bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
Condition: Abuse Potential
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6
      treatment, 6-period crossover single-dose, Williams square design study in healthy male
      and/or female adult, non-drug-dependent recreational opioid users.
    

Detailed description: 
      The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and
      Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful
      completion of the Qualification Phase the participants will be enrolled in the Treatment
      phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active
      controlled, 6 treatment, 10-sequence, 6 period crossover, single-dose, Williams square design
      study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of
      each of the Treatment Phase 6 periods, which will be separated by a washout of at least 14
      days, participants will receive an oral dose of either gabapentin 600 mg or 1200 mg alone, or
      concomitantly with a 20 mg dose of oxycodone HCl or 20 mg monotherapy of oxycodone HCl or a
      placebo. Study treatments will be administered under fasted conditions (overnight fast and no
      food until 4 hours after dosing). Water will be allowed without restriction until 1 hour
      prior to dosing and 1 hour after dosing.
    

Intervention name(s): gabapentin 600 mg; gabapentin 1200 mg; gabapentin 600 mg and oxycodone HCl 20 mg; gabapentin 1200 mg and oxycodone HCl 20 mg; oxycodone HCl 20 mg; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl; Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl; Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg; Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg; Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin; Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
Intervention MeSH terms: Oxycodone; Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Neurontin; Oxycodone; Abuse Liability; Gabapentin
Pilot Evaluation of a Walking School Bus Program
Condition: Obesity; Physical Activity; Pedestrian Safety; Injury Prevention
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Walking to school is one of the objectives for children and adolescents in Healthy People
      2010 and in previous studies was associated with higher levels of overall physical activity,
      which has been shown to decrease obesity. Therefore, more children walking to school should
      result in increased physical activity and presumably reduce obesity. However, increasing
      child pedestrian activity could increase the risk of child pedestrian injuries. Walking with
      an adult who provides instruction in pedestrian skills and monitors the child's actual
      behavior may be the most important component of a successful intervention. Walking with an
      adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB)
      addresses safety concerns by providing a period of physical activity supervised by several
      responsible adults and teaching opportunities around pedestrian safety skills on the way to
      and from school. Children may join the WSB at various points along the set route. Despite the
      growing popularity of WSB programs in the United States, randomized, controlled-studies are
      lacking that examine the impact on children's safety, physical activity, and health. We seek
      to help fill this gap in the literature by piloting a WSB program in elementary schools in
      the Houston Independent School District to test feasibility. We hypothesize that a WSB
      program will: (1) increase the number of students walking to school and decrease the number
      of students driven to school by car, (2) increase students' pedestrian safety behaviors (3)
      increase students' physical activity, and (4) decrease students' excess weight gain.
    


Intervention name(s): Walking School Bus
Intervention type(s): Behavioral
Intervention description(s): Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.
Other intervention name(s): Safe Routes to School
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Physical activity; Injury Prevention; Pedestrian safety; Self efficacy; School; Walking School Bus; Safe Routes to School
Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
Condition: Breast Cancer; Vascularization; Fat Necrosis
MeSH terms: Necrosis; Neovascularization, Pathologic; Fat Necrosis
Study type: Interventional

Summary: 
      It is a single-center, prospective, randomized and controlled study focused in microsurgical
      autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography
      for the study of the vascularization of DIEP flaps. The aim of the study is to determine
      whether there are differences in complications and aesthetic results when ICG is used to
      discard the poorly vascularized areas of the flap. The study includes adult women undergoing
      unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There
      are two groups. In group 1, the investigators use the usual clinical criteria to discard the
      poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the
      flap.
    


Intervention name(s): Tailoring the flap according to clinical assessment; Tailoring the flap according to ICG Angiography assessment
Intervention type(s): Procedure; Procedure
Intervention description(s): After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.; After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study is to:

        -  Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept

        -  Evaluate how the above mentioned treatments influence the immune system and endogenous
           insulin secretion
    


Intervention name(s): GAD-Alum; Vitamin D; Etanercept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
Other intervention name(s): Diamyd; Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diamyd; Diabetes; Juvenile Diabetes; Diabetes Type 1; Type 1 Diabetes; Autoimmune Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes MellitusType 1 Diabetes Mellitus; rhGAD65; GAD65; GAD-Alum; Diabetes Mellitus; Diabetes mellitus Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D; Etanercept
Effects of BI 44370 TA Orally Applied as Tablets on the Pharmacokinetics of Orally Administered Midazolam Solution in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the long-term (48 h) and short-term (1 h) effects of BI 44370 BS on the
      pharmacokinetics of midazolam as marker of a possible inhibition of CYP 3A4; safety and
      tolerability.
    


