bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
Condition: Healthy Adult Female Participants; Prevention; Papillomavirus Infection; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: Placebo
Intervention description: qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1; Placebo intramuscular injection in three 0.5 mL doses over 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3819.0
Sex: Female
Minimum age: 24 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was conducted to assess the safety, immunogenicity, efficacy and long-term
      effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV)
      infection and disease in mid-adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal
             intraepithelial neoplasia (VaIN)

          -  Not pregnant and agrees to use effective contraception through Month 7 of the study

          -  Additional criteria applied

        Exclusion Criteria:

          -  Pregnant

          -  Concurrently enrolled in a clinical study involving collection of cervical specimens

          -  Previously received any HPV vaccine

          -  History of severe allergic reaction that required medical intervention

          -  Received any immune globulin or blood-derived products within 3 months prior to the
             first study injection

          -  History of splenectomy, known immune disorders, or receiving immunosuppressives

          -  Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection

          -  Known thrombocytopenia or any coagulation disorders that could contraindicate
             intramuscular injections

          -  History of recent or ongoing alcohol or drug abuse

          -  Prior treatment for genital warts, VIN, or VaIN

          -  History of cervical disease (ie, surgical treatment for cervical lesions)

          -  Hysterectomy
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fluoride; Placebo
Intervention description: Fluoride Toothpaste; Fluoride free toothpaste
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 11 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An in situ model will be used to evaluate and compare enamel remineralization of human enamel
      specimens after single use of experimental children's toothpastes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary
             flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least
             0.8 mL/minute (Screening Visit 1).

        Exclusion Criteria:

        -
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole; Aripiprazole
Intervention description: Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally; Up to 20 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Mental Disorders; Psychotic Disorders; Antipsychotic; Cognitive testing

Summary:

      The purpose of this study is to explore changes in efficacy, cognitive functioning, and
      safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of
             schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International
             Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies

          -  Would benefit from hospitalization or continued hospitalization for treatment of a
             current acute relapse of schizophrenia at trial entry

          -  Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration
             of usual function as demonstrated by all of the following:

          -  Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80

          -  Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory
             behavior, unusual thought content, conceptual disorganization, or suspiciousness

          -  Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately
             ill)

        Exclusion Criteria:

          -  Are presenting with a first episode of schizophrenia based on the clinical judgment of
             the investigator

          -  Have been hospitalized > 21 days for the current acute episode at the time of the
             baseline visit

          -  Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not
             limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar
             disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia,
             amnestic, or other cognitive disorders; also borderline, paranoid, histrionic,
             schizotypal, schizoid, antisocial personality disorders or mental retardation.

          -  Improvement of ≥ 20% in total PANSS score between the screening and baseline
             assessments.
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: almorexant; almorexant; Placebo; zolpidem
Intervention description: 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem; 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem; 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem; 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Intervention MeSH terms: Zolpidem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: sleeplessness; orexin receptor antagonist; almorexant; insomnia

Summary:

      A polysomnography study to evaluate the effect, safety and tolerability of oral
      administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (18-64 years) with a diagnosis of primary insomnia.

        Exclusion Criteria:

          -  History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.

          -  Sleep apnea, or restless legs syndrome.

          -  Daytime napping of more than 1 hour per day.

          -  Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2
             years prior to the screening visit.

          -  Unwillingness to refrain from drugs, over-the-counter or herbal medication having an
             effect on sleep or behavior.
Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Condition: Hypertension; Hypertrophy, Left Ventricular
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Intervention: Valsartan; Amlodipine; Hydrochlorothiazide; Losartan
Intervention description: 160 mg film coated tablets taken orally once daily in the morning.; 5 mg or 10 mg tablets taken orally once daily in the morning.; 12.5 mg or 25 mg tablets taken orally once daily in the morning.; 100 mg tablets taken orally once daily in the morning.
Intervention MeSH terms: Losartan; Amlodipine; Valsartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine

Summary:

      This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients
      with hypertension and left ventricular hypertrophy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.

          -  Patients with a history of essential hypertension and who are actually treated either
             with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <=
             105mmHg or with a combination therapy (limited to two active compounds) and with a
             diastolic blood pressure of >=90 and <= 100mmHg.

          -  Patients with Left Ventricular Hypertrophy

        Exclusion Criteria:

          -  Severe hypertension

          -  Symptomatic heart failure

          -  History of stroke, heart attack, coronary bypass surgery etc.

          -  Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.

