiving prednisone plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling, while those assigned to the AUD usual care will receive brief advice and referral to a 12-step program. The design of the ITAALD trial is shown in the following diagram. More information about ITAALD" }, { "title": "AlcHepNet - Legacy Studies", "url": "Clinical/legacy-studies.html", - "snippet": "Legacy Studies: AlcHepNet Observational Study: The purpose of this observational study is to establish a clinical database for personal health information and a biorepository for blood, urine, saliva, and stool samples from persons with alcohol-associated hepatitis, heavy drinkers, and healthy contr", - "content": "Legacy Studies: AlcHepNet Observational Study: The purpose of this observational study is to establish a clinical database for personal health information and a biorepository for blood, urine, saliva, and stool samples from persons with alcohol-associated hepatitis, heavy drinkers, and healthy controls. Data and biosamples will be used for research related to alcoholic hepatitis or other diseases. More information about the AHN Observational Study can be found at https://clinicaltrials.gov/study/NCT03850899?term=NCT3850899&rank=1 Trial of Anakinra (Plus Zinc) or Prednisone in Patients with Severe Alcoholic Hepatitis (AlcHepNet) This multicenter, randomized, double-blind, placebo-controlled clinical trial has focused on new treatments of severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH. More information about the Anakinra vs. Prednisone trial can be found at https://clinicaltrials.gov/study/NCT04072822?term=NCT4072822&rank=1 $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Legacy Studies: --> AlcHepNet Observational Study: This observational study aimed to create a clinical database for personal health information and a biorepository for blood, urine, saliva, and stool samples from individuals with alcohol-associated h...", + "content": "Legacy Studies: --> AlcHepNet Observational Study: This observational study aimed to create a clinical database for personal health information and a biorepository for blood, urine, saliva, and stool samples from individuals with alcohol-associated hepatitis, heavy drinkers, and healthy controls. Data and biosamples were utilized for research related to alcohol-associated hepatitis and other conditions. More information about the AHN Observational Study can be found at https://clinicaltrials.gov/study/NCT03850899?term=NCT3850899&rank=1 Trial of Anakinra (Plus Zinc) or Prednisone in Patients with Severe Alcoholic Hepatitis (AlcHepNet) This multicenter, randomized, double-blind, placebo-controlled clinical trial focused on new treatments of severe alcoholic hepatitis (AH). The primary objective of the study was to assess the efficacy and safety of Anakinra (with zinc) compared with prednisone in participants with severe AH. Key secondary goals included: (a) evaluating biomarkers to measure disease severity and treatment response; and (b) creating new endpoints to address the limitations of existing assessment methods for severe AH. More information about the Anakinra vs. Prednisone trial can be found at https://clinicaltrials.gov/study/NCT04072822?term=NCT4072822&rank=1" }, { "title": "Administrative Structure - AlcHepNet", "url": "Collaboration/administrative-structure.html", - "snippet": "Administrative Structure $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\"", - "content": "Administrative Structure $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Administrative Structure AlcHepNet's administrative structure is designed to foster collaboration across multiple institutions and disciplines. The network operates through a coordinated system of leadership, steering committees, and specialized work...", + "content": "Administrative Structure AlcHepNet's administrative structure is designed to foster collaboration across multiple institutions and disciplines. The network operates through a coordinated system of leadership, steering committees, and specialized working groups to ensure effective research coordination and data management." }, { "title": "Clinical Centers - AlcHepNet", "url": "Collaboration/clinical-centers.html", - "snippet": "Clinical Centers Click on a star to view Clinical Center details AlcHepNet Clinical Center Indiana University DCC Website https://fsph.iupui.edu/research-centers/research/biostatistics.html Address Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN", - "content": "Clinical Centers Click on a star to view Clinical Center details AlcHepNet Clinical Center Indiana University DCC Website https://fsph.iupui.edu/research-centers/research/biostatistics.html Address Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Carla Kettler Data Management ckettler@iu.edu Dr. Wanzhu Tu Biostatistics wtu1@iu.edu Dr. Samer Gawrieh Hepatology sgawrieh@iu.edu Dr. Jing Su Bioinformatics Dr. Melissa Allard Pharmacy Savannah Yarnelle Project Management samussel@iu.edu Dr. Marwan Ghabril Hepatology Dr. Yang Li Biostatistics Dr. Schwantes-An Biorepository Cleveland Clinic Website https://my.clevelandclinic.org/departments/digestive/research-innovations Address Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31, 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD PI DASARAS@ccf.org David Streem, MD PI Streemd@ccf.org Indiana University Clinical Center Website https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Address Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Dr. Lauren Nephew Hepatology Dr. Liangpunsakul Hepatology Dr. Naga Chalasani Hepatology Dr. Olawale O. Ojo Psychiatry Dr. Raj Vuppalanchi Hepatology rvuppala@iu.edu Mayo Clinic Clinical Center Website Mayo Clinic Clinical Trials Address 200 First St. SW Rochester, MN 55905 Dr Shah Hepatology, Principal Investigator Shah.Vijay@mayo.edu Dr Karpyak Psychiatry, Principal Investigator Dr Kamath Hepatology, Co-Investigator Dr Simonetto Hepatology, Co-Investigator Dr Schneekloth Psychiatry, Co-Investigator Virginia Commonwealth University Website https://studyfinder.cctr.vcu.edu/ Address VCU School of Medicine McGlothlin Medical Education Center (MMEC) 1201 E Marshall St., 4th Floor, Suite 4-100 Richmond, VA 23298 Arun Sanyal, MD PI arun.sanyal@vcuhealth.org F. Gerard Moeller, MD PI frederick.moeller@vcuhealth.org University of Louisville (UofL) Clinical Center Website http://louisville.edu/research/ctu Address University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Craig McClain, MD Professor Chris Stewart, MD Associate Professor Ashwani Singal, MD Professor ashwani.singal@louisville.edu Luis Marsano, MD Professor Loretta Jophlin, MD Assistant Professor Lorenzo Leggio, M.D., Ph.D. NIAAA Senior Investigator Consultant Vatsalya Vatsalya, MD Assistant Professor Andrea Reyes Vega, MD Assistant Professor Josiah Hardesty, PhD Assistant Professor Leila Gobejishvili, PhD Associate Professor Wenke Feng, PhD Professor, Consultant, Tulane Gyongyi Szabo, MD, PhD Chief Academic Officer Consultant, Harvard University of UTSW Website UTSW Clinical Trials Address Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, TX 75390-8887 Mack Mitchell, MD PI mack.mitchell@utsouthwestern.edu Sherwood Brown, MD, PhD PI Sherwood.Brown@utsouthwestern.edu AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); // Load and Initialize Map loadUSMap(); }); async function loadUSMap() { const mapWrapper = document.getElementById('usMapWrapper'); try { // Load the professional US map SVG const response = await fetch('../utilities/us.svg'); const svgText = await response.text(); mapWrapper.innerHTML = svgText; // Wait for SVG to be in DOM, then fix styles setTimeout(() => { const svg = document.querySelector('#usMapWrapper svg'); if (svg) { // Override the inline styles that prevent display svg.removeAttribute('style'); svg.style.strokeLinejoin = 'round'; svg.style.stroke = '#fff'; svg.style.fill = 'none'; // Make sure all paths are visible const paths = svg.querySelectorAll('path'); paths.forEach(path => { // Remove inline styles that might hide the map const currentStyle = path.getAttribute('style'); if (currentStyle) { path.setAttribute('style', currentStyle.replace('fill:#f9f9f9', 'fill:#e8e8e8')); } }); } initializeMap(); }, 100); } catch (error) { console.error('Error loading map:', error); mapWrapper.innerHTML = '

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'; } } function initializeMap() { const svg = document.querySelector('#usMapWrapper svg'); if (!svg) return; // Create tooltip const tooltip = document.createElement('div'); tooltip.className = 'map-tooltip'; tooltip.id = 'mapTooltip'; document.querySelector('.us-map-wrapper').appendChild(tooltip); // Map of state IDs to clinical centers (adjusted to match state centers) const stateCenters = { 'TX': [{ id: 'cc-utsw', name: 'University of Texas Southwestern', x: 510, y: 410 }], 'MN': [{ id: 'cc-mayo', name: 'Mayo Clinic', x: 560, y: 160 }], 'IN': [ { id: 'cc-iu-dcc', name: 'Indiana University DCC', x: 675, y: 225 }, { id: 'cc-iu-clinical', name: 'Indiana University Clinical Center', x: 690, y: 235 } ], 'OH': [{ id: 'cc-cleveland', name: 'Cleveland Clinic', x: 740, y: 210 }], 'KY': [{ id: 'cc-louisville', name: 'University of Louisville', x: 705, y: 265 }], 'VA': [{ id: 'cc-vcu', name: 'Virginia Commonwealth University', x: 825, y: 250 }] }; // Highlight states with centers Object.keys(stateCenters).forEach(stateId => { const statePath = svg.querySelector(`path[id=\"${stateId}\"]`); if (statePath) { statePath.classList.add('has-center'); // Add click handler to state statePath.style.cursor = 'pointer'; statePath.addEventListener('click', function() { // If multiple centers in state, scroll to first one const centers = stateCenters[stateId]; if (centers && centers.length > 0) { scrollToCenter(centers[0].id); } }); // Add hover tooltip statePath.addEventListener('mouseenter', function(e) { const centers = stateCenters[stateId]; const centerNames = centers.map(c => c.name).join(', '); tooltip.textContent = centerNames; tooltip.classList.add('show'); updateTooltipPosition(e); }); statePath.addEventListener('mousemove', updateTooltipPosition); statePath.addEventListener('mouseleave', function() { tooltip.classList.remove('show'); }); } }); // Add marker circles for each center const markersGroup = document.createElementNS('http://www.w3.org/2000/svg', 'g'); markersGroup.setAttribute('id', 'clinical-markers'); Object.keys(stateCenters).forEach(stateId => { stateCenters[stateId].forEach(center => { const marker = document.createElementNS('http://www.w3.org/2000/svg', 'g'); marker.classList.add('map-marker'); marker.setAttribute('data-target', center.id); marker.setAttribute('data-name', center.name); // Create visible circle const circle = document.createElementNS('http://www.w3.org/2000/svg', 'circle'); circle.setAttribute('cx', center.x); circle.setAttribute('cy', center.y); circle.setAttribute('r', '6'); // Create invisible larger circle for easier clicking const clickArea = document.createElementNS('http://www.w3.org/2000/svg', 'circle'); clickArea.setAttribute('cx', center.x); clickArea.setAttribute('cy', center.y); clickArea.setAttribute('r', '15'); clickArea.setAttribute('fill', 'transparent'); clickArea.setAttribute('stroke', 'none'); marker.appendChild(clickArea); marker.appendChild(circle); markersGroup.appendChild(marker); // Add click handler marker.addEventListener('click', function() { scrollToCenter(center.id); }); // Add hover handlers marker.addEventListener('mouseenter', function(e) { tooltip.textContent = center.name; tooltip.classList.add('show'); updateTooltipPosition(e, circle); }); marker.addEventListener('mousemove', function(e) { updateTooltipPosition(e, circle); }); marker.addEventListener('mouseleave', function() { tooltip.classList.remove('show'); }); }); }); svg.appendChild(markersGroup); function scrollToCenter(centerId) { const targetCard = document.getElementById(centerId); if (targetCard) { targetCard.scrollIntoView({ behavior: 'smooth', block: 'center' }); targetCard.classList.add('highlight'); setTimeout(() => { targetCard.classList.remove('highlight'); }, 1500); } } function updateTooltipPosition(e, element) { const mapWrapper = document.querySelector('.us-map-wrapper'); const rect = mapWrapper.getBoundingClientRect(); let x, y; if (element) { // For circles, get their center position const elementRect = element.getBoundingClientRect(); x = elementRect.left + elementRect.width / 2 - rect.left; y = elementRect.top - rect.top; } else { // For mouse events x = e.clientX - rect.left; y = e.clientY - rect.top; } tooltip.style.left = x + 'px'; tooltip.style.top = y + 'px'; } }" - }, - { - "title": "Committees - AlcHepNet", - "url": "Collaboration/committees.bk.html", - "snippet": "Committees Clinical sub-committee The Clinical Sub-Committee provides expert guidance on the clinical aspects of the trial to ensure medical relevance, patient safety, and protocol feasibility. Key responsibilities include reviewing and advising on clinical protocol design, inclusion/exclusion crite", - "content": "Committees Clinical sub-committee The Clinical Sub-Committee provides expert guidance on the clinical aspects of the trial to ensure medical relevance, patient safety, and protocol feasibility. Key responsibilities include reviewing and advising on clinical protocol design, inclusion/exclusion criteria, safety monitoring procedures, and standard-of-care considerations. The committee supports site investigators, addresses clinical questions that arise during trial conduct, and ensures that trial interventions are practical and ethically sound within real-world clinical settings. The chair and co-chairs of the clinical sub-committee have been selected by NIAAA. This committee will make recommendations and bring to full steering committee for final decision. Chair Juan Pablo Arab Verdugo- VCU He/Him JuanPablo.Arab@vcuhealth.org Co-Chair Sherwood Brown, MD, PhD, (PI) -UTSW He/Him Sherwood.Brown@utsouthwestern.edu Co-Chair Samer Gawrieh, MD MPI, Clinical Director at IU DCC He/Him Sherwood.Brown@utsouthwestern.edu Publication and Ancillary study Committee The Publication and Ancillary Study Committee is responsible for overseeing the review, approval, and coordination of all publications and ancillary study proposals related to the clinical trial. This includes ensuring alignment with the trial's scientific goals, protecting participant confidentiality, maintaining data integrity, and preventing duplicate or conflicting analyses. The committee evaluates proposals for scientific merit, feasibility, and appropriate use of trial data or biospecimens, while promoting timely dissemination of results and adherence to authorship and publication guidelines. Chair Ashwani Singal, MD (PI)- University of Louisville He/Him ashwani.singal@louisville.edu Co-chair Suthat Liangpunsakul- IU He/Him sliangpu@iu.edu Co-chair David Streem, MD (PI)- Cleveland Clinic He/Him Streemd@ccf.org Data Science Committee The Data Science Committee provides oversight and strategic guidance on all aspects of data management and analysis within the clinical trial. Responsibilities include advising on data collection protocols, ensuring data quality and integrity, reviewing statistical analysis plans, and supporting the integration of advanced analytic methods. The committee also promotes transparency, reproducibility, and adherence to regulatory standards, while facilitating timely and accurate interpretation of trial data to inform clinical and operational decision-making. Chair Douglas Simonetto- Mayo He/Him Simonetto.Douglas@mayo.edu Co-chair Nicole Welch- Cleveland Clinic She/Her welchn@ccf.org Co-chair Wanzhu Tu, PhD MPI, Data-analytical Director at IU DCC He/Him wtu1@iu.edu $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function () { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function () { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "Clinical Centers Click on a star to view Clinical Center details AlcHepNet Clinical Center Indiana University DCC Website https://fsph.iupui.edu/research-centers/research/biostatistics.html Address Indiana University School of Medicine 340 West 10th ...", + "content": "Clinical Centers Click on a star to view Clinical Center details AlcHepNet Clinical Center Indiana University DCC Website https://fsph.iupui.edu/research-centers/research/biostatistics.html Address Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Carla Kettler Data Management ckettler@iu.edu Wanzhu Tu, PhD MPI of DCC, Biostatistics, IU wtu1@iu.edu Samer Gawrieh, MD MPI of DCC, Hepatology, IU sgawrieh@iu.edu Jing Su, PhD Lead, Alcohol Research Data Commons Team, IU su1@iu.edu Melissa Allard, PharmD Pharmacy, IU Savannah Yarnelle Project Management samussel@iu.edu Marwan Ghabril, MD Safety Officer, Hepatology, IU Yang Li, PhD Biostatistics, IU Tae-Hwi Linus Schwantes-An, PhD Lead, AlcHepNet Biorepository Team, IU Cleveland Clinic Website https://my.clevelandclinic.org/departments/digestive/research-innovations Address Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31, 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD PI, Cleveland Clinic DASARAS@ccf.org David Streem, MD PI, Cleveland Clinic Streemd@ccf.org Indiana University Clinical Center Website https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Address Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Lauren Nephew, MD Hepatology, IU Suthat Liangpunsakul, MD Hepatology, IU Naga Chalasani, MD Hepatology, IU Olawale O. Ojo, MD Psychiatry, IU Raj Vuppalanchi, MD Hepatology, IU rvuppala@iu.edu Mayo Clinic Clinical Center Website Mayo Clinic Clinical Trials Address 200 First St. SW Rochester, MN 55905 Vijay Shah, MD Hepatology, PI, Mayo Clinic Shah.Vijay@mayo.edu Victor Karpyak, MD, PhD Psychiatry, PI, Mayo Clinic Patrick Kamath, MD Hepatology, Co-I, Mayo Clinic Douglas Simonetto, MD Hepatology, Co-I, Mayo Clinic Terry Schneekloth, MD Psychiatry, Co-I, Mayo Clinic Virginia Commonwealth University Website https://studyfinder.cctr.vcu.edu/ Address VCU School of Medicine McGlothlin Medical Education Center (MMEC) 1201 E Marshall St., 4th Floor, Suite 4-100 Richmond, VA 23298 Arun Sanyal, MD PI, VCU arun.sanyal@vcuhealth.org F. Gerard Moeller, MD PI, VCU frederick.moeller@vcuhealth.org Juan Pablo Arab, MD Investigator, VCU JuanPablo.Arab@vcuhealth.org University of Louisville (UofL) Clinical Center Website http://louisville.edu/research/ctu Address University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Craig McClain, MD Professor, UofL Chris Stewart, MD Associate Professor, UofL Ashwani Singal, MD Professor, UofL ashwani.singal@louisville.edu Luis Marsano, MD Professor, UofL Loretta Jophlin, MD Assistant Professor, UofL Lorenzo Leggio, MD, PhD NIAAA Senior Investigator Consultant Vatsalya Vatsalya, MD Assistant Professor, UofL Andrea Reyes Vega, MD Assistant Professor, UofL Josiah Hardesty, PhD Assistant Professor, UofL Leila Gobejishvili, PhD Associate Professor, UofL Wenke Feng, PhD Professor, Consultant, Tulane; UofL Gyongyi Szabo, MD, PhD Chief Academic Officer Consultant, Harvard; UofL University of UTSW Website UTSW Clinical Trials Address Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, TX 75390-8887 Mack Mitchell, MD PI, UTSW mack.mitchell@utsouthwestern.edu Sherwood Brown, MD, PhD PI, UTSW Sherwood.Brown@utsouthwestern.edu Jacqueline O'Leary, MD Investigator, UTSW Jacqueline.OLeary@UTSouthwestern.edu AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH." }, { "title": "Committees - AlcHepNet", "url": "Collaboration/committees.html", - "snippet": "Committees Steering Committee The steering committee comprises of the site-PIs (both AUD and ALD) of the clinical centers, the directors of the DCC, and NIAAA. The committee will provide oversight of the entire trial. The Chair and co-chairs of the steering committee have been selected by the NIAAA.", - "content": "Committees Steering Committee The steering committee comprises of the site-PIs (both AUD and ALD) of the clinical centers, the directors of the DCC, and NIAAA. The committee will provide oversight of the entire trial. The Chair and co-chairs of the steering committee have been selected by the NIAAA. All study committees will be formed by the steering committee and will report to the steering committee for final decisions. Committee provides strategic guidance, oversight, and decision-making authority for the clinical trial. Chair Vijay Shah - Mayo Shah.Vijay@mayo.edu Clinical sub-committee The Clinical Sub-Committee provides expert guidance on the clinical aspects of the trial to ensure medical relevance, patient safety, and protocol feasibility. Key responsibilities include reviewing and advising on clinical protocol design, inclusion/exclusion criteria, safety monitoring procedures, and standard-of-care considerations. The committee supports site investigators, addresses clinical questions that arise during trial conduct, and ensures that trial interventions are practical and ethically sound within real-world clinical settings. The chair and co-chairs of the clinical sub-committee have been selected by NIAAA. This committee will make recommendations and bring to full steering committee for final decision. Chair Juan Pablo Arab Verdugo- VCU He/Him JuanPablo.Arab@vcuhealth.org Co-Chair Sherwood Brown, MD, PhD, (PI) -UTSW He/Him Sherwood.Brown@utsouthwestern.edu Co-Chair Samer Gawrieh, MD MPI, Clinical Director at IU DCC He/Him sgawrieh@iu.edu Member Amon Asgharpour - VCU amon.asgharpour@vcuhealth.org Member Douglas Simonetto - Mayo Simonetto.Douglas@mayo.edu Member Jacqueline O'Leary - UTSW Jacqueline.OLeary@UTSouthwestern.edu Member Raj Vuppalanchi - IU rvuppala@iu.edu Member Olawale Ojo - IU olaojo@iu.edu Member Vatsalya Vatsalya - University of Louisville vatsalya.vatsalya@louisville.edu Member David Streem - Cleveland Clinic Streemd@ccf.org Member Nicole Welch - Cleveland Clinic welchn@ccf.org Publication and Ancillary study Committee The Publication and Ancillary Study Committee is responsible for overseeing the review, approval, and coordination of all publications and ancillary study proposals related to the clinical trial. This includes ensuring alignment with the trial's scientific goals, protecting participant confidentiality, maintaining data integrity, and preventing duplicate or conflicting analyses. The committee evaluates proposals for scientific merit, feasibility, and appropriate use of trial data or biospecimens, while promoting timely dissemination of results and adherence to authorship and publication guidelines. Chair Ashwani Singal, MD (PI)- University of Louisville He/Him ashwani.singal@louisville.edu Co-chair Suthat Liangpunsakul- IU He/Him sliangpu@iu.edu Co-chair David Streem, MD (PI)- Cleveland Clinic He/Him Streemd@ccf.org Member Richard Sterling - VCU richard.sterling@vcuhealth.org Member Mack Mitchell - UTSW Mack.Mitchell@utsouthwestern.edu Member Naga Chalasani - IU nchalasa@iu.edu Member Nicole Welch - Cleveland Clinic welchn@ccf.org Member Laura Nagy - Cleveland Clinic nagyl3@ccf.org Member Patrick Kamath - Mayo kamath.patrick@mayo.edu Member Joe Wang - NIH wangh4@mail.nih.gov Member Yang Li - IU yli18@iu.edu Data Science Committee The Data Science Committee provides oversight and strategic guidance on all aspects of data management and analysis within the clinical trial. Responsibilities include advising on data collection protocols, ensuring data quality and integrity, reviewing statistical analysis plans, and supporting the integration of advanced analytic methods. The committee also promotes transparency, reproducibility, and adherence to regulatory standards, while facilitating timely and accurate interpretation of trial data to inform clinical and operational decision-making. Chair Douglas Simonetto- Mayo He/Him Simonetto.Douglas@mayo.edu Co-chair Nicole Welch- Cleveland Clinic She/Her welchn@ccf.org Co-chair Wanzhu Tu, PhD MPI, Data-analytical Director at IU DCC He/Him wtu1@iu.edu Member Arun Sanyal - VCU arun.sanyal@vcuhealth.org Member Jing Su - IU su1@iu.edu Member Ashwani Singal - University of Louisville ashwani.singal@louisville.edu Member Craig McClain - University of Louisville craig.mcclain@louisville.edu Member Dasarathy - Cleveland Clinic DASARAS@ccf.org $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function () { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function () { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "Committees The collaboration is organized into the following committees: --> Steering Committee The steering committee comprises the site-PIs (both AUD and ALD) of the clinical centers, the directors of the DCC, and NIAAA. The committee will provide ...", + "content": "Committees The collaboration is organized into the following committees: --> Steering Committee The steering committee comprises the site-PIs (both AUD and ALD) of the clinical centers, the directors of the DCC, and NIAAA. The committee will provide oversight of the trial. The Chair and co-chairs of the steering committee have been selected by the NIAAA. All study committees will be formed by the Steering Committee and will report to it for final decisions. The Committee provides strategic guidance, oversight, and decision-making authority for the clinical trial. Chair Vijay Shah, MD Steering Committee; Mayo Clinic Shah.Vijay@mayo.edu Clinical Subcommittee The Clinical Subcommittee provides expert guidance on the clinical aspects of the trial to ensure medical relevance, patient safety, and protocol feasibility. Key responsibilities include reviewing and advising on clinical protocol design, inclusion/exclusion criteria, safety monitoring procedures, and standard-of-care considerations. The committee supports site investigators, addresses clinical questions that arise during trial conduct, and ensures that trial interventions are practical and ethically sound within real-world clinical settings. The chair and co-chairs of the Clinical Subcommittee have been selected by NIAAA. This committee will make recommendations and bring them to the full Steering Committee for final decision. Chair Juan Pablo Arab Verdugo, MD Clinical sub-committee; VCU JuanPablo.Arab@vcuhealth.org Co-Chair Sherwood Brown, MD, PhD Clinical sub-committee, PI; UTSW Sherwood.Brown@utsouthwestern.edu Co-Chair Samer Gawrieh, MD MPI, Clinical Director, IU DCC sgawrieh@iu.edu Member Amon Asgharpour, MD Clinical sub-committee; VCU amon.asgharpour@vcuhealth.org Member Douglas Simonetto, MD Clinical sub-committee; Mayo Clinic Simonetto.Douglas@mayo.edu Member Jacqueline O'Leary, MD Clinical sub-committee; UTSW Jacqueline.OLeary@UTSouthwestern.edu Member Raj Vuppalanchi, MD Clinical sub-committee; IU rvuppala@iu.edu Member Olawale O. Ojo, MD Clinical sub-committee; IU olaojo@iu.edu Member Vatsalya Vatsalya, MD Clinical sub-committee; UofL vatsalya.vatsalya@louisville.edu Member David Streem, MD Clinical sub-committee; Cleveland Clinic Streemd@ccf.org Member Nicole Welch, MD Clinical sub-committee; Cleveland Clinic welchn@ccf.org Publication and Ancillary Study Committee The Publication and Ancillary Study Committee manages the review, approval, and coordination of all publications and ancillary study proposals related to the AlcHepNet studies. Its duties include ensuring consistency with the trial's scientific goals, safeguarding participant confidentiality, maintaining data integrity, and avoiding duplicate or conflicting analyses. The committee assesses proposals for scientific merit, feasibility, and proper use of trial data or biospecimens, while encouraging timely reporting of results and compliance with authorship and publication guidelines. Chair Ashwani Singal, MD Publication and Ancillary Study Committee, PI; UofL ashwani.singal@louisville.edu Co-chair Suthat Liangpunsakul, MD Publication and Ancillary Study Committee; IU sliangpu@iu.edu Co-chair David Streem, MD Publication and Ancillary Study Committee, PI; Cleveland Clinic Streemd@ccf.org Member Richard Sterling, MD Publication and Ancillary Study Committee; VCU richard.sterling@vcuhealth.org Member Mack Mitchell, MD Publication and Ancillary Study Committee; UTSW Mack.Mitchell@utsouthwestern.edu Member Naga Chalasani, MD Publication and Ancillary Study Committee; IU nchalasa@iu.edu Member Nicole Welch, MD Publication and Ancillary Study Committee; Cleveland Clinic welchn@ccf.org Member Laura Nagy, PhD Publication and Ancillary Study Committee; Cleveland Clinic nagyl3@ccf.org Member Patrick Kamath, MD Publication and Ancillary Study Committee; Mayo Clinic kamath.patrick@mayo.edu Member Joe Wang, PhD Publication and Ancillary Study Committee; NIAAA wangh4@mail.nih.gov Member Yang Li, PhD Publication and Ancillary Study Committee; IU yli18@iu.edu Data Science Committee The Data Science Committee provides oversight and strategic guidance on all aspects of data management and analysis within the clinical trial. Responsibilities include advising on data collection protocols, ensuring data quality and integrity, reviewing statistical analysis plans, and supporting the integration of advanced analytic methods. The committee also promotes transparency, reproducibility, and adherence to regulatory standards, while facilitating timely and accurate interpretation of trial data to inform clinical and operational decision-making. Chair Douglas Simonetto, MD Data Science Committee; Mayo Clinic Simonetto.Douglas@mayo.edu Co-chair Nicole Welch, MD Data Science Committee; Cleveland Clinic welchn@ccf.org Co-chair Wanzhu Tu, PhD MPI, Data-analytical Director, IU DCC wtu1@iu.edu Member Arun Sanyal, MD Data Science Committee; VCU arun.sanyal@vcuhealth.org Member Jing Su, PhD Data Science Committee; IU su1@iu.edu Member Ashwani Singal, MD Data Science Committee; UofL ashwani.singal@louisville.edu Member Craig McClain, MD Data Science Committee; UofL craig.mcclain@louisville.edu Member Srinivasan Dasarathy, MD Data Science Committee; Cleveland Clinic DASARAS@ccf.org" }, { "title": "Data Coordinating Centers - AlcHepNet", "url": "Collaboration/dcc.html", - "snippet": "IU DCC (Data Coordinating Center) The DCC will play a central role in coordinating the implementation of all aspects of the trial and the communications between the clinical centers, study committees, data safety and monitoring board, the steering committee, and with the NIAAA. The DCC will be respo", - "content": "IU DCC (Data Coordinating Center) The DCC will play a central role in coordinating the implementation of all aspects of the trial and the communications between the clinical centers, study committees, data safety and monitoring board, the steering committee, and with the NIAAA. The DCC will be responsible for data integrity. The DCC will also oversee the performance of the biorepository and coordinate movement of biospecimens in and out of the biorepository. Samer Gawrieh, MD He/Him MPI, Clinical Director sgawrieh@iu.edu Wanzhu Tu, PhD He/Him MPI, Data-analytical Director wtu1@iu.edu Savannah Yarnelle She/Her Program Coordinator and Main Contact samussel@iu.edu Carla Kettler She/Her Lead Data Manager ckettler@iu.edu Jing Su He/Him Lead, Alcohol Research Data Commons Team su1@iu.edu Tae-Hwi Linus Schwantes-An He/Him Lead, AlcHepNet Biorepository Team tlschwan@iu.edu DCC Organization Chart $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "snippet": "IU DCC (Data Coordinating Center) The DCC will play a central role in coordinating the implementation of all aspects of the trial and the communications between the clinical centers, study committees, data safety and monitoring board, the steering co...", + "content": "IU DCC (Data Coordinating Center) The DCC will play a central role in coordinating the implementation of all aspects of the trial and the communications between the clinical centers, study committees, data safety and monitoring board, the steering committee, and with the NIAAA. The DCC will be responsible for data integrity. The DCC will also oversee the performance of the biorepository and coordinate movement of biospecimens in and out of the biorepository. Samer Gawrieh, MD MPI, Clinical Director sgawrieh@iu.edu Wanzhu Tu, PhD MPI, Data-analytical Director wtu1@iu.edu Savannah Yarnelle Program Coordinator and Main Contact samussel@iu.edu Carla Kettler Lead Data Manager ckettler@iu.edu Jing Su, PhD Lead, Alcohol Research Data Commons Team su1@iu.edu Tae-Hwi Linus Schwantes-An, PhD Lead, AlcHepNet Biorepository Team tlschwan@iu.edu DCC Organization Chart" }, { "title": "Investigators Directory - AlcHepNet", "url": "Collaboration/directory.html", - "snippet": "Directory Filter Directory Personnel Group All Study Staff Coordinators Pharmacists DSMB Members Committee Members Roles on Project All Principal Investigator (PI) Investigator Statistician Project Scientist Program Officer Safety Officer Program Manager Data Manager Monitor Nurse Manager Lead Coord", - "content": "Directory Filter Directory Personnel Group All Study Staff Coordinators Pharmacists DSMB Members Committee Members Roles on Project All Principal Investigator (PI) Investigator Statistician Project Scientist Program Officer Safety Officer Program Manager Data Manager Monitor Nurse Manager Lead Coordinator Coordinator Pharmacist Committee Chair Committee Co-Chair Committee Member Institution All NIAAA Indiana University (IU DCC) Cleveland Clinic Mayo Clinic Virginia Commonwealth University University of Louisville UT Southwestern DSMB (External) Apply filters Clear Directory Results 0 researchers found // Researchers data const researchers = [ // NIAAA { name: \"Joe Wang\", roles: { \"Study Staff\": \"Project Scientist\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"NIAAA\", title: \"Project Scientist\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"wangh4@mail.nih.gov\", image: \"../images/committees/placeholder.svg\", bio: \"Project Scientist, PAC Member\" }, { name: \"Peter Gao\", role: \"Program Officer\", group: \"Study Staff\", institution: \"NIAAA\", title: \"Site Program Officer\", email: \"gaozh@mail.nih.gov\", image: \"../images/committees/placeholder.svg\", bio: \"Site Program Officer\" }, { name: \"Liz Perruccio\", role: \"Program Officer\", group: \"Study Staff\", institution: \"NIAAA\", title: \"DCC Program Officer\", email: \"liz.perruccio@nih.gov\", image: \"../images/committees/placeholder.svg\", bio: \"DCC Program Officer\" }, // IU DCC { name: \"Wanzhu Tu, PhD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"PI (Contact), Biostatistician\", committees: \"Co-chair, Data Science Committee\", email: \"wtu1@iu.edu\", image: \"../images/dcc/Wanzhu.jpg\", bio: \"Biostatistician, Data-analytical Director, Co-chair DSC\" }, { name: \"Samer Gawrieh, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"PI, Hepatologist\", committees: \"Co-chair, Clinical Sub-committee\", email: \"sgawrieh@iu.edu\", image: \"../images/dcc/Samer.jpg\", bio: \"Hepatologist, Clinical Director, Co-chair Clinical Sub-committee\" }, { name: \"Marwan Ghabril, MD\", role: \"Safety Officer\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Safety Officer\", email: \"mghabril@iu.edu\", image: \"../images/admin/Marwan Ghabril.jpg\", bio: \"Safety Officer\" }, { name: \"Savannah Yarnelle\", role: \"Program Manager\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Program Manager\", email: \"samussel@iu.edu\", image: \"../images/dcc/Savannah.png\", bio: \"Bioinformatician, Co-lead of ARDaC Core\" }, { name: \"Carla Kettler\", role: \"Data Manager\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Lead Data Manager\", email: \"ckettler@iu.edu\", image: \"../images/dcc/Carla.png\", bio: \"Lead Data Manager\" }, { name: \"Ronny Ovando\", role: \"Data Manager\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Data Manager\", email: \"rmovando@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Data Manager\" }, { name: \"Timothy Hotchkiss\", role: \"Data Manager\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Data Manager\", email: \"thotchl@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Data Manager\" }, { name: \"Jo Davies\", role: \"Monitor\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Monitor\", email: \"jhdavies@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Monitor\" }, { name: \"Jennifer Terrell\", role: \"Nurse Manager\", group: [\"Study Staff\", \"Coordinators\"], institution: \"Indiana University\", title: \"Nurse Manager & Coordinator\", email: \"jkramey@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Nurse Manager & Coordinator\" }, // IU Coordinators { name: \"Yang Li, PhD\", roles: { \"Study Staff\": \"Statistician\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Statistician\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"yli18@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Statistician, PAC Member\" }, { name: \"Jing Su, PhD\", roles: { \"Study Staff\": \"Statistician\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Statistician\", committees: \"Member, Data Science Committee\", email: \"su1@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Statistician, DSC Member\" }, // IU Coordinators { name: \"Caitlin Snoeberger\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"Indiana University\", title: \"Lead Coordinator\", email: \"csnoeber@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, { name: \"Christopher Rusie\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Indiana University\", title: \"Coordinator\", email: \"cgrusie@iu.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, // IU Pharmacist { name: \"Melissa Allard\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"Indiana University\", title: \"Pharmacist\", email: \"mallard@iuhealth.org\", image: \"../images/admin/Melissa Allard.jpg\", bio: \"Pharmacist\" }, // Cleveland Clinic { name: \"Srinivasan Dasarathy, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Cleveland Clinic\", title: \"Principal Investigator\", committees: \"Member, Data Science Committee\", email: \"DASARAS@ccf.org\", image: \"../images/dcc/Srinivasan.jpg\", bio: \"PI, DSC Member\" }, { name: \"David Streem, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Cleveland Clinic\", title: \"Principal Investigator\", committees: \"Co-chair, Publication and Ancillary Study Committee; Member, Clinical Sub-committee\", email: \"Streemd@ccf.org\", image: \"../images/dcc/David.jpg\", bio: \"PI, Co-chair PAC, Clinical Sub-committee Member\" }, { name: \"Nicole Welch\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Cleveland Clinic\", title: \"Investigator\", committees: \"Co-chair, Data Science Committee; Member, Clinical Sub-committee & PAC\", email: \"welchn@ccf.org\", image: \"../images/committees/Nicole.jpg\", bio: \"Investigator, Co-chair DSC, Clinical Sub-committee & PAC Member\" }, { name: \"Laura Nagy\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Cleveland Clinic\", title: \"Investigator\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"nagyl3@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Investigator, PAC Member\" }, // Cleveland Clinic Coordinators { name: \"Lana Khatib\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"Cleveland Clinic\", title: \"Lead Coordinator\", email: \"khatibl2@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, { name: \"Rahul Yerrapothu\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Cleveland Clinic\", title: \"Coordinator\", email: \"yerrapr@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, { name: \"Annette Bellar\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Cleveland Clinic\", title: \"Coordinator\", email: \"bellara@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, { name: \"Shashi Kant\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Cleveland Clinic\", title: \"Coordinator\", email: \"shashik@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, { name: \"Anja Tichy\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Cleveland Clinic\", title: \"Coordinator\", email: \"tichya@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, // Cleveland Clinic Pharmacists { name: \"Rachael Yim\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"Cleveland Clinic\", title: \"Pharmacist\", email: \"yimr@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacist\" }, { name: \"IDS Pharmacy Pool\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"Cleveland Clinic\", title: \"Pharmacy Pool\", email: \"ids@ccf.org\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacy Pool\" }, // Indiana University (Clinical Site) { name: \"Raj Vuppalanchi, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Principal Investigator\", committees: \"Member, Clinical Sub-committee\", email: \"rvuppala@iu.edu\", image: \"../images/dcc/Raj.jpg\", bio: \"PI, Clinical Sub-committee Member\" }, { name: \"Olawale Ojo, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Principal Investigator\", committees: \"Member, Clinical Sub-committee\", email: \"olaojo@iu.edu\", image: \"../images/dcc/Olawale.jpg\", bio: \"PI, Clinical Sub-committee Member\" }, { name: \"Lauren Nephew, MD\", role: \"Investigator\", group: \"Study Staff\", institution: \"Indiana University\", title: \"Investigator\", email: \"lnephew@iu.edu\", image: \"../images/admin/Lauren Nephew.jpg\", bio: \"Investigator\" }, { name: \"Naga Chalasani, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Investigator\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"nchalasa@iu.edu\", image: \"../images/admin/Naga Chalasani .jpg\", bio: \"Investigator, PAC Member\" }, { name: \"Suthat Liangpunsakul, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Indiana University\", title: \"Investigator\", committees: \"Co-chair, Publication and Ancillary Study Committee\", email: \"sliangpu@iu.edu\", image: \"../images/admin/Liangpunsakul.jpg\", bio: \"Investigator, Co-chair PAC\" }, // Mayo Clinic { name: \"Vijay Shah, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Mayo Clinic\", title: \"Principal Investigator\", committees: \"Chair, Steering Committee\", email: \"Shah.Vijay@mayo.edu\", image: \"../images/dcc/Vijay.jpg\", bio: \"PI, Chair Steering Committee\" }, { name: \"Victor Karpyak, MD, PhD\", role: \"PI\", group: \"Study Staff\", institution: \"Mayo Clinic\", title: \"Principal Investigator\", email: \"karpyak.victor@mayo.edu\", image: \"../images/dcc/Victor.jpg\", bio: \"PI, Addiction Medicine & Genetics\" }, { name: \"Patrick Kamath, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Mayo Clinic\", title: \"Investigator\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"kamath.patrick@mayo.edu\", image: \"../images/admin/Dr Kamath.png\", bio: \"Investigator, PAC Member\" }, { name: \"Douglas Simonetto, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Mayo Clinic\", title: \"Investigator\", committees: \"Chair, Data Science Committee; Member, Clinical Sub-committee\", email: \"Simonetto.Douglas@mayo.edu\", image: \"../images/committees/Douglas.jpg\", bio: \"Investigator, Chair DSC, Clinical Sub-committee Member\" }, { name: \"Terry Schneekloth, MD\", role: \"Investigator\", group: \"Study Staff\", institution: \"Mayo Clinic\", title: \"Investigator\", email: \"schneekloth.terry@mayo.edu\", image: \"../images/admin/Dr Schneekloth.png\", bio: \"Investigator, Addiction Psychiatry\" }, // Mayo Clinic Coordinators { name: \"Amy Olofson\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"Mayo Clinic\", title: \"Lead Coordinator\", email: \"olofson.amy@mayo.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, { name: \"Lauren (Ren) Cutrer\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Mayo Clinic\", title: \"Coordinator\", email: \"cutrer.lauren@mayo.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, // Mayo Clinic Pharmacist { name: \"Melissa Manley\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"Mayo Clinic\", title: \"Pharmacist\", email: \"manley.melissa@mayo.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacist\" }, // Virginia Commonwealth University { name: \"Arun Sanyal, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Virginia Commonwealth University\", title: \"Principal Investigator\", committees: \"Member, Data Science Committee\", email: \"arun.sanyal@vcuhealth.org\", image: \"../images/dcc/Arun.jpg\", bio: \"PI, DSC Member\" }, { name: \"Gerry Moeller, MD\", role: \"PI\", group: \"Study Staff\", institution: \"Virginia Commonwealth University\", title: \"Principal Investigator\", email: \"frederick.moeller@vcuhealth.org\", image: \"../images/dcc/F_Gerard.jpg\", bio: \"PI, Substance Use Disorders\" }, { name: \"Juan Pablo Arab, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Virginia Commonwealth University\", title: \"Investigator\", committees: \"Chair, Clinical Sub-committee\", email: \"JuanPablo.Arab@vcuhealth.org\", image: \"../images/committees/Juan.png\", bio: \"Investigator, Chair Clinical Sub-committee\" }, { name: \"Richard Sterling, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Virginia Commonwealth University\", title: \"Investigator\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"richard.sterling@vcuhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Investigator, PAC Member\" }, { name: \"Amon Asgharpour, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"Virginia Commonwealth University\", title: \"Investigator\", committees: \"Member, Clinical Sub-committee\", email: \"amon.asgharpour@vcuhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Investigator, Clinical Sub-committee Member\" }, // VCU Coordinators { name: \"Sara O'Connor\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"Virginia Commonwealth University\", title: \"Lead Coordinator\", email: \"sara.oconnor@vcuhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, { name: \"Mona Shah\", role: \"Coordinator\", group: \"Coordinators\", institution: \"Virginia Commonwealth University\", title: \"Coordinator\", email: \"Mona.Shah1@vcuhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, // VCU Pharmacist { name: \"7 Rotating Pharmacists\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"Virginia Commonwealth University\", title: \"Rotating Pharmacists\", email: \"Investigational.drug@vcuhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Rotating Pharmacists\" }, // University of Louisville { name: \"Ashwani Singal, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"University of Louisville\", title: \"Principal Investigator\", committees: \"Chair, Publication and Ancillary Study Committee; Member, Data Science Committee\", email: \"ashwani.singal@louisville.edu\", image: \"../images/dcc/Ashwani.jpg\", bio: \"PI, Chair PAC, DSC Member\" }, { name: \"Chris Stewart, MD\", role: \"PI\", group: \"Study Staff\", institution: \"University of Louisville\", title: \"Principal Investigator\", email: \"christopher.stewart@louisville.edu\", image: \"../images/dcc/Chris.jpg\", bio: \"PI, Addiction Psychiatry\" }, { name: \"Vatsalya Vatsalya, PhD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"University of Louisville\", title: \"Investigator\", committees: \"Member, Clinical Sub-committee\", email: \"vatsalya.vatsalya@louisville.edu\", image: \"../images/admin/Vatsalya Vatsalya.jpg\", bio: \"Investigator, Clinical Sub-committee Member\" }, { name: \"Craig McClain, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"University of Louisville\", title: \"Investigator\", committees: \"Member, Data Science Committee\", email: \"craig.mcclain@louisville.edu\", image: \"../images/admin/Craig McClain.jpg\", bio: \"Investigator, DSC Member\" }, // University of Louisville Coordinators { name: \"Amber Jackson\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"University of Louisville\", title: \"Lead Coordinator\", email: \"amber.jackson.1@louisville.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, { name: \"Mariel Basa\", role: \"Coordinator\", group: \"Coordinators\", institution: \"University of Louisville\", title: \"Coordinator\", email: \"mariel.basa@louisville.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, { name: \"Theresa Durham\", role: \"Coordinator\", group: \"Coordinators\", institution: \"University of Louisville\", title: \"Coordinator\", email: \"theresa.durham@louisville.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Coordinator\" }, // University of Louisville Pharmacists { name: \"Cathy Whalen\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"University of Louisville\", title: \"Pharmacist\", email: \"cathy.whalen@uoflhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacist\" }, { name: \"Amanda Sell\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"University of Louisville\", title: \"Pharmacist\", email: \"amanda.sell@uoflhealth.org\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacist\" }, // UT Southwestern { name: \"Mack Mitchell, MD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"UT Southwestern\", title: \"Principal Investigator\", committees: \"Member, Publication and Ancillary Study Committee\", email: \"Mack.Mitchell@utsouthwestern.edu\", image: \"../images/dcc/Mack.jpg\", bio: \"PI, PAC Member\" }, { name: \"Sherwood Brown, MD, PhD\", roles: { \"Study Staff\": \"PI\", \"Committee Members\": \"Co-Chair\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"UT Southwestern\", title: \"Principal Investigator\", committees: \"Co-chair, Clinical Sub-committee\", email: \"Sherwood.Brown@utsouthwestern.edu\", image: \"../images/dcc/Sherwood.jpg\", bio: \"PI, Co-chair Clinical Sub-committee\" }, { name: \"Jaqueline O'Leary, MD\", roles: { \"Study Staff\": \"Investigator\", \"Committee Members\": \"Member\" }, group: [\"Study Staff\", \"Committee Members\"], institution: \"UT Southwestern\", title: \"Investigator\", committees: \"Member, Clinical Sub-committee\", email: \"Jacqueline.OLeary@UTSouthwestern.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Investigator, Clinical Sub-committee Member\" }, // UT Southwestern Coordinators { name: \"Leticia Rodriguez\", role: \"Lead Coordinator\", group: \"Coordinators\", institution: \"UT Southwestern\", title: \"Lead Coordinator\", email: \"leticia.rodriguez@utsouthwestern.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Lead Coordinator\" }, // UT Southwestern Pharmacists { name: \"UTSW Pharmacy Pool\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"UT Southwestern\", title: \"Pharmacy Pool\", email: \"IDSUTSWCUH@UTSouthwestern.edu\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacy Pool\" }, { name: \"Parkland Pharmacy Pool\", role: \"Pharmacist\", group: \"Pharmacists\", institution: \"UT Southwestern\", title: \"Pharmacy Pool\", email: \"IDSPHHS@phhs.org\", image: \"../images/committees/placeholder.svg\", bio: \"Pharmacy Pool\" }, // DSMB Members { name: \"Anna Mae Diehl, MD\", role: \"Chair\", group: \"DSMB Members\", institution: \"DSMB\", title: \"DSMB Chair\", additionalInfo: \"Duke University\", email: \"annamae.diehl@duke.edu\", image: \"../images/committees/placeholder.svg\", bio: \"DSMB Chair, Duke University\" }, { name: \"Valerie Durkalski-Mauldin, PhD\", role: \"Statistician\", group: \"DSMB Members\", institution: \"DSMB\", title: \"DSMB Statistician\", additionalInfo: \"Medical University of South Carolina\", email: \"durkalsv@musc.edu\", image: \"../images/committees/placeholder.svg\", bio: \"DSMB Statistician, Medical University of South Carolina\" }, { name: \"Stephanie O'Malley, PhD\", role: \"Member\", group: \"DSMB Members\", institution: \"DSMB\", title: \"DSMB Member\", additionalInfo: \"Yale University\", email: \"stephanie.omalley@yale.edu\", image: \"../images/committees/placeholder.svg\", bio: \"DSMB Member, Yale University\" }, { name: \"Gene Im, MD\", role: \"Member\", group: \"DSMB Members\", institution: \"DSMB\", title: \"DSMB Member\", additionalInfo: \"Columbia University\", email: \"gyi2101@cumc.columbia.edu\", image: \"../images/committees/placeholder.svg\", bio: \"DSMB Member, Columbia University\" } ]; let filteredResearchers = [...researchers]; // Function to render researchers function renderResearchers(researchersList) { const container = document.getElementById('researchersList'); const count = document.getElementById('resultsCount'); const groupFilter = document.getElementById('groupFilter').value; container.innerHTML = ''; count.textContent = researchersList.length; researchersList.forEach(researcher => { const card = document.createElement('div'); card.className = 'researcher-card'; // Get groups (default to [\"Study Staff\"] if not specified) const groups = researcher.group ? (Array.isArray(researcher.group) ? researcher.group : [researcher.group]) : [\"Study Staff\"]; // Determine role to display based on current filter or group let displayRole; if (researcher.roles && typeof researcher.roles === 'object') { // New structure: roles is an object mapping group to role if (groupFilter && researcher.roles[groupFilter]) { // If filtering by a specific group, show that group's role displayRole = researcher.roles[groupFilter]; } else { // Show role for the first group this person belongs to displayRole = researcher.roles[groups[0]] || Object.values(researcher.roles)[0]; } } else { // Fallback to old structure for backward compatibility displayRole = researcher.role; if (researcher.additionalRoles && researcher.additionalRoles.length > 0) { displayRole = researcher.additionalRoles[0]; } } // Generate group badges HTML const groupBadges = groups.map(g => `${g}`).join(''); const bioText = researcher.bio || `${researcher.title}${researcher.committees ? '. ' + researcher.committees : ''}`; card.innerHTML = ` \"${researcher.name}\"

${researcher.name}

${groupBadges} ${displayRole}
${researcher.institution}
${researcher.email}

${bioText}

`; container.appendChild(card); }); } // Function to apply filters function applyFilters() { const groupFilter = document.getElementById('groupFilter').value; const roleFilter = document.getElementById('roleFilter').value; const institutionFilter = document.getElementById('institutionFilter').value; filteredResearchers = researchers.filter(researcher => { // Handle group as array or string const researcherGroups = researcher.group ? (Array.isArray(researcher.group) ? researcher.group : [researcher.group]) : [\"Study Staff\"]; const matchesGroup = !groupFilter || researcherGroups.includes(groupFilter); // Handle role matching for both old and new structure let matchesRole = !roleFilter; if (roleFilter) { if (researcher.roles && typeof researcher.roles === 'object') { // New structure: check if any role in the roles object matches // Treat both \"PI\" and \"MPI\" as \"PI\" matchesRole = Object.values(researcher.roles).some(r => { if (roleFilter === \"PI\") { return r === \"PI\" || r === \"MPI\"; } return r === roleFilter; }); } else { // Old structure: check role and additionalRoles // Treat both \"PI\" and \"MPI\" as \"PI\" if (roleFilter === \"PI\") { matchesRole = researcher.role === \"PI\" || researcher.role === \"MPI\"; } else { matchesRole = researcher.role === roleFilter || (researcher.additionalRoles && researcher.additionalRoles.includes(roleFilter)); } } } const matchesInstitution = !institutionFilter || researcher.institution === institutionFilter; return matchesGroup && matchesRole && matchesInstitution; }); renderResearchers(filteredResearchers); } // Function to clear filters function clearFilters() { document.getElementById('groupFilter').value = ''; document.getElementById('roleFilter').value = ''; document.getElementById('institutionFilter').value = ''; filteredResearchers = [...researchers]; renderResearchers(filteredResearchers); } // Initialize $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function () { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function () { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); // Initial render renderResearchers(filteredResearchers); });" - }, - { - "title": "Participating Institutions - AlcHepNet", - "url": "Collaboration/participating-institutions-bk.html", - "snippet": "Administrative Structure Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@i", - "content": "Administrative Structure Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data Manager) Ronny Ovando, rmovando@iu.edu (Data Manager) Savannah Yarnelle, samussel@iu.edu (Program Coordinator) Carla Kettler, ckettler@iu.edu (Lead Data Manager) Cleveland Clinic https://my.clevelandclinic.org/departments/digestive/research-innovations Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD (PI) Indiana University https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Raj Vuppalanchi, MD (PI) Mayo Clinic – Rochester https://www.mayo.edu/research/clinical-trials/search-results?keyword=alcoholic%20hepatitis&status=open-unknown 200 First St. SW Rochester, MN 55905 Vijay Shah, MD (PI) Virginia Commonwealth University https://studyfinder.cctr.vcu.edu/ VCU School of Medicine Physical Address: McGlothlin Medical Education Center (MMEC), 1201 E Marshall St., 4th Floor, Suite 4-100 Mailing Address: Box 980565 Richmond, VA 23298 Arun Sanyal, MD (PI) University of Louisville http://louisville.edu/research/ctu University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Ashwani Singal, MD (PI) University of UTSW https://clinicaltrials.utswmed.org/studies?utf8=%E2%9C%93&search%5Bhealthy_volunteers%5D=&search%5Bgender%5D=&search%5Bq%5D=alcoholic+hepatitis&commit=Search Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, TX 75390-8887 Mack Mitchell, MD (PI) AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Directory Filter Directory Personnel Group All Study Staff Coordinators Pharmacists DSMB Members Steering Committee Clinical Sub-committee Publication and Ancillary Study Committee (PAC) Data Science Committee Roles on Project All Principal Investiga...", + "content": "Directory Filter Directory Personnel Group All Study Staff Coordinators Pharmacists DSMB Members Steering Committee Clinical Sub-committee Publication and Ancillary Study Committee (PAC) Data Science Committee Roles on Project All Principal Investigator (PI) Investigator Statistician Project Scientist Program Officer Safety Officer Program Manager Data Manager Monitor Nurse Manager Lead Coordinator Coordinator Pharmacist Committee Chair Committee Co-Chair Committee Member Institution All NIAAA Indiana University (IU DCC) Cleveland Clinic Mayo Clinic Virginia Commonwealth University University of Louisville UT Southwestern DSMB Apply filters Clear Directory Results 0 researchers found" }, { "title": "Data Access - AlcHepNet", "url": "Data_Access/about.html", - "snippet": "Data Access AlcHepNet is committed to responsible data sharing to advance research in alcohol-associated hepatitis. Study data from completed trials and observational studies are available to qualified investigators, while data from ongoing projects will be released after publication of primary resu", - "content": "Data Access AlcHepNet is committed to responsible data sharing to advance research in alcohol-associated hepatitis. Study data from completed trials and observational studies are available to qualified investigators, while data from ongoing projects will be released after publication of primary results. Policies guiding data and biospecimen use can be found in the Access Policy section. Clinical data are maintained in the Alcohol Research Data Commons (ARDaC), and investigators may submit requests through the Data and Sample Request Form. Upon review and approval by the Publication and Ancillary Study Subcommittee, the DCC will release the data. Code books for completed studies are provided to support data interpretation and secondary analyses. Data and Biospecimen Access Policy AlcHepNet supports responsible and equitable sharing of clinical data and biospecimens to advance research in alcohol-associated hepatitis. Requests are reviewed for scientific merit, feasibility, protection of participant confidentiality, and compliance with regulatory and IRB requirements. Priority access is given to AlcHepNet investigators, with opportunities for external researchers, particularly through collaboration with network members. Approved projects require data-use or material-transfer agreements, and users must return derived data and acknowledge AlcHepNet contributions in resulting publications. View Page Download Policy Document (DOCX) Codebooks Codebooks for completed AlcHepNet studies are provided to help investigators understand variable definitions, data formats, and study-specific measures. These documents serve as a reference for secondary analyses and support accurate interpretation of shared datasets. View Page Download AlcHepNet Codebook (PDF) Research Proposal Forms Investigators interested in accessing AlcHepNet clinical data or biospecimens may submit a formal request using the Research Proposal Form. Proposals should outline research aims, analytic plans, and requested materials. All requests are reviewed by the AlcHepNet Publication and Ancillary Study Committee, and approved projects will proceed under the appropriate Data Use or Material Transfer Agreements before release of data or samples. View Page Download Proposal Template (DOCX) Submit Form to Savannah $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Data Access AlcHepNet is committed to responsible data sharing to advance research in alcohol-associated hepatitis. Study data from completed trials and observational studies are available to qualified investigators, while data from ongoing projects ...", + "content": "Data Access AlcHepNet is committed to responsible data sharing to advance research in alcohol-associated hepatitis. Study data from completed trials and observational studies are available to qualified investigators, while data from ongoing projects will be released after publication of primary results. Policies guiding data and biospecimen use can be found in the Access Policy section. Clinical data are maintained in the Alcohol Research Data Commons (ARDaC) , and investigators may submit requests by completing the Ancillary Study Proposal Form . Upon review and approval by the Publication and Ancillary Study Subcommittee, the DCC will release the data. Code books for completed studies are provided to support data interpretation and secondary analyses. Data and Biospecimen Access Policy AlcHepNet supports responsible and equitable sharing of clinical data and biospecimens to advance research in alcohol-associated hepatitis. Requests are reviewed for scientific merit, feasibility, protection of participant confidentiality, and compliance with regulatory and IRB requirements. Priority access is given to AlcHepNet investigators, with opportunities for external researchers, particularly through collaboration with network members. Approved projects require data-use or material-transfer agreements, and users must return derived data and acknowledge AlcHepNet contributions in resulting publications. View Page Download Policy Document (DOCX) Codebooks Codebooks for completed AlcHepNet studies are provided to help investigators understand variable definitions, data formats, and study-specific measures. These documents serve as a reference for secondary analyses and support accurate interpretation of shared datasets. View Page Download AlcHepNet Codebook (PDF) Ancillary Study Proposal Form Please refer to the guidelines above for the data and biospecimen request process. Investigators interested in accessing AlcHepNet clinical data or biospecimens will need to fill out the Ancillary Study Proposal Form. Proposals should outline research aims, analytic plans, and requested materials. All requests are reviewed by the AlcHepNet Publication and Ancillary Study Committee, and approved projects will proceed under the appropriate Data Use or Material Transfer Agreements before release of data or samples. View Page Download Proposal Template (DOCX) Email completed form to Savannah" + }, + { + "title": "ARDaC - AlcHepNet", + "url": "Data_Access/ardac.html", + "snippet": "ARDaC The Indiana University Data Coordinating Center (IU DCC) provides the Alcohol-associated hepatitis Research Data Commons (ARDaC). ARDaC is an essential research infrastructure that supports experimental design, study implementation, data manage...", + "content": "ARDaC The Indiana University Data Coordinating Center (IU DCC) provides the Alcohol-associated hepatitis Research Data Commons (ARDaC). ARDaC is an essential research infrastructure that supports experimental design, study implementation, data management, and statistical analysis in alcohol-associated hepatitis (AH) research. ARDaC contains data generated by the Alcoholic Hepatitis Network project, AlcHepNet ( http://www.alchepnet.org/ ), which is sponsored by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). AlcHepNet conducts clinical studies, provides clinical data management and statistical analysis. It also functions as the central biorepository of the network. ARDaC is a web-based data commons, functions as an interactive user interface of the collected study data and biospecimens. ARDaC currently presents demographic and behavioral features, clinical conditions, laboratory tests, treatments and outcomes. It is being extended to include multiomics data from microbiome, immunologic, proteomic, metabolomic, lipidomic, and RNA/ChIP-sequencing analyses. ARDaC facilitates effective research use of the rich and complex AlcHepNet data. It serves as the central data hub and research nexus ( https://portal.ardac.org/ ). For more information, visit https://ardac.org/" }, { "title": "Code Book - AlcHepNet", "url": "Data_Access/codebook.html", - "snippet": "Code Book This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Access 目", - "content": "Code Book This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Access 目录下的链接,直接使用文件名 if(href.startsWith(\"Data_Access/\")) { $(this).attr(\"href\", href.replace(\"Data_Access/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); // 修复图片路径 $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Codebooks Codebooks provide detailed documentation of all variables, measurements, and coding schemes used in AlcHepNet studies. These data dictionaries are essential for understanding and analyzing the research data. Legacy Studies - Available Now C...", + "content": "Codebooks Codebooks provide detailed documentation of all variables, measurements, and coding schemes used in AlcHepNet studies. These data dictionaries are essential for understanding and analyzing the research data. Legacy Studies - Available Now Codebooks for completed AlcHepNet studies are available for download: AlcHepNet Observational Study Data dictionary for the observational cohort study (NCT03850899). Codebook document will be available soon. Please contact the Data Coordinating Center for access. Anakinra vs. Prednisone Trial Data dictionary for the completed clinical trial (NCT04072822). Codebook document will be available soon. Please contact the Data Coordinating Center for access. Ongoing Studies ITAALD Trial Codebooks for ongoing studies will be published after associated manuscripts are released to ensure data integrity and publication priority. Request Access For questions about codebooks or to request early access for collaborative research purposes, please contact: Data Coordinating Center: samussel@iu.edu See our Data Requesting Process for information on accessing AlcHepNet data" }, { "title": "Data and Sample Requesting Process - AlcHepNet", "url": "Data_Access/data-requesting-process.html", - "snippet": "AlcHepNet Consortium Ancillary Study Proposal 1. Name and contact information for principal investigator of the proposed study and clinical center PI sponsorship: 2. Study Design a. Study title: b. Study Hypothesis and aim: c. Estimated study timeline: d. Brief description of study design: 3. Sample", - "content": "AlcHepNet Consortium Ancillary Study Proposal 1. Name and contact information for principal investigator of the proposed study and clinical center PI sponsorship: 2. Study Design a. Study title: b. Study Hypothesis and aim: c. Estimated study timeline: d. Brief description of study design: 3. Samples Requested: OBS: Healthy Control, Heavy Drinker, or Alc. Hep HC HD AH # of Samples per diagnosis x x x Sample Baseline 1 month 3 months 6 months Plasma Serum PBMC Urine Stool DNA Saliva # of Slides Unstained Slides H&E Stained Slides Trichrome Slides RCT: Sample Baseline Day 7 Day 14 Day 28 Day 60 Day 90 Day 180 Plasma Serum PBMC Urine Stool DNA Saliva 4. Data items requested (specify time points for the data): 5. Sample size calculation/power estimation and justification: 6. Potential negative impact on the consortium (if any): 7. Deliverables (abstract or proposal): Please include biosketch and any available literature to support the proposal 8. Funding Sources: 9. List any resources available to complete the analysis: Date Form Submitted: Signature of Principal Investigator: Date Received by AlcHepNet Consortium Manager: $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Data_Access/\")) { $(this).attr(\"href\", href.replace(\"Data_Access/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { // 修复footer中的链接 $(\"#footer-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 检查是否是需要修正的Collaboration页面链接 if(href === \"about.html\" || href === \"participating-institutions.html\" || href === \"pis.html\" || href === \"dcc.html\" || href === \"committees.html\") { $(this).attr(\"href\", \"../Collaboration/\" + href); } // 检查是否是需要修正的Data Access页面链接 else if(href === \"data-system.html\") { $(this).attr(\"href\", \"data-system.html\"); // 当前目录下 } // 其他链接添加../前缀 else { $(this).attr(\"href\", \"../\" + href); } } }); console.log('Footer loaded and links updated'); }); });" + "snippet": "AlcHepNet Consortium Ancillary Study Proposal Form Download Proposal Template (DOCX) Email completed form to Savannah 1. Name and contact information for principal investigator of the proposed study and clinical center PI sponsorship: 2. Study Design...", + "content": "AlcHepNet Consortium Ancillary Study Proposal Form Download Proposal Template (DOCX) Email completed form to Savannah 1. Name and contact information for principal investigator of the proposed study and clinical center PI sponsorship: 2. Study Design a. Study title: b. Study Hypothesis and aim: c. Estimated study timeline: d. Brief description of study design: 3. Samples Requested: OBS: Healthy Control, Heavy Drinker, or Alc. Hep HC HD AH # of Samples per diagnosis x x x Sample Baseline 1 month 3 months 6 months Plasma Serum PBMC Urine Stool DNA Saliva # of Slides Unstained Slides H&E Stained Slides Trichrome Slides RCT: Sample Baseline Day 7 Day 14 Day 28 Day 60 Day 90 Day 180 Plasma Serum PBMC Urine Stool DNA Saliva 4. Data items requested (specify time points for the data): 5. Sample size calculation/power estimation and justification: 6. Potential negative impact on the consortium (if any): 7. Deliverables (abstract or proposal): Please include biosketch and any available literature to support the proposal 8. Funding Sources: 9. List any resources available to complete the analysis: Date Form Submitted: Signature of Principal Investigator: Date Received by AlcHepNet Consortium Manager:" }, { "title": "Data System - AlcHepNet", "url": "Data_Access/data-system.html", - "snippet": "Data System This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Access", - "content": "Data System This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Access 目录下的链接,直接使用文件名 if(href.startsWith(\"Data_Access/\")) { $(this).attr(\"href\", href.replace(\"Data_Access/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); // 修复图片路径 $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Data System This page is under construction. Content will be added soon.", + "content": "Data System This page is under construction. Content will be added soon." }, { - "title": "Policy - AlcHepNet", - "url": "Data_Access/policy.html", - "snippet": "Data Request Policy To apply for AlcHepNet data, the investigator must meet the following criteria: Funding should be available Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to apply Non-AlcHepNet affiliates can apply accompanied by the SC PI as their sponsor Must have", - "content": "Data Request Policy To apply for AlcHepNet data, the investigator must meet the following criteria: Funding should be available Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to apply Non-AlcHepNet affiliates can apply accompanied by the SC PI as their sponsor Must have prior approval from the AlcHepNet publications and ancillary study committee (PAC) IU DCC will only offer data within the scope of SC PI's proposal. Additional data requests will be reviewed by PAC for amended approval. If original data (e.g, omics or genotyping, or cytokines) are generated on AHN samples at the investigator's site, those data must be first deposited with the DCC prior to DCC transferring the associated phenotyping data to the investigator. The investigator agrees not to share the phenotype data to a third party without written approval from the AHN DCC or Publications/Ancillary Studies or Steering Committees. If using genomic data, SC PI must follow NIH's genomic data sharing policy and procedures. If not, please skip Please reference policies at the following link, agree to the following, and sign below: https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html Using the data only for the approved research. Protecting data confidentiality. Following, as appropriate, all applicable national, tribal, and state laws and regulations, as well as relevant institutional policies and procedures for handling genomic data. Not attempting to identify individual participants from whom the data were obtained. Not selling any of the data obtained from NIH-designated data repositories. Not sharing any of the data obtained from controlled-access NIH-designated data repositories with individuals other than those listed in the data access request. Agreeing to the listing of a summary of approved research uses in dbGaP along with the investigator's name and organizational affiliation. Agreeing to report any violation of the GDS Policy to the appropriate DAC(s) as soon as it is discovered. Reporting research progress using controlled-access datasets through annual access renewal requests or project close-out reports. Acknowledging in all oral or written presentations, disclosures, or publications the contributing investigator(s) who conducted the original study, the funding organization(s) that supported the work, the specific dataset(s) and applicable accession number(s), and the NIH-designated data repositories through which the investigator accessed any data. Printed Name/Signature of PI Data Request Process Data request can be submitted by the PIs of the AlcHepNet consortium. Internal and external collaborators are encouraged, but the actual request must be submitted by one of the PIs. Data requests by the PI automatically imply he/she is responsible for completing the study in a timely and rigorous fashion, avoids \"mission creep\" and abides by other AlcHepNet policies. Request process Savannah will send approval from ancillary study/publication proposal. With this approval, she will send the data dictionary for PI to review PI will create a table of data for request. Table should include: Subjects to include (i.e., healthy controls, those with 90-day mortality, RCT, etc.) Time points Specific data points such as those with liver transplant, AKI, PT/INR. Not \"outcome related clinical data\" Savannah will subsequently send to IU DCC for review IU DCC will prioritize requests as they come in. Requests can take 1-4 weeks depending on queue $(function () { $(\"#navbar-include\").load(\"../navbar.html\", function () { $(\"#navbar-include a\").each(function () { var href = $(this).attr(\"href\"); if (href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if (href.startsWith(\"Data_Access/\")) { $(this).attr(\"href\", href.replace(\"Data_Access/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); $(\"#navbar-include img\").each(function () { var src = $(this).attr(\"src\"); if (src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function () { console.log('Footer loaded'); }); });" + "title": "Design - AlcHepNet", + "url": "Data_Access/design.html", + "snippet": "Design of ARDaC The architecture of the ARDaC system is composed of the following components: 1. The ARDaC Data Warehouse The heterogeneous clinical data, biosample information, and omics data information will be extracted from the randomized clinica...", + "content": "Design of ARDaC The architecture of the ARDaC system is composed of the following components: 1. The ARDaC Data Warehouse The heterogeneous clinical data, biosample information, and omics data information will be extracted from the randomized clinical trial and all other alcohol-associated hepatitis (AH) research projects, standardized according to the ARDaC Data Standard, harmonized according to the ARDaC Common Data Model, and hosted in a central ARDaC Data Warehouse. Specifically, the novel ARDaC Common Data Model is derived from and compatible with the Genomics Data Common (GDC) Data Model and is compliant with the FAIR Principles so that AlcHepNet multimodal data will be findable, accessible, interoperable, and reusable. The ARDaC Data Warehouse is the data source for the ARDaC web application, which is open to the public, as well as for regular reporting and customized services within the AlcHepNet consortium. A graph-based provenance model is used for comprehensive data dependency and version control. The ARDaC digital entities, including the standards, data model, data, metadata, scripts, and codes, are attributable, trackable, and reproducible. 2. The ARDaC web application The ARDaC system uses the Gen3 data common framework, which is widely used in NIH-sponsored projects. At the data layer, the standardized and harmonized data is extracted from the ARDaC Data Warehouse and injected into the ARDaC Staging Data Warehouse according to the ARDaC Graph Data Model. In the middleware layer, based on the user's input of the filtering criteria, the graph-based data is queried using GraphQL through the elastic search engine, analyzed with Python, and delivered interactively to users using the JavaScript-based react and Storybook libraries.It also integrates the Anagine (ARDaC Analytical Engine) to enhance analytical capacity and translational research potential. The ARDaC web application is containerized as a series of images, each providing a specific service. The ARDaC system can be deployed to the AWS cloud services through the Kubernetes platform or to a dedicated server through the Docker platform. By leveraging the GDC common data model and the Gen3 data commons ecosystem, ARDaC enables data integration with other NIH-funded data commons, delivering a broad impact of AlcHepNet research and data to other research communities. For more information, visit https://ardac.org/" + }, + { + "title": "Link - AlcHepNet", + "url": "Data_Access/link.html", + "snippet": "ARDaC Resources Access ARDaC ARDaC Portal portal.ardac.org ARDaC Website ardac.org GitHub github.com/jing-su/ardac Contact Email ardac@iu.edu", + "content": "ARDaC Resources Access ARDaC ARDaC Portal portal.ardac.org ARDaC Website ardac.org GitHub github.com/jing-su/ardac Contact Email ardac@iu.edu" }, { - "title": "Query System - AlcHepNet", - "url": "Data_Access/query-system.html", - "snippet": "Query System This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Acces", - "content": "Query System This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { // 对于 Data_Access 目录下的链接,直接使用文件名 if(href.startsWith(\"Data_Access/\")) { $(this).attr(\"href\", href.replace(\"Data_Access/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); // 修复图片路径 $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "Policy - AlcHepNet", + "url": "Data_Access/policy.html", + "snippet": "Data Request Policy To apply for AlcHepNet data, the investigator must meet the following criteria: Should have sufficient funds available to support the proposed work Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to ap...", + "content": "Data Request Policy To apply for AlcHepNet data, the investigator must meet the following criteria: Should have sufficient funds available to support the proposed work Any AlcHepNet Steering Committee Principal Investigator (SC PIs) is eligible to apply Non-AlcHepNet affiliates can apply accompanied by the SC PI as their sponsor Must have prior approval from the AlcHepNet publications and ancillary study committee (PAC) IU DCC will only offer data within the scope of SC PI's proposal. Additional data requests will be reviewed by PAC for amended approval. If an investigator generates original data (e.g., omics or genotyping, or cytokines) using the AHN biosamples and later requests clinical data, the DCC will require the investigator to deposit the omics data with the DCC before the clinical data are released. The investigator agrees not to share the phenotype data with a third party without written approval from the AHN DCC or to Publications/Ancillary Studies or Steering Committees. If using genomic data, SC PI must follow NIH's genomic data sharing policy and procedures. Please reference policies at the following link, agree to the following, and sign below: https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html Using the data only for the approved research. Protecting data confidentiality. Following, as appropriate, all applicable national, tribal, and state laws and regulations, as well as relevant institutional policies and procedures for handling genomic data. Not attempting to identify individual participants from whom the data were obtained. Not selling any of the data obtained from NIH-designated data repositories. Not sharing any of the data obtained from controlled-access NIH-designated data repositories with individuals other than those listed in the data access request. Institutional Certifications are expected for the submission of large-scale human genomic data. Agreeing to the listing of a summary of approved research uses in dbGaP along with the investigator's name and organizational affiliation. Agreeing to report any violation of the GDS Policy to the appropriate DAC(s) as soon as it is discovered. Reporting research progress using controlled-access datasets through annual access renewal requests or project close-out reports. Acknowledging in all oral or written presentations, disclosures, or publications the contributing investigator(s) who conducted the original study, the funding organization(s) that supported the work, the specific dataset(s) and applicable accession number(s), and the NIH-designated data repositories through which the investigator accessed any data. Printed Name/Signature of PI Data Request Process Data request can be submitted by the PIs of the AlcHepNet consortium. Internal and external collaborators are encouraged, but the actual request must be submitted by one of the PIs. Data requests by the PI automatically imply he/she is responsible for completing the study in a timely and rigorous fashion, avoids \"mission creep\" and abides by other AlcHepNet policies. Request process Savannah will send approval from ancillary study/publication proposal. With this approval, she will send the data dictionary for PI to review PI will create a table of data for request. Table should include: Subjects to include (i.e., healthy controls, those with 90-day mortality, RCT, etc.) Time points Specific data points such as those with liver transplant, AKI, PT/INR. Not \"outcome related clinical data\" Savannah will subsequently send to IU DCC for review IU DCC will prioritize requests as they come in. Requests can take 1-4 weeks depending on queue" }, { "title": "News & Publications - AlcHepNet", "url": "News_Training/new-publications.html", - "snippet": "News & Publications Latest updates, announcements, and publications from AlcHepNet Latest News & Announcements xxxx Recent Publications xxxx $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !h", - "content": "News & Publications Latest updates, announcements, and publications from AlcHepNet Latest News & Announcements xxxx Recent Publications xxxx $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "News & Publications Latest updates, announcements, and publications from AlcHepNet Latest News & Announcements Jan 2026 News ITAALD Trial Enrollment Began Clinical Trial The ITAALD trial started enrollment in January 2026. The first two patients were...", + "content": "News & Publications Latest updates, announcements, and publications from AlcHepNet Latest News & Announcements Jan 2026 News ITAALD Trial Enrollment Began Clinical Trial The ITAALD trial started enrollment in January 2026. The first two patients were enrolled at the Cleveland Clinic. Congratulations to the Cleveland Clinic team! Recent Publications Loading recent publications..." }, { "title": "Training MI-MET - AlcHepNet", "url": "News_Training/training-mi-met.html", - "snippet": "Training – MI-MET Standardized MI-MET training video for alcohol use intervention techniques. 1. MI-MET Training Video This video demonstrates the full MI-MET interview workflow. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href", - "content": "Training – MI-MET Standardized MI-MET training video for alcohol use intervention techniques. 1. MI-MET Training Video This video demonstrates the full MI-MET interview workflow. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Training – MI-MET Standardized MI-MET training video for alcohol use intervention techniques. 1. MI-MET Training Video This video demonstrates the full MI-MET interview workflow. Members only. The MI-MET training video is available in the restricted ...", + "content": "Training – MI-MET Standardized MI-MET training video for alcohol use intervention techniques. 1. MI-MET Training Video This video demonstrates the full MI-MET interview workflow. Members only. The MI-MET training video is available in the restricted member section. Please log in via the Members portal to access the video." }, { "title": "Training TLFB - AlcHepNet", "url": "News_Training/training-tlfb.html", - "snippet": "Training – Time-Line Follow-Back (TLFB) Standardized TLFB training materials for ITAALD alcohol use assessment. 1. TLFB Training Video This video demonstrates the full TLFB interview workflow. 2. TLFB Training Materials Resource Description Format Download ITAALD TLFB Instruction Manual Full intervi", - "content": "Training – Time-Line Follow-Back (TLFB) Standardized TLFB training materials for ITAALD alcohol use assessment. 1. TLFB Training Video This video demonstrates the full TLFB interview workflow. 2. TLFB Training Materials Resource Description Format Download ITAALD TLFB Instruction Manual Full interviewer training manual and certification guidelines. DOC Download Alcohol Pattern Chart (P1) Used to summarize typical weekly drinking patterns. DOC Download TLFB Calendar (Source Document) Calendar with holidays and anchor events (2025–2030). PDF Download TLFB SDU Calculator Excel tool for converting drinking data into standard drink units. XLSX Download $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { $(this).attr(\"href\", \"../\" + href); } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { console.log('Footer loaded'); }); });" + "snippet": "Training – Time-Line Follow-Back (TLFB) Standardized TLFB training materials for ITAALD alcohol use assessment. 1. TLFB Training Video This video demonstrates the full TLFB interview workflow. Members only. The TLFB training video is available in the...", + "content": "Training – Time-Line Follow-Back (TLFB) Standardized TLFB training materials for ITAALD alcohol use assessment. 1. TLFB Training Video This video demonstrates the full TLFB interview workflow. Members only. The TLFB training video is available in the restricted member section. Please log in via the Members portal to access the video. 2. TLFB Training Materials Resource Description Format Download ITAALD TLFB Instruction Manual Full interviewer training manual and certification guidelines. DOC Download Alcohol Pattern Chart (P1) Used to summarize typical weekly drinking patterns. DOC Download TLFB Calendar (Source Document) Calendar with holidays and anchor events (2025–2030). PDF Download TLFB SDU Calculator Excel tool for converting drinking data into standard drink units. XLSX Download" }, { "title": "Publication Subcommittee - AlcHepNet", "url": "Publishing/publication-subcommittee.html", - "snippet": "Publication Subcommittee Charter The Publication and Ancillary Study Committee (PAC) oversees all publications and ancillary studies arising from AlcHepNet research. The committee reviews proposals, ensures scientific merit, and coordinates authorship across the network. Charter The PAC Charter defi", - "content": "Publication Subcommittee Charter The Publication and Ancillary Study Committee (PAC) oversees all publications and ancillary studies arising from AlcHepNet research. The committee reviews proposals, ensures scientific merit, and coordinates authorship across the network. Charter The PAC Charter defines the committee's roles, responsibilities, and procedures for reviewing publication and ancillary study proposals. It outlines the governance structure and ensures equitable collaboration across the AlcHepNet consortium. Download Charter (DOCX) Guidelines The PAC Guidelines provide detailed instructions for preparing and submitting publication proposals and ancillary study applications. These guidelines help investigators understand requirements, timelines, and expectations for proposal review. Download Guidelines (DOCX) Publication Process Flow Diagram The flow diagram illustrates the step-by-step process for submitting, reviewing, and approving publication proposals within the AlcHepNet network. $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { // 修复navbar中的链接路径 $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { $(\"#footer-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); console.log('Footer loaded and links updated'); }); });" + "snippet": "Publication Subcommittee Charter The Publication and Ancillary Study Committee (PAC) oversees all publications and ancillary studies arising from AlcHepNet research. The committee reviews proposals, ensures scientific merit, and coordinates authorshi...", + "content": "Publication Subcommittee Charter The Publication and Ancillary Study Committee (PAC) oversees all publications and ancillary studies arising from AlcHepNet research. The committee reviews proposals, ensures scientific merit, and coordinates authorship across the network. Charter The PAC Charter defines the committee's roles, responsibilities, and procedures for reviewing publication and ancillary study proposals. It outlines the governance structure and ensures equitable collaboration across the AlcHepNet consortium. Download Charter (DOCX) Guidelines The PAC Guidelines provide detailed instructions for preparing and submitting publication proposals and ancillary study applications. These guidelines help investigators understand requirements, timelines, and expectations for proposal review. Download Guidelines (DOCX) Publication Process Flow Diagram The flow diagram illustrates the step-by-step process for submitting, reviewing, and approving publication proposals within the AlcHepNet network." }, { "title": "AlcHepNet - Publications", "url": "Publishing/publications.html", - "snippet": "AlcHepNet Publications Loading publications... Loading publications... // Load publications data from external source let publicationsData = null; let allYears = []; // Initialize $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var hre", - "content": "AlcHepNet Publications Loading publications... Loading publications... // Load publications data from external source let publicationsData = null; let allYears = []; // Initialize $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { $(\"#footer-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); }); // Load publications data loadPublications(); }); function loadPublications() { $.getJSON('doc/all_publications.json') .done(function(data) { publicationsData = data; // Sort years in descending order (2025 -> 2008) allYears = Object.keys(data.publicationsByYear).sort((a, b) => { return parseInt(b) - parseInt(a); }); // Update total count $('.total-count').html(`Total: ${data.grantInfo.totalPublications} publications (${allYears[allYears.length - 1]} - ${allYears[0]})`); // Hide loading message $('#pubContainer').hide(); // Render all publications renderPublications(); }) .fail(function() { $('#pubContainer').html(`

Error Loading Publications

Unable to load publications data. Please try again later or download the complete list:

Download Publication List (DOCX)

`); }); } function renderPublications() { if (!publicationsData) return; // Clear container $('#yearContainer').empty(); // Render all year sections as collapsible details allYears.forEach((year, index) => { const pubs = publicationsData.publicationsByYear[year]; // Create collapsible section const yearSection = $('
'); // Open first year by default if (index === 0) { yearSection.attr('open', 'open'); } const yearHeader = $(`${year} ${pubs.length} publications`); yearSection.append(yearHeader); const yearContent = $('
'); const pubList = $('
    '); pubs.forEach(pub => { pubList.append(`
  • ${pub.content}
  • `); }); yearContent.append(pubList); yearSection.append(yearContent); $('#yearContainer').append(yearSection); }); }" + "snippet": "AlcHepNet Publications Loading publications... Loading publications...", + "content": "AlcHepNet Publications Loading publications... Loading publications..." }, { "title": "Submission of Publication Proposal - AlcHepNet", "url": "Publishing/submission-of-publication-proposal.html", - "snippet": "AlcHepNet Consortium Publication Proposal Download Template (DOCX) Submit to Savannah 1. Title: 2. Paper Category (Choose one): _________________ Primary papers: Describing the primary objectives. _________________ Secondary papers: Describing the secondary key observations _________________ Explora", - "content": "AlcHepNet Consortium Publication Proposal Download Template (DOCX) Submit to Savannah 1. Title: 2. Paper Category (Choose one): _________________ Primary papers: Describing the primary objectives. _________________ Secondary papers: Describing the secondary key observations _________________ Exploratory papers: Posthoc analyses. 3. Primary investigator proposing: 4. Writing group (should always include a DCC investigator): 5. Background: 6. Hypothesis and aim: 7. Brief study design: 8. Data/Variables: 9. Sample size calculation/power estimation: 10. Statistical analysis plan: 11. Timeline: 12. Deliverable: 13. Funding source: Date Form Submitted: Signature of Principal Investigator: $(function() { $(\"#navbar-include\").load(\"../navbar.html\", function() { $(\"#navbar-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); $(\"#navbar-include img\").each(function() { var src = $(this).attr(\"src\"); if(src && !src.startsWith(\"http\") && !src.startsWith(\"data:\")) { $(this).attr(\"src\", \"../\" + src); } }); console.log('Navbar loaded and links updated'); }); $(\"#search-modal-include\").load(\"../search-modal.html\"); $(\"#footer-include\").load(\"../footer.html\", function() { // 修复footer中的链接 $(\"#footer-include a\").each(function() { var href = $(this).attr(\"href\"); if(href && !href.startsWith(\"http\") && !href.startsWith(\"#\")) { if(href.startsWith(\"Publishing/\")) { $(this).attr(\"href\", href.replace(\"Publishing/\", \"\")); } else { $(this).attr(\"href\", \"../\" + href); } } }); console.log('Footer loaded and links updated'); }); });" + "snippet": "AlcHepNet Consortium Publication Proposal --> Download the publication proposal form below, complete and sign it, then email the completed form to Savannah Yarnelle. Download Proposal Template (DOCX) Email completed form to Savannah Contact: Savannah...", + "content": "AlcHepNet Consortium Publication Proposal --> Download the publication proposal form below, complete and sign it, then email the completed form to Savannah Yarnelle. Download Proposal Template (DOCX) Email completed form to Savannah Contact: Savannah Yarnelle (samussel@iu.edu)" }, { - "title": "ARDaC - AlcHepNet", - "url": "Data_Access/ardac.html", - "snippet": "ARDaC This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer lo", - "content": "ARDaC This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet", + "url": "index.html", + "snippet": "About AlcHepNet Learn more A Clinical Trial of Integrated Therapies for AH and AUD Learn more Previous Next --> About AlcHepNet AlcHepNet: The Alcohol-associated Hepatitis Network AlcHepNet is a collaborative research consortium supported by the Nati...", + "content": "About AlcHepNet Learn more A Clinical Trial of Integrated Therapies for AH and AUD Learn more Previous Next --> About AlcHepNet AlcHepNet: The Alcohol-associated Hepatitis Network AlcHepNet is a collaborative research consortium supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Six leading academic medical centers collaborate to enhance our understanding and treatment of alcohol-associated hepatitis (AH) - a severe inflammatory liver condition linked to heavy alcohol use. AH is one of the most serious causes of liver-related illness and death worldwide. The causes and mechanisms behind the disease are not fully understood, and current treatment options are limited. AlcHepNet brings together experts in hepatology, addiction medicine, clinical trials, and basic science to: study how AH develops and progresses identify biological pathways that may be targeted for therapy conduct clinical trials to test promising new treatments improve outcomes and quality of life for patients and families affected by AH By combining resources and expertise, our network aims to accelerate discovery and translate scientific advances into better care. A Twitter List by AlcHepNet A Clinical Trial of Integrated Therapies for AH and AUD Advancing Treatment Through Research In the current funding cycle, AlcHepNet is conducting a multicenter, randomized, double-blinded, placebo-controlled clinical trial to evaluate new integrated therapies for patients with severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD) . The study’s primary goal is to determine whether combining novel therapy for sAH with treatment of the underlying alcohol use disorder (AUD) leads to better outcomes, including improved composite endpoints of liver and alcohol use events, in comparison with usual care. Participants in the integrated treatment arm receive: F-652 , a human recombinant IL-22 protein being studied for its regenerative and anti-inflammatory properties or Prednisone , corticosteroid that is used as the current standard therapy for sAH Acamprosate , an FDA-approved medication for AUD Structured counseling focused on alcohol cessation The usual AUD care arm receives brief counseling and referral to community-based support, such as 12-step programs. This trial represents a major step toward evidence-based therapy that treats both the liver disease and the underlying alcohol use disorder. For more detailed information about the trial, see ClinicalTrials.gov . AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. -->" }, { - "title": "Design - AlcHepNet", - "url": "Data_Access/design.html", - "snippet": "Design This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer l", - "content": "Design This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet - Site Contacts", + "url": "site-contact.html", + "snippet": "Site Contacts ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY --> Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 620...", + "content": "Site Contacts ALCOHOL-ASSOCIATED HEPATITIS NETWORK OBSERVATIONAL STUDY --> Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data Manager) Ronny Ovando, rmovando@iu.edu (Data Manager) Savannah Yarnelle, samussel@iu.edu (Program Coordinator) Carla Kettler, ckettler@iu.edu (Lead Data Manager) Cleveland Clinic https://my.clevelandclinic.org/departments/digestive/research-innovations Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD (PI) Indiana University https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Raj Vuppalanchi, MD (PI) Mayo Clinic – Rochester https://www.mayo.edu/research/clinical-trials/search-results?keyword=alcoholic%20hepatitis&status=open-unknown 200 First St. SW Rochester, MN 55905 Vijay Shah, MD (PI) Virginia Commonwealth University https://studyfinder.cctr.vcu.edu/ VCU School of Medicine Physical Address: McGlothlin Medical Education Center (MMEC), 1201 E Marshall St., 4th Floor, Suite 4-100 Mailing Address: Box 980565 Richmond, VA 23298 Arun Sanyal, MD (PI) University of Louisville http://louisville.edu/research/ctu University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Ashwani Singal, MD (PI) University of UTSW https://clinicaltrials.utswmed.org/studies?utf8=%E2%9C%93&search%5Bhealthy_volunteers%5D=&search%5Bgender%5D=&search%5Bq%5D=alcoholic+hepatitis&commit=Search Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, Texas 75390 Mack Mitchell, MD (PI) AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. © 2017-2025 Alcohol-associated Hepatitis Network Privacy · Terms --> Back to top" }, { - "title": "Home", - "url": "index.html", - "snippet": "About AlcHepNet Learn more A Clinical Trial of Integrated Therapies for AH and AUD Learn more Previous Next About AlcHepNet AlcHepNet: The Alcohol-associated Hepatitis Network AlcHepNet is a collaborative research consortium supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)", - "content": "About AlcHepNet Learn more A Clinical Trial of Integrated Therapies for AH and AUD Learn more Previous Next About AlcHepNet AlcHepNet: The Alcohol-associated Hepatitis Network AlcHepNet is a collaborative research consortium supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Six leading academic medical centers work together to improve our understanding and treatment of alcohol-associated hepatitis (AH) - a severe inflammatory liver condition linked to heavy alcohol use. AH is one of the most serious causes of liver-related illness and death worldwide. The causes and mechanisms behind the disease are not fully understood, and current treatment options are limited. AlcHepNet brings together experts in hepatology, addiction medicine, clinical trials, and basic science to: study how AH develops and progresses identify biological pathways that may be targeted for therapy conduct clinical trials to test promising new treatments improve outcomes and quality of life for patients and families affected by AH By combining resources and expertise, our network aims to accelerate discovery and translate scientific advances into better care. A Twitter List by AlcHepNet A Clinical Trial of Integrated Therapies for AH and AUD Advancing Treatment Through Research In the current funding cycle, AlcHepNet is conducting a multicenter, randomized, double-blinded, placebo-controlled clinical trial to evaluate new integrated therapies for patients with severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The study’s primary goal is to determine whether combining novel therapy for sAH with treatment of the underlying alcohol use disorder (AUD) leads to better outcomes, including improved composite endpoints of liver and alcohol use events, in comparison with usual care. Participants in the integrated treatment arm receive: F-652, a human recombinant protein being studied for its regenerative and anti-inflammatory properties Acamprosate, an FDA-approved medication for AUD structured counseling focused on alcohol cessation The standard care arm receives brief counseling and referral to community-based support, such as 12-step programs. For more detailed information about the trial, see ClinicalTrials.gov. This trial represents a major step toward evidence-based therapy that treats both the liver disease and the underlying alcohol use disorder. AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. $(function () { $(\"#navbar-include\").load(\"navbar.html\", function () { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function () { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2026)", + "url": "Publishing/publications.html", + "snippet": "Nguyen CM, Blaney HL, Su J, Jiang S, Li Y, Li Y, Gawrieh S, Tu W, Liangpunsakul S. Real-world impact of AUD pharmacotherapy on healthcare utilization, cost, and cost-effectiveness in the US. Hepatology.:10-97. Nguyen CM, Su J, Li Y, Healey R, Jiang S...", + "content": "AlcHepNet Publications 2026. Nguyen CM, Blaney HL, Su J, Jiang S, Li Y, Li Y, Gawrieh S, Tu W, Liangpunsakul S. Real-world impact of AUD pharmacotherapy on healthcare utilization, cost, and cost-effectiveness in the US. Hepatology.:10-97. Nguyen CM, Su J, Li Y, Healey R, Jiang S, Li J, Chalasani N, Gawrieh S, Liangpunsakul S, Tu W. Short-term costs of alcohol-associated hepatitis care in different clinical settings. Hepatology Communications. 2026 Feb 1;10(2):e0634." }, { - "title": "Link - AlcHepNet", - "url": "Data_Access/link.html", - "snippet": "Link This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loa", - "content": "Link This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2025)", + "url": "Publishing/publications.html", + "snippet": "Singal AK, Piano S. Tapered Corticosteroids in Severe Alcohol-Associated Hepatitis: A Strategy to Maximize Benefit and Minimize Harm. Am J Gastroenterol. 2025 Dec 1;120(12):2761–2763. Ismail A, Awadalla M, Pothuraju S, Singal AK. Hepatic hydrothorax:...", + "content": "AlcHepNet Publications 2025. Singal AK, Piano S. Tapered Corticosteroids in Severe Alcohol-Associated Hepatitis: A Strategy to Maximize Benefit and Minimize Harm. Am J Gastroenterol. 2025 Dec 1;120(12):2761–2763. Ismail A, Awadalla M, Pothuraju S, Singal AK. Hepatic hydrothorax: A review. Curr Hepatol Rep. 2025 Dec;24(1). Burton R, Leggio L, Louvet A, Sheron N, Singal AK. Prevention of alcohol-associated liver disease. Am J Gastroenterol. 2025 Nov 1;120(11):2487–2501. Lü L, Bai M, Wang X, Liu J, Wu X, Zhang H-G, Feng W, Chen S-Y. Ethanol exposure impaired mitotic division in apical radial glial cells and disrupted early cortical development in human forebrain organoids: Implications for ethanol-induced microcephaly. Toxicology. 2025 Nov;517:154244. Xu Q, Teng Y, Huang Y, Mu J, Teng L, Qian H, Huang Q, Liu M, Zou Y, Zhang L, Merchant ML, Zhang X, Yan J, Zhang H-G. Onion-mitochondria inhibit lipopolysaccharide-induced acute lung injury by shaping lung macrophage mitochondrial function. Adv Sci (Weinh). 2025 Oct 6;e06107. Warner DR, Warner JB, Hardesty JE, Abdelfadil Y, Soni C, Bauer P, Maldonado C, McClain CJ, Kirpich IA. Hepatocyte-specific transcriptional responses to liver-targeted delivery of a soluble epoxide hydrolase inhibitor in a mouse model of alcohol-associated liver disease. Biology (Basel). 2025 Sep 13;14(9). Dasarathy S, Tu W, Welch N, Gawrieh S, Yu Y, Tang Q, Kettler C, Sanyal AJ, Szabo G, Shah VH, Bataller R, Nagy LE, McClain CJ, Chalasani N, Kerr T, Mitchell MC; AlcHepNet Investigators. Natural history and development of a novel composite endpoint in patients with alcohol-associated hepatitis: Data from a prospective multicenter study. Hepatology. 2025 Sep 9. PMID: 40924794. Dasarathy S, Tu W, Welch N, Gawrieh S, Yu Y, Tang Q, Kettler C, Sanyal AJ, Szabo G, Shah VH, Bataller R. Natural history and development of a novel composite endpoint in patients with alcohol-associated hepatitis: Data from a prospective multicenter study. Hepatology. 2025 Sep 9:10-97. Vilar-Gomez E, Nephew L, Gawrieh S, Vuppalanchi R, Kettler C, Pike F, Tu W, Samala N, Liangpunsakul S, Chalasani N. Healthy eating and physical activity significantly lower sex-specific alcohol-attributable liver mortality in the United States. Journal of Hepatology. 2025 Aug 27. Thakurdesai A, Kumari A, Shay H, Elgharabawy K, Winrich EJ, Zhang W, Jackson A, Cave MC, Kong M, Zhang X, Singal AK, McClain CJ, Vatsalya V. Chronic and heavy drinking, nutrition status, and progression of liver injury negatively affect the mortality risk in patients suffering from alcohol-associated hepatitis. J Clin Med. 2025 Aug 31;14(17). Dlugas H, Zhang X, Kim S. Comparative analysis of continuous similarity measures for compound identification in mass spectrometry-based metabolomics. Chemom Intell Lab Syst. 2025 Aug 15;263. Ekuban FA, Gripshover TC, Ames P, Biswas K, Bolatimi OE, Abramson J, Iyer M, Luo J, Ekuban A, Hwang JY, Park JW, Banerjee M, Watson WH, Wahlang B, Bello D, Schlezinger JJ, McClain CJ, Cave MC. Perfluorooctane sulfonate exposure and alcohol-associated liver disease severity in a mouse chronic-binge ethanol feeding model. Toxicol Sci. 2025 Aug 1;206(2):388–408. Feng J, He L, Ma X, Yin X, Mueller EG, Zhou Z, Feng W, McClain CJ, Zhang X. Comparison of liver bile acid profiles in chronic alcohol feeding and NIAAA binge-on-chronic alcohol feeding mouse models. J Chromatogr B. 2025 Aug 1;1262:124650. Warner DR, Warner JB, Abdelfadil Y, Hardesty JE, Treves R, Lei C, Hanford HE, McClain CJ, Kirpich IA. Effects of soluble epoxide hydrolase inhibition on liver injury and gut microbiota in mice chronically fed ethanol. Alcohol Clin Exp Res. 2025 Aug;49(8):1730–1743. Wang Q, Chen W-J, Su J, Wang G, Song Q. HECLIP: histology-enhanced contrastive learning for imputation of transcriptomics profiles. Bioinformatics. 2025 Jul 1;41(7). PMID: 40569046. Cabré N, et al. Activation of intestinal endogenous retroviruses by alcohol exacerbates liver disease. J Clin Invest. 2025 Jul 1;135(13). PMID: 40359032. Hsu CL, et al. Viral antibody response predicts morbidity and mortality in alcohol-associated hepatitis. Hepatology. 2025 Jul 1;82(1):127–139. PMID: 39325984. Yang Y, et al. Targeted inhibition of pathobiont virulence factor mitigates alcohol-associated liver disease. Cell Host Microbe. 2025 Jun 11;33(6):957–972.e6. PMID: 40441146. Tu W, Gawrieh S, Nephew L, McClain C, Tang Q, Dasarathy S, Vatsalya V, Simonetto DA, Kettler C, Szabo G, Barton B, Yu Y, Kamath PS, Sanyal AJ, Nagy L, Mitchell MC, Liangpunsakul S, Shah VH, Chalasani N, Bataller R; AlcHepNet Investigators. Parental liver disease mortality is associated with unfavorable outcomes in patients with alcohol-associated hepatitis. Hepatol Commun. 2025 Jun 1;9(6). PMID: 40408279. Tu W, Gawrieh S, Nephew L, McClain C, Tang Q, Dasarathy S, Vatsalya V, Simonetto DA, Kettler C, Szabo G, Barton B, et al. Parental liver disease mortality is associated with unfavorable outcomes in patients with alcohol-associated hepatitis. Hepatology Communications. 2025;9(6):e0666. Welch N, Kannan P, Mishra S, Bellar A, Agrawal V, Kidd G, Benson E, Musich R, Tabbalat R, Li L, Brown JM, Willard B, Esser KA, Nagy LE, Dasarathy S. Integrated Multiomics Analyses of the Molecular Landscape of Sarcopenia in Alcohol-Related Liver Disease. J Cachexia Sarcopenia Muscle. 2025 Jun;16(3):e13818. PMID: 40308032. Singal AK. Preface (Introduction): Metabolic Liver Disease: A New Era in Hepatology. Semin Liver Dis. 2025 Jun;45(2):145–147. Singal AK, Wong RJ, Dasarathy S, Abdelmalek MF, Neuschwander-Tetri BA, Limketkai BN, Petrey J, McClain CJ. ACG Clinical Guideline: Malnutrition and Nutritional Recommendations in Liver Disease. Am J Gastroenterol. 2025 May 1;120(5):950–972. Singal AK, Zhang W, Shetty A, Patel A, Mohammed S, Bhandari P, Abdallah M, Vatsalya V, Leggio L, Kong M. Treatment of alcohol use disorder in alcohol-associated liver disease: A meta-analysis. Hepatol Commun. 2025 May 1;9(5). Norden-Krishmar TM, Rotroff D, Schwantes-An T-H, Bataller R, Goldman D, Nagy LE, Liangpunsakul S. Genomic approaches to explore susceptibility and pathogenesis of alcohol use disorder and alcohol-associated liver disease. Hepatology. 2025 May 1;81(5):1595–1606. PMID: 37796138. Singal AK, Dunn W, Wong R, Kulkarni A, Kuo Y-F. Differential candidate characteristics associated with increasing ALD and MASH among liver transplant listings in the US. Dig Liver Dis. 2025 May;57(5):578–584. Fujiki J, et al. Insertion sequence-mediated phage resistance contributes to attenuated colonization of cytolytic Enterococcus faecalis variants in the gut. Microbiol Spectr. 2025 Apr 15;13(5):e0330324. PMID: 40231830. Patidar KR, Tu W, et al. Acute kidney injury in severe alcohol-associated hepatitis treated with anakinra plus zinc or prednisone. Hepatology. 2025 Apr 1;81(4):1256–1268. PMID: 39028887. Patidar KR, Tu W, Cotter TG, Simonetto DA, Asgharpour A, Jan MY, Tang Q, Yu Y, Li Y, Taiwo M, Thevkar Nagesh P, Dasarathy S, Kamath PS, McClain CJ, Chalasani N, Szabo G, Bataller R, Mitchell M, Mehal WZ, Nagy LE, Shah VH, Gawrieh S, Sanyal AJ; AlcHepNet Investigators. Acute kidney injury in severe alcohol-associated hepatitis treated with anakinra plus zinc or prednisone. Hepatology. 2025 Apr 1;81(4):1256–1268. PMID: 39028887. Patidar KR, Tu W, Cotter TG, Simonetto DA, Asgharpour A, Jan MY, Tang Q, Yu Y, Li Y, Taiwo M, Nagesh PT. Acute kidney injury in severe alcohol-associated hepatitis treated with anakinra plus zinc or prednisone. Hepatology. 2025 Apr 1;81(4):1256-68. Arab JP, Díaz LA, Rehm J, Im G, Arrese M, Kamath PS, Lucey MR, Mellinger J, Thiele M, Thursz M, Bataller R, Burton R, Chokshi S, Francque SM, Krag A, Lackner C, Lee BP, Liangpunsakul S, MacClain C, Mandrekar P, Mitchell MC, Morgan MY, Morgan TR, Pose E, Shah VH, Shawcross D, Sheron N, Singal AK, Stefanescu H, Terrault N, Trépo E, Moreno C, Louvet A, Mathurin P. Metabolic dysfunction and alcohol-related liver disease (MetALD): Position statement by an expert panel on alcohol-related liver disease. J Hepatol. 2025 Apr;82(4):744–756. PMID: 39608457. Le P, Tatar M, Rothberg MB, Wilson LA, Allende D, Diehl AM, Loomba R, Chalasani N, Neuschwander-Tetri BA, Kowdley K, Sanyal AJ, Tonascia J; NASH Clinical Research Network (CRN). Association of Components of Metabolic Syndrome and the Progression of Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2025 Mar 31. PMID: 40163040. Alkhouri N, Cheuk-Fung Yip T, Castera L, Takawy M, Adams LA, Verma N, Arab JP, Jafri S-M, Zhong B, Dubourg J, Chen VL, Singal AK, Díaz LA, Dunn N, Nadeem R, Wong W-SV, Abdelmalek MF, Wang Z, Duseja A, Almahanna Y, Omeish HA, Ye J, Harrison SA, Cristiu J, Arrese M, Robert S, Wong L-HG, Bajunayd A, Shao C, Kubina M, Dunn W. ALADDIN: A machine learning approach to enhance the prediction of significant fibrosis or higher in metabolic dysfunction-associated steatotic liver disease. Am J Gastroenterol. 2025 Mar 27. Cotter TG, Anouti A, Zhang B, Rady ED, Patel M, Patel S, Ellis DJ, Lieber SR, Rich NE, O'Leary JG, Mitchell MC, Singal AG. Disparities in Alcohol-Associated Liver Disease Hospital Encounters Amongst a Texas-Based Cohort of Patients. Aliment Pharmacol Ther. 2025 Mar;61(6):988–999. PMID: 39821471. Ghare S, Warner D, Warner J, Chilton PM, Lee J, Zhang JW, Wang M, Hardesty J, Treves R, Gabbard J, Anderson C, Batra L, Sreenivasan C, Kraenzle J, McCulley M, McCoy S, Zhang L, Feng W, Gondim DD, Barve S, Zheng J, Palmer K, McClain C, Kirpich I. Impact of chronic ethanol consumption and SARS-CoV-2 on the liver and intestine: A pilot dose-response study in mice. Alcohol Clin Exp Res. 2025 Mar;49(3):587–598. Ritzenthaler JD, Ekuban A, Horsman B, Roman J, Watson WH. Alcohol-induced liver injury is mediated via α4-containing nicotinic acetylcholine receptors expressed in hepatocytes. Alcohol Clin Exp Res. 2025 Mar;49(3):515–525. Yamazaki T, Schnabl B. Acute alcohol-associated hepatitis: latest findings in non-invasive biomarkers and treatment. Liver Int. 2025 Mar;45(3):e15608. PMID: 37183549. Teng Y, Luo C, Qiu X, Mu J, Sriwastva MK, Xu Q, Liu M, Hu X, Xu F, Zhang L, Park JW, Hwang JY, Kong M, Liu Z, Zhang X, Xu R, Yan J, Merchant ML, McClain CJ, Zhang H-G. Plant-nanoparticles enhance anti-PD-L1 efficacy by shaping human commensal microbiota metabolites. Nat Commun. 2025 Feb 3;16:1295. Nguyen CM, Su J, Li Y, Healey R, Jiang S, Li J, Chalasani N, Gawrieh S, Liangpunsakul S, Tu W. Short-term costs of alcohol-associated hepatitis care in different clinical settings. Hepatol Commun. 2025 Feb 1;9(2). PMID: 39878651. Nguyen CM, Su J, Li Y, Healey R, Jiang S, Li J, Chalasani N, Gawrieh S, Liangpunsakul S, Tu W. Short-term costs of alcohol-associated hepatitis care in different clinical settings. Hepatology Communications. 2025;9(2):e0634. Yamazaki T, Cable EE, Schnabl B. Peroxisome proliferator-activated receptor delta and liver diseases. Hepatol Commun. 2025 Feb 1;9(2). PMID: 39899669. Gripshover TC, Treves RS, Rouchka EC, Chariker JH, Zheng S, Hudson E, Smith ML, Singal AK, McClain CJ, Hardesty JE. Visium spatial transcriptomics and proteomics identifies novel hepatic cell populations and transcriptomic signatures of alcohol-associated hepatitis. Alcohol Clin Exp Res. 2025 Jan;49(1):106–116." }, { - "title": "Observational Study - AlcHepNet", - "url": "obs.html", - "snippet": "Observational Study (OBS) This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { co", - "content": "Observational Study (OBS) This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2024)", + "url": "Publishing/publications.html", + "snippet": "Kreimeyer H, et al. Faecal proteomics links neutrophil degranulation with mortality in patients with alcohol-associated hepatitis. Gut. 2024 Dec 10;74(1):103–115. PMID: 39033024. Xu M, Taylor MS, Hill BG, Li X, Rouchka EC, McClain CJ, Song M. Intesti...", + "content": "AlcHepNet Publications 2024. Kreimeyer H, et al. Faecal proteomics links neutrophil degranulation with mortality in patients with alcohol-associated hepatitis. Gut. 2024 Dec 10;74(1):103–115. PMID: 39033024. Xu M, Taylor MS, Hill BG, Li X, Rouchka EC, McClain CJ, Song M. Intestine epithelial-specific hypoxia-inducible factor-1α overexpression ameliorates western diet-induced MASLD. Hepatol Commun. 2024 Dec 1;8(12). Bolatimi OE, Hua Y, Ekuban FA, Gripshover TC, Ekuban A, Luulay B, Watson WH, Hardesty JE, Wahlang B. Low dose exposure to dioxins alters hepatic energy metabolism and steatotic liver disease development in a sex-specific manner. Environ Int. 2024 Dec;194:109152. Goldscheitter GM, Seneshaw M, Mirshahi F, Buettmann EG, Genetos DC, Sanyal AJ, Donahue HJ. Sexual dimorphism of MASLD-driven bone loss. bioRxiv [preprint]. 2024 Nov 28. PMID: 39651131. He L, Xu R, Ma X, Yin X, Mueller E, Feng W, Menze M, Kim S, McClain CJ, Zhang X. Multiomics studies on metabolism changes in alcohol-associated liver disease. J Proteome Res. 2024 Nov 1;23(11):4962–4972. Hardesty JE, McClain CJ. Current pharmacotherapy and nutrition therapy of alcohol-associated liver disease. Clin Liver Dis. 2024 Nov;28(4):731–745. Tu W, Liangpunsakul S, Nguyen CM, Healey R, Li Y, Radaeva S, Gawrieh S, Bataller R, Su J. Risk of mortality among patients with alcohol-associated hepatitis in the US from 2007 to 2021. Alcohol. 2024 Nov;120:143–150. PMID: 38908609. Yang Y, Schnabl B. Gut bacteria in alcohol-associated liver disease. Clin Liver Dis. 2024 Nov;28(4):663–679. PMID: 39362714. Wu Z, Chen S-Y, Zheng L. Sulforaphane attenuates ethanol-induced teratogenesis and dysangiogenesis in zebrafish embryos. Int J Mol Sci. 2024 Oct 27;25(21). Sun D, Guo Y, Li Y, Sun J, Tu W. A flexible time-varying coefficient rate model for panel count data. Lifetime Data Anal. 2024 Oct;30(4):721–741. PMID: 38805094. Brown K, Funk K, Figueroa Barrientos A, Bailey A, Shrader S, Feng W, McClain CJ, Song Z-H. The modulatory effects and therapeutic potential of cannabidiol in the gut. Cells. 2024 Sep 26;13(19). Hardesty JE, Warner JB, Wilkey DW, Phinney BS, Salemi MR, Merchant ML, McClain CJ, Warner DR, Kirpich IA. Hepatic proteomic changes associated with liver injury caused by alcohol consumption in Fpr2-/- mice. Int J Mol Sci.2024 Sep 11;25(18). Lee BP, Witkiewitz K, Mellinger J, et al. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nat Rev Gastroenterol Hepatol. 2024 Sep;21(9):626–645. PMID: 38849555. Attaway AH, Mehra R, Zein JG, et al. Nocturnal Hypoxemia Is Associated with Sarcopenia in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2024 Sep;21(9):1316–1325. PMID: 38843487. Liu H, Su P, Li Y, et al. VAMP2 controls murine epidermal differentiation and carcinogenesis by regulation of nucleophagy. Dev Cell. 2024 Aug 5;59(15):2005–2016.e4. Sayed K, Dolin CE, Wilkey DW, et al. A plasma peptidomic signature reveals extracellular matrix remodeling and predicts prognosis in alcohol-associated hepatitis. Hepatol Commun. 2024 Aug 1;8(8). Yamazaki T, et al. Serum aryl hydrocarbon receptor activity is associated with survival in patients with alcohol-associated hepatitis. Hepatology. 2024 Aug 1;80(2):403–417. PMID: 38377466. Xu F, Ren Y, Teng Y, et al. Tryptophan as a new member of RNA-induced silencing complexes prevents colon cancer liver metastasis. Adv Sci (Weinh). 2024 Aug;11(31):e2307937. Zeng S, Schnabl B. Gut mycobiome alterations and implications for liver diseases. PLoS Pathog. 2024 Aug;20(8):e1012377. PMID: 39116092. Mishra S, Welch N, Singh SSK, et al. Ammonia transporter RhBG initiates downstream signaling and functional responses by activating NFκB. Proc Natl Acad Sci U S A. 2024 Jul 30;121(31):e2314760121. PMID: 39052834. Xu M, Li M, Benz F, Merchant M, McClain CJ, Song M. Ileum proteomics identifies distinct pathways associated with different dietary doses of copper-fructose interactions: Implications for the gut-liver axis and MASLD. Nutrients.2024 Jun 29;16(13). Chen J, Li F, Lee J, et al. Peripherally restricted CB1 receptor inverse agonist JD5037 treatment exacerbates liver injury in MDR2-deficient mice. Cells. 2024 Jun 25;13(13). Welch N, Mishra S, Bellar A, et al. Differential impact of sex on regulation of skeletal muscle mitochondrial function and protein homeostasis by hypoxia-inducible factor-1α in normoxia. J Physiol. 2024 Jun;602(12):2763–2806. PMID: 38761133. Gawrieh S, Dasarathy S, Tu W, et al.; AlcHepNet Investigators. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis. J Hepatol. 2024 May;80(5):684–693. PMID: 38342441. Gawrieh S, Dasarathy S, Tu W, et al.; AlcHepNet Investigators. Randomized trial of anakinra plus zinc vs prednisone for severe alcohol-associated hepatitis. J Hepatol. 2024 May;80(5):684–693. 2024 May. Condon S, Hu H, Kong M, Cave MC, McClain CJ. ALT poorly predicts NAFLD and liver fibrosis as determined by vibration-controlled transient elastography in adult NHANES 2017–2018. 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Risk of mortality among patients with alcohol-associated hepatitis in the US from 2007 to 2021. Alcohol. 2024. (accepted)" }, { - "title": "Randomized Controlled Trial - AlcHepNet", - "url": "rct.html", - "snippet": "Randomized Controlled Trial (RCT) This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", functio", - "content": "Randomized Controlled Trial (RCT) This page is under construction. Content will be added soon. $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2023)", + "url": "Publishing/publications.html", + "snippet": "Sayed K, Dolin CE, Wilkey DW, Li J, Sato T, Beier JI, Argemi J, Vatsalya V, McClain CJ, Bataller R, Wahed AS, Merchant ML, Benos PV, Arteel GE. A plasma peptidomic signature reveals extracellular matrix remodeling and predicts prognosis in alcohol-re...", + "content": "AlcHepNet Publications 2023. Sayed K, Dolin CE, Wilkey DW, Li J, Sato T, Beier JI, Argemi J, Vatsalya V, McClain CJ, Bataller R, Wahed AS, Merchant ML, Benos PV, Arteel GE. A plasma peptidomic signature reveals extracellular matrix remodeling and predicts prognosis in alcohol-related hepatitis. medRxiv. 2023 Dec 14. 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PMCID: PMC10544749." }, { - "title": "AlcHepNet - Site Contacts", - "url": "site-contact-backup.html", - "snippet": "Site Contacts Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data", - "content": "Site Contacts Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data Manager) Ronny Ovando, rmovando@iu.edu (Data Manager) Savannah Yarnelle, samussel@iu.edu (Program Coordinator) Carla Kettler, ckettler@iu.edu (Lead Data Manager) Cleveland Clinic https://my.clevelandclinic.org/departments/digestive/research-innovations Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD (PI) Indiana University https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Raj Vuppalanchi, MD (PI) Mayo Clinic – Rochester https://www.mayo.edu/research/clinical-trials/search-results?keyword=alcoholic%20hepatitis&status=open-unknown 200 First St. SW Rochester, MN 55905 Vijay Shah, MD (PI) Virginia Commonwealth University https://studyfinder.cctr.vcu.edu/ VCU School of Medicine Physical Address: McGlothlin Medical Education Center (MMEC), 1201 E Marshall St., 4th Floor, Suite 4-100 Mailing Address: Box 980565 Richmond, VA 23298 Arun Sanyal, MD (PI) University of Louisville http://louisville.edu/research/ctu University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Ashwani Singal, MD (PI) University of UTSW https://clinicaltrials.utswmed.org/studies?utf8=%E2%9C%93&search%5Bhealthy_volunteers%5D=&search%5Bgender%5D=&search%5Bq%5D=alcoholic+hepatitis&commit=Search Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, TX 75390-8887 Mack Mitchell, MD (PI) University of Michigan https://www.uofmhealth.org/conditions-treatments/digestive-and-liver-health University of Michigan Health System 1500 E Medical Center Dr Ann Arbor, MI 48109 Robert Fontana, MD (PI) University of Pittsburgh https://www.upmc.com/services/liver-disease University of Pittsburgh Medical Center 200 Lothrop Street Pittsburgh, PA 15213 Ramon Bataller, MD (PI) University of California San Francisco https://liver.ucsf.edu/ UCSF Medical Center 505 Parnassus Avenue San Francisco, CA 94143 Norah Terrault, MD (PI) University of North Carolina https://www.med.unc.edu/gi/ UNC School of Medicine 101 Manning Drive Chapel Hill, NC 27514 Andrew Muir, MD (PI) $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2022)", + "url": "Publishing/publications.html", + "snippet": "Kim A, Cajigas-Du Ross CK, Dasarathy J, Bellar A, Streem D, Welch N, Dasarathy S, Nagy LE. Diminished function of cytotoxic T- and NK- cells in severe alcohol-associated hepatitis. Metab Target Organ Damage. 2022 Dec;2(4). PMID: 39148503. Gao B, et a...", + "content": "AlcHepNet Publications 2022. Kim A, Cajigas-Du Ross CK, Dasarathy J, Bellar A, Streem D, Welch N, Dasarathy S, Nagy LE. Diminished function of cytotoxic T- and NK- cells in severe alcohol-associated hepatitis. Metab Target Organ Damage. 2022 Dec;2(4). PMID: 39148503. Gao B, et al. Correlation between serum steroid hormones and gut microbiota in patients with alcohol-associated liver disease. Metabolites. 2022 Nov 13;12(11). PMID: 36422247. Szabo G, Mitchell M, McClain CJ, Dasarathy S, Barton B, McCullough AJ, Nagy LE, Kroll-Desrosiers A, Tornai D, Min HA, et al. Reply. Hepatology. 2022 Nov;76(5):E114–E115. PMID: 35778779. Li Y, Liu H, Wang X, Tu W. Semi-parametric time-to-event modelling of lengths of hospital stays. J R Stat Soc Ser C Appl Stat. 2022 Nov;71(5):1623–1647. PMID: 36632280. Warner JB, et al. Analysis of alcohol use, micronutrient and macronutrient consumption, and liver health in NHANES 2017–2018. Alcohol Clin Exp Res. 2022 Nov;46(11):2025–2040. Szabo G, Mitchell M, McClain CJ, Dasarathy S, Barton B, McCullough AJ, Nagy LE, Kroll-Desrosiers A, Tornai D, Min HA, et al. IL-1 receptor antagonist plus pentoxifylline and zinc for severe alcohol-associated hepatitis. Hepatology. 2022 Oct;76(4):1058–1068. PMID: 35340032. Hartmann P, Schnabl B. Inexpensive, accurate, and stable method to quantitate blood alanine aminotransferase (ALT) levels. Methods Protoc. 2022 Oct 14;5(5). PMID: 36287053. Lei C, et al. Enteric VIP-producing neurons maintain gut microbiota homeostasis through regulating epithelium fucosylation. Cell Host Microbe. 2022;30(10):1417–1434.e8. Cummins TD, et al. Advances in proteomic profiling of pediatric kidney diseases. Pediatr Nephrol.2022;37(10):2255–2265. Maccioni L, et al. Duodenal CD8⁺ T resident memory cell apoptosis contributes to gut barrier dysfunction and microbial translocation in early alcohol-associated liver disease in humans. Aliment Pharmacol Ther. 2022 Sep;56(6):1055–1070. PMID: 35919965. Liu J, et al. A semiparametric model for between-subject attributes: applications to beta-diversity of microbiome data. Biometrics. 2022 Sep;78(3):950–962. PMID: 34010477. Hasa E, Hartmann P, Schnabl B. Liver cirrhosis and immune dysfunction. Int Immunol. 2022 Sep 6;34(9):455–466. PMID: 35792761. Martino C, et al. Acetate reprograms gut microbiota during alcohol consumption. Nat Commun. 2022 Aug 8;13(1):4630. PMID: 35941112. Watson WH, et al. Mice lacking α4 nicotinic acetylcholine receptors are protected against alcohol-associated liver injury. Alcohol Clin Exp Res. 2022;46(8):1371–1383. Kim S, Kato I, Zhang X. Comparative analysis of binary similarity measures for compound identification in mass spectrometry–based metabolomics. Metabolites. 2022;12(8). Carvalho-Gontijo R, et al. Metabolic injury of hepatocytes promotes progression of NAFLD and AALD. Semin Liver Dis. 2022 Aug;42(3):233–249. PMID: 36001995. Hsu CL, et al. Intestinal virome in patients with alcohol use disorder and after abstinence. Hepatol Commun. 2022 Aug;6(8):2058–2069. PMID: 35368152. Hardesty J, et al. Hepatic protein and phosphoprotein signatures of alcohol-associated cirrhosis and hepatitis. Am J Pathol. 2022;192(7):1066–1082. Kouno T, et al. Selective PPARδ agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 via the fibroblast growth factor 21 signaling pathway. J Biol Chem. 2022 Jul;298(7):102056. PMID: 35605662. Teng Y, et al. Gut bacterial isoamylamine promotes age-related cognitive dysfunction by promoting microglial cell death. Cell Host Microbe. 2022;30(7):944–960.e8. Bajaj JS, Ng SC, Schnabl B. Promises of microbiome-based therapies. J Hepatol. 2022 Jun;76(6):1379–1391. PMID: 35589257. Gao B, et al. Lipidomics for the prediction of progressive liver disease in patients with alcohol use disorder. Metabolites. 2022 May 11;12(5). PMID: 35629937. Madathanapalli A, Tang Q, Lammert C, Samala N, Shah VH, Sanyal A, Chalasani N, Desai AP. Health-related quality of life is dynamic in alcoholic hepatitis and responds to improvement in liver disease and reduced alcohol consumption. Alcohol Clin Exp Res. 2022 Feb;46(2):252–261. PMID: 34862610. Mendes BG, Duan Y, Schnabl B. Immune response of an oral Enterococcus faecalis phage cocktail in a mouse model of ethanol-induced liver disease. Viruses. 2022 Feb 27;14(3). PMID: 35336897. Duan Y, Young R, Schnabl B. Bacteriophages and their potential for treatment of gastrointestinal diseases. Nat Rev Gastroenterol Hepatol. 2022 Feb;19(2):135–144. PMID: 34782783. Agarwal R, Tu W. NIH Funding, Research Productivity, and Scientific Impact: a 20-Year Study. J Gen Intern Med.2022 Jan;37(1):104–109. PMID: 33655385. Gao B, et al. Machine learning applied to omics datasets predicts mortality in patients with alcoholic hepatitis. Metabolites. 2022 Jan 5;12(1). PMID: 35050163. Schnabl B, et al. Liver specific, systemic and genetic contributors to alcohol-related liver disease progression. Z Gastroenterol. 2022 Jan;60(1):36–44. PMID: 35042252. Ferragut Cardoso AP, et al. Temporal modulation of differential alternative splicing in HaCaT keratinocytes chronically exposed to arsenic. Environ Health Perspect. 2022;130(1):17011. Cave MC, et al. Circulating microRNAs, polychlorinated biphenyls, and environmental liver disease in the Anniston Community Health Survey. Environ Health Perspect. 2022;130(1):17003. Hu K, Perez-Matos MC, Argemi J, et al. Lipoprotein Z, a hepatotoxic lipoprotein, predicts outcome in alcohol-associated hepatitis. Hepatology. 2022 Apr;75(4):968–982. PMID: 34662439. Demir M, et al. The fecal mycobiome in non-alcoholic fatty liver disease. J Hepatol. 2022 Apr;76(4):788–799. PMID: 34896404. Zeng S, Schnabl B. Roles for the mycobiome in liver disease. Liver Int. 2022 Apr;42(4):729–741. PMID: 34995410. Hartmann P, et al. Colesevelam ameliorates non-alcoholic steatohepatitis and obesity in mice. Hepatol Int. 2022 Apr;16(2):359–370. PMID: 35075592. Ma S, et al. RORγt phosphorylation protects against T cell-mediated inflammation. Cell Rep. 2022 Mar 15;38(11):110520. PMID: 35294872. Sundaram K, et al. Garlic exosome-like nanoparticles reverse high-fat diet–induced obesity via the gut/brain axis. Theranostics. 2022;12(3):1220–1246. Kumar A, et al. Ginger nanoparticles–mediated induction of Foxa2 prevents high-fat diet–induced insulin resistance. Theranostics. 2022;12(3):1388–1403. Sriwastva MK, et al. Exosome-like nanoparticles from mulberry bark prevent DSS-induced colitis via the AhR/COPS8 pathway. EMBO Rep. 2022;23(3):e53365. (month/day not specified in citation) Xu F, Mu J, Teng Y, et al. Restoring oat nanoparticle-mediated brain memory function of mice fed alcohol by sorting inflammatory Dectin-1 complex into microglial exosomes. Small.2022;18(6):e2105385. (month/day not specified in citation) Salazar-González RA, et al. Arylamine N-acetyltransferase 1 activity is regulated by the protein acetylation status. Front Pharmacol. 2022;13:797469. (month/day not specified in citation) Hardesty J, et al. Alterations in hepatic albumin phosphorylation in patients with alcohol-associated hepatitis and cirrhosis. FASEB J. 2022;36(Suppl 1). (month/day not specified in citation) Hu H, et al. Prevalence and treatment for alcohol use disorders based on Kentucky Medicaid 2012–2019 datasets. J Alcohol Drug Depend. 2022;10. (month/day not specified in citation) Hong KU, et al. Proteomic analysis of arylamine N-acetyltransferase 1 knockout breast cancer cells: Implications in immune evasion and mitochondrial biogenesis. Toxicol Rep. 2022;9:1566–1573. (month/day not specified in citation) Srivastava S. Effects of environmental polycyclic aromatic hydrocarbon exposure and pro-inflammatory activity on type 2 diabetes mellitus in US adults. Open J Air Pollut. 2022;11:29–46. (month/day not specified in citation) Cummins TD, et al. Quantitative mass spectrometry normalization in urine biomarker analysis in nephrotic syndrome. Glomerular Dis. 2022;2(3):121–131. (month/day not specified in citation) Helsley RN, et al. Gut microbial trimethylamine is elevated in alcohol-associated hepatitis and contributes to ethanol-induced liver injury in mice. eLife. 2022;11:e. (month/day not specified in citation) Hein DW, Doll MA, Habil MR. Human N-acetyltransferase 1 and 2 differ in affinity towards acetyl-CoA cofactor and N-hydroxy-arylamine carcinogens. Front Pharmacol. 2022;13:821133. (month/day not specified in citation) Hong KU, et al. Dataset for proteomic analysis of arylamine N-acetyltransferase 1 knockout MDA-MB-231 breast cancer cells. Data Brief. 2022;45:108634. (month/day not specified in citation) Sun R, et al. Alcohol-driven metabolic reprogramming promotes development of RORγt-deficient thymic lymphoma. Oncogene. 2022;41(16):2287–2302. (month/day not specified in citation) Ghare S, et al. Age-associated gut dysbiosis… in older people living with HIV. J Acquir Immune Defic Syndr. 2022;89(Suppl 1):S56–S64. (month/day not specified in citation) Fulghum KL, et al. In vivo deep network tracing reveals phosphofructokinase-mediated coordination of biosynthetic pathway activity in the myocardium. J Mol Cell Cardiol. 2022;162:32–42. (month/day not specified in citation) Fan H, et al. Up-regulation of microRNA-34a mediates ethanol-induced impairment of neural crest cell migration… via Snail1. Toxicol Lett. 2022;358:17–26. (month/day not specified in citation) Oh YJ, et al. Antitumor activity of a lectibody targeting cancer-associated high-mannose glycans. Mol Ther. 2022;30(4):1523–1535. (month/day not specified in citation) Su J, Jin N, Li Z, Kettler C, Barton B, Puetz G, Nguyen CM, McGrath D, Chen Y, Yang B, Shah V, Tu W. The Alcoholic Hepatitis Network Research Data Commons (ARDaC): Design and Development. AMIA Symposium. 2022:1493–1494." }, { - "title": "AlcHepNet - Site Contacts", - "url": "site-contact.html", - "snippet": "Site Contacts Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data", - "content": "Site Contacts Indiana University DCC https://fsph.iupui.edu/research-centers/research/biostatistics.html Indiana University School of Medicine 340 West 10th Street Fairbanks Hall, Suite 6200 Indianapolis, IN 46202-3082 Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs) Timothy Hotchkiss, thotchk@iu.edu (Data Manager) Ronny Ovando, rmovando@iu.edu (Data Manager) Savannah Yarnelle, samussel@iu.edu (Program Coordinator) Carla Kettler, ckettler@iu.edu (Lead Data Manager) Cleveland Clinic https://my.clevelandclinic.org/departments/digestive/research-innovations Cleveland Clinic Department of Gastroenterology and Hepatology Mail Code A31 9500 Euclid Avenue Cleveland, OH 44195 Srinivasan Dasarathy, MD (PI) Indiana University https://medicine.iu.edu/research/clinical/trials/ https://research.indianactsi.org/ Gastroenterology Rotary Building, Suite 225 702 Rotary Cir Indianapolis, IN 46202-5175 Raj Vuppalanchi, MD (PI) Mayo Clinic – Rochester https://www.mayo.edu/research/clinical-trials/search-results?keyword=alcoholic%20hepatitis&status=open-unknown 200 First St. SW Rochester, MN 55905 Vijay Shah, MD (PI) Virginia Commonwealth University https://studyfinder.cctr.vcu.edu/ VCU School of Medicine Physical Address: McGlothlin Medical Education Center (MMEC), 1201 E Marshall St., 4th Floor, Suite 4-100 Mailing Address: Box 980565 Richmond, VA 23298 Arun Sanyal, MD (PI) University of Louisville http://louisville.edu/research/ctu University of Louisville School of Medicine 550 S. Jackson Street (ACB, Room A3L15) Louisville, Kentucky 40202 Ashwani Singal, MD (PI) University of UTSW https://clinicaltrials.utswmed.org/studies?utf8=%E2%9C%93&search%5Bhealthy_volunteers%5D=&search%5Bgender%5D=&search%5Bq%5D=alcoholic+hepatitis&commit=Search Digestive Disease Clinic at Outpatient Building 1801 Inwood Road, 6th Floor, Suite 102 Dallas, Texas 75390 Mack Mitchell, MD (PI) AlcHepNet Organizations AlcHepNet is a clinical and translational research initiative funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of NIH. © 2017-2025 Alcohol-associated Hepatitis Network Back to top $(function() { $(\"#navbar-include\").load(\"navbar.html\", function() { console.log('Navbar loaded'); }); $(\"#search-modal-include\").load(\"search-modal.html\"); $(\"#footer-include\").load(\"footer.html\", function() { console.log('Footer loaded'); }); });" + "title": "AlcHepNet Publications (2021)", + "url": "Publishing/publications.html", + "snippet": "Kumar A, Welch N, Mishra S, Bellar A, Silva RN, Li L, Singh SSK, Sharkoff M, Kerr A, Chelluboyina AK, et al. Metabolic reprogramming during hyperammonemia targets mitochondrial function and postmitotic senescence. JCI Insight. 2021 Dec 22;6(24). PMID...", + "content": "AlcHepNet Publications 2021. Kumar A, Welch N, Mishra S, Bellar A, Silva RN, Li L, Singh SSK, Sharkoff M, Kerr A, Chelluboyina AK, et al. Metabolic reprogramming during hyperammonemia targets mitochondrial function and postmitotic senescence. JCI Insight. 2021 Dec 22;6(24). PMID: 34935641. Duan Y, et al. CRIg on liver macrophages clears pathobionts and protects against alcoholic liver disease. Nat Commun. 2021 Dec 9;12(1):7172. PMID: 34887405. Hsu CL, et al. Intestinal virome and therapeutic potential of bacteriophages in liver disease. J Hepatol. 2021 Dec;75(6):1465–1475. PMID: 34437908. Yang Z, Zhang T, Kusumanchi P, Tang Q, Sun Z, Radaeva S, Peiffer B, Shah VH, Kamath P, Gores GJ, Sanyal A, Chalasani N, Jiang Y, Huda N, Ma J, Liangpunsakul S. Transcriptomic analysis reveals the microRNAs responsible for liver regeneration associated with mortality in alcohol-associated hepatitis. Hepatology. 2021 Nov;74(5):2436–2451. PMID: 34096637. Gao B, et al. Integrative analysis of metabolome and microbiome in patients with progressive alcohol-associated liver disease. Metabolites. 2021 Nov 10;11(11). PMID: 34822424. Musto JA, et al. The level of alcohol consumption in the prior year does not impact clinical outcomes in patients with alcohol-associated hepatitis. Liver Transpl. 2021 Oct;27(10):1382–1391. PMID: 34109723. Shamseddeen H, Madathanapalli A, Are VS, Shah VH, Sanyal AJ, Tang Q, Liang T, Gelow K, Zimmers TA, Chalasani N, Desai AP. Changes in serum myostatin levels in alcoholic hepatitis correlate with improvement in MELD. Dig Dis Sci. 2021 Sep;66(9):3062–3073. PMID: 33074470. Mathur K, Vilar-Gomez E, Connelly MA, He H, Sanyal AJ, Chalasani N, Jiang ZG. Circulating high density lipoprotein distinguishes alcoholic hepatitis from heavy drinkers and predicts 90-day outcome: lipoproteins in alcoholic hepatitis. J Clin Lipidol. 2021;15(6):805–813. PMID: 34756674. Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the AASLD. Hepatology. 2021 Sep;74(3):1611–1644. PMID: 34233031. Welch N, Singh SSK, Kumar A, Dhruba SR, Mishra S, Sekar J, Bellar A, Attaway AH, Chelluboyina A, Willard BB, et al. Integrated multiomics analysis identifies molecular landscape perturbations during hyperammonemia in skeletal muscle and myotubes. J Biol Chem. 2021 Sep;297(3):101023. PMID: 34343564. Schnabl B. Update on the role of the gut microbiota on alcohol-associated liver disease. Gastroenterol Hepatol (N Y). 2021 Aug;17(8):381–383. PMID: 34602901. Tandon P, Montano-Loza AJ, Lai JC, Dasarathy S, Merli M. Sarcopenia and frailty in decompensated cirrhosis. J Hepatol. 2021 Jul;75(Suppl 1):S147–S162. PMID: 34039486. Attaway A, Bellar A, Dieye F, Wajda D, Welch N, Dasarathy S. Clinical impact of compound sarcopenia in hospitalized older adult patients with heart failure. J Am Geriatr Soc. 2021 Jul;69(7):1815–1825. PMID: 33735939. Trebicka J, et al. The microbiota in cirrhosis and its role in hepatic decompensation. J Hepatol. 2021 Jul;75(Suppl 1):S67–S81. PMID: 34039493. Cabré N, et al. Colesevelam reduces ethanol-induced liver steatosis in humanized gnotobiotic mice. Cells. 2021 Jun 14;10(6). PMID: 34198609. Cariou B, Byrne CD, Loomba R, Sanyal AJ. Nonalcoholic fatty liver disease as a metabolic disease in humans: a literature review. Diabetes Obes Metab. 2021 May;23(5):1069–1083. PMID: 33464677. Davuluri G, Welch N, Sekar J, et al. Activated Protein Phosphatase 2A Disrupts Nutrient Sensing Balance Between mTORC1 and AMPK, Causing Sarcopenia in Alcohol-Associated Liver Disease. Hepatology. 2021 May;73(5):1892–1908. PMID: 32799332. Li R, Wang H, Tu W. Robust estimation of heterogeneous treatment effects using electronic health record data. Stat Med. 2021 May 20;40(11):2713–2752. PMID: 33738800. Kirschner SK, Deutz NEP, Jonker R, Olde Damink SWM, Harrykissoon RI, Zachria AJ, Dasarathy S, Engelen MPKJ. Intestinal function is impaired in patients with Chronic Obstructive Pulmonary Disease. Clin Nutr. 2021 Apr;40(4):2270–2277. PMID: 33873268. Yang J, Syed F, Xia Y, Sanyal AJ, Shah VH, Chalasani N, Zheng X, Yu Q, Lou Y, Li W. Blood biomarkers of intestinal epithelium damage regenerating islet-derived protein 3α and trefoil factor 3 are persistently elevated in patients with alcoholic hepatitis. Alcohol Clin Exp Res. 2021 Apr;45(4):720–731. PMID: 33587293. Beaudoin JJ, Liang T, Tang Q, Banini BA, Shah VH, Sanyal AJ, Chalasani NP, Gawrieh S. Role of candidate gene variants in modulating the risk and severity of alcoholic hepatitis. Alcohol Clin Exp Res. 2021 Apr;45(4):709–719. PMID: 33616244. Gao B, et al. An introduction to next generation sequencing bioinformatic analysis in gut microbiome studies. Biomolecules. 2021 Apr 2;11(4). PMID: 33918473. Fairfield B, Schnabl B. Gut dysbiosis as a driver in alcohol-induced liver injury. JHEP Rep. 2021 Apr;3(2):100220. PMID: 33598648. Attaway AH, Welch N, Yadav R, Bellar A, Hatipoğlu U, Meli Y, Engelen MPKJ, Zein J, Dasarathy S. Quantitative CT Assessment of Pectoralis and Erector Spinae Muscle Area and Disease Severity in COPD Referred for Lung Volume Reduction. COPD. 2021 Apr;18(2):191–200. PMID: 33736550. Gao B, et al. Microbial products and metabolites contributing to alcohol-related liver disease. Mol Nutr Food Res.2021 Mar;65(5):e2000023. PMID: 32583604. Hartmann P, et al. Dynamic changes of the fungal microbiome in alcohol use disorder. Front Physiol.2021;12:699253. PMID: 34349667. Miyata T, Wu X, Fan X, Huang E, Sanz-Garcia C, Cajigas-Du Ross CK, Roychowdhury S, Bellar A, McMullen MR, Dasarathy J, Allende DS, Caballeria J, Sancho-Bru P, McClain CJ, Mitchell M, McCullough AJ, Radaeva S, Barton B, Szabo G, Dasarathy S, Nagy LE. Differential role of MLKL in alcohol-associated and non-alcohol-associated fatty liver diseases in mice and humans. JCI Insight. 2021 Feb 22;6(4). PMID: 33616081. Gao B, et al. Serum acylcarnitines associated with high short-term mortality in patients with alcoholic hepatitis. Biomolecules. 2021 Feb 14;11(2). PMID: 33672832. Gao B, Zhang X, Schnabl B. Fungi-bacteria correlation in alcoholic hepatitis patients. Toxins (Basel). 2021 Feb 14;13(2). PMID: 33672887. Attaway AH, Welch N, Hatipoğlu U, Zein JG, Dasarathy S. Muscle loss contributes to higher morbidity and mortality in COPD: An analysis of national trends. Respirology. 2021 Jan;26(1):62–71. PMID: 32542761. McClain CJ, Vatsalya V, Mitchell MC. Keratin-18: Diagnostic, Prognostic, and Theragnostic for Alcohol-Associated Hepatitis. Am J Gastroenterol. 2021 Jan 1;116(1):77–79. PMID: 33306505. Sharpton SR, et al. Current concepts, opportunities, and challenges of gut microbiome-based personalized medicine in nonalcoholic fatty liver disease. Cell Metab. 2021 Jan 5;33(1):21–32. PMID: 33296678. Jiang L, et al. The gut mycobiome: a novel player in chronic liver diseases. J Gastroenterol. 2021 Jan;56(1):1–11. PMID: 33151407. Lang S, Demir M, Schnabl B. Targeting pathobionts for the treatment of alcohol-associated liver disease. Liver Int.2021 Jan;41(1):239–240. PMID: 33159427. Hartmann P, Schnabl B. New developments in microbiome in alcohol-associated and nonalcoholic fatty liver disease. Semin Liver Dis. 2021 Jan;41(1):87–102. PMID: 33957682. Wang R, et al. Gut microbiome, liver immunology, and liver diseases. Cell Mol Immunol. 2021 Jan;18(1):4–17. PMID: 33318628. (month/day not specified in citation) Thomas S, Tu W. Learning Hamiltonian Monte Carlo in R. Am Stat.2021;75(4):403–413. PMID: 37465458. (month/day not specified in citation) Warner DR, et al. Beneficial effects of endogenous enrichment in n-3 PUFAs on Wnt signaling are associated with attenuation of alcohol-mediated liver disease in mice. FASEB J. 2021;35(2):e21377. (month/day not specified in citation) Fan X, et al. Diagnostic and prognostic significance of complement in patients with alcohol-associated hepatitis. Hepatology. 2021;73(3):983–997. (month/day not specified in citation) Gu Z, et al. Exosome-like nanoparticles from Lactobacillus rhamnosus GG protect against alcohol-associated liver disease through intestinal aryl hydrocarbon receptor. Hepatol Commun.2021;5(5):846–864. (month/day not specified in citation) McClain CJ, et al. Malnutrition and alcohol-associated hepatitis. Clin Liver Dis.2021;25(3):557–570. (month/day not specified in citation) Warner D, et al. 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Chang B, Hao S, Zhang L, Gao M, Sun Y, Huang A, Teng G, Li B, Crabb DW, Kusumanchi P, Wang L, Liangpunsakul S, Zou Z. Association between aldehyde dehydrogenase 2 Glu504Lys polymorphism and alcoholic liver disease. Am J Med Sci. 2018 Jul;356(1):10–14. PMID: 29779728. Walline CC, Blum JS, Linton T, Mangiacarne D, Liangpunsakul S. Early activation of peripheral monocytes with hallmarks of M1 and M2 monocytic cells in excessive alcohol drinkers: a pilot study. J Investig Med. 2018 Jun;66(5):1–4. PMID: 29519798. Puri P, Liangpunsakul S, Christensen JE, Shah VH, Kamath PS, Gores GJ, Walker S, Comerford M, Katz B, Borst A, Yu Q, Kumar DP, Mirshahi F, Radaeva S, Chalasani NP, Crabb DW, Sanyal AJ; TREAT Consortium. The circulating microbiome signature and inferred functional metagenomics in alcoholic hepatitis. Hepatology. 2018 Apr;67(4):1284–1302. PMID: 29083504. Hollister K, Kusumanchi P, Ross RA, Chandler K, Oshodi A, Heathers L, Teagarden S, Wang L, Dent AL, Liangpunsakul S. Levels of circulating follicular helper T cells, T helper 1 cells, and the prognostic significance of soluble form of CD40 ligand on survival in patients with alcoholic cirrhosis. Liver Res. 2018 Mar;2(1):52–59. PMID: 30221017. Jinjuvadia R, Jinjuvadia C, Puangsricharoen P, Chalasani N, Crabb DW, Liangpunsakul S; Translational Research and Evolving Alcoholic Hepatitis Treatment Consortium. Concomitant psychiatric and nonalcohol-related substance use disorders among hospitalized patients with alcoholic liver disease in the United States. Alcohol Clin Exp Res.2018 Feb;42(2):397–402. PMID: 29197092. Liangpunsakul S, Beaudoin JJ, Shah VH, Puri P, Sanyal AJ, Kamath PS, Lourens SG, Tang Q, Katz BP, Crabb DW, Chalasani NP. Interaction between the patatin-like phospholipase domain-containing protein 3 genotype and coffee drinking and the risk for acute alcoholic hepatitis. Hepatol Commun. 2018 Jan;2(1):29–34. PMID: 29404510. Song M, Li X, Zhang X, et al. Dietary copper-fructose interactions alter gut microbial activity in male rats. Am J Physiol Gastrointest Liver Physiol. 2018;314(1):G119–G130. Gosney JA, Wilkey DW, Merchant ML, Ceresa BP. Proteomics reveals novel protein associations with early endosomes in an epidermal growth factor-dependent manner. J Biol Chem. 2018;293(16):5895–5908. Beier JI, Banales JM. Pyroptosis: An inflammatory link between NAFLD and NASH with potential therapeutic implications. J Hepatol. 2018;68(4):643–645. Dou X, Menkari C, Mitsuyama R, et al. L1 coupling to ankyrin and the spectrin-actin cytoskeleton modulates ethanol inhibition of L1 adhesion and ethanol teratogenesis. FASEB J. 2018;32(3):1364–1374. Wang K, Chen X, Liu J, et al. Embryonic exposure to ethanol increases the susceptibility of larval zebrafish to chemically induced seizures. Sci Rep. 2018;8:1845. Ghosh Dastidar S, Warner JB, Warner DR, et al. Rodent models of alcoholic liver disease: Role of binge ethanol administration. Biomolecules. 2018;8(1). Kharbanda KK, Ronis MJJ, Shearn CT, et al. Role of nutrition in alcoholic liver disease: Summary of the symposium at the ESBRA 2017 Congress. Biomolecules. 2018;8(2). Salazar-González RA, Turiján-Espinoza E, Hein DW, et al. Expression and genotype-dependent catalytic activity of NAT2 in human PBMCs and its modulation by Sirtuin 1. Biochem Pharmacol. 2018;156:340–347. Wahlang B, McClain C, Barve S, Gobejishvili L. Role of cAMP and phosphodiesterase signaling in liver health and disease. Cell Signal. 2018;49:105–115. He L, Prodhan MAI, Yuan F, et al. Simultaneous quantification of straight-chain and branched-chain short chain fatty acids by GC–MS. J Chromatogr B. 2018;1092:359–367. Liang Y, Lang AL, Zhang J, et al. Exposure to vinyl chloride and its influence on Western diet-induced cardiac remodeling. Chem Res Toxicol. 2018;31(6):482–493. Song M, Vos MB, McClain CJ. Copper-fructose interactions: A novel mechanism in the pathogenesis of NAFLD. Nutrients. 2018;10(11). Schuster S, Johnson CD, Hennebelle M, et al. Oxidized linoleic acid metabolites induce liver mitochondrial dysfunction, apoptosis, and NLRP3 activation in mice. J Lipid Res. 2018;59(9):1597–1609. Prodhan MAI, Yin X, Kim S, et al. Surface fitting for calculating the second dimension retention index in GC×GC–MS. J Chromatogr A. 2018;1539:62–70. Warner DR, Liu H, Ghosh Dastidar S, et al. Ethanol and unsaturated dietary fat induce unique hepatic ω-6 and ω-3 PUFA oxylipins in a mouse model of ALD. PLoS One. 2018;13(9):e0204119. Vatsalya V, Kong M, Cave MC, et al. Association of serum zinc with markers of liver injury in very heavy drinking alcohol-dependent patients. J Nutr Biochem. 2018;59:49–55. Zheng Y, Ritzenthaler JD, Burke TJ, et al. Age-dependent oxidation of extracellular cysteine/cystine redox state in mouse lung fibroblasts is mediated by a decline in Slc7a11 expression. Free Radic Biol Med. 2018;118:13–22. Yuan F, Chen S-Y. Manipulation of microRNAs in cultured mouse embryos: Applications for developmental toxicology. Methods Mol Biol. 2018;1797:205–214. Lang AL, Beier JI. Interaction of volatile organic compounds and underlying liver disease: A new paradigm for risk. Biol Chem. 2018;399(11):1237–1248. Ramsden CE, Hennebelle M, Schuster S, et al. Effects of diets enriched in linoleic acid and its peroxidation products on brain fatty acids, oxylipins, and aldehydes in mice. Biochim Biophys Acta Mol Cell Biol Lipids.2018;1863(10):1206–1213. Teng Y, Ren Y, Sayed M, et al. Plant-derived exosomal microRNAs shape the gut microbiota. Cell Host Microbe.2018;24(5):637–652.e8. Hardesty JE, Al-Eryani L, Wahlang B, et al. Epidermal growth factor receptor signaling disruption by endocrine and metabolic disrupting chemicals. Toxicol Sci. 2018;162(2):622–634. Clair HB, Pinkston CM, Rai SN, et al. Liver disease in a residential cohort with elevated polychlorinated biphenyl exposures. Toxicol Sci. 2018;164(1):39–49. Shao T, Zhao C, Li F, et al. Intestinal HIF-1α deletion exacerbates alcoholic liver disease by inducing intestinal dysbiosis and barrier dysfunction. J Hepatol. 2018;69(4):886–895. Carlisle SM, Trainor PJ, Doll MA, et al. Knockout of human NAT1 in MDA-MB-231 breast cancer cells leads to increased reserve/maximum mitochondrial capacity and glycolytic reserve. Mol Carcinog. 2018;57(11):1458–1466. Yuan F, Chen X, Liu J, et al. Sulforaphane restores acetyl-histone H3 binding to Bcl-2 promoter and prevents apoptosis in ethanol-exposed neural crest cells and mouse embryos. Exp Neurol. 2018;300:60–66." + }, + { + "title": "AlcHepNet Publications (2017)", + "url": "Publishing/publications.html", + "snippet": "Comerford M, Lourens S, Liangpunsakul S, Chalasani NP, Sanyal AJ, Shah VH, Kamath PS, Puri P, Katz BP, Radaeva S, Crabb DW. Challenges in patient enrollment and retention in clinical studies for alcoholic hepatitis: experience of the TREAT Consortium...", + "content": "AlcHepNet Publications 2017. Comerford M, Lourens S, Liangpunsakul S, Chalasani NP, Sanyal AJ, Shah VH, Kamath PS, Puri P, Katz BP, Radaeva S, Crabb DW. Challenges in patient enrollment and retention in clinical studies for alcoholic hepatitis: experience of the TREAT Consortium. Alcohol Clin Exp Res. 2017 Dec;41(12):2000–2006. PMID: 28981151. Merchant ML, Rood IM, Deegens JKJ, Klein JB. Isolation and characterization of urinary extracellular vesicles: Implications for biomarker discovery. Nat Rev Nephrol. 2017;13(12):731–749. Chen W-Y, Wang M, Zhang J, Barve SS, McClain CJ, Joshi-Barve S. Acrolein disrupts tight junction proteins and causes endoplasmic reticulum stress-mediated epithelial cell death leading to intestinal barrier dysfunction and permeability. Am J Pathol. 2017;187(12):2686–2697. Beaudoin JJ, Long N, Liangpunsakul S, Puri P, Kamath PS, Shah V, Sanyal AJ, Crabb DW, Chalasani NP, Urban TJ; TREAT Consortium. An exploratory genome-wide analysis of genetic risk for alcoholic hepatitis. Scand J Gastroenterol. 2017 Nov;52(11):1263–1269. PMID: 28776448. Warner DR, Liu H, Miller ME, Ramsden CE, Gao B, Feldstein AE, Schuster S, McClain CJ, Kirpich IA. Dietary linoleic acid and its oxidized metabolites exacerbate liver injury caused by ethanol via induction of hepatic proinflammatory response in mice. Am J Pathol. 2017;187(10):2232–2245. Zhao Y, Wu J, Liangpunsakul S, Wang L. Long non-coding RNA in liver metabolism and disease: current status. Liver Res. 2017 Sep;1(3):163–167. PMID: 29576888. Xu Z, Tong Q, Zhang Z, et al. Inhibition of HDAC3 prevents diabetic cardiomyopathy in OVE26 mice via epigenetic regulation of the DUSP5-ERK1/2 pathway. Clin Sci (Lond). 2017;131(15):1841–1857. Li W, Amet T, Xing Y, Yang D, Liangpunsakul S, Puri P, Kamath PS, Sanyal AJ, Shah VH, Katz BP, Radaeva S, Crabb DW, Chalasani N, Yu Q. Alcohol abstinence ameliorates the dysregulated immune profiles in patients with alcoholic hepatitis: a prospective observational study. Hepatology. 2017 Aug;66(2):575–590. PMID: 28466561. Lourens S, Sunjaya DB, Singal A, Liangpunsakul S, Puri P, Sanyal A, Ren X, Gores GJ, Radaeva S, Chalasani N, Crabb DW, Katz B, Kamath PS, Shah VH; TREAT Consortium. Acute alcoholic hepatitis: natural history and predictors of mortality using a multicenter prospective study. Mayo Clin Proc Innov Qual Outcomes. 2017 Jul;1(1):37–48. PMID: 30225400. Liangpunsakul S, Toh E, Ross RA, Heathers LE, Chandler K, Oshodi A, McGee B, Modlik E, Linton T, Mangiacarne D, Jimenez C, Dong XC, Wang L, Tu W, Nelson DE. Quantity of alcohol drinking positively correlates with serum levels of endotoxin and markers of monocyte activation. Sci Rep. 2017 Jun 30;7(1):4462. PMID: 28667254. Peng JL, Patel MP, McGee B, Liang T, Chandler K, Tayarachakul S, O'Connor S, Liangpunsakul S. Management of alcohol misuse in patients with liver diseases. J Investig Med. 2017 Mar;65(3):673–680. PMID: 27940551. Jinjuvadia R, Antaki F, Lohia P, Liangpunsakul S. The association between nonalcoholic fatty liver disease and metabolic abnormalities in the United States population. J Clin Gastroenterol. 2017 Feb;51(2):160–166. PMID: 27580477. Jinjuvadia C, Jinjuvadia R, Mandapakala C, Durairajan N, Liangpunsakul S, Soubani AO. Trends in outcomes, financial burden, and mortality for acute exacerbation of COPD in the United States from 2002 to 2010. COPD. 2017 Feb;14(1):72–79. PMID: 27419254. Yuan F, Chen X, Liu J, Feng W, Wu X, Chen S-Y. Up-regulation of Siah1 by ethanol triggers apoptosis in neural crest cells through p38 MAPK-mediated activation of p53 signaling pathway. Arch Toxicol. 2017;91(2):775–784. Shen H, Peng JL, Tayarachakul S, Liangpunsakul S. Association between serum cotinine level and prevalence of non-alcoholic fatty liver disease: a cross-sectional study from NHANES III. J Investig Med. 2017 Jan;65(1):43–48. PMID: 27634642. Mitchell MC, Friedman LS, McClain CJ. Medical management of severe alcoholic hepatitis: Expert review from the AGA Institute. Clin Gastroenterol Hepatol. 2017;15(1):5–12. Massey VL, Dolin CE, Poole LG, et al. The hepatic “matrisome” responds dynamically to injury… Hepatology.2017;65(3):969–982. McClain C, Vatsalya V, Cave M. Role of zinc in the development/progression of alcoholic liver disease. Curr Treat Options Gastroenterol. 2017;15(2):285–295. Avila DV, Myers SA, Zhang JW, et al. Phosphodiesterase 4b expression plays a major role in alcohol-induced neuro-inflammation. Neuropharmacology. 2017;125:376–385. Wei X, Lorkiewicz PK, Shi B, Salabei JK, Hill BG, Kim S, McClain CJ, Zhang X. Analysis of stable isotope assisted metabolomics data acquired by high resolution mass spectrometry. Anal Methods. 2017;9(15):2275–2283. Wei X, Shi B, Koo I, Yin X, Lorkiewicz P, Suhail H, Rattan R, Giri S, McClain CJ, Zhang X. Analysis of stable isotope assisted metabolomics data acquired by GC-MS. Anal Chim Acta. 2017;980:25–32. Shahrjooihaghighi A, Frigui H, Zhang X, Wei X, Shi B, Trabelsi A. An ensemble feature selection method for biomarker discovery. Proc IEEE Int Symp Signal Process Inf Technol. 2017:416–421. Mendoza M, Caltharp S, Song M, Collin L, Konomi JV, McClain CJ, Vos MB. Low hepatic tissue copper in pediatric NAFLD. J Pediatr Gastroenterol Nutr. 2017;65(1):89–92. Barve S, Chen S-Y, Kirpich I, Watson WH, McClain C. Development, prevention, and treatment of alcohol-induced organ injury: The role of nutrition. Alcohol Res Curr Rev. 2017;38(2):289–302. Gibb AA, Lorkiewicz PK, Zheng Y-T, et al. Correction: Integration of flux measurements… Biochem J.2017;474(24):4271–4272. Kim S, Jang H, Koo I, Lee J, Zhang X. Normal-Gamma-Bernoulli peak detection for GC×GC–MS data. Comput Stat Data Anal. 2017;105:96–111. McClain C, Barve S. A tale of two institutions. J Hepatol. 2017;66(4):682–684. Teng Y, Ren Y, Hu X, Mu J, Samykutty A, Zhuang X, Deng Z, Kumar A, Zhang L, Merchant ML, Yan J, Miller DM, Zhang H-G. MVP-mediated exosomal sorting of miR-193a promotes colon cancer progression. Nat Commun.2017;8:14448. Kirpich IA, McClain CJ, Vatsalya V, Schwandt M, Phillips M, Falkner KC, Zhang L, Harwell C, George DT, Umhau JC. Liver injury and endotoxemia in male and female alcohol-dependent individuals admitted to an alcohol treatment program. Alcohol Clin Exp Res. 2017;41(4):747–757. Gibb AA, Lorkiewicz PK, Zheng Y-T, Zhang X, Bhatnagar A, Jones SP, Hill BG. Integration of flux measurements to resolve changes in anabolic and catabolic metabolism in cardiac myocytes. Biochem J. 2017;474(16):2785–2801. Poole LG, Dolin CE, Arteel GE. Organ-organ crosstalk and alcoholic liver disease. Biomolecules. 2017;7(3). Guardiola JJ, Beier JI, Falkner KC, Wheeler B, McClain CJ, Cave M. Occupational exposures at a PVC production facility are associated with significant changes to the plasma metabolome. Toxicol Appl Pharmacol. 2017;313:47–56. Anders LC, Lang AL, Anwar-Mohamed A, Douglas AN, Bushau AM, Falkner KC, Hill BG, Warner NL, Arteel GE, Cave M, McClain CJ, Beier JI. Vinyl chloride metabolites potentiate inflammatory liver injury caused by LPS in mice. Toxicol Sci. 2017;151(2):312–323. Cave MC, Clair HB, Hardesty JE, Falkner KC, Feng W, Clark BJ, Sidey J, Shi H, Aqel BA, McClain CJ, Prough RA. Nuclear receptors and nonalcoholic fatty liver disease. Biochim Biophys Acta. 2017;1859(9):1083–1099." + }, + { + "title": "AlcHepNet Publications (2016)", + "url": "Publishing/publications.html", + "snippet": "Liangpunsakul S, Puri P, Shah VH, Kamath P, Sanyal A, Urban T, Ren X, Katz B, Radaeva S, Chalasani N, Crabb DW; Translational Research and Evolving Alcoholic Hepatitis Treatment Consortium. Effects of age, sex, body weight, and quantity of alcohol co...", + "content": "AlcHepNet Publications 2016. Liangpunsakul S, Puri P, Shah VH, Kamath P, Sanyal A, Urban T, Ren X, Katz B, Radaeva S, Chalasani N, Crabb DW; Translational Research and Evolving Alcoholic Hepatitis Treatment Consortium. Effects of age, sex, body weight, and quantity of alcohol consumption on occurrence and severity of alcoholic hepatitis. Clin Gastroenterol Hepatol.2016 Dec;14(12):1831–1838.e3. PMID: 27320325. Tran M, Yang Z, Liangpunsakul S, Wang L. Metabolomics analysis revealed distinct cyclic changes of metabolites altered by chronic ethanol-plus-binge and Shp deficiency. Alcohol Clin Exp Res. 2016 Dec;40(12):2548–2556. PMID: 27790731. Vatsalya V, Pandey A, Schwandt ML, Cave MC, Barve SS, Ramchandani VA, McClain CJ. Safety assessment of liver injury with quetiapine fumarate XR management in very heavy drinking alcohol-dependent patients. Clin Drug Investig. 2016;36(11):935–944. Deng B, Kim S, Li H, Heath E, Zhang X. Global peak alignment for comprehensive two-dimensional gas chromatography mass spectrometry using point matching algorithms. J Bioinform Comput Biol. 2016;14(6):1650032. Wang L, Liangpunsakul S. Circadian clock control of hepatic lipid metabolism: role of small heterodimer partner (Shp). J Investig Med. 2016 Oct;64(7):1158–1161. PMID: 27473715. Vatsalya V, Song M, Schwandt ML, Cave MC, Barve SS, George DT, Ramchandani VA, McClain CJ. Effects of sex, drinking history, and omega-3 and omega-6 fatty acids dysregulation on the onset of liver injury in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2016;40(10):2085–2093. McClain CJ. Nutrition in patients with cirrhosis. Gastroenterol Hepatol (N Y). 2016;12(8):507–510. Ju C, Liangpunsakul S. Role of hepatic macrophages in alcoholic liver disease. J Investig Med. 2016 Aug;64(6):1075–1077. PMID: 27382116. Liangpunsakul S, Gao B. Alcohol and fat promote steatohepatitis: a critical role for fat-specific protein 27/CIDEC. J Investig Med. 2016 Aug;64(6):1078–1081. PMID: 27342423. Srivastava R, Zhang Y, Xiong X, Zhang X, Pan X, Dong XC, Liangpunsakul S, Janga SC. Prediction and validation of transcription factors modulating the expression of Sestrin3 gene using an integrated computational and experimental approach. PLoS One. 2016;11(7):e0160228. PMID: 27466818. Tu W, Chu C, Li S, Liangpunsakul S. Development and validation of a composite score for excessive alcohol use screening. J Investig Med. 2016 Jun;64(5):1006–1011. PMID: 27001945. Crabb DW, Bataller R, Chalasani NP, Kamath PS, Lucey M, Mathurin P, McClain C, McCullough A, Mitchell MC, Morgan TR, Nagy L, Radaeva S, Sanyal A, Shah V, Szabo G; NIAAA Alcoholic Hepatitis Consortia. Standard definitions and common data elements for clinical trials in patients with alcoholic hepatitis: recommendation from the NIAAA Alcoholic Hepatitis Consortia. Gastroenterology. 2016 Apr;150(4):785–790. PMID: 26921783. Matheson PJ, Fernandez-Botran R, Smith JW, Matheson SA, Downard CD, McClain CJ, Garrison RN. Association between MC-2 peptide and hepatic perfusion and liver injury following resuscitated hemorrhagic shock. JAMA Surg.2016;151(3):265–272. Liangpunsakul S, Crabb DW. Early detection of alcoholic liver disease: are we a step closer? Gastroenterology.2016 Jan;150(1):29–31. PMID: 26615116. Kirpich IA, Miller ME, Cave MC, Joshi-Barve S, McClain CJ. Alcoholic liver disease: Update on the role of dietary fat. Biomolecules. 2016;6(1):1. Liu Y, Zhao C, Xiao J, et al. Fibroblast growth factor 21 deficiency exacerbates chronic alcohol-induced hepatic steatosis and injury. Sci Rep. 2016;6:31026. Vatsalya V, Barve SS, McClain CJ, Ramchandani VA. Elevated linoleic acid (a pro-inflammatory PUFA) and liver injury in a treatment naive HIV-HCV co-infected alcohol-dependent patient. J Biosci Med. 2016;4(7):23–27. Chen W-Y, Zhang J, Ghare S, Barve S, McClain C, Joshi-Barve S. Acrolein is a pathogenic mediator of alcoholic liver disease and the scavenger hydralazine is protective in mice. Cell Mol Gastroenterol Hepatol. 2016;2(5):685–700. Vatsalya V, Liaquat HB, Ghosh K, Mokshagundam SP, McClain CJ. A review on the sex differences in organ and system pathology with alcohol drinking. Curr Drug Abuse Rev. 2016;9(2):87–92. Kirpich IA, Petrosino J, Ajami N, Feng W, Wang Y, Liu Y, Beier JI, Barve SS, Yin X, Wei X, Zhang X, McClain CJ. Saturated and unsaturated dietary fats differentially modulate ethanol-induced changes in gut microbiome and metabolome in a mouse model of alcoholic liver disease. Am J Pathol. 2016;186(4):765–776. Dasarathy S. Nutrition and alcoholic liver disease: Effects of alcoholism on nutrition, effects of nutrition on alcoholic liver disease, and nutritional therapies for alcoholic liver disease. Clin Liver Dis. 2016;20(3):535–550. Vatsalya V, Avila D, Frimodig JC, Barve SS, McClain CJ, Gobejishvili L. Liver injury assessment by Vetscan VS2 analyzer and most frequently used ALT/GTP reagent. Gastroenterol Hepatol (Bartlesville). 2016;12(4). Ghare SS, Donde H, Chen W-Y, Barker DF, Gobejishvili L, McClain CJ, Barve SS, Joshi-Barve S. Acrolein enhances epigenetic modifications, FasL expression and hepatocyte toxicity induced by anti-HIV drug zidovudine. Toxicol In Vitro. 2016;35:66–76. Avila DV, Barker DF, Zhang JW, McClain CJ, Barve S, Gobejishvili L. Dysregulation of hepatic cAMP levels via altered Pde4b expression plays a critical role in alcohol-induced steatosis. J Pathol. 2016;240(1):96–107. Wang S, Luo M, Zhang Z, et al. Zinc deficiency exacerbates while zinc supplement attenuates cardiac hypertrophy in high-fat diet–induced obese mice through modulating p38 MAPK-dependent signaling. Toxicol Lett. 2016;258:134–146. Anders LC, Yeo H, Kaelin BR, Lang AL, Bushau AM, Douglas AN, Cave M, Arteel GE, McClain CJ, Beier JI. Role of dietary fatty acids in liver injury caused by vinyl chloride metabolites in mice. Toxicol Appl Pharmacol.2016;311:34–41. Joshi-Barve S, Kirpich I, Cave MC, Marsano LS, McClain CJ. Alcoholic, nonalcoholic, and toxicant-associated steatohepatitis: Mechanistic similarities and differences. Cell Mol Gastroenterol Hepatol. 2016;1(4):356–367." + }, + { + "title": "AlcHepNet Publications (2015)", + "url": "Publishing/publications.html", + "snippet": "Liangpunsakul S. Carbohydrate-responsive element-binding protein, sirtuin 1, and ethanol metabolism: a complicated network in alcohol-induced hepatic steatosis. Hepatology. 2015 Oct;62(4):994–996. PMID: 26044569. Gough G, Heathers L, Puckett D, Weste...", + "content": "AlcHepNet Publications 2015. Liangpunsakul S. Carbohydrate-responsive element-binding protein, sirtuin 1, and ethanol metabolism: a complicated network in alcohol-induced hepatic steatosis. Hepatology. 2015 Oct;62(4):994–996. PMID: 26044569. Gough G, Heathers L, Puckett D, Westerhold C, Ren X, Yu Z, Crabb DW, Liangpunsakul S. The utility of commonly used laboratory tests to screen for excessive alcohol use in clinical practice. Alcohol Clin Exp Res. 2015 Aug;39(8):1493–1500. PMID: 26110815. Jinjuvadia R, Liangpunsakul S; Translational Research and Evolving Alcoholic Hepatitis Treatment Consortium. Trends in alcoholic hepatitis-related hospitalizations, financial burden, and mortality in the United States. J Clin Gastroenterol. 2015 Jul;49(6):506–511. PMID: 25198164." + }, + { + "title": "AlcHepNet Publications (2014)", + "url": "Publishing/publications.html", + "snippet": "Chayanupatkul, Maneerat; Liangpunsakul, Suthat. Alcoholic hepatitis: a comprehensive review of pathogenesis and treatment. World J Gastroenterol. 2014 May 28;20(20):6279–6286. PMID: 24876748.", + "content": "AlcHepNet Publications 2014. Chayanupatkul, Maneerat; Liangpunsakul, Suthat. Alcoholic hepatitis: a comprehensive review of pathogenesis and treatment. World J Gastroenterol. 2014 May 28;20(20):6279–6286. PMID: 24876748." } ] \ No newline at end of file diff --git a/src/simple-dropdown.js b/src/simple-dropdown.js index 420064a..8964e72 100644 --- a/src/simple-dropdown.js +++ b/src/simple-dropdown.js @@ -64,21 +64,53 @@ $(document).ready(function() { let searchResults = []; let currentPage = 1; let searchIndex = []; + let searchablePages = new Set(); - function getSearchIndexPath() { + function getRelativePrefix() { const currentPath = window.location.pathname; + let pathParts = currentPath.split('/').filter(Boolean); + console.log('Current path:', currentPath); - - if (currentPath.includes('/src/')) { - const srcIndex = currentPath.indexOf('/src/'); - const afterSrc = currentPath.substring(srcIndex + 5); // +5 for '/src/' - const depth = (afterSrc.match(/\//g) || []).length; - const path = '../'.repeat(depth) + 'searchIndex.json'; - console.log('Calculated path:', path); - return path; + + const srcIndex = pathParts.lastIndexOf('src'); + if (srcIndex !== -1) { + pathParts = pathParts.slice(srcIndex + 1); } - - return 'searchIndex.json'; + + if (pathParts.length > 0 && pathParts[pathParts.length - 1].includes('.')) { + pathParts = pathParts.slice(0, -1); + } + + const prefix = '../'.repeat(pathParts.length); + console.log('Calculated relative prefix:', prefix || './'); + return prefix; + } + + function getSearchIndexPath() { + return `${getRelativePrefix()}searchIndex.json`; + } + + function normalizeInternalPath(url) { + if (!url || url.startsWith('http') || url.startsWith('#') || url.startsWith('mailto:')) { + return null; + } + + return url.replace(/^(\.\.\/)+/, '').replace(/^\.\//, '').replace(/^\//, ''); + } + + function refreshSearchablePages() { + searchablePages = new Set(); + + $('#navbar-include a').each(function() { + const href = $(this).attr('href'); + const normalizedHref = normalizeInternalPath(href); + + if (normalizedHref && normalizedHref.endsWith('.html')) { + searchablePages.add(normalizedHref); + } + }); + + console.log('Searchable navbar pages:', Array.from(searchablePages)); } $.getJSON(getSearchIndexPath(), function(data) { @@ -101,27 +133,17 @@ $(document).ready(function() { const start = (currentPage - 1) * SEARCH_PAGE_SIZE; const end = start + SEARCH_PAGE_SIZE; const pageResults = searchResults.slice(start, end); + const relativePrefix = getRelativePrefix(); let html = ''; + pageResults.forEach(item => { let correctUrl = item.url; - const currentPath = window.location.pathname; - - // add debug info + console.log('Original URL:', item.url); - console.log('Current path:', currentPath); - - if (currentPath.includes('/src/')) { - const srcIndex = currentPath.indexOf('/src/'); - const afterSrc = currentPath.substring(srcIndex + 5); // +5 for '/src/' - const depth = (afterSrc.match(/\//g) || []).length; - - console.log('After src part:', afterSrc); - console.log('Calculated depth:', depth); - - if (!item.url.startsWith('http') && !item.url.startsWith('/')) { - correctUrl = '../'.repeat(depth) + item.url; - console.log('Corrected URL:', correctUrl); - } + + if (!item.url.startsWith('http') && !item.url.startsWith('/')) { + correctUrl = `${relativePrefix}${item.url}`; + console.log('Corrected URL:', correctUrl); } html += `
    @@ -171,9 +193,12 @@ $(document).ready(function() { } const results = searchIndex.filter(item => - (item.title && item.title.toLowerCase().includes(keyword)) || - (item.snippet && item.snippet.toLowerCase().includes(keyword)) || - (item.content && item.content.toLowerCase().includes(keyword)) + searchablePages.has(normalizeInternalPath(item.url)) && + ( + (item.title && item.title.toLowerCase().includes(keyword)) || + (item.snippet && item.snippet.toLowerCase().includes(keyword)) || + (item.content && item.content.toLowerCase().includes(keyword)) + ) ); showSearchModal(results); }); @@ -182,4 +207,10 @@ $(document).ready(function() { $('#searchModal').on('hidden.bs.modal', function() { $('#searchInput').val(''); }); + + $(document).ajaxComplete(function(event, xhr, settings) { + if (settings && settings.url && settings.url.includes('navbar.html')) { + refreshSearchablePages(); + } + }); }); \ No newline at end of file diff --git a/src/site-contact-backup.html b/src/site-contact-backup.html deleted file mode 100644 index d0f87db..0000000 --- a/src/site-contact-backup.html +++ /dev/null @@ -1,239 +0,0 @@ - - - - - - - - - AlcHepNet - Site Contacts - - - - - - - -
    - -
    -
    -
    -
    -
    -

