bioihbjkbjnl/mcl2 huggingface dataset:
Balance Control During Gait
Condition: Healthy
Study type: Interventional

Summary: 
      Gait and balance disorders are important public health problem necessitating studies to try
      to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance
      during quiet standing (posturography). Nevertheless, falls occurred predominantly during
      gait, and rarely during quiet standing. We have developed a tool to measure balance during
      gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the
      vertical velocity of the CM recorded with a force plate.

      In previous studies, we have shown that the braking of the CM was a physiological and a
      active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM
      measured on a force plate provide an important intra-individual variability.

      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The
      primary goal of this study is to compare intra-individual variability of the braking of the
      CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in
      healthy subjects.
    


Intervention name(s): Gait analysis
Intervention type(s): Other
Intervention description(s): Subjects, barefoot and standing upright and motionless on a force plate, were instructed to walk for 10 m following a beep delivered by the experimenter. Two experimental conditions were tested: (i) the 'natural' gait condition where subjects walked normally and (ii) the 'fast' gait condition where subjects walked as fast as they could, taking large steps. Each subject performed 10 trials in each condition.
Other intervention name(s): - Force plate; - 3D optoelectronic gait analysis system (VICON)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: subjects
Study of the Safety and Immunogenicity of Reduced Doses of the US Yellow Fever Vaccine
Condition: Yellow Fever Vaccination Reaction
MeSH terms: Yellow Fever; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, exploratory study to evaluate the human immune response to
      reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA
      approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever
      vaccine is approximately 55,000 plaque-forming unit(s) (PFU) in 0.5 mL administered SQ. Using
      the licensed dosage as standard, investigators are evaluating reduced doses of 1/5th (0.10
      mL) and 1/10th (0.05 mL) Yellow Fever vaccine (YF-VAX).
    

Detailed description: 
      Up to 150 individuals will be screened in order to randomize 90 eligible individuals to one
      of three groups: Group 1- YF-VAX® standard dose 0.5 mL SQ = 30 subjects; Group 2-0.10 mL
      (1/5th) SQ = 30 subjects; Group 3-0.05 mL (1/10th) SQ = 30 subjects.
    

Intervention name(s): Yellow Fever Vaccine
Intervention type(s): Biological
Intervention description(s): Administered subcutaneously once.
Other intervention name(s): YF-VAX
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to compare the relative efficacy of Budesonide
      administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients
      with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC
      model.
    

Detailed description: 
      A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Three-Way Cross-Over Study to
      Compare the Relative Efficacy of Budesonide administered via Captisol-Enabled® Budesonide
      Nasal Solution and Rhinocort Aqua® (32 µg/spray) in the Treatment of the Symptoms of Allergic
      Rhinitis in an Environmental Exposure Chamber (EEC).
    

Intervention name(s): Budesonide; Placebo; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nasal spray, one spray per nostril at time 0; nasal spray, one spray per nostril at time 0; nasal spray, one spray per nostril at time 0
Other intervention name(s): CDX947; Captisol; phosphate buffered saline solution; Rhinocort Aqua
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAR
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to
      obtain first-in-human data on its safety and immunogenicity in infants and to identify the
      preferred dose of Shigella4V in 9 month old infants.
    

Detailed description: 
      Shigella4V is a tetravalent bioconjugate vaccine including O antigen-polysaccharides of the
      most predominant Shigella serotypes.

      The study will be conducted in two steps. In Step1: safety and reactogenicity of the vaccine
      will be evaluated first in adults and subsequently in children and infants through an
      age-descending and dose escalation approach. In Step 2: in order to further evaluate safety
      and to identify the optimum immunogenic dose, infants will be randomised to receive 1 of 4
      different vaccine doses or control vaccine.

      Adults will receive a 2 dose schedule, children and infants will receive a 3 dose schedule.
      For each vaccine dose, formulation with and without Aluminium adjuvant will be tested.
    

Intervention name(s): Shigella 4V; MenACWY; Rabies; Diphtheria, Tetanus and Pertussis (DTaP); Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Non-adjuvanted and adjuvanted Shigella 4V administrated at 4 different doses: very low, low, medium and high.; Control vaccine administrated to adults and infants; Control vaccine administrated to children; Control vaccine administrated to infants; Control administrated to adults
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This phase 1/2 trial is a multicentre, randomized, controlled, double blind, with two steps; a step 1 with a safety cohort and a step 2 with a dose-finding cohort. Safety of the vaccine will be evaluated first in adults and subsequently in children and infants through an age-descending and dose escalation approach (safety cohort, step 1). Following confirmation of vaccine safety, further cohorts of infants (dose-finding cohort) will be enrolled to evaluate immunogenicity of the vaccine at different doses and expand safety data (step 2). Vaccination in Step 1 will be staggered with adults being the first to be vaccinated and infants last. In step 2 infants will be vaccinated concurrently, with each group randomised to receive 1 of 4 different vaccine doses. A control vaccine will be used, and participants will be randomized at a ratio of 3:1 in adults, 2:1 in children, 2:1 in infants in step 1 and 8:1 in infants in step 2, to receive the candidate vaccine versus the control vaccine.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Kinesio-Taping and Rigid-Taping on Vertical Jump in Individuals With Pes Planus
Condition: Pes Planus
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The effects of Kinesio-taping and rigid-taping on vertical jump performance have been
      investigated; however, results remain unclear.
    

Detailed description: 
      The effect of Kinesio-taping and rigid-taping on controlling foot pronation remains unclear
      due to contradicted results. Moreover, to our knowledge, there is not any study to elucidate
      the effect of rigid-taping on vertical jump performance. Therefore, the investigators
      hypothesised that rigid-taping would be more effective on vertical jump performance because
      of its direct mechanical correction in pes planus, and the study was aimed to compare the
      effects of Kinesio-taping and RT on vertical jump performance in sedentary adults with pes
      planus.
    

Intervention name(s): Taping
Intervention type(s): Other
Intervention description(s): Kinesio taping and Rigid taping was applied.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Low dye bandage technique was used with a 3.8 cm wide rigid band (Leuko® Sportstape Premium, Germany) for rigid taping. RT was performed on both feet in the subtalar neutral position while participants in the prone position with their heels and feet out of the bed. The taping protocol described elsewhere was followed. To optimise rigid tape adhesion, feet were washed and dried before taping. To increase consistency, the same researcher (MU) applied all taping.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4
      weeks in postmenopausal women over 12 weeks of product use.
    

Detailed description: 
      Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted
      diamino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1.
      Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2-
      pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg
      of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is
      known to be well-suited for delivery via VR, as evidenced by favorable safety and
      pharmacokinetic data to date described below.
    

Intervention name(s): Dapivirine Vaginal Ring; Placebo Vaginal Ring
Intervention type(s): Drug; Drug
Intervention description(s): Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR; The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.
Other intervention name(s): TMC-120
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Dose-response Effect of Alcohol Ingestion on Steroid Profile
Condition: Alcohol Consumption; Healthy
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      The aim of the clinical trial is to study the intra-individual variation of steroid profile
      parameters after experimental administration of different doses of ethanol in Caucasian
      women.
    

Detailed description: 
      The introduction of the so called 'endocrine module' of the athlete's biological passport
      needs to consider the numerous reports showing the effect of ethanol ingestion on the steroid
      profile. A steroid profile would only be useful for longitudinal monitoring and statistical
      evaluation if it has not been altered by any uncontrolled circumstance, very particularly
      alcohol consumption.

      There is an urgent need to study the perpetuation that alcohol ingestion causes to the
      individual steroid profile and if possible establish cut-off values for markers of ethanol
      ingestion granting that the steroid profile determined has not been affected by such
      ingestion.

      Subjects will be genotyped for genetic deletion polymorphism in the uridine
      diphosphoglucuronosyltransferase family 2 member B17 gene (UGT2B17) related to testosterone
      glucuronidation regulation.

      The objective of the clinical trial is to study the intra-individual variation of steroid
      profile parameters as a result of the ingestion of different doses of ethanol in Caucasian
      women (complementing previous studies performed in men).
    

Intervention name(s): 10 g ethanol; 20 g ethanol; Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 31 mL of Vodka Absolut® diluted in 369 mL of lemon flavored-water (LFW) Fontvella®.
A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.; 63 mL of Vodka Absolut® diluted in 337 mL of lemon flavored-water (LFW) Fontvella®.
A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.; 400 mL of lemon flavored-water Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. The administration will be controlled: participants will have 5 minutes to drink each glass.
Other intervention name(s): Vodka Absolut®; Vodka Absolut®; Lemon flavored-water Fontvella®
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ethanol; Steroid profile; Pharmacokinetics
The Manikin Study of Chest Compression With One Accelerometer Feedback Device
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Chest compression (CC) feedback devices are used to perform CC measurements effectively and
      accurately on patients in hospital beds. However, these devices do not take account of the
      compression of the mattress, which results in overestimation of CC depth. This study is the
      validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to
      overcome this limitation and thus measure compression depth more accurately when performing
      cardiopulmonary resuscitation (CPR) on patients.
    

Detailed description: 
      Data collection The participants will be divided into three groups by random drawings. Each
      performer in the three-groups will compress the chest of the manikin on the bed with
      real-time 5cm,6cm and 7cm feed-back by one accelerometer (U-cpr).We will use two beds
      [Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo,
      Michigan, US) ,Shinchang SB-34p (Transport stretcher® , 850 x 2080 mm,Shinchang
      Co.,Busan,ROK)]. Each participants will do 6 cycles of chest compression and 1cyle will be
      2minutes. Between each cycles, participants will take a rest 5minutes.
    

Intervention name(s): Stryker ST104-747; Shinchang SB-34p
Intervention type(s): Device; Device
Intervention description(s): 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US; , 850 x 2080 mm,Shinchang Co.,Busan,ROK
Other intervention name(s): Transport stretcher®; Transport stretcher®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Chest compression; One accelerometer; Manikin Study
TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      A placebo controlled study to determine the efficacy and mode of action of ondansetron in the
      treatment of irritable bowel syndrome with diarrhoea.
    

