bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study is to compare cardiac MRI with positron emission tomography (PET)
      with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better,
      than PET with FDG.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Age > 25 yrs, mean + SD = 60.3 + 10.2, 83% male, are patients referred by cardiologist or
        cardiac surgeon for assessment of myocardial viability by PET FDG.
      
Keywords: CAD
Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
Condition: Major Depressive Disorder; Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      In developing countries, electroconvulsive therapy (ECT) is typically delivered without the
      use of an anesthetic prior to the treatment, known as unmodified ECT. This interventional
      study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical
      University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose anesthetic
      (propofol) prior to ECT delivery. In so doing, the investigators hope to facilitate the
      transition from unmodified to modified ECT without incurring excessive costs to the center.
      It is hypothesized that ECT patients will opt for modified treatment, that adverse effects
      will be minimal, and that costs will not rise prohibitively.
    

Detailed description: 
      Patients that are currently receiving unmodified ECT at C.S.M Hospital will be eligible for
      the first phase of the study in which only data is collected. Three months after study start,
      patients who are to receive ECT for a psychiatric disorder will be eligible to participate in
      the intervention (introduction of propofol at a low dose prior to ECT). Data collection will
      include information such as demographics, ratings scales, seizure length, anxiety level,
      adverse events, and number of treatments.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): The major intervention proposed in this study is the introduction of low dose IV propofol for sedation prior to ECT treatment at C.S.M Medical University. The investigators will use a dose of 0.25 to 0.50 mg/kg of IV propofol. The maximum dose of 0.50 mg/kg is not sufficient for anesthesia (i.e., to make unconscious), but should provide a light level of sedation and be "amnestic," meaning the patient should have memory loss for the period of time around the ECT procedure itself. The propofol dose will be titrated upwards (from an initial dose of 0.25 mg/kg) with successive treatments in increments of 0.05mg/kg, until it is just sufficient to be lightly sedating. ECT will be administered 30 to 60 seconds after propofol is injected. ECT may be given up to three times per week.
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: electroconvulsive therapy; ECT; unmodified; anesthesia; propofol
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
Condition: Prediabetic State; Non-alcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc
      (CVC) to be conducted in approximately 50 adult obese subjects [body mass index (BMI) ≥ 30
      kg/m^2] with prediabetes or type 2 diabetes mellitus and suspected NALFD.
    

Detailed description: 
      Approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type 2 diabetes
      mellitus and suspected NALFD will be randomized into the study.

      Eligible subjects will receive either CVC (n=25) or matching placebo (n=25), once daily (QD)
      for 24 weeks, followed by a safety follow-up visit 4 weeks after last intake of study
      medication.
    

Intervention name(s): Cenicriviroc 150 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food.; Placebo-matching CVC administered orally once daily and taken every morning with food.
Intervention MeSH terms: Cenicriviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of ALKS 5461.
    


Intervention name(s): ALKS 5461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Alkermes; ALKS 5461; Samidorphan
Assessing Student Learning of Spinal Mobilization With Real-time Objective Feedback
Condition: Healthy
Study type: Interventional

Summary: 
      This is a research project on physical therapy education. Subjects will be recruited using
      convenience sampling from second-year physical therapy students on the campus of Youngstown
      State University. There are currently 28 students in the class. All students will be
      recruited to participate in the study. The objective of the study is to assess student
      learning of grades of spinal mobilization with real-time objective feedback.
    

Detailed description: 
      Sampling: Subjects will be recruited using convenience sampling from second-year physical
      therapy students on the campus of Youngstown State University.

      Research Design: Randomized controlled trial (RCT). Subjects will be randomly assigned to the
      experimental group or control group. Subjects will attend a spinal mobilization lecture
      followed by a practice lab.

      Randomization: Once enrolled in the study, each student will be randomly assigned to
      experimental or control groups. Randomization will occur via a random number generator and
      allocation will be concealed in opaque envelopes.

      Intervention:

      The experimental group will use a force sensor (Active5) while learning spinal mobilization
      during the practice lab portion of the class. The force sensor will provide objective
      feedback to the students. Each student will be instructed on how to use the Active 5 device
      prior to utilizing it in the classroom setting. The device can display the amount of force
      generated by the student on a smartphone or a tablet in real-time so the students would be
      able to adjust the amount of force.

      The Control group will participate in the same classroom lecture and activity. However,
      during the practice lab portion of the class, the control group will only receive traditional
      subjective feedback from the class instructor and/or student peers.

      A perceived competence scale survey (score between 0-10 with 10 being confident and 0 being
      not confident) with demographic information will be administered immediately after the
      intervention. An independent blinded instructor will serve as the assessor of student skill
      level to avoid bias immediately after the intervention/procedure. Student t-test will be used
      for data analysis.
    

Intervention name(s): learning spinal mobilization with a force sensor
Intervention type(s): Other
Intervention description(s): Experimental group will use a force sensor (Active5) while learning spinal mobilization during the practice lab portion of the class. The force sensor will provide objective feedback to the students. Each student will be instructed on how to use the Active 5 device prior to utilization it in the classroom setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Theracurmin vs Curcumin Bioavailability Study
Condition: Bioavailability
Study type: Interventional

Summary: 
      A randomized, open-label, cross-over, single administration study to compare bioavailability
      of curcumin in health adults
    

Detailed description: 
      -  Randomization, Open-label, 3-period, 6-sequence, Crossover, Single

        -  Drug-free inverval : more than 7 days

        -  Sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h
    

Intervention name(s): curmin
Intervention type(s): Dietary Supplement
Intervention description(s): curcumin 90mg/day cross-over
Other intervention name(s): Theracurmin CR-033P; Theracurmin CR-031P; Curcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs
      ketorolac 0.5% among patients undergoing cataract surgery.
    

Detailed description: 
      This will be a randomized, prospective, controlled, open-label study, comparing the
      tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye
      drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one
      eye of each subject. The study will follow good clinical practices (GCP). The primary outcome
      measure will be tolerability of the study medication as measured by the eye drop comfort
      survey instrument.
    

Intervention name(s): nepafenac 0.3%; ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.; Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.
Other intervention name(s): Ilevro
Intervention MeSH terms: Ketorolac; Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cataract
Neurological Consequences of Perinatal Listeriosis Infection
Condition: Perinatal Listeriosis
MeSH terms: Listeriosis
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether perinatal listeriosis is associated with
      long-term neurological consequences, and to evaluate the respective contribution of perinatal
      sepsis, of prematurity and of the known neurological tropism of the involved pathogen,
      Listeria monocytogenes.
    

Detailed description: 
      Perinatal listeriosis is defined by the occurrence of maternal listeriosis at birth and/or of
      early-onset listeriosis in the neonate (defined by the positive culture of any sample of
      maternal or neonatal origin).

      Neurological involvement is defined by the presence of inflammation of the cerebrospinal
      fluid of positive culture or the cerebro-spinal fluid.

      Evaluation is performed at the age of 5 years, and includes WPPSI evaluation of the
      Intelligence Quotient (IQ), NEPSY evaluation of the executive functions and clinical
      evaluation checking for any motor, sensorial or other focal deficiency among 90 cases and 270
      controls matched for gestational age.
    

Intervention name(s): Clinical and neuropsychological evaluation procedure
Intervention type(s): Other
Intervention description(s): WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Perinatal listeriosis; Neurological impairment; Sepsis; Prematurity; Neurotropism; Listeria monocytogenes; Intellectual Quotient
Safety and Efficacy of Prochymal® for the Salvage of Treatment-Refractory Acute GVHD Patients
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured
      Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute
      GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one
      second-line therapy.
    

Detailed description: 
      Allogeneic hematopoetic stem cell transplantation (HCT) is used in the treatment of a variety
      of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies
      involving solid tumors. Patients receiving HCT can develop a life-threatening condition
      called graft versus host disease (GVHD). GVHD occurs when donor T cells from the donor bone
      marrow recognize host cells as "foreign" and initiate an inflammatory immunological response.
      The standard of care for treatment of acute GVHD consists of intravenous delivery of
      methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus.
      This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some
      patients are refractory to current standard of care treatment. For treatment-refractory
      patients with grades III-IV GVHD mortality is approximately 80%. A therapy that could
      effectively suppress the immunological response from GVHD and help repair the damaged tissue
      could significantly decrease the mortality rate from this disease.
    

