bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if 3 months of interval training improves
      obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep
      apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions
      improve obstructive sleep apnea and sleep quality in obese patients.
    

Detailed description: 
      Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and
      collapse of the upper airway resulting in successive episodes of cessation of or decreased
      respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime
      sleepiness in patients. Sleep apnea is frequently associated with co-morbidity such as
      obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. Lack of
      exercise is associated with OSAS severity, independent of body mass. Participation and
      motivation to exercise is low in OSAS patients, with less that one third of the patients
      reporting regular exercise routines. We aim to investigate if aerobic interval training
      improves OSAS in obese subjects.
    

Intervention name(s): Aerobic Interval training; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treadmill walking or running - 3 times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes high intensity intervals at 90-95% of maximal heart rate. Training intensity will be supervised through the use of Polar pulse monitors and the BORG scale of subjective perceived exhaustion.; Standard medical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Randomized controlled study; Exercise training; Lung function; Heart function
Organophosphate Pesticides and Human Reproductive Health
Condition: Fecundability; Spermatazoa Disorders; Menstruation Disorders; Endocrine Dysfunction
MeSH terms: Menstruation Disturbances
Study type: Observational

Summary: 
      This prospective cohort study assesses the effects of exposure to organophosphate (OP)
      pesticides on adverse reproductive outcomes in both male and female agricultural workers in
      China. We will enroll women and their spouses, who are attempting to become pregnant, and
      observe reproductive endpoints including (1) semen parameters (concentration, total count,
      motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea,
      polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and
      irregular menstruation); (3) alterations in hormone patterns including reduced estrogen
      excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase
      (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men;
      (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm
      delivery, low birth weight, and intrauterine growth retardation.
    


Observational model: Defined Population
Time perspective: Prospective
Drug Eluting Balloon Angioplasty for Dialysis Access Treatment
Condition: Dialysis; Angioplasty
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to compare the feasibility and the effectiveness, by means of
      immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon
      angioplasty for the treatment of failing dialysis access.
    

Detailed description: 
      In total 40 patients already diagnosed with hemodynamically significant stenosis of the
      dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous
      transluminal angioplasty by our department, will sign informed consent and will be randomized
      to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The
      protocol includes the description of patient's demographics (age, gender,dialysis access
      details, risk factors) and procedural details, as well as immediate results and long-term
      follow up.
    

Intervention name(s): Percutaneous Transluminal Angioplasty (PTA); Percutaneous Transluminal Angioplasty (PTA)
Intervention type(s): Device; Device
Intervention description(s): Angioplasty performed with the use of the novel paclitaxel eluting balloons; Angioplasty performed with the use of conventional angioplasty balloons
Other intervention name(s): IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter; Conquest PTA Balloon Dilatation Catheter
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dialysis access; angioplasty; drug eluting balloon
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System
      is safe to use and functions as intended with personalized basal insulin rates and when basal
      insulin rates are increased.
    


Intervention name(s): AID System; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): AID system; Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other intervention name(s): LY8888AU; LY275585
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Effects of Intubation Via McGrath Videolaryngoscope on Intraocular Pressure
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      In this study, the investigators aimed to compare the effects of endotracheal intubation via
      direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.
    

Detailed description: 
      Total of 50 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age
      between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study.
      Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American
      Society of Anesthesiologist Grade III and IV, Body mass index more than 35, difficult
      intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated
      will be excluded from the study. Patients will be divided randomly into 2 groups as direct
      laryngoscopic and videolaryngoscopic intubation group. Patients will be preoxygenated with
      %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1
      mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients
      will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube) by oral route.
      systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen
      saturation, perfusion indexwill be recorded and intraocular pressure measured by
      ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction,
      1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or
      videolaryngoscope after termination of mask ventilation and obtain end tidal carbon dioxide
      will be accepted as application time and recorded. Study will be terminated after 5th minute
      values taken.
    

