bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The Efector study is an open, randomized and controlled trial assessing the effect of regular
      exercise training on endothelial function, inflammatory markers, progression of disease,
      heart rate variability and mental health in patients who have been successfully treated with
      percutaneous coronary intervention and stent implantation for angina pectoris.
    

Detailed description: 
      Pas er randomized to a 6 months training group or none training. At baseline and at 6 months
      patients are examined with blood tests to measure serum concentrations of inflammatory
      markers, a test for endothelial function, heart rate variability and a coronary angiogram.
      Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).
    

Intervention name(s): exercise training
Intervention type(s): Behavioral
Intervention description(s): Exercise training in groups
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCI; stent; training; endothelial function; restenosis; late luminal loss; heart rate variability; oxygen uptake capacity; inflammatory markers
Oral Imaging for Porphyrin Biomarkers
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The purpose of this study was to use the principle of fluorescence to identify oral diseases
      not readily visible to the naked eye. A imaging device with a removable and modular head
      consisting of arrays of Light Emitting Diodes (LEDs) with differing wavelengths (405nm,450nm
      or white) was used to image teeth to detect fluorescent biomarkers such as porphyrins
      associated with poor oral health (plaque). The process utilizes illumination of the teeth and
      gums using a specific array of LEDs in the visible and near-visible spectrum and is
      non-invasive. Successful implementation of the device would provide proof-of- concept
      validation for its use as a safe, rapidly deployable solution to assess oral hygiene.
    

Detailed description: 
      To use the device, an interchangeable head with a specific LED wavelength was selected (to
      target a specific oral disease). The optical filter can be exchanged for another if necessary
      (this is done prior to the subject visit as to not prolong the time of the visit). During
      operation, LED intensity can be altered using the rotary dimmer switch. The procedure took
      place during a routine dental visit once consent was obtained. The device was covered in a
      clear disposable plastic sheath (Consolidated Plastics, Stow, OH) or equivalent sterile
      disposable camera bag. After both the subject and clinician wore UV protective eyeware, a
      series of images and videos were taken. These included detailed frames of all 4 incisors and
      all 4 canines. A video of the camera aperture passing over the select teeth was also taken.
      Additional images focusing on areas of interest to the clinician were taken, with area of
      capture and device mode recorded. The total time required to capture all images and video is
      expected to be approximately 5 minutes. As a control, an Acteon Soprocare a commercial device
      operating under the same fluorescence principle was also used. Images and video of the
      aforementioned eight target teeth in each mode were similarly captured for comparison to the
      test device.
    

Intervention name(s): Dental imaging
Intervention type(s): Diagnostic Test
Intervention description(s): The target teeth positions for imaging included 4 incisors and all 4 canines. Only the vestibular and interproximal regions were of interest. Images were taken of these target teeth positions regardless of whether or not they exhibited plaque, consisted of full or partial restorations, contained major cracks/fractures, chips, or were missing. Other captured images included any abnormality of the tooth or gum exhibiting red fluorescence physically accessible by the devices.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Imaging
The Effects of e+Shots Energy Beverage on Mental Energy
Condition: Caffeine
Study type: Interventional

Summary: 
      The aim of the research project is to determine the changes in motivation to perform mental
      and physical tasks, feelings of vigor and fatigue, mental task vigilance and fine motor
      function after consumption of a commercially available energy product. The purpose of this
      study is determine whether e+shot, a product containing natural caffeine, will impact mood
      and performance up to 108 minutes post consumption compared to a sweetened solution
      containing synthetic caffeine.
    

Detailed description: 
      Enrolled participants who are low consumers of caffeine will be administered either a placebo
      (3mg caffeine), caffeinated placebo (~100mg of caffeine) or e+shot first and then will be
      crossed over to receive the other two interventions. The study consists of 3 treatment
      periods of 108 minutes each with a washout period of 48 hours.
    

Intervention name(s): Intervention/treatment
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects received all 3 interventions Placebo ~3mg caffeine Caffeinated placebo ~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crosover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
Condition: Femoral Shaft Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which method is better for treatment of femoral
      fracture in children in outcomes.
    

Detailed description: 
      There is no consensus on treatment of closed femoral shaft fractures in children 6-12years
      old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment
      of femoral shaft fractures in children.
    

Intervention name(s): titanium elastic nailing; Hip spica casting
Intervention type(s): Procedure; Device
Intervention description(s): we inserted titanium nail in femoral fractures retrogradely; we applied cast for three weeks in patients with femoral shaft fracture
Other intervention name(s): TEN; TEN
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spica Cast; TEN; Femoral Shaft Fracture; Children
Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance
Condition: Impaired Glucose Tolerance; Type 2 Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance; Glucose Intolerance; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine if increased intake of low-fat milk products and
      calcium as part of a calorie restricted diet helps achieve a healthier body weight and body
      composition and decrease blood glucose levels in people with insulin resistance or type 2
      diabetes.
    

Detailed description: 
      Obesity can cause many health problems as it is linked to several chronic diseases including
      type 2 diabetes. We know that individuals who are overweight or obese, and have impaired
      glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes.
      Research tells us that the risk of developing type 2 diabetes can be decreased by losing
      weight and making dietary changes. A promising area of study involves using low-fat milk
      products and calcium to prevent and/or control obesity and diabetes. This study is important
      because it will determine if including low-fat milk products in weight reducing diets can
      enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in
      individuals with impaired glucose tolerance or type 2 diabetes not treated with medication.
      This information is directly applicable to treating diseases such as obesity, type 2 diabetes
      and heart disease.
    

Intervention name(s): High dairy and calcium intake; Usual intake
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.; Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet
Other intervention name(s): Jamieson Mega Cal™ Chewable Calcium (350 mg) tablet
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prediabetes; Type 2 diabetes; Metabolic syndrome; Insulin resistance syndrome; Weight loss; Milk products; Calcium
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine
Condition: Major Depressive Disorder
MeSH terms: Neurobehavioral Manifestations; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to describe the association/correlation between change in
      patient-reported cognitive symptoms and work productivity in gainfully employed patients
      receiving vortioxetine for a Major Depressive Episode (MDE).
    

Detailed description: 
      This is an interventional, Canadian, multi-site, open-label, single cohort, flexible-dose
      study. The study will emulate a naturalistic real-life setting. Investigators will include
      Primary Care Physicians and Psychiatrists working in outpatient clinics. The study will
      include adult patients diagnosed with MDD according to the DSM-5™. Approximately 200 patients
      will be enrolled in the study. There will be approximately 100 patients who receive
      vortioxetine as a first treatment for the current MDE and 100 patients switched to
      vortioxetine due to inadequate response to their current antidepressant medication treatment.
      All patients will be treated with vortioxetine as per the product monograph, and at the doses
      determined appropriate by the investigator. The total study duration from Baseline to the end
      of follow-up will be approximately 56 weeks.
    

Intervention name(s): vortioxetine
Intervention type(s): Drug
Intervention description(s): The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
Other intervention name(s): Trintellix
Intervention MeSH terms: Vortioxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Cognition; Cognitive symptoms; vortioxetine; real life; naturalistic
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the antibody response to one and two doses of
      influenza A/H1N1v vaccine in healthy adults.
    

Detailed description: 
      An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults
      ≥18-50 years of age will be randomly allocated to receive two doses of cell culture
      non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen
      vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose
      of the same vaccine containing the same quantity of antigen as in the first dose will be
      administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted
      influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin
      by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed
      for local and systemic reactions for 30 minutes after each immunisation and will be monitored
      for any reactions and other adverse events for 7 days after each immunisation.
    

Intervention name(s): MF59 H1N1 vaccine; Plain H1N1 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 3.75-7.5ug dose; 7.5-15ug
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza; immunogenicity; vaccine
First-Sight Refractive Error Correction in the Developing World
Condition: Vision Loss
MeSH terms: Refractive Errors
Study type: Observational

Summary: 
      The aim of this study is to test the efficacy of the First-Sight refractive kit designed to
      provide refractive correction of simple hyperopia, myopia and astigmatism with
      autorefraction.
    

Detailed description: 
      In remote and underserved areas, a patient may have limited or no access to eye specialists
      or healthcare facilities that offer equipment to provide standard refraction and purchase
      corrective lenses. First Sight Refracting system (FSR) is designed specifically to be used in
      remote and underserved areas. FSR is not considered the standard of care in the US. FSR is a
      portable refraction and lens-frame dispensing system with low cost of production. As a kit,
      it contains +/- 6.00 diopters of corrective lenses, color coordinated flipper, - 1.25 diopter
      astigmatism lens, visual acuity chart, astigmatic eye chart, measuring tape to measure the
      distance of the subject to the eye charts, pupillary distance ruler to measure for the frame
      size of the glasses to be dispensed, and lint free gloves. The kit comes with two standard
      frames. The corrective lenses are designed to be placed in the frames that can be readily
      dispensed to the patient after the refraction is done. The refraction technique is simple and
      straightforward and any healthcare worker in remote and underserved areas can provide the
      test and dispense glasses at no cost.

      This is the third phase of First Sight refractive study to be done in Haiti. Adult and
      children subjects will be recruited during their routine examinations and/or visual acuity
      screenings at the Justinien Hospital. The proposed study will compare the visual acuity
      measurements obtained from the First Sight refraction system (test procedure) with the visual
      acuity measurements obtained from the autorefraction (standard care). The international study
      will recruit 150 subjects which will test FSR's effectiveness as a refracting tool of choice
      to be used in remote and underserved areas. Data from this study will be compared with the US
      studies.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population with refractive error between -4.50 to +4.50 diopter spherical error and
        astigmatism up to 1.50 diopters.
      
