bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more
      sensitive than FEV1. It can be used to measure lung function in children younger than 6 years
      of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic
      Fibrosis (CF) population. As such, determining if it can be used as a short term
      pharmacodynamic biomarker is paramount.
    

Detailed description: 
      Inhaled Hypertonic saline (7%) is a treatment intervention for Cystic Fibrosis patients and
      has previously been shown to improve lung function and decrease the number of pulmonary
      exacerbations. The Cystic Fibrosis Transmembrane Regulator Gene (CFTR) protein is essential
      for maintaining fluid and electrolyte homeostasis in the lung and CFTR defects cause
      depletion of the periciliary liquid layer which results in impaired mucociliary clearance.
      Inhaled hypertonic saline (7%) acts as an osmotic agent in the lungs; it repletes the airway
      surface liquid (ASL) and improves mucociliary clearance.

      In addition, we have recently demonstrated that the Lung Clearance Index (LCI) is also a
      responsive outcome measure. In an intervention study in which patients were treated with
      hypertonic saline inhalation twice daily for 28 days, LCI but not FEV1 significantly improved
      in 17 pediatric Cystic Fibrosis (CF) patients with mild lung disease. In this study, LCI was
      more sensitive to a change in response to treatment than spirometry in a small number of
      patients. However, it still remains unknown if the LCI will be able to detect a treatment
      effect on a shorter time scale after an intervention. Its use as a short-term pharmacodynamic
      biomarker in CF patients remains unknown. The ability of the LCI to detect treatment effects
      within hours after an intervention would be invaluable to the development of new therapeutic
      interventions for CF patients.
    

Intervention name(s): Hypertonic Saline 7%; Isotonic Saline 0.9% (Placebo)
Intervention type(s): Drug; Drug
Intervention description(s): PARI Hyper-Sal™ Sodium Chloride Solution - 7%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pediatric; lung clearance index; Multiple Breath Washout; Hypertonic Saline
Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953
      ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048
      MS, in healthy male subjects. This was the first administration of this substance to humans.
    


Intervention name(s): BIBR 1048 MS dose 1; BIBR 1048 MS dose 2; BIBR 1048 MS dose 3; BIBR 1048 MS dose 4; BIBR 1048 MS dose 5; Placebo to BIBR 1048 MS
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study
Condition: Sensory Nerve Conduction; Oxyneurogram Index
Study type: Interventional

Summary: 
      There are a number of risk factors for development of chronic pain that have been evaluated
      including age, gender, type and duration of surgery, duration of pain prior to surgery and
      tourniquet application. There is some scientific evidence from animal studies demonstrating
      that prolonged tourniquet application can result in lack of oxygen supply to nerves, and
      subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans.
      In this study the investigators will indirectly assess the evidence for abnormalities caused
      by tourniquet application on subjects' nerves using well established devices to determine the
      function of these nerves.
    


Intervention name(s): tourniquet, sensory nerve conduction abnormality
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tourniquet; Endoneural; Ischemia
Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
Condition: Severe Acute Pancreatitis Patients; Duodenal Fistula; Inflammatory Intestinal Obstruction
MeSH terms: Pancreatitis; Intestinal Obstruction; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      Different studies suggest that early enteral nutrition (EEN) has benefits in reducing
      infectious complications, there is no data that addresses whether delayed enteral nutrition
      (EN) is detrimental and if it may have effects on inflammatory responses and immune function.
    


Intervention name(s): enteral nutrition
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Joovvin' for Your Skin Health Study
Condition: Skin Inflammation; Acne; Skin Diseases; Dermatological Non-Disease; Skin Condition; Eczema
MeSH terms: Skin Diseases; Dermatitis; Inflammation
Study type: Interventional

Summary: 
      Sixty day single arm trial examining self-report and remote dermatology assessment of
      cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device
      (the Joovv Mini)
    


Intervention name(s): Joovv Mini
Intervention type(s): Device
Intervention description(s): Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.
Other intervention name(s): Infrared light therapy device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes
Condition: Quality of Life
Study type: Interventional

Summary: 
      Diagnostic of diabetes in childhood brought modification of family way of life, particularly
      in child and caregivers lifes.

      The education patient programs are in France centered on curative competencies of care.

      It is possible that art-therapy improve psycho-social competencies The aim of the study is to
      evaluate art-therapy sessions on quality of life of caregivers
    


Intervention name(s): art-therapy sessions
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Art Therapy; Caregiver's
Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
Condition: Ketogenic Dieting
Study type: Interventional

Summary: 
      The study will examine the performance and body composition effects of ketogenic vs
      carbohydrate-based diets, determine the carbohydrate tolerance ("carbohydrate threshold") for
      active individuals on a ketogenic diet, and then, reexamine the performance and body
      composition effects when the diets are modified with supplemental carbohydrate up to the
      newly defined "ketogenic threshold."
    

Detailed description: 
      Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized
      fashion that considers dietary preferences. They will then undergo baseline testing, begin
      the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate
      titration period in the ketogenic diet group (phase 2). In the following academic semester,
      the training intervention will be repeated with an adjusted dietary carbohydrate level,
      delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).

      Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation
      adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized
      (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2
      days/week) exercise program designed to improve body composition and performance variables.
      During phase 2, the ketogenic diet participants will continue exercising with the same
      program while consuming incrementally greater quantities of carbohydrate pre-workout until
      the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be
      modified to include more carbohydrate. As of completing Phase 2, this amount has been
      determined to be 20g of Carb10 (pea starch).
    

Intervention name(s): Carbohydrate Supplement (Carb10); Diet; Exercise
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): 2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA); 2 groups will be on a carbohydrate-based diet (% energy from carbohydrate:fat:protein, 53:24:23) and 2 groups will be on a ketogenic diet (72:5:23); All groups will participate in a standardized exercise intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Semi-randomized, parallel-group, single-blind diet and exercise intervention
Masking: Single (Participant)
Primary purpose: Other
Keywords: body composition; exercise performance; keto-adaptation
Driving in Adults With Attention-deficit/Hyperactivity Disorder (ADHD) Before and During Treatment With Atomoxetine
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      According available data individuals with ADHD are impaired in their driving ability which
      can be improved by stimulant medication. The impact of the specific
      noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has
      never been studied so far.

      The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD
      on practical driving abilities which will be assessed with a standardized driving test, a
      structured one-week driving diary and driving related neuropsychological processing
      especially different aspects of attention and executive functions which will be assessed with
      a neuropsychological test battery designed for the assessment of drivers fitness. A
      functional magnetic resonance imaging (fMRI) - investigation will also be performed at the
      beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a
      single-blind placebo controlled parallel group design in cooperation of the academic Adult
      ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute
      of Legal and Traffic Medicine of the University of Heidelberg, Germany.

      It is expected that treatment with atomoxetine will improve practical driving abilities and
      driving related neuropsychological processing. It is expected that risk taking and impulsive
      decision making will be reduced and sustained attention and overview of complex traffic
      situations will be improved while driving.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): 40-80 mg atomoxetine once daily, including titration 10 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; adults; driving performance; atomoxetine
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine
      Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese
      population with urgent micturition, frequent micturition and/or urge urinary incontinence.
    

Detailed description: 
      This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison
      with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the
      efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of
      Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or
      urge urinary incontinence.
    

Intervention name(s): Propiverine Hydrochloride; Tolterodine Extended-release Tablet
Intervention type(s): Drug; Drug
Intervention description(s): drug of oral capsule; 4mg/tablet; oral; once per day
Other intervention name(s): Mictonorm; Propierine Hydrochloride Extended-Release Capsule
Intervention MeSH terms: Tolterodine Tartrate; Propiverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overactive Bladder; urgent micturition; frequent micturition; urge urinary incontinence
Role of Slowly Digesible Starch on Diabetes Risk Factors
Condition: Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a slowly digesting starch on gut
      bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with
      pre-diabetes.
    

Detailed description: 
      In a double blind randomized controlled clinical trial, the investigators will test the
      effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk
      factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with
      pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either
      the experimental or placebo starch daily for 3 months. The investigators will test the
      hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will
      improve risk factors for the development of type 2 diabetes (insulin sensitivity and
      secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a
      change in colonic microbial populations.
    

