bioihbjkbjnl/mcl2 huggingface dataset:
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
Condition: Metastatic Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: pembrolizumab; capecitabine; eribulin; gemcitabine; vinorelbine
Intervention MeSH terms: Gemcitabine; Capecitabine; Pembrolizumab; Vinorelbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Summary:

      In this study, participants with metastatic triple negative breast cancer (mTNBC) will be
      randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy
      chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with
      local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine,
      or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival
      compared to TPC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Centrally confirmed Stage IV/M1 mTNBC

          -  Newly obtained tumor biopsy from metastatic site

          -  Central determination of programmed cell death ligand 1 (PD-L1) tumor status

          -  Received either one or two prior systemic treatments for metastatic breast cancer and
             have documented disease progression on or after the most recent therapy

          -  Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or
             metastatic setting

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days
             prior to study start

          -  Adequate organ function

        Exclusion Criteria:

          -  Participation in another clinical trial within 4 weeks

          -  Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks

          -  Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2
             weeks

          -  Active autoimmune disease that required systemic treatment in the past 2 years

          -  Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form
             of immunosuppressive therapy within 7 days

          -  Known additional malignancy that required treatment or progressed in last 5 years

          -  Known active brain metastases and/or carcinomatous meningitis

          -  Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1
             (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory
             T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40,
             CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: ABT-335 and rosuvastatin calcium; ABT-335; rosuvastatin calcium
Intervention description: ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks; ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks; Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Intervention MeSH terms: Calcium, Dietary; Rosuvastatin Calcium; Fenofibric acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 760.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin
      calcium combination therapy to monotherapy in subjects with dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria

          -  Adult male and female participants who voluntarily sign the informed consent.

          -  Fasting lipid results following greater than 12-hour fasting period:

               -  Triglycerides level greater than or equal to 150 mg/dL,

               -  High-density lipoprotein cholesterol less than 40 mg/dL for males and less than
                  50 mg/dL for females, and

               -  Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.

          -  Participant must agree to utilize adequate birth control methods and adhere to the
             American Heart Association (AHA) diet.

        Exclusion Criteria

          -  Participants with unstable medical conditions, medical conditions considered
             inappropriate in a clinical trial, or participants who are taking excluded concomitant
             medications are not allowed in the study.

          -  Participants receiving coumarin anticoagulants or systemic cyclosporine.
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab
Intervention description: Subcutaneous Injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: efficacy; safety; adalimumab; japanese participants

Summary:

      This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese
      subjects with moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a diagnosis of HS;

          -  Participant must have any HS symptom at least 6 months prior to Baseline;

          -  HS lesions must be present in at least 2 distinct anatomic areas, one of which must be
             Hurley Stage II or Hurley Stage III;

          -  Participant must have stable HS for at least 2 months (60 days) prior to Screening and
             also at the Baseline visit;

          -  Participant must have a total abscess and inflammatory nodule (AN) count of greater
             than or equal to 3 at the Baseline visit.

        Exclusion Criteria:

          -  Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or
             participation in adalimumab trial;

          -  Any other active skin lesion or condition that may interfere with assessment of HS;

          -  Participants received antibiotic treatment for HS within 28 days prior to the Baseline
             visit other than those allowed per protocol. Participant on permitted oral antibiotic
             treatment (doxycycline or minocycline only) for HS who have not been on a stable dose
             for at least 28 days prior to the Baseline visit;

          -  Participants received prescription topical therapies for the treatment for HS within
             14 days prior to the Baseline visit;

          -  Participants received systemic non-biologic therapies with potential therapeutic
             impact for HS less than 28 days prior to the Baseline visit;

          -  Participants received oral concomitant analgesics (non-opioids and opioids) for
             HS-related pain within 14 days prior to the Baseline visit.
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenACWY-CRM conjugate vaccine; Licensed comparator
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 389.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Adolescents; Persistence

Summary:

      The primary objective is to evaluate the persistence of bactericidal antibodies in
      adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY
      Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also
      enroll age-matched subjects who have never received any other meningococcal vaccine (naïve
      subjects) to serve as an additional control group.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects enrolled in V59P13:

          -  healthy subjects who have completed the V59P13 study.

        Naïve subjects:

          -  healthy subjects aged-matched with subjects who had completed the V59P13
             trial.(currently 16-23 years old).