        Other protocol-defined inclusion/exclusion criteria may apply
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin, Onglyza; Dapagliflozin, Farxiga; Glargine insulin; Metformin
Intervention description: Tablets, Oral, 5mg , Once daily, 24 weeks; Tablets, Oral, 10mg , Once daily, 24 weeks; 100 Units/ml solution for injection in a prefilled SoloStar pen; Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Intervention MeSH terms: Metformin; Insulin Glargine; Dapagliflozin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 650.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)
      will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin
      and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects
      receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a
      treatment period of 52 weeks.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  At least 18 years of age at screening

          -  HbA1c ≥ 8% and ≤ 12% at screening

          -  Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)

          -  Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea
             (defined as at least 50% maximal dose per local label) for at least 8 weeks

          -  estimated glomerular filtration rate (eGFR) &lt; 60 ml/ml/1.73m2

          -  Body Mass Index ≤ 45.0 kg/m2

        Exclusion Criteria:

          -  Clinical diagnosis of Type 1 diabetes

          -  History of ketoacidosis

          -  Renal, hepatic or pancreatic disease

          -  Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

          -  Cardiovascular or vascular diseases identified within 3 months of
             participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60
             mL/min
A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Amlodipine; Hydrochlorothiazide
Intervention description: 300 mg tablet; 5 mg tablet; 12.5 mg and 25 mg capsule
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential hypertension; High blood pressure

Summary:

      This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide
      in participants with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients 18 years of age or older

          -  Male or female participants are eligible.

          -  Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure
             (msSBP) Requirements:

               -  For newly diagnosed/untreated participants, msDBP ≥ 100 and < 120 millimeters of
                  mercury (mmHg), and/or msSBP ≥ 160 and < 200 mmHg at Visit 1 and Visit 2.

               -  For previously treated participants, msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥
                  160 and < 200 mmHg at Visit 2, Visit 3, or Visit 4.

          -  For participants requiring tapering off their previous antihypertensive medication,
             they must meet the above criteria and completely discontinue all antihypertensive
             treatment prior to entering the treatment phase of the study.

          -  Participants who are eligible and able to participate in the study, and who consent to
             do so after the purpose and nature of the investigation has been clearly explained to
             them (written informed consent).

        Exclusion Criteria:

          -  Inability to discontinue all prior antihypertensive medications safely for a period of
             1 week to 4 weeks as required by the protocol.

          -  Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180
             mmHg at Visit 1.

          -  Participants on four or more antihypertensive drugs at Visit 1.

          -  Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout
             period of the study Visit 1-4 must be discontinued from the study.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test (>= 5 milli-international
             units per milliliter mIU/mL).
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia; Unstable Angina
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Myocardial Ischemia; Angina, Unstable; Syndrome; Infarction; Ischemia
Intervention: Rivaroxaban 2.5 mg; Rivaroxaban 5 mg; Placebo; Standard of care
Intervention description: One tablet twice daily; One tablet twice daily; One placebo tablet twice daily
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15526.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rivaroxaban; Acute Coronary Syndrome; ACS; Aspirin; Thienopyridine; Unstable Angina; Myocardial Infarction; Anticoagulation; Clopidogrel (Plavix)

Summary:

      The purpose of this study is to determine whether rivaroxaban in addition to standard care
      reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke
      in patients with a recent acute coronary syndrome compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be currently receiving aspirin therapy alone or in combination with a
             thienopyridine per national or local dosing recommendation

          -  Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted
             at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

        Exclusion Criteria:

          -  Any condition that, in the opinion of the investigator, contraindicates anticoagulant
             therapy or would have an unacceptable risk of bleeding

          -  Need for continued anticoagulant therapy

          -  Significant renal impairment or known significant liver disease
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Macitentan
Intervention description: Macitentan tablet, dose of 10 mg, once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension (PAH); psychometric instrument; PAH-SYMPACT

Summary:

      SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,
      Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to
      psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the
      long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure.

          -  Patients with PAH who completed study AC-055-401

          -  Women of childbearing potential must:

          -  Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum
             pregnancy tests.

          -  Agree to use two methods of contraception from Visit 1 until 1 month after study drug
             discontinuation.

        Exclusion Criteria:

          -  Patients who prematurely discontinued study drug in study AC-055-401

          -  Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to
             become pregnant during the study

          -  Known hypersensitivity to macitentan or its excipients or drugs of the same class
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Condition: Chronic Hepatitis C (CHC)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: MP-424; RBV; PEG-IFN alfa-2a
Intervention description: MP-424: 750mg every 8 hours (q8h) for 12 weeks; RBV: 600 - 1000 mg/day based on body weight for 24 weeks; PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Intervention MeSH terms: Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pegasys

Summary:

      This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in
      patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after
      previous treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1 CHC

          -  treatment-naïve or relapsers (patient who relapsed after previous treatment)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus)
             antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia, or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Condition: Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: Metronidazole; Ceftriaxone sodium
Intervention description: Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.; Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.
Intervention MeSH terms: Metronidazole; Ceftriaxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 16 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Metronidazole; intra-abdominal infection; pelvic inflammatory disease; anaerobe

Summary:

      The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult
      subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day
      in combination with ceftriaxone sodium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  16 years of age or older.

          -  Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.

          -  Can be obtained a specimen for bacteriological efficacy assessment.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole,
             Ceftriaxone sodium, or other cephem antibiotics.

          -  Severe renal dysfunction (creatinine clearance < 30 mL/min.) Reference:
             Cockcroft-Gault calculation formula.

          -  Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range
             values).

          -  Severe underlying disease; patients in which drug clinical evaluation is difficult
             because of confounding diseases.