bioihbjkbjnl/mcl2 huggingface dataset:
Prevention Trial to Achieve Cardiovascular Targets
Condition: Coronary Artery Disease; Peripheral Arterial Disease; Hyperlipidemia; Hypertension; Diabetes; Prediabetes; Obesity
MeSH terms: Coronary Artery Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases; Hyperlipidemias
Study type: Interventional

Summary: 
      The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults
      to Achieve Cardiovascular Targets) is to determine the best management strategy for patients
      undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will
      enroll 400 patients post-cardiovascular intervention. The study will compare different
      cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult,
      and (3) cardiovascular prevention consult with a behavioral intervention program over a
      6-month period. The trial hypothesis is that for patients undergoing a cardiovascular
      intervention, a prevention consult and behavioral intervention is superior to usual care in
      reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary
      endpoints include other lipid values, metabolic risk, smoking cessation, physical activity,
      nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin
      enrollment in the June of 2012.
    

Detailed description: 
      SPECIFIC AIMS

      Primary aim:

      The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL
      cholesterol compared to usual care at 6 months post-intervention.

      Secondary aim:

      The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral
      intervention will reduce non-HDL cholesterol compared to usual care at 6 months
      post-intervention.
    

Intervention name(s): Prevention Consult; Consult & Behavioral Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.; In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Choroidal Thickness in Beta-thalassemia Patients
Condition: Beta-Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Observational

Summary: 
      The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and
      compare it to the one of healthy controls.

      An equal number of transfusion dependent beta-thalassemic patients and age and sex matched
      healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the
      enhanced depth imaging application to visualize and measure the choroid.
    

Detailed description: 
      Beta thalassemia is an inherited hemoglobinopathy, associated with defective production of
      beta-chain globin resulting in problematic HbA production. It is classified according to the
      severity as minor, intermedia and major. Patients suffering from beta-thalassemia intermedia
      and beta-thalassemia major require regular blood transfusions. Transfusion related
      hemosiderosis in these patients necessitates the use of chelating agents to prevent iron
      overload in vital organs such as the liver and heart.

      A number of ocular abnormalities can present in beta-thalassemia patients. Those are
      categorized as pseudoxanthoma elasticum (PXE)-like changes that include angioid streaks, peau
      d'orange like fundus and optic nerve head drusen and non-PXE-like changes such as increased
      venous tortuosity.

      Furthermore, it is well established that prolonged treatment with some of the chelating
      agents such as deferoxamine are associated with ocular toxicity, namely nyctalopia, colour
      perception anomalies, visual field disturbances, cataract formation, optic neuropathy and
      pigmentary retinopathy.

      The pathophysiology of those ocular manifestations has not been fully clarified. The role of
      the choroid has not been determined since this particular tissue was previously unaccessible
      to imaging. Enhanced depth imaging optical coherence tomography is able to image the choroid
      providing reasonable clarity compared to spectral domain optical coherence tomography.

      The aim of this study is to evaluate possible alterations of choroidal thickness in beta
      thalassemia as compared to healthy controls.
    

Intervention name(s): EDI-OCT
Intervention type(s): Diagnostic Test
Intervention description(s): EDI-OCT (enhanced depth imaging spectral domain optical coherence tomography) wiil be performed in all study participants.
Three sets of measurements in the macular (horizontal and vertical) and peripapillary area will be averaged.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with beta-thalassemia major or intermedia undergoing blood transfusions will be
        examined utilizing EDI-OCT.

        A group of equal healthy volunteers will also be included to serve as controls.
      
Keywords: beta-thalassemia; choroidal thickness; enhanced depth imaging; optical coherence tomography
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
Condition: Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Rheumatic Diseases; Musculoskeletal Diseases; Muscular Diseases; Nervous System Diseases; Neuromuscular Diseases; Collagen Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of
      Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202
      study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial
      effects upon pain, sleep and other FM symptomatology.

      The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,
      taken daily at bedtime over 12 weeks to treat fibromyalgia.
    


Intervention name(s): TNX-102 SL Tablet, 2.8mg; Placebo SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Other intervention name(s): Low dose cyclobenzaprine sublingual tablets; Placebo sublingual tablets
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Sleep
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of different doses of
      asimadoline in the treatment of patients with irritable bowel syndrome.
    

Detailed description: 
      A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the
      efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
    

Intervention name(s): Asimadoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks; Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Other intervention name(s): EMD 61753; EMR 63320
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Asimadoline
Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The primary aim of this study is to learn about who is most likely to benefit from guided
      self-help (GSH) for obsessive-compulsive disorder (OCD).
    

Detailed description: 
      40 Participants with OCD will be recruited. They will be given access to OC Fighter, an
      internet OCD treatment program. During the 17 week program, participants will meet with a
      therapist 9 times. Assessments will occur at pretreatment, post-treatment, 3-month follow up
      and 6-month follow up.
    

Intervention name(s): "OCFighter"
Intervention type(s): Behavioral
Intervention description(s): OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).
Other intervention name(s): OCFighter; Guided Self-help
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of the Microbiota in the Systemic Immune Response
Condition: Healthy; Sepsis
Study type: Interventional

Summary: 
      The objective of this study is to investigate the role of the gut microbiota in the systemic
      priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be
      treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven
      days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24
      hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include
      laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation
      assay) and gut microbiota composition.
    

Detailed description: 
      Rationale: Sepsis ranks among the top ten leading causes of death worldwide. Most
      nonsurvivors die in a state of immunosuppression. The gut microbiota exerts numerous
      beneficial functions in the host response against infections. Gut flora components express
      microorganism-associated molecular patterns (MAMPs) such as lipopolysaccharide (LPS), which
      are recognized by pattern recognition receptors (PRRs) expressed by neutrophils and
      macrophages. MAMPs from the intestinal microbiota constitutively translocate to the
      circulation and prime bone marrow derived neutrophils via PRRs. Antibiotic treatment, which
      is standard of care for all patients with sepsis, depletes the gut microbiota and leads to a
      diminished release of MAMPs and other bacteria derived products. This causes diminished
      priming of systemic immunity, which may attribute to sepsis associated immunosuppression and
      an increased susceptibility to invading bacteria.

      Objective: To investigate the role of the gut microbiota in the systemic priming of immune
      effector cells

      Study design: Within-subject-controlled intervention study in human volunteers

      Study population: Twelve healthy male subjects, 18-35 years of age

      Intervention: All subjects will be treated with broad spectrum antibiotics (ciprofloxacin,
      vancomycin, metronidazole) for seven days, in order to deplete the gut microbiota. Blood and
      faeces will be sampled before, 24 hours and 6 weeks after the 7-day period of antibiotics.

      Main study parameters/endpoints: Laboratory parameters for inflammatory responses, functional
      assays (ex vivo stimulation assay) and gut microbiota composition.
    

Intervention name(s): Vancomycin; Ciprofloxacin; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250mg 3dd2; 500mg 2dd1; 500mg 3dd1
Intervention MeSH terms: Metronidazole; Vancomycin; Ciprofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gut flora; antibiotics; systemic immune response; Volunteers
Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Condition: MRSA Infections
Study type: Observational

Summary: 
      This study prospectively selects the patients to examine the effectiveness of the
      investigators' current standard of prophylaxis prior to vascular surgery and to compare the
      effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular
      surgical patients.
    

Detailed description: 
      According to Medqic.org (site for the Surgical Care Improvement Project) the current
      recommended drug of choice for prophylaxis prior to vascular surgery is Cefazolin (Ancef).
      The exception would be to allow the use of Vancomycin as an acceptable antibiotic for
      patients undergoing cardiac, vascular or orthopedic surgery due to the increasing risk of
      methicillin-resistantStaphylococcus aureus (MRSA). The significance of the study is to
      demonstrate that MRSA coverage is needed in vascular surgery with prosthetic graft placement
      in areas of the body that is at high risk for infection. By decreasing post surgical site and
      prosthetic infections, we could significantly reduce vascular surgery mortality and
      morbidity. Cost and amputation rates we feel could also be reduced. patients will be
      randomized in three groups such as cefazolin,vancomycin and cefazolin, daptomycin and
      cefazolin and then patients will be monitored per usual post-operative course (30 days and 90
      days follow-up) with wound and incision evaluation. Outcome measures include hospital length
      of stay, the presence of a graft infection, skin infection at incision site, vascular
      procedure failure secondary to infection, cost, thirty day readmits, amputation, and
      mortality.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients 18 years of age and older undergoing a vascular surgery and or vascular access
        (vascular fistula or vascular graft) procedure were eligible for enrollment in the study.
      
Keywords: Vascular Surgery
A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose
      Study of Aramchol in Healthy Male Volunteers.

      Primary Objectives:

        1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male
           subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight,
           mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses
           (Part B)

        2. To assess the pharmacokinetics of Aramchol at the administered doses
    

Detailed description: 
      Number of Subjects:

      Total: A total of 46 healthy subjects will be enrolled. Part A: Sixteen (16) subjects will
      participate in four, 8-person dosing periods. Each cohort will be alternately dosed twice.

      Part B: Thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts.

      Main Inclusion Criteria:

      Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written
      informed consent Part B: Mildly overweight (25<BMI<33), with fasting cholesterol levels of
      200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male
      volunteers aged 18-50 (inclusive) years, who have provided written informed consent
    

Intervention name(s): Aramchol; Aramchol; Aramchol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B); Oral Aramchol at dose 30 mg to 900 mg; Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days
Other intervention name(s): 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid); fatty-acid bile-acid conjugate
Intervention MeSH terms: Cholic Acids; Bile Acids and Salts
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase-I; Hypercholesterolemia; Obesity; fatty liver; Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers
Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
Condition: Neurocognitive Correlates of Eating Habits
Study type: Interventional

Summary: 
      This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the
      filling of two on-line questionnaires.

      The first visit to the University-Hospital of Rennes, during which a blood sample will be
      taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting
      energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation
      Unit.

      During this visit, the volunteers will also have to bring a sample of urine and faeces
      previously collected at home.

      The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on
      photos) will have to be completed by the volunteers between the first and the second visit to
      the University-Hospital.

      Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on
      the Neurinfo platform, during which they will be subjected to a cognitive two-choice test
      based on food and drink pictures, during fMRI. Before and after the fMRI session, an
      assessment of the state of hunger, thirst, and general status of the volunteer will be
      carried out using a numerical scale ranging from 1 to 10.
    


Intervention name(s): First Visit; on-line questionnaires; fMRI
Intervention type(s): Other; Other; Device
Intervention description(s): blood sample , morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry, sample of urine and faeces previously collected at home; The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.; a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be looking at the objective response rate (ORR) as measured by RECIST in in
      patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated
      with CY/GVAX in combination with Pembrolizumab.
    


Intervention name(s): CY; GVAX; Pembrolizumab
Intervention type(s): Drug; Biological; Drug
Intervention description(s): CY is administered intravenously at 200 mg/m2; GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting; Pembrolizumab is administered intravenously at 200 mg
Other intervention name(s): Cyclophosphamide, Cytoxan; Colon cancer vaccine; KEYTRUDA, MK-3475
Intervention MeSH terms: Cyclophosphamide; Pembrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases
Vitamin D in Diabetic Children
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to
      the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure
      between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back,
      or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also
      found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.

      Vitamin D supplement is recommended in all infants until enough formula, milk, or other food
      sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type
      1 diabetes is an autoimmune disease, and the self immune system plays a central role in the
      destruction of the beta cell of pancrease.
    


Intervention name(s): blood sample test
Intervention type(s): Diagnostic Test
Intervention description(s): blood sample will be taken from all diabetic children for assessment of vitamin D level
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Use of Standing Powered Wheelchairs in Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study was to explore the experiences of standing powered wheelchair users
      with spinal cord injury.
    

Detailed description: 
      There is limited research exploring the comfort, satisfaction, adverse effects, need for
      repair, and benefit in terms of secondary complications in standing powered wheelchair users
      with spinal cord injury.

      The purpose of this study was to explore the experiences of standing powered wheelchair users
      with spinal cord injury.
    

Intervention name(s): standing powered wheelchair evaluation
Intervention type(s): Other
Intervention description(s): standing powered wheelchair evaluation
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with spinal cord injury who were prescribed a standing powered wheelchair at a
        tertiary hospital
      
Keywords: standing powered wheelchair; spinal cord injury; satisfaction; secondary complication