        Exclusion Criteria:

        Subjects who had completed the V59P13 study:

          -  who received any meningococcal vaccine after the V59P13 trial;

          -  who have had previous confirmed or suspected disease caused by N. meningitidis;

          -  who have had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis (serogroups A, C, W135, or Y);

          -  subjects with any serious, acute or chronic progressive disease.

        Naïve subjects:

          -  who previously received any meningococcal vaccine;

          -  who have had previous confirmed or suspected disease caused by N. meningitidis;

          -  who have had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis (serogroups A, C, W135, or Y);

          -  subjects with any serious, acute or chronic progressive disease.
Head to Head Study Against Sevelamer Hydrochloride
Condition: Chronic Kidney Disease, Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Fosrenol (Lanthanum Carbonate); Sevelamer hydrochloride
Intervention description: The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.; The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the
      reduction of serum phosphorus levels from baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with end stage renal disease who are receiving dialysis

        Exclusion Criteria:

          -  Subjects with significant gastrointestinal disorders

          -  Subjects who are pregnant or nursing

          -  Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet
             hydrochloride

          -  Subjects who are HIV positive

          -  Subjects with clinical significant liver disease
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention description: Tazarotene 0.045% Lotion; Vehicle Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 801.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Tiotropium; placebo
Intervention description: QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI; Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI; placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1215.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; QVA149; QAB149; NVA237; Indacaterol maleate; Glycopyronnium bromide

Summary:

      The study will assess the long-term safety of the fixed combination product QVA149 versus
      placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary
      Disease (COPD) 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.
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Intervention: 13 valent pneumococcal conjugate vaccine with Polysorbate 80; 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 500.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Infant

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared
      to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given
      concomitantly with routine paediatric vaccinations.
    

Eligibility criteria:

        Inclusion criteria:

          1. Aged 2 months (42 through 98 days) at the time of enrollment.

          2. Available for the entire study period and whose parent(s)/legal guardian(s) could be
             reached by telephone.

          3. In good health as determined by medical history, physical examination, and judgment of
             the investigator.

          4. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during
             study participation.

        Exclusion criteria:

          1. Previous vaccination with licensed or investigational pneumococcal vaccine.

          2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio
             vaccines.

          3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
             polio, hepatitis B, or pneumococcal vaccines.

          5. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          6. Known or suspected immune deficiency or suppression.

          7. History of culture-proven invasive disease caused by S pneumoniae.

          8. Major known congenital malformation or serious chronic disorder.

          9. Significant neurological disorder or history of seizure (including febrile seizure),
             or significant stable or evolving disorders (such as cerebral palsy, encephalopathy,
             or hydrocephalus), or other significant disorders. This did not include resolving
             syndromes because of birth trauma such as Erb palsy.

         10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and
             monoclonal antibodies [eg, Synagis]).
Duloxetine Versus Placebo for Osteoarthritis Knee Pain
Condition: Osteoarthritis Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Duloxetine; placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine if duloxetine reduces pain severity in
      patients with osteoarthritis knee pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients with osteoarthritis knee pain.

        Exclusion Criteria:

          -  Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical
             or psychiatric condition that, in the opinion of the investigator, would compromise
             participation or be likely to lead to hospitalization during the course of the study.

          -  Acute liver injury (such as hepatitis) or severe cirrhosis.

          -  Previous exposure to duloxetine.

          -  Body Mass Index (BMI) over 40.

          -  Major depressive disorder.

          -  Daily use of narcotics.
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Condition: HIV-1
Intervention: Maraviroc; Emtricitabine/tenofovir; darunavir/ritonavir 800/100 mg; placebo for emtricitabine/tenofovir; placebo for maraviroc
Intervention description: Maraviroc tablet 150 mg once daily for 96 weeks.; Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.; darunavir/ritonavir 800/100 mg; placebo for emtricitabine/tenofovir; placebo for maraviroc
Intervention MeSH terms: Ritonavir; Darunavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 813.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Double-blind; comparative; trial; maraviroc; versus; emtricitabine/tenofovir; both with darunavir/ritonavir; antiretroviral-naive; Ccr5 tropic; Hiv 1; patients.

Summary:

      The purpose of this study is to assess whether maraviroc administered once daily is
      non-inferior to emtricitabine/tenofovir also administered once daily each in combination with
      darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48
      of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening
             Visit.

          -  CD4 count equal to or greater than 100 cells/mm3 at Screening.

          -  Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

        Exclusion Criteria:

          -  Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any
             time.

          -  Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and
             emtricitabine.

          -  CXCR4 using virus detected using randomized tropism determination or repeated failure
             to obtain an interpretable tropism result.