Intervention name(s): Prochymal®
Intervention type(s): Drug
Intervention description(s): Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells
Other intervention name(s): Remestemcel-L
Intervention MeSH terms: Remestemcel-l
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GVHD; Graft vs Host Disease; Graft versus Host Disease
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of itraconazole, phenytoin and
      gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795.
      Participants will be randomly assigned to one of four groups and will remain in the study
      clinic for the duration of treatment.
    


Intervention name(s): BMS-986166; Itraconazole; Extended Phenytoin Sodium; Gemfibrozil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Sporanox; Dilantin; Lopid
Intervention MeSH terms: Itraconazole; Phenytoin; Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; BMS-986166
Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
Condition: Fecal Incontinence; Constipation - Functional
MeSH terms: Fecal Incontinence; Constipation
Study type: Interventional

Summary: 
      The aim of this study is to investigate if a new irrigation system for transanal irrigation
      (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at
      Aarhus University Hospital.
    

Detailed description: 
      This is a randomized, controlled study.

      This study will be performed at Aarhus University Hospital (Denmark) and Aalborg University
      Hospital (Denmark) following the same protocol.

      According to the initial randomization, children will be allocated to treatment with the new
      system (group A) or with the currently used system (group B). After a period of 6 weeks the
      child will crossover to use the contrary system.

      The hypothesis is that A TAI system specifically developed for children will enhance the
      child's toleration of irrigation due to fewer reports on pain at insertion which will lead to
      better compliance. This outcome will induce a comparable or better effect on their fecal
      incontinence and reduce the needed follow-up period due to fewer incontinence relapse.
    

Intervention name(s): Cone Small, Qufora A/S; Colotip, Coloplast A/S
Intervention type(s): Device; Device
Intervention description(s): Newly developed cone in a softer material and a design matching the use for transanal irrigation.; Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transanal irrigation
Psychological Status and Self-care in Chronic Cardiovascular Disease
Condition: Anxiety; Depression; Emotional Stress; Quality of Life; Self-care; Chronic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This is an observational study aimed at exploring the relationship between psychological
      status and self-care in patients with chronic cardiovascular disease
    

Detailed description: 
      400 patients with chronic cardiovascular disease were enrolled in this observational study
      aiming at exploring the relationship between their psychological status (anxiety, depression,
      emotional distress and quality of life) and their self-care.
    

Intervention name(s): There was no intervention, the study was a cross-sectional observational study
Intervention type(s): Other
Intervention description(s): Questionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with chronic cardiovascular disease
Nit-Occlud PDA Post-Approval Study
Condition: Patent Ductus Arteriosus (PDA)
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and
      effectiveness of the device in the post-approval phase.
    


Intervention name(s): PDA Coil
Intervention type(s): Device
Intervention description(s): The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients age 6 months to 21 years weighing >/= 5kg with an angiographically confirmed PDA
        with a minimum diameter of <4 mm.
      
Keywords: Occluder
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy
      in Kidney Transplant Patients receiving Prograf and Cellcept
    


Intervention name(s): tacrolimus; CellCept; steroids (methylprednisone or prednisone)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; IV or Oral; IV or Oral
Other intervention name(s): Prograf; FK506; MMF; Mycophenolate mofetil; methylprednisone; prednisone
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Renal Transplantation; Prograf
Dietary Supplement With and Without a Probiotic
Condition: Healthy Adult Subjects
Study type: Interventional

Summary: 
      Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain
      organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance
      gastrointestinal colonization.
    

Detailed description: 
      The study will evaluate the synergy of the use of a complex oligosaccharide with and without
      a probiotic on the human microbiome in healthy volunteers. The combination should support
      general gastrointestinal health.

      The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60
      healthy adult volunteers ages 18-75.
    

Intervention name(s): Complex oligosaccharide; Probiotic; PPI
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Complex oligosaccharide concentrate; Probiotic; Over-the-counter proton pump inhibitor (PPI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Peer Support for Weight Loss Maintenance
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this study is to test the efficacy of patient-provided treatment for
      weight-loss maintenance.
    


Intervention name(s): Peer-delivered Weight Maintenance; Professionally-Delivered Weight Maintenance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).; Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight loss; weight maintenance; weight control; peer support; patient-provided care