Intervention name(s): Videolaryngoscope; Direct laryngoscope
Intervention type(s): Other; Other
Intervention description(s): This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.; This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Intraocular pressure; videolaryngoscope; direct laryngoscope
Internet-based CBT for Insomnia in Chronic Pain
Condition: Chronic Insomnia; Chronic Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Interventional

Summary: 
      The main goal is to study the effect of therapist-guided internet-delivered cognitive
      behavioural therapy for insomni comorbid with chronic pain in a clinical sample.
    

Detailed description: 
      Both chronic pain and sleep disorders are prevalent and potentially very debilitating
      problem. The prevalence of insomnia in people with chronic pain seems to be about 50%, but
      figures up to 88% have been reported. Cognitive behavioral therapy for insomnia (CBT-I) has
      been shown to be an effective treatment for both primary insomnia and co-morbid insomnia.
      CBT-I is a psychotherapeutic multicomponent treatment that seeks to influence the behaviors
      and cognitions which perpetuates the problem. Usually, the treatment is 6-8 weeks long with
      one session a week, individually or in a small group setting.

      Internet Mediated CBT-I has been shown to be an effective alternative to more traditional
      CBT. How well internet mediated CBT-I work for individuals with insomnia and co-morbid
      chronic pain has however not previously been investigated. The aim of the project is to study
      the effects of internet mediated cognitive behavioral therapy for individuals with insomnia
      and co chronic benign pain. The aim is to compare the effect of Internet-mediated cognitive
      behavioral therapy with a group that offered internet-based relaxation training. CBT-I
      comprises eight modules with evidence-based treatment components for insomnia (e.g. sleep
      restriction, stimulus control and cognitive techniques). The relaxation training comprises
      eight modules of applied muscular relaxation.

      Hypothesis: Patients suffering from both insomnia and chronic benign pain gets significantly
      better treatment outcome with respect to insomnia symptoms if they receive internet-based
      cognitive behavioral therapy compared to those receiving internet mediated relaxation
      training.

      Primary outcome measure: the Insomnia Severity Index (ISI), a well-used, valid and reliable
      self-report scale, which has been shown possible to administer via internet.
    

Intervention name(s): Cognitive behavioural therapy; Applied relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.; Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive behavioural therapy; Non-pharmacological treatment; Internet mediated
6 Minute Push & 30 Second Sprint Tests Reliability & Relationship to Fitness, Participation, & Environmental Assessments
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The purpose of this study is to assess the relationship between physical fitness and
      wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers;
      and 3) self-reported avoidance of environmental features.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample of persons with spinal cord injury.
Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Compulsive Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      3 groups of subjects (healthy controls, OCD subjects and stimulant-dependent subjects) will
      receive pramipexole (1.5 mg, single dose), amisulpride (400 mg, single dose) or placebo in a
      cross-over, double-blind, placebo-controlled design.

      Effects of compulsive behaviour will be assessed using fMRI and cognitive testing.

      Assess biomarkers including cardiovascular responses and plasma levels. All groups studied on
      3 separate occasions following screening, with at least a week intervening between
      consecutive assessments. The procedures to be adopted for study assessment will be identical
      on each occasion.
    


Intervention name(s): Pramipexole, Amisulpride
Intervention type(s): Drug
Intervention description(s): Study Drug
Other intervention name(s): Pramipexole; Amisulpride
Intervention MeSH terms: Pramipexole; Amisulpride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dopamine; OCD; MRI; stimulant users
Renal NCE-MRI in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.

      Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood
      Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA),
      phase-contrast MRI), which could be used in combination with structural MRI in a single
      acquisition session, have been identified to investigate in more detail renal function and
      structure, opening the possibility to estimate local renal diffusion and blood perfusion,
      beyond providing high-resolution anatomical accuracy.

      Preliminary to the identification of novel imaging biomarkers of renal disease progression,
      perfusion and diffusion MR sequences need to be optimized for the renal compartment.
      Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and
      diffusion changes in pathological kidneys as compared to normal and physiological condition.

      The objective of this study is to provide normal control NCE-MRI sequences to be used as
      reference for the investigation of perfusion and diffusion changes in the kidney of patients
      affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal
      dominant polycystic kidney disease).
    


Intervention name(s): Non contrast-enhanced magnetic resonance imaging
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Non-contrast enhanced MRI; healthy volunteers; renal diffusion; renal perfusion
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is going to assess the safety and tolerability of PF-06291874 in adults with Type
      2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control
      in these subjects.
    


Intervention name(s): Placebo; PF-06291874; PF-06291874; PF-06291874; PF-06291874
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, once daily for 28 days; Tablet, 15 mg, once daily for 28 days; Tablet, 35 mg, once daily for 28 days; Tablet, 75 mg, once daily for 28 days; Tablet, 150 mg, once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
Condition: Memory Functions
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in
      healthy humans.
    


Intervention name(s): Cinacalcet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single administration, 90mg; single administration
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol
      Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions
      using a single-dose, randomized, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Condition: End Stage Liver Disease; Physical Activity
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Interventional

Summary: 
      The primary outcome of this study is to demonstrate the feasibility of a prehabilitation
      program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent
      to participate in the study and are placed on the transplant list will be randomized into
      either the control or intervention group. The intervention group receives a personalized home
      exercise program along with weekly phone calls to provide coaching, mentoring and motivation.
      Data collected at baseline, post-transplant and, post-transplant follow up will be compared
      among the two study groups. The secondary outcomes include: normative data of functional
      measures for patients with end stage liver disease and to determine the effect size for
      future research on prehabilitation in the patient population.
    


Intervention name(s): Exercise
Intervention type(s): Procedure
Intervention description(s): Subjects will be given and individualized exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: liver diseases; liver transplantation; preoperative care; physical therapy
COX-2 Inhibition in Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study is part of a research programme into mechanisms of asthmatic airway obstruction,
      focusing on the role of lipid mediators such as the prostaglandins.

      To this end the effect of a non-steroidal anti-inflammatory drug, the selective COX-2
      inhibitor etoricoxib, will be evaluated in the allergen challenge setting in twelve subjects
      with intermittent allergic asthma. Active treatment for 10 to 13 days will be compared with
      an identical study period with no treatment in a cross-over, randomised design. Rising dose
      allergen challenges will be performed on three occasions to assess possible changes in
      airways responsiveness. Sampling of blood, urine, saliva and sputum will be done to allow for
      analyses of the production of prostaglandins and other lipid mediators, of the efficacy of
      COX-2 inhibition as well as of regulation of immune cells.

      It is hypothesized that inhibition of COX-2 by virtue of inhibition of bronchoprotective
      prostaglandin E2 leads to a slightly exaggerated airway response to allergen exposure.
    


Intervention name(s): Etoricoxib
Intervention type(s): Drug
Intervention description(s): 90 mg/day orally for 10-13 days
Other intervention name(s): Arcoxia
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Asthma; Allergen challenge; Airway responsiveness; Prostaglandins; Eicosanoids
Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has
      become a standard management strategy for patients with acute coronary syndrome. On this
      background, an increasing percentage of patients presenting for surgical coronary
      revascularization is the subject to irreversible platelet inhibition.

      Investigations on the effect of antiplatelet treatment on postoperative bleeding after
      cardiac surgery have shown that patients treated with antiplatelet agents until surgery have
      increased postoperative bleeding, and also an increased need for transfusions of blood
      products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious
      bleeding complications has increased significantly, as seen in patients requiring coronary
      artery bypass grafting(CABG), especially when they received clopidogrel until surgery.

      Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute
      for aprotinin when the latter has seceded in 2007.The release of plasmin during
      cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet
      dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate
      platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding.
      Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.

      Concerning the cessation of aprotinin and the increasing proportion of patients with
      persistence on clopidogrel until their surgery, evolutional work is expected, especially in
      the eastern population.

      The purpose of this study is to assess the effect of tranexamic acid in patients with
      clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that
      tranexamic acid would lower postoperative blood loss and transfusion requirements in these
      patients and would attenuate bleeding complication of antiplatelet therapy.
    


Intervention name(s): Tranexamic Acid; Saline
Intervention type(s): Drug; Drug
Intervention description(s): A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery; Saline served as placebo
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clopidogrel; Tranexamic Acid; Cardiac Surgical Procedures; Hemostasis