bioihbjkbjnl/mcl2 huggingface dataset:
Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?
Condition: Schizophrenia; Schizoaffective
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to prospectively examine adherence to oral atypical
      antipsychotics in patients with schizophrenia. We are psrticularly interested in examining
      the level of agreement among self-report, physician impressions and objective measures of
      adherence. We believe that physicians, casemanagers, and clients significantly overestimate
      the level of adherence.
    

Detailed description: 
      Fifty schizophrenia patients will be recruited at the time of their clinic visit to
      Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients
      will be asked to rate the patient's medication adherence on their index clinic visit. Initial
      ratings will also occur at this visit. After filling their medication prescription, all
      subjects will be given electronic medication caps that record each time and date their
      medication container is opened. Patients will then be followed in the community for the next
      12 weeks to observe actual adherence to medication from the index visit to the next
      successive clinic visit. Every two weeks pills will be counted and data will be retrieved
      from the electronic medication caps. During the first and last two weeks of study, blood will
      be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and
      physician assessment of adherence, symptom and attitudinal measures will be obtained a second
      time at the second clinic visit 12 weeks after the index visit.
    

Intervention name(s): MEMS caps
Intervention type(s): Device
Time perspective: Prospective
Keywords: Schizophrenia; Schizoaffective; MEMS; adherence to antipsychotic medication
First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known
      to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating
      population of eosinophils. This is a single ascending dose FTIH study to investigate safety,
      tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3511294,
      administered SC in subjects with mild to moderate asthma maintained on a low-medium daily
      dose of inhaled corticosteroids (ICS) or ICS/long acting beta-agonist (LABA), and short
      acting beta-agonist (SABA). The subjects will attend a pre-screen visit of up to 12 weeks
      before dosing for assessment of blood eosinophils. Eligible subjects with blood eosinophils
      >=200 cells per microliter (cells/µL) will undergo a screening period of up to 4 weeks. The
      subjects will then be randomized into 5 cohorts. In each cohort, the subjects will be
      randomized to receive a single dose of GSK3511294 or placebo in a ratio of 3:1. The follow-up
      period will be up to 40 weeks post dose and will be dose-dependent. The scheduled maximum
      duration for each subject will be up to 44 weeks including up to 28 days of screening.
    


Intervention name(s): GSK3511294; Placebo; Salbutamol/albuterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.; Matching Placebo will consist of 0.9% w/v sodium chloride which will be administered by the SC route.; Salbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, double-blind study in which subjects will be allocated to five cohorts. The subjects in each cohort will be randomized to receive GSK3511294 and placebo in a ratio of 3:1. In each cohort, dosing will be staggered: one subject will receive GSK3511294 and one subject will receive placebo at least 72 hours before the remaining subjects in that cohort are dosed. The remaining subjects will be dosed if the review of all safety data up to 72 hours after dosing of the first two subjects in each cohort is satisfactory.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: eosinophils; pharmacokinetics; First time in Human; GSK3511294; pharmacodynamics; asthma
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      In a previous study, 24 volunteers consumed two conventional eggs or two eggs naturally
      enriched with omega 3, 5 and 7 every day for 3 months. It was shown that these eggs were well
      tolerated and that the omega enrichment led to a reduction in waist circumference of 3 cm in
      3 months.

      The objective of Omegasnack study was therefore to go further in the evaluation of these
      effects on waist circumference; 1) confirm the effects of these eggs on waist circumference
      when included in a snack, 2) determine whether this reduction in waist circumference is
      linked to a reduction in muscle and/or fat mass (subcutaneous and/or visceral) and 3)
      evaluate whether these effects are associated with a modification in the accumulation of
      ectopic fat in the muscle and/or liver.
    


Intervention name(s): Control; Test
Intervention type(s): Other; Other
Intervention description(s): Control group ate snacks composed of dried vegetables, one classical egg yolk and 2.3g of sunflower oil during 10 weeks; Tes group ate snacks composed of dried vegetables, one test egg yolk naturally enriched in rumenic acid, docosahexaenoic acid and punicic acid, 0.34g of pomegranate seed oil and 2.26g of olive oil during 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
MOTIVOB-(Acceptance and Commitment Therapy Group Intervention for Obesity)Section
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT)
      group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese
      individuals with respect to mid-term outcome.
    

Detailed description: 
      Effective weight-management programs often include a combination of physical activity, diet,
      and psychological intervention, in particular Cognitive Behavioral Therapy (CBT). The effects
      of these programs are frequently not stable, and usually the maintenance of achieved
      weight-loss lasts only for a short period of time. Acceptance and Commitment Therapy, ACT,
      keeps on gaining recognition in obesity treatment. The purpose of the study is to compare
      weight loss and indicator of psychological functioning in a population of obese subjects
      belonging to three different diagnostic categories: without ED, with ED NAS and with BED.
      Participants were exposed respectively to a CBT or an ACT treatment and were assessed three
      times: pre intervention, post intervention and follow-up. The investigators hypothesize that
      CBT and ACT are both effective in the post-intervention. ACT intervention should be more
      effective in the follow-up both for weight and psychological functioning, due to its focus on
      the flexible managing of the global context instead of the focus on the pathology itself,
      more typical in standard CBT treatment.
    

Intervention name(s): ACT-based intervention; CBT-based intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACT; CBT obesity; Eating disorders; Health psychology
Physiological Constraints Associated With Trail Running
Condition: Muscle Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The practice of mountain running or "trail" is in full development in France and elsewhere in
      the world. This sporting practice associates specific physiological constraints related in
      particular to the duration of the efforts made (several hours) and to the ground (important
      elevation, technical ground, average altitude). Some studies have allowed the last 10 years
      to initiate the exploration of the physiological consequences of this type of practice,
      especially from a muscular point of view. However, some important questions remain to be
      clarified such as the impact of these sports events on fatigue and muscle recovery,
      cardiovascular, energy and water balance disturbances caused, induced sleep changes and the
      kinetics of recovery of the various parameters. . These elements remain in particular to be
      studied in very different racing contexts as currently developed by the organizers, namely
      race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days,
      4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).
    


Intervention name(s): Pre and post running evaluations
Intervention type(s): Other
Intervention description(s): Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.
Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate
      controlled-release capsules in subjects with chronic low back pain.
    

Detailed description: 
      A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy
      and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with
      chronic low back pain. Subjects will go through an open-label conversion and titration phase
      followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release
      (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label
      Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase,
      and a 2-week Follow-Up Phone Call
    

Intervention name(s): Placebo; Hydrocodone bitartrate
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, no active substance, shells identical to active comparator capsules; dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg
Other intervention name(s): Sugar pill
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; back pain
Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,
      allegedly due to the substantial load of these body regions during work. Work disability is a
      common consequence of these pains. Lowering the physical exposure through ergonomic
      intervention may be a strategy to reduce the workload. An alternative strategy could be to
      increase the physical capacity through strength training of the shoulder-, arm- and
      hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load
      reduction (ergonomic intervention) versus training of physical capacity (strength training)
      on pain and work disability in slaughterhouse workers.

      The main hypothesis is that strength training intervention for 10 weeks compared with
      ergonomic intervention results in reduced pain of the shoulder, arm and hand.
    


Intervention name(s): Strength training; Ergonomic
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Validation of Structured Light Plethysmography: Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients
      with acute asthma; an observational study in healthy participants and during patients'
      clinical investigation of broncho-reversibility in the asthma groups.
    

Detailed description: 
      A non-randomised observational study to validate Structured Light Plethysmography in three
      groups of participants: those with stable asthma and those with acute asthma, who are
      undergoing routine clinical investigation of broncho-reversibility using spirometry. We will
      also observe a normal healthy group who will receive no clinical intervention. SLP data
      capture and spirometry (as part of the patients clinical care) will be performed before and
      after a Bronchodilator reversibility test which is part of the patients normal clinical care
      (except in the normal healthy group where no bronchodilator will be given). The data
      collected from this study will allow us to examine the effect of bronchodilators on breathing
      patterns in these patients and also compare breathing patterns in asthma patients to those in
      healthy individuals.

      The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken
      on bare skin or with the participant (if female) wearing a plain material white bra. The
      participant is asked to sit down on a chair or lie down with their neck in a neutral position
      and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare
      Ltd). The projector is lined up to project the grid of light over the participant's chest and
      upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing,
      They will otherwise be asked to remain as still as possible throughout the measurement.
      During the sequence of breathing, thoracoabdominal wall movements will be captured by the
      device.

      participant on completion of their Bronchodilator Challenge within the Lung Function
      Department or clinic

      The SLP measurement is repeated on completion of their Bronchodilator reversibility test
      within the Lung Function Department or clinic.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 participants between the ages of 2 and 80 with stable asthma who are undergoing routine
        clinical investigation of broncho-reversibilty.

        100 participants between the ages of 2 and 80 with acute asthma who are undergoing routine
        clinical investigation of broncho-reversibilty.

        100 participants between the ages of 2 and 80 with no history of respiratory disease
        ('Normal'). These participants will not undergo a bronchodilator challenge.
      
Keywords: Acute Asthma,
Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention
Condition: Limited Participation in Daily Life Activities
Study type: Observational

Summary: 
      This study evaluates the improvement of participation in everyday occupation among preschool
      children with mild developmental disabilities as a result of Occupational Therapy
      intervention.
    

Detailed description: 
      Preschoolers suffering from mild developmental disabilities are being referred to
      Occupational Therapy (OT) clinics according to limitation in participating of daily
      occupations. As well these children often demonstrate behavior or emotional difficulties. The
      primary treatment goal is promoting participation yet many times the treatment focuses on
      child's performance skills and not on occupation based activities. Respectively its outcome
      measures are the child performance skills. This study will document the therapeutic
      intervention, and evaluate its impact on child participation as well on his performance
      skills and emotional aspects. Participants will be recruited from waiting list for
      Occupational Therapy at Clalit Health services, Child Development Institute, and will be
      evaluate four times. First time on referral to waiting list ( At the present time due to long
      waiting list, children are waiting about three to four months before starting OT
      intervention), second time before treatment, third time after three of treatments and last
      follow-up after three months.
    

Intervention name(s): direct occupational therapy intervention
Intervention type(s): Other
Intervention description(s): Short term direct individual occupational therapy (9-12 weeks).Participants will receive occupational therapy intervention according to health law. The study will document the therapeutic intervention implemented in practice using the Documentation of Occupational Therapy Session during Intervention (DOTSI).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Kindergarten's children referred to Occuptaion Therapy
Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years
Condition: Gastrointestinal Tract
Study type: Interventional

Summary: 
      The current intake of dietary fiber by children in France and Europe is below established
      nutritional recommendations. Therefore, promoting fiber consumption from childhood as part of
      a diversified diet is crucial. For over 20 years, the food industry has been using scFOS
      (short-chain fructo-oligosaccharides), a fiber produced from sugar beet, as an additional
      source of dietary fiber. This solution can help increase daily fiber intake, meet nutritional
      recommendations, and provide positive health effects. Although scFOS are commonly used, there
      has not yet been a prospective study specifically on children aged 6 to 12 to assess
      gastrointestinal comfort following their regular consumption at dietary doses of 10-20 g per
      day.

      The European Food Safety Authority (EFSA) recommends that all manufacturers document the
      safety of food ingredients (EFSA, 2021). This is based on Directive 2002/46/EC, which states
      that substances added to foods, including those intended for specific groups, must be safe
      and bioavailable. The study aims to assess gastrointestinal comfort and scFOS tolerance in
      children aged 6 to 12 and is fully compliant with Directive 2002/46/EC and EFSA
      recommendations.
    


Intervention name(s): short-chain fructo-oligosaccharides (dose 1); short-chain fructo-oligosaccharides (dose 2); Baseline
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 10 g / day at breakfast during 7 days (Day 8 - Day 14); 20 g / day at breakfast during 7 days (Day 8 - Day 14); 0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ScFOS; Tolerability; Childrens
PFA-100 Responsive to Effect of Energy Drinks on Platelet Function
Condition: Platelet Function; Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the
      effect of energy drinks on platelet function. Participants' will have blood drawn prior to
      and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.
    

Detailed description: 
      Two previous studies have demonstrated increased platelet aggregation 60 minutes after
      drinking a commercially available sugar-free energy drink. These studies utilized traditional
      platelet function studies, such as light transmission aggregometry (LTA), where platelet
      function is examined while adding varying concentrations of a panel of agonist to platelets.
      These studies are technically difficult, time intensive studies requiring specialized
      laboratories. They are relatively non-physiologic and do not mimic platelet response to
      vessel wall damage. Other tests better represent the reactions to vessel wall damage,
      including the PFA-100, which measures platelet aggregation and adhesion under conditions of
      high shear.

      Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming
      than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker
      of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has
      also shown differences in closure time between sedentary and athletic individuals PFA-100 has
      not been used to investigate the effect of energy drinks.
    

Intervention name(s): PFA-100
Intervention type(s): Device
Intervention description(s): The PFA-100 will be used to assess platelet function before and after energy drink consumption.
Other intervention name(s): Platelet function analyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other