bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: Patisiran
Intervention description: Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks [Q3W]: Day 0 and Day 21) and an alternative premedication regimen.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic

Summary:

      This was a multiple dose, dose escalation study designed to determine the safety,
      tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants
      with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index must be between 17 kg/m^2 and ≤ 33 kg/m^2;

          -  Women of child-bearing potential must have a negative pregnancy test, cannot be breast
             feeding, and must use appropriate contraception;

          -  Males agree to use appropriate contraception;

          -  Diagnosis of TTR amyloidosis;

          -  Adequate blood counts, liver and renal function;

          -  Willing to give written informed consent and are willing to comply with the study
             requirements.

        Exclusion Criteria:

          -  Known human immunodeficiency virus (HIV) positive status or known or suspected
             systemic bacterial, viral, parasitic, or fungal infection;

          -  Received an investigational agent, other than tafamidis or diflunisal, within 30 days
             prior to first dose study drug administration;

          -  Prior liver transplant;

          -  Poor cardiac function;

          -  Considered unfit for the study by the Principal Investigator;

          -  Employee or family member of the sponsor or the clinical study site personnel.
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABT-494; Placebo
Intervention description: ABT-494 capsule administered orally twice daily (BID).; Placebo for ABT-494 capsule administered orally twice daily (BID).
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-inflammatory agents; Joint Diseases; Arthritis; Musculoskeletal Disease; antirheumatic agents

Summary:

      The primary objective is to compare the safety and efficacy of multiple doses of ABT-494
      versus placebo in moderately to severely active RA subjects on stable background MTX therapy
      with inadequate response or intolerance to anti-TNF biologic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American
             College of Rheumatology (ACR) classification criteria or the 2010 American College of
             Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.

          -  Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3
             months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to
             initiating the study drug. Subjects should also be on a stable dose of folic acid (or
             equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should
             continue with their stable doses of MTX and folic acid throughout the study

          -  Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics
             (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to
             discontinue due to intolerability or toxicity. In addition, subjects with prior
             exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab,
             anakinra, or tocilizumab) are allowed.

          -  Have active RA as defined by the following minimum disease activity criteria: ≥ 6
             swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints
             (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive
             protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor
             and anti-cyclic citrullinated peptide (anti-CCP) antibody.

        Exclusion Criteria:

          -  Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib,
             baricitinib)

          -  Pregnant or breastfeeding female

          -  Ongoing or active infection.
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Condition: Gastric Cancer; Cancer of the Stomach; Esophagogastric Junction
MeSH terms: Stomach Neoplasms
Intervention: BMS-986213; Nivolumab; XELOX; FOLFOX; SOX
Intervention description: Relatlimab + Nivolumab specified dose on specified days; Specified dose on specified days; Oxaliplatin + capecitabine; Oxaliplatin + leucovorin + fluorouracil; Oxaliplatin + tegafur/gimeracil/oteracil potassium
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of investigational drug
      relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable,
      untreated, locally advanced or metastatic gastric or GEJ cancer.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

          -  Histologically- or cytologically-confirmed diagnosis of unresectable and either
             locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma

          -  No prior treatment with systemic treatment (including HER 2 inhibitors) given as
             primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ
             adenocarcinoma

          -  Tumor tissue must be provided for biomarker analyses

        Exclusion Criteria:

          -  Participants with HER2 positive status

          -  Participants with known untreated central nervous system (CNS) metastases

          -  Uncontrolled or significant cardiovascular disease

        Other protocol defined inclusion/exclusion criteria could apply
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
Condition: Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: ADU-S100
Intervention description: intratumoral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and
      safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab
      in the first-line setting. The population will consist of adults with PD-L1 positive
      recurrent or metastatic HNSCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of recurrent or metastatic HNSCC

          -  Measurable disease as defined by RECIST v1.1

          -  PD-L1 positive

        Exclusion Criteria:

          -  Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell
             carcinoma of unknown primary histology; or salivary gland or non-squamous histologies
             (e.g. mucosal melanoma)

          -  Disease amenable to local therapy with curative intent (surgery or radiation therapy
             with or without chemotherapy)

          -  Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small
             molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or
             metastatic HNSCC
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Condition: Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PXL770; Placebo Oral Capsule
Intervention description: Oral capsule; Oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12
      weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have given written informed consent

          -  Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²

          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or
             under stable oral glucose lowering drug

          -  Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]

          -  Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males

          -  Hepatic steatosis (MRI-PDFF ≥ 10%)

          -  Effective contraception for women of child bearing potential

        Exclusion Criteria:

          -  Evidence of another form of liver disease

          -  Evidence of liver cirrhosis

          -  Evidence of hepatic impairment

          -  Positive serologic evidence of current infectious liver disease

          -  History of excessive alcohol intake

          -  Acute cardiovascular disease with 24 weeks prior to screening

          -  Uncontrolled high blood pressure

          -  Any disease which in the Investigator's opinion which in the Investigator's opinion
             would exclude the patient from the study

          -  Use of non-permitted concomitant medication

          -  Pregnancy or lactation
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: NCX 4251; Placebo
Intervention description: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily; Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double-masked
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial
      evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal)
      Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  documented history of blepharitis and meet qualifying criteria for an acute
             exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits

          -  have a qualifying best-corrected visual acuity

        Exclusion Criteria:

          -  abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid
             surgery

          -  IOP > 21 mmHg at Screening or Baseline/Day 1 Visits

          -  use of steroids in the past 30 days or retinoids in the past 12 months

          -  uncontrolled systemic disease
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
Condition: Transplantation Infection; Epstein-Barr Virus Infections; Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Epstein-Barr Virus Infections
Intervention: Valacyclovir; Valganciclovir
Intervention description: Experimental Arm; Standard of care
Intervention MeSH terms: Valacyclovir; Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Healthy volunteers: No
Keywords: EBV; CMV; Kidney transplant; valganciclovir; valacyclovir

Summary:

      Our study will compare all kidney transplant recipients receiving valganciclovir vs.
      valacyclovir for one year following kidney transplant and compare:

        1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after
           transplant.

