bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis
Intervention: Daclatasvir; Daclatasvir; Daclatasvir; Placebo; Peginterferon alpha-2a; ribavirin
Intervention description: Tablets, oral, 3 mg, Daily, 48 weeks; Tablets, oral, 10 mg, Daily, 48 weeks; Tablets, oral, 60 mg, Daily, 48 weeks; Tablet, oral, 0 mg, Daily 48 weeks; Syringe, subcutaneous, 180 µg, Weekly, 48 weeks; Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Antivirals

Summary:

      The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in
      combination with pegylated interferon alpha and ribavirin, are safe and demonstrate
      sufficient anti-hepatitis C virus activity.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients chronically infected with hepatitis C virus (HCV) genotype 1

          -  HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening

          -  Treatment naive

        Key Exclusion Criteria:

          -  Women of child-bearing potential

          -  Cirrhosis

          -  Coinfection with HIV or hepatitis B virus
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: K-161; Placebo (Vehicle)
Intervention description: K-161 alternate dosage; Placebo solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing
      regimen of K-161 in adult subjects with moderate to severe dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age at the time of informed consent visit.

          -  Have a reported history of dry eye disease in both eyes and a history of eye drop use
             for dry eye symptoms.

          -  Meet all inclusion criteria outlined in the clinical study protocol.

        Exclusion Criteria:

          -  Have any clinically significant ocular condition.

          -  Have a history of corneal refractive surgery and/or any other ocular surgical
             procedure within 12 months.

          -  Must not meet any other exclusion criteria outlined in the clinical study protocol.
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Condition: Neoplasms; Constipation; Opioid-Related Disorders
MeSH terms: Constipation; Opioid-Induced Constipation; Opioid-Related Disorders
Intervention: Methylnaltrexone bromide
Intervention description: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methylnaltrexone; Constipation; Narcotic Antagonists; Analgesics, Opioid; Neoplasms

Summary:

      The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving
      opioid-induced constipation in cancer patients at various stages of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed neoplasm

          -  18 years of age or older

          -  Have received opioids for analgesia for at least 2 weeks and been on a stable regimen
             of opioids and laxatives for 3 or more days before study entry

          -  Fewer than three laxation during the preceding week and no laxation within 24 hours
             before study entry, or no laxation within 48 hours before study entry

          -  Life expectancy of at least 6 months

          -  World Health Organization Performance Status 0-3

          -  Women of childbearing potential must have a negative pregnancy test

          -  Breastfeeding should be discontinued prior to study entry

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Laboratory values within a week of study entry:

        Absolute neutrophil count > 1,500/microliter Hemoglobin > 7 g/dL Platelet count >
        100,000/microliter Calculated calcium < 10.5 mg/dL Calculated creatinine clearance > 30
        mg.min Alanine aminotransferase < 3 x upper limit of normal (ULN) Aspartate
        aminotransferase < 3 x ULN Alkaline phosphatase < 2.5 x ULN Bilirubin < 1.5 x ULN

        Exclusion Criteria:

          -  Constipation not primarily caused by opioids, such as mechanical gastrointestinal
             obstruction or ongoing vinca alkaloid administration

          -  Indwelling peritoneal catheter

          -  Clinically active diverticular disease

          -  Fecal impaction

          -  Acute surgical abdomen

          -  Fecal ostomy

          -  Peritoneal carcinomatosis

          -  Known hypersensitivity to methylnaltrexone, naltrexone, or naloxone

          -  Administration of any investigational drug or experimental product within the previous
             30 days

          -  Initiation of a new bowel regimen or prokinetic agents within a week of study entry
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: eribulin mesylate
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well E7389 works in treating patients with recurrent or
      progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy,
      such as E7389, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

          -  Stage IIIB or IV disease

          -  Recurrent or progressive disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  Must have received prior treatment with platinum-based therapy and a taxane

          -  Asymptomatic brain metastasis allowed provided off steroids for > 2 weeks

          -  Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%

          -  Life expectancy > 3 months

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 2.0 mg/dL

          -  AST/ALT ≤ 2.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No neuropathy ≥ grade 2

          -  No uncontrolled illness including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would preclude study compliance

          -  No other concurrent investigational agents

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
             and recovered

          -  At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and
             recovered

          -  No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant
             setting

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

        Exclusion Criteria:

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to E7389
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LYS006; Placebo
Intervention description: capsule for oral use; capsule for oral use
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each such including the 4 week screening period is 16 weeks.
At the beginning of the treatment period, subjects will be randomized to one of the two following treatment groups in 2:1 ratio:
LYS006
matching placebo
Masking: Double (Participant, Investigator)
Masking description: Subject and investigator blinded via randomization
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ulcerative colitis, efficacy, safety

Summary:

      The purpose of the study was to assess preliminary efficacy, safety, and tolerability of
      LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006
      has an adequate clinical profile for further development in this indication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects 18-75 years of age with an established diagnosis of
             ulcerative colitis at least 3 months prior to screening are eligible for the study.

          -  Patients must have active disease with a full Mayo Score between 5 and 10 (inclusive)
             with an endoscopy score of 2 or 3; rectal bleeding and stool frequency scores 1 to 3
             and a physician's global assessment of 1 or 2.

          -  Patients must have responded inadequately to conventional therapy with oral 5-ASA
             prior to screening.

        Key Exclusion Criteria:

          -  Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic
             colitis or acute diverticulitis based on medical history.

          -  History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or
             stoma; history or is at risk of colectomy.

          -  Treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior
             to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to
             screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week,
             topical treatment with 5-ASA or steroids within 2 weeks prior to screening endoscopy
Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent Plasma
Intervention description: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open label pilot study designed to provide access to treatment with
      investigational convalescent plasma and assess the relationship between NAb titers in the
      investigational convalescent plasma compared to changes in NAb levels in the recipient in
      hospitalized patients with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be 18 years of age or older.

          2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19
             SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment,
             test results must be positive prior to administration of convalescent plasma.

          3. Patient (or legally authorized representative, LAR) is willing and able to provide
             written informed consent and comply with all protocol requirements.

          4. For patients unable to consent, consent by the legally authorized representative (LAR)
             may be obtained by phone.

        Exclusion Criteria:

          1. Female subjects with positive pregnancy test or breastfeeding.

          2. Receipt of pooled immunoglobulin in past 30 days.

          3. Contraindication to transfusion or history of prior severe allergic reactions to
             transfused blood products.

          4. On ECMO or in refractory shock at entry
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Mavyret
Intervention description: Patients will be on 8 weeks of Mavyret
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung
      transplant at NYULH who consent to participate in this study will receive a lung transplant
      from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the
      pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week
      treatment course. Patients will be monitored post-transplant for the development of viremia,
      and for the time course of clearance of viremia among those who develop viremia.
    

Eligibility criteria:

        Inclusion Criteria:

        Recipient criteria:

          -  Listed for an isolated lung transplant at NYU Langone Health

          -  Between 18-70 years of age

          -  Able to travel to the NYU Langone Health for routine post-transplant visits and study
             visits for a minimum of 6 months after transplantation

          -  No active illicit substance abuse

          -  Weight at least 40kg

          -  Women of childbearing potential must agree to use birth control in accordance with
             Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to
             the increased risk of birth defects and/or miscarriage

          -  Both men and women must agree to use at least one barrier method after transplant to
             prevent any secretion exchange

          -  Able and willing to provide informed consent

        Donor criteria:

          -  Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody

          -  Donor lung meets standard NYU Langone Health clinical criteria for procurement

        Exclusion Criteria:

        Recipient criteria:

          -  HIV positive

          -  HCV RNA positive or history of previously treated HCV

          -  Evidence of active hepatitis B infection or on active antiviral treatment for HBV

          -  Pregnant or nursing (lactating) women

          -  Use of strong CYP3A inducers

          -  Requires multi-organ transplant

        Donor criteria:

          -  Confirmed HIV positive

          -  Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable
             Hepatitis B virus DNA)

          -  Known previously failed treatment for HCV

          -  Donor age >60 years
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Differing doses and frequencies of sc administration
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will determine the appropriate dose and frequency of administration of sc Mircera
      maintenance therapy in dialysis patients with chronic renal anemia who were previously
      receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and
      the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;

          -  receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  use of any investigational drug within 30 days preceding the run-in phase, or during
             the run-in or study treatment period.
PSMA PET and MRI in Gynecological Cancers
Condition: Gynecologic Cancer
Intervention: PSMA-based 18F-DCFPyL PET tracer
Intervention description: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Uterine cancer; Ovarian cancer; Hysterectomy; Salpingo-oophorectomy

Summary:

      The goal of this research is to determine the accuracy of PSMA positron emission tomography
      (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of
      gynecological cancer cells in the body.
    

Eligibility criteria:

        Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry
        participants):

          -  Women with no suspected gynecological cancer.

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years of age.

          -  Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

        Inclusion Criteria for female controls (Dosimetry):

          -  Women with or without suspected gynecological cancer.

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years of age.

        Inclusion Criteria for gynecological cancer patients (N=40):

          -  Women with known or suspected gynecological cancer

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years

          -  Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

        Exclusion Criteria:

          -  Women that are pregnant or breast-feeding.

          -  Age <18

          -  Inability to provide informed consent on their own behalf

          -  Severe kidney dysfunction (GFR <30 mL/min/1.73m2)
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
Condition: Chronic Refractory Cough
MeSH terms: Cough
Intervention: Orvepitant Maleate; Placebo
Intervention description: Tablet, once daily, oral; Tablet, once daily, oral
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of three doses of orvepitant,
      taken once a day, in the treatment of chronic refractory cough.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects ≥18 years of age.

          -  Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines
             attached).

          -  An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during
             the screening period.

        Key Exclusion Criteria:

          -  Subjects with respiratory tract infection (<4 weeks prior to study start)

          -  Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10
             pack years

          -  Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of
             screening

          -  FEV1 <80% predicted, measured at screening using spirometry

          -  History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant
             bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease
             (COPD)

          -  Any clinically significant abnormal laboratory test result(s)

          -  Inability to comply with the use of prohibited and allowed medications as described in
             the protocol.