bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
Condition: Cerebral Palsy; Children With Brain Injury
MeSH terms: Brain Injuries; Cerebral Palsy; Wounds and Injuries
Study type: Interventional

Summary: 
      This study was designed to establish the clinical evidence for effect of video-game based
      rehabilitation therapy system using IMU sensors as a game interface, newly-developed in
      Korea, on upper limb function of children with cerebral palsy. First, the investigators would
      compare the effect of video-game based rehabilitation therapy to conventional occupational
      therapy.
    

Detailed description: 
      -  Purpose: to elucidate the effect of video-game based rehabilitation therapy system on
           upper limb function of children with cerebral palsy compared to conventional
           occupational therapy

        -  Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired
           (all 30 children will receive the conventional occupational therapy, but 15 of these
           children will receive the additional video-game based rehabilitation therapy)

        -  Intervention: 4 weeks of therapy (6 days per week)

        -  Studies: functional MRI, computerized motion analysis, upper limb functional assessment
           (MUUL, ULPRS), ADL evaluation, cognitive evaluation

        -  Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after
           end of intervention
    

Intervention name(s): digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids); Conventional OT group
Intervention type(s): Device; Other
Intervention description(s): 1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks.; 2. Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: upper limb function; multi-IMU (inertial measurement unit) sensors; Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
Active Games: Increasing the Attractiveness of Active Video Game Play for Youth
Condition: Child; Overweight; Sedentary Lifestyle
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to look at the effects of active video game play on youth
      physical activity.
    

Detailed description: 
      Child obesity is increasing worldwide and has major implications for health, both during
      youth and later in life. Physical activity declines sharply during adolescence, making ages
      8-12 a critical period to encourage healthy exercise habits. Increased childhood weight has
      been linked to sedentary leisure time activities, such as video games. "Active video games"
      (AVGs) are now being studied as a method to increase children's interest and participation in
      physical activity. Although research indicates that AVG play may lead to energy expenditure
      comparable to light/ moderate physical activity, children prefer sedentary video games to
      AVGs and often find AVGs boring. Children do not play AVGs as often or with the same
      intensity as traditional games/sports and lose interest in them; efforts must be made to
      increase the appeal of AVGs so they are competitive with sedentary video games. This study
      will examine whether children's motivation to engage in AVG play may be increased with
      greater autonomy, as well as whether increasing children's motivation to play AVGs also
      increases their motivation to play sedentary video games.
    

Intervention name(s): High Autonomy; Low Autonomy
Intervention type(s): Other; Other
Intervention description(s): Children will be given two active video games (AVGs) of their choice. After two weeks, a researcher will monitor progress and exchange the AVGs and sedentary games. At each exchange, children will be allowed to select their next game.; Children will be given their most-liked active video game (AVG) from the baseline relative reinforcing value assessment. After two weeks, a researcher will monitor progress and exchange the AVGs and sedentary games. At each exchange, children will receive a pre-determined game.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to determine if temporary gastric electrical stimulation will
      help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when
      the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
    

Detailed description: 
      Gastric Electrical Stimulation is an established treatment for drug-refractory patients who
      have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting,
      anorexia/early satiety, bloating/distention and abdominal pain and are classically associated
      with delayed gastric emptying of solids. The technique of GES was first used, in a patient
      seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials,
      particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a
      double-blind trial begun in 1997. Both were international trials, showing promising results,
      and both have been published in the last 2 years. However, a number of issues related to who
      would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these
      issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis,
      such as post-surgical gastropathy, which is often related to rapid, not delayed gastric
      emptying could be helped.

      Most recently a technique for the temporary placement of a Gastric Electrical Stimulation
      electrode in the stomach with an upper endoscope, combined with an external Gastric
      Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock,
      AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until
      the present time. Using the technique of temporary gastric electrical stimulation, we have
      been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a
      patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and
      an improvement and normalization in solid gastric emptying.
    

Intervention name(s): Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
Intervention type(s): Device
Intervention description(s): All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
Other intervention name(s): No other name currently exists.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nausea; Vomiting; Delayed gastric emptying; Diabetes Mellitus; Post-Surgical; Idiopathic
A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
Condition: Hepatic Impairment; Normal Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of
      intranasally administered esketamine in both participants with varying stages of hepatic
      impairment and healthy participants.
    

Detailed description: 
      This is a parallel group, single-center, single-dose, open-label (all people know the
      identity of the intervention), study to assess the pharmacokinetics and safety of a single 28
      milligram (mg) dose of esketamine in both participants with varying stages of hepatic
      impairment and healthy participants. The participants will be assigned to 1 of 3 groups (8
      participants per group) based on hepatic impairment which will be classified during
      Screening. Cohort 1 (participants with moderate hepatic impairment), Cohort 2 (participants
      with mild hepatic impairment), and Cohort 3 (participants with normal hepatic function and no
      evidence of liver damage). Participants will self-administer a single dose of intranasal
      Esketamine 28 mg. The total duration of the study from Screening through Follow-up, is
      approximately 34 to 38 days. Blood and urine samples for assessment of Esketamine
      pharmacokinetics will be collected for up to 60 hours after study drug administration.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Esketamine
Intervention type(s): Drug
Intervention description(s): Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Esketamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Esketamine; Hepatic Impairment; Pharmacokinetics
Personalized Computerized Inhibitory Control Training for OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effects of a computerized training program coupled with
      cognitive behavioral therapy (CBT) for OCD.
    

Detailed description: 
      This study will evaluate the effectiveness of a computerized training program (called
      Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral
      therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive
      compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual
      symptoms.
    

Intervention name(s): Personalized Computer Program; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training with a personalized computerized inhibitory training program; Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy
Bioequivalence Study of Cephalexin Suspension 250
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of cephalexin suspension are
      bioequivalent.

      Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product
      Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for
      Ceporex and 20 ml of suspension for Keflex® .

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 28 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Cephalexin 125 mg/5ml; Cephalexin 250mg/5ml
Intervention type(s): Drug; Drug
Intervention description(s): Reference product 20 ml; Test product 10 ml
Other intervention name(s): Keflex® suspension ELI LILLY Y COMPAÑIA DE MEXICO SA de CV; Ceporex® suspension GLAXOSMITHKLINE MEXICO SA de CV
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mexico; Respiratory infections; Bioequivalence; Cepphalexin
The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Background: Low back pain (LBP) is still a frequent health problem. Recurrance of symptoms
      leads to high absence at work. It was proved in previous studies that low back manual massage
      has a significant impact on pain reduction. Trabert current (TC) is common physical modality
      used in rehabilitation of patients with LBP. The aim of study was to assess the effectiveness
      of manual massage in comparison to TC in patients with LBP.

      Methods: Sixty patients with LBP were enrolled in to the study. In all patients discopathy
      and spondyloarthrosis were diagnosed. The subjects were randomly assigned to two groups:
      massage (I=30) and TC (II=30) therapy. The procedures were performed for ten days. Pain
      intensity was assessed by Numerical Rating Scale. Quality of life and the degree of
      disability were evaluated by Oswestry Disability Index and Roland-Morris Disability
      Questionnaire.

      Results: In both groups pain reduction and functional improvement were observed after
      therapy. However, better results were noticed in group I.
    


Intervention name(s): Trabert current; Manual massage
Intervention type(s): Device; Other
Intervention description(s): Trabert current is an interrupted direct current of low frequency (143 Hz) applied via medium sized electrodes supported on a thick moist viscose sponge. These electrodes are placed near the spinal column along the thoracolumbar region. The electrodes are separated from each other by a distance of 3-4 cms.The current is passed through electrodes placed on the body. The intensity of the current is gradually increased short of pain. The feeling should be a pronounced but a comfortable 'tingling' sensation ('comfortably strong'). By doing this, the optimum current strength specific to the patient is found. The intensity of the current is slowly increased in the first few minutes as patients get used to the sensation. It is thought that this current provides pain relief, reduces muscle spasm and increases blood flow.; Therapeutic massage is the manipulation of the soft tissue of whole body areas to bring about generalised improvements in health.Massage is thought to work through a mechanical action and a reflex action. A mechanical action is created by moving the muscles and soft tissues of the body using pressure and stretching movement. This mechanical action is based on breaking up fibrous tissue and loosen stiff joints.It may help heal damaged muscle, stimulate circulation, clear waste products via the lymphatic system, boost the activity of the immune system, reduce pain and tension and induce a calming effect.
Other intervention name(s): Ultra-Reiz current
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: massage; low back pain; Trabert current; Ultra-Reiz current
Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of this 8-week intervention trial is to investigate the effect of a dietary
      supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in
      healthy hyperlipidemic subjects
    


Intervention name(s): FishOil; CBE75; CBE150; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Vildagliptin on Gastric Accommodation
Condition: Healthy
Study type: Interventional

Summary: 
      Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4
      inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.

      The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric
      accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be
      evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will
      include ten volunteers.

      Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be
      intragastrically infused and intragastric pressure (IGP) will be measured for one hour.

      Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal).
      Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for
      30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma
      levels.
    


Intervention name(s): Vildagliptin 50 mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Acute administration of Vildagliptin, 50 mg.; Acute administration of placebo tablet
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: gastric accommodation; food intake; gastrointestinal hormones
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
Condition: Infectious Diseases; Healthy Subjects; Respiratory Tract Infections; Sore Throat; Sinusitis; Otitis; Bronchitis; Pneumonia; Influenza; Gastroenteritis
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Bronchitis; Sinusitis; Pharyngitis; Gastroenteritis; Otitis
Study type: Interventional

Summary: 
      This single-center, randomized, double-blind and controlled study aims to examine the effect
      of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001
      (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common
      infectious diseases (cumulated number of infections during the intervention period: primary
      criteria), and on immune functions in healthy shift workers. Volunteers received either
      200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a
      1-month follow-up.
    


Intervention name(s): Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®); Non fermented dairy product (control)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotic - Lactobacillus casei DN114-001; dairy product - infections - shiftworkers; Common infectious diseases,; occuring in healthy subjects,; including upper respiratory tract infections (defined as rhinopharyngitis, sore throat, sinusitis and otitis),; lower respiratory tract infections (defined as bronchitis,; pneumopathy and flu and flu-like syndromes), and; gastrointestinal tract infection defined as gastroenteritis.
Diode Laser Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the V-Raser diode laser system with investigational
      Nail Fungus Handpiece in the treatment of onychomycosis.
    


Intervention name(s): Diode Laser Treatment
Intervention type(s): Device
Intervention description(s): Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Other intervention name(s): V-Raser
Intervention model: Single Group Assignment
Intervention model description: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Onychomycosis; Toenail Fungus
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the effect of ezetimibe on glucose metabolism in participants with
      Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated
      hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the
      placebo control group.
    


Intervention name(s): Ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg oral dose once daily for 24 weeks; Placebo to match ezetimibe orally once daily for 24 weeks.
Other intervention name(s): MK-0653; SCH 058235
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
Condition: Healthy Volunteer; Pharmacokinetics of YM178
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of
      YM178 in healthy, non-elderly adult subjects.
    


Intervention name(s): YM178
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): mirabegron
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Overactive Bladder; Urinary incontinence; YM178; mirabegron
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this clinical investigation is to demonstrate safety and
      effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory
      symptomatic paroxysmal atrial fibrillation.
    

Detailed description: 
      The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of
      the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness
      of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal
      atrial fibrillation (PAF).
    

Intervention name(s): Multi-Electrode RF Balloon Catheter
Intervention type(s): Device
Intervention description(s): Multi-Electrode RF Balloon Catheter will be inserted
Other intervention name(s): HELIOSTAR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation