bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions
Condition: Prostate Cancer; Hirsutism
MeSH terms: Hirsutism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50
      mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.
    


Intervention name(s): Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA); Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment
Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, crossover, single dose study. Two single doses of
      LC350189(tablet or capsule formulations) will be administered with a washout period of at
      least 4-day between the doses to investigate the relative bioavailability of LC350189 after
      administration via tablet formulation compared with capsule formulation and to evaluate basic
      systemic pharmacokinetic parameters of the tablet formulation compared to the capsule
      formulation of LC350189.
    


Intervention name(s): LC350189 Tablet; LC350189 Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5; Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5
Other intervention name(s): LC350189; LC350189
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; relative
Childhood Cancer Survivor Survey
Condition: Cancer
Study type: Observational

Summary: 
      Objectives:

        1. To explore current lifestyle practices, health status, and quality of life among
           childhood cancer survivors and parent/guardians who are identified as "primary
           caregivers."

        2. To explore childhood cancer survivors' and "primary caregivers'" awareness of future
           health risks.

        3. To explore interest in various lifestyle interventions and delivery channels among
           childhood cancer survivors and their "primary caregivers."

        4. To explore factors which may serve as mediators or moderators of future lifestyle
           interventions that target childhood cancer survivors and their "primary caregivers,"
           e.g., strength of the caregiver-child bond, geographic distance from one another, and
           level of education.
    

Detailed description: 
      A mailed survey will be conducted that will assess the health behaviors (diet, exercise, and
      tobacco-use) of childhood cancer survivors, and the behaviors of identified "primary
      caregivers" (see definition under inclusion criteria). In addition, these surveys will assess
      awareness of longterm health risks, quality of life (QOL), strength of the child-caregiver
      bond, body image, body weight status, functional status, barriers to lifestyle change, and
      interest in various lifestyle interventions and potential channels for delivery. Mailed
      surveys (with telephone follow-up) will be sent to MDACC childhood cancer survivors diagnosed
      from 1998 - 2007 who are survivors of central nervous system (CNS) tumors, sarcomas, lymphoma
      or leukemia.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Survey packets to adult (>18 years old) childhood cancer survivors who return to MDACC for follow-up appointments within the next 12-months and conduct a mailed survey with the remaining participants and their "primary caregivers" i.e. guardians of survivors who are currently under age 18.
Other intervention name(s): Questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Childhood cancer survivors between ages of 8 and 28 years of age and their primary
        caregivers.
      
Keywords: Needs Assessment Survey; Childhood Cancer Survivors; Parents; Primary Caregiver; Survey
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Condition: Opioid Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain
      activity and behavior associated with decision-making about rewards (DD task), working memory
      and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate
      dependent participants initiating buprenorphine. While stably using opiates (initial study
      appointment) and again during withdrawal (approximately 3 days later), participants will
      receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will
      receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve
      weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to
      the first scanning session, weekly for two weeks and biweekly thereafter.

      Participation for all individuals will last 4 months. Assessments will occur at baseline, and
      weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second
      scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12.
      All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will
      include a taper).
    


Intervention name(s): FMRI; Suboxone
Intervention type(s): Other; Drug
Intervention description(s): all participants will complete 2 FMRIs; all participants will be prescribed Suboxone for 4 months during their study participation
Other intervention name(s): functional magnetic resonance imaging; buprenorphine
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children
Condition: Anesthesia, General; Neuromuscular Blockade
Study type: Interventional
Phase: Phase 2

Summary: 
      This study administers sugammadex sodium to pediatric patients under general anesthesia with
      rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma
      concentration of sugammadex sodium and monitoring of neuromuscular blockade.
    

Detailed description: 
      This study enrolls pediatric patients undergoing surgery under general anesthesia with need
      for reversal of neuromuscular blockade, aged between 2 and 18 years old.

      After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance
      of anesthesia with total intravenous anesthesia is commenced. For neuromuscular monitoring,
      train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to
      recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

      On reappearance of T2 after rocuronium administration , 2 or 4 or 8mg/kg of sugammadex sodium
      or conventional neuromuscular reversal agent is administered according to randomization
      table.

      For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after
      rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min
      after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are
      analyzed via high-performance liquid chromatography with mass spectrometric detection.
    

Intervention name(s): Sugammadex Injection 2mg/kg; Sugammadex Injection 4mg/kg; Sugammadex Injection 8mg/kg; Neuromuscular reversal agent injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2; Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2; Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2; Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Other intervention name(s): Bridion 2mg/kg; Bridion 4mg/kg; Bridion 8mg/kg; Atropine and neostigmine
Intervention MeSH terms: Atropine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sugammadex; Pharmacokinetics; Pharmacodynamics; Pediatric anesthesia
Effect of Prolotherapy in Knee Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the
      affected knee, followed by musculoskeletal ultrasound assessment will be done. The
      intervention: intra-articular injection and extra-articular injections of 25% dextrose.
      Follow up will be done at 24 weeks after the last injection both clinically and
      ultrasonographically .

      Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee
      osteoarthritis and determine ultrasonographic changes before and after prolotherapy.
    

Detailed description: 
      Sixty knees with primary knee osteoarthritis will be included in the study, clinical
      assessment will be done, then plain X-ray for the affected knee (s), followed by
      musculoskeletal ultrasound assessment will be done.

      The intervention:

        1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or
           infero-lateral approach will be done.

        2. extra-articular injections will be done at major tender tendons and ligaments through 15
           skin punctures using peppering technique and placing a possible total of 22.5 mL of 25%
           dextrose.

             -  Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks
                intervals.

      Follow up will be done at 24 weeks after the last injection both clinically and
      ultrasonographically .
    

Intervention name(s): Prolotherapy with 25% Dextrose
Intervention type(s): Drug
Intervention description(s): Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose
Other intervention name(s): 25% dextrose intra and extra-articilar injection
Intervention model: Single Group Assignment
Intervention model description: Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary knee osteoarthritis,; prolotherapy,; musculoskeletal ultrasound
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis
Condition: Atopic Diathesis; Eczema-prone Skin
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy and tolerability and of a cosmetic product
      to one that is already available on the market (benchmark product). Efficacy is assessed by
      instrumental measurements of skin condition, clinical examinations, and questionnaires.
    

Detailed description: 
      The objective of this exploratory study is to investigate the efficacy and tolerability of a
      cosmetic product on subjects with atopic dermatitis after 5 days of use in comparison to a
      benchmark product.

      The efficacy will be evaluated via instrumental measurements of skin hydration by
      Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter as well as by
      evaluation of itch by using a Numerical Rating Scale (NRS). For efficacy and tolerability
      evaluation an objective and, in the case of adults, an additional subjective dermatological
      assessment will be performed.
    

Intervention name(s): Atopi intensive care BNO 3731; Benchmark product
Intervention type(s): Other; Other
Intervention description(s): Crem twice daily; Crem twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intra-individual comparison
Masking: Single (Participant)
Primary purpose: Other
Evaluation of Physiological and Vocal Parameters in Volunteers of Both Genders Submitted to an Anxiogenic Task
Condition: Anxiety; Communication
Study type: Observational

Summary: 
      Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated
      Public Speaking (SPS) test, would change the responses of healthy individuals regarding
      physiological and vocal parameters. Method: The sample comprised 30 participants of both
      genders, 19-42 years old, with no history of psychiatric disorders. The score in the
      STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and
      HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin
      conductance, temperature in the extremities, electromyogram of the frontal muscle and
      salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and
      vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thirty individuals participated in the study, being 18 (60.0%) female and 12 (40.0%) male.
        They were between 19 and 42 years old and their schooling ranged from fundamental school
        (primary and middle school) to post-graduation.

        All the volunteers were in good health, had no history of psychiatric problems or alcohol
        and/or drug abuse, and did not report any vocal problems. Subjects excluded from the sample
        were chronic smokers; had paralysis or neurological diseases; had problems in the upper
        airways or allergic rhinitis at the moment of the experiment; used stimulant, psychotropic,
        anxiolytic, phytotherapic or antidepressant substances, and those who had ingested alcohol
        or coffee on the day of the experiment.
      
