bioihbjkbjnl/mcl2 huggingface dataset:
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Condition: Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Retigabine; Retigabine; Placebo
Intervention description: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.; Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.; Oral tablet.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 539.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Partial Seizures; Complex Partial Seizures; Epilepsy; Potassium Channels; Anticonvulsant

Summary:

      This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed
      at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in
      patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or
             without secondary generalization

          -  28-day partial seizure frequency rate of four or more partial seizures over the 8-week
             baseline phase

          -  Currently treated with up to three established AEDs

          -  Vagal Nerve Stimulator may be included

        Exclusion Criteria:

          -  Existing medical or psychiatric condition which could affect patient's health or
             compromise ability to participate in the study

          -  Clinically significant abnormalities on physical exam, vital signs, ECG, or liver
             function tests

          -  Impaired renal function (creatinine clearance less than 50 mL/minute)

          -  Evidence of progressive central nervous disease, lesion, or encephalopathy

          -  History of primary generalized seizures

          -  History of clustering or flurries or status epilepticus within 12 months of study
             entry
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: vaniprevir; peg-IFN; ribavirin
Intervention description: vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks; peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks; Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin
      (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous
      therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage
      of participants achieving sustained virologic response 24 weeks after completion of all study
      therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is
      greater than 20% (historical data of standard of care treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese participant diagnosed with compensated CHC GT 1

          -  Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other
             signs or symptoms of advanced liver disease

          -  Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN)
             with or without use of ribavirin, but failed to respond to the prior treatment
             (relapse or breakthrough)

          -  No evidence of cirrhosis

        Exclusion Criteria:

          -  Co-infection with human immunodeficiency virus (HIV)

          -  Positive hepatitis B surface antigen or other evidence of active hepatitis B infection

          -  Any other condition that is contraindicated or for which caution is required for
             treatment with peg-IFN or RBV

          -  Any condition or pre-study laboratory abnormality, or history of any illness, that, in
             the opinion of the investigator, might confound the results of the study or pose
             additional risk in administering the study drugs, peg-IFN and RBV, to the participant
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DFD01 Spray; Comp01 Lotion; Vehicle Lotion; Vehicle Spray
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for
      topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to
      Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must present with a clinical diagnosis of stable (at least 3 months)
             plaque-type psoriasis.

          -  Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin,
             axillae and other intertriginous areas.

          -  Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

        Exclusion Criteria:

          -  Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          -  Other inflammatory skin disease that may confound the evaluation of the plaque
             psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

          -  Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which
             could interfere with the rating of efficacy parameters.

          -  History of psoriasis unresponsive to topical treatments.

          -  History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Amlodipine; Hydrochlorothiazide
Intervention description: All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration; All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration; Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 556.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, aliskiren, amlodipine, HCTZ, blood pressure

Summary:

      To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg
      / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood
      Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients 18 years of age or older

          -  Male or female patients are eligible

          -  For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥
             90 and < 110 mmHg at Visit 1 and Visit 4

          -  For previously treated patients with essential hypertension defined as msDBP ≥ 90 and
             < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

        Exclusion Criteria:

          -  Severe hypertension

          -  History or evidence of a secondary form of hypertension

          -  History of Hypertensive encephalopathy or cerebrovascular accident.

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab [MabThera/Rituxan]; Standard chemotherapy
Intervention description: 375mg/m2 iv monthly for 8 cycles; As prescribed
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the
      East German Study Group for Hematology and Oncology versus standard chemotherapy plus
      MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and
      mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  advanced, low-grade non-Hodgkin's and mantle cell lymphoma.

        Exclusion Criteria:

          -  possibility of curative radiation therapy;

          -  secondary NHL;

          -  participation in another clinical trial eg with cytostatic chemotherapy or cytokines;

          -  concomitant diseases and/or restricted organ function precluding therapy according to
             the study protocol.
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
Condition: Peripheral Neuropathy; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Peripheral Nervous System Diseases
Intervention: pregabalin
Intervention description: 75mg BID, titrated up to 300mg according to individual response and tolerability
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated
      with HIV neuropathy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in the preceding A0081066 double-blind trial met the entry criteria for
             that trial and completed A0081066 study through visit 7

        Exclusion Criteria:

          -  Experienced serious adverse event during the A0081066 trial that was considered
             related or possibly related to study medication by the investigator or sponsor

          -  non-compliant during A0081066 trial

          -  clinically significant or unstable medical condition both HIV-related and non-HIV
             related including but not limited to, cardiac, pulmonary or hepatorenal disease that,
             in the opinion of the investigator, would compromise participation in the study
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Salmeterol 50 μg; Placebo to indacaterol; Placebo to salmeterol
Intervention description: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.; Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 552.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Indacaterol; COPD; salmeterol

Summary:

      This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo
      and salmeterol.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]
             Guidelines, 2008) and:

               1. Smoking history of at least 10 pack-years

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
                  of the predicted normal value

               3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization in the 6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
Condition: Chronic Nonmalignant Pain
Intervention: Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic nonmalignant pain; Opioid; Transdermal; Butrans (BTDS)

Summary:

      The objective of this study was to evaluate the long-term safety and tolerability of 7-day
      BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain
      syndromes whose pain had been previously controlled by oral opioid combination therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Include:

          -  Subjects of either sex aged 18 years or older.

          -  Subjects who have completed or discontinued the double-blind evaluation phase of study
             BUP3201 are eligible to continue to receive open-label BTDS in the extension.

        Exclusion Criteria:

        Include:

          -  Subjects currently receiving daily morphine or oxycodone (mono-therapy).

          -  Subjects who are discontinued from BUP3201 due to adverse events.

          -  Subjects who are scheduled for surgery of the disease site (e.g. major joint
             replacement surgery) or any other major surgery which would fall within the study
             period.

        Refer to core study for additional inclusion/exclusion information.
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab
Intervention description: Monthly intravenous infusions dosed as 10 mg/kg body weight
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment holiday; PGA; belimumab; Lymphostat-B; rebound; SELENA SLEDAI; Systemic Lupus Erythematosus; immunogenicity

Summary:

      This study will assess the effect of a 24-week withdrawal followed by a 28-week
      reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with
      stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be
      assessed for subjects who have permanently withdrawn from further belimumab treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current
             SLE belimumab continuation study.

          -  Be 18 years of age at the Day 0 visit.

          -  Non-prenant, non-lactating females willing to comply with specific birth control
             requirements as set forth in the protocol.

          -  Able to provide written informed consent to participate.

          -  Subjects who wish to enroll in the control group and the group taking a 6 month
             belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the
             minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels
             at or above the lower limit of the central laboratory reference range, and are on a
             stable SLE treatment regimen during the 30 day screening period prior to Day 0.

          -  Subjects who wish to enroll in the long-term discontinuation group have voluntarily
             withdrawn from their continuation studies.

        Exclusion Criteria:

          -  Subjects who have developed clinical evidence of significant, unstable or
             uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse
             event (AE) in their belimumab continuation study that could, in the opinion of the
             principle investigator, put the subject at undue risk.

          -  Subjects who have developed any other medical diseases, laboratory abnormalities, or
             conditions that, in the opinion of the principle investigator, makes the subject
             unsuitable for the study.
A Clinical Study to Evaluate the Safety of Ospemifene
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Ospemifene 60 mg; Placebo
Intervention description: 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.; Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Urogenital atrophy; Menopausal symptoms; Vulvar and vaginal atrophy in postmenopausal women; Vaginal atrophy

Summary:

      The purpose of this study is to determine the efficacy and long-term safety of 60mg
      ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically menopausal

          -  Intact uterus

          -  Vaginal pH greater than 5.0

          -  5% or fewer superficial cells in maturation index of vaginal smear

        Exclusion Criteria:

          -  Evidence of endometrial hyperplasia, cancer or other pathology

          -  Abnormal Pap smear

          -  Uterine bleeding of unknown origin or uterine polyps

          -  Current vaginal infection requiring medication

          -  Use of hormonal medications

          -  Clinically significant abnormal gynecological findings other than signs of vaginal
             atrophy
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin; Metformin; Dapagliflozin Placebo
Intervention description: Tablets, Oral, 5 mg, Once daily, 24 weeks; Tablets, Oral, 10 mg, Once daily, 24 weeks; Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks; Tablets, Oral, 0 mg, Once daily, 24 weeks
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
      improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never
      been treated with medication or have been on medication for less than 24 weeks since their
      original diagnosis of Diabetes. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic
             control

          -  Drug naive or treated with anti-diabetic medication for < 24 weeks

          -  C-peptide ≥ 1.0 ng/mL

          -  Body Mass Index ≤ 45.0 kg/m²

        Exclusion Criteria:

          -  AST and/or ALT > 3 times ULN

          -  Serum total bilirubin > 2 mg/dL

          -  Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women

          -  Creatine kinase ≥ 3 times ULN

          -  Symptoms of severely uncontrolled diabetes

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases