bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits
Condition: Sleep
Study type: Interventional

Summary: 
      The study aim to test the effect of a meal complement to be taken in combination with an
      evening meal with a glycemic load of 55, to improve sleep quality.
    

Detailed description: 
      Considering emerging evidence on the role of the macro and micro-nutrient composition of
      evening meals, the intervention used in this study will be designed to provide the necessary
      nutrients to promote sleep quality. The IP will be a low caloric nutritional solution,
      combining:

        -  Ingredients lowering glycemic response to evening meals to promote sleep quality

        -  a protein source rich in bioavailable tryptophan to promote sleep quality

        -  supporting ingredients contributing to sleep initiation
    

Intervention name(s): Test Product; Control Product
Intervention type(s): Other; Other
Intervention description(s): Whey Protein Isolate with Mulberry leaf extract; Wheat Protein Hydrolysate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a double-blind, controlled, randomized, 2-arm, cross-over, group sequential design clinical trial. Subjects will receive the two different interventions in a randomized order.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Subjective sleep complaints
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,
      characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after
      subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation
      of anti-GS-5745 antibodies after SC and IV administration.
    


Intervention name(s): GS-5745 SC; GS-5745 IV
Intervention type(s): Drug; Drug
Intervention description(s): GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe; GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine whether titration of Avonex reduces the
      severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine
      whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety
      and tolerability of Avonex intramuscular (IM) injections.
    


Intervention name(s): Avonex
Intervention type(s): Drug
Intervention description(s): Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Condition: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat
      and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to
      Cystic Fibrosis.
    


Intervention name(s): Pancrelipase Delayed Release; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 12,000 unit Capsules, dosed individually based on fat intake.; Placebo
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
Prevention of School Dropout for Mexican American Adolescents
Condition: Depression; Conduct Disorder
MeSH terms: Conduct Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the efficacy of a family-based psychosocial intervention
      to prevent school disengagement and reduce the incidence of depression, conduct disorders,
      and school dropout for Mexican American adolescents.
    

Detailed description: 
      Mexican American adolescents are at an increased risk for interrelated problems of poor
      mental health and school dropout. Unfortunately, there is a lack of interventions
      specifically designed to address this risk. This study will evaluate a preventive
      intervention for low-income Mexican American adolescents.

      Participants are randomly assigned to either a multi-component intervention called the
      Bridges to High School Program or a Low Dose Workshop. The 11-week multi-component
      intervention takes place during the fall semester of seventh grade and consists of an
      adolescent group, a parenting group, a combined (parent-adolescent) family group, and a
      school liaison. This intervention focuses on adolescent coping skills, parenting practices,
      family cohesion, and parental support for education. The Low-Dose Workshop consists of a
      3-hour workshop in which adolescents and parents are given information and resources to
      facilitate school engagement. Participants are assessed prior to and immediately following
      the intervention and again in eighth and ninth grade. Academic and mental health outcomes are
      measured with questionnaire-based interviews given to caregivers and adolescents. Teachers
      are asked to complete questionnaires; archival school data are also collected. Diagnostic
      interviews are conducted at the ninth grade assessment.
    

Intervention name(s): Bridges to High School Project
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.
Condition: Coronary Heart Disease; Angina Pectoris; Atherosclerosis
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina Pectoris
Study type: Interventional
Phase: Phase 4

Summary: 
      In the ASCET study, 1000 patients with documented coronary heart disease will be randomized
      to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical
      endpoints will be recorded for at least 2 years and related to the initial aspirin response,
      assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher
      composite event rate than responders or whether Clopidogrel treatment in patients
      non-responsive to aspirin will reduce their risk of future clinical events. The clinical
      events are the composite of unstable angina, myocardial infarction, stroke or death.
    

Detailed description: 
      Background: Aspirin is widely used as an antiplatelet drug in patients with coronary heart
      disease. Despite documented clinical benefit, many patients on aspirin still experience
      severe cardiovascular events. Several laboratory reports have shown lack of platelet
      inhibition in 5-40% of aspirin-treated patients, and the term aspirin resistance has been
      introduced. The clinical relevance of these laboratory findings is, however, still unknown.
      New antiplatelet drugs have been developed, and the adenosin diphosphate (ADP) receptor
      inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety
      profile. Laboratory methods for determination of platelet reactivity and treatment efficacy
      have been complicated and time consuming. New methodologies, like the PFA-100® system, have
      made such analyses more suitable for clinical use.

      Design: In the ASCET study, 1000 patients with documented coronary heart disease will be
      randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel
      75mg/d after initial determination of their platelet reactivity while on aspirin treatment.
      Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin
      response.

      Scand Cardiovasc J. 2004 Dec;38(6):353-6.
    

Intervention name(s): aspirin; clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin 160 mg once daily for two years; clopidogrel 75 mg once daily for two years
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antiplatelet therapy; aspirin non-responders; aspirin resistance; clopidogrel; coronary heart disease; stable angina pectoris
Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
Condition: Middle Aged Patients; Sevoflurane; General Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to
      investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC
      of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
      in middle aged subjects.
    

Detailed description: 
      Patients received sevoflurane for anesthesia induction and maintenance at preselected
      concentrations according to an 'up and down' design, with 0.2% as a stepsize. General
      anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated
      with cisatracurium. After a steady-state period of 30min without surgical stimulation, the
      state of isoelectric EEG was considered as significant when a burst suppression ratio of 100%
      last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor
      requirement to maintain cardiovascular system were also analysed according to the EEG state.
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): The design of experiment is referred to the "Dixon up-and-down" method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted.
Intervention MeSH terms: Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anaesthesia; middle aged; minimal alveolar concentration; sevoflurane; isoelectric EEG
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA,
      under fasting condition in healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 500 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 12 days including washout period of 9
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Tablets USP 500mg; Etodolac Tablets USP 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet once a day; 500 mg tablet once a day
Other intervention name(s): Test Product; Reference Product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity
Condition: Obesity; Non-obese Controls
Study type: Interventional

Summary: 
      We want to asses the role of adipose tissue for metabolic complications to obesity before and
      after weight loss (surgery).
    


Intervention name(s): Obese; Control group
Intervention type(s): Other; Other
Intervention description(s): gastric bypass; Cholecystectomy and anti-reflux surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Topical Double-blind, Randomized, Placebo-controlled Study in Psoriasis Patients
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the safety, tolerability and efficacy of DLX105 administered topically onto
      the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.
    


Intervention name(s): DLX105 Hydrogel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical administration on psoriatic plaque; topical administration on psoriatic plaque
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Meal Patterning on Carotenoid Absorption From Vegetables
Condition: Carotenoid; Bioavailability; Dietary Modification
Study type: Interventional

Summary: 
      The purpose of this research study is to determine how different meal patterns influence the
      absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that
      carotenoid absorption will be lower when daily vegetables are consumed in one meal compared
      two smaller meals throughout the day.
    


Intervention name(s): Meal Pattern Treatment A; Meal Pattern Treatment B; Meal Pattern Treatment C
Intervention type(s): Other; Other; Other
Intervention description(s): In treatment A, subjects consumed 100% of salad vegetables and canola oil in the first meal and 0% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.; In treatment B, subjects consumed 50% of salad vegetables and canola oil in the first meal and 50% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.; In treatment C, subjects consumed 75% of vegetables and oil in the first meal and 25% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Lumbar Kinematics in People With the Low Back Pain
Condition: Lumbar Disc Herniation; Protrusion; Extrusion of Migrated Disc; Hernia
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Observational

Summary: 
      This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic
      region during daily living activities.
    

Detailed description: 
      Lumbar disc herniation (LDH) is one of the causes of low back pain and contributes to
      increasing the socio-economic problem. Depending on the reason for the dysfunction, various
      classifications describing the level of advancement are used. The literature on the subject
      commonly uses the division into protrusion and extrusion of the intervertebral disc, as
      approved by the American Society of Neuroradiology.

      The lumbopelvic kinematics, including gait and daily living activities, can be affected by
      the LDH: protrusion or extrusion. This pathology may be different due to the direction of
      disc migration: centre, left, right or all mentioned. Therefore, we believe that from the
      different direction of the disc migration the different symptoms can be observed.
    

Intervention name(s): G-Walk
Intervention type(s): Diagnostic Test
Intervention description(s): Every individual will be examined with a non-invasive "G-Walk" device which is a sensor mounted on a belt and fasten on individuals' lumbar spine region during two test activities: Timed up and go and 6-meter walk tests. Data collection will include kinematic parameters. Oswestry Disability Index (ODI) score will also be collected.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Primary care clinic, students
      
Keywords: degenerative disc disease; protrusion; extrusion; gait; kinematics
Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence
Condition: Stress Urinary Incontinence; Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
Study type: Observational

Summary: 
      In this retrospective study the outcome of pelvic floor muscle training in 150 women will be
      tested regarding patients reported satisfaction and achievement of the incontinence
      improvement.

      Comparison of two age groups, controlled for BMI, parity and previous incontinence
      operations.
    

Detailed description: 
      Pelvic floor muscle exercise is an established conservative treatment for female urinary
      incontinence. Up to now, the investigators don't know whether treatment outcome in elderly
      women is as good as in younger premenopausal women. The International Incontinence Society
      states 2009: "There is no good evidence to date to suggest that "healthy" older women with
      urinary incontinence do not benefit from pelvic floor muscle training as much as younger
      women".

      In this retrospective study the investigators analyze patient charts from 2003-2008 regarding
      subjective patients and physiotherapists reported outcome after physiotherapy as well as for
      objective parameters like the need of an incontinence surgery in the follow-up of at least 2
      years.

      Eligibility criteria are age younger than 50 years (premenopausal) and age older than 65
      years and a urodynamically proven urinary incontinence. As incontinence forms the
      investigators include in this study the following three form: stress urinary incontinence,
      mixed urinary incontinence and urgency urinary incontinence.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        women from a tertiary referral center with urodynamically proven incontinence willig to
        perform physiotherapy
      
Keywords: outcome of pelvic floor muscle physiotherapy; female; stress urinary incontinence; urgency urinary incontinence; mixed urinary incontinence
A Study of LY2784544 in Healthy Male Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the
      absorption, distribution, metabolism and excretion of LY2784544. This study is for research
      purposes only and is not intended to treat any medical condition.
    

Detailed description: 
      This study is approximately 10 days long, (minimum 5 days, maximum 15 days) not including
      screening or follow up. Screening is required within 28 days prior to the first dose of study
      drug and follow up is required at least 7 days after discharge from the clinical research
      unit.
    

Intervention name(s): Drug
Intervention type(s): Radiation
Intervention description(s): Single 30 mg oral dose containing 100 micro curies of LY2784544
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Fat on Vitamin D Absorption
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3
      (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal
      associated with the administration of the supplement.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplement of vitamin D3; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Vitamin D; Cholecalciferol; Supplementation; Dietary Supplements; Dietary Fats; 25-hydroxyvitamin D