bioihbjkbjnl/mcl2 huggingface dataset:
Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk (R-Vets Sleep)
Condition: Insomnia; Mental Health Functioning; Physical Health Functioning
MeSH terms: Sleep Initiation and Maintenance Disorders; Suicide
Study type: Interventional

Summary: 
      Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental
      health functioning and is associated with reduced quality of life. Cognitive Behavioral
      Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however,
      access to CBT-I is severely limited by a lack of trained clinicians within the Veterans
      Health Administration (VHA). There is a critical need to offer innovative approaches to meet
      the demand and need for insomnia treatment. Leveraging technology to meet treatment demands
      is consistent with service delivery models based upon stepped care principles. This
      randomized controlled trial will determine whether a computerized, self-guided, web-based
      version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning
      compared to a computerized program control.
    


Intervention name(s): Computerized Cognitive Behavioral Therapy for Insomnia; Sleep Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.; A web-based program will deliver components of sleep education via an Internet platform
Other intervention name(s): cCBT-I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT-I; Insomnia
Biomarkers of Whole Grain Wheat and Rye Intake
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye
      grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in
      measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are
      absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable
      biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting
      this proposal. Different AR species are present in characteristic quantities in WG wheat in
      comparison to WG rye cereals, which can allow identification of the main source of WG (wheat
      or rye) in individuals by analysing the AR concentrations in blood. However the patterns of
      urinary AR metabolite excretion following wheat or rye intake have not yet been investigated
      to determine if there are differences according to WG source.

      The present study aims to:

      (i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine
      samples after following a predominantly WG rye-based diet in comparison to a predominantly WG
      wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity
      and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine
      samples.
    


Intervention name(s): Whole grain rye; Whole grain wheat; Refined cereal
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nutritional biomarker; Dietary assessment; Whole grain; Wheat; Rye; Alkylresorcinol; Urine
Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the relative bioavailability of
      three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation
      (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and
      administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy
      volunteers, with the aim to compare the bioavailability of the three formulations. All
      treatments will be applied fed, 30 minutes after start of the intake of a standard normal
      breakfast.
    


Intervention name(s): BI 207127; BI 207127; BI 207127
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Medium dose film-coated tablet; Medium dose film-coated tablet; Medium dose film-coated tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crustacean Allergy and Dust Mites Sensitization
Condition: Food Allergy; Respiratory Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier
      polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects
      allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but
      with a positive CAP to shrimp, to identify those at greatest risk of food reactions.
    

Detailed description: 
      Most epidemiological data related to allergy to shellfish come from the USA, where 2.5% of
      the adult population is subject to an allergy to shellfish, which is also the leading cause
      of anaphylaxis in adults in these areas. This allergy affects also the European adult
      population, so that the crustaceans were included in the European Directive 2003/89/EC on the
      labeling requirement to indicate any allergenic ingredients (listed in Annex 3 a) used in the
      production of a food and present, although in other form, in the finished product. The
      allergen mainly involved in allergic reactions to shellfish food is the tropomyosin protein
      of PM of about 34-36 kDa, isolated for the first time in the shrimp (Pen to 1), involved in
      the mechanisms of muscle activation and identified in the muscle fiber of many crustaceans
      (Pen i 1, Cha f 1, Cra c 1, Hom a 1, v 1 Lit, Pan s 1, Pen m 1) and molluscs (Hel as 1, d 1
      Hal, Cra g 1, Oct 1 st, Tod p 1). The tropomyosins, identified in many other invertebrates,
      such as dust mites and cockroaches, seem to be cross-reactive with each other, suggesting the
      role of allergens inside of the Invertebrates. In those circumstances, the positivity of
      specific IgE for the crustaceans can thus be determined also by sensitization to tropomyosin
      even for simple cross-reactivity with tropomyosin of the mites, which represents a minor
      allergen Der known as p10.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Will be selected a group of patients (group A) consisted of 50 subjects with a history of
        allergic reactions to shellfish, both slight localized to the oral cavity than severe
        systemic, these patients will show positive IgE to the extract of whole shrimp. In this
        group may also be included subjects with symptoms and circulating IgE positive for dust
        mites, both symptomatic and asymptomatic
      
Biospecimen description: 
      Blood for in vitro investigations
    
Keywords: shellfish; tropomyosin; mites; food allergy
Duchenne Muscular Dystrophy Clinical Trial
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      The primary objective of this investigation is to assess the effectiveness of transcutaneous
      electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne
      Muscular Dystrophy and reduce the impact of DMD upon the participants' quality of life.

