bioihbjkbjnl/mcl2 huggingface dataset:
High Versus Low Frequency rTMS on Motor Dysfunction in PD
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD.
      Forty patients with PD participated in the study.

      The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd
      one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the
      patients clinically is blind for the frequency of rTMS, also patients don't know which type
      of stimulation they received. The patients were followed up before and after the 10 sessions
      and one month later.
    

Detailed description: 
      The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD.
      Forty patients with PD participated in the study.

      The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd
      one received 20 Hz rTMS daily for 10 days 5 sessions every week and 2 days off per week. The
      doctors who assess the patients clinically is blind for the frequency of rTMS, also patients
      don't know which type of stimulation they received. The patients were followed up before and
      after the 10 sessions and one month later.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK
      1557484A is immunogenic when given to adults aged 18-64 years.
    

Detailed description: 
      All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal
      study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182
      with a telephone safety contact on Day 364.

      This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08
    

Intervention name(s): GSK A/turkey H5N1 Influenza vaccine
Intervention type(s): Biological
Intervention description(s): One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: human; Avian; safety; vaccines; influenza; pandemic; immunogenicity; H5N1
Smart Phone App Intervention In Young Adults With Cancer
Condition: Cancer; Young Adults; Behavioral Intervention; Smartphone Application
Study type: Interventional

Summary: 
      This research study aims to explore the feasibility and acceptability of a smartphone
      application intervention, called iaya, among young adults with cancer.
    

Detailed description: 
      The iaya app was developed by clinicians from the Young Adult Program at the Dana-Farber
      Cancer Institute. The iaya app is a smartphone application intervention that -through a
      variety of approaches, such as exercises aimed at identifying and changing thoughts and
      behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of
      cancer.

      The investigators are conducting this study to see if the iaya app, specifically developed
      for young adults with cancer, is practical, to determine patient satisfaction with the iaya
      app, and to test study procedures.
    

Intervention name(s): iaya
Intervention type(s): Other
Intervention description(s): The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; Young Adults; Behavioral Intervention; Smartphone Application
Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations
Condition: LCA (Leber Congenital Amaurosis); RP (Retinitis Pigmentosa)
MeSH terms: Blindness; Retinitis; Retinitis Pigmentosa; Leber Congenital Amaurosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  to evaluate the safety of oral QLT091001

        -  to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in
           subjects with LCA or RP due to RPE65 or LRAT mutations

        -  to evaluate duration of visual function improvement (if observed)
    


Intervention name(s): QLT091001
Intervention type(s): Drug
Intervention description(s): oral QLT091001 administered once daily for 7 days
Intervention MeSH terms: Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance Study With MT-8554
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, mass balance study in healthy male subjects utilising a
      single oral dose of [14C] MT 8554.
    


Intervention name(s): [14C] MT-8554
Intervention type(s): Drug
Intervention description(s): 14-C MT-8554
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mass Balance Study with MT-8554
A Bioequivalence Study of Hetrombopag in Healthy Subjects
Condition: Sever Aplastic Anaemia
MeSH terms: Anemia, Aplastic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study
      to demonstrate the bioequivalence of test and reference formulation, both of which adopt a
      single-center, randomized, open-label, three-period crossover design.
    


Intervention name(s): Hetrombopag Olamine Tablet
Intervention type(s): Drug
Intervention description(s): Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for the Transdermal Application of Teriparatide
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to help answer the following research questions:

        1. How teriparatide given using a skin patch (transferred through the skin using the
           ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a
           needle (pen injector) affects your bone density (how solid or porous your bones are).

        2. The safety of the teriparatide skin patch and any side effects that might be associated
           with it.
    

Detailed description: 
      Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ)
      injection and many patients with severe osteoporosis for whom anabolic therapy with
      teriparatide is appropriate are either unwilling or physically unable to self-inject. The
      purpose of this Phase 2 study is to identify a transdermal dose or doses that will be
      comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety
      standpoint for use in future Phase 3 studies.
    

Intervention name(s): Subcutaneous Teriparatide; Transdermal Teriparatide
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously once daily for 12 months; Administered transdermally, applied once daily for 6 hours over 12 months
Other intervention name(s): recombinant human parathyroid hormone (rhPTH) (1-34); recombinant human teriparatide; Forteo; Forsteo; LY333334; synthetic human parathyroid hormone (shPTH) (1-34); synthetic human teriparatide
Intervention MeSH terms: Teriparatide; Hormones; Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Age Related Osteoporosis; Senile Osteoporosis
Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
Condition: Extrusion of Tooth
Study type: Interventional

Summary: 
      Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of
      either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.
    

Detailed description: 
      Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first
      time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by
      evaluating anxiety, heart rate and behavior during administration of local anesthesia and
      extraction.
    

Intervention name(s): Propranolol; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): This drug will be given before the extraction procedure; This drug will be given before the extraction procedure
Intervention MeSH terms: Propranolol; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups, with 20 children in each group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa
Condition: Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The
      active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or
      BCG revaccination administered intradermally on Study Day 0.
    

Detailed description: 
      This is a Phase 1b/2a, double-blind, randomized, BCG-controlled, dose-escalation safety and
      immunogenicity study in 144 healthy adults with and without LTBI. All participants will have
      received previous BCG vaccination in infancy. The investigational product is MTBVAC at four
      dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control
      is BCG (5 x 10^5 CFU).

      Participants meeting the inclusion/exclusion criteria will be randomized within a study
      cohort to receive a single dose of MTBVAC or BCG revaccination administered intradermally on
      Study Day 0. The study will be conducted at one site in South Africa. Participants will be
      enrolled into one of eight cohorts and followed for safety and immunogenicity endpoints
      through Study Day 365. The estimated time to complete enrolment is approximately 12 months.

      Cohorts 1-8 will include 72 QFT-negative (Cohorts 1-4) and 72 QFT-positive (Cohorts 5-8)
      participants. Participants will be randomized within each cohort, to receive either MTBVAC
      (N=96) or BCG (N=48). The cohorts will be enrolled as described in the protocol, as long as
      no pausing/stopping rules are triggered
    

Intervention name(s): MTBVAC; BCG
Intervention type(s): Biological; Biological
Intervention description(s): Escalating dose levels (5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU; BCG 5 x 10^5 CFU
Other intervention name(s): BCG 5 x 10^5 CFU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers
Condition: Hypercholesterolemia and Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      In order to meet the preferences and needs of different patients for injection sites and
      improve the medication compliance of patients, it is planned to compare the bioavailability,
      pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection
      sites for administration.
    


Intervention name(s): SHR-1209
Intervention type(s): Drug
Intervention description(s): SHR-1209，single subcutaneous injection of 450mg
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, random, parallel, open-label
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns
Condition: Burns; Skin Burn Requiring Skin Graft
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the
      Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in
      burn wounds resulting from thermal burn injuries.
    


Intervention name(s): P6 Low Adherent Dressing; Standard of Care (SOC)
Intervention type(s): Device; Other
Intervention description(s): Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).; Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, randomised, open-label, two-way crossover study to investigate whether
      multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the
      pharmacokinetics of gliclazide.
    


Intervention name(s): BIA 2-093; Gliclazide
Intervention type(s): Drug; Drug
Intervention description(s): tablets containing gliclazide 80 mg (Diamicron® 80 mg)
Other intervention name(s): ESL, Eslicarbazepine acetate
Intervention MeSH terms: Gliclazide; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of our study is to make a comparison between the effectiveness of physical
      resistance exercise and imaginary resistance exercise in improving handgrip strength,
      dexterity, and eye-hand coordination among stroke patients.
    

Detailed description: 
      A Randomized Control Trial study will be conducted in which patients with stroke will be
      allocated to Group A that will receive imaginary resistance exercises and patients in group B
      will receive physical resistance exercises.

      The intervention will be applied (3 days /week) for 12 weeks, which consists of 5 different
      types of resistance using 5 different resistive objects, each will have 15 repetitions. Each
      session includes handgrip exercises with physical resistance exercises for one group and
      imaginary resistance exercises using Virtual Reality Box for another group. As for improving
      dexterity and eye-hand coordination, the Purdue pegboard test and finger-to-nose test will be
      used respectively in both groups with 15-15 repetitions.
    

Intervention name(s): Imaginary Resistance Exercises; Physical Resisted Exercises
Intervention type(s): Other; Other
Intervention description(s): In imaginary resistance exercises, resistive force is assumed to get applied by the patient after demonstrating some resistive objects and the kind of force exerted by them.; In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects.
Other intervention name(s): Rehabilitation following Imaginary Resistance Exercises; Rehabilitation following Physical Resisted Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Physical Resisted exercise; Imaginary Resisted exercise; Hand grip strength
Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists
Condition: Compare Performance of Colonoscopists
Study type: Observational

Summary: 
      The study is to evaluate how doctors in training are different from very experienced doctors
      when using force to perform colonoscopy with a device that monitors the amount of force
      applied to the colonoscope during colonoscopy.
    

Detailed description: 
      The study consists of two sequential observational studies designed to identify which
      instrument should be used to assess trainee performance and to quantify trainee skill
      development in performance of colonoscopy over the course of their training program.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult male and female patients between the ages of 30 and 75 presenting for screening
        or diagnostic colonoscopy to be performed by any of the investigators.
      
Keywords: Colonoscopy; Force; Monitor; Endoscopist; Trainee
Comparison of Fatigue in Varying Hot Environments
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of varying hot environments on
      physiological and perceptual fatigue during work.
    

Detailed description: 
      After providing written informed consent and screening, subjects will complete two
      experimental visits during which they will complete treadmill work in either a hot/dry or
      warm/humid environment.
    

Intervention name(s): Hot/Dry; Warm/Humid
Intervention type(s): Other; Other
Intervention description(s): Work is completed in a hot/dry environment.; Work is completed in a warm/humid environment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, counterbalanced crossover design
Masking: None (Open Label)
Primary purpose: Other
MI Practice and tDCS With Aging
Condition: Aging; Motor Learning
Study type: Interventional

Summary: 
      The mental repetition of movements - or motor imagery (MI) practice - facilitates motor
      learning. It allows avoiding fatigue that occurs during physical practice; this method is
      thus particularly interesting for elderly people. Transcranial direct current stimulation
      (tDCS) is a noninvasive method of neurostimulation during which a low direct current is
      applied to the brain via electrodes placed on the scalp. This method has been successfully
      used to enhance motor learning in both young and elderly subjects.

      The main aim of this study is to assess the impact of MI practice combined with tDCS on the
      learning of a complex finger sequence, in young and elderly subjects.

      For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation
      and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly
      Stim, and Elderly Sham.

      All subjects will participate to three training sessions spread over five days, and a
      retention test one week after the third training session.

      During training they will mentally repeat a complex finger sequence with the left hand, for
      13 min:

        -  Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in
           parallel an anodal tDCS of the primary motor cortex.

        -  Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a
           sham tDCS of the primary motor cortex.

      Immediately before (pretest) and after (posttest) each training session, as well as during
      the retention test, subjects will repeat the sequence as many times of possible, for 1 min.
      During these tests (pretests, posttests and retention test) electroencephalographic activity
      will be recorded to assess the Mu rhythm power.
    


Intervention name(s): tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min:
- Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.; All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min:
- Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Motor imagery; transcranial direct current stimulation; motor learning; aging