Intervention name(s): Amylose; Amylopectin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.; The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Autonomic Adaptations to Hydration and Brain Functioning
Condition: Hydration
Study type: Interventional

Summary: 
      The influence of relatively small decreases in hydration status have been little studied. On
      two occasions subjects will be allowed to lose about 0,5% of their body weight and one
      occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain
      functioning when performing a mental arithmetic task. Heart rate variability will be
      monitored and related to differences in brain functioning when water has and has not been
      drunk
    

Detailed description: 
      On two mornings twelve male participants will be exposed to a temperature of 30oC for four
      hours and either drink or not drink two 150ml glasses of water during that time. The subjects
      the participate in an fMRI protocol during which they complete a modified version of the
      Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit
      autonomic arousal.

      Throughout the morning subjects will their heart rate variability (HRV) monitored. At
      periodic intervals subjects will rate their thirst and mood by visual analogue scales and at
      the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid
      loss (perspiration and urine) and urine osmolality will be monitored.
    

Intervention name(s): Water; No drink
Intervention type(s): Biological; Other
Intervention description(s): 150 mil of water was drunk on two occasions; Although body weight lost no drink consumed
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over design where on one occasion subjects lost 0.5% body weight,and drank 300ml water and on another occasion nothing was consumed
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hydration; Brain functioning; Heart-rate variability
Imagery Ability in Obstetric Brachial Plexus Palsy
Condition: Brachial Plexus Palsy; Image, Body
MeSH terms: Paralysis
Study type: Observational

Summary: 
      Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity
      after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial
      experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or
      kinesthetic sensation. Imagery is used as a new technique in rehabilitation recently. Various
      studies have reported the importance of imagery and using imagery as a rehabilitation
      technique in different neurologic and orthopedic conditions. This study aimed to evaluate
      imagery ability in children with OBPP.
    


Intervention name(s): Assessment of imagery ability
Intervention type(s): Behavioral
Intervention description(s): Movement imagery, kinesthetic imagery, and visual imagery ability assessed.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with obstetric brachial plexus palsy and healthy children.
      
Keywords: brachial plexus; imagery; body image; sensation; questionnaires
Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the clinical equivalence and the general tolerability
      of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when
      administered to patients undergoing IVF.
    

Detailed description: 
      This is a prospective, multicenter, randomized, investigator blind, parallel group, active
      control, phase III clinical trial. Patients meeting the eligibility requirements of the study
      will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference
      drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any
      contact with the study medications (supplied in boxes labeled in a manner that does not
      reveal the content of the boxes), and requesting that patients do not make any statements to
      the investigator that might indicate the treatment to which they were assigned. Equivalence
      testing with regard to the primary outcome variable will establish whether the two treatments
      are indeed similarly effective.
    

Intervention name(s): hCG-IBSA
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Infertility, sterility, hCG, IVF
Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is the evaluation of concomitant association of
      ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma
      multiforme; study of tolerance and objective response rate.

      The secondary purposes of this study are the evaluation of progression free survival, global
      survival and tolerance through toxicity study. The therapeutic response according to
      methylation or not of MGMT is also evaluated.
    


Intervention name(s): Ultrafractionated brain irradiation; Temozolomide
Intervention type(s): Radiation; Drug
Intervention description(s): 0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy); 75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
Other intervention name(s): Temodal
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are the following:

        -  To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active
           components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single
           oral dose alone and in combination with IW-3718 in healthy adult female participants.

        -  To evaluate the PK of levothyroxine following a single oral dose alone and in
           combination with IW-3718 in healthy adult participants.

        -  To evaluate the PK of glyburide following a single oral dose alone and in combination
           with IW-3718 in healthy adult participants.

        -  To evaluate the PK of digoxin following a single oral dose alone and in combination with
           IW-3718 in healthy adult participants.
    


Intervention name(s): Microgestin®; Levothyroxine; Glyburide; Digoxin; IW-3718
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30 μg/1500 μg tablets for oral administration; 600 μg tablets for oral administration; 5 mg tablets for oral administration; 0.25 mg tablets for oral administration; 500-mg film-coated tablets for oral administration
Other intervention name(s): ethinyl estradiol 30 μg and norethindrone 1500 μg
Intervention MeSH terms: Glyburide; Digoxin; Ethinyl Estradiol; Norethindrone; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Survivor Health and Resilience Education
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      An intervention to assist pediatric cancer survivors to behaviorally manage late effects.
    


Intervention name(s): Health education counseling
Intervention type(s): Behavioral
Intervention description(s): Health education counseling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care