bioihbjkbjnl/mcl2 huggingface dataset:
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether the provision of societal cost information
      affects patients' decisions whether or not to undergo surgical management in carpal tunnel
      syndrome, using a hypothetical scenario.
    

Detailed description: 
      Given the large societal costs of carpal tunnel surgery and existence of a relatively
      inexpensive treatment option, carpal tunnel release provides fertile ground for testing
      whether societal costs can influence patient decision-making in hand surgery. Such work would
      inform future efforts to reduce societal healthcare costs by elucidating whether appeals to
      societal cost are effective at driving stewardship of limited healthcare resources at the
      patient level. In this study, the investigators aimed to answer this question by presenting
      participants with a hypothetical scenario in which the participants had to choose between
      surgery and wrist bracing for carpal tunnel syndrome. Participants were randomized into two
      cohorts and societal cost information was presented to the intervention group. The effect of
      societal cost information on treatment choice is assessed, along with participants'
      healthcare attitudes.
    

Intervention name(s): Societal cost
Intervention type(s): Other
Intervention description(s): Annual societal cost information to the US for carpal tunnel release surgery was displayed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized in an intervention group that reviewed societal costs associated with carpal tunnel release and a control group that did not.
Masking: None (Open Label)
Primary purpose: Treatment
MRI Study of Saccadic Adaptation
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Accurate execution of our directed behaviors in the immediate environment allows the vast
      majority of our daily activities. Through the movements of our eyes and different parts of
      our body, we perceive, explore and act on our environment and can exchange and communicate
      with others. The mechanisms of sensorimotor adaptation of saccades (saccadic adaptation)
      contribute on the one hand to maintain the accuracy of saccades in the short, medium and long
      term, by opposing the deleterious effects of various physiological changes (development,
      aging), pathological or environmental (optical corrections).

      The aim of this study is to identify neuronal structures and networks involved in saccadic
      adaptation through the study of brain metabolic activation (BOLD) during the development of
      the adaptation of reactive saccades. The study will be organized in a single session with 3
      runs. Each run include 4 blocks: 3 include the double-step target paradigm RND, U+, U-) and
      one without target jump (STA). The 'U+'/ 'U-'blocks include saccadic trials with
      forward/backward displacement of the target during a targeting saccade, the 'RND' block
      include saccadic trials with random target jump (forward or backward) and the 'STA' block are
      trials without displacement of the target. Each subject will make 12 repetitions of the 4
      blocks.
    


Intervention name(s): fMRI
Intervention type(s): Behavioral
Intervention description(s): saccadic adaptation (target presentations, with or without target jump) during fMRI exam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: saccadic adaptation; visual-spatial perception; fMRI
A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine a safe and effective dose of ADX415 for the
      treatment of hypertension.
    


Intervention name(s): ADX415; ADX415; ADX415; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ADX415 taken three times a day to achieve a high total daily dose; ADX415 taken three times a day to achieve a mid level total daily dose; ADX415 taken three times a day to achieve a low total daily dose; Placebo taken three times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; High blood pressure; Htn; Addrenex
Study of a Self-Help Depression Skills Program for College-Aged Youth
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We propose to conduct a pilot trial of an Internet-only depression skills training program
      for adolescents and young adults. The intervention, MoodHelper.org already exists and has
      been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling
      frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a
      enrollment target of 150. Interested members will go to the study Internet site, and if they
      choose to participate, complete the online consent and assessment battery (used in the
      previous pilots). Participants will be randomly assigned by the site's software to one of two
      conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org web
      site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health
      care, but with no access to the therapeutic portion of the SADhelper site. All participants
      (those with and without access to the research intervention) will be reminded by e-mail and,
      if necessary, by telephone to return to the web site and complete follow-up questionnaires
      four, eight, sixteen, and thirty-two weeks after enrolling in the study.
    

Detailed description: 
      We propose to conduct a pilot trial of an Internet-only depression skills training program
      for adolescents and young adults. The intervention, MoodHelper.org already exists and has
      been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling
      frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a
      enrollment target of 150. Interested members will go to the study Internet site, and if they
      choose to participate, complete the online consent and assessment battery (used in the
      previous pilots). Participants will be randomly assigned by the site's software to one of two
      conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org web
      site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health
      care, but with no access to the therapeutic portion of the SADhelper site. All participants
      (those with and without access to the research intervention) will be reminded by e-mail and,
      if necessary, by telephone to return to the web site and complete follow-up questionnaires
      four, eight, sixteen, and thirty-two weeks after enrolling in the study.
    