Keywords: Vision Nearsighted; Vision Farsighted
Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
Condition: Asthma; Obesity
MeSH terms: Asthma; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to examine whether there are higher levels of cysteinyl
      leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are
      pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The
      investigators want to see if subjects with increased fat stores and therefore increased
      leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of
      leukotrienes in the blood, lung and urine. The investigators would also like to determine the
      relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics
      with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene
      synthesis.
    

Detailed description: 
      This is a cross-sectional observational study to characterize the association between obese
      asthmatics and the inflammatory mediators cysteinyl leukotrienes. Our hypothesis is that
      altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that
      play a significant role in the pathogenesis of asthma in these subjects.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        UM Housing Residents/Student Dorms UM Human Research Recruiting Registry (e.g., ENGAGE -
        http://www.med.umich.edu/engage/) Department or unit-specific research recruiting registry
        (provide UM IRB project number below) Other UM subject pools (describe below) Patients or
        their medical records from the UM Health System or any other UM health care provider (e.g.,
        School of Dentistry, University Health Service, University Center for Language and
        Literacy)
      
Biospecimen description: 
      Subjects will provide 30 cc of blood, a urine sample and we will collect 1-2 ml. of exhaled
      breath condensate for analysis.
    
Keywords: Asthma; Obesity
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Condition: Gallbladder Disease
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The objectives of this trial are:

        1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic
           Cholecystectomy

        2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC
           to objectively document the scientific merit and the perceived advantages of SILS™ Port
           Laparoscopic Cholecystectomy.
    


Intervention name(s): SILS™ port laparoscopic cholecystectomy; Four Port Laparoscopic Cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): This interventional arm will have a single incision laparoscopic cholecystectomy procedure.; This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy; Single Incision Laparoscopic Surgery; Surgical Procedures, Minimally Invasive
Xcellerated T CellsTM in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a phase II, randomized study of patients with multiple myeloma. All patients
      will receive Xcellerated T Cells, with or without prior fludarabine therapy.

      15 patients in each study arm will be followed for 6 months.
    

Detailed description: 
      This randomized Phase II clinical study is designed to examine the safety and efficacy of
      Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple
      myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic
      therapies prior to study registration and may not have relapsed or progressed within one year
      following hematopoietic stem cell transplantation. Patients will be randomized to treatment
      with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by
      Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients
      will be followed for six months following treatment.
    

Intervention name(s): Xcellerated T Cells
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma; fludarabine; Xcellerated T Cells
Effects of Blueberry on Cognition and Mobility in Older Adults
Condition: Aging; Age-Related Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      This study is being conducted to assess the effect of dietary blueberry supplementation on
      cognition and mobility in older adults. It is hypothesized that plant compounds, present in
      blueberries, may improve cognition and mobility by protecting against oxidative stress and
      inflammation.
    

Detailed description: 
      This study is being conducted to assess the effect of dietary blueberry supplementation vs.
      placebo on measures of cognition and mobility in older adults. Participants will visit the
      HNRCA on 4 occasions. During the first visit, participants will complete a dietary assessment
      and familiarize themselves with some of the cognitive tests used in the study. After a period
      of up to 45 days participants will return for the second visit. Participants will be
      randomized to consume either freeze dried blueberry powder or a placebo powder that tastes
      like blueberry. At visits 2, 3 and 4, participants will undergo tests of cognition, memory,
      gait and balance. In addition, blood samples and 24-hour urine will be collected at these
      visits. Tests include balance and gait assessment using a treadmill instrumented with
      pressure sensors which will measure postural sway and a variety of spatial/temporal gait
      parameters. Participants will also be affixed with surface electrodes to measure the
      activation of muscles in their legs during these balance and gait measurements. Participants
      will complete a battery of cognitive tests on paper and by computer. In the time between
      participants' visit 2 and visit 4, participants will receive a weekly telephone call to check
      in with them and remind them to continue taking the study powder. At the very end of the
      study, when all participants are finished, participants will receive a telephone call to
      debrief them and notify them which group they were randomized into. An optional tissue
      banking protocol will be offered for collection of additional blood to be banked at visits
      2-4.
    

Intervention name(s): Freeze-dried Blueberry; Blueberry Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12g freeze-dried blueberry (powder), twice daily with water, for 90 days; 12g blue, blueberry-flavored powder, twice daily with water, for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postural Balance; Walking; Gait; Cognition; Learning; Memory; Blueberry; Antioxidants; Anti-Inflammatory Agents; Brain