bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe with simvastatin; simvastatin
Intervention description: Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks; Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: cholesterol; drugs; hypercholesterolemia; adolescent; randomized controlled trials

Summary:

      This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to
      evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages
      10-17 years with Heterozygous Familial Hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).

          -  Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more
             than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.

        Exclusion Criteria:

          -  Subjects diagnosed with delayed puberty.

          -  Subjects who are sensitive to simvastatin and/or ezetimibe.

          -  Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse
             within the past 2 years.

          -  Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma
             apheresis, or have had a partial ileal bypass.
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren 300 mg; Aliskiren/Amlodipine 300/5 mg; Aliskiren/Amlodipine 300/10 mg; Placebo to Aliskiren; Placebo to Aliskiren/Amlodipine
Intervention description: Aliskiren 300 mg tablet taken orally once a day with a glass of water.; Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.; Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.; Placebo to Aliskiren tablet taken orally once a day.; Placebo to Aliskiren/Amlodipine taken orally once a day.
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 818.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aliskiren, Amlodipine, Non-responder to aliskiren

Summary:

      This study will assess the safety and efficacy of combination aliskiren/amlodipine in
      patients not adequately controlled with aliskiren alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed patients or patients who have not been treated for hypertension within
             the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP)
             ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2

          -  Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1
             must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2

          -  All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 4

        Exclusion Criteria:

          -  Severe hypertension

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential

          -  Previous or current diagnosis of heart failure New York Heart Association (NYHA Class
             II-IV)

          -  Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus

          -  Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
             Similar chemical structures

          -  History of hypertensive encephalopathy or cerebrovascular accident, or history of
             transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or
             any percutaneous coronary intervention

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain
Condition: Pain; Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Intervention: Sativex®; Placebo
Intervention description: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours; containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Peripheral Neuropathy

Summary:

      The purpose of this study is to assess the maintenance of effect after long-term treatment of
      Sativex® in subjects with neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving
             GW-1000-02 treatment) and had completed the study up to Visit 5

          -  Had complied with all of the study requirements to-date, including the completion of
             the diary cards

          -  Had shown tolerability to the study medication in this study

          -  Ability (in the investigators opinion) and willingness to comply with all study
             requirements, including the completion of diary cards and study questionnaires

        Exclusion Criteria:

          -  Had experienced or was currently experiencing any adverse events or untoward medical
             occurrences which, in the opinion of the investigator, would prevent them from safely
             participating in this phase of the study
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: Oral tablet, once daily for 24 weeks; Oral tablet, once daily for 24 weeks
Intervention MeSH terms: Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPP-4 inhibitors; HbA1c; Incretins

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients
      with inadequate glycaemic control with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Type 2 diabetes

          -  Patients should be drug naïve ie, not received medical treatment for diabetes

          -  HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

        Exclusion Criteria:

          -  Insulin therapy within one year of enrolment (with the exception of insulin therapy
             during a hospitalization or use in gestational diabetes)

          -  Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: LEO 43204 gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to compare the short term efficacy of LEO 43204 gel with
      vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days
      as field treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment
             area of sun-damaged skin on either the full face or a contiguous area of approximately
             250 cm2 (40 in2) on the chest

          -  Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking
             area of 50 cm2 (8 in2). The tracking area must be within the treatment area

        Exclusion Criteria:

          -  Location of the treatment area (full face or chest) within 5 cm of an incompletely
             healed wound or within 5 cm of a suspected BCC or SCC

          -  Treatment with ingenol mebutate gel in the treatment area within the last 12 months

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g.
             hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g.
             did not respond to cryotherapy on two previous occasions)

          -  History or evidence of skin conditions other than the trial indication that would
             interfere with the evaluation of the trial medication (e.g., eczema, unstable
             psoriasis, xeroderma pigmentosum)
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 capsule; SAGE-217 matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; SAGE-217

Summary:

      This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB),
      placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in
      adults with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for
             Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been
             present for at least a 4-week period.

          2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior
             to Screening (not including the current episode).

          3. Participant was willing to delay the start of any antidepressant, anxiolytic,
             insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy
             (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study
             completion.

        Exclusion Criteria:

          1. Participant had attempted suicide associated with the current episode of MDD.

          2. Participant had treatment-resistant depression, defined as persistent depressive
             symptoms despite treatment with adequate doses of antidepressants within the current
             major depressive episode (excluding antipsychotics) from two different classes for at
             least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment
             Response Questionnaire (MGH ATRQ) was used for this purpose.

