bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
Condition: Healthy; Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics, safety and
      tolerability of a single dose of PF-04991532 in healthy adult subjects with and without
      co-administration of cyclosporine.
    


Intervention name(s): PF-04991532 alone; PF-04991532 + cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of 150 mg PF-04991532, fasted; a single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
Intervention MeSH terms: Nicotinic Acids; Cyclosporine; Cyclosporins; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk
      period for increasing the rate of cesarean delivery. The more recent studies and the
      investigators' previous data indicated epidural analgesia can be performed as early as the
      cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix
      diameter had different rate of cesarean delivery. This trial would investigate the
      correlation amongst different cervical dilation and the risk of cesarean section in
      nulliparous women at term.
    


Intervention name(s): Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia; Epidural labor analgesia
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Epidural analgesia initiated at the onset of regular uterine contraction; Epidural analgesia initiated at the cervix diameter 0.5cm; Epidural analgesia initiated at the cervix diameter 1.0cm; Epidural analgesia initiated at the cervix diameter 1.5cm; Epidural analgesia initiated at the cervix diameter 2.0cm; Epidural analgesia initiated at the cervix diameter 3.0cm; Epidural analgesia initiated at the cervix diameter 4.0cm; Epidural analgesia initiated at the cervix diameter 5.0cm
Other intervention name(s): Peridural analgesia; Peridural analgesia; Peridural analgesia; Peridural analgesia; Peridural analgesia; Peridural analgesia; Peridural analgesia; Peridural analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural analgesia; Patient-controlled analgesia
The Effects of Flaxseed Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To study the effects of Flaxseed supplement on lipid profile, liver enzymes, inflammatory
      factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50
      patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be
      randomly allocated to receive placebos or 30 grams Flaxseed powder for 12 weeks; both groups
      will be advised to adherence the investigators' diet and exercise program too. At the first
      and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers,
      and liver fibrosis will be assessed and compared between groups.
    


Intervention name(s): Flaxseed; control
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): no supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dasotraline Binge Eating Disorder Study
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with
      moderate to severe Binge Eating Disorder (BED)
    

Detailed description: 
      This is a randomized, double blind, parallel group, multicenter, outpatient study evaluating
      the efficacy and safety of flexibly-dosed dasotraline in adults with BED using dasotraline
      (4, 6, and 8 mg/day) versus placebo over a 12 week treatment period.
    

Intervention name(s): Dasotraline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dasotraline 4, 6, 8mg flexibly dosed once daily; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
Condition: Celiac Disease; Diabetes Mellitus, Type 1
MeSH terms: Celiac Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac
      disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to
      clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing
      will be evaluated in this study. A randomized controlled study longitudinally evaluating
      HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine
      the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.
    


Intervention name(s): Gluten Free Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects assigned to the intervention group will receive a standardized dietary education intervention that will inform subjects and family members of the effects of gluten on the gastrointestinal tract and emphasize the need to adhere to a diet that is gluten-free. This intervention will be delivered by a dietician who is trained in celiac disease and gluten free diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; dietary treatment; celiac disease; T1D
Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension
Condition: Resistant Hypertension; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      The objectives of this study are to investigate the effect of continuous positive airway
      pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects
      with resistant hypertension and moderate obstructive sleep apnea (OSA).
    

Detailed description: 
      Resistant hypertension is defined as blood pressure that remains above goal in spite of
      concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is
      defined in order to identify patients who are at risk of having secondary causes of
      hypertension, and who may benefit from specific diagnostic and therapeutic applications.
      Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works
      has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT.
      There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects
      with resistant HT, though both studies were flawed by not including the control group, no
      randomization and limited sample size. We aim at conducting a randomized controlled study to
      explore the beneficial effect of CPAP treatment in subjects with OSA and resistant
      hypertension.
    

Intervention name(s): continuous positive airway pressure
Intervention type(s): Device
Intervention description(s): Use CPAP whenever sleep
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; resistant hypertension; refractory hypertension; continuous positive airway pressure; blood pressure control
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      This is a pilot study including 20 cirrhotic patients that will be randomized to receive
      during 3 months leucine vs leucine plus a programme of physical exercise specially designed
      for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could
      increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood
      ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients
      will be strictly assessed.
    


Intervention name(s): Leucine supplements
Intervention type(s): Dietary Supplement
Intervention description(s): leucine supplements
Other intervention name(s): No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; exercise; leucin; glutamine synthetase
Effect of Pilates Training in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance
      and is an important determinant of walking capacity. Exercise training has beneficial effects
      on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and
      resistant exercise training in MS patients are often emphasized, today the effect of
      different exercise types is also wondered. Pilates is a core stability-based exercise method
      that improves endurance, flexibility, movement, posture, and respiratory control. The aim of
      this study is to examine the effect of Pilates training on sensation, muscle strength,
      balance, and walking in MS patients.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      will be included in the study. The balance, gait, position sense, and muscle strength will be
      evaluated. The study was designed as a prospective, randomized controlled study. The patients
      will be randomly assigned to two groups, the "Pilates training" group, and the control group.
      Pilates training will be performed by the Pilates training group 2 times for 8 weeks under
      supervision in the outpatient clinic. The control group will be taught relaxation exercises
      and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses
      will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The
      pre-training and post-training measurements of groups will be compared with the paired sample
      t-test.
    

Intervention name(s): Pilates training; control
Intervention type(s): Other; Other
Intervention description(s): The program consisted of core-based Pilates exercises on the mat for 60 minutes.; The program consisted of progressive relaxation exercises at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomize controlled study
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; sensation; gait; Pilates
Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated
      Resonance Assistance. LARA facilitates patients in performing a high amount of practice using
      their moderate to severely impaired upper extremity after stroke.

      Investigators will recruit 44 subjects with subacute strokes to participate in the study
      through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants
      will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA
      therapy group will use LARA to propel themselves to therapy appointments in the unit and to
      play video games with the affected upper extremity for 30 mins / day. The standard therapy
      group will use a standard wheelchair to propel themselves using their unaffected upper and
      lower extremities. They will be asked to perform a matched duration of standard arm exercises
      for 30 mins/ day. This program of standard arm exercises was developed by an OT at the
      Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported
      exercises.

      This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge
      from the acute rehabilitation unit if sooner, and a 3-month follow up.
    


Intervention name(s): LARA; Standard
Intervention type(s): Device; Behavioral
Intervention description(s): Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.; Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
Other intervention name(s): Conventional Arm and Hand Exercise Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM
Condition: Alcohol; Harmful Use; Sex, Unsafe
Study type: Interventional

Summary: 
      This is a small pilot study to provide effect size estimates for a brief intervention
      designed to reduce hazardous drinking and sexual risk behavior among men who have sex with
      men. The intervention consists of an "in-person" brief motivational intervention followed by
      a series of text messages related to alcohol and sexual risk reduction. The primary outcome
      is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.
    

Detailed description: 
      This is a pilot study designed to provide initial effect size estimates for an intervention
      addressing hazardous drinking and sexual risk behavior among men who have sex with men. In
      this study, 24 participants initially recruited through advertisements in the community will
      be randomly assigned to either Assessment Only or Intervention Condition. Those in the
      Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments.
      Those in the intervention condition will receive a 50-min brief intervention in person
      followed by 6 weeks of tailored app-based messaging to support the intervention content, then
      another 6-weeks of goal setting text-based messages. Data will be analyzed to determine
      effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary
      outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.
    

Intervention name(s): MI&TXT4MSM
Intervention type(s): Behavioral
Intervention description(s): brief in-person intervention followed by text messaging
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of two groups
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Condition: Obesity, Morbid; Bariatric Surgery; Adolescent; Young Adult; Drug Therapy
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this pilot study is to establish the feasibility and initial efficacy of the
      combination of phentermine and topiramate for adolescents and young adults who require
      additional risk reduction after bariatric surgery. This study will use a randomized,
      placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of
      phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after
      bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who
      remain severely obese (n=10 total).
    


Intervention name(s): Phentermine; Immediate Release Topiramate; Placebo for Phentermine; Placebo for Immediate Release Topiramate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Phentermine tablet; Topiramate tablet; Compounded tablet to mimic phentermine 8mg tablet; Compounded tablet to mimic immediate release topiramate 25mg tablet
Other intervention name(s): Lomaira; Adipex-P; C045TQL4WP; 2-methyl-1-phenylpropan-2-amine; Topamax; 0H73WJJ391; [(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilot; Feasibility; Initial Efficacy; Randomized Controlled Trial
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Condition: Breast Cancer; Infertility; Menopausal Symptoms
MeSH terms: Breast Neoplasms; Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether
      ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women
      receiving chemotherapy for breast cancer.

      PURPOSE: This randomized phase III trial is studying how well giving goserelin together with
      chemotherapy works compared with chemotherapy alone in preventing early menopause in women
      with stage I, stage II, or stage IIIA breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the rate of premature ovarian failure in women with stage I-IIIA hormone
           receptor-negative breast cancer treated with chemotherapy with vs without goserelin.

      Secondary

        -  Compare the rate of ovarian dysfunction in patients treated with these regimens.

        -  Compare ovarian reserve in patients treated with these regimens.

        -  Describe the pregnancy rates in patients treated with these regimens.

      OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40
      to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to
      8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to
      8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

        -  Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are
           followed at 1, 2, and 5 years.

        -  Arm 2: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week
           before start of cyclophosphamide-containing chemotherapy. Treatment continues until
           completion of chemotherapy in the absence of disease progression or unacceptable
           toxicity.

      PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): cyclophosphamide; goserelin acetate
Intervention type(s): Drug; Drug
Intervention description(s): Part of planned chemotherapy regimen; Given subcutaneously
Intervention MeSH terms: Cyclophosphamide; Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infertility; menopausal symptoms; stage II breast cancer; stage IIIA breast cancer; stage IA breast cancer; stage IB breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer
Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multicenter, dose escalation study evaluating the
      tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination
      with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.
    


Intervention name(s): veliparib; carboplatin; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Veliparib will be given orally, twice daily on Days 1-21, every 21 days.; Carboplatin will be administered on Day 1 of each cycle, intravenously.; Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Other intervention name(s): ABT-888; paraplatin; taxol
Intervention MeSH terms: Paclitaxel; Carboplatin; Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABT-888; BRCA; Primary peritoneal cancer; carboplatin; Fallopian tube; Poly (ADP-ribose) polymerase (PARP); paclitaxel; Ovarian cancer; veliparib