bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety after administration of
      TS-091 compared with placebo in patients with narcolepsy.
    


Intervention name(s): TS-091 5mg; TS-091 10mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orally taken once daily for 3 weeks; Orally taken once daily for 3 weeks; Orally taken once daily for 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Narcolepsy
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
Condition: Moderate to Severe Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no
      inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of
      hospital stay will be analyzed.
    

Detailed description: 
      Acute viral bronchiolitis is the most common lower respiratory tract infection in the first
      year of life and leads to a large number of hospital admissions. The only recommended
      treatment is supportive. However many different types of drug inhalations have been studied
      but their efficacy remains controversial.

      Our study will compare recommended supportive therapy to supportive therapy combined to
      hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis.
      This will be the first study to use a true control group with no inhalation.
    

Intervention name(s): NaCl 3%; Standard therapy
Intervention type(s): Drug; Other
Intervention description(s): NaCl 3%: 4ml QID; Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Other intervention name(s): Mucoclear 3%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bronchiolitis; Moderate to Severe; Hypertonic saline; NaCl 3% inhalations; Standard therapy; Wang score; in-patients
Establishing a Non-invasive Method to Measure Your Heart's Performance
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of the study is to evaluate a new way to examine cardiac function, using software
      developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is
      used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where
      the carotid pulse can be felt. In this study the information collected from the iPhone app is
      compared to cardiac function data obtained from the current gold standard for measuring
      cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from
      cardiologists will also generally have echocardiography information available for comparison
      with the iPhone app. For the study, subjects will have completely non-invasive studies done
      in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)
      arteries), tonometry (another non-invasive method using a modified stethoscope), standard
      pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study
      will be done about 6 months after the first. The complete study session takes about 1.5
      hours.
    

Detailed description: 
      Investigators at Caltech have developed an iPhone-based application that allows them to
      capture an arterial waveform using the iPhone camera held over the skin. Then based on the
      captured waveform and previous laboratory experiments and models, the investigators are able
      to calculate ejection fraction, the percentage of blood that goes out of the heart into the
      circulation with each beat. Previous studies suggested that the iPhone app measurements of
      ejection fraction were similar to those obtained with traditional cardiac echocardiography.
      In the current study the iPhone app measures are being compared to ejection fraction obtained
      using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta
      that the investigators call "intrinsic frequencies". Using healthy subjects they have
      established the normal pattern/range of intrinsic frequencies, and in this study, a more
      diverse population of subjects (some with heart disease) will be studied, to determine how
      intrinsic frequency measures compare to traditional clinical measures of cardiac function.
    

Intervention name(s): cardiac MRI
Intervention type(s): Device
Intervention description(s): cardiac MRI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with normal and abnormal cardiac function will be studied.
      
Keywords: arterial waveform; cardiac magnetic resonance imaging; echocardiography; intrinsic frequency measures of cardiac function
L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
Condition: Peripheral Neuropathy; Cancer
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced
      peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin
      and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And
      then neuropathy together with some oxidative stress markers will be assessed at the end of
      treatment duration (three months) .
    

Detailed description: 
      Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side
      effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is
      intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing
      Oxaliplatin induced peripheral neuropathy in cancer patients.

      Blood samples will be collected from the patients before starting the chemotherapy and at the
      end of treatment duration (3 months) and then oxidative stress markers will be measured in
      these samples
    

Intervention name(s): L-CARNOSINE
Intervention type(s): Drug
Intervention description(s): L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.
Other intervention name(s): CARNOSINE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxaliplatin, peripheral neuropathy, L-CARNOSINE
Ischemic Preconditioning and Thiol-disulfide Balance
Condition: Tourniquets
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Various strategies have been proposed to prevent or mitigate the effects of
      ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One
      of them is applying "remote ischemic preconditioning." This randomized controlled trial is
      planned to evaluate the effectiveness of remote ischemic preconditioning in preventing
      tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic
      thiol-disulfide homeostasis.
    


Intervention name(s): Remote Ischemic Preconditioning; sham group
Intervention type(s): Other; Other
Intervention description(s): Three cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure of systolic blood pressure plus 50 mm Hg.; a deflated cuff placed on the upper arm for 30 min
Other intervention name(s): RIPC group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: thiol/disulfide homeostasis; ischemic preconditioning
Carnitine, Aclycarnitine, Myocardial Function, and CRRT
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Observational

Summary: 
      Carnitine is essential for the transport of fatty acids into the mitochondria and energy
      production in different muscles, including the myocardium. It is also needed to protect
      myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups.
      Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk
      for carnitine deficiency as a result of its removal during the dialysis procedure, lack of
      endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of
      children undergoing continuous renal replacement therapy (CRRT) has not been studied.
      Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk
      for carnitine deficiency due to its continuous removal, lack of carnitine production by the
      kidney, and absence of carnitine intake (as majority of these children can not eat and there
      is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase
      the risk of cardiac dysfunction in critically ill children. This is the first study to
      examine carnitine status in children undergoing CRRT. Standard echo as well as more sensitive
      speckle tracking echo will be used to evaluate the effect of carnitine deficiency on
      myocardial function.
    

Detailed description: 
      Study Design:The research design consists of a prospective study group that would be compared
      to two control groups (a prospective control groups and a retrospective control group). The
      study group will consist of critically ill children receiving CRRT and IV carnitine
      supplementation (added in the TPN). The prospective control group will consist of critically
      ill children not receiving CRRT or carnitine Retrospective control group will consist of
      critically ill children who received CRRT but did not receive carnitine supplementation. .
      Subjects for the prospective study and control groups will be recruited from the pediatric
      intensive care unit (PICU) and the cardiac intensive care unit (CICU) at Children's National.
      Informed consent will be obtained from participants enrolled in the prospective study and
      control groups. Data for the retrospective control group will be obtained from the medical
      record.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and young adults, age 1-21 years Critically ill, receiving care in intensive care
        unit
      
Keywords: acute renal failure; CRRT; continuous dialysis; carnitine; cardiac strain
A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether EMG-Biofeedback is effective in the
      treatment of Fibromyalgia.
    

Detailed description: 
      The objective of this randomized controlled trial is to evaluate the effectiveness of
      EMG-biofeedback in patients with Fibromyalgia. The assessors are blinded to the group
      assignment. There are three time points of assessment: before intervention, at the end of
      treatment (T1) and 3-months follow-up (T2). Patients are recruited from the waiting list of
      the Fibromyalgia day hospital program at the University Hospital Munich fulfilling the
      inclusion criteria. The intervention group is treated with 14 sessions of EMG-biofeedback
      during eight weeks in addition to usual care. The control group receives usual care only. The
      main specific aim is to assess the change in fibromyalgia specific health status.
    

Intervention name(s): EMG-Biofeedback and Usual care
Intervention type(s): Other
Intervention description(s): Please refer to arm description
Other intervention name(s): Schuhfried Biofeedback apparatus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Complementary Therapies; Biofeedback; Randomized controlled trial; Relaxation Therapy
Kinesio Taping on Chronic Nonspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back
      pain. All the subjects will be submitted to an evaluation of the painful sensation,
      functional performance, trunk range of motion and neuromuscular performance at three
      different times.
    


Intervention name(s): Functional elastic tape tensioned; Functional elastic tape non-tensioned; Rigid Tape
Intervention type(s): Other; Other; Other
Intervention description(s): Application of Kinesio Taping with tension in the erector spine muscles.; Application of Kinesio Taping without tension in the erector spine muscles.; Application of Micropore tape in the erector spine muscles.
Other intervention name(s): Kinesio Taping with tension; Kinesio Taping without tension; Micropore Tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis, Osteoporosis
MeSH terms: Osteoporosis; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with
      increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less
      weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the
      skin. Prevention of osteoporosis is a high priority, because treatment of the established
      disease remains sub-optimal.

      We have designed a double-blind randomised controlled trial of two years' duration including
      90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a
      weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.

      The primary objective of this study is to determine changes in BMD over the 2 year study
      period comparing treatment and placebo groups.

      The most important secondary objective is to determine cytokine profiles in blood samples. We
      will also assess parameters related to vitamin D status and physical performance.
    


Intervention name(s): cholecalciferol; calcium carbonate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily; calcium carbonate 500 mg daily for 2 years
Other intervention name(s): Dekristol, Weifa-kalsium; Weifa-kalsium
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM)
Condition: Malignant Pleural Mesotheliomas
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Observational

Summary: 
      The purpose of this study is to To assess the correlation between the predictive factor of
      vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate,
      and overall survival) .
    

Detailed description: 
      This is a randomized controlled retrospective study through Examination of paraffin blocks of
      the patient selected to be included in the study for assessment of the selected vascularity
      marker of malignant pleural mesothelioma of both types . The CD74 (LN2) antibody is intended
      for qualified laboratories to qualitatively identify by light microscopy the presence of
      associated antigens in sections of formalin-fixed paraffin-embedded tissue sections using
      Immunohistochemistry test methods.
    

Intervention name(s): marker CD74 and vascular endothelial growth factor VEGF
Intervention type(s): Other
Intervention description(s): correlate the result of vascularity test done on paraffin blocks on both types of malignant pleural mesothelioma patients diagnosed and receive treatment and evaluated after treatment
Intervention MeSH terms: Mitogens; Endothelial Growth Factors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Egyptian patients with confirmed malignant pleural mesothelioma
To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to identify novel imaging markers for characterizing the
      biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after
      intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.

      We hypothesize that:

        1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical
           changes within knee synovial fluid after HA injection;

        2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of
           glutamate will predict patient response of pain relief after HA injection;

        3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical
           changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and
           T2 will decrease in patients who respond to the treatment, indicating potential
           beneficial effects of HA injection to cartilage preservation.
    


Intervention name(s): Euflexxa; Magnetic Resonance Imaging (MRI)
Intervention type(s): Drug; Device
Intervention description(s): Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.; MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).
Other intervention name(s): hyaluronic acid injection
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: knee osteoarthritis (OA); hyaluronic acid injection
Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate effects on the brain after complex somatosensory
      stimulation with acupuncture needle. EEG and fMRI measurements will be performed.
    

Detailed description: 
      The aim of the study is to evaluate whether the point locations chosen for a complex
      somatosensory stimulation with acupuncture needles have an essential impact on the change of
      brain activity in healthy volunteers. For this, the investigators compare three different
      point locations (one acupuncture point and two non-acupuncture points) stimulated with
      acupuncture needles. Two measurements each with 20 subjects are planned.

        -  With the EEG measurements the impact of the stimulation's location on background rhythm
           especially in the somatosensoric cortex is evaluated.

        -  With the fMRI (functional magnetic resonance imaging) measurements the impact of the
           stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional
           connectivity is evaluated.
    

Intervention name(s): needle stimulation
Intervention type(s): Other
Intervention description(s): stimulation with acupuncture needles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: basic science; healthy volunteers
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Condition: Constipation; Fecal Incontinence
MeSH terms: Fecal Incontinence; Constipation
Study type: Observational

Summary: 
      We propose to develop parent and child disease-specific instruments to assess health related
      quality of life (HRQoL) in children with constipation and fecal incontinence.
    

Detailed description: 
      Chronic constipation is a common problem in childhood, accounting for almost 3% of
      consultations in pediatric practice. In many children constipation is accompanied by overflow
      soiling (fecal incontinence). This condition often gives rise to behavioral, social, and
      emotional problems.

      We plan to develop a disease-specific instrument to assess HRQoL in children with
      constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with
      fecal incontinence compared to children with constipation but no fecal incontinence. The
      instrument will involve both parent and child self-reporting measures and will enable
      researchers to evaluate how disease and treatment strategies impact both child and parent
      perceptions of quality of life. In the long run this will enable physicians to develop a
      child friendly approach to management of chronic constipation and fecal incontinence.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children will be recruited from the Constipation Clinic at Children's Hospital of
        Wisconsin, as well as four coolaborating sites.
      
Keywords: Constipation; Fecal incontinence; Quality of life; Health related quality of life