bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Retigabine (INN), Ezogabine (USAN)
Intervention description: Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Partial Seizures; Epilepsy; RTG115097; Complex Partial Seizures; Anticonvulsant; Potassium Channels; Epilepsies, Partial

Summary:

      This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind
      VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet
      inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an
      adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.
      Treatment will be continued until the subject withdraws from the study or until the program
      is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia,
      and South Africa. The primary objective of the study is to evaluate the safety and
      tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult
      epilepsy patients with partial-onset seizures, who completed the double-blind Study
      VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with
      retigabine and patient quality of life and to evaluate whether retinal pigmentation,
      unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of
      nails, lips, skin or mucosa change over time after discontinuation of retigabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has successfully completed the Maintenance and Transition phases of Study
             VRX-RET-E22-302 for the treatment of partial-onset seizures

          -  Patient is expected to benefit from participation in the study in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or
             is experiencing an ongoing serious adverse event.

          -  Patient is receiving any investigational drug or using any experimental device in
             addition to Retigabine for treatment of epilepsy or any other medical condition.

          -  Patient has any other condition that would prevent compliance with the study
             procedures or proper reporting of adverse events.
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day; comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Intervention description: Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.; Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2
      Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Males

          -  Females who are highly unlikely to become pregnant

          -  Patients poorly controlled while taking one or two oral antidiabetic medications

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient required insulin therapy within the prior 8 weeks

          -  Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos®
             (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta®
             (exenatide) within the prior 12 weeks of the screening visit
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Condition: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Intervention: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg); tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention description: oral; oral
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1067.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Vesomni; Solifenacin succinate; EC905; Tamsulosin hydrochloride OCAS; Treatment; Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary:

      Clinical study to examine the safety, tolerability and efficacy of long-term combination
      therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract
      symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage
      component.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of 12 weeks double-blind treatment in Study 905-CL-055

        Exclusion Criteria:

          -  Any significant PVR volume (>150 mL)
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Condition: Venous Thromboembolism (VTE)
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Betrixaban; Enoxaparin
Intervention description: Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days; Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days
Intervention MeSH terms: Enoxaparin; Betrixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7513.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Phase III

Summary:

      The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban
      can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for
      an acute medical illness and to compare these results with standard of care enoxaparin. The
      safety of betrixaban will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and non-pregnant, non-breastfeeding women

          -  anticipated to be severely immobilized for at least 24 hours after randomization

          -  hospitalized with one of the following

               -  congestive heart failure

               -  acute respiratory failure,

               -  acute infection without septic shock,

               -  acute rheumatic disorders

               -  acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

        Exclusion Criteria:

          -  a condition requiring prolonged anticoagulation or anti-platelets

          -  active bleeding or at high risk of bleeding

          -  contraindication to anticoagulant therapy

          -  general conditions in which subjects are not suitable to participate in the study
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; SOC
Intervention description: 0.05mg/kg; Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of
      children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term
      period. It will evaluate how these children fared after the TED-C13-003 study ended. This
      study will also offer teduglutide treatment to eligible subjects, regardless of treatment
      received in TED-C13-003.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject provides written informed consent (subject, parent or legal guardian and, as
             appropriate, subject informed assent) to participate in the study before completing
             any study-related procedures.

          2. Subject completed the TED-C13-003 study (including subjects in the standard of care
             treatment arm).

          3. Subject understands and is willing and able to fully adhere to study requirements as
             defined in this protocol.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Metoprolol ER (TM)
Intervention description: nebivolol 10mg, 20mg, 40mg daily dosage, oral administration; Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Hypertension; Blood pressure; Nebivolol; Bystolic (TM); Metoprolol ER (TM)

Summary:

      The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another
      beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the
      mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other
      biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ambulatory outpatients 18-79 years old at screening

          -  Minimum 2-year history of Stage I/II hypertension

          -  Qualifying blood pressure criteria for study entry and for randomization

          -  Willing to adhere to the dietary compliance and undergo protocol procedures

          -  Have a lifestyle that will permit him/her to attend all evaluations, including those
             conducted on consecutive days

        Exclusion Criteria:

          -  Have any form of secondary hypertension

          -  Have clinically significant respiratory or cardiovascular disease

          -  Presence/history of coronary artery disease or peripheral vascular disease

          -  Have diabetes mellitus, Type I or II

          -  Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Role of Soy Supplementation in Prostate Cancer Development
Condition: Prostate Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: Soy Supplement; Placebo
Intervention description: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).; Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 86.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Estrogen Receptor; Isoflavones; Prostate Neoplasm; Soy Supplementation

Summary:

      This is a randomized study evaluating the effectiveness and direct effect a commercial soy
      supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it
      either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned
      surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be
      evaluated to determine the effects of the soy supplement on the prostate tissue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven prostate cancer.

          -  Surgical candidate for prostatectomy.

          -  During study period, must agree not to take new supplements.

          -  No concurrent chemotherapy, radiation or hormonal therapy.

          -  No history of prior allergy to soy based products.

          -  Must not have been taking soy supplements or soy isoflavones within 90 days prior to
             study enrollment.

          -  Must be able to safely be on study supplements for period of at least two weeks prior
             to scheduled prostatectomy.

          -  Must give written and informed consent in accordance with institutional and federal
             guidelines.

        Exclusion Criteria:

        During study period, must agree not to take new supplements.

          -  No concurrent chemotherapy, radiation or hormonal therapy.

          -  No history of prior allergy to soy based products.

          -  Must not have been taking soy supplements or soy isoflavones within 90 days prior to
             study enrollment.

          -  Must be able to safely be on study supplements for period of at least two weeks prior
             to scheduled
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
Condition: Open-Angle Glaucoma
MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle
Intervention: iStent plus Cataract Surgery; Cataract surgery only
Intervention description: ab interno trabecular bypass stent surgery; Cataract surgery only
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: IOP measurement
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open angle; Glaucoma; Cataract; Surgery

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular
      micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle
      glaucoma or ocular hypertension and co-existing cataract.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and
             pigmentary glaucoma are also acceptable diagnoses.

          -  Subject on at least one glaucoma medication

          -  Able and willing to attend follow up visits for two years post operative

          -  Able and willing to sign informed consent

        Exclusion Criteria:

          -  Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt
             implant, collagen implant, cyclo destructive procedures etc)

          -  Angle closure glaucoma

          -  Fellow eye already enrolled
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Tiotropium 18 μg; Placebo to indacaterol
Intervention description: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).; Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1142.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol; tiotropium; bronchodilation

Summary:

      This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when
      combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients
      with chronic obstructive pulmonary disease (COPD).
    

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, 2007) and:

               -  Smoking history of at least 10 pack-years

               -  Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30%
                  of the predicted normal value

               -  Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria:

          -  Patients who have received systemic corticosteroids and/or antibiotics and/or was
             hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the
             run-in period

          -  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.
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LMF237 50/250 mg; LMF237 50/500 mg; Placebo
Intervention description: Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily; Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily; Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and
      50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin
      monotherapy. This study was conducted to support registration of the fixed-dose combination
      of vildagliptin and metformin for the treatment of T2DM in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes inadequately controlled with diet, exercise and oral
             anti-diabetic therapy

          -  HbA1c in the range of 7.0-10.0%

          -  Body mass index in the range of 20-35 kg/m^2

        Exclusion Criteria:

          -  Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or
             secondary forms of diabetes

          -  Significant heart diseases Other protocol-defined inclusion/exclusion criteria may
             apply