    Site Contacts

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    - -
    Indiana University DCC
    - -https://fsph.iupui.edu/research-centers/research/biostatistics.html - - -
    - Indiana University School of Medicine
    - 340 West 10th Street
    - Fairbanks Hall, Suite 6200
    - Indianapolis, IN 46202-3082
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    Samer Gawrieh, MD & Wanzhu Tu, PhD (MPIs)

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    Timothy Hotchkiss, thotchk@iu.edu (Data Manager)

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    Ronny Ovando, rmovando@iu.edu (Data Manager)

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    Savannah Yarnelle, samussel@iu.edu (Program Coordinator)

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    Carla Kettler, ckettler@iu.edu (Lead Data Manager)

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    - -
    - Cleveland Clinic -
    - -https://my.clevelandclinic.org/departments/digestive/research-innovations - -
    - Cleveland Clinic
    - Department of Gastroenterology and Hepatology
    - Mail Code A31
    - 9500 Euclid Avenue
    - Cleveland, OH 44195
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    Srinivasan Dasarathy, MD (PI)

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    - Indiana University -
    - -https://medicine.iu.edu/research/clinical/trials/ -https://research.indianactsi.org/ - -
    - Gastroenterology
    - Rotary Building, Suite 225
    - 702 Rotary Cir
    - Indianapolis, IN 46202-5175
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    Raj Vuppalanchi, MD (PI)

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    - -
    - Mayo Clinic – Rochester -
    - -https://www.mayo.edu/research/clinical-trials/search-results?keyword=alcoholic%20hepatitis&status=open-unknown - -
    - 200 First St. SW
    - Rochester, MN 55905
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    Vijay Shah, MD (PI)

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    - -
    - Virginia Commonwealth University -
    - -https://studyfinder.cctr.vcu.edu/ - -
    - VCU School of Medicine
    - Physical Address: McGlothlin Medical Education Center (MMEC), 1201 E Marshall St., 4th Floor, Suite 4-100
    - Mailing Address: Box 980565
    - Richmond, VA 23298
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    Arun Sanyal, MD (PI)

    - -
    - - -
    - University of Louisville -
    - -http://louisville.edu/research/ctu - -
    - University of Louisville School of Medicine
    - 550 S. Jackson Street (ACB, Room A3L15)
    - Louisville, Kentucky 40202
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    Ashwani Singal, MD (PI)

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    - -
    - University of UTSW -
    - -https://clinicaltrials.utswmed.org/studies?utf8=%E2%9C%93&search%5Bhealthy_volunteers%5D=&search%5Bgender%5D=&search%5Bq%5D=alcoholic+hepatitis&commit=Search - -
    - Digestive Disease Clinic at Outpatient Building
    - 1801 Inwood Road, 6th Floor, Suite 102
    - Dallas, TX 75390-8887
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    Mack Mitchell, MD (PI)

    - -
    - -
    - University of Michigan -
    - -https://www.uofmhealth.org/conditions-treatments/digestive-and-liver-health - -
    - University of Michigan Health System
    - 1500 E Medical Center Dr
    - Ann Arbor, MI 48109
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    Robert Fontana, MD (PI)

    - -
    - -
    - University of Pittsburgh -
    - -https://www.upmc.com/services/liver-disease - -
    - University of Pittsburgh Medical Center
    - 200 Lothrop Street
    - Pittsburgh, PA 15213
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    Ramon Bataller, MD (PI)

    - -
    - -
    - University of California San Francisco -
    - -https://liver.ucsf.edu/ - -
    - UCSF Medical Center
    - 505 Parnassus Avenue
    - San Francisco, CA 94143
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    Norah Terrault, MD (PI)

    - -
    - -
    - University of North Carolina -
    - -https://www.med.unc.edu/gi/ - -
    - UNC School of Medicine
    - 101 Manning Drive
    - Chapel Hill, NC 27514
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    Andrew Muir, MD (PI)

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    This page is under construction. Content will be added soon.

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    © 2017-2025 Alcohol-associated Hepatitis Network

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