        2. the side effects of the anti-viral drugs requiring dose reduction or cessation

      In addition, we will test renal tissue obtained from any biopsies post-transplant
      (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and
      fluorescence in situ hybridization to assess for latent CMV and/or EBV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All consenting kidney transplant recipients.

        Exclusion Criteria:

          -  Non-consent.

          -  Recipients with allergies to valacyclovir or valganciclovir

          -  Recipients that are unable to independently understand the consent form and do not
             have a legally authorized representative.
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Condition: Diarrhoea;Acute
MeSH terms: Diarrhea
Intervention: Carbowhite; Carbowhite placebo
Intervention MeSH terms: Silicon
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Diarrhoea; Carbowhite; Colloidal silicon dioxide

Summary:

      The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon
      dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed Informed Consent Form for patient's study participation

          -  male and female patients at the ages from 18 to 55 years

          -  acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or
             less in patients with usually normal stool

          -  body temperature of ≤ 38 °C

          -  patient's ability to adequately cooperate in the process of study

        Exclusion Criteria:

          -  aged of <18 or >55 years;

          -  blood or pus in stool;

          -  body temperature of >38 °C;

          -  episodes of acute diarrhea for the last 30 days;

          -  administration of antidiarrheal products for the last 24 hours;

          -  salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi;
             ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii;
             ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which
             require administration of antimicrobial products;

          -  pregnancy, lactation;

          -  concomitant decompensated diseases or acute conditions which, according to an
             investigator, may affect study results

          -  alcoholism and drug abuse;

          -  participation in any other clinical study.
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vancomycin Pre-Treatment; Placebo for Vancomycin Pre-Treatment; SER-287; Placebo for SER-287
Intervention description: Four times per day dosing of vancomycin pre-treatment; Four times per day dosing of placebo pre-treatment; Once-daily dosing of SER-287; Once-daily dosing of Placebo for SER-287
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: microbiome

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess
      Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of UC at least three months prior to screening, and with a
             minimum disease extent of 15 cm from the anal verge

          -  Active mild-to-moderate UC

          -  Inadequate response to, loss of response to, or intolerance of, at least one of the
             following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine
             (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

        Exclusion Criteria:

          -  Known history of Crohn's disease

          -  No previous history of treatment for UC (treatment-naïve)

          -  Subjects on steroid medication who are unable to have steroids tapered and be
             completely off steroids at least two weeks prior to screening

          -  Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at
             least two weeks prior to screening

          -  Subjects who have received any investigational or approved biologic therapy within
             eight weeks or five half-lives prior to screening (whichever is longer)

          -  Subjects who have received any investigational or approved non-biologic therapy,
             except for those specifically listed in the Permitted Concomitant Medications, for the
             treatment of underlying disease, within 30 days or five half-lives prior to screening
             (whichever is longer)

          -  Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within
             two months before screening, or any history of total colectomy
Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Condition: Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Tauopathies
MeSH terms: Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Tauopathies; Frontotemporal Lobar Degeneration
Intervention: 18F-AV-1451
Intervention description: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: FTLD; FTD

Summary:

      The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect
      depositions of a protein, called tau, in the brains of people with a mutation in the tau gene
      that causes deposition of the protein, and in people without the mutation. Up to three
      18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT
      mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Members of families with established MAPT mutations, who either have the capacity to
             consent to participate in the protocol, or else have designated a surrogate/proxy to
             consent to participate in this study

        Exclusion Criteria:

          -  Unwillingness to participate

          -  Usage of medication which significantly prolongs QT interval

          -  Pregnancy or plans for pregnancy within 90 days after participating in study
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab (BMS-936558)
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1009.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0
      Grade 3 or higher), treatment-related, select adverse events in subjects with histologically
      confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment
      containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with
      Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with histologically confirmed malignant melanoma

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):

               -  PS 0 to 1

               -  PS 2

          -  Previously treated unresectable stage III or stage IV melanoma as per the American
             Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status

          -  Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors
             (RECIST 1.1)-defined disease progression

          -  Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2),
             BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or
             extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras
             Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with
             known cKIT mutations are allowed

          -  Patients with CNS metastases are eligible:

               -  if CNS metastases are treated, patients are asymptomatic or neurologically
                  returned to baseline

               -  if they have previously untreated CNS metastases and are asymptomatic

               -  if they have leptomeningeal metastases, are treated and asymptomatic or
                  neurologically returned to baseline with life expectancy > 3 months

          -  Patients with a known history of Grades 3-4 immune-related adverse reactions
             during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1

        Exclusion Criteria:

          -  Subjects with untreated, active Central Nervous System (CNS) metastases are excluded