bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Filgotinib; Placebo; Standard of Care
Intervention description: 200 mg tablet administered orally once daily; Placebo to match filgotinib tablet administered orally once daily; Locally approved treatment, accepted by medical experts as a proper treatment for IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 139.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the testicular safety of filgotinib in
      adult males with moderately to severely active inflammatory bowel disease (IBD).

      Results of this study may be pooled with the results of a separate study being conducted in
      participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or
      non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the
      same objective. The total planned number of participants in both studies combined will be up
      to approximately 250 participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4
             months. Endoscopic and histopathologic documentation of UC or CD.

          -  Have moderately to severely active UC or CD

        Key Exclusion Criteria:

          -  Previously or currently documented problems with male reproductive health

          -  Current use of sulfasalazine or its use within the 26 weeks leading up to Screening;
             sulfasalazine is not permitted at any point during the study

          -  Current use of corticosteroids at a dosage of > 20 mg/day of prednisone or equivalent
             at randomization

          -  Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative
             proctitis, or toxic mega colon

          -  Active tuberculosis (TB) or untreated latent tuberculosis

          -  Use of concomitant prohibited medications as outlined by protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Condition: Heart Failure; Cardiac Failure; Reduced Ventricular Ejection Fraction
MeSH terms: Heart Failure
Intervention: HNO Donor; Nitroglycerin (NTG); Placebo
Intervention description: Infusion; Infusion; Infusion
Intervention MeSH terms: Nitroglycerin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic
      parameters in patients with heart failure and low ejection fraction.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)

          -  Stable guideline directed therapy for heart failure including oral diuretics, ACEi,
             ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these
             medications in the past 2 weeks

          -  Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10
             pmol/L)

        Exclusion Criteria:

          -  Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization

          -  Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization

          -  Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial
             Flutter

          -  Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2

          -  Ventricular assist device or prior heart transplant

          -  Prior solid organ transplant

          -  Body weight < 45 kg or ≥ 140 kg

          -  Low quality echocardiographic visualization windows and image acquisition

          -  Permanent paced rhythm (VVI, DDD or BiV pacing)

        Other protocol defined inclusion/exclusion criteria could apply
A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate

Summary:

      Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between 18 and 55 years of age (inclusive)

          -  Hemizygous for Fabry disease

          -  Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation
             (individual or familial)

          -  Had enhanceable enzyme activity

          -  In the judgment of the investigator, were either able to safely suspend ERT throughout
             the study, or be ERT naive

          -  Agreed to be sexually abstinent or use a condom with spermicide when engaging in
             sexual activity during the course of the study and for a period of 30 days following
             completion of the study

          -  Were willing and able to sign an informed consent form

        Exclusion Criteria:

          -  History of significant disease other than Fabry disease (for example, end-stage renal
             disease; Class III or IV heart disease [per the New York Heart Association
             classification]; current diagnosis of cancer, except for basal cell carcinoma of the
             skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have
             impaired the participant's ability to participate in the study)

          -  History of organ transplant

          -  Serum creatinine >2 mg per deciliter on Day -2

          -  Screening 12-lead electrocardiogram demonstrating corrected QT interval >450
             milliseconds prior to dosing

          -  Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta),
             Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any
             experimental therapy for any indication

          -  Participated in a previous clinical trial in the last 30 days

          -  Any other condition, which, in the opinion of the investigator, would jeopardize the
             safety of the participant or impact the validity of the study results
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: elezanumab; placebo
Intervention description: solution for infusion; solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Multiple sclerosis; Elezanumab; ABT-555

Summary:

      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with relapsing Multiple Sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or
             secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24
             months.

          -  Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s)
             consistent with multiple sclerosis (MS).

          -  Participant has evidence of physical disability according to Expanded Disability
             Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

        Exclusion Criteria:

        - Participants must not have experienced or be recovering from a clinical MS relapse within
        6 months of Screening.
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™; GSK1247446A
Intervention description: GlaxoSmithKline Biologicals' licensed influenza vaccine; Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine; Prophylaxis Influenza vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity and the safety of candidate
      vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female aged 18-59 years at the time of the first vaccination.

          -  Free of obvious health problems

        Exclusion Criteria:

          -  Use of non-registered products

          -  Administration of immune-modifying drugs.

          -  Administration of vaccine 30 days before enrolment in study.

          -  Immunosuppressive or immunodeficient condition.

          -  Hypersensitivity to a previous dose of influenza vaccine

          -  Previous vaccination against influenza in 2006

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality.

          -  History of confirmed influenza infection within the last 12 Months.

          -  Acute disease at the time of enrolment/vaccination.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Estriol; Placebo; Copaxone
Intervention description: Estriol 8 mg capsule, once per day, duration of treatment is 2 years; Placebo capsule, once a day, treatment duration is 2 years; Injection, once a day, all subjects
Intervention MeSH terms: Glatiramer Acetate; Estrogens; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 158.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; estrogen; estriol; progesterone

Summary:

      This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in
      relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone
      injections in all subjects. The primary outcome measure is a reduction in relapses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing remitting multiple sclerosis

          -  At least one relapse in the last two years

        Exclusion Criteria:

          -  Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T
             cell vaccination, cladribine, bone marrow transplantation, azathioprine,
             cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri

          -  Clinically significant diseases other than multiple sclerosis
Study of Ataluren (PTC124) in Hemophilia A and B
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Ataluren
Intervention description: Oral powder
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia A; Hemophilia B; Factor VIII; Factor IX; FVIII; FIX; Nonsense mutation; Premature stop codon; HA; HB; PTC124; Ataluren

Summary:

      Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations
      in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are
      essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause
      damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a
      nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30%
      of participants with hemophilia and results in severe manifestations. Ataluren (PTC124) is an
      orally delivered, investigational drug that acts to overcome the effects of the premature
      stop codon, potentially enabling the production of functional FVIII/FIX. This study is a
      Phase 2a trial evaluating the safety and efficacy of ataluren in participants with HA or HB
      due to a nonsense mutation. The main purpose of this study is to understand whether ataluren
      can safely increase FVIII/FIX activity levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent

          -  Age ≥18 years

          -  Presence of a nonsense mutation as the sole disease-causing mutation in the FVIII or
             FIX gene

          -  At least 20 prior treatments with FVIII or FIX concentrates

          -  Willingness and ability to comply with scheduled visits, drug administration plan,
             study restrictions, and study procedures

        Exclusion Criteria:

          -  Known hypersensitivity to any of the ingredients or excipients of the study drug

          -  Any history of prior anti-FVIII/FIX inhibitors

          -  Unable or unwilling to forego prophylactic FVIII/FIX concentrate use during the
             screening and on-study periods (Note: Participants were allowed use of FVIII/FIX
             concentrates for treatment of bleeding episodes while on study)
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Condition: Moderate or Severe Submental Fullness
Intervention: Deoxycholic acid injection; Placebo
Intervention description: Phosphate buffered saline placebo for injection
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the
      reduction of submental fat (fat below the chin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or severe submental fat

          -  Dissatisfaction with submental area

          -  History of stable body weight

          -  Signed informed consent

        Exclusion Criteria:

          -  Any medical or other condition that would affect subject safety or evaluation of
             efficacy

          -  Previous intervention in the submental area
Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy
Condition: Extensive Stage Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: becatecarin
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor
      cells from dividing so they stop growing or die. This phase II trial is studying how well
      rebeccamycin analog works as second-line therapy in treating patients with limited-stage or
      extensive-stage small cell lung cancer that has relapsed after previous first-line
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of small cell lung cancer (SCLC)

               -  Limited or extensive stage

          -  At least 1 unidimensionally measurable lesion at least 20 mm by conventional
             techniques OR at least 10 mm by spiral CT scan

          -  Sensitive* relapsed disease after only 1 prior chemotherapy regimen

          -  Brain metastasis allowed provided the following criteria are met:

               -  Stable brain disease

               -  Not receiving irradiation

               -  No steroid requirement to control symptoms

          -  Performance status - ECOG 0-2

          -  Performance status - Karnofsky 60-100%

          -  At least 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement
             is present)

          -  Bilirubin ≤ 1.5 mg/dL

          -  Creatinine < 2.0 mg/dL

          -  Creatinine clearance ≥ 60 mL/min

          -  No New York Heart Association class III or IV heart disease

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active or ongoing infection

          -  No other concurrent uncontrolled illness

          -  No psychiatric illness or social situation that would preclude study compliance

          -  See Disease Characteristics

          -  See Disease Characteristics

          -  See Disease Characteristics

          -  Prior radiotherapy allowed

          -  No other concurrent investigational agents

          -  No other concurrent therapies for SCLC

          -  No concurrent combination antiretroviral therapy for HIV-positive patients
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Prexasertib
Intervention description: Administered IV
Intervention MeSH terms: Prexasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SCLC; LY2606368; CHK1

Summary:

      The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to
      participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will
      evaluate how the body processes the drug and how the drug affects the body. The study will
      also evaluate the association between tumor response and the participant's perceived quality
      of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have ED-SCLC and have received a prior platinum-based regimen

          -  Participants in Cohort 1 and in the addendum must have had an objective response to
             prior platinum-based therapy with subsequent progression ≥90 days after the last dose
             of platinum

          -  Participants in Cohort 2 must have either not had an objective response to prior
             platinum based therapy or had progression <90 days after the last dose of platinum

          -  Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

        Exclusion Criteria:

          -  Have received more than 2 prior therapies for ED-SCLC (including immunotherapy,
             targeted therapies, or chemotherapy)

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic
             participants with treated CNS metastases are eligible for this study if they are not
             currently receiving corticosteroids to treat CNS metastases

          -  Have previously completed or withdrawn from this study or any other study
             investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown
             hypersensitivity to any of the components of the prexasertib formulation

          -  Have a serious cardiac condition
Peanuts and Glycemic Control
Condition: Type2 Diabetes; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Peanut; High carbohydrate snack
Intervention description: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.; Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A two-period randomized crossover study will be conducted to determine the effect of peanuts
      on glycemic control, and elucidate the role of the microbiome in glucose regulation, in
      individuals with impaired fasting glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoking

          -  Impaired fasting glucose at screening (≥ 100 mg/dL).

          -  BMI ≥20 and ≤40 kg/m2.

        Exclusion Criteria:

          -  Diagnosed diabetes or fasting glucose >126 mg/dl

          -  Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)

          -  Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs

          -  Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune
             disease or inflammatory conditions

          -  Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
             and not willing to cease for the duration of the study

          -  Pregnancy or lactation

          -  Weight loss of >=10% of body weight within the 6 months prior to enrolling in the
             study

          -  Smoking or use of any tobacco products

          -  Allergy to test foods

          -  Consumption of >14 alcoholic drinks/week