bioihbjkbjnl/mcl2 huggingface dataset:
The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will test the hypothesis that a wearable automated bionic pancreas system that
      automatically delivers both insulin and glucagon can improve glycemic control vs. usual care
      for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.
    


Intervention name(s): Bionic Pancreas; Usual Care
Intervention type(s): Device; Other
Intervention description(s): Automated blood glucose control via a closed-loop bionic pancreas device.; As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Other intervention name(s): Boston University Bionic Pancreas
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bionic pancreas; artificial pancreas; insulin; glucagon; continuous glucose monitoring (CGM); outpatient; insulin pump; pediatrics; children; camp; summer camp
Effects of Steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir Concentration at Steady-state in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effects of steady-state Efavirenz (600 mg QD) on the steady-state
      pharmacokinetics of Tipranavir (500 mg BID) coadministered with Ritonavir (200 mg BID)
    


Intervention name(s): Tipranavir; Ritonavir; Efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir; Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gut Decontamination In Pediatric Allogeneic Hematopoietic
Condition: Hematopoietic Stem Cell Transplantation (HSCT); Acute GVH Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is for participants who are undergoing allogeneic hematopoietic stem cell
      transplantation (HSCT) and are at risk for developing acute graft-versus-host disease (GVHD).
      GVHD is a complication of HSCT in which immune cells from the donor cause inflammation and
      injury to tissues and organs of the HSCT recipient. Vancomycin-polymyxin B (commonly called
      "vancopoly") is an oral antibiotic that is given to people undergoing allogeneic HSCT as a
      preventive measure for acute GVHD. This research study is studying the effects of vancopoly
      on the microorganisms living in the intestine during and after stem cell transplantation.
    

Detailed description: 
      This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and
      effectiveness of an investigational intervention to learn whether the intervention works in
      treating a specific disease.

      "Investigational" means that the intervention is being studied.

      Pre-clinical studies performed in the 1970's showed that killing all the bacteria in the
      intestine with oral antibiotics could decrease the risk of acute GVHD following allogeneic
      HSCT. Based on this observation, many stem cell transplant centers adopted the practice of
      "gut decontamination" with oral antibiotics as a preventive measure for acute GVHD. There is
      no standard regimen for gut decontamination between transplant centers, and there are no
      definitive human studies showing that gut decontamination is beneficial for lowering the risk
      of acute GVHD.

      Recent studies in adult patients undergoing stem cell transplant indicate that the types of
      bacteria living in the intestine can influence bone marrow transplant outcomes such as
      survival and development of acute GVHD. Some types of bacteria may be protective against GVHD
      and others may increase the risk of GVHD. Based on this newer research, it is possible that
      the practice of gut decontamination ("vancopolys") may not be beneficial for HSCT patients.
    

Intervention name(s): Vancomycin-polymyxin B
Intervention type(s): Drug
Intervention MeSH terms: Vancomycin; Polymyxins; Polymyxin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hematopoietic Stem Cell Transplantation (HSCT); Acute GVH Disease
ECGI in Patients With Persistent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      To determine the values and limitations of ECGI in guiding ablation and risk stratification
      in patients with persistent atrial fibrillation.
    

Detailed description: 
      The patient population will include symptomatic persistent AF patients (N=50). The total of
      fifty patients will be studied to determine:

        -  The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF
           initiators and AF perpetuators as targets sites for catheter ablations in patients with
           persistent AF.

        -  The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate
           ablations by targeting complex fractionated atrial electrograms (CFAE).

        -  If there is a relationship between primary CFAE sites and driver sites or other distinct
           patterns from the ECGI mapping system.

        -  The rate of AF termination to sinus rhythm after ablation at target sites identified by
           ECGI
    

Intervention name(s): Radiofrequency ablation
Intervention type(s): Procedure
Intervention description(s): RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population will include symptomatic persistent AF patients (N=50). The total of
        fifty patients will be studied.
Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in
      HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected
      participants who will be randomized to receive either MK-6325 or placebo. If the drug is
      shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected
      participants who will be randomized to receive either MK-6325 or placebo.
    


Intervention name(s): MK-6325; Placebo to MK-6325; MK-6325; Placebo to MK-6325; MK-6325; Placebo to MK-6325
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Two 100 mg capsules, orally, once per day for 7 days; Two 100 mg capsules, orally, once per day for 7 days; Four 100 mg capsules, orally, once per day for 7 days; Four 100 mg capsules, orally, once per day for 7 days; Eight 100 mg capsules, orally, once per day for 7 days; Eight 100 mg capsules, orally, once per day for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fibtem Predicts Postoperative Bleeding
Condition: Postoperative Hemorrhage
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Observational

Summary: 
      Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in
      total knee replacement patients.
    

Detailed description: 
      This retrospective study evaluate patients who underwent total knee replacement arthroplasty.
      Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after
      admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and
      amount of transfusion were reviewed.

      A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44
      subjects with an α value of 0.05 and a power of 0.8.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        total knee replacement patients
      
Keywords: fibtem; total knee replacement
The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
Condition: Prostate Cancer Patients
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics
      of Midazolam, S-Warfarin and Omeprazole
    


Intervention name(s): Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
Intervention type(s): Drug
Intervention description(s): Experimental: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
Midazolam, Warfarin, Omeprazole and VitaminK1 QD on Day 1 and Day 22, SHR3680 240 mg once daily (QD) from Study Day 6 - 27
Intervention MeSH terms: Vitamin K 1; Vitamin K; Midazolam; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein
      gp160. To evaluate the duration of antibody response and its relationship to dose and
      frequency of inoculation.

      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate
      that, although serum anti-gp160 antibody responses were detected, the level and duration of
      those responses were limited. A preliminary observation suggests that weak functional
      antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a
      dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
    

Detailed description: 
      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate
      that, although serum anti-gp160 antibody responses were detected, the level and duration of
      those responses were limited. A preliminary observation suggests that weak functional
      antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a
      dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

      Healthy volunteers are injected on days 0, 30, 180, and 365 with either 160 mcg gp160 vaccine
      (20 volunteers) or an alum placebo preparation (10 volunteers).
    

Intervention name(s): gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to
      evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe
      ulcerative colitis.
    


Intervention name(s): placebo; rhuMAb Beta7
Intervention type(s): Drug; Drug
Intervention description(s): Repeating subcutaneous injection; Repeating subcutaneous injection
Intervention MeSH terms: Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Observational

Summary: 
      As there are no clinical data in cardiology about the relationship between metabolism
      collagen changes and their clinical significance, the investigators will check the hypothesis
      that collagen metabolism changes, detected by biochemical markers for collagen metabolism,
      could predict the left ventricle remodelling and prognosis in patient with clinically
      significant pressure overloaded left ventricle.
    

Detailed description: 
      Clinical assessment and endpoints:

      1ST day (the day of entering the hospital or the day of the first contact): Informed consent
      (see below), clinical examination, ECG, complete echocardiography evaluating the function of
      the left ventricle (EF) and the presence and the significance of valvular disease, basic
      laboratory tests incl. CKMB, troponin I, taking of blood samples (5 ml) for the detection of
      collagen metabolism markers serum level, X-ray of chest, 2nd-3rd day: clinical examination,
      ECG, basic laboratory tests incl.CKMB, troponin I (only group I) 4th day: clinical check up,
      ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism
      markers serum level (only group I) 30th day: clinical examination l, ECG, echocardiography,
      taking of blood samples (5ml) for the detection of collagen metabolism markers serum level,
      24 hrs ECG monitoring (holter) 6 months: clinical examination, ECG, echocardiography, taking
      of blood samples (5ml) for the detection of collagen metabolism markers serum level, holter
      monitoring

      1 year: history, clinical examination

      Primary endpoint: combined clinical endpoint: death/repeated hospitalisation due to heart
      failure/myocardial infarction within 30 days and during 1 year follow up.

      Secondary endpoints: rehospitalisation for cardiovascular reason, clinically significant
      arrhythmias, correlations between left ventricle parameters evaluated by echocardiography and
      collagen metabolism changes evaluated by serum markers
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with aortic stenosis and left ventricular hypertrophy
      
Biospecimen description: 
      frozen serum for collagen metabolism detection
    
Keywords: ventricular hypertrophy; collagen; aortic stenosis
Effects of Soy Isoflavones on Menopausal Hot Flashes
Condition: Menopausal Symptoms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of
      life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy
      for hot flashes. The study examines the effect of a new soy supplement, as compared to a
      placebo, in menopausal women on hot flash symptoms.
    

Detailed description: 
      Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen
      in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect
      of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji
      fungus, on the severity and frequency of hot flashes in postmenopausal women is being
      examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a
      13 week trial in which subjects record their hot flash frequency and severity in a diary.
      Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This
      isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product
      prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing
      ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using
      a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10%
      genistein, and 20% glycitein).
    

Intervention name(s): Isoflavone supplement
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hot flashes; Menopausal symptoms; Soybean germ; Aglycones; Menopause
Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of MK-1029 on lung function in the
      treatment of adults who have persistent asthma that is uncontrolled with the use of
      montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for
      two separate 4-week treatment periods. All participants will also use ML during the treatment
      periods. The primary hypothesis is that MK-1029 is superior to placebo in change from
      baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment
      period.
    


Intervention name(s): MK-1029; Placebo; Montelukast (ML)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-1029 150 mg tablets taken QD; Placebo tablets (matching the MK-1029 150 mg tablets) QD; ML 10 mg tablets QD
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who receive tailored navigation (consisting of a letter and patient navigation
      services) and get screened will be significantly greater than the control group who receives
      treatment as usual.

      A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their
      preferred tests, after undergoing the "Patient Navigator" intervention and that proportion
      will be significantly greater than the group who opt for FOBT in the control group.
    

Detailed description: 
      Primary Outcome Measure:

      Number of patients who receive a letter and patient navigation services and get screened
      compared to the control group.

      Secondary Outcome Measures:

      Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and
      screening preference.

      Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care
      practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened
      for eligibility and those who are eligible and agree to participate in the study will be
      randomized to either of the two study arms: intervention group or control group.
    

Intervention name(s): Health counselling by nurse navigator; Usual primary care counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral; Usual care health counselling on colorectal cancer and screening options
Other intervention name(s): Nurse navigator assistance; Usual primary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal cancer screening; 50 years or older
Task-oriented Training for Stroke: Impact on Function Mobility
Condition: Cerebrovascular Accident; Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an
      extremely high energy cost of movement and contributing to overall disability and lower
      quality of life. Therefore, interventions targeting movement economy should be developed for
      those in the chronic phase of stroke recovery. This study is designed to compare the effect
      of two distinctly different exercise paradigms (a higher-intensity treadmill training program
      and a lower-intensity group exercise program) on economy of movement during over-ground
      walking and activities of daily living, as well as the extent to which gains in muscular
      strength, muscular endurance, and balance predict changes in movement economy.
    


Intervention name(s): High-intensity Treadmill Exercise; Low-intensity Lifestyle Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High-intensity treadmill walking program; A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Exercise; Rehabilitation; Stroke
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Condition: Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for
      the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder
      (IED).
    

Detailed description: 
      IED is a condition characterized by a failure to resist aggressive impulses. IED is a
      behavioral defined condition for which effective treatments have not been identified.
      Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions,
      may play a role in the response to pharmacological IED treatments. This study will examine
      the relationship between 5-HT receptors and response to treatment with fluoxetine or
      divalproex. In addition, this study will examine people with IED and those without the
      condition to determine whether there are differences in their 5-HT receptor and transporter
      systems.

      Participants in this study will be randomly assigned to receive either fluoxetine,
      divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression
      levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout
      the study.
    

Intervention name(s): Fluoxetine; Divalproex; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluoxetine capsules by mouth, up to 60 mg daily; Divalproex ER capsules by mouth, up to 3000 mg daily; Placebo capsules by mouth, up to 8 capsules daily
Intervention MeSH terms: Valproic Acid; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment