bioihbjkbjnl/mcl2 huggingface dataset:
Pharmaco-metabolomic Effects of Statins: METASTATINE
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but
      also through other mechanisms poorly understood. Our hypothesis is that some of these effects
      are mediated by microbiota alteration, leading to diminution of expression of microbiota
      derived pro-atherogenic metabolites.
    

Detailed description: 
      The aim of this prospective double blind placebo-controlled study is to evaluate the acute
      effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.
    

Intervention name(s): Atorvastatin 40mg Tablet; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Patient participation for 6 weeks of treatment; Patient participation for 6 weeks of treatment
Other intervention name(s): No other name; No other name
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups of patients having treatment or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statins; cardiovascular risk; primary prevention microbiota; metabolomics
Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate whether tailored print material can promote
      physical activity and exercise, and subsequently improve quality of life and fitness levels
      among people with multiple sclerosis (MS). Research suggests that routine physical activity
      is beneficial in people with mild to moderate MS. However, people with MS may face many
      barriers for engaging in regular physical activity. Prescribing a home exercise program and
      receiving tailored motivational print material may help people engage in physical activity.
      Thus, the investigators hope to figure out whether tailored print material can be used as
      strategy to promote physical activity and improve physical function in people with MS.
    

Detailed description: 
      The objective of the proposed study is to further our understanding of methods to promote
      physical activity (PA) in people with multiple sclerosis (MS). The investigators will
      evaluate the efficacy of a print-based multifaceted intervention that consists of prescribing
      an exercise program and teaching self-management strategies.
    

Intervention name(s): Immediate exercise; Delayed exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the immediate exercise group will be prescribed a home exercise program during the first meeting and will begin the 12 week training period immediately following the first meeting.; Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
Other intervention name(s): Treatment arm; control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Multiple Sclerosis; Exercise; Physical activity; Quality of life
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The study objective is to observe and measure clinical outcomes, urine output, and safety
      events occurring during standard medical treatment of ADHF patients deemed to have
      insufficient diuretic response.
    


Intervention name(s): Standard of care
Intervention type(s): Other
Intervention description(s): Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute Heart Failure Patients with Insufficient Response to Diuretics
      
Keywords: ADHF
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
Condition: Diabetic Neuropathy, Painful
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether a new treatment will be safe and effective in
      treating pain. Patients with diabetic peripheral neuropathy will be included.
    


Intervention name(s): Placebo; Pregabalin; LY545694 21 mg; LY545694 49 mg; LY545694 105 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): LY545694 placebo BID po for 5 weeks
Pregabalin placebo capsules TID po for 6 weeks; Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
LY545694 placebo BID po for 5 weeks; LY545694 21 mg BID po for 1 week
Pregabalin placebo TID po for 6 weeks; LY545694 escalated to 49 mg BID po for 1 week during Week 2.
Pregabalin placebo TID po for 6 weeks.; LY545694 105 mg BID po for 5 weeks
Pregabalin placebo TID po for 6 weeks
Other intervention name(s): LY545694; LY545694; LY545694
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NDT Effectiveness Study
Condition: Cerebral Palsy; Neuromuscular Diseases; Neurodevelopment Treatment
MeSH terms: Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is a functional change in children
      with Cerebral Palsy (CP) and other neuromuscular disorders participating in
      Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).
    


Intervention name(s): Therapy
Intervention type(s): Behavioral
Intervention description(s): The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation
Condition: Bronchiolitis Obliterans Syndrome
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Observational

Summary: 
      A major source of graft failure and dysfunction in lung transplantation is known to be
      bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans
      syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year
      post transplant. Currently, our ability to assess lung injury after transplant is less than
      ideal.

      The purpose of this study is to use new computerized tomography(CT) technology, specifically
      , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of
      finding better therapies that currently exist.
    

Detailed description: 
      Total enrollment : 10

      Lung transplant patients will undergo CT Scans before scheduled bronchoscopies which are
      routinely performed at 1, 3, 6, 9, and 12 months post transplant. Imaging will be done with
      the newest generation scanner, with intent to analyze all pertinent areas of the lung for
      pathology, but especially the bronchial anastomoses, the lung parenchyma with focus on gas
      exchanging lobules of the lung, and any suspected abnormalities from physical exam,
      laboratory tests, or prior chest xray.

