bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Sofosbuvir; Placebo; PEG; RBV
Intervention description: Sofosbuvir tablet(s) administered orally once daily; Placebo to match sofosbuvir administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.; Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C infection Genotype 1; HCV; GT1; GT 1

Summary:

      Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100
      mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B
      status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg
      active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in
      order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day
      0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study
      which continued for 48 weeks. Participants were evaluated for sustained virologic response
      (SVR) for an additional 24 weeks following completion of study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naive males and females, 18-65 years of age

          -  Genotype 1 HCV infection

          -  Negative pregnancy test for females of childbearing age

          -  Females of childbearing age and males with female partners of childbearing age must
             use two forms of contraception during treatment and following the last dose of
             ribavirin in accordance with locally approved label for ribavirin

        Exclusion Criteria:

          -  Hepatitis B or HIV infection

          -  Pregnant or breast feeding females or male partners of pregnant females

          -  Previous interferon or ribavirin-based therapy or investigational anti-HCV agent

          -  History or evidence of medical condition associated with chronic liver disease other
             than HCV
ESBA1008 Microvolume Study
Condition: Exudative Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: ESBA1008 solution; Ranibizumab
Intervention description: Intravitreal injection or infusion; Intravitreal injection
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Exudative Age-Related Macular Degeneration; Wet AMD; Choroidal neovascularization (CNV); Vascular endothelial growth factor (VEGF)

Summary:

      The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a
      microvolume injection or infusion on retinal function and morphology in subjects with
      exudative age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign informed consent document;

          -  Able to make the required study visits and follow instructions;

          -  Age-related macular degeneration in the study eye;

          -  Visual acuity within protocol-specified range;

          -  340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent)

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Both eyes: Any active infection or inflammation;

          -  Study eye: Any treatment for exudative age-related macular degeneration (AMD) other
             than vitamin supplements;

          -  Study eye: Any current or history of macular or retinal disease;

          -  Study eye: Any concurrent intraocular condition such as cataract or diabetic
             retinopathy that, in the opinion of the Investigator, could either require medical or
             surgical intervention during the course of the study to prevent or treat visual loss;

          -  Study eye: Other ocular conditions or diseases that, in the opinion of the
             Investigator, could compromise visual acuity;

          -  Study Eye: Uncontrolled glaucoma;

          -  History of a medical condition that, in the opinion of the Investigator, would
             preclude scheduled study visits, completion of the study, or a safe administration of
             investigational product;

          -  Women of childbearing potential who are lactating, pregnant, planning to become
             pregnant, or not using adequate birth control methods for the duration of the study;

          -  Intraocular surgery within 3 months of baseline;

          -  Study eye: Any history or current evidence of retinal angiomatous proliferation (RAP)
             lesions based on clinical exam;

          -  Other protocol-defined exclusion criteria may apply.
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Condition: Tobacco Use Disorder; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia
Intervention: sensorimotor replacement; 42 mg transdermal nicotine replacement; Placebo transdermal nicotine; usual brand smoking
Intervention description: denicotinized cigarettes; 2 21-mg nicotine patches; 2 placebo patches matched to 21-mg nicotine patches; participant smokes usual brand of cigarette
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within-subjects design study that investigated the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches). Participants were smokers with schizophrenia and equally-heavy smokers without psychiatric disorders. Each participant underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, usual-brand cigarettes + no patches.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Participants and outcomes assessor were blind to patch condition (NIC or PLA)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine; craving; dual-diagnosis; comorbidity

Summary:

      The objective of this study is to investigate the relative contributions of nicotine
      replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on
      abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms,
      cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with
      schizophrenia and non-psychiatric smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  schizophrenia or no psychiatric illness

          -  18 and older

          -  men and women

          -  cigarette smokers, 20-50 cigarettes per day

          -  would like to quit someday

        Exclusion Criteria:

          -  medical conditions excluding transdermal nicotine replacement

          -  pregnancy or lactation
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Condition: APOE 4
MeSH terms: Alzheimer Disease
Intervention: AGB101 220 mg; Placebo
Intervention description: AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.; Placebo, oral capsule given once-daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled crossover study in which a low dose of AGB101 (220mg QD) or placebo will be administered to 50 healthy 55-75-year-old subjects, with the order of treatments counterbalanced in a within-subject crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 55 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Adult; Normal Memory; APOE 4; Brain; Magnetic Resonance Imaging; MRI; Alzheimer's disease; Hippocampus; Genetic testing; Dementia; AGB101

Summary:

      The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam
      extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus
      in normal, healthy adults. The investigators will compare the functional connectivity results
      after taking AGB101 or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fluent in English

          -  At least eight (8) years of education

          -  Geriatric Depression Scale (GDS) (62) score < 6

          -  Hachinski Ischemic Score ≤ 4

          -  Normal general cognitive function as well as 1) normal memory function, documented by
             MOCA score of 23 or greater, and a RBANS Delayed Memory Index score of 85 or greater.

        Exclusion Criteria:

          -  Neurological disease, such as Parkinson's disease, multi-infarct dementia,
             Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive
             supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or a
             history of significant head trauma or known structural brain abnormalities

          -  Major psychiatric disease or chronic unstable medical conditions

          -  History of drug abuse

          -  History of alcohol abuse (4 or greater drinks per day on average)

          -  Unable to complete MRI scans (no Pacemaker/Defibrillator)

          -  Known clinically significant abnormalities in B12 or thyroid function tests

          -  End Stage Renal Disease (ESRD)

          -  Hemodialysis (HD)
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tezacaftor/Ivacaftor; Ivacaftor; Tezacaftor/Ivacaftor matching placebo; Ivacaftor matching placebo
Intervention description: Tezacaftor/Ivacaftor FDC
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661
      (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic
      fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance
      regulator (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants, homozygous for the F508del CFTR mutation

          -  Confirmed diagnosis of CF by sweat chloride testing

          -  Forced Expiratory Volume in 1 Second (FEV1) ≥40% and ≤90% of predicted normal for age,
             sex, and height at Screening Visit

          -  Stable CF disease as judged by the investigator.

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             subject.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy for pulmonary disease within 28 days before Day 1

          -  History or evidence of clinically significant findings on ophthalmologic examination
             during the Screening Period.

          -  History of solid organ or hematological transplantation

          -  Pregnant or nursing females

          -  Participants who have had radiation exposure within 1 year before the first
             mucociliary clearance (MCC) procedure that would cause them to exceed federal
             regulations by participating in this study

          -  In the opinion of the investigator, unable to adequately perform inhalation maneuvers
             during the MCC procedures
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MEDI0382 100 μg; MEDI0382 200 μg; MEDI0382 300 μg; PlaceboA; MEDI0382 50 ug; PlaceboB
Intervention description: Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose; 1.0 mL liquid formulation per Vial; Solution for injection, 1.0 mL per vial, 50 ug; Solution for injection in 1.0 mL pre-filled syringe.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Diabetes; MEDI0382; D5674C00001; T2DM; Type 2 Diabetes

Summary:

      This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated
      up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese
      subjects.

      The study D5674C00001 can be conducted with a reasonable expectation of safety and
      tolerability in Japanese T2DM patients. The design of this study has taken into account the
      known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as
      the translatable effects observed in nonclinical studies of MEDI0382.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.

