bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic
Condition: Cystic Fibrosis; Covid19; Social Isolation
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the peripheral muscle function, sleep disorders and
      physical activity level in children with cystic fibrosis who are physically inactive at home
      due to social isolation and to examine the effect of the 6-week online exercise protocol.
    

Detailed description: 
      Considering the new coronavirus (COVID-19) pandemic global information, some patient
      populations have been identified at higher risk of this pandemic like older age,
      hypertension, cardiovascular and respiratory diseases. Self- isolation is recommended for
      preventive strategy in cystic fibrosis patients. Long-term social isolation and school
      closure can have negative effects on childrens' physical and mental health. Due to social
      isolation childrens are less physical active, have longer screen exposure and irregular sleep
      patterns.

      There is no study to evaluate the the peripheral muscle function, sleep disorders and
      physical activity level and examine the effects of exercise training in children with cystic
      fibrosis in social isolation due the COVID-19 pandemic.

      This study will be included children with cystic fibrosis who had stabile conditions
      Patients' peripheral muscle function, sleep quality and physical activity level will be
      assess and record at beginning, after the twelve and eighteen session.
    

Intervention name(s): Telerehabilitation-based; Follow-up based
Intervention type(s): Other; Other
Intervention description(s): 15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. Online exercise training protocol will be apply for patients. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks with a physiotherapist. Exercise protocol will start with the warm-up exercises and finish with cooling exercises.; 15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. An exercise document including the same exercise protocol in study group will be sent the patients. Patients will be called by the physiotherapist once a week for follow-up. .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; sleep; cystic fibrosis
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain; Nociceptive Pain
Study type: Interventional

Summary: 
      Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling
      has shown an effective technique for the treatment of shoulder and neck disorders. The
      mechanisms of action of the dry needling are not well-known. This study aims to evaluate the
      effects of dry needling in the upper trapezius on the autonomic nervous system and
      nociceptive pain processing in patients with non-specific neck pain.

      Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck
      pain produced greater activation of the autonomic nervous system and nociceptive pain
      processing than sham dry needling.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is
      a technique to treat musculoskeletal pain and physical impairment that consists of
      introducing needling filaments in the muscle trigger points.

      Study Aims:

      Aim #1: The primary aim of the study is to compare the effect (during the technique and five
      minutes after intervention) of a single session of DN on autonomic nervous system as measured
      by skin conductance in patients with non-specific neck pain with random assignment to two
      treatments: DN or Sham DN

      Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity
      as measured by pressure pain threshold, activation of descending inhibition pain pathways as
      measured by temporal summation and conditioned pain modulation in patients with non-specific
      neck pain with random assignment to two treatments: DN and Sham DN.

      Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of
      pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain
      Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and
      Catastrophizing (Pain Catastrophizing Scale)

      Aim #4: The secondary aim of the study is to correlate effects between clinical and other
      variables.
    

Intervention name(s): Real Dry Needling; Sham Dry Needling
Intervention type(s): Other; Other
Intervention description(s): Needle will be placed at trapezius muscle. "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.; Sham needle will be placed at trapezius muscle. Simulated "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Ache; Cervicalgia; Cervicodynia; Neckache; Cervical Pain; Dry Needling
Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      The objective of this study is to characterize through spectral analysis intra-thalamic local
      field potentials (LFPs) recorded through implanted DBS leads during periods with and without
      tremor in patients suffering from severe essential tremor.
    

Detailed description: 
      Essential tremor (ET) is one of the most common adult movement disorders with a prevalence of
      4% in the general population. Although several medications (primidone, beta-adrenergic
      blockers, benzodiazepines…) are commonly used, few of them are truly effective for
      controlling the severe forms of ET. Since 1987, an alternative has emerged with the
      development of high frequency deep brain stimulation (DBS) of the thalamic nucleus ventralis
      intermedius (VIM). This surgical technique now represents the gold standard treatment for
      tremor-disabled ET patients. Although VIM-DBS is clearly effective for treatment of essential
      tremor (ET) a partial loss of DBS effectiveness may occur over time in some patients. This
      loss of DBS effectiveness could be related to an adaptation of the local neuronal network to
      chronic stimulation (changes in synaptic plasticity). In order to avoid this problem,
      investigators plan to develop a intermittent mode of VIM stimulation using a new Medtronic
      device combining a DBS system with local field potential (LFPs) sensing capability. First,
      investigators propose to analyse VIM LFPs in order to define a tremor biomarker in 10
      patients operated for severe ET. Thereafter, investigators will automatically detect this
      biomarker using a specific algorithm and use it to trigger stimulation at the onset of tremor
      only. Thus, this project will allow us to optimize DBS therapy in ET, by improving the
      longevity of implantable devices and avoiding the loss of efficacy previously reported
    

Intervention name(s): Deep Brain Stimulation with Medtronic Activa PC+S systems
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation of VIM.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Essential tremor; Deep brain stimulation (DBS); Ventral intermediate Thalamus (VIM); Local field potentials (LFPs); Closed loop therapy
Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
Condition: Heart Failure, Congestive; Cardiovascular Diseases
MeSH terms: Heart Failure; Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW)
      study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to
      either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW
      study is evaluating the dose-response of exercise training in regard to changes in multiple
      cardiac risk factors. This study will measure diastolic heart function in a subset of the
      DREW population in order to examine the relationship between dose response, changes in
      physical activity, and diastolic function. Diastolic heart function will be assessed using
      both traditional and novel echocardiographic measures.
    

Detailed description: 
      BACKGROUND:

      Congestive heart failure (CHF) has become the number one reason for hospitalization in the
      United States. Diastolic heart dysfunction is becoming increasingly recognized as a
      significant factor in the etiology of CHF. Of the total affected population, 70% of patients
      with diastolic heart failure are female, the majority of which are elderly. There is
      currently no effective pharmacological therapy for the treatment of diastolic heart
      dysfunction. Existing cross-sectional studies and limited training trials supporting the
      hypothesis that exercise may improve diastolic function have only studied men. There is a
      need for more properly controlled and adequately powered studies examining the effect of
      exercise training on diastolic function, particularly in populations at high risk for CHF,
      such as sedentary, postmenopausal women with elevated blood pressure.

      DESIGN NARRATIVE:

      A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease
      will be randomly assigned to receive either exercise training or no exercise for six months.
      This study will measure diastolic heart function using novel echocardiographic measurements,
      such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow
      propagation velocity. The study will also measure the left ventricular mass.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Postmenopause
Multiple Dose Study of SHR4640 in Healthy Subjects
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic
      properties of multiple dose adminstration of SHR4640 in healthy volunteers.
    


Intervention name(s): SHR4640; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Day1~Day7:oral administration; Day1~Day7:oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR4640 pharmacokinetics pharmacodynamics
The Effect of Changing the Eating Speed on Energy Intake
Condition: Oral Intake Reduced
Study type: Interventional

Summary: 
      It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and
      lesser feelings of hunger and desire to eat and higher levels of fullness after the meal
      compared to eating the same meal more quickly.
    


Intervention name(s): Slow eating condition; Fast eating condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The subjects were asked to eat their meal slowly during the slow eating condition; The subjects were asked to eat their meal quickly during the fast eating condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Eating speed; energy intake
The efﬁcacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method
Condition: Colonoscopy; Colon Disease
MeSH terms: Colonic Diseases
Study type: Interventional

Summary: 
      This prospective randomized controlled trial compared integrated water jet channel
      colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among
      patients undergoing WE method colonoscopy.
    

Detailed description: 
      When the WE method colonoscopy were done with the accessory channel for both infusing and
      suctioning of water. The water had to be suctioned or infused alternatively and increaed the
      insertion time.

      With the new designed endoscopy that integrated a separate water jet channel for infusing
      water, infusing and suctioning of water can be done at the same time. Besides, water jet
      pumping system could provide a powerful jet to help us open the collapse lumen and keep an
      appropriate distance between the mucosa and the lens, thus preventing loss of visualization.
      It will help the colonoscopist to find the way during insertion.
    

Intervention name(s): Water jet channel; Accessory channel
Intervention type(s): Device; Device
Intervention description(s): The separate water jet channel was used for infusing water.; The accessory channel was used for infusing and/or suctioning water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: water exchange; water jet channel colonoscopy; colonoscopy; cecal insertion time; adenoma detection rate
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
Condition: Healthy
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in
      healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study
      infusion. A single dose of human monoclonal antibody will be administered. The study duration
      is 56 days. During this time, safety will be assessed via physical examinations, laboratory
      testing, concomitant medication usage and review of treatment emergent adverse events should
      they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during
      the 56 day study.
    

Detailed description: 
      This is a phase I, open-label, dose escalation study in healthy adult volunteers. Eligible
      volunteers will be admitted to a phase I unit for study infusion and be discharged after
      collection of a 24 hour post infusion sample. Thirty subjects are anticipated to be enrolled.
      There will be five cohorts of 6 subjects each. A single dose of human monoclonal antibody
      MBL-HCV1 will be administered on Day 0 and subjects will be followed for 56 days. Dose
      escalation to the next cohort will occur after review of safety data by the principal
      investigator, sponsor and an independent safety monitor through day 10 for all subjects in a
      cohort. Assessment of safety will be determined from vital sign measurements, physical
      examinations, hematology, chemistry and urinalysis laboratory testing, electrocardiograms,
      use of concomitant medications and review of treatment-emergent adverse events should they
      occur. Subjects will be evaluated at study visits on days 0, 1, 2, 3, 7, 14+/-1, 28+/-3 and
      56+/-7. Blood samples and urinalysis for safety analyses will be drawn during screening and
      on days 0, 1, 3, 7 and 28+/-3. Blood samples for Pharmacokinetic analysis will be drawn on
      days 0, 1, 2, 3, 7, 14+/-1, 28+/-3 and 56+/-7. Blood samples for human anti-human antibody
      detection will be drawn on days 0, 14+/-1 and 56+/-7.
    

Intervention name(s): MBL-HCV1
Intervention type(s): Biological
Intervention description(s): Single infusion of MBL-HCV1 at escalating doses as determined by cohort assignment: Cohort 1 @ 1 mg/kg, Cohort 2 @ 3 mg/kg, Cohort 3 @ 10 mg/kg, Cohort 4 @ 30 mg/kg, Cohort 5 @ 50 mg/kg.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Phase I; Infusion; Pharmacokinetics; MBL-HCV1; Monoclonal antibody; Safety Assessment
High Intensity and Moderate Training and Maximal Oxygen Uptake and Activity Levels
Condition: Ageing
Study type: Interventional

Summary: 
      Aim of the study is to investigate the effect of different types of training (high intensity
      and moderate training) on maximal oxygen uptake and activity levels in an elderly Norwegian
      population after one year training intervention. Baseline data include the activity levels
      assessed through self reported means as well as objectively measured activity data using
      activity monitors.
    


Intervention name(s): High Intensity Training; Moderate Intensity Training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maximal oxygen uptake, activity levels, elderly
Omalizumab in the Treatment of Peanut Allergy
Condition: Food Allergy; Peanut Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can
      eliminate or reduce symptoms of peanut allergy.
    

Detailed description: 
      The study will evaluate if omalizumab is an effective treatment for peanut allergy. In
      addition we will further evaluate the role of allergic cells (mast cells and basophils) and
      IgE in food allergy.
    

Intervention name(s): omalizumab
Intervention type(s): Drug
Intervention description(s): omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peanut; allergy
fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.
Condition: Growth and Development
Study type: Interventional

Summary: 
      The study will aim to compare the effects of a beverage powder fortified with multiple
      micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric
      beverage powder (control product) on cognitive outcomes of attention and working memory.
    


Intervention name(s): Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation; Non-fortified isocaloric beverage powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks; The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and
      tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
    


Intervention name(s): DA-1229
Intervention type(s): Drug
Other intervention name(s): Evogliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: patients
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK)
      of BEA 2180 BR
    


Intervention name(s): BEA 2180 BR; Placebo; Respimat®
Intervention type(s): Drug; Drug; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Amino Acid Balance During Physical Inactivity
Condition: Assessing Muscle Amino Acid Balance
Study type: Interventional

Summary: 
      The aim is to assess the impact of physical inactivity on muscle amino acid balance and
      forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate
      muscle amino acid balance and forearm glucose uptake.
    

Detailed description: 
      The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance
      and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during
      immobilization will modulate muscle amino acid balance and forearm glucose uptake.
    

Intervention name(s): High-fat overfeeding; Forearm immobilization
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Observational Study to Assess Safety and Utility Pattern of Topical Steroids
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Observational [Patient Registry]

Summary: 
      To assess incidence of adverse drug reactions and use pattern of topical steroids among
      patients who are prescribed or purchase over the counter (OTC) topical steroids for skin
      conditions in Korea
    

Detailed description: 
      -  Active collection of safety data, systemic and local adverse events.

        -  In addition to spontaneous adverse event reports, patients will be asked on occurrence
           of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after
           study enrollment by e-mail or phone call

        -  Causality of adverse events will be assessed by independent two professionals

        -  Document the utility pattern of topical steroid, misuse (inappropriate indication) or
           overuse (in terms of application frequency or treatment duration)

        -  Collection of information related with adverse event management
    

Intervention name(s): Topical Steroids
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients or guardian of child purchased topical steroids in Korea
      
Keywords: Dermatologic Agent