      CT imaging will precede bronchoscopy and biopsy so that CT interpretation will be
      unencumbered by changes due to the bronchoscopic procedure.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lung transplant patients meeting inclusion criteria will be recruited from the lung
        transplant clinic.
      
Keywords: Bronchiolitis Obliterans Syndrome
Serum Erythropoietin Level in Perinatal Asphyxia
Condition: Perinatal Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      This study is to evaluate brain and kidney injuries in full-term neonates with perinatal
      asphyxia by detecting specific biomarker in blood (Erythropoietin).
    

Detailed description: 
      Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the
      newborn and can result in long-term devastating consequences. Acute kidney injury (AKI)
      occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make
      erythropoietin are sensitive to low oxygen levels in the blood that travels through the
      kidney. These cells make and release erythropoietin when the oxygen level is too low.
    

Intervention name(s): Serum erythropoietin level
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group
Intervention MeSH terms: Epoetin Alfa
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Data will be collected from full-term neonates (first 28 days of life) with perinatal
        hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males & females)
        .
Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation
Condition: Polycystic Ovarian Syndrome (PCOS); Insulin Resistance; Overweight; Obese
MeSH terms: Polycystic Ovary Syndrome; Overweight; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      A goal of this study is to use a novel methodology to determine whether insulin resistance in
      women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with
      modifications. This could lead to future research to determine if these modifications
      interfere with their proper function. Additionally, the investigators will determine how
      protein quality is affected by exercise training. Aerobic exercise enhances the endogenous
      oxidant buffering systems which may minimize oxidative damage to proteins. The investigators
      propose that aerobic exercise minimizes the accrual of modified proteins by increasing the
      synthesis of new proteins, but also by increasing the degradation and removal of old and
      damaged proteins. Based on our previous studies the investigators observed that insulin
      affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only
      in muscle but also in liver. The investigators therefore propose that aerobic exercise and
      related increase in insulin sensitivity (and decline in insulin levels) will reduce
      accumulation of old and modified skeletal muscle and plasma proteins leading to improved
      function.
    


Intervention name(s): Aerobic Exercise Training
Intervention type(s): Behavioral
Intervention description(s): A progressive increase in duration, frequency and intensity so the last 8 weeks of exercise are performed for 60 min, 5 days per week and at 80% of aerobic capacity. The duration includes a 5 minute warm up and 5 minute cool down. All exercise will be performed on a stationary bicycle (i.e., cycle ergometer).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polycystic Ovarian Syndrome (PCOS); Insulin Resistance; Overweight, Obese Women; Protein Metabolism; Post Translational Modifications
Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Studies suggest that dietary omega-3 fatty acids influence the extent to which the time
      interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated
      with increased risk of sudden cardiac death (SCD). The purpose of this research is to
      investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid
      levels in patients who have recently commenced haemodialysis.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have
        recently commenced haemodialysis treatment.
      
Biospecimen description: 
      Blood Plasma Washed and isolated red blood cells
    
Keywords: Haemodialysis; Heart rate variability; n-3 PUFA
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether intramuscular injections of VM202 into the
      calf is safe and effective in the treatment of critical limb ischemia.
    

Detailed description: 
      In the absence of revascularization options, most patients with CLI require amputation within
      6 months. Patients requiring major amputation face a diminished quality of life, an
      unfavorable natural history and need extensive resources for their post-amputation
      rehabilitation and course. The 1-year amputation-free survival rate for patients diagnosed
      with CLI is 45%; the mortality rate is approximately 25% and may be as high as 45% in those
      who have undergone amputation. Management of this end-stage disease process consumes a
      significant amount of healthcare resources. Clearly, new therapeutic approaches are required.

      Hepatocyte growth factor (HGF) has been shown to be a potent angiogenic growth factor
      stimulating the growth of endothelial cells and migration of vascular smooth muscle cells.
      Because of its pluripotent capabilities, increasing the availability of HGF in ischemic
      tissues to achieve therapeutic angiogenesis has been a growing area of research.

      This study will use VM202, which is a DNA plasmid that contains novel genomic cDNA hybrid
      human HGF coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723. As
      there are currently no approved drugs that can reverse CLI and as most patients have
      exhausted surgical and endovascular intervention options, inducing angiogenesis in the
      affected limb with VM202 may result in an increase in tissue perfusion, which, in turn
      improve wound healing, reduce pain and improve limb salvage rates.
    

Intervention name(s): Low Dose VM202; High Dose VM202; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202); Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 42: 4mg of VM202 (16 injections of 0.5ml of VM202); Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
Other intervention name(s): DNA Plasmid; HGF-X7; DNA Plasmid; HGF-X7; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Painful legs; Ischemic legs; Treatment for Claudication; Gene therapy
Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Exacerbations are important events in the natural history of chronic obstructive pulmonary
      disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that
      exacerbations negatively affect the natural history of the disease; e.g. lung function
      decline is accelerated in patients with frequent exacerbations. Bacteria are considered the
      most relevant cause of exacerbations, but there is evidence that viral infections are equally
      contributing.

      Either alone or in combination with viruses, airway bacterial load in stable COPD correlates
      with both the frequency of exacerbations and the decline in lung function.

      A long-term clinical trial recently showed that the regular treatment with inhaled
      corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it
      reduces the frequency of acute COPD exacerbations in COPD.

      In a recent study it was found that airway bacterial load increases over time (1 yr follow
      up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.

      This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral
      and/or bacterial load in the sputum of COPD patients.
    


Intervention name(s): Salmeterol/Fluticasone combination; Salmeterol
Intervention type(s): Drug; Drug
Intervention description(s): Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid; Salmeterol 50 mcg 1 inhalation bid
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; Bacteria; Virus; Inhaled Corticosteroids
Glucomannan for Childhood Functional Constipation.
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether administration of glucomannan (dietary
      fiber) is effective in treating functional constipation in children.
    

Detailed description: 
      Constipation is a common condition in children. In many patients symptoms persist to
      adulthood and decrease quality of life. The standard treatment, mostly osmotic laxatives such
      as lactulose or polyethyleneglycols, are often ineffective and may cause adverse events.
      Therefore, alternative treatment measures are being searched for.

      Glucomannan, a water-soluble fiber polysaccharide from the tubers of the Japanese Konjac
      plant, has been reported to be effective in constipated children. To date, 2 randomized
      trials were performed.1,2 One evaluated the effect as glucomannan as an adjunct to standard
      treatment.1 Another was conducted in neurologically impaired children, who constitute a
      specific population that cannot be compared to patients with functional constipation.2 In
      both trials, the number of patients was relatively small.

      Well-powered, randomized controlled study is required to evaluate clinical effectiveness of
      glucomannan as a sole treatment in childhood functional constipation.
    

Intervention name(s): Glucomannan; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.26 g per sachet; 2 sachets per day for 4 weeks.; prepared in sachets (1.3g); 2 sachets per day for 4 weeks
Other intervention name(s): Dicoman Junior, Vitis Pharma
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: constipation; children
Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The investigators hypothesize that application of electrical stimulation would augment the
      effects of exercises in patients with stroke. Combined electrical stimulation with exercises
      for 6 weeks would lead to earlier and greater improvement in motor functions when compared
      with placebo-stimulation with exercises.
    

Detailed description: 
      Previous studies have shown that repeated sensory inputs from transcutaneous electrical
      stimulation (TES) could enhance brain plasticity and conical motor output. Home-based
      rehabilitation is shown to be effective in motor recovery and improvement of functional
      ability in stroke rehabilitation.

      The aim of this study was to develop a home-based rehabilitation program to investigate
      whether combined electrically induced sensory inputs through TES with task-related trunk
      training (TRTT) in a home-based program would induce earlier and/or greater improvement in,
      seated reaching distance and trunk control when compared with placebo TES and TRTT, or
      control with no active treatment in subjects with chronic stroke.
    

Intervention name(s): electrical stimulation with exercises; placebo stimulation with exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): electrical stimulation with exercises; placebo stimulation with exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sitting balance; Stroke
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with
      the use of active comparator and placebo. Total duration of therapy of about 2 years. Study
      hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original
      drug Rebif®.
    


Intervention name(s): BCD-033 (interferon beta 1a); Rebif (interferon beta 1a); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks; Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks; Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other