Intervention name(s): Midazolam; BI 44370 low dose; BI 44370 medium dose; BI 44370 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Dormicum®
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Wharton Jelly in Erectile Dysfunction
Condition: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
MeSH terms: Erectile Dysfunction; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment
      of erectile dysfunction in diabetic patients.
    

Detailed description: 
      This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male
      patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This
      diagnosis is based on medical history, validated questionnaires, physical examinations,
      laboratory tests and specific diagnostic tests.

      The patients are followed by clinical assessment, laboratory investigations as well as
      Doppler ultrasound.
    

Intervention name(s): Wharton Jelly Mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wharton jelly mesenchymal stem cells; Erectile Dysfunction; Diabetes; safety
Body Contouring After Bariatric Surgeries in Jordan
Condition: Body Contouring
Study type: Observational

Summary: 
      This study aimed to describe Jordanians' awareness and knowledge of body-contouring surgeries
      and estimate their prevalence. Additionally, we aimed to identify the limitations reported by
      our population and compare them with those reported in the literature.
    

Detailed description: 
      We aimed to reach out to 351 patients who underwent bariatric surgery at JUH as well as an
      additional 100 patients who underwent BS at one of the largest private medical facilities in
      Amman between January and June of 2021. We distributed a validated questionnaire to all
      patients. Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The
      inclusion criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass),
      and completion of the questionnaire. Responses that did not meet these criteria or contained
      duplicates were excluded (n=11). The remaining 294 responses were collected and entered into
      a database for the analysis.Three main variables were assessed in each group in addition to
      multiple other observations. The main variables were sex, marital status, and employment
      status.
    

Intervention name(s): Assessment of knowledge and behaviour
Intervention type(s): Other
Intervention description(s): Assessment of knowledge and behaviour
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The inclusion
        criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass), and
        completion of the questionnaire.
Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to further evaluate the long-term safety and
      tolerability profiles of BG00002 (natalizumab) in Japanese participants with
      relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to
      further evaluate the long-term efficacy profile of BG00002 in Japanese participants with
      RRMS.
    

Detailed description: 
      This is a multicenter, long-term, open-label, extension study in participants who have
      successfully completed Study 101MS203 (NCT01440101).
    

Intervention name(s): natalizumab
Intervention type(s): Drug
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in
      human dental sockets.
    


Intervention name(s): hyaluronic acid; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Hyaluronan; Sodium hyaluronate
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyaluronic acid; bone repair; dental socket; cone beam computed tomography
An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents
Condition: HIV Prevention
Study type: Interventional

Summary: 
      This is Phase II of a study previously registered on ClinicalTrials.gov (NCT02812329). Phase
      II focuses on adapting and expanding the reach of a previously developed video game aimed at
      HIV prevention. The game will be adapted to include web access/distribution and be evaluated
      using a randomized controlled trial.
    

Detailed description: 
      The specific aims for Phase II of this study are to:

      Further adapt and expand our culturally and socially-tailored videogame to have a greater
      focus on HIV testing and counseling (HTC) in addition to HIV prevention in an older age group
      of 14-18 year old boys and girls.

      This will be accomplished by refining the conceptual model of the theoretical mechanisms of
      behavior change to be applied specifically within the game. New content will be created with
      additional input from 4 focus groups of 5 adolescents each (n = 20, aged 14-18) and these
      participants will also play-test the game. In addition, this model will inform new
      intervention manuals ("Game Playbooks") targeting these new outcomes. Building the new
      content from focus groups into the game are intended to adapt and expand its scope.

      A system will be established for the newly adapted game for web access/distribution and
      program integration. Work will continue with commercialization partners on widespread
      distribution of the adapted game.

      The final piece of the study will be to conduct a randomized controlled trial in 296
      adolescents (aged 14-18) to evaluate the acceptability and efficacy of the adapted game on
      its new web-based platform compared with a set of control games.
    

