bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
Condition: Atherosclerotic Coronary Vascular Disease
MeSH terms: Cardiovascular Diseases; Vascular Diseases
Intervention: Ranolazine 500 mg
Intervention description: Ranolazine 500 mg, oral tablet, b.i.d.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cardiovascular disease; Exercise Treadmill Test; Ranolazine; Angina; Myocardial ischemia

Summary:

      The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as
      biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of stable coronary artery disease

        Exclusion Criteria:

          -  Inability or unwillingness to participate in multiple exercise treadmill tests and/or
             any other requirements of this study as assessed by the Investigator.

               -  History of chronic atrial fibrillation.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GB004; Placebo
Intervention description: oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammatory Bowel Disease

Summary:

      A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week
      open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of
      GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without
      systemic steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects aged ≥ 18 years at the time of signing the informed
             consent form (ICF) prior to initiation of any study specific activities/procedures.

          -  UC diagnosed at least 3 months prior to first dose of investigational product (IP) on
             Day 1.

          -  Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to
             flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine)
             alone or with one of the following oral treatments:

               1. prednisone ≤ 20 mg/day or equivalent or

               2. beclomethasone ≤ 5 mg/day or

               3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

        Exclusion Criteria:

          -  Prior approved biologic therapy used for the treatment of UC.

          -  Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of
             bacterial or parasitic infection.

          -  Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of
             Day 1.

          -  Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

        NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: LY573636-sodium
Intervention description: LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to estimate the time from the first dose of
      LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines
      that your disease has progressed or worsened.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of soft tissue sarcoma that is unresectable or metastatic

          -  Have received one or two (but no more than two) prior treatment regimens for
             metastatic soft tissue sarcoma, one of which must have included doxorubicin
             (adriamycin).

          -  Must have stopped all previous treatments for cancer, including chemotherapy,
             radiation therapy or other investigational treatments for cancer for at least 30 days

        Exclusion Criteria:

          -  Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma,
             chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma

          -  Serious pre-existing medical problems (as determined by your doctor)

          -  Have received more than two previous systemic treatment regimens for unresectable or
             metastatic soft tissue sarcoma

          -  Have a second primary cancer (unless cancer-free for more than 2 years)

          -  Active treatment with Warfarin (Coumadin)
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Condition: Schizophrenia; Alcohol Use Disorder
MeSH terms: Alcoholism; Schizophrenia; Alcohol Drinking
Intervention: Samidorphan + olanzapine (ALKS 3831); Placebo + olanzapine
Intervention description: Oral tablet, taken once daily; Oral tablet, taken once daily
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; Schizophrenia; Alcohol Use Disorder; ALKS 3831

Summary:

      This double-blind, randomized study will evaluate the efficacy, safety and tolerability of
      ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a BMI between 18.0 and 40.0 kg/m2, inclusive

          -  Has a diagnosis of schizophrenia

          -  Has a diagnosis of alcohol use disorder (AUD)

          -  Has experienced an acute exacerbation of schizophrenia within the past 6 months

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Is pregnant or breastfeeding

          -  Had first lifetime psychotic episode less than 1 year before screening or has
             experienced only a single lifetime psychotic episode

          -  Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine

          -  Has current or pending legal charges with the potential for incarceration

          -  Has a positive drug screen for opiates

          -  Additional criteria may apply
BIIB033 In Acute Optic Neuritis (AON)
Condition: Acute Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: BIIB033 (anti-LINGO-1 mAb); Placebo
Intervention description: 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).; via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Optic Neuritis

Summary:

      The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with
      their first episode of unilateral acute optic neuritis (AON). The secondary objective of this
      study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this
      study population.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to provide written consent and any authorization required by law.

          -  Confirmed diagnosis of AON

          -  All male or female subjects of childbearing potential must practice effective
             contraception during the study and be willing and able to continue contraception for
             at least 6 months after their last dose of study treatment.

        Key Exclusion Criteria:

          -  Prior episode(s) of optic neuritis or loss of vision not due to AON.

          -  Subjects with an established diagnosis of multiple sclerosis are excluded except if
             newly diagnosed based on the current episode of AON and positive brain magnetic
             resonance imaging results consistent with the 2010 revisions to the McDonald's
             criteria.

          -  Previous history of a clinically significant disease.

          -  Females who have a positive pregnancy test result, or who are pregnant, breastfeeding,
             or planning to conceive during the study.

          -  History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or
             hepatitis B virus.

          -  History or evidence of drug or alcohol abuse within 2 years prior to Screening.

          -  Current enrollment in any other study treatment or disease study within 3 months prior
             to Day 1/Baseline.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Dexamethasone Treatment of Congenital Adrenal Hyperplasia
Condition: Adrenal Hyperplasia, Congenital
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Intervention: dexamethasone; Hydrocortisone
Intervention description: Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.; Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.
Intervention MeSH terms: Dexamethasone; Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if dexamethasone given at night is a more effective
      treatment for congenital adrenal hyperplasia in young children than standard three times per
      day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more
      efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over
      trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone
      and one on nocturnal dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Classic salt-wasting 21-hydroxylase deficient congenital adrenal hyperplasia

          -  Pre-pubertal children with bone ages below 8 years

        Exclusion Criteria:

          -  Age less than 2 years

          -  Patients with additional medical conditions necessitating glucocorticoid therapy.

          -  Patients on phenytoin, barbiturates, and rifampin as these medications accelerate the
             metabolism of glucocorticoids.

          -  Patients on ketoconazole as this medication increases the bioavailability of
             glucocorticoids.
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Condition: Renal Transplant
Intervention: Belatacept; Sirolimus; Anti-thymocyte globulin; methylprednisolone
Intervention description: 10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks; 4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year; 1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.; 500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
Intervention MeSH terms: Sirolimus; Methylprednisolone; Abatacept; Thymoglobulin; Antilymphocyte Serum; Immunoglobulins; Glucocorticoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: renal transplantation; kidney transplantation; renal allograft recipient; anti-rejection drugs; immunosuppression protocol; immunosuppression withdrawal

Summary:

      Belatacept is an experimental medication shown in clinical trials to have immune system
      suppression properties in people who have had renal (e.g., kidney) transplants. This study
      will determine whether a combination of anti-rejection drugs, including belatacept, can
      prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal
      transplant and allow patients to be safely withdrawn from anti-rejection therapy one year
      post-transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving first renal (e.g., kidney) transplant

          -  Transplant is from a non-HLA-identical living donor

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Positive for anti-human globulin (AHG) or T-cell cross-match with the donor

          -  Receiving multiple-organ transplant

          -  History of cancer within the 5 years prior to study entry. Patients who have certain
             nonmelanoma skin cancers are not excluded

          -  Human immunodeficiency virus (HIV) infected

          -  Hepatitis B (HBV) or C (HCV) virus infected

          -  Other active infections

          -  Active tuberculosis (TB) infection within the 3 years prior to study entry

          -  Pregnancy or breastfeeding
Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Merck L-830982; Placebo
Intervention description: The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.; Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: schizophrenia

Summary:

      The purpose of this research study is to determine whether a short-term administration of an
      investigational study drug may provide evidence of improvement in cognitive functioning in a
      group of stable male subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants

          -  Between the ages of 18 and 50

          -  Meet diagnostic criteria for schizophrenia or schizoaffective disorder

          -  Are clinically stable for a minimum of 3 months on current dose of medication

          -  Are unemployed (i.e., work less than 20 hours per week at competitive employment)

        Exclusion Criteria:

          -  Psychoactive substance dependence within the past 6 months or substance abuse within
             the past month

          -  History of head trauma or other neurological disorder

          -  Medical illness or medications, such as benzodiazepine treatment or HIV medications,
             that may be affected by study participation (the study doctor will discuss this with
             potential subjects)

          -  Mental retardation

          -  Seizure disorder

          -  History of a heart attack, arrhythmia, or other heart disease
Phase II Study of Oral Nafithromycin in CABP
Condition: Community-Acquired Bacterial Pneumonia (CABP)
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Nafithromycin 800 mg 3 days; Nafithromycin 800 mg 5 days; Moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin; Nafithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral
      Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial
      Pneumonia (CABP) in Adults
    

Eligibility criteria:

        Inclusion Criteria:

        Meet the clinical criteria for CABP based on following:

          1. Clinical symptoms (new or worsening)

          2. Vital sign abnormalities

          3. Laboratory abnormalities

          4. Radiographic evidence of CABP

          5. PORT score

        Exclusion Criteria:

          1. Subjects with any of the following confirmed or suspected types of pneumonia:

               1. Aspiration pneumonia

               2. Hospital-acquired bacterial pneumonia (HABP)

               3. Healthcare-associated bacterial pneumonia (HCAP)

               4. Ventilator-associated bacterial pneumonia (VABP)

               5. Pneumonia that may be caused by pathogen(s) resistant to either study drug

          2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial
             treatment for treatment of the current CABP

          3. Suspected or confirmed non-infectious causes of pulmonary infiltrates

          4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic
             antibacterial treatment for management of CABP
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: TMC278 25 mg; TMC278 75 mg; TMC278 150 mg; Efavirenz; Non-nucleoside reverse transcriptase inhibitor (NRTIs)
Intervention description: TMC278 25 mg tablet will be administered once daily.; TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.; TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.; Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.; Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.
Intervention MeSH terms: Efavirenz; Reverse Transcriptase Inhibitors; Rilpivirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus Type 1; Human immunodeficiency virus (HIV); Antiretroviral; Antiviral; ARV; TMC278; Efavirenz; Combivir; Truvada; Zidovudine; Lamivudine; Tenofovir disoproxil fumarate; Emtricitabine

Summary:

      The purpose of this study is to evaluate the dose-response relationship of antiviral activity
      after 48 weeks treatment with 3 different dose regimens of TMC278.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented human immunodeficiency virus type 1 (HIV-1) infection

          -  Never been treated with an antiretroviral (ARV) treatment or therapeutic HIV vaccine,
             or received less than or equal to 2 weeks treatment prior to screening with an
             nucleoside reverse transcriptase inhibitors

          -  HIV-1 plasma viral load above 5000 HIV-1 RNA copies per milliliter, at screening

          -  Cortisol of at least 550 nano moles per liter (19.9 microgram per deciliter) at
             screening

          -  Sensitivity to investigator selected nucleosides, at screening

        Exclusion Criteria:

          -  Currently having active Acquired Immunodeficiency Syndrome (AIDS) defining illness

          -  Known or suspected acute (primary) HIV-1 infection

          -  Any current or history of adrenal disorder, and an acute hepatitis A, B, or C
             infection

          -  Documented genotypic evidence of Non-Nucleoside Reverse Transcriptase Inhibitor
             (NNRTI) resistance at screening

          -  Pregnant or breastfeeding females

          -  Not agree to protocol-defined effective use of contraception
Efficacy and Safety Study of SUNPG1623
Condition: Active Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: SUNPG1623 I; SUNPG1623 II; SUNPG1623 III; SUNPG1623 IV; PLACEBO
Intervention description: injection; injection; injection; injection; injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to
      demonstrate the safety and efficacy of SUNPG1623
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written informed consent

          -  Subject is ≥ 18 years of age at time of Screening

          -  Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP

          -  Subject has a negative evaluation for TB within 4 weeks before initiating IMP

          -  Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR]
             criteria) with symptoms present for at least 6 months.

          -  Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

        Exclusion Criteria:

          -  Subject has a planned surgical intervention between Baseline and the Week 24
             evaluation for a pretreatment condition

          -  Subject has an active infection or history of infections

          -  Subject has any concurrent medical condition or uncontrolled, clinically significant
             systemic disease

          -  Subject has a known history of infection with hepatitis B, hepatitis C, or human
             immunodeficiency virus