Keywords: Behavior; Anxiety; Communication; Voice
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
Condition: Trypanosomiasis; Trypanosomiasis, African; Protozoan Infections; Parasitic Diseases
MeSH terms: Trypanosomiasis; Parasitic Diseases; Protozoan Infections; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158
      in healthy volunteers. In animal models of both acute and chronic experimental
      Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.
    

Detailed description: 
      The present study is designed to obtain safety, tolerability and PK data after single oral
      administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects.
      This study will also assess the impact on the relative bioavailability of SCYX-7158
      administered as a capsule after single oral dose administration.

      The study will be divided in 3 different parts. Study Part I will be a randomized,
      double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as
      a capsule.

      A other part is scheduled to evaluate the impact of activated charcoal intake on the PK
      characteristics of SCYX-7158 and determine the most adapted treatment schedule for charcoal
      to enhance SCYX-7158 elimination while allowing a sustained drug exposure likely to be
      therapeutically active.

      A last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of
      SCYX-7158 in healthy male volunteers
    

Intervention name(s): SCYX-7158; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neglected disease; africa; new drug; oral drug; parasite
Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid
      homeostasis in healthy subjects.
    


Intervention name(s): Aprocitentan; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Formulated in capsules in 2 different strengths; 2 capsules per day; Matching active drug
Other intervention name(s): ACT-132577
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
Condition: Diastasis Recti
MeSH terms: Diastasis, Muscle
Study type: Interventional

Summary: 
      Participants will be randomly divided into three groups as core stabilization group,
      combination of core stabilization and corset group and only corset group.
    

Detailed description: 
      30 volunteer women who were diagnosed with diastasis recti abdominis by an obstetrician in
      Çamlıca Medipol Hospital, aged between 18-35 and met the inclusion criteria will be included
      in the study. Participants will be randomly divided into three groups. Participants in the
      first group will do core stabilization exercises for the transversus abdominis muscle 3 days
      a week for 8 weeks with 10 repetitions. In the second group, in addition to the first group,
      core stabilization exercises will be performed by wearing an abdominal corset. Participants
      included in the third group will be asked to wear only this corset all day (except for the
      bathroom) for 8 weeks. Anthropometric measurements, ultrasonographic evaluation, Visual
      Analogue Scale (VAS), Edinburgh Postnatal Depression Scale, abdominal muscle strength and
      endurance, Oswestry Disability Index will be evaluated as pretest and posttest.
    

Intervention name(s): Exercise intervention; Exercise intervention by wearing abdominal corset; Corset intervention
Intervention type(s): Other; Other; Other
Intervention description(s): Women with diastasis recti abdominis will do core stabilization exercises for the transversus abdominis muscle with 10 repetitions 3 days a week for 8 weeks. The exercises include diaphragmatic breathing exercises, core stabilization exercises for the transversus abdominis muscle, and pelvic floor contractions; In this group, in addition to the first group, core stabilization exercises will be performed by wearing an abdominal corset. Participants will be asked to wear their corsets while performing their exercises.; Participants included in this group will be required to wear only this corset all day (except for the bathroom) for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diastasis recti abdominis; core stabilization exercise; physiotherapy
Clinical Characteristics in Congenital Cataract Eyes
Condition: Congenital Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      This study involved children with congenial cataract eyes, who underwent cataract surgeries
      at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were
      reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon
      (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery
      were also recorded for further analysis.
    


Intervention name(s): eyes with congenital cataracts
Intervention type(s): Other
Intervention description(s): observation
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        children with congenital cataracts
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of administration of AFQ056 in combination
      with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease
      patients.
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's, L-dopa, dyskinesia
Copanlisib Mass Balance Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to provide understanding of the relative relevance of the different excretion
      pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
    


Intervention name(s): Copanlisib (BAY80-6946)
Intervention type(s): Drug
Intervention description(s): Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C]
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This long term, placebo-controlled trial is intended to assess the efficacy and safety of
      exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with
      oral antidiabetic(s) but not well controlled.
    


Intervention name(s): exenatide; exenatide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg, twice a day; subcutaneous injection, 10mcg, twice a day; subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
Other intervention name(s): LY2148568; Byetta; LY2148568; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; LY2148568; Byetta; Lilly; Amylin