bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
Condition: Chronic Hepatitis C Virus
MeSH terms: Infections; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1 (GT-1); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Open Label; Sofosbuvir; Additional relevant MeSH terms:; Hepatitis; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action

Summary:

      This study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV)
      administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1
      hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18, with chronic genotype 1 HCV infection

          -  HCV treatment-experienced, including patients who have previously failed a
             nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV
             regimen

          -  HCV RNA > 10,000 IU/mL at screening

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Coinfection with HIV or hepatitis B virus

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin
             cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Placebo
Intervention description: IV Ferumoxytol; IV Placebo
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 812.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; IDA

Summary:

      To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for
      the treatment of iron deficiency anemia (IDA).
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Males and females ≥18 years of age

          2. Participants with IDA defined as having:

               1. Hemoglobin <10.0 g/deciliter (dL)

               2. Transferrin saturation <20%

          3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral
             iron cannot be used

          4. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to screening and agree to
             remain on birth control until completion of participation in the study

        Key Exclusion Criteria include:

          1. History of allergy to IV iron

          2. Allergy to two or more classes of drugs

          3. Participants on dialysis or with an estimated glomerular filtration rate <30
             mL/minute/1.73 m^2

          4. Female participants who are pregnant, intend to become pregnant, are breastfeeding,
             within 2 weeks postpartum, or have a positive serum/urine pregnancy test

          5. Hemoglobin ≤7.0 g/dL

          6. Serum ferritin >600 nanograms/mL
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Condition: Various Advanced Cancer
Intervention: Nivolumab; Placebo
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness and safety of Nivolumab compared
      to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Must have had invasive urothelial cancer at high risk of recurrence originating in the
             bladder, ureter, or renal pelvis

          -  Must have had radical surgical resection (e.g. radical cystectomy), performed within
             the last 120 days

          -  Must have disease free status as determined by imaging within 4 weeks of dosing

          -  Tumor tissue must be provided for biomarker analysis

          -  Patients who have not received prior neoadjuvant cisplatin chemotherapy must be
             ineligible for or refuse cisplatin-based adjuvant chemotherapy

        Exclusion Criteria:

          -  Partial bladder or partial kidney removal (eg, partial cystectomy or partial
             nephrectomy)

          -  Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following
             surgical removal of bladder cancer

          -  Subjects with active, known or suspected autoimmune disease

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured

          -  Condition requiring systemic treatment with either corticosteroids or other
             immunosuppressive medications within 14 day of study drug administration

          -  Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
             ribonucleic acid (HCV antibody) indicating acute or chronic infection
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Condition: Symptomatic Neurogenic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Intervention: ampreloxetine
Intervention description: Oral tablet, QD
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Symptomatic Neurogenic Orthostatic Hypotension; sympomatic nOH; multiple symptom atrophy; MSA; Parkinson's disease; PD; pure autonomic failure; PAF; orthostatic hypotension; OH; ampreloxetine; 171; low blood pressure; dizziness; fainting; blacking out; lightheadedness; norepinephrine; hypotension; OAK

Summary:

      A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of
      ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic
      nOH over 182 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of Study 0170 and, in the opinion of the Investigator, would benefit from
             long-term treatment with ampreloxetine.

          -  The subject must be able to understand the nature of the study and must provide
             written informed consent prior to the conduct of any study procedures (including any
             changes occurring in the subject's current therapeutic regimen).

          -  The subject must be willing to continue on treatment and must continue to meet all the
             inclusion criteria for the preceding study (Study 0170) except, a score of >4 in
             OHSA#1.

        Exclusion Criteria:

          -  Subjects may not be enrolled in another clinical trial.

          -  Psychiatric, neurological, or behavioral disorders that may interfere with the ability
             of subjects to give informed consent, or interfere with the conduct of the study.

          -  Medical, laboratory, or surgical issues deemed by the Investigator to be clinically
             significant.

          -  Hypersensitivity to ampreloxetine or the formulation excipients.
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661 plus ivacaftor combination; Ivacaftor; Placebo (matched to VX-661 plus ivacaftor combination); Placebo (matched to ivacaftor)
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through
      Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del
      mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR
      mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive
      [NR]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF defined as a sweat chloride value greater than or equal to
             (>=)60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis.

          -  Heterozygous for the F508del-CFTR mutation and with a second CFTR mutation that is not
             likely to respond to VX-661 and/or ivacaftor therapy, genotype to be confirmed via
             assessment at the Screening Visit.

          -  Forced Expiratory Volume in 1 Second (FEV1) >=40 percent (%) and less than or equal to
             (<=)90% of predicted normal for age, sex, and height at Screening Visit.

