bioihbjkbjnl/mcl2 huggingface dataset:
The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
Condition: Physical Activity; Obesity, Childhood; Cardiovascular Diseases; High Intensity Interval Training; Cognition
MeSH terms: Cardiovascular Diseases; Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Pilot study to test the acceptability and feasibility of an intervention aimed to test the
      effectiveness, in preschool children, of an integrated physical activity intervention in the
      classroom based on intervallic training (MOVI-HIIT) on improving executive function, body
      composition and cardiorespiratory fitness.
    

Detailed description: 
      The evolution of the MOVI studies, conducted by the research group, has led to create the
      last project (MOVI-HIIT; ClinicalTrials.gov Identifier: NCT04863040).

      This pilot study will include children aged 4-6 years from 2 public schools of the province
      of Ciudad Real, Spain, with 2 arms (intervention and control) and the intervention will last
      8 weeks.

      The intervention proposed in the study is implemented through an online platform developed to
      achieved the intensities required for the age-range of participants, but this platform has
      never been tested accurately in the classroom.

      Thus, it seems necessary to pilot the intervention to evaluate the acceptability and
      feasibility of the intervention, in order to improve facts, if necessary, to achieved
      proposed objectives.
    

Intervention name(s): MOVI-HIIT intervention
Intervention type(s): Behavioral
Intervention description(s): Each HIIT break will last approximately 5 minutes and will not require any specific materials. The structure of the HIIT-Rest will be as follows: 1' to describe the work to be done; 3' of work following the HIIT protocol: 6 repetitions of a functional movement such as squats, Jumping Jack or running on site for 20" at high intensity (85-90% of HR -heart rate- max) followed by 10" of recovery (65-75% of HR max); and 1' to perform a return to calm in order to lower the activation and prepare the student body to return to class activities.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Children; obesity; High Intensity Interval Training; cognition; cardiorespiratory fitness; Aerobic capacity; Preschool; Adiposity; Physical Activity
Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users
Condition: Abuse, Drug
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized crossover study to assess the subjective abuse potential of
      intravenous remimazolam compared to midazolam and placebo in recreational CNS depressant
      users
    


Intervention name(s): Remimazolam; Midazolam; Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): IV administration over 1 minute; IV administration over 1 minute; IV administration over 1 minute
Other intervention name(s): CNS7056
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remimazolam
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus With Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a single center, double-blind, randomized trial in subjects with type 1 diabetes
      mellitus applying an adaptive design approach.
    

Detailed description: 
      Subjects were be studied on two occasions, in randomized sequence, whereby glycemic
      excursions are assessed following an oral mixed meal challenge while treated with either
      insulin alone or co-administered insulin and glucagon.
    

Intervention name(s): Glucagon; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): calculated IV insulin:Glucagon molar ratio; calculated IV Insulin dose infused at a constant rate
Other intervention name(s): Glucagen Hypokit; Human Insulin (Eli Lilly)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Community Based Rehabilitation After Knee Arthroplasty
Condition: Knee Arthroplasty
Study type: Interventional

Summary: 
      Background The CORKA study was developed in response to a commissioned call by the National
      Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme for
      research into a functional home based rehabilitation programme for patients who may be at
      risk of poor outcome after knee arthroplasty.

      Design The CORKA trial is a prospective individually randomised controlled trial with blinded
      outcome assessment at baseline, 6 and 12 months. The study will also include a qualitative
      and a health economic analysis. Participants will be randomised to one of two arms,
      'home-based rehabilitation' or 'Usual Care'. Those in the usual care arm will receive a
      minimum of 1 and a maximum of 6 sessions of physiotherapy as delivered locally, e.g. class,
      one to one, etc. Those in the intervention arm will receive 7 sessions of a functional
      rehabilitation programme over a 12 week timescale. The intervention will be delivered using
      physiotherapists and physiotherapy assistants in the participants' home. Participants will be
      followed up at 6 months and 12 months
    


Intervention name(s): Home based rehabilitation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm RCT
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs
Condition: Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study of a new experimental drug called darusentan. Darusentan is not
      currently approved by the U.S. Food and Drug Administration (FDA) for use in the United
      States, which means that a doctor cannot prescribe this drug. The purpose of this study is to
      determine if darusentan is effective in reducing systolic blood pressure in subjects with
      resistant systolic hypertension, despite treatment with full doses of three or more blood
      pressure lowering drugs, including a diuretic.
    


Intervention name(s): darusentan
Intervention type(s): Drug
Intervention MeSH terms: Darusentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Condition: Paraplegia
MeSH terms: Paraplegia
Study type: Interventional

Summary: 
      It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to
      many secondary medical problems such as diabetes and insulin resistance, obesity,
      constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of
      life, and more. The ReWalk-I exoskeleton walking device permits investigation of the
      potential benefits of frequent upright posture and walking on many of the secondary
      consequences of spinal cord injury. The researchers are investigating the ability of persons
      with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright
      and walking on several of these secondary medical consequences of spinal cord injury.
    

Detailed description: 
      Potential participants will be pre-screened with the inclusion criteria for eligibility. The
      informed consent process will begin for those participants who have been determined to meet
      the inclusion criteria. After the potential participant's signed consent has been provided,
      further evaluations for eligibility will be performed (e.g., there are several medical and
      physical exclusion criteria). Those potential participants who meet both the inclusion and
      exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations
      and personalized measurements for fitting to the ReWalk-I will be performed over one week,
      before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12
      sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by
      each participant's ReWalk learning curve. Training will begin with sit-to-stand,
      stand-to-sit, and standing balance activities. Progression to walking will occur as skills
      advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to
      be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm
      standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated
      after the Learning Phase, after the Training Phase and 1-month post training follow-up.
    

Intervention name(s): powered exoskeleton
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: exoskeleton walking system; paraplegia; paralysis
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of the study are:

        1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT
           (reverse cholesterol transport) in men and post-menopausal women diagnosed with
           dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated
           triglyceride [TG] concentrations).

        2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.

        3. To obtain pilot data for power calculations for subsequent comparative study.
    

Detailed description: 
      This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate
      of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux
      (mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and
      during a treatment period (94 days).

      The goal of using RCT to reverse atherosclerosis is to increase the rate of cholesterol
      export or "efflux" from the tissues and plaques. An increase in this cholesterol efflux rate
      should shrink arterial plaques by decreasing their static accumulation of cholesterol. While
      some currently marketed drugs have a positive impact on RCT by increasing the rate of
      cholesterol excretion from the body, no drug has yet been approved to increase the rate of
      cholesterol efflux from the tissues
    

Intervention name(s): choline fenofibrate
Intervention type(s): Drug
Intervention description(s): 135 mg choline fenofibrate daily(oral, capsule)
Other intervention name(s): ABT-335
Intervention MeSH terms: Choline; Fenofibrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effects on safety and pharmacokinetics (PK) of MK-1942 and
      donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate
      cognitive impairment stably treated with donepezil. The objectives of this study include
      determining if the combination of MK-1942 with donepezil increases the incidence or severity
      of adverse events (AEs) previously reported for these agents, or results in unanticipated AEs
      in the patient population targeted for MK-1942 treatment. In addition, any changes in the PK
      parameters of either MK-1942 or donepezil as a result of co-administration will be assessed.
    


Intervention name(s): MK-1942; Donepezil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-1942, oral, 1-mg, 5-mg and/or 10-mg capsules, BID dosing up to 28 days; Donepezil, oral, 5-mg and/or 10-mg tablet (maximum dose 15 mg QD), QD dosing for up to 28 days; Placebo to MK-1942, oral, capsule, all dosage levels, BID dosing for up to 28 days.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Donepezil
Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this study is to compare the how the body changes the blood level of a single
      dose of darifenacin when given as 7.5 mg modified release tablet and the modified release
      liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.
    


Intervention name(s): Darifenacin (DAR328)
Intervention type(s): Drug
Intervention MeSH terms: Darifenacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; oral; single dose; table; suspension; release; darifenacin; healthy subjects; Healthy volunteers study
The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain
Condition: Implant Complication
Study type: Interventional

Summary: 
      Few previous studies have employed HA in the implant socket; instead, the majority have
      applied it topically to the area around dental implants after they have been placed. The
      application was done after suturing in these investigations. Therefore, the goal of the
      current study was to inject HA into the implant socket and onto the alveolar bone prior to
      implant insertion and suturing in order to preserve the HA for an extended period of time.

      This study aims to use a visual analog scale (VAS) on the first, third, and tenth days
      following the surgical intervention to assess the efficacy of employing HA in dental implants
      in terms of pain reduction that may accompany dental implant surgery.
    


Intervention name(s): Hyaluronic Acid
Intervention type(s): Biological
Intervention description(s): This material will be injected into the prepared impact socket prior to inserting the implant. This injection will be done inside the socket as well as on the periphery of the socket.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Condition: Single Ventricle Fontan Palliation
MeSH terms: Univentricular Heart
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis:

      Patients with a Fontan type palliation are limited by preload, or the rate at which blood
      returns to the heart after passively traversing the pulmonary capillary bed. By decreasing
      pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular
      filling pressures and volumes will increase with a simultaneous decrease in systemic
      impedance to flow and decrease in central venous pressures, leading to an improved capacity
      to increase cardiac output, and thereby an improvement in patient functional status.

      Patients who are candidates for the study will be randomized to a double-blind single
      crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks,
      with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2
      max test to evaluate exercise capacity at enrolment, and on the last day of each treatment
      period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope,
      ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic
      parameters as typically obtained from cardiopulmonary testing will be assessed. In addition,
      each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment,
      and on the last day of each study period.
    


Intervention name(s): Ambrisentan
Intervention type(s): Drug
Other intervention name(s): Letaris
Intervention MeSH terms: Ambrisentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Project Health Link: Connecting Patients With Services
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The proposed study will compare three alternative interventions in the emergency department
      (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those
      who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1)
      a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational
      Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary
      outcome variables for this trial include receiving an assessment and referral and treatment
      entry. Other outcomes include degree of treatment completion, substance-related measures,
      health service utilization, health status changes, and psychosocial factors.
    


Intervention name(s): Strengths Based Case Management (SBCM); Motivational Enhancement Therapy (MET); Brief Informational Feedback (BIF) session
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
To Assess Safety, Tolerability and Pharmacokinetics of BI 443651 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651
    


Intervention name(s): BI 443651; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Repositioning Frequency Neonates Receiving Phototherapy
Condition: Bilirubinemia; Newborn Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Purpose: The present study was conducted to determine the effect of repositioning frequency
      during phototherapy on bilirubin level and neonates comfort.

      Design and methods: This was a single-centered, single-blind, 3-arm, pretest-posttest
      parallel-group randomized controlled trial conducted in a neonatal intensive care unit.
      Participants were randomly assigned to one of three groups: Supine position group (n = 20),
      hourly position change group (n = 20), and control group (n = 20). The bilirubin level and
      comfort levels of the neonates were evaluated.
    

Detailed description: 
      Purpose: The present study was conducted to determine the effect of repositioning frequency
      during phototherapy on bilirubin level and neonates comfort.
    

Intervention name(s): Supine position group; Hourly position change group; Control Group (2-hour position change)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.; Infants in this group were repositioned "every hour" based on the time of phototherapy initiation. Neonates were initially placed in supine position and then changed to the prone position. Infants were alternated between supine and prone positions every hour for 24 hours.; Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation. Phototherapy was started with neonates in supine position. In the second period, the neonate was placed in the prone position after routine feeding was performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: bilirubin; comfort; neonates; phototherapy; positioning
A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole
Condition: Pharmacokinetic Assessments in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to:

        -  Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK)
           profile of midazolam following a single oral dose in human subjects.

        -  Evaluate the potential effects of PPI-668 at steady state on the PK profile of
           omeprazole following a single oral dose in human subject
    


Intervention name(s): PPI-668; Midazolam; Omeprazole; Telaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Midazolam; Omeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib
      (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
    

Detailed description: 
      This trial was randomized, single blind, prospective intervention study. Total 220 subject
      (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110
      subjects.
    

Intervention name(s): DTP/HB/Hib vaccine; DTP/HB and Hib vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Dosage equal to 0.5 mL administered intramuscularly; Dosage equal to 0.5 mL administered intramuscularly
Other intervention name(s): Pentavalent
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: DTP/HB/Hib vaccine; Immunogenicity; Infants; Safety