Intervention name(s): PlayTest!; Control games
Intervention type(s): Other; Other
Intervention description(s): Participants in the PlayTest! intervention arm played the game on their assigned iPads once per week for an hour over the course of 4-5 weeks.; Participants in the control arm played the games on their assigned iPads once per week for an hour over the course of 4-5 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV testing and counseling (HTC)
Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for
      Parkinson's disease
    

Detailed description: 
      Parkinson's disease (PD), the second most prevalent neurodegenerative disease (after
      Alzheimer's disease), affects more than a million Americans and is a common condition in the
      Veteran population. Although there is currently no cure for the disease, many of the symptoms
      of the disease can be effectively managed with medications and with deep brain stimulation
      (DBS). This study seeks to build upon the original CSP#468 protocol by providing an efficient
      long-term follow-up study. The objectives of this study are to:

      determine whether the motor benefits of deep brain stimulation persist beyond two years of
      follow-up in patients with Parkinson's disease; determine whether the target of stimulation
      (GPi vs. STN) affects the durability of long-term motor improvement; define the impact of DBS
      on long-term function and quality of life in patients with Parkinson's disease; identify
      clinical features that predict favorable or unfavorable long-term outcome; and describe the
      long-term performance of the DBS devices, including device durability, device explanation
      rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve
      optimum symptom control.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.
      
Keywords: Deep Brain Stimulation; Subthalamic Nucleus; Globus Pallidus; Parkinson Disease
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes
Condition: Silicone Tamponade
Study type: Observational

Summary: 
      The study was conducted to investigate how postural changes including sitting, supine, and
      LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone
      oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes
      and the fellow eyes in each body position.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        silicone tamponade patients
Alendronate Osteoporosis Study
Condition: Glucocorticoid-Associated Osteopenia and Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial will test the hypothesis that among 20 children and adolescents from Children's
      Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid
      arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue
      disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis
      with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater
      improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2)
      determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of
      standard of care therapy.
    


Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's disease; systemic-onset juvenile rheumatoid arthritis; juvenile dermatomyositis; systemic lupus erythematosus (SLE); Mixed connective tissue disease (MCTD); vasculitis
A Prospective Pharmacodynamic Study of Rivaroxaban
Condition: Blood Clot
MeSH terms: Thrombosis
Study type: Observational

Summary: 
      The ability to explain bleeding or clotting complications in patients treated with
      rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests
      perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of
      coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding
      abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic
      reference range for peak and trough coagulation tests in patients taking FDA approved doses
      of rivaroxaban and to determine which tests may be most clinically useful for monitoring
      rivaroxaban.
    


Intervention name(s): Rivaroxaban; no anticoagulation
Intervention type(s): Drug; Other
Intervention description(s): Patients will continue on their Rivaroxaban dose as previously prescribed by their individual physician. No dose adjustments will be made for the purpose of this study.
Other intervention name(s): Xarelto
Intervention MeSH terms: Rivaroxaban
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients taking FDA-approved doses of rivaroxaban and control subjects not taking an
        anticoagulant or antiplatelet were eligible for inclusion
Effect of Bacillus Subtilis DE111® on Daily Bowel Movements
Condition: Bowel Movement Regulation; Occasional Constipation; Occasional Diarrhea
MeSH terms: Constipation; Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic
      for regulation of bowel movements.
    

Detailed description: 
      The purpose of this study is to determine the efficacy of the probiotic B. subtilis DE111®
      for regulation of bowel movements. A single capsule containing 1 x 10^9 CFU B. subtilis is to
      be consumed once a day per participant. 50 adults (18-65 years of age at the time of
      participation) suffering from occasional constipation and/or diarrhea will be enrolled.
      Participants will be double-blindly and randomly assigned to either the probiotic (Bacillus
      subtilis) or the placebo (maltodextrin) group. Efficacy will be assessed with
      participant-reported bowel movement (BM) records. As a secondary outcome, the study will
      provide further insight into the tolerance of the supplement. Tolerance will be assessed
      using a digestive health questionnaire and blood samples to analyze pertinent metabolic
      biomarkers. Participants will be asked to complete a daily dietary intake record as well.
      Prior to capsule consumption, participants will complete a two-week pre-testing phase in
      order to provide a more inclusive diagnostic baseline. This phase will consist of daily BM
      and dietary intake record keeping.
    

Intervention name(s): Bacillus subtilis DE111®
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects were administered a dose of Bacillus subtilis at levels of 1x10^9 CFU once a day for 90-days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Bowel movement regulation; Occasional constipation; Occasional diarrhea; Gastrointestinal health