bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a long-term follow-up protocol for patients who participated in study
      NK-104-3.01EU or study NK-104-3.02EU.
    

Detailed description: 
      Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either
      pitavastatin or the comparator statin for 1 year.
    

Intervention name(s): Pitavastatin
Intervention type(s): Drug
Intervention description(s): Pitavastatin 4 mg once daily
Intervention MeSH terms: Pitavastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kowa; Hypercholesterolemia; dyslipidemia; pitavastatin; NK-104; Hypercholesterolemia or combined dyslipidemia
Efficacy Study of Water Drinking on PKD Progression.
Condition: Autosomal Dominant Polycystic Kidney Disease; Disease Progression
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Disease Progression
Study type: Observational

Summary: 
      This is a prospective 5-year study to compare the change in total kidney volume (TKV) before
      and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
    

Detailed description: 
      Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney
      disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in
      total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in
      patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research
      paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who visit Kyorin University Hospital.
      
Biospecimen description: 
      Urine
    
Keywords: Autosomal Dominant Polycystic Kidney Disease.; Arginine vasopressin; Total Kidney Volume; Glomerular Filtration Rate
The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure
Condition: Critically Ill Patients
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The investigators aim to compare the bladder pressure to the gastric pressure in critically
      ill patients.
    

Detailed description: 
      In critically ill patients, we will measure the gastric pressure by a gastric balloon and the
      bladder pressure by the intra-vesical pressure to find the optimal method to estimate the
      abdominal pressure.
    

Intervention name(s): measurement of abdominal pressure
Intervention type(s): Procedure
Intervention description(s): measurement of abdominal pressure with different volume and saline temperature
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12
      months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's
      milk allergic children and to assess the long-term safety and therapeutic benefit with
      Viaskin Milk.
    


Intervention name(s): Viaskin Milk 150 mcg; Viaskin Milk 300 mcg; Viaskin Milk 500 mcg; Viaskin Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.; Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.; Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.; Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Milk Allergy,; Viaskin Milk,; Specific Immunotherapy,; Epicutaneous ImmunoTherapy (EPIT); IgE-Mediated Cow's Milk Allergy
Continued Ventilation During Cardiopulmonary Bypass
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The
      investigators examined whether continued mechanical ventilation during CPB alters systemic
      immune activation.
    

Detailed description: 
      Cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. Studies
      had been shown that the contact of blood components with artificial surfaces, the surgical
      trauma, endotoxemia and a reperfusion injury are in part responsible for the seen
      immunological affect after surgery. The purpose of this study is to test the effect of
      continued mechanical ventilation during surgery on a blood marker called soluble ST2 in
      patients sera. Soluble ST2 acts as a decoy receptor of IL-33 and has anti-inflammatory
      effects. Elevated soluble ST2 concentrations are reported in patients with acute myocardial
      infarction, sepsis, congestive heart failure and elevates soluble ST2 levels are associated
      with adverse outcome.
    

Intervention name(s): Lung Ventilation; Non-ventilated Group
Intervention type(s): Other; Other
Intervention description(s): In the ventilated group, mechanical ventilation was done with the half of the initial tidal volume (i.e. 3-4 ml/kg, 250-300ml) during the aortic cross-clamp.; . In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Thoracic Surgery; Endotoxins; Respiration, Artificial; Immune System
Nexalin Therapy for the Treatment of Depressive Symptoms
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this Phase II study are to demonstrate the safety of Nexalin
      Therapy and to investigate the efficacy of Nexalin Therapy.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, multi-center trial has 3 different
      treatment arms.

      Study Tools:

        -  Hamilton Depression Rating Scale (HAM-D21)

        -  Clinical Global Impressions (CGI)

        -  Montgomery-Asberg Depression Rating Scale (MADRS)

        -  Beck's Depression Inventory

        -  Hamilton Anxiety Rating Scale (HAM-A)

        -  Hospital Anxiety and Depression Scale (HADS)
    

