bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GSK573719; GSK573719; Placebo
Intervention description: 62.5 mcg; 125mcg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; long acting muscarinic antagonist

Summary:

      The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation
      Powder is safe and effective compared with placebo or no active drug intake, when
      administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD

          -  10 pack-year or greater history of cigarette smoking

          -  Post-bronchodilator FEV1/FVC of <0.7

          -  Predicted FEV1 of 70% of normal or less

          -  Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning to become pregnant

          -  Respiratory disorders other than COPD, including a current diagnosis of asthma

          -  Clinically significant non-respiratory diseases or abnormalities that are not
             adequately controlled

          -  Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the
             excipients of magnesium stereate or lactose used in the inhaler delivery device

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to screening

          -  Lung volume reduction surgery within 12 weeks prior to screening

          -  Abnormal and clinically significant ECG findings at screening

          -  Clinically significant laboratory findings at screening

          -  Use of systemic corticosteroids, antibiotics for respiratory tract infections, high
             dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4
             inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled
             beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational
             medicines for defined time periods prior to the screening visit

          -  Use of long-term oxygen therapy (12 hours or greater per day)

          -  Regular use of nebulized treatment with short-acting bronchodilators

          -  Participation in the acute phase of a pulmonary rehabilitation program

          -  A know or suspected history of alcohol or drug abuse

          -  Affiliation with the investigational site

          -  Previous use of GSK573719 or the combination of GSK573719/GW642444
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Condition: Kidney Transplantation
Intervention: Belatacept; Tacrolimus; Cyclosporine
Intervention MeSH terms: Cyclosporine; Abatacept; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose is to assess the benefits and risks of changing from Cyclosporine or
      Tacrolimus to Belatacept between 6-60 months after kidney transplant.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women, ages 18-75 inclusive

          -  Adult recipients of a renal allograft from a living donor or a deceased donor between
             6-60 months prior to enrollment

          -  Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A
             (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated
             Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids

          -  Stable renal function for 12 weeks prior to enrollment without new onset proteinuria

          -  Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification
             of Diet in Renal Disease study (MDRD) 4-formula]

        Exclusion Criteria:

          -  Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown

          -  History of acute rejection (AR) within 3 months prior to enrollment

          -  History of antibody mediated rejection

          -  Positive T-cell lymphocytotoxic cross match

          -  Proteinuria >1 g/day or >0.5 g/day if diabetic
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sirukumab 100 mg; Sirukumab 50 mg; Placebo
Intervention description: Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.; Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.; Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Sirukumab; CNTO 136; CNTO136ARA3002; SIRROUND-D; CNTO136ARA3003; SIRROUND-T; SIRROUND-LTE

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136
      (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment
      with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003

          -  Signed an informed consent form (ICF) indicating that they understand the purpose of
             and procedures required for the study and are willing to participate in the study

          -  Signed an informed consent form (ICF) for pharmacogenetics research (how a person's
             genes may affect a drug's effects) in order to participate in the optional
             pharmacogenetics component of this study. Refusal to give consent for this component
             does not exclude a participant from participation in this clinical study

        Exclusion Criteria:

          -  Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or
             CNTO136ARA3003

          -  Is pregnant

          -  Has active diverticulitis

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (eg, compromise the well-being) of the participant or that
             could prevent, limit, or confound the protocol-specified assessments
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CyclASol Ophthalmic Solution
Intervention description: Cyclosporine A solution in vehicle
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate safety and tolerability of CyclASol during
      long-term use in subjects with Dry Eye Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the clinical trial CYS-004 and habe been compliant with trial
             procedures

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of DED in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Early termination of CYS-004

          -  Clinically significant slit-lamp findings or ocular conditions that require
             prescriptive medical treatment and/or in the opinion of the investigator may interfere
             with trial parameters

          -  Have a history of herpetic keratitis;

          -  Have an ocular or periocular malignancy;

          -  Be unwilling to avoid wearing contact lenses during the trial;

          -  Have any planned ocular or eyelid surgeries during the trial period

          -  Be a woman who is pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing
             potential

          -  Women of childbearing potential not using an acceptable means of contraception

          -  Presence of known allergy and/or sensitivity to the study drug or its components

          -  Be currently using an investigational drug or device or have used an investigational
             drug or device within 60 days before Visit 1 other than for CYS-004

          -  Have a condition or be in a situation (eg language barrier) which the investigator
             feels may put the subject at significant risk,may confound the trial results, or may
             interfere with the subject's participation in the trial significantly
Cognitive Therapy for Recurrent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Continuation phase cognitive therapy; Continuation phase fluoxetine; Continuation phase pill placebo; Acute phase cognitive therapy
Intervention description: Continuation phase cognitive therapy included 10 sessions over 8 months.; The dosage of fluoxetine was increased to 40 mg over 8 months.; The dosage of pill placebo was increased to 40 mg over 8 months.; For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Intervention MeSH terms: Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 523.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cognitive therapy; Antidepressants; Psychotherapy

Summary:

      This study determined the effectiveness of continuation phase cognitive therapy versus
      antidepressant medication in preventing relapse of depression in people with recurrent
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent unipolar major depressive disorder

          -  Have experienced at least two episodes of major depression

          -  Have experienced at least one period of recovery during a depressive episode or have a
             history of dysthymia (a mood disorder characterized by depression) prior to the onset
             of current or past depressive episodes

          -  Willing and able to comply with all study requirements

          -  Able to speak and read English

        Exclusion Criteria:

          -  Active alcohol or other substance dependence within 6 months prior to study entry

          -  Currently at risk for suicide

          -  Mood disorders due to a medical condition or substance abuse

          -  Bipolar, schizoaffective, obsessive compulsive, or eating disorders

          -  Schizophrenia

          -  Unable to stop mood-altering medications

          -  Current use of medication or diagnosis of a medical disorder that may cause depression
             (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)

          -  Previous failure to experience a reduction in depressive symptoms after 8 weeks of
             cognitive therapy with a certified therapist

          -  Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40
             mg of Prozac

          -  Pregnancy or plan to become pregnant in the next 11-12 months

          -  Unable to attend clinic twice weekly during business hours

          -  Unable to complete questionnaires
Effects of Biktarvy on CFR in Stable HIV Patients
Condition: HIV
Intervention: Biktarvy
Intervention description: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was
      approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is
      Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was
      found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes.
      B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result,
      B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on
      coronary flow reserve.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with HIV on abacavir/lamivudine/dolutegravir STR regimens for at least 1 year
        fulfilling the following inclusion criteria:

          1. age ≥ 45 years for men and ≥ 55 years for women;

          2. at least one coronary risk factor including smoking, dyslipidemia, hypertension,
             obesity (BMI >30) or diabetes, or a calculated 10-year risk of heart attack of 7.5% or
             higher;

          3. HIV RNA < 200 copies/mL at last clinical measurement, done within the past 12 months
             prior to screening, with no intervening HIV RNA > 200;

          4. Screening HIV RNA < 50 copies/mL, CBC, and chemistries that, in the judgment of the
             investigator, do not preclude the use of Biktarvy.

        Exclusion Criteria:

          1. patients not fulfilling inclusion criteria;

          2. unstable HIV disease or other medical condition that, in the opinion of the
             investigator, would interfere with the conduct of the study;

          3. history of cardiomyopathy (LVEF <40%) or significant valvular heart disease;

          4. cirrhosis;

          5. end stage renal disease on dialysis;

          6. uncontrolled hypertension (defined as SBP >200 or DBP >110);

          7. pregnancy;

          8. Patients requiring medications contraindicated with the components of B/F/TAF;

          9. Patients on active treatment for severe asthma or severe COPD.
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: pantoprazole
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 1 Day
Maximum age: 28 Days
Healthy volunteers: No
Keywords: Safety

Summary:

      The purpose of this study is to determine whether or not consistent drug levels can be
      achieved in infants with presumed Gastroesophageal Reflux Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized patients

          -  Presumed diagnosis of GERD

          -  Term or post-term infants within the neonatal period less than 28 days or preterm
             infants with a corrected gestational age of less than 44 weeks

        Exclusion Criteria:

          -  cardiovascular instability

          -  clinically significant laboratory abnormalities

          -  use of warfarin, carbamazepine, phenytoin, or rifampin
Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir
Intervention MeSH terms: Peramivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute uncomplicated; Elderly

Summary:

      This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
      600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza
      infection and in subjects with acute uncomplicated influenza infection at higher risk for
      influenza complications. All subjects will receive IV peramivir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at
             least one clinical sign or symptom consistent with acute influenza infection as listed
             below OR

          -  Clinical signs and symptoms consistent with acute influenza infection consisting of an
             oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least
             moderate severity (cough or rhinitis) and at least one constitutional symptom of at
             least moderate severity (myalgia [aches and pains], headache, feverishness, or
             fatigue)

          -  Influenza symptom onset < 48 hours. However, due to historically delayed presentation
             for medical care in the adult population, approximately 20% of the elderly population
             may be enrolled with symptoms starting > 48-hours but ≤ 72-hours

        Exclusion Criteria:

          -  Women who plan to breast-feed for the first 48 hours after study drug administration

          -  Subjects requiring hospital admission to treat medical condition(s) which could
             represent complications of influenza.

          -  Recent worsening of any chronic medical condition consistent with complications of
             influenza

          -  Current evidence of a bacterial infection requiring antibiotic treatment
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX101; Vehicle Foam
Intervention description: FMX101, 4% minocycline foam; Vehicle Foam
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1488.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of
      Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne
      Vulgaris (Study FX2017-22)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has facial acne vulgaris with:

               1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)

               2. 25 to 100 non-inflammatory lesions (open and closed comedones)

               3. No more than 2 nodules on the face

               4. IGA score of moderate (3) to severe (4)

          2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study.

        Exclusion Criteria:

          1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations.

          2. Sunburn on the face.
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CT-P13; Remicade
Intervention description: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose; Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is to assess noninferiority in efficacy and to assess overall safety of CT P13
      compared to Remicade in patients with active Crohn's disease up to Week 54.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with active Crohn's disease and a Crohn's disease activity
             index score between 220 and 450 points

        Exclusion Criteria:

          -  Patient who has previously received a biological agent for the treatment of Crohn's
             disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of
             other disease.

          -  Patient who has allergies to any of the excipients of infliximab, any other murine
             and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.