      The primary outcome measures will include:

        1. increased muscle strength,

        2. increased range of joint motions and

        3. improved sleep parameters of ASI, N3 and REM.
    

Detailed description: 
      Muscle Strength and Joint Range of Motion Testing - All muscle and joint testing was
      performed at the MedCenter Therapy clinic in Houston, Texas. JTech computerized testing
      system was utilized including Goniometry, Grip testing, Inclinometry, Muscle Testing and
      Joint Range of Motion testing occurred on Day 0, 30, 60, 90, 180, and repeated at 12 months
      to determine muscular strength and joint Range of Motion. JTech computerized testing system
      was chosen on the basis of reliability and accuracy. At each of the testing intervals, the
      testing was administered by the same technician with the same equipment to all of the
      participants. Inter-and intra-tester reliability of the JTech computerized testing system has
      been the subject of multiple studies. Each of which found high ICCs (>0.93) for both inter-
      and intra-tester reliability.

      All sleep studies were performed at Sleep Diagnostics of Texas in The Woodlands, Texas. Prior
      to the clinical trial, all of the participants spent two nights in the sleep unit and their
      sleep study examinations were performed. The second night was used as the Day 0 data. Sleep,
      breathing, arousals and limb movements were scored manually according to guidelines set forth
      by the American Academy of Sleep Medicine. The sleep studies were repeated at 6 months and 1
      year.
    

Intervention name(s): VECTTOR
Intervention type(s): Device
Intervention description(s): The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence.
Other intervention name(s): electrical nerve stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Developing Methods for Completing Future Satiety Studies
Condition: Lack of Satiety
Study type: Interventional

Summary: 
      Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming
      food. Being able to effectively measure satiety is an important concept that has implications
      in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is
      recognized a useful strategy for weight management. Recently, the category of foods marketed
      as having satiating effects has seen significant growth and this trend is expected to
      continue. The purpose of this project is to develop and validate methods for assessing the
      degree of satiety induced by foods and natural health products using commercially available
      food products.

      This trial will examine the effects of a commercially available yogurt (containing added
      protein and fibre) on self-reported satiety and hunger, as well as food intake in both
      controlled and uncontrolled settings.
    


Intervention name(s): Yogurt
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Satiety; Food intake; Yogurt
Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial
Condition: Hyperuricemia; Gout; Kidney Calculi; Diabetes; Cardiovascular Disease
MeSH terms: Kidney Calculi; Nephrolithiasis; Cardiovascular Diseases; Calculi; Hyperuricemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to test the effect of chronic consumption of Quercetin 500 mg
      tablets on blood uric acid and other biomarkers in adult males.
    

Detailed description: 
      The main goal of the research is to determine the long term effects of daily supplementation
      of quercetin, a compound naturally and normally present in food, on the chemical composition
      (uric acid ii and glucose) of blood and urine and on blood pressure, of healthy males.

      Six of the volunteers will collect urine after consuming a standard meal made from fresh
      onion and after quercetin supplement intake, in the same way, with 3 days washout before
      each. The urine collected here will be analysed to check that the supplement is equivalent to
      the food. Stage 2 will only be conducted with supplement and placebo.

      Healthy male volunteers with higher (than average) blood uric acid will be selected and will
      be asked to consume a standard supplement/placebo added to their own diet for 4 weeks per
      phase. Two arms are separated by 4 weeks resting period: quercetin supplement and placebo.
      Blood and urine samples will be taken every other week to detect any changes of uric acid and
      other biomarkers.

      ----- i) Quercetin is found in a variety of foods including apples, berries, brassica
      vegetables, capers, grapes, onions, shallots, tea, and tomatoes, as well as many seeds, nuts,
      flowers, barks, and leaves.

      ii) Uric acid, a compound found in both in the human body and urine, is produced by the
      breakdown of purines, which are nitrogen-containing compounds in substances such as nucleic
      acids (DNA). They enter the circulation from digestion of certain foods, drinks (alcoholic
      beverages like beer and wine) or from normal breakdown and turnover of cells in the body.
      Most uric acid is removed by the kidneys and disposed of in the urine; the remainder is
      excreted in the stool.
    

