bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Condition: Graft Rejection
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was to examine the impact of everolimus and reduced dose of cyclosporine on
      efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in
      heart transplant recipients.
    


Intervention name(s): everolimus; mycophenolate mofetil; cyclosporine; corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.; Mycophenolate mofetil supplied as 500 mg tablets.; Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.; Corticosteroids standard dose.
Other intervention name(s): Zortress®; Certican®; Cellcept®; Neoral®
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Everolimus; heart transplant; heart disease; transplantation; heart IVUS assessment at 12 months; rate of graft loss; acute rejection episodes; survival
Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia
Condition: Neuropraxia
Study type: Observational

Summary: 
      This study hypothesizes that an automated device using small electronic impulses can detect
      nerve impairment in unconscious patients.
    

Detailed description: 
      Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1)
      bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3)
      on forehead will permit microvolt current to to be detected and analyzed against a
      proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in
      received SSEP signals.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Intraoperative adult patients undergoing surgical procedure
      
Keywords: SSEP; neuropraxia; intraoperative; automated
A Study of RTA 402 in Obese Adults
Condition: Obese Adult Male
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate changes in body weight and body composition in obese adults after repeated
      oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
    


Intervention name(s): Bardoxolone methyl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bardoxolone methyl 5 mg capsules; Capsules containing an inert placebo
Other intervention name(s): RTA 402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Bardoxolone Methyl; Obese adult; body weight; body composition
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
Condition: Excessive Daytime Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to demonstrate the efficacy and safety of pitolisant versus
      placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness
      (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal
      Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining
      of EDS.
    


Intervention name(s): Pitolisant; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Wakix tablet; Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Undiagnosed Sleep Apnea and Bypass OperaTion
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Observational

Summary: 
      Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous
      studies suggested sleep apnea was associated with coronary plaque burden and future adverse
      cardiovascular events after percutaneous coronary intervention. In the SABOT study, the
      investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate
      the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary
      artery bypass surgery.
    

Detailed description: 
      The SABOT Study is an observational study designed to study the impact of sleep apnea on
      cardiovascular outcomes after non-urgent coronary artery bypass surgery (CABG). Patients
      between the ages of 18 and 90 who are scheduled undergo an non-urgent CABG were eligible for
      the study

      The recruited patients participants were scheduled to undergo a hospital-based overnight
      sleep study using a US Food and Drug Administration-approved portable monitoring devices: the
      Watch-PAT (Itamar Medical, Caesarea, Israel). Watch-PAT is a four-channel unattended sleep
      monitoring device that measures peripheral arterial tone (PAT), pulse oximetry, heart rate,
      and actigraphy from a built-in actigraph. Respiratory events are identified by digital
      vasoconstriction mediated by α-adrenergic receptors that are sensitive to surges in
      sympathetic activity. Respiratory events are considered to be present when one of the
      following three criteria was met: a reduction in PAT amplitude with an acceleration of the
      pulse rate or an increase in wrist activity; a reduction in PAT amplitude with ≥3%
      oxyhemoglobin desaturation; and ≥4% oxyhemoglobin desaturation only. Although manual scoring
      and editing of the Watch-PAT signals are possible, we adopted results generated by the device
      algorithm alone with no intervention by the operator. The diagnosis of sleep apnea is
      confirmed if the AHI was greater than 15 events/h.

      End Points The pre-specified primary end point is a major adverse cardiac and cerebrovascular
      event (MACCE), defined as a composite of cardiovascular mortality, non-fatal myocardial
      infarction, non-fatal stroke, and repeat revascularization.

      The secondary end point comprised sudden cardiac death or resuscitated cardiac arrest,
      all-cause mortality, and hospitalization for heart failure.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with coronary artery disease scheduled to undergo coronary artery bypass
        surgery
      
Keywords: sleep apnea; coronary artery bypass grafting; outcomes
Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Middle-aged and Older Men
Condition: Healthy Aging
Study type: Interventional

Summary: 
      The present study aims at analyzing the dose-response effects of a recreational team
      handball-based exercise programme on cardiovascular, metabolic, musculoskeletal and physical
      fitness markers of inactive middle-aged and older men, without previous experience with the
      sport. The researchers hypothesized a positive weekly training frequency effect on health and
      physical fitness outcomes.
    


Intervention name(s): Recreational Team Handball programme
Intervention type(s): Other
Intervention description(s): All training sessions consisted of a standardized 15-min warm-up (running, coordination, strength, flexibility and balance exercises), followed by 3x15-min periods of recreational team handball matches interspersed by 2-min breaks, performed in an indoor team handball court. The matches were played as small and formal game formats (4v4, 5v5, 6v6 or 7v7).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
Condition: Vaginal Vault Prolapse; Sexual Function
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of performing prophylactic McCall
      culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be
      measuring pelvic support (using POP-Q) and sexual function before and at different time
      points (up to 12 months) postoperatively.

      The investigators hypothesize that women undergoing the McCall culdoplasty will not have
      different immediate surgical outcomes (operative time, etc) and may have better pelvic
      support and sexual function in the future.
    


Intervention name(s): McCall culdoplasty
Intervention type(s): Procedure
Intervention description(s): The modified McCall Culdoplasty procedure is a relatively simple procedure that is performed after removal of the uterus and cervix from the apex of the vagina wherein the angles of the vagina are attached to their respective uterosacral ligament and the cul-de-sac is surgically obliterated for support postoperatively. This is done with a single 0-vicryl suture. There will be no additional interventions applied during the hysterectomy aside from the McCall culdoplasty.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: McCall culdoplasty; Total laparoscopic hysterectomy; Vaginal vault prolapse; Sexual function
Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to clinically compare the incidence of post-operative pain after
      using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual
      glide path preparation in lower molars with asymptomatic non-vital pulp.
    


Intervention name(s): Rotary Neoniti GPS file; Manual stainless steel K-files
Intervention type(s): Other; Other
Intervention description(s): Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.; Glide path preparation will be done by hand instrumentation using K-files #10 and 15.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Nutri Diet Goal Setting Software Pilot Trial
Condition: Type 2 Diabetes; Pre-diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Prediabetic State
Study type: Interventional

Summary: 
      The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision
      support software to support collaborative diet goal setting in primary care. Nutri is
      designed within the Chronic Care Model framework, specifically with the intention of
      leveraging clinical information systems to connect clinical care with patients' lives in the
      community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative
      goal setting between the patient and provider to identify a behavioral intention (i.e., diet
      goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective
      norms/social support, and perceived behavioral control.

      In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40
      patients) receives collaborative diet goal setting via Nutri, and the control group receives
      usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report
      food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to
      surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when
      the Nutri workflow is available for a patient and asked to complete it during their visit
      with that patient.
    


Intervention name(s): Collaborative Diet Goal Setting Clinical Decision Support
Intervention type(s): Behavioral
Intervention description(s): Receives Nutri
Other intervention name(s): Nutri
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Clinical Decision Support; Dietary Management
The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study
Condition: Learning; Behaviour
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether DHA (in a daily dose of 600 mg.) will
      improve the behaviour and learning of normal children aged 7-9 years in mainstream state
      schools who are underperforming according to nationally standardized tests.
    

Detailed description: 
      The study has two stages, as its primary aim is to find out whether there is a real link
      between children's fatty acid status and their reading and behaviour. Previous reviews have
      stated the importance of objective measures, as did our referees.

      We will aim to address this by using well validated tests of reading and behaviour, and
      comparing results from these with children's fatty acid status as assessed from a pinprick
      blood sample. In Stage 1 we will primarily aim to establish the degree of association between
      fatty acid status and reading and behaviour. Secondarily, we will look at whether the
      children who have a higher DHA status have better sleep, and whether in turn they have better
      reading and/or behaviour, as previous work has suggested this.

      In Stage 2 we aim to carry out a randomised trial where children will be given either DHA or
      a taste- and appearance-matched dummy capsule for 16 weeks. Neither the children, parents nor
      the researchers will know which children will get which treatment until the study is over.
    

Intervention name(s): DHA (docosahexaenoic acid); Sunflower oil capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 x 500 mg capsules per day orally, each capsule providing 200 mg of DHA as a triglyceride. The liquid fill contains DHASCO®-S oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).; The placebo will consist of 3 x 500 mg capsules per day orally containing high-oleic sunflower oil. The dimensions, taste, appearance and colour will be identical to those of the DHA capsules. The shell of the capsule will be the same as the DHA capsule. The liquid fill contains high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitat and rosemary extract (flavouring).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DHA; Learning; Reading; Memory; Children; Omega 3; Education; Learning and behaviour in children
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Condition: Amputation
Study type: Interventional

Summary: 
      Many service members suffering major limb amputation(s) during active duty seek to return to
      active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic
      differences exist between popular multi-function prosthetic feet that would facilitate return
      to duty for soldiers with amputations.
    

Detailed description: 
      Specific Aims

        -  Compare the effectiveness of popular prostheses for improving performance in physically
           demanding tasks and environments.

        -  Compare amputee performance to a group of high-functioning non-amputees to determine
           performance differences between the groups.

      Hypotheses:

      Prosthetic feet with shock absorbing and torsional features will perform better in field
      activities. Prosthetic feet with high energy return and low mass will perform better during
      treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes
      in both field and laboratory environments compared to amputee subjects.

      Relevance:

      This study has the potential to quantify differences between highly mobile amputees and
      non-amputees. Additionally, it will provide objective measures of how different prostheses
      may enhance mobility of soldiers with amputations. The study will compare laboratory and
      field measures to indicate which conditions increase efficiency of prostheses during rapidly
      changing mobility demands. This has the potential to permit retention of already trained
      soldiers.
    

Intervention name(s): Ossur Variflex prosthetic foot; Ossur Ceterus prosthetic foot; Endolite Elite Blade prosthetic foot
Intervention type(s): Device; Device; Device
Intervention description(s): Lightweight energy-storing prosthetic foot; Shock-absorbing prosthetic foot; Multi-axial prosthetic foot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amputee; Transtibial; Military; Gait; Rehabilitation
Tissue Flossing and Lower Limb Neuromuscular Function
Condition: Physical Performance; Neuromuscular Function; Tissue Flossing; Ischemic Preconditioning
Study type: Interventional

Summary: 
      There is no study investigating different volumes, that is various sets of the configuration
      of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of
      TF impaired neuromuscular function assessed with TMG. Therefore, the aim is to compare the
      effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle
      contractile properties.
    

Detailed description: 
      The primary purpose of the study will be to examine the differences in one and two sets of
      applying tissue flossing to the thigh muscles on neuromuscular function using tensiomyography
      (TMG) and CMJ, while considering several measurement points after flossing application (i.e.,
      +0.5min, +3min, +6min, +9min, +12min, +15min). A better understanding of the effects of
      flossing on acute performance enhancement as well as on individual muscle contractile
      properties could help practitioners to develop specific pre-conditioning activities and
      consequently improve athletic performance on the field. The investigators hypothesized that:
      (i) the application of tissue flossing will improve the contraction time of the vastus
      lateralis muscle as well as the maximal jumping performance, regardless of sets of
      configuration.
    

Intervention name(s): Tissue flossing
Intervention type(s): Procedure
Intervention description(s): After the standardized warm-up, participants will be instructed to stand still with their legs shoulder-width apart. The floss band (1.3 mm thick, 50 mm wide, 2 meters long, and strength level 3), consisting of a thick elastic latex band (COMPRE Floss, Sanctband), will be applied bilaterally around the distal third of the thigh. The applied pressure will be individualized by thigh circumferences, whereas low target pressure was chosen for this study, showing potential to elicit the most beneficial outcomes following flossing. The pressure will be monitored by the PicoPress device, which was placed at the middle distance of the application of the floss band to ensure that the entire surface of the pressure sensors was always completely covered. The flossing will be applied for 2 minutes with 2 minutes rest between sets. During flossing application subjects will be instructed to conduct 10 deep squats followed by 15 repetitions of knee extensions without added weight.
Other intervention name(s): ischemic preconditioning
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical Performance, Neuromuscular Function, CMJ, TMG, PAP
Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two period study of healthy adult subjects to characterize the effect of the dosing
      of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the
      safety profile of oral casopitant with and without ketoconazole. This study will consist of a
      screening period, two treatment periods and a post-treatment follow-up visit.
    


Intervention name(s): ketoconazole; casopitant 100 mg; Casopitant 50 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.; Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time; Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
Other intervention name(s): casopitant; ketoconazole
Intervention MeSH terms: Ketoconazole; Casopitant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects; Pharmacokinetics; Drug interaction; Ketoconazole; Casopitant
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to assess the immunogenicity and safety of vaccine
      GSK2321138A in children.
    


Intervention name(s): Influenza vaccine GSK2321138A; Fluarix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: vaccine; Influenza