Detailed description: 
      Irritable bowel syndrome (IBS) affects around 10% of the population and accounts for 1.8
      million consultations/year in primary care in England and Wales (0.6 million patients).
      Around one third of patients meet the criteria for IBS with diarrhoea (IBS-D) and despite its
      high prevalence, there is no satisfactory treatment at present. Loperamide is currently used
      to reduce bowel frequency, however it does not improve symptoms such abdominal pain.

      Other symptoms of IBS-D include frequent, loose, or watery stools with associated urgency,
      which can severely limit socialising, travelling, and eating out, resulting in a reduced
      quality of life and work productivity.

      The primary aim of the study is to determine the effectiveness and safety of the use of
      ondansetron in patients with the symptoms of IBS-D including urgency, looseness of stool,
      frequency of defecation and abdominal discomfort. Ondansetron belongs to a class of drug
      known as 5HT3RAs and a recent meta-analysis shows that 5HT3RAs is an effective treatment for
      IBS-D, improving stool consistency and reducing frequency and urgency of defecation.

      400 patients with IBS-D will be randomised on a 1:1 basis to receive either Ondansetron or
      Placebo. Both treatments will be administered in oral doses of between 4-24mg daily for 12
      weeks. Dose titration will be undertaken in the first two weeks of the study to avoid
      constipation.

      The primary outcome of response will be assessed at 12 weeks post randomisation using patient
      reported data on daily stool frequency and abdominal pain.

      If ondansetron is effective in the trial, it could easily be widely adopted since it is an
      inexpensive, safe, and generic drug. By providing an effective treatment, it could not only
      reduce patient symptoms, but also reduce costs of repeated referral and investigation.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Ondansetron is a highly selective receptor antagonist (5-HT3RA)
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TRITON is a parallel group, randomised, double-blinded, placebo controlled trial, to determine the superiority of Ondansetron.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diarrhoea
GSK573719 IV Enabling Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability
      and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a
      single 1000μg inhaled dose of GSK573719 in healthy male volunteers.
    

Detailed description: 
      GSK573719 is a high-affinity, specific, reversible muscarinic receptor (mAChR) antagonist
      which is being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
      The long duration of action of GSK573719, when administered via inhalation to humans,
      supports the potential for use as a long acting bronchodilator for COPD.

      This will be an open-label, single dose, dose-ascending study in healthy male subjects to
      establish well tolerated intravenous (IV) dose of GSK573719 to be administered in a
      subsequent definitive human radiolabel metabolic study. The pharmacokinetics and the
      bioavailability of a single oral and a single inhaled dose of GSK573719 will also be
      evaluated.

      Blood and urine samples for pharmacokinetic analysis will be taken at regular intervals up to
      48 hours after dosing. Safety will be assessed by measurement of heart rate, blood pressure,
      ECG, lead II monitoring and twenty four hour Holter monitoring, safety laboratory data and
      review of adverse events.
    

Intervention name(s): GSK573719 (SOLUTION); GSK573719 (INHALATION POWDER)
Intervention type(s): Drug; Drug
Intervention description(s): 20μg /mL solution for IV and Oral dosing; 500μg inhalation powder delivered via Novel Dry Powder Inhaler. GSK573719 1000μg per dose (2x 500μg strips in device).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability; COPD; Safety; Muscarinic receptor (mAChR) antagonist; GSK573719; Healthy subjects; Pharmacokinetics; IV study
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
Condition: Burn Injury
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to find out if burn injured patients do better receiving fewer
      blood transfusions than what is traditionally given. We traditionally provide blood
      transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood
      cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter
      and is the standard measurement used to indicate the level of red blood cells in your blood).
      However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8
      g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above,
      would reduce the occurrence of blood infection, duration on the respirator and length of
      hospital stay, yet would achieve similar survival in both groups.
    


Intervention name(s): Restrictive transfusion threshold; Liberal transfusion threshold
Intervention type(s): Other; Other
Intervention description(s): maintain hemoglobin at 7-8 g/dL; Maintain hemoglobin at 10-11 g/dL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burn; Transfusion; blood; hemoglobin
Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course
Condition: PANS; PANDAS
Study type: Observational

Summary: 
      This study is a brief (3 month) longitudinal study following children between the ages of
      4-16 years old who have been diagnosed with Pediatric Acute-Onset Neuropsychiatric Syndrome
      (PANS). Parents and children (who are at a 2nd grade reading level) will complete
      questionnaires online or in person weekly for 3 months. Additionally, parents will track
      their child's symptoms 3 times/week using a mobile application for 3 months. The
      investigators are hoping to begin to characterize the longitudinal trajectory of
      neuropsychiatric symptoms in children with PANS. Additionally, the study will seek to
      identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus
      chronic course, GAS versus other triggers) that predict severity of baseline neuropsychiatric
      symptoms and predict change in symptoms over time.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention; observation only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with an established or suspected diagnosis of PANS/PANDAS.