bioihbjkbjnl/mcl2 huggingface dataset:
taVNS for Upper Limb Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study explores the use of a new form of neuromodulation known as transcutaneous
      auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be
      delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4
      weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments
      (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments
      (including a second brain scan)
    

Detailed description: 
      This study aims to refine and develop closed loop taVNS, establish activity with key
      biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to
      succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS
      platform that delivers stimulation concurrently during specific movements of the motor
      rehabilitation training.

      Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony
      with specific upper limb motor activation (n=5) Aim 2 will combine the development of the
      closed-loop system with the investigator's mechanistic understanding to explore an open-label
      pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine
      the feasibility, safety, and potential effect size of this novel combination therapy.
    

Intervention name(s): Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
Intervention type(s): Device
Intervention description(s): A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Rehabilitation; Vagus Nerve Stimulation; Brain Stimulation; Occupational Therapy
Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
Condition: Attention-deficit/Hyperactivity Disorder; Autism Spectrum Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether methylphenidate hydrochloride extended
      release liquid formulation is safe and effective in the treatment of
      attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism
      spectrum disorders (ASD).
    


Intervention name(s): Methylphenidate extended-release liquid formulation
Intervention type(s): Drug
Other intervention name(s): Quillivant extended release
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention-deficit/hyperactivity disorder; ADHD; Autism spectrum disorder; ASD; High-functioning ASD; Asperger's disorder; Asperger's
Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the postprandial
      glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1
      diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.; Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
Condition: Autonomic Dysreflexia
MeSH terms: Spinal Cord Injuries; Autonomic Dysreflexia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in
      patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of
      increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary
      bladder contractions.
    

Detailed description: 
      This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine
      for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia
      (AD) triggered by neurogenic detrusor overactivity (NDO).
    

Intervention name(s): Fesoterodine
Intervention type(s): Drug
Intervention description(s): 4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
Other intervention name(s): Toviaz
Intervention MeSH terms: Fesoterodine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Episodic Hypertension; Spinal Cord Injury; Traumatic Spinal Cord Injury; Blood Pressure; Fesoterodine; Neurogenic Detrusor Overactivity; Autonomic Dysreflexia; Urodynamic Studies; 24 Hour Ambulatory Blood Pressure Monitoring; Cerebral Blood Flow
Macronutrients and Postprandial Vascular Function
Condition: Dietary Fats; Carbohydrates; Proteins; Macronutrients; Vascular Function; Postprandial Metabolism
Study type: Interventional

Summary: 
      Vascular function decreases following the intake of a mixed meal in some, but not all
      studies. Differences in the relative amounts of dietary fat, carbohydrates and protein
      present in the mixed-meal challenges may have contributed to these apparently inconsistent
      results. Well-designed trials - comparing under rigorously standardized conditions - on the
      effects of macronutrients on postprandial vascular function are missing. The primary
      objective of the current study is thus to evaluate in overweight and slightly obese men the
      effects of the three macronutrients (fat, carbohydrates, and protein) on postprandial
      vascular function, as assessed by brachial artery flow-mediated vasodilation (FMD). Secondary
      objectives are to examine postprandial effects on other markers reflecting vascular function,
      plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood
      pressure, and serum lipid and plasma glucose metabolism.
    


Intervention name(s): High-fat (HF-LC-LP) milkshake; High-carbohydrate (LF-HC-LP) milkshake; High-protein (LF-LC-HP) milkshake
Intervention type(s): Other; Other; Other
Intervention description(s): During this experimental day, men will receive a high-fat milkshake; During this experimental day, men will receive a high-carbohydrate milkshake; During this experimental day, men will receive a high-protein milkshake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Ketoprofen Before Hysterosalpingography
Condition: Pain Relief
Study type: Interventional
Phase: Phase 3

Summary: 
      hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the cannula; and injection of the dye
    


Intervention name(s): Ketoprofen; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): bi profenid
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Epigenetics of Muscle Insulin Resistance
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      The investigators are trying to understand the role of DNA (deoxyribonucleic acid)
      methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a
      normal chemical process in the body that modifies DNA. By studying this, the investigators
      hope to better understand the causes of insulin resistance.
    

Detailed description: 
      Insulin resistance is defined as the decreased ability of insulin to perform its biological
      function in the muscle, liver and fat. Genetic and environmental factors are known to
      influence insulin sensitivity. It is not known how this is mediated. This study looks at the
      role of epigenetics (modifications of proteins associated with DNA and methylation of DNA) in
      alterations in insulin resistance. The investigators will study lean healthy people, obese
      non-diabetic people and people with type 2 diabetes to characterize the DNA methylation
      patterns in muscle in each group. The second aim of the study is to see how a single bout of
      exercise affects the DNA methylation in the muscle. The third aim looks at the effect of 8
      weeks of supervised exercise on the DNA methylation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups of volunteers will be studied: 1) lean, healthy volunteers, 2) obese
        volunteers without type 2 diabetes, and 3) volunteers with type 2 diabetes
      
Biospecimen description: 
      DNA will be extracted from vastus lateralis skeletal muscle biopsies and blood samples
Food and the Brain
Condition: Binge Eating
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Observational

Summary: 
      The proposed study will examine the role of reward and emotion in women with and without a
      history of binge eating. It is important to understand how the brain responds to reward and
      emotion in binge eating in order to identify different pathways toward binge eating and
      provide individualized targets for treatment. This is particularly important in light of the
      fact that for many patients, the current treatments for binge eating are not effective.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women ages 18-35
      
Keywords: fMRI; emotion conflict task; monetary incentive delay
Resting Energy Expenditure Using a Handheld Calorimeter
Condition: Obesity
Study type: Observational

Summary: 
      High prevalence of obesity in children has increased associated complications such as type 2
      diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts
      caloric intake by estimating the resting and total daily energy expenditures.Estimation of
      energy needs is most commonly done using predictive equations. Reliable and valid energy
      requirements can be obtained using a traditional metabolic system, however this is an
      expensive option. Handheld indirect calorimeters may be a good alternative to measure energy
      needs. Several studies have been conducted to determine the validity and accuracy of handheld
      calorimeters in adults and health children, however, to the best of our knowledge, there are
      no such studies in the overweight and obese pediatric population.

      The purpose of this study is to validate a handheld indirect calorimeter against a
      traditional metabolic system in overweight and obese children.

      If handheld calorimeters can accurately measure resting energy expenditure in overweight and
      obese adolescents, dietitians will have an opportunity to tailor pediatric weight management
      interventions based on parameters that are unique to each individual.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese children aged 13-18y of both gender
      
Keywords: Resting energy expenditure; Handheld calorimeter; Obese and overweight; Pediatrics
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of
      age and older. In addition, patient delay in seeking care for symptoms results in diagnosis
      at a more advanced stage than that seen in younger individuals. However, clinical trials on
      gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which
      have been reported to have clinically significant response rates and survival with mild or
      negligible toxicities, have been widely used for the patients with AGC. However, few studies
      have been conducted in elderly patients.
    


Intervention name(s): S-1; Capecitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach cancer; Palliative chemotherapy; Capecitabine; S-1
Weight Loss With Risedronate for Bone Health
Condition: Bariatric Surgery Candidate; Bone Loss; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and
      following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT)
      examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical
      weight loss associated loss of bone mass and quality.
    

Detailed description: 
      This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo
      capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be
      approached during their pre-surgical evaluation for possible participation in the study.
      Eligible participants will be referred onto the study coordinator to read/sign an
      IRB-approved informed consent prior to enrollment.

      Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)]
      occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow
      up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week
      post-surgery date will be conducted, as well as monthly medication compliance reminders and
      adverse event reporting via phone. Optional additional exploratory assessments include
      CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood
      assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve
      as a source of recruitment for potential study participants.
    

Intervention name(s): Risedronate Sodium 150 MG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.; Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Other intervention name(s): Code A; Code B
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Bone Health
Local Injection of PRP During Repair of Disrupted Surgical Wounds
Condition: Role of Platelet Rich Plasma in Wound Healing
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      Patients with disrupted wounds will either managed as usual or managed by Platelet rich
      plasma local infiltration in the wound edges
    

Detailed description: 
      The patients with disrupted surgical wounds will be cleansed, debrided and closed with
      infiltration of platelet rich plasma in one group and the other group will be closed without
      infiltration of Platelet rich plasma
    

Intervention name(s): Platelet rich plasma infiltration in the wound edges; Closure of wound without platelet rich plasma infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): platelet rich plasma will be injected in the wound edges; No infiltration of platelet rich plasma is done
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Platelet rich plasma; disrupted wounds; Obstetrics and Gynecology
Relative Bioavailability Study of One Amlodipine 10mg Tablet and One Rosuvastatin 20mg Tablet to Two Fixed Dose Combinations of Amlodipine (10mg) and Rosuvastatin (20mg) in Healthy Subjects Under Fasting Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-centre, randomized, single dose, three-way crossover, six
      sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination
      (FDC) tablet formulations of amlodipine and rosuvastatin relative to innovator samples under
      fasting conditions, in healthy adult subjects. Subjects will be 12 Chinese and 12 Caucasian
      subjects living in Singapore. The randomisation will be stratified by ethnicity to ensure an
      equal number of subjects will be assigned to each dosing sequence. Subjects will receive each
      of the following three treatments administered in a randomized three-way crossover design: a
      reference treatment consisting of a single 10mg amlodipine tablet and 20mg rosuvastatin
      tablet ; a single fixed dose combination tablet consisting of 10mg amlodipine and 20mg
      rosuvastatin (Test Formulation - FDC 1); and another single fixed dose combination tablet
      consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 2). Two test
      formulations have same active pharmaceutical ingredients (amlodipine and rosuvastatin), same
      doses and different inactive ingredients. Each subject will participate in three treatment
      periods. The study consists of a screening phase, three treatment periods and a follow-up
      visit. The three treatment periods will be separated by a washout period of 12-17 days.
    


Intervention name(s): Amlodipine+Rosuvastatin; GSK3074477 FDC - 1; GSK3074477 FDC - 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amlodipine 10mg will be supplied as white or off-white, emerald shaped tablet. Rosuvastatin 20mg will be supplied as pink round film coated tablet.; GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.; GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amlodipine; Healthy volunteers; Rosuvastatin; Dyslipidaemia; Pharmacokinetics; Hypertension
Real Life Effectiveness of Easyhaler (Orion)
Condition: Asthma
Study type: Observational

Summary: 
      The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the
      Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care
      asthma population of patients aged 6 to 80 years.
    

Detailed description: 
      A recent observational study by Price et al carried out using the UK's General Practice
      Research Database (CPRD) to compare asthma-related outcomes for different inhaled
      corticosteroid (ICS) inhaler devices, using Easyhaler and dry powder inhalers (DPIs).
    

Intervention name(s): Budesonide Easyhaler; Budesonide dry powder inhaler
Intervention type(s): Device; Device
Intervention MeSH terms: Budesonide
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This will be a retrospective, observational study consisting of a one-year baseline period
        immediately prior to an index prescription date (IPD), and a one-year outcome period
        immediately following the index date.

        At the IPD, patients either:

          -  Initiation cohort: receive their first prescription for ICS therapy as one of the
             study drugs

          -  Step-up cohort: receive a prescription for one of the study drugs at a dose ≥50% that
             of their prescribed ICS dose during baseline.

          -  Switch cohort: switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other)
             with no change in ICS dose
      
Keywords: GPRD; effectiveness; cost-effectiveness; Easyhaler; Primary care; DPI
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy of low dose aspirin appears to be substantially lower in diabetic patients,
      compared to patients without diabetes. The aim of the investigators study is to test the
      laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The
      investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320
      mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve
      the response to aspirin.
    


Intervention name(s): Aspirin; aspirin
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg per day versus 75 mg twice daily and 320mg once daily; crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.
Other intervention name(s): Trombyl; Trombyl
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NIDDM; Aspirin; platelet inhibition; Aspirin treatment
An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this pilot study is to investigate feasibility and patients´ assessment using
      an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console)
      for patients with rheumatoid arthritis.
    


Intervention name(s): animated home-based exercises (Wii-fit); conventional home-based exercise program
Intervention type(s): Device; Procedure
Other intervention name(s): software Wii-fit plus
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: physical exercises; physical therapy; Wii game console; patients perspective