          -  Individuals who are diagnosed with T2DM

          -  Individuals whose current condition at enrolment (Visit 1) is drug naïve

          -  BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

        Exclusion Criteria:

          -  Subjects with any of the following results at screening:

          -  Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)

          -  Alanine transaminase (ALT) ≥ 2.5 × ULN

          -  Total bilirubin (TBL) ≥ 2 × ULN

          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60
             mL/minute/1.73 m2 at screening

          -  Participation in another clinical study with an investigational product administered
             in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of
             screening
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; gemcitabine
Intervention description: 1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days; 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: after; anthracycline; taxane; regimen

Summary:

      To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with
      anthracycline and taxane regimen for patients with metastatic breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and/or cytologically confirmed breast cancer

          -  Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane
             regimen

          -  To have at least one measurable region

          -  PS: 0-1

          -  To have adequate organ function (bone marrow, liver and renal function)

        Exclusion Criteria:

          -  To have Interstitial pneumonia or pulmonary fibrosis

          -  To have inflammatory carcinoma

          -  Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest
             hormonal/immunotherapy or 7 days after surgery

          -  To have brain metastasis with symptom

          -  To have severe complication (cardiac infarction, infection, drug hyper sensitivity or
             diabetes)
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-RM2 (RM2); PET/CT Scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 68Ga-RM2; PET/CT scan; Gastrin Releasing Peptide Receptor (GRPr); 14-146

Summary:

      The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can
      show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled
      DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study
      is being done because there are unmet medical needs to improve the current ways of detecting
      prostate cancers before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Biopsy proven adenocarcinoma of the prostate

          -  Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN
             guidelines (2.2014) will be included

          -  Planned radical prostatectomy at MSKCC

          -  Multiparametric MRI of the pelvis (performed or planned) as routine care

        Exclusion Criteria:

          -  Patients meeting any of the following exclusion criteria will not be eligible for
             study entry:

          -  Hematologic

               -  Platelets <75K/mcL

               -  ANC <1.0 K/mcL

          -  Hepatic laboratory values

               -  Bilirubin >2.0 x ULN (institutional upper limits of normal)

               -  AST/ALT >2.5 x ULN

          -  Renal laboratory values

             o Creatinine > 2.0 x ULN

          -  Claustrophobia interfering with MRI and PET/CT imaging

          -  Prior pelvic radiation

          -  Prior androgen deprivation therapy

          -  Patients deemed not surgical candidates due to prohibitive co-morbidities
Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
Condition: Hidradenitis Suppurativa (Acne Inversa)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: CJM112; Placebo
Intervention description: CJM112 Fully human IgG1 monoclonal antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa

Summary:

      This is a randomized, double blind, multicenter study in patients with moderate to severe
      chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of
      multiple doses of CJM112 in comparison to placebo. The study has two periods to explore
      preliminary dose effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients 18 to 65 years of age with clinically diagnosed chronic HS
             for at least 1 year (prior to screening) who have undergone previous antibiotic
             therapy

          2. Weight between 50 kg and 150 kg

          3. HS-PGA score of at least moderate severity at the time of inclusion with at least 4
             abscesses and/or nodules. HS lesions must be present in at least two distinct
             anatomical areas, and at least one area must be minimally Hurley Stage II (moderate)

        Exclusion Criteria:

          1. Use of previous biologics or other specified concomitant medications

          2. Use of any systemic treatment for HS in the last 4 weeks prior to randomization

          3. Presence of more than 25 draining fistulae.

          4. Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.

          5. Women of child-bearing potential and sexually active males unwilling to use a condom
             during intercourse while taking drug and for 15 weeks after stopping investigational
             medication.

          6. Evidence of active tuberculosis at screening

          7. History of severe systemic Candida infections or evidence of Candidiasis in the last
             two weeks

          8. Active systemic or skin infections (other than common cold or HS related) during the
             two weeks before randomization/first treatment

          9. Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before
             randomization.

        Other protocol-defined inclusion/exclusion criteria may apply
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab
Intervention MeSH terms: Ipilimumab
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: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese
      subjects with advanced melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of malignant melanoma

          -  Previously-treated or untreated unresectable Stage III or Stage IV melanoma

          -  Measurable/evaluable disease per modified World Health Organization (mWHO) criteria,
             within 28 days of first dose of study drug

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Active brain metastases

          -  Primary ocular or mucosal melanoma

          -  History of or current active autoimmune disease