bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; QVA149; QAB149; Placebo
Intervention description: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI; QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI; QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI; To mimic QAB149
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 614.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide

Summary:

      This study is to assess the safety and tolerability of two different doses of QVA149 and
      QAB149 in patients with moderate to severe airflow limitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults aged ≥40 years

          -  Patients with stable COPD according to GOLD strategy (GOLD 2011).

          -  Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and
             <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients with an mMRC ≥ grade 2

        Exclusion Criteria:

          -  History of long QT syndrome or prolonged QTc

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics
             and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit
             1.

          -  Patients with Type I or uncontrolled Type II diabetes

          -  Patients with a history of asthma or have concomitant pulmonary disease

          -  Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with
             persistent atrial fibrillation and controlled with a rate control strategy for at
             least six months could be eligible

          -  Patients who have clinically significant renal, cardiovascular, neurological,
             endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
             abnormalities which could interfere with the assessment of safety

          -  Other protocol defined inclusion/exclusion criteria may apply
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Placebo; SAGE-547 90 μg/kg/h
Intervention description: Intravenous infusion of matching placebo for SAGE-547.; Intravenous infusion of SAGE-547
Intervention MeSH terms: Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Moderate Postpartum Depression; SAGE-547

Summary:

      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate
      postpartum depression (PPD) compared to placebo injection as assessed by the change from
      baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at screening; or if still lactating or
             actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to
             their infant(s).

          -  Participant 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 DSM-IV Axis I Disorders (SCID-I).

          -  Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to
             dosing).

          -  Participant was ≤ six months postpartum.

          -  Participant was amenable to intravenous therapy.

        Key Exclusion Criteria:

          -  Active psychosis.

          -  Attempted suicide associated with index case of postpartum depression.

          -  Medical history of bipolar disorder.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
Condition: HIV Infections; Pneumococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine (13vPnC); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); Blood draw; Blood draw
Intervention description: 13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3; 23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3); Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).; 1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: vaccine; 13-valent pneumococcal conjugate vaccine; 23-valent pneumococcal polysaccharide vaccine; human immunodeficiency virus

Summary:

      The study will evaluate the safety, tolerability and immunogenicity of a 13-valent
      pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who
      have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3
      doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with
      each dose given approximately 1 month apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older

          -  Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before
             study vaccination

          -  Receiving stable highly active antiretroviral therapy (HAART) or not currently
             receiving any antiretroviral therapy

          -  No previous vaccination with a pneumococcal vaccine

          -  Subject or parent/legal guardian able to complete an electronic diary

        Exclusion Criteria:

          -  Acquired immune deficiency syndrome (AIDS) at time of enrollment

          -  Current illicit substance and/or alcohol abuse

          -  History of active chronic viral hepatitis

          -  Previous anaphylactic reaction to a vaccine or vaccine-related component

          -  Serious chronic disorders including metastatic malignancy and end-stage renal disease
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Placebo; Dacarbazine
Intervention description: Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent
In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression; Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent; Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
Intervention MeSH terms: Ipilimumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 681.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage IIIc N3 (unresectable); Stage IV melanoma

Summary:

      The purpose of this clinical research study is to examine the safety and effectiveness (how
      well the drug works) of two different treatments for patients with melanoma. One treatment is
      an investigational compound (a drug that is not currently approved by the United States Food
      and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016)
      together with an approved chemotherapy drug called Dacarbazine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent

          -  Measurable Disease

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

          -  Lab / imaging requirements

          -  Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C

          -  Men and Women > 18 years (16 were allowable)

          -  Prior therapy restriction (adjuvant only)

        Exclusion:

          -  Pregnant / nursing

          -  Inadequate contraception

          -  Brain metastasis

          -  Primary ocular or mucosal melanoma
MK-0524B Lipid Study (MK-0524B-063)
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Comparator: simvastatin; MK-0524A; Placebo; MK-0524B
Intervention description: Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Intervention MeSH terms: Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2414.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed
      dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on
      lipid values.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has primary hypercholesterolemia or mixed dyslipidemia based on medical history
             (previous diagnosis), historic lipid values, or as otherwise determined through
             optional lipid measurements at screening visit

          -  meets one of the following triglyceride (TG) criteria:

               1. is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of
                  washout

               2. is not on any lipid altering therapy or is on lipid altering therapy other than
                  niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of
                  screening

        Exclusion Criteria:

          -  is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin

          -  is pregnant or breast-feeding, or expecting to conceive during the study including the
             14-day post study follow-up

          -  has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled,
             is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated
             hypoglycemia or unstable glycemic control or is taking new or recently adjusted
             anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3
             months of Visit 1

          -  has the following conditions: chronic heart failure, uncontrolled/unstable cardiac
             arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or
             hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: OxiplexTS
Intervention description: OxiplexTS is a Frequency Domain Near-Infrared Tissue oximeter which provides absolute values of tissue oxygenation in real time. It also provides physiological quantities of oxy, deoxy and total hemoglobin concentration, which form the basis for the functional measurement of brain hemodynamics. Both the control and OSA groups will undergo standard overnight sleep study (PSG). In addition to the standard PSG, with or without Continuous Positive Airway Pressure (CPAP), we will add the OxiplexTS, allowing us to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to the OSA sufferers. Participants with OSA who undergo PSG/CPAP will be also tested with the OxiplexTS. Their PSGs and PSG/CPAP data will be compared.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obstructive Sleep Apnea Syndrome; sleep disordered breathing; polysomnography (psg); continuous positive airway pressure (cpap); brain vascular autoregulation; brain tissue oxygenation; near-infrared spectroscopy; Obstructive Sleep Apnea

Summary:

      The goal of this trial is to assess the performance of the OxiplexTS-an absolute
      near-infrared oximeter-as an instrument to measure brain oxygenation and hemodynamics in
      sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy individuals (controls)

          -  Individuals undergoing overnight polysomnography foe suspected obstructive sleep apnea

        Exclusion Criteria:

          -  Documented severe cardiovascular disease.

          -  Documented cerebrovascular disease

          -  Documented cardiopulmonary disease

          -  Pregnancy
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Condition: Hypoalbuminemia
MeSH terms: Hypoalbuminemia; Systemic Inflammatory Response Syndrome
Intervention: Thalidomide; Sugar pill
Intervention description: Thalidomide by mouth at night for a total of 24 weeks; Placebo by mouth at night for a total of 24 weeks
Intervention MeSH terms: Thalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammation; albumin

Summary:

      Both malnutrition and inflammation are associated with death in dialysis patients and also
      with cardiovascular disease. The researchers are testing the idea that inflammation causes
      malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out
      whether that will increase blood tests that are associated with malnutrition. The researchers
      will give hemodialysis patients who have both inflammation and malnutrition either
      thalidomide or a placebo and compare the effects of treatment on the levels of two proteins
      in the blood, albumin and prealbumin, that are normally reduced in malnourished patients.
      Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to
      have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with
      CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those
      with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment
    

Eligibility criteria:

        Inclusion Criteria:

          1. End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.

          2. Serum C reactive protein level of ≥ 0.8 mg/dl.

          3. Serum albumin < 3.8 g/dl (BCG).

          4. Signing a written informed consent form.

          5. Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.

          6. Age > 18 years.

        Exclusion Criteria:

          1. Pregnant and/ or lactating female.

          2. Active infection within the previous 8 weeks requiring administration of antibiotics.

          3. Patients receiving systemic immunosuppressive therapy.

          4. Patients with HIV.
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Condition: Osteoporosis in Men
MeSH terms: Osteoporosis
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection once a month.; Administered by subcutaneous injection once a month.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 245.0
Sex: Male
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis in men

Summary:

      The study is designed to evaluate if treatment with romosozumab once a month for 12 months
      compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar
      spine. Additionally, the study will assess the effect of treatment with romosozumab for 12
      months compared with placebo on BMD at the femoral neck and total hip.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age

          -  Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the
             spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

        Exclusion Criteria:

          -  A BMD T score ≤ -3.50 at the hip,

          -  History of hip fracture

          -  Severe metabolic bone diseases

          -  Significant laboratory abnormalities

          -  Recent treatment with agents affecting bone metabolism
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: terbinafine; Placebo; terbinafine; Placebo
Intervention description: Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks; Vehicle (placebo) once daily for 48 weeks; Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks; Vehicle (placebo) once daily for 24 weeks
Intervention MeSH terms: Terbinafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 526.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses

Summary:

      This study is designed to assess the efficacy, safety and tolerability of a topical
      formulation of terbinafine solution applied daily in patients with toenail fungus. This trial
      will study patients with mild to moderate toenail fungus disease of the big toenail and their
      responses to two treatment durations, 24 or 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 12 - 75 years of age

          -  Fungal toenail infection of one or both of the large (great) toenails

          -  The nail infection must be due to a dermatophyte, (mixed infections dermatophyte and
             non-dermatophyte] are not allowed)

        Exclusion Criteria:

          -  Target foot must not have severe plantar (moccasin) tinea pedis that would require
             systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be
             treated with terbinafine prior to baseline or at any time during the trial. Other
             topical treatments for athlete's foot may be recommended at the discretion of the
             investigator.

          -  Subjects must not have abnormalities of the nail that could prevent a normal appearing
             nail if clearing of infection is achieved

          -  No administration of systemic antifungal medications within 6 months prior to
             screening visit

          -  No application of prescription topical antifungal medications for toenail fungus
             within 3 months or other commercially available topical medications for toenail fungus
             applied directly to the toenails within 1 month prior to screening visit

          -  No professional pedicures or application of any nail polish product or nail cosmetic
             to the toenails after the screening visit

          -  Known pregnancy or lactation at time of enrollment

        Other protocol-defined inclusion/exclusion criteria may apply