          3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: ABT-712; Placebo
Intervention description: ABT-712 extended-release tablet; Placebo tablet
Intervention MeSH terms: Acetaminophen; Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Effect on sleep interference by pain

Summary:

      The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of
      ABT-712, compared to placebo, administered over a 4-week period in participants with moderate
      to severe mechanical chronic low back pain (CLBP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects who voluntarily sign the informed consent

          -  Diagnosis of CLBP of 6 months duration

        Exclusion Criteria:

          -  Incapacitated or bedridden subjects

          -  Subjects with history of surgical or invasive intervention
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Condition: Pain
MeSH terms: Tension-Type Headache; Headache
Intervention: Novel Ibuprofen; Standard Ibuprofen; Placebo
Intervention description: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo; Single-dose of standard ibuprofen (400mg) plus placebo; Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache

Summary:

      This study will compare the ability of a single-dose of a novel ibuprofen formulation to
      relieve pain compared to placebo and standard ibuprofen in the treatment of episodic
      tension-type headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females at least 18 years to 65 years of age

          -  A diagnosis of an episodic tension-type headache, as defined by the International
             Headache Society

          -  A history of episodic tension-type headache with the following characteristics: 4
             headache episodes per month for the last 6 months of moderately severe intensity;
             headache generally lasts more than 3 hours if left untreated; adequate headache relief
             is generally obtained with over-the-counter (OTC) doses of OTC analgesics

        Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Alcohol or substance abuse

          -  Any serious medical or psychiatric disorder

          -  History of stomach ulcers, stomach bleed, or other bleeding disorders
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: pegylated interferon alpha-2b; pegylated interferon alpha-2b; pegylated interferon alpha-2b
Intervention description: 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks; 1.5 mcg/kg S.C. QW for 24 weeks; 1.5 mcg/kg S.C. QW for 48 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 671.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron
      for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the
      approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks.
      This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg
      once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks
      after their treatment ends.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with chronic hepatitis B:

               -  Serum hepatitis B surface antigen positive for at least 6 months

               -  Serum hepatitis B e antigen positive

               -  Serum negative for hepatitis B surface and e antibodies

               -  Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000
                  IU/mL

               -  Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal

          -  Compensated liver disease with certain minimum hematological and serum biochemical
             criteria

        Exclusion Criteria:

          -  Significant hepatic disease from an etiology other than hepatitis B virus

          -  Antiviral treatment for hepatitis within previous 6 months

          -  History of severe psychiatric disease, especially depression

          -  Unstable or significant cardiovascular disease

          -  Prolonged exposure to known hepatotoxins such as alcohol or drugs

          -  Any condition that could interfere with the subject participating in and completing
             the study
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Condition: Transthyretin (TTR) Amyloid Cardiomyopathy
MeSH terms: Cardiomyopathies
Intervention: Tafamidis; Tafamidis; Placebo
Intervention description: Tafamidis 20 mg in soft gel capsules administered once a day for 30 months; Tafamidis 80 mg in soft gel capsules administered once a day for 30 months; Placebo in soft gel capsules administered once a day for 30 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: amyloidosis; amyloid; transthyretin; TTR

Summary:

      This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily
      dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with
      either transthyretin genetic variants or wild-type transthyretin resulting in amyloid
      cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or
             clinical evidence of HF (without hospitalization) manifested by signs or symptoms of
             volume overload or elevated intracardiac pressures (e.g., elevated jugular venous
             pressure, shortness of breath or signs of pulmonary congestion on x-ray or
             auscultation, peripheral edema) that required/requires treatment with a diuretic for
             improvement,

          -  Evidence of cardiac involvement by echocardiography with an end-diastolic
             interventricular septal wall thickness > 12 mm,

          -  Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype
             and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or
             mass spectrometry

        Exclusion Criteria:

          -  A New York Heart Association (NYHA) classification of IV.

          -  Presence of primary (light chain) amyloidosis.

          -  Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Condition: ATTR-PN
MeSH terms: Amyloidosis
Intervention: Tafamidis
Intervention description: 20 mg oral Fx-1006A daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, open-label study designed to obtain additional long-term safety and
      efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD).
      In addition, this study continued to provide tafamidis to Val30Met subjects who had completed
      Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a
      randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and
      efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase
      2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for
      up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon
      regulatory approval for the treatment of ATTR-PN in their respective country and access to
      prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were
      considered study completers.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.

          -  Male or female subjects with ATTR-PN who had not undergone liver or heart
             transplantation at time of enrollment.

          -  If female, subject was post-menopausal, surgically sterilized, or willing to use an
             acceptable method of birth control

        Key Exclusion criteria:

          -  Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)

          -  Pregnant or breast feeding female subjects.

          -  Clinically significant medical condition that, in the opinion of the investigator,
             would place the subject at an increased risk to participate in the study.

          -  An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value >3 ×
             upper limit of normal (ULN) that, in the medical judgment of the investigator, was due
             to reduced liver function or active liver disease.

          -  Sexually active males with partners of childbearing potential not using highly
             effective contraception or not agreeing to continue highly effective contraception for
             at least 3 months after last dose of study drug.