bioihbjkbjnl/mcl2 huggingface dataset:
Hypoglycemia and Cardiac Arrhythmias in Type 1 Diabetes
Condition: Diabetes type1; Hypoglycemia; Arrhythmias, Cardiac
MeSH terms: Arrhythmias, Cardiac; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      The investigators hypothesise that following episodes of hypoglycemia, rebound hyperglycemia
      may result in a prolonged period of increased QTc and, thereby, increased susceptibility to
      serious cardiac arrhythmias in patients with type - 1 diabetes.
    

Detailed description: 
      In this study, changes in cardiac rhythm, haemodynamic regulation, and hormonal response will
      be evaluated during insulin-induced hypoglycemia followed by hyperglycemia and euglycemia,
      respectively, on two separate experimental days. Twenty-four patients with type-1 diabetes
      are included. Patients are randomised 1:1 to start with either the combined hypo- and
      hyperglycemic or the hypo- and euglycemic clamp. After an overnight 10 hour fast,
      participants are admitted for a 255 minute clamp. An individualised insulin infusion will be
      initiated targeting a plasma glucose level of 5.0-8.0 mmol/l. When the targeted plasma
      glucose level is achieved, the hyperinsulinemic euglycemic clamp will be initiated at time 0.
      The insulin infusion will be fixed at an infusion rate 80 mU/m2/min and a 20% glucose
      infusion will be initiated in order to regulate plasma glucose levels. After 45 min of
      monitoring at euglycemic plasma glucose level, plasma glucose will be decreased over a period
      of 30 minutes, targeting 2.5 mmol/l for a period of 60 min in a hyperinsulinemic hypoglycemic
      clamp. From 135 min to 195 min, plasma glucose levels will be increased to either
      hyperglycemic level or euglycemic level and will be kept constant for 105 minutes.
      Echocardiography is performed at baseline, at hypoglycemic level and at hyper-or
      normoglycemic level. Blood samples are taken every 15 minutes throughout the entire clamp,
      however bedside plasma glucose is analysed every fifth minute. A Holter-ECG is obtained
      throughout the entire clamp.
    

Intervention name(s): Hypoglycemic combined with either normo or hyperglycemic clamp.
Intervention type(s): Other
Intervention description(s): Twenty-four patients with type 1 diabetes has been recruited for a cross-over study including two experimental days, a combined hypo- and hyperglyemic clamp and a combined hypo- and euglycemic clamp, respectively. Patients will be randomised 1:1 to start with either the combined hypo- and hyperglycemic or the hypo- and euglycemic clamp. The hypo- and hyperglycemic or the hypo- and euglycemic clamp are estimated to last 255 minutes. The two clamp days will be separated by at least 30 days.
Intervention MeSH terms: Hypoglycemic Agents
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        24 patients with type 1 diabetes with insulin treatment for ≥ 3 years.
Examining Bladder Control Using Mindful Based Approach
Condition: Urinary Urgency Incontinence
Study type: Interventional

Summary: 
      Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge
      to urinate that is difficult to prevent) is commonly experienced in patients with overactive
      bladder. New findings have discovered that urgency incontinence may be connected to the
      interactions of certain regions of the brain and the bladder. Although this is a common
      problem, researched still do not know how these interactions impact the process of urgency
      incontinence. Furthermore, there is preliminary data to suggest that interventions such as
      Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose
      of this study is to determine the impact MBSR training on UI symptoms, quality of life, and
      anxiety measures.
    

Detailed description: 
      Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge
      to urinate that is difficult to prevent) is commonly experienced in patients with overactive
      bladder. New findings have discovered that urgency incontinence may be connected to the
      interactions of certain regions of the brain and the bladder. Although this is a common
      problem, researched still do not know how these interactions impact the process of urgency
      incontinence. Furthermore, there is preliminary data to suggest that interventions such as
      Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose
      of this study is to determine the impact MBSR training on UI symptoms, quality of life, and
      anxiety measures.

      To determine the impact of MBSR training on Urinary Incontinence(UI) symptoms, quality of
      life and anxiety measures in women affected with UI. We hypothesize that participants will
      have significant improvement in UI and anxiety related symptoms and quality of life measures.
    

Intervention name(s): Mindfulness Based Stress Reduction Course
Intervention type(s): Other
Intervention description(s): The MBSR course developed by Jon Kabat-Zinn is a mind-body intervention that incorporates mindfulness techniques. This is an eight week MBSR course at OHSU. Class instruction will be augmented by daily home practices of listening to audiotapes, diary reflections, and reading preloaded on itouch devices provided to participants. Adherence will be assessed through in-house iMINDr tracking program loaded on the itouch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional MRI (fMRI); Resting state functional connectivity MRI (rs-fcMRI); Diffusion Tensor Imaging (DTI)
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics
      of CLG561 in subjects with advanced age-related macular degeneration (AMD).
    

Detailed description: 
      Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a
      single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest.
      All subjects received active CLG561. Progress from one cohort to the next was time-lagged to
      allow for safety review. Dosing was also time-lagged within each cohort. Only one eye
      (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular
      examination occurred immediately after the IVT injection and continued throughout the
      outpatient visits at pre-determined timepoints. Collection of post-injection blood samples
      began after the IVT injection at pre-determined timepoints. Subjects were followed for up to
      84 days.
    

Intervention name(s): CLG561
Intervention type(s): Drug
Intervention description(s): Administered by intravitreal injection, Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: First in human; Safety; Tolerability; Serum PK; Intravitreal (IVT); Age-related macular degeneration; AMD; Geographic Atrophy; Choroidal neovascularization
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
Condition: Dupuytrens Contracture
MeSH terms: Dupuytren Contracture; Contracture
Study type: Interventional

Summary: 
      Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's
      contracture affecting proximal interphalangeal joints. An open label, medico-independent
      randomized controlled trial.
    


Intervention name(s): Xiapex; Percutaneous needle fasciotomy
Intervention type(s): Drug; Procedure
Intervention description(s): Collagenase Clostridium Histolyticum; Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Other intervention name(s): XIAPEX® - Pfizer UK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brief Intervention Combined With Health Coaching Via Social Media for Cannabis Use
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of the study is to develop and test social media interventions to help young
      people increase well-being and reduce risky behaviors. The study will help researchers learn
      about ways to deliver wellness information in a way that is appealing and helpful to young
      people who use Snapchat.
    


Intervention name(s): Snapcoach
Intervention type(s): Behavioral
Intervention description(s): A brief motivational interviewing-based intervention combined with health coaching via social media for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
Condition: Von Willebrand Disease
MeSH terms: Von Willebrand Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF,
      and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding
      events in subjects with severe hereditary von Willebrand disease (VWD).
    


Intervention name(s): Recombinant von Willebrand factor (rVWF); Placebo; Recombinant factor VIIII (rFVIII)
Intervention type(s): Biological; Drug; Biological
Intervention description(s): Intravenous administration; Syringe supplied with physiologic saline solution for infusion; Intravenous administration
Other intervention name(s): BAX 111; rVWF; saline; physiologic saline; rFVIII; ADVATE
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Rehabilitation During Transcranial Direct Current Stimulation
Condition: Transcranial Direct Current Stimulation; Neurocognitive Disorders
MeSH terms: Neurocognitive Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to explore whether active transcranial direct current
      stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without
      severe side effects in mild cognitive impairment or mild dementia patients.
    

Detailed description: 
      This study explores the additive effect of transcranial direct stimulation compared to sham
      stimulation during cognitive rehabilitation tasks in mild cognitive impairment or mild
      dementia patients. Potential participants are recruited by physicians' referral or
      self-entry. Informed consent by a clinical research coordinator and research physician is
      performed followed by screening. Participants who passed screening go through 10 sessions of
      active or sham transcranial direct current stimulation and are evaluated their cognitive
      function at screening, at the end, and two weeks after the intervention. For quality
      assurance, independent researcher regularly monitor and audit as participants are enrolled in
      the trial.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive rehabilitation
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients
Condition: Patient Outcome Assessment
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation of effect of perioperative Dexmedetomedine administration on mortality, length
      of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events,
      acute kidney injury in cardiac surgery patients.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Benefits of Online Mahjong by Older Adults
Condition: Aged
Study type: Interventional

Summary: 
      This study aims to examine the clinical efficacy of online Mahjong in improving physical
      health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging
      (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to
      expand the scope of healthy aging intervention activities with strong scientific evidence.
    

Detailed description: 
      Psychomotor function among older adult's decline was associated with reducing people
      interaction during pandemic has been reported. The research focused on examining the benefit
      and efficacy of digital based Mahjong games with 6-month intervention is very limited or
      none. A random control design was conducted with comparing intervention group and with
      control group, followed the CONSORT guidelines. Six months program was intervened to ensure
      the impact of the intervention. Primary outcome is brain imagery changes between groups,
      which showed changes in temporal fusiform cortex but not in resting-state fMRI. The total
      score of MoCA, delayed recall was increase from baseline to after intervention in
      experimental group. Overall cognitive function and visuospatial/executive, in experimental
      group improved more than control group. Improving self-rating daily health status as
      associated with achievement rate of Mahjong game. Increasing level of resilience was
      associated with demoralization level, subtraction of cognitive function, and 5th month
      walking steps. In addition, affecting incased self -rate overall heath was related to
      demoralization. In short, online mahjong intervention has positive impact on older adults in
      cognitive function , resilience, demoralization and overall quality of life.
    

Intervention name(s): Bonus Winner Mahjong
Intervention type(s): Device
Intervention description(s): Bonus Winner Mahjong developed by Bonus Winner Online Entertainment Co., Ltd. The participants in experimental group played three times a week, each time requiring at least lasting 30 minutes, for half of a year.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a single-blind, parallel-group randomized controlled trial. Eligible participants were allocated randomly 1:1, without stratification, to either the intervention or the control group, according to a computer-generated random number sequence.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: online Mahjong; physical activity; cognitive function; quality of life in older adults
Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Condition: Erosion; Cornea, Traumatic
MeSH terms: Corneal Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This research aims to compare between bandage contact lens and pressure patching in reducing
      size of erosion area and pain scale in corneal erosion patients as well as its complications.
    

Detailed description: 
      This is a randomized open-label clinical trial in patients with mechanical corneal erosion.
      Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All
      subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5%
      Tropicamide eye drops. Evaluation was done 24 hours after treatment
    

Intervention name(s): Bandage contact lens; Pressure patching
Intervention type(s): Device; Device
Intervention description(s): Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm); Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mechanical corneal erosion; bandage contact lens; pressure patching; erosion area; pain scale
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
Condition: Body Fat
Study type: Observational

Summary: 
      The researchers believe that the multifunction Keito devices shares with TANITA TBF-300
      (K014009) the same efficacy on the body fat measurement. Even if the body contact points are
      not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate
      gives results as similar as the multifunction keito does.
    

Detailed description: 
      177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the
      devices under test, the observers measured the weight and height of each volunteer prior to
      measure the body fat. This was done to configure a preliminary idea about the body
      composition of the subject.

      Both devices are designed by the same technology to emit a low current through the body, and
      finally make a measurement of the impedance found between the body contact points. We
      expected the results to be very similar.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        To include the maximum types of patients, the selection was opened to all the general
        public who could use the multifunction Keito in a public site, where is is intended to be
        placed. The test was carried out following the user's manual rules about who can use the
        device.
      
Keywords: To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.
A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to
      placebo for treating Chinese patients with subclinical atherosclerosis.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, multicenter parallel group
      study assessing the effects of rosuvastatin 20 mg treatment for 104 weeks on the change in
      intimamedia thickness (IMT) of the common carotid artery (CCA), carotid bulb, and internal
      carotid artery (ICA) in adult Chinese subjects with subclinical atherosclerosis.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20mg tablets, orally once daily for the duration of the 104-week treatment period; Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosuvastatin 20 mg treatment, Carotid Intima-Media Thickness, Chinese subjects, Subclinical atherosclerosis
A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to provide initial safety and tolerability data as well as to
      provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered
      in healthy male adults
    


Intervention name(s): GW856553
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GW856553,; drug-drug interactions,; rosuvastatin
Genomic Endometrial Expression in Obesity
Condition: Obesity and Embryo Implantation
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Determine if different genomic endometrial expression exists during embryo implantation in
      obese women in comparison with non obese women.
    


Intervention name(s): endometrial biopsy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Meal-based Comparison of Protein Quality, Complementary Proteins and Muscle Anabolism
Condition: Protein; Diet; Skeletal Muscle
Study type: Interventional

Summary: 
      To highlight the importance of protein quality rather than the total protein content of a
      meal, the investigators will demonstrate that unlike high quality proteins, a single meal
      containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein
      synthesis. Secondly, the investigators will directly challenge a prevalent, but untested,
      assertion that has the potential to negatively impact health. The goal is to demonstrate that
      complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed
      at the same meal to stimulate protein synthesis.
    

Detailed description: 
      The investigators will test the following hypotheses in middle-aged men and women (45-60)
      years old using a randomized, cross over design. All study objectives will be met
      concurrently:

        1. Meals containing 30 g of high quality, predominantly beef-protein (PRO-A) will stimulate
           acute (i.e., single meal response) and 24 h skeletal muscle protein synthesis
           [confirmatory hypothesis]

        2. Meals containing 30 g of complementary plant-based proteins (PRO-B: complete essential
           amino acid profile at each meal) will stimulate acute and 24 h skeletal muscle protein
           synthesis, but to a lesser extent than beef-protein.

        3. A single meal containing 30 g of an incomplete plant-based protein source (PRO-C:
           lacking one essential amino acid) will fail to acutely stimulate skeletal muscle protein
           synthesis

        4. Meals containing 30 g of plant-based protein that are incomplete at each separate meal,
           but complementary over a 24 h period, will fail to stimulate 24 h skeletal muscle
           protein synthesis.

        5. Beef-and plant-based meals will have a similar effect on satiety and 24 h blood glucose
           [descriptive]

      If these hypotheses are correct, the investigators will demonstrate that meals containing a
      moderate amount of high quality protein, such as beef, are an efficient and effective way to
      augment a largely plant based diet and stimulate skeletal muscle protein synthesis - a
      prerequisite for outcomes related to physical function, performance, successful aging and
      metabolic health.
    

Intervention name(s): PRO-A; PRO-B; PRO-C
Intervention type(s): Other; Other; Other
Intervention description(s): 30 g of beef protein will be consumed at each meal; 30 g of complementary proteins will be consumed at each meal; 30 g of complementary proteins will be consumed over 24 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other