        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
             participant.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug).

          -  History of solid organ or hematological transplantation.

          -  Ongoing or prior participation in an investigational drug study or use of commercially
             available CFTR modulator within 30 days of screening.

          -  Pregnant or nursing females.
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Intervention: Asenapine
Intervention description: Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluates the safety and tolerability of Asenapine in elderly patients with
      psychosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elderly subjects with psychosis

        Exclusion Criteria:

          -  Have an uncontrolled, unstable clinically significant

        medical condition.

          -  Have an established diagnosis of dementia
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid foam, 15% (BAY39-6251); Vehicle foam
Intervention description: Azelaic acid twice daily topical application; twice daily topical application
Intervention MeSH terms: Azelaic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 961.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rosacea

Summary:

      The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam,
      15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea
      compared to its vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of papulopustular rosacea

          -  Free of any clinically significant disease, which could interfere with the study

          -  Male or female subject aged ≥ 18 years

          -  Willingness of subject to follow all study procedures

          -  Signed written informed consent before any study-related activities are carried out

        Exclusion Criteria:

          -  Subjects who are known to be non-responders to azelaic acid

          -  Presence of dermatoses that might interfere with rosacea diagnosis

          -  Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions,
             papulopustular rosacea that requires systemic treatment

          -  Topical use of any prescription or non-prescription medication to treat rosacea within
             6 weeks prior to randomization and throughout the study

          -  Systemic use of any prescription or non-prescription medication to treat rosacea
             (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids,
             erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to
             randomization and throughout the study

          -  Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to
             randomization

          -  Known hypersensitivity to any ingredients of the investigational product formulation

          -  Participation in another clinical research in parallel or within the last 4 weeks
             before randomization in this study

          -  Any condition or therapy that in the investigator's opinion may pose a risk to the
             subject or that could interfere with any evaluation in the study
Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Imatinib
Intervention description: 200 mg or 400 mg qd
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension; imatinib; 6MWD

Summary:

      This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety,
      tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed in CQTI571A2102 clinical trial including all Study Completion
             assessments at the end of study visit met the eligibility criteria for that study and
             did not meet withdrawal criteria for safety reasons during study conduct

        Exclusion Criteria:

          -  Patients with left ventricular ejection fraction (LVEF) < 45%

          -  Patients with thrombocytopenia, platelet count < 50 x109/L (50 x 103/µL).

          -  Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160
             mmHg or diastolic pressure > 90 mmHg.

          -  Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of
             right bundle branch block.

        Other protocol-defined inclusion/exclusion criteria may apply
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone gel (FE 999303)
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and
      safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between 18-75 years of age

          -  Two fasting serum testosterone levels <300 ng/dL

        Exclusion Criteria:

          -  Previous use of the study drug

          -  History of prostate or breast cancer

          -  Prostate-Specific Antigen (PSA) ≥3 ng/mL

          -  Subject is sexually active and not willing to use adequate contraception
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 oral capsules.; SAGE-217 matched-placebo oral capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: SAGE-217; Postpartum depression

Summary:

      The purpose of this study is to determine if treatment with SAGE-217 reduces depressive
      symptoms in females with severe postpartum depression (PPD) as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has ceased lactating or agrees not to provide breastmilk to her infant(s)
             from just prior to receiving the investigational product (IP) on Day 1 until 7 days
             after the last dose of IP.

          -  Participant has had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version
             (SCID-5-CT).

          -  Participant is ≤12 months postpartum at screening and Day 1.

        Exclusion Criteria:

          -  Participant is at significant risk of suicide or has attempted suicide associated with
             the current episode of PPD.

          -  Participant has active psychosis per investigator assessment.

          -  Participant has a medical history of nonfebrile seizures.

          -  Participant has a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.

          -  Participant has a history of sleep apnea.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Intervention: OTO-104; Placebo
Intervention description: Single intratympanic injection of 12 mg dexamethasone; Single intratympanic injection of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Meniere's Disease; Vertigo; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Summary:

      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
             Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
             for the 2 months prior to the study lead-in period.

          -  Subject has experienced active vertigo during the lead-in period.

          -  Subject has documented asymmetric sensorineural hearing loss.

          -  Subject agrees to maintain their current treatments for Meniere's disease while
             on-study.

        Exclusion Criteria:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has a history of significant middle ear or inner ear surgery, or endolymphatic
             sac surgery in the affected ear.

          -  Subject has a history of tympanostomy tubes with evidence of perforation or lack of
             closure.

          -  Subject has a history of vestibular migraine.

          -  Subject has used an investigational drug or device in the 3 months prior to screening.

          -  Subject has previously been randomized to a clinical study of OTO-104.