Intervention name(s): Treatment; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk; Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
Other intervention name(s): Quercetin dihydrate 500 mg tablet; Brand: Nature's Best; Batch Number:114501; Serial Number: 5055148404901; Placebo: lactose tablet; Brand: Fagron; Serial Number: PZN-0921071; Batch Number:1208D001A
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Functional Food
Breakfast and Muscle Health in Children
Condition: Body Weight Changes; Body Composition; Muscle Mass; Energy Expenditure; Nutrition
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      One in every three children ages 2-19 years is overweight or obese. Although multifactorial
      in nature, obesity is primarily attributed to a mismatch between energy intake and energy
      expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE
      associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to
      the energy needed to sustain the body functions at rest and is also related to body
      composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a
      large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more
      energy expended at rest). In addition, muscle plays a central role in whole body protein
      metabolism and disrupted muscle metabolism is associated with the development of many common
      chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease.
      Although the contribution of disrupted muscle metabolism to chronic disease is
      well-established in older adults, the potential impact in children is unknown. The overall
      objective for this primary project application is to determine the role of breakfast protein
      consumption in improving energy metabolism, energy balance and skeletal muscle health in
      obese, school-aged children.
    


Intervention name(s): Carbohydrate; Protein
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.; Participants will receive a protein-based breakfast beverage everyone morning for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia
Condition: Cardiovascular Disease; Preeclampsia; Hypertension; Post-partum Weight Retention
MeSH terms: Pre-Eclampsia; Hypertension; Cardiovascular Diseases; Gestational Weight Gain
Study type: Interventional

Summary: 
      This study will compare two arms in a randomized clinical trial of cardiovascular risk
      prevention in women with a history of preeclampsia. The first arm will provide postpartum
      patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle
      Recommendations for women with a history of preeclampsia. The second arm will additionally
      receive access to a customized patient-informed online program with modules on how to achieve
      the AHA recommendations for diet, activity and weight management.
    

Detailed description: 
      The study team will work with patients via focus groups to develop a novel internet-based
      program to provide information and tools for cardiovascular disease (CVD) risk reduction for
      women who are at increased risk of CVD by virtue of their history of preeclampsia, a common
      complication of pregnancy. The American Heart Association has recently issued guidelines that
      physicians should include history of the hypertensive pregnancy disorder, preeclampsia, as a
      risk factor for CVD. Indeed, research demonstrates that roughly 2 out of 3 women with a
      history of preeclampsia will die from CVD. This study will work with patients with prior
      preeclampsia and with the Preeclampsia Foundation, a patient- based organization, to create
      an online lifestyle modification program ( accessible by computer or smart phone) for women
      with recent preeclampsia to reduce CVD risk. The study is a randomized controlled trial to
      test the program's acceptability, use, and impact on diet, postpartum weight retention,
      physical activity, blood pressure, and patient knowledge and self-efficacy to improve health.
    

Intervention name(s): Web-based educational and motivational modules; Information and Screening Group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preeclampsia; cardiovascular disease; health behaviors; behavioral intervention; web-based; Hypertension; Post-partum Weight Retention
Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0
Condition: Gastrointestinal Symptoms
Study type: Interventional

Summary: 
      The study evaluated the safety, tolerability and acceptability of a lifestyle modification
      program with nutritional supplementation designed to restore balance to healthy bowel
      function in generally healthy subjects
    

Detailed description: 
      To investigate the safety, tolerance and acceptability of a lifestyle modification and
      targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To
      evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic
      profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life
      questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and
      week 4. Vitals signs, weight and body composition were monitored at each visit.
    

Intervention name(s): Prog: Purify-2
Intervention type(s): Other
Intervention description(s): Nutritional Supplements to be administered:
Protein Shakes: one protein shake twice a day
Probiotics (Bacillus Coagulans) once a day
Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day
In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
Condition: Restless Legs Syndrome
MeSH terms: Restless Legs Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or
      gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn
      alone and in combination as well as the tolerability of morphine administered with GEn. The
      dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be
      administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a
      controlled release formulation of morphine will be given. Blood samples for evaluation of
      gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect
      of co-administering both treatments will be assessed using visual analog scales for
      somnolence/sedation, dizziness and nausea.
    

Detailed description: 
      This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or
      gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn
      alone and in combination as well as the tolerability of morphine administered with GEn. The
      dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be
      administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a
      controlled release formulation of morphine will be given. Blood samples for evaluation of
      gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect
      of co-administering both treatments will be assessed using visual analog scales for
      somnolence/sedation, dizziness and nausea.
    

Intervention name(s): morphine Placebo; GEn 600 mg; Morphine; GEn Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Morphine Placebo; Gabapentin enacarbil 600 mg; morphine extended release 60 mg; Gabapentin enacarbil placebo
Other intervention name(s): XP13512; GSK1838262
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment