bioihbjkbjnl/mcl2 huggingface dataset:
Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles,
      loss of movement, and speech disturbances. These disorders are caused by injuries to the
      brain that occur during fetal development or near the time of birth. The purpose of this
      study is to determine the effects of high frequency, low magnitude vibration on bone and
      muscle in children with cerebral palsy.
    

Detailed description: 
      The extent of bone mass built up during childhood and adolescence is the most important
      determinant of osteoporosis later in life. Some disabled children, such as those with
      cerebral palsy, are particularly vulnerable to low bone mass accumulation due to decreased
      mobility and weight-bearing. These children also have poor muscle strength and control, which
      limits function and contributes to the lack of mechanical stimulation needed to build bone
      mass. The most common treatment for these children is physical therapy, which is time- and
      labor-intensive and may not be adequately available to them. Whole body vibration has shown
      promise as an alternative method for stimulating increases in bone mass and improvements in
      muscle. The purpose of this study is to evaluate the effects of high frequency, low magnitude
      vibration on bone and muscle in children with cerebral palsy. This intervention may be useful
      as a noninvasive, nonpharmacological treatment for low bone mass and poor muscle function in
      these children.

      This study will last 1 year. All participants will visit the hospital 3 times, at study entry
      and Months 6 and 12. At each visit, height and weight will be measured, muscle strength and
      balance will be tested, and bones and muscles in the spine and lower leg will be imaged with
      computed tomography (CT), a special x-ray machine. Participants will be randomly assigned to
      one of two groups. For this study, all participants will be asked to stand for 10 minutes
      every day for 1 year. For Group 1, a vibrating platform will be used for the 10-minute
      standing sessions during the first half of the study but not during the second half of the
      study. For Group 2, this will be reversed and the vibrating platform will not be used during
      the first half of the study but will be used during the second half of the study.
    

Intervention name(s): High frequency, low magnitude vibration; Standing
Intervention type(s): Device; Other
Intervention description(s): High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.; Standing 10 min/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vibration; bone density
CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is designed as a phase II evaluation of the effect of CY-503 on progression free
      survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy.
      The aim of the study is at least a rate of 25% (PFS >/= 3 months).
    


Intervention name(s): CY-503
Intervention type(s): Drug
Intervention description(s): solution for subcutaneous injection, 350 ng twice weekly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma, Stage IV, Phase II
The Therapeutic Effect of Exercise Training on Patients With Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This study aimed to clarify whether strength training or aerobic training could bring more
      benefits for patients with dementia
    

Detailed description: 
      Exercise training has been evidenced to bring various of benefits for patients with dementia
      in past studies. However, whether strength training or aerobic training could bring better
      benefits has not been confirmed in the past. This study designed to recruit 30 patients with
      mild dementia in the first year. Every patient will receive strength training using
      dumbbells, butterfly machine and vertical leg press machine for four weeks. Outcome measures
      including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree
      of depression will be recorded before and after the training. In the second year, the
      investigators also designed to recruit 31 patients with mild dementia. These participants
      will instead receive aerobic training using stationary bicycle for four weeks. The same
      outcome measures will be tested as in the first year. Via the results of this study, whether
      strength training or aerobic training could bring better benefits in dementia patient can
      thus be elucidated.
    

Intervention name(s): Strength training; Aerobic training
Intervention type(s): Device; Device
Intervention description(s): Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks; Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison of therapeutic effect between aerobic and strength training on dementia patient
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia
Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment
      duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the
      treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side
      effects.

      The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment
      of hospitalised, uncomplicated malaria cases was assessed.
    

Detailed description: 
      One main concern of clinicians in malaria endemic areas is to find a simple malaria treatment
      with short treatment duration. The concept of combination therapy, which may reduce treatment
      duration and delay the spread of drug resistance in addition to an increase in efficacy, has
      been therefore introduced.

      In contrast to the outpatient treatment of malaria where emergence of resistance has lead to
      new drugs policies, the treatment of hospitalised malaria cases remains, in many endemic
      countries, intravenous quinine for 7 days. The efficacy of this regimen is well established
      throughout Africa. The effectiveness of the quinine treatment may be considerably lower
      because of discontinuation of treatment due to early discharge, the occurrence of side
      effects or because of the fact that patients feel better and stop the treatment. Therefore,
      sulfadoxine-pyrimethamine (SP) is often added at discharge. This regimen has been shown to be
      effective. But in Africa, where the practice seems widespread, it has been assessed in only
      two trials.

      Since resistance of Plasmodium falciparum to SP is increasing rapidly in Africa and there is
      evidence that SP monotherapy induce gametocytaemia, we hypothesize that the combination
      quinine/SP increases SP efficacy and prevents induction of gametocytaemia. In addition, since
      the use of the full course of quinine therapy may be hampered by many factors (hospital cost,
      hospitalisation duration, availability of beds, compliance and side effects), the addition of
      the long acting SP to complete a short course of quinine treatment may prevent recrudescence
      or reinfection and may increase effectiveness of malaria treatment and reduce postdischarge
      morbidity.

      The efficacy and safety of the short course of intravenous quinine (3-day treatment) plus a
      single dose of oral SP for the treatment of falciparum malaria was investigated.
    

Intervention name(s): Quinine plus sulfadoxine-pyrimethamine
Intervention type(s): Drug
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Quinine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Quinine; Sulfadoxine-pyrimethamine; Gabon
The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping in Athletes With Chronic Ankle Instability
Condition: Sports Rehabilitation Program; Hydrotherapy; Ankle Instability
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      There will be a difference in ankle functional ability between athletes with chronic ankle
      instability in the intervention group and in the control group.
    


Intervention name(s): hydrotherapy
Intervention type(s): Procedure
Intervention description(s): hydrotherapy and ankle taping and land-based
Other intervention name(s): ankle taping; land-based
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hydrotherapy; chronic ankle instability; ankle taping
Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
Condition: Premature; Respiratory Distress Syndrome in Premature Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-blind randomized controlled trial done in a Level III neonatal intensive
      care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble
      CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation,
      number of surfactant and CPAP failure rate between study groups were analyzed.
    

Detailed description: 
      Background and Objective: Respiratory distress syndrome (RDS) among premature infants is one
      of the major causes of neonatal death. The use of continuous positive airway pressure (CPAP)
      has become a standard of care for preterm newborns with RDS. In countries faced with the
      challenge of improving neonatal care, cost-effective innovations for respiratory support are
      a promising intervention. This study determined the efficacy of a low-cost bubble CPAP as an
      alternative non-invasive oxygen therapy for newborn infants with RDS.

      METHODS: This is a single-blind randomized controlled trial done in a Level III neonatal
      intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy
      through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen
      saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
    

Intervention name(s): Vayu bCPAP; Mechanical Ventilator Driven CPAP
Intervention type(s): Device; Device
Intervention description(s): The Vayu bCPAP uses a constant flow of dry oxygen from the source with an adjustable flow meter. Oxygen is blended by Venturi blender with ambient air to create a source of oxygen-enriched air of adjustable concentration.; Mechanical Ventilator Driven CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
Condition: Severe Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      Online self-help is an innovative way of providing self-help. The investigators want to study
      the effect of an interactive online self-help-program (Deprexis) in the treatment of severe
      depressive symptoms. Participants will be randomised to either twelve weeks of online-self
      help or a waiting-list control. Symptoms of depression and other aspects will be assessed
      over a six months period. The investigators hypothesise that online self-help is superior to
      the control condition in alleviating depressive symptoms and preventing full blown
      depression.
    


Intervention name(s): Deprexis; CAU
Intervention type(s): Behavioral; Other
Intervention description(s): Online self-help; Care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Stamford Group Family Nurture Intervention
Condition: Behavior Problem; Developmental Delay; Emotional Disturbances; Family Conflict
MeSH terms: Problem Behavior; Affective Symptoms
Study type: Interventional

Summary: 
      The purpose of this current study is to investigate the efficacy of a group model of Family
      Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The
      behavioral, neurobiological and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral, and developmental disorders. The
      investigator hypothesizes that the children who are treated with Family Nurture Intervention
      (FNI), which incorporates interactive touch with vocal soothing, and family practice in
      comforting, will show increased emotional connection and mother child co-regulation with
      better results in the outcome measures in the short term and long term.
    

Detailed description: 
      There are several early intervention programs that are available for children with emotional,
      behavioral and developmental disorders, ranging from behavioral treatment and sensory
      exposure therapy to pharmaceutical treatments. Although improvements in behavior have
      resulted from these interventions, they are limited in numerous ways. They are usually
      time-consuming, both for the child and the teacher or clinician providing the intervention.
      In order to see an effect of the intervention, most children must engage in the intervention
      procedure for several years. Moreover, the effects of most current intervention procedures
      are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable
      side effects that may modulate behavior, emotion, and physiological functions. The
      behavioral, neurobiological, and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral and developmental disorders.
    

Intervention name(s): Nutrition and Play Intervention; Family Nurture Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.; The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state though sustained physical contact; comfort touch, soothing words, and eye contact.
Other intervention name(s): NPI; FNI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Family Nurture Intervention; Martha G. Welch MD; Randomized Controlled Trial; Preschool Intervention; Pre-school Intervention; Multiple Family Group Intervention; Emotional Connection; Co-regulation
The CZT Dynamic Myocardial Perfusion Imaging
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging
      with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart
      disease.
    

Detailed description: 
      Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental
      diagnostic and prognostic information over relative perfusion alone. Recent development of
      dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic
      SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with
      cardiovascular risks and heart failure warrant further investigations.

      The present project aims to develop and validate the noninvasive measurement of MBF and MFR
      by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic
      implications.
    

Intervention name(s): thallium-201
Intervention type(s): Radiation
Intervention description(s): Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects with clinically suspected coronary artery disease, heart failure, or intermediate
        and high cardiovascular risks
      
Keywords: cadmium-zinc-telluride，CZT cameras; myocardial blood flow，MBF; myocardial flow reserve，MFR
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose block-randomized, double-blind, placebo- and active-controlled, single and
      multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in
      healthy male volunteers.
    


Intervention name(s): DWP16001; Placebo; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DWP16001 tablets; DWP16001 placebo-matching tablets, Active control placebo-matching tablets; Forxiga®
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
Condition: Cardiac Resynchronization Therapy; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The primary goal of this study is to evaluate the use of robotically -assisted device leads
      as a primary strategy for heart resynchronization.This trials aims to compare transvenous
      lead placement with robotic lead placement for cardiac resynchronization therapy.
    

Detailed description: 
      A secondary goal is to explore the link between efficacy of CRT and inotropic contractile
      reserve as measured by dobutamine stress echocardiography.
    

Intervention name(s): Primary epicardial placement of left ventricular lead; Transvenous placement of left ventricular lead
Intervention type(s): Procedure; Procedure
Intervention description(s): Epicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device; Conventional placement of left ventricular leads performed in the electrophysiology department.
Other intervention name(s): cardiac resynchronization therapy; Cardiac resynchronization Therapy; CRT/ AICD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biventricular pacing
The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Condition: Exercise; Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Aim:

      To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy
      exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most
      effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS
      surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used
      to quantify balance and gait performance before and after two PT-supervised, intensive,
      exercise programs, expected to improve balance and gait. The first program is a published
      Treadmill training program and the second is the investigators new Agility training program
      with sensorimotor progressions, targeted at specific impairments that underlie the
      abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot
      clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in
      preparation for a larger clinical trial to determine the most effective exercise for mobility
      disability in PD. The effects of exercise will be compared with no treatment during a 5-week
      delay prior to start of exercise.

      This trial will also determine the relative responsiveness (compared to traditional clinical
      scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve
      mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic
      balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to
      show there is a difference between the exercise groups. Superior responsiveness of the
      iMOBILITY system will be determined by larger differences with exercise intervention with the
      iMOBILITY system than with traditional clinical measures of mobility in PD.
    


Intervention name(s): Aerobic vs. Agility Training
Intervention type(s): Behavioral
Intervention description(s): High Intensity 4x's per week for 4 weeks with a physical therapist.
Other intervention name(s): agility, treadmill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Novel Endpoints in Cough Challenge Testing
Condition: Chronic Obstructive Pulmonary Disease; Asthma; Healthy; Chronic Cough; Smokers
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cough
Study type: Observational

Summary: 
      The sensitivity of a person's cough reflex can be measured by getting them to breathe in
      (inhale) irritant chemicals. There are different methods by which subjects are asked to
      inhale these chemicals, either by taking one deep breath in, or by asking them to just
      continue to take a number of breaths. The purpose of this clinical research study is to see
      if the coughing responses are different in healthy people and people with respiratory
      problems that make them cough when they are given these chemicals in these two methods.
    


Intervention name(s): Cough challenge test; 24 hour ambulatory cough recording; Cough quality of life questionnaire
Intervention type(s): Other; Other; Other
Intervention description(s): Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.; Cough recording by using an ambulatory sound recording device.; questionnaire designed to assess impact of cough on a person's life
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Selected from secondary care.
      
Keywords: COPD; Asthma; Healthy volunteers; Chronic cough; Smokers; Cough challenge; Cough challenge testing.