Intervention name(s): Nexalin 1.3mA Device; Nexalin 15mA device; placebo device and Citalopram
Intervention type(s): Device; Device; Drug
Intervention description(s): 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
Daily receipt of placebo antidepressant; 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
Daily receipt of a placebo antidepressant; 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
Daily receipt of a a SSRI (Citalopram or similar)
Other intervention name(s): Nexalin Device; Nexalin Device; Nexalin Device
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Depression; Mild; Moderate; Anxiety; Kalaco Scientific, Inc.
Effects of Peppermint Oil in Cardiometabolic Outcomes
Condition: Cardiometabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the
      leading health burden and cause of mortality worldwide; therefore, the necessity for an
      intervention is paramount. Dietary interventions to improve cardiometabolic health are highly
      sought after as they possess less risk than pharmacological drugs. Previous non-randomized
      interventions have shown that oral peppermint may be beneficial in improving cardiometabolic
      outcomes. However, to date, no research has explored this using a placebo randomized
      intervention.

      Therefore, the primary purpose of the proposed investigation is to test the ability of oral
      peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.
    


Intervention name(s): Peppermint oil.; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Peppermint oil.; Placebo
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Randomized Crossover Study of Magnesium Supplementation
Condition: Diabetes Mellitus, Type 2; Inflammation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional

Summary: 
      The investigators recent epidemiologic work in several national surveys and cohorts of men
      and women have shown that dietary patterns high in plant-based foods and phytochemicals are
      associated with lower plasma levels of insulin, triglycerides, and C-reactive protein, and
      reduced risk of type 2 DM and CHD. While the physiologic impact of different foods on serum
      glucose and insulin is of critical importance, the extent to which specific dietary nutrients
      can modify insulin resistance is not well understood. Magnesium is a biologically active
      constituent in whole-grain, green leafy vegetables, and nuts and appears to play an essential
      role in hundreds of physiologic processes in humans. However, it remains uncertain whether
      magnesium intake can exert effects on insulin sensitivity and inflammation. Moreover, little
      is known of the extent to which magnesium intake elicits changes in the expression levels of
      key genes responsible for glucose homeostasis and systemic inflammation. The ultimate
      clinical question is whether magnesium supplementation would be clinically effective for the
      improvement of metabolic disorders in not yet diabetic but high-risk individuals, especially
      those who are susceptible to insulin resistance. Therefore, as a direct follow up on our
      previous work in studying the health benefits of plant-based foods such as whole grains,
      fruits and vegetables, we propose a pilot randomized trial to unravel the metabolic and
      anti-inflammatory effects of magnesium supplementation versus placebo among overweight
      individuals with the metabolic syndrome who are particularly prone to the adverse effects of
      magnesium deficiency. Recent advancements in molecular genetics and genomic technologies have
      also enabled us to analyze the expression levels of thousands of genes simultaneously in
      different experimental conditions. The application of high throughput microarray technology
      in randomized-controlled setting when analyzed with novel statistical methods, will not only
      help our understanding of nutrient-disease relations, but also afford the investigators the
      opportunity to gain important insight into the molecular mechanism for complex biological
      systems of inflammation, insulin resistance, and metabolic abnormalities in response to
      nutrition intervention.
    


Intervention name(s): Magnesium Citrate: a total of 500 mg elemental magnesium; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 500 mg elemental magnesium; Inactive placebo pill
Intervention MeSH terms: Magnesium citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Randomized Controlled Trial; Magnesium; Diabetes Mellitus, Type 2; Inflammation
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Condition: Femoral Fractures
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of
      intramedullary nails for the fixation of long bone fractures. This study is designed to
      compare the union rates between fractures reamed by standard reaming versus reaming with a
      Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based
      outcomes on these patients. Little information exists on the patient based outcomes following
      femur fractures. We hope that the patient based outcomes of this study will also be able to
      aid physicians in advising patients with femur fractures of their possible outcomes.
    


Intervention name(s): Standard Reaming; Reaming/Irrigating/Aspirating
Intervention type(s): Procedure; Procedure
Intervention description(s): Femoral reaming using standard reaming techniques of multiple reamers; Reaming using the Reamer/Irrigator/Aspirating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis; Protein Metabolism
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a
      disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and
      growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any
      part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in
      the colon. Children with inflammatory bowel disease frequently suffer from disturbances in
      growth, which may continue into adulthood and result in altered growth outcomes. The
      metabolic response to inflammatory bowel disease, including increased protein breakdown and
      decreased protein synthesis may play a significant role in the resulting malnutrition and
      growth failure from which children with inflammatory bowel disease suffer. The purpose of
      this study is to compare the rates of protein synthesis within the mucosal lining of the
      gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have
      normal endoscopic examinations. By comparing children with inflammatory bowel disease to
      normal children, we can begin to determine how alterations in protein metabolism within the
      lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent
      effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a
      follow-up study will be conducted two weeks following the initiation of steroid therapy to
      determine its effects on protein metabolism. We hypothesize that children with active
      inflammatory bowel disease will have increased rates of protein synthesis in the lining of
      the gastrointestinal tract than patients who have normal endoscopy, and that increases in
      protein breakdown and protein synthesis will be improved following steroid therapy in
      children with newly diagnosed inflammatory bowel disease.
    


Intervention name(s): stable isotope infusions
Intervention type(s): Other
Intervention description(s): Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Crohn's disease; Ulcerative colitis
Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level
Condition: Perioperative Complication
Study type: Interventional

Summary: 
      Background:Hyperglycemia and hypoglycemia both cause detrimental side effects for pediatric
      patients. Prolonged fasting time, age dependent physiological diffences and individual
      differences of patients make complicated the perioperative fluid therapy. Isotonic
      electrolyte solutions without glucose or with lower glucose concentrations recommended for
      intraoperative period in pediatric patients.

      Objective: The aim of this prospective study is to evaluate the different glucose
      concentrations(without dextrose, 1 % dextrose+LR, 2 % dextrose+LR) in perioperative infusion
      solutions according to preoperative blood glucose level to maintain normoglycemia in
      pediatric patients.

      Method: The consecutive 250 eligible pediatric patients aged between 6 months- 12 years with
      ASA risk score of I-II undergoing surgery lasting less than four hours were enrolled the
      study in six months period. Patient demographics, procedure, preoperative fasting time,
      preoperative and postoperative glucose levels were documented. Lactate ringer (LR) solution
      with % 2 glucose was infused to the patients with preoperative blood glucose level lower than
      60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood
      glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with
      preoperative blood glucose level higher than 90 mg/dL.
    

Detailed description: 
      Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative
      blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the
      patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without
      glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL
    

Intervention name(s): Drug: dextrose containing infusion
Intervention type(s): Procedure
Intervention description(s): Drug: infusing dextrose containing or non glucose fluid according to blood glucose level
Other intervention name(s): drug: non dextrose containing infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 different type of fluid
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Proprioceptive Activities on Hand Function in Chronic Stroke Patients
Condition: Stroke; Proprioceptive Disorders
MeSH terms: Stroke; Somatosensory Disorders
Study type: Interventional

Summary: 
      To determine effects of proprioceptive activities on hand function in chronic stroke patients
    

Detailed description: 
      Stroke is causing the long term disability worldwide. The patient in the chronic phase of
      stroke may suffer from long term hand disability along with both motor and sensory
      dysfunction. That causes hindrance in performing the ADLs. As the hand is the important organ
      performing major functions of daily living .So the early restoration of the motor as well as
      sensory function is necessary.

      The motive of this study IS to determine effects of proprioceptive activities on hand
      function in chronic stroke patients. Total 40 chronic stroke patients will be included in the
      study. They will be randomly allocated in two groups by lottery method that fulfills the
      inclusion criteria of the study. In group A patients will be recruited and proprioceptive
      activities will be given to the affected hand for 3 days /week for 2 months. On the other
      hand in group B conventional therapy will be given for 3 days /week for 2 months. In sensory
      training graphesthesia and stereognosis will be checked by modified subtest of sensory
      integration praxis test and Byl-Cheney-Boczai Sensory Discriminator Test respectively. The
      motor task will be assessed by the wolf motor test. As a baseline treatment hot pack for 15
      min will be given to both of the groups
    

Intervention name(s): experimental group; conventional treatment
Intervention type(s): Combination Product; Combination Product
Intervention description(s): patients will receive the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints,stereognosis will be of 15 minutes. For motor training patients will practice 15 mints motor tasks; patients will receive the baseline treatment of hot pack for 15 minutes. The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: graphesthesia; stereognosis; stroke