bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the pharmacokinetics of a new oral liquid
      moxifloxacin formulation and the influence of concommitant food intake on the
      pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is
      to see how the body absorbs, distributes and gets rid of the study drug. The absorption of
      the drug administered in a different dosage form may be altered due to the influence of
      different excipients used. The safety of moxifloxacin when administered as an oral liquid
      formulation will also be looked at. Results from this study will be used to guide dosing
      strategies of the larger clinical trial planned for children.
    


Intervention name(s): Moxifloxacin (Avelox, BAY12-8039); Moxifloxacin (BAY12-8039); Moxifloxacin (BAY12-8039)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions; Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions; Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fed conditions
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Bioavailability; Food effect; Oral liquid formulation
Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
Condition: Brain Cancer
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing
      profound neuromuscular block induced by rocuronium in infant patients
    


Intervention name(s): Sugammadex
Intervention type(s): Drug
Other intervention name(s): Bridion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sugammadex; Rocuronium; Infant patients
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and
      oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
    


Intervention name(s): Canakinumab (investigational); Placebo; Methotrexate (MTX)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.; Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.; Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
Other intervention name(s): ACZ885
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACR20, ACR50, ACZ885 (anti-interleukin-1beta monoclonal antibody), rheumatoid arthritis, methotrexate
TENS and Spasticity in Stroke Patients
Condition: Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength
      and functional status in stroke patients. It may provide further knowledge concerning the use
      of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.
    

Detailed description: 
      Despite the positive effects of electrical stimulation proved on motor impairments of
      affected limb, the evidence is still not conclusive. There still remains a question mark
      regarding the effectiveness and optimal stimulation parameters of TENS. there has been
      conflict regarding the TENS parameters (frequency, duration, intensity) among different
      studies. To date TENS parameters used in different studies to reduce spasticity range from
      frequency of 1.7-100 Hz, duration from 15-60 minutes and sessions from 1-30. The use of
      different parameters may account for the contradictory results related to effectiveness of
      TENS.
    

Intervention name(s): High Frequency TENS; Low Frequency TENS; Task Related Training
Intervention type(s): Device; Device; Other
Intervention description(s): 30 minutes of high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.; 30 minutes of low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks. And combined with 30 minutes of TRT.; Each session of TRT would include:
1. postural control, 2. shoulder mobilization, 3. weight bearing exercises 4. Functional activities that will comprise of simple tasks to more advanced movement patterns as follows:
Reaching activities
Forward supported reach with cane on tabletop
Reaching against gravity
Reaching overhead with active wrist/hand movements
Dynamic reaching to target e.g. catch a ball
Grasping, holding and release
Grasp, hold and release objects with gravity minimized
Pick up and move/release small objects on table
Pick up and move/release large objects without proximal support
Incorporate pinch grips in hold and release including stacking, lifting and overhead activity
Upper limb ADL
Brushing hair, putting on scarf
Opening bottles, turning off water tap
Writing, drawing
Folding of towels, hanging towels and setting table
Self-feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spasticity; Upper limb; TENS
The Effect of Whey Protein on Short-Term Food Intake and Post-Meal Blood Glucose Response in Young Men
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objective of this study was to describe relationships among whey protein when consumed
      before a meal on food intake and pre- and post-meal satiety, blood glucose in healthy young
      adults.
    

Detailed description: 
      A randomized, cross-over design study was conducted. Whey protein preloads (10-40 g) were
      provided in 300 ml water. At 30 min following consumption, subjects were fed an ad libitum
      pizza meal. Satiety, and blood glucose were measured at baseline and selected intervals pre-
      (0, 15 and 30 min) and post-meal (50, 65, 80 and 95 min).
    

Intervention name(s): dietary intervention; water control
Intervention type(s): Other; Other
Intervention description(s): whey protein 10-40 g; Iso-volumetric (300 ml) water control (Crystal Springs, Canada)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: whey protein; subjective appetite; shor-term food intake; blood glucose
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Condition: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a high prevalence of smoking among people with schizophrenia, and there are few
      smoking treatment programs for these smokers. The aims of this study are to investigate the
      separate and combined effects of bupropion and a voucher incentive program on smoking in
      people with schizophrenia.
    

Detailed description: 
      There is a high prevalence of smoking among people with schizophrenia, and there are few
      smoking treatment programs for these smokers. In this study, we are investigating whether the
      combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment
      program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a
      3-week study aimed to investigate the feasibility of this treatment approach. Participants
      are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one
      week on medication, participants are randomly assigned to the active behavioral treatment
      (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week
      period, participants come to the study site about 2-3 times per week, and provide information
      about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine
      samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the
      active behavioral treatment group receive gift cards to local grocery stores when their
      cotinine levels indicate that they have reduced their smoking. Participants in the control
      behavioral treatment group receive gift cards regardless of cotinine level. Any participant
      who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks
      after the end of the trial too see if they have sustained these smoking reductions. If we
      have favorable results from this trial, we will expand it into a smoking treatment program.
    

Intervention name(s): Bupropion; Contingent reinforcement plus placebo; non-contingent reinforcement plus bupropion; Non-contingent reinforcement plus placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Contingent reinforcement plus bupropion (300 mg/day for 3 weeks); contingent reinforcement plus placebo (3 weeks); non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks); Non-contingent reinforcement plus placebo
Other intervention name(s): zyban, wellbutrin; zyban, wellbutrin
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco
Health Education in Perimenopausal Women to Promote Self-care and Quality of Life
Condition: Perimenopausal Women
Study type: Interventional

Summary: 
      Objective: To evaluate the efficiency of a group intervention opposite to the usual care to
      improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55
      years to the primary health care centres.
    

Detailed description: 
      Methods: clinical controlled trial with parallel groups, random assignment of primary care
      units and blinded evaluation of principal label.

      Setting: study in primary health care centres (PHCCs) of Madrid Health Service and Castilla
      León Health Service.

      Subjects: Women between 45-55 years to medical consultation in primary care. Intervention:
      application of good clinical practice procedure and cognitive - behavioural grupal
      intervention.

      Sample size: N=355 patients. Data: Principal response variables: quality of life measured
      with the SF-12 questionnaire. Secondary response Variables: visits number, medicine /month
      number, and transitory disability days. Other prognosis and descriptive variables.

      Data analysis: Main effectiveness will be analyzed by comparing the improvement in 4 or more
      points in the SF-12 Mental Health area at 6, 12, 18 y 24 months post- intervention, between
      intervention and control group. Logistic regression will be used to adjust for prognostic
      factors. Confounding factors or factors that might alter the effect, recorder will be taken
      in account in this analysis. All statistical tests will be performed with intention to treat.
    

Intervention name(s): Training health professionals; Behavioral group intervention; Usual clinical practice
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and; Intervention on patients (educational workshop).; Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
Condition: Shoulder Surgery
Study type: Interventional

Summary: 
      To investigate the difference between an opiate sparing pain management protocol versus a
      standard opiate-based protocol following shoulder arthroplasty in the ninety day
      postoperative period regarding visual analog scores and oral morphine equivalents.
    

Detailed description: 
      This is a single center, investigator initiated, prospective, randomized, controlled trial
      conducted among patients who have given voluntary consent to participate. Participation will
      last until the completion of the twelve weeks standard of care follow up visit.
    

Intervention name(s): Cryotherapy
Intervention type(s): Device
Intervention description(s): see opiate sparing description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
Condition: Healthy Participants
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule
      formulation to the commercial tablet formulation in healthy participants under fed condition.
      The comparison will be performed using the pharmacokinetic parameters that define the rate
      and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed
      comparing these parameters calculated after administration of a single 100 mg dose with the
      tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100
      mg x 1) as the Test treatment.
    


Intervention name(s): Bosutinib capsule; Bosutinib tablet
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg dose of bosutinib pediatric capsule; 100 mg dose of bosutinib tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bosutinib,; bioequivalence,; Cmax,; AUC
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the immune response, safety and reactogenicity following
      administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4
      years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or
      Prevenar™ vaccine within the first 6 months of life and a booster dose of plain
      polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

      Antibody persistence will also be assessed at approximately 4 years of age in children
      previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a
      booster dose of Pneumovax 23™.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      4. The objectives & outcome measures of the primary phase are presented in a separate
      protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are
      presented in a separate protocol posting (NCT 00333450).
    


Intervention name(s): Pneumococcal conjugate vaccine GSK 1024850A; Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Intervention type(s): Biological; Biological
Intervention description(s): One dose of vaccine will be injected intramuscularly into the deltoid.; One dose of vaccine will be injected intramuscularly into the deltoid.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; safety; Pneumococcal conjugate vaccine; immunogenicity
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting
      anti-inflammatory compound, aimed at obtaining initial information on the tolerability,
      safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory
      activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis.

      The study is designed as a randomized, double-blind, double-dummy, placebo-controlled,
      sequential dose escalating trial, with an active control (ASACOL) group as internal control.
      Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with
      mild-moderately active ulcerative colitis not limited to the rectum, will be included, one
      for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized
      in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing
      with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.

      An interim analysis of fecal markers and disease activity data will be performed by the end
      of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either
      Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a
      dose-response relationship) or, in the case of a robust efficacy signal at any dose level
      previously studied, Cohort 5 (to expand the sample size for given dose level in order to
      evaluate the efficacy of GSK1399686). The number of patients and randomization allocation
      ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is
      initiated upon interim analysis, then a second interim analysis may be performed at the end
      of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be
      justifiable.
    


Intervention name(s): GSK1399686
Intervention type(s): Drug
Intervention description(s): Each dose level of GSK1399686 will be subsequently tested in a cohort of approximately 20 patients, who will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mesalazine; ulcerative colitis; pharmacokinetics/dynamics; GSK1399686
Brief Intervention for Substance Use and Partner Abuse Among Females in the ER
Condition: Substance Related Disorders; Domestic Violence
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to target co-occurring problems of substance use and intimate
      partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for
      Substance use and partner Abuse for Females in the Emergency Room). This project will develop
      and test the computer-based intervention, examining primary outcomes of substance use and
      utilization of relationship safety resources.
    


Intervention name(s): Computer Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.; Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Explore the Routes of Elimination of MDV3100
Condition: Healthy Subjects; Pharmacokinetics of MDV3100
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the excretion routes of radio-labelled MDV3100.
    


Intervention name(s): MDV3100
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Xtandi; enzalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Mass Balance; MDV3100; Xtandi; Enzalutamide; Metabolism; Excretion