Intervention name(s): MoodHelper Internet program for Depression Self-Help
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's
      Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in
      healthy, adult, human, male subjects under fed conditions.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single
      dose, crossover bioequivalence study in healthy, adult, human, male subjects under fed
      conditions.64 healthy male adults were enrolled.A washout period of 07 days was maintained
      between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was
      administered orally with 240 mL water in sitting posture, after an overnight fast of at least
      10 hours in each period. This activity was followed by a mouth check to assess compliance to
      dosing. The subjects were not allowed to lie down for the first two hours after dosing.
    

Intervention name(s): Mycophenolate Mofetil; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited; 250 mg capsules of Roche Laboratories Inc.
Other intervention name(s): Cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence; Mycophenolate Mofetil; crossover
VI-1121 for the Treatment Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and
      effective as a daily treatment for Alzheimer's disease that is worsening despite current
      treatment.
    


Intervention name(s): VI-1121; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: donepezil; VI-1121
Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis
Condition: Liver Cirrhosis; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis; Fibrosis
Study type: Observational

Summary: 
      Several studies have confirmed that patients with cirrhosis possess an imbalance in
      procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein
      C. Moreover, in the last two decades there has been an increased recognition that not only
      bleeding but also thrombosis complicates the clinical course of cirrhosis. The prevalence and
      pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without
      hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the
      prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular
      carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these
      patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The
      patients are going to follow up for one year and evaluate at baseline and every 6 months by
      liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical
      events will be evaluated at every follow up.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cirrhosis of any etiology and severity
      
Biospecimen description: 
      serum, plasma
CP-690,550 Pharmacokinetics In Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese
      subjects following both single doses and multiple doses of drug.
    


Intervention name(s): CP-690,550
Intervention type(s): Drug
Intervention description(s): Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      There are few studies evaluating best bathing practices in the management of pediatric atopic
      dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In
      concert with application of topical corticosteroids (TCS), we sought to investigate whether
      frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application
      of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent
      soaking baths (i.e. twice weekly for two weeks) in the management of AD.
    

Detailed description: 
      To evaluate the effectiveness of twice daily soak-and-seal baths for improving severity of
      disease in children with AD, we implemented a randomized clinical trial using a single-blind,
      crossover-controlled design. Patients received the same moisturizer, cleanser, and class VI
      topical corticosteroid (TCS), and only bathing varied. After a 1 week run-in, children were
      randomized 1:1 into 2 groups: Group 1 underwent twice weekly soak-and-seal baths for 2 weeks
      ("dry method") followed by twice daily soak-and-seal baths for 2 weeks ("wet method"), and
      group 2 did the converse. A single treating physician assessed outcomes and, along with those
      analyzing the data, was masked to group assignment. Participants and their caregivers could
      not be masked. Analyses were based on intention to treat.
    

Intervention name(s): Infrequent versus Frequent Soaking Baths
Intervention type(s): Behavioral
Intervention description(s): Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.
Other intervention name(s): Soak and seal baths; Soak and smear baths
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Single-blinded, Prospective Crossover Controlled Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis; bathing; baths
Understanding Experimentally Induced Hot Flushes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to examine the impact of hot flushes on sleep, mood, and
      well-being. The investigators will cause hot flushes by giving study participants the hormone
      medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the
      body think that it has reached menopause temporarily. Most women begin to have hot flushes
      within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators
      will administer questionnaires to evaluate changes in sleep and mood over the course of the
      study.
    


Intervention name(s): Leuprolide acetate
Intervention type(s): Drug
Intervention description(s): Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection
Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.
Other intervention name(s): Lupron
Intervention MeSH terms: Leuprolide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lupron; Premenopausal; Hot flashes
Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Condition: Penicillin Allergy
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Study type: Interventional

Summary: 
      Currently it is estimated that at least 25 million people in the United States are labeled as
      penicillin allergic although less than 1.5 million of these are truly allergic. Although
      combined skin testing and oral challenge is an evidence-based de-labeling strategy the high
      burden of penicillin allergy labels means these services are available only through specialty
      allergy practices. There is therefore a need to provide evidence for alternative penicillin
      de-labeling strategies such as direct oral challenge. Previous studies have utilized
      quasi-experimental designs. Test dose challenges are currently recommended as a strategy for
      removal of low risk drug allergies, but the current experience is limited to single arm
      observational studies and evidence-based strategies for identifying low risk patients are
      lacking. The investigators objective is to demonstrate the benefit of providing risk
      stratification in removing penicillin allergy labels for low risk penicillin allergy patients
      in a single arm intervention pilot trial in the ICU setting, which will pave the way for a
      future stepped wedge randomized control trial (stepped wedge trial entered separately in
      clinical trials.gov as NCT03702270)
    


Intervention name(s): Penicillin Allergic Risk Stratification Best Practice Alert
Intervention type(s): Other
Intervention description(s): Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Intervention MeSH terms: Penicillins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140
      mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions
    

Detailed description: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Sumatriptan Succinate
      Tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan)
      manufactured by OHM Laboratories Inc. with IMITREX® tablets 100 mg (containing sumatriptan
      succinate equivalent to 100 mg sumatriptan) manufactured by GlaxoSmithkline Research Triangle
      Park, NC 27709, Made in Canada in healthy, adult, male, human subjects under fasting
      condition.

      Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate
      tablets 100 mg (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan)
      of either test or reference formulation was administered during each period of the study,
      along with 240 mL of drinking water at ambient temperature under low light condition and
      supervision of trained study personnel.

      32 subjects were enrolled into the study. However, twenty seven (27) subjects completed both
      the periods of the study. Pharmacokinetic and Statistical analysis was performed on twenty
      seven subjects (27) subjects.
    

Intervention name(s): sumatriptan 100mg
Intervention type(s): Drug
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Simulation Based Training in Colonoscopy
Condition: Group Identification
Study type: Observational

Summary: 
      The aim of this study is to create simulation-based tests with credible pass/fail-standards
      for two different fidelities of colonoscopy models

        1. virtual reality simulator

        2. physical model simulator To create pass/ fail standards for certification
    

Detailed description: 
      Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first
      year of fellowship without endoscopic experience) will be tested twice on each of the two
      different simulator models.

      Metrics with discriminatory ability will be identified for both modalities. Reliability will
      be determined A pass/ fail standard will be determined and the concequences explored.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (>350
        procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy
        (<2 procedures)
      
Keywords: Colonoscopy; assessment; certification,; simulation,; standard setting
Evaluation of Salt Sensitivity in Young Adults
Condition: Healthy Volunteers
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The current prospective cross-sectional pilot study is proposed to determine a set of
      characteristic factors associated with salt sensitivity in young adults by measuring blood
      pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central
      arterial pressure in response to short term increases in salt intake.
    

Detailed description: 
      Since salt sensitivity at an early age is associated with subsequent hypertension and an
      increase in mortality, intervention by lifestyle modification including the reduction of
      sodium intake could prevent subsequent increases in blood pressure and development of
      hypertension, cardiovascular disease and death. It would therefore be beneficial to have a
      simple method of identifying salt sensitive young adults so that risk factor modification can
      be achieved to prevent progression of the effects of hypertension on heart function.

      This study is a longitudinal pilot study to identify characteristics of salt sensitive young
      adults so that this population of people can be identified early on and appropriate lifestyle
      modifications can be made to prevent the subsequent progression of hypertension and
      cardiovascular disease.

      The study will be conducted at 2 visits separated by one week. At the first visit, eligible
      subjects will be asked to complete questionnaires regarding childhood and current sodium
      intake.Subjects will be asked about family history of hypertension and cardiovascular
      disease. Subjects will also undergo blood pressure measurement in both arm, and will provide
      a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times
      a day for one week, and then return to the study center for a repeat of the above
      measurements.
    

Intervention name(s): Salt tablet
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be given salt tablets and instructed to take 4 grams of sale three times a day (total of 12 grams of salt/day) for one week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic