bioihbjkbjnl/mcl2 huggingface dataset:
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral
      agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults
      and children. Documented literature elucidates that simultaneous administration of multiple
      sorbitol-containing products could increase the potential for a significant interaction and
      may contribute to the lower 3TC exposures.

      In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be
      administered with lamivudine to investigate dose dependency and mimic the situation where
      multiple sorbitol-containing antiretroviral medications may be co-administered with
      lamivudine. It will be open label, randomized, 4-way crossover (by William's design method)
      design at a single centre. Randomized participants will receive a single dose of each of four
      treatments after wash out period of minimum 7 days.
    


Intervention name(s): Lamivudine; Sorbitol
Intervention type(s): Drug; Drug
Intervention description(s): It is a clear, colorless to pale yellow solution with the odour of fruit. It will be provided in a 240 mL bottle with the strength of 10 mg/mL Lamivudine 300 mg (30 mL of solution) will be administered orally to the participants; It is a clear, colorless, odourless solution. It will be available in 3 dosage levels viz;. 3.2 g (low dose), 10.2 g (medium dose) and 13.4 g (high dose) sorbitol total dose.
Intervention MeSH terms: Lamivudine; Sorbitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lamivudine; Safety; Sorbitol; Pharmacokinetics
Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections; Gastroenteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the
      hospitalization of infants and young children in developed and developing countries and can
      be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000
      annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against
      human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative
      buffer, was developed. This study will be conducted to evaluate the new formulation compared
      to the existing formulation of the HRV vaccine.
    

Detailed description: 
      The study consists of four groups of children recruited in different centers in Finland. One
      group of children will receive the existing formulation of HRV vaccine and one group will
      receive the new formulation of the HRV vaccine. The other two groups will receive the placebo
      for existing formulation or the new formulation based on the allocation. The vaccine or
      placebo will be administered starting at 6 - 12 weeks of age according to 0, 1 month
      schedule. Routine childhood vaccinations are allowed according to local practice, but at
      least 14 days apart from each dose of study vaccine. The duration of the study will be
      approximately 2 months per child.
    

Intervention name(s): Live attenuated rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prophylaxis of rotavirus gastroenteritis
Effects of Anthocyans on Cardiovascular and Sympathetic Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Anthocyans modify cardiovascular and sympathetic function
    


Intervention name(s): Anthocyans; placebo; Anthocyans
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Anthocyans
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First-In-Human PainCart Study for STR-324
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part,
      ascending doses study to investigate the safety, tolerability and efficacy of STR-324
      infusions in healthy volunteers.
    

Detailed description: 
      Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting
      infusion
    

Intervention name(s): Placebo; STR-324 Dose Level 1; STR-324 Dose Level 2; STR-324 Dose Level 3; STR-324 Dose Level 4; STR-324 Dose Level 5; STR-324 Dose Level 6; STR-324 Dose Level 7; STR-324 Dose Level 8; STR-324 Dose Level A; STR-324 Dose Level B; STR-324 Dose Level C; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Short infusion of a solution for intravenous administration; Long infusion of a solution for intravenous administration; Long infusion of a solution for intravenous administration; Long infusion of a solution for intravenous administration; Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For part I: crossover model For part II: parallel model
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression
Condition: Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene Expression
Study type: Interventional

Summary: 
      o determine effects of hula-hooping on android obesity, metabolic parameters and adipose
      tissue (AT) gene expression.
    


Intervention name(s): Exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Condition: Obesity
MeSH terms: Intellectual Disability; Obesity
Study type: Interventional

Summary: 
      Considering that children with intellectual disability (ID) might be more vulnerable to
      obesity than their counterparts in the general population. This study aimed to develop and
      evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight
      among adolescents with ID. The hypothesis of the study was the APA program would be able to
      decrease obesity among adolescents with ID.
    

Detailed description: 
      Background: Children with intellectual disability (ID) might be more vulnerable to obesity
      than their counterparts in the general population. This study aimed to evaluate the
      effectiveness of an adapted physical activity (APA) program in reducing weight among
      adolescents with ID.

      Methods: A 9-month randomized controlled trial of a school-based APA program was conducted in
      adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the
      APA program which consisted of endurance and strength-building exercises at a frequency of
      two sessions per week, while the control group received routine PE classes as usual. Data on
      obesity-related variables were collected before the intervention, at the midpoint of the
      intervention and after the intervention. Linear mixed-effect models were used to examine the
      intervention effects.
    

Intervention name(s): Adapted physical activity
Intervention type(s): Other
Intervention description(s): This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescents; intellectual disability; overweight; obesity; physical activity; intervention
Effect of Sedation on Diagnostic Injections
Condition: Sacroiliac Joint Pain; Sympathetically Maintained Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is
      well-documented that the reference standard for identifying a pain generator is a low-volume
      block performed with local anesthetic, with or without steroid. Many factors may increase the
      false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of
      sedation is the most controversial and remediable. Proponents of sedation argue that it has
      little effect on the rate of positive diagnostic blocks, and may even reduce the
      false-negative rate. The purpose of this study is to determine the effect of intravenous
      sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.
    

Detailed description: 
      Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be
      randomized in a crossover fashion to receive diagnostic nerve blocks either with or without
      intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this
      2nd procedure will be done with sedation if the first was done without sedation, and vice
      versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis
      and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be
      recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit
      will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report
      significant pain or who might otherwise benefit from a repeat procedure will have this second
      procedure performed with sedation if no sedation was given for the first procedure, and
      without sedation if sedation was administered for the first procedure. The post-procedure
      pain data will be recorded in the same fashion as the initial nerve block. The second
      follow-up visit will be 4 weeks after the 2nd block.
    

Intervention name(s): Midazolam; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Used for anxiolysis; Used for analgesia and as a sedative
Intervention MeSH terms: Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sedation; sensitivity; specificity; validity; diagnostic injection
Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable
Condition: Body Temperature; Oxygen Saturation; Heart Rate; Respiratory Rate; Sleep Pattern
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effectiveness of Kangarooing small babies on the
      back of a mother
    

Detailed description: 
      After the study was explained (risks and benefits) and written informed consent was received
      from participants, an individually controlled randomized crossover clinical trial was
      conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC)
      compared with the standard. The trial was done in accordance with the protocol, good clinical
      practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with
      the Helsinki declaration).
    

Intervention name(s): Chest-to-back
Intervention type(s): Other
Other intervention name(s): The standard/or Chest-to-chest
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans
Condition: Safety; Tolerability; Pharmacokinetics of ASP7962
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to see how safe the study drug is and how well it is tolerated
      after dosing. The study will also investigate how the study drug is taken up, metabolized
      (chemically broken down), distributed through the body and excreted. A further aim is to look
      at how this process is possibly altered by food by giving the study drug in the presence and
      absence of meals.
    


Intervention name(s): ASP7962; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy Subjects; Safety; Tolerability; Pharmacokinetics; Single Ascending Oral Dose; Food Effect
An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema
Condition: Nummular Eczema; Eczema; Dermatitis Eczema; Nummular Dermatitis
MeSH terms: Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an investigator-initiated, single-center, prospective, randomized, double-blind,
      interventional phase IIb study. Forty patients with clinically and histologically confirmed
      nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will
      be included after written informed consent is obtained. Prior to randomization, average
      application rate of class II topical steroids per day will be measured for 4 weeks.
      Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast
      30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically
      matching placebo for 16 weeks. From beginning of week 17, all patients will start an
      open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical
      steroids (class II) is allowed during the study. During the treatment period both placebo and
      Apremilast will be applied p.o. from week 0 until week 32.
    


Intervention name(s): Apremilast; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): This study aims on investigating the efficacy of Apremilast in nummular eczema patients.; This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Dose-Response on Features of the Metabolic Syndrome
Condition: Insulin Resistance; Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      This study investigates the degree of improvement in insulin resistance and features of the
      metabolic syndrome in non-diabetic overweight or obese subjects after training in a
      low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated
      exercise behavior after the assigned exercise program.
    

Detailed description: 
      The proposed study is a randomized, open study comparing low-intensity and moderate-intensity
      aerobic exercise versus non-aerobic (stretching) exercise on direct measurements of insulin
      resistance and variables associated with the metabolic syndrome. This 6-month intervention
      will be followed by an additional 6-month follow-up period during which subjects will be
      encouraged to maintain their exercise regimen (along with their prescribed diet) but without
      scheduled supervision. Behavioral variables associated with adherence will be analyzed along
      with changes in the above physiological variables.
    

Intervention name(s): Low-intensity treadmill exercise; Moderate-intensity treadmill exercise; Non-aerobic stretching exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.; Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.; Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.
Other intervention name(s): "Casual" walking program; "Brisk" walking program; Non-aerobic control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin resistance; Metabolic syndrome; Aerobic exercise; Exercise behavior
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations
Condition: Auditory Hallucinations
MeSH terms: Hallucinations
Study type: Interventional
Phase: Phase 2

Summary: 
      First clinical studies indicate an effect of repetitive transcranial magnetic
      stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size,
      optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled
      clinical trial we test the efficacy and safety of bilateral continuous theta burst
      stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment
      will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be
      treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and
      T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil
      tilted 45°). During weeks 4-6, all subjects receive real cTBS.
    


Intervention name(s): continuous theta burst stimulation (cTBS); sham cTBS
Intervention type(s): Procedure; Procedure
Intervention description(s): bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4); bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4) with the stimulation coil tilted 45°
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Concussion Pen Screening Tool
Condition: Fixation, Ocular; Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      To compare the use of the Concussion Pen to current clinical care practice. This will be a
      prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in
      each cohort). All subjects will undergo clinical evaluation for concussion and will also be
      evaluated using the Concussion Pen. Randomization to being evaluated using clinical care
      first then the Concussion Pen and vice versa will be utilized. This randomization will help
      to control for evaluation fatigue on the part of study participants.
    

Detailed description: 
      This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20
      subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion
      and will also be evaluated using the Concussion Pen. All subjects (both controls and
      concussion patients) will undergo all eye tracking measurements. Randomization to being
      evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.

      This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational
      Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of
      Philosophy(PhD)s who specialize in concussion assessment. This study will include a
      population of concussed patients as well as non-concussed patients (controls) who will be
      seen in CM clinics per standard of care.
    

Intervention name(s): Concussion Pen
Intervention type(s): Device
Intervention description(s): Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ocular motor function; Concussion
The Effects of Horse-back Riding on Core Muscles in Adolescents
Condition: Health, Subjective; Activity, Motor; Muscle Strength
Study type: Interventional

Summary: 
      The aim of the study is to examine the effects of riding on the core muscles, balance and
      muscle strength of the extremities in healthy adolescents.

      Core strength, core endurance, balance, upper extremity and lower extremity strength
      assessments were performed on the study group before and after the riding training.
    

Detailed description: 
      Twenty participants, aged between 10-19 years, research (n=10) and control (n=10) groups,
      were included in the study. The study group (n=10) received riding training for eight weeks.
      The study group was evaluated twice before and after riding.The control group only
      participated in the assessments at the start of the study. Demographic information of all
      volunteer participants were recorded.

      Core strength was evaluated with a stabilizer pressure biofeedback device, and core endurance
      was evaluated with isometric endurance tests. Balance was evaluated with Star Excursion
      Balance Test, upper extremity strength was evaluated with hand dynamometer and lower
      extremity strength was evaluated with back-leg dynamometer.
    

Intervention name(s): Recreational activity
Intervention type(s): Other
Intervention description(s): Horse-back riding
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Balance; Core stability; Adolescent; muscle strength; horseback riding