bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Different Support Surfaces on Balance in Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      This study will evaluate how age, visual sensation and different ground properties affect of
      postural sways and stability limits at different support surface widths. 60 individuals will
      be included in this study.
    

Detailed description: 
      Balance is considered to be an important component of performance during activity as a result
      of a complex process in which musculoskeletal and neurological systems function. Two
      different balance states are defined as the static balance where the individuals maintain
      their inactive position or the dynamic balance when they perform a foreseen movement. The
      balance is maintained by keeping the center of gravity within the boundaries of the support
      surface and is provided by sensory impulses from the visual, vestibular and somatosensory
      systems organized by the central nervous system. Balance is an important factor to lead an
      independent life, and it is imperative that the balance be ensured in order to ensure that
      daily living activities are performed safely. The neural control of the bipedal posture
      varies depending on the width of the supporting surface, which has a significant impact on
      the frontal plane biomechanics. There is a linear relationship between increased support
      surface size and mechanical stability. In experimental studies, it has been shown that
      increasing muscle width levels in response to translational perturbations seen on the support
      surface on the horizontal plane have decreased with increasing step width. The changes in the
      preferred support surface vary depending on the age of the external environment, recurrent
      falls due to decreased sensory input, or various neurological disorders. However, there are
      few quantitative studies examining the relationship between different support surface widths
      and equilibrium, and the effect of posture width on sensory feedback control is still poorly
      understood. This study was planned to evaluate the effect of age, visual sensation and
      different soil properties on postural release and stability limits at different support
      surface widths.
    

Intervention name(s): balance analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Computerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces.
Intervention model: Single Group Assignment
Intervention model description: Clinical trials with a single arm
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Balance; Stance width; Postural sway; Limits of stability
Oleuropein and Muscle Energy Metabolism
Condition: Muscular Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel
      activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake
      resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is
      linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as
      increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle
      fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen
      consumption rates are decreased in isolated skeletal muscle fibers. The next step in the
      evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and
      decreased physical fatigue in a healthy aging population.
    


Intervention name(s): Olive leaf extract; Placebo
Intervention type(s): Other; Other
Intervention description(s): The investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days).; The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Skeletal muscle energy and fatigue
Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      compare 2-year clinical performance of recent bioactive ionic resin composite to
      resin-modified glass ionomer liner in indirect dental pulp treatment.
    

Detailed description: 
      patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one
      on each side of the mouth. After selective caries removal, cavities were lined with bioactive
      ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner
      (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite
      (Filtek Z350xt). All materials were placed according to the manufacturers' instructions.
      Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline
      and after 6 months, one year, one and half years, and two years.
    

Intervention name(s): ACTIVA bioactive; Riva LC
Intervention type(s): Other; Other
Intervention description(s): bioactive ionic resin composite; resin-modified glass ionomer
Other intervention name(s): Riva light cure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nutritional and Culinary Habits to Empower Families - A Feasibility Study
Condition: Family Research
Study type: Interventional

Summary: 
      Background: Currently, one of the health challenges in the field of public health is to
      improve the quality of life of people with metabolic diseases, using new strategies to
      promote eating habits and lifestyle that allow an active involvement in health.

      Within the new strategies to promote an improvement in the eating habits of the population,
      culinary-nutritional interventions based on culinary medicine or strategies such as
      home-cooking, have been proposed as effective measures for the implementation of healthy
      eating habits in the population. Intervention with families (the environment in which the
      eating habits of children are implemented for the future) should be highlighted.

      Methods: The present project will cover culinary medicine and home-cooking as innovative
      strategies to improve the eating habits of families through an intervention based on
      face-to-face (2) and online (2) cooking workshops, where apart from receiving nutritional
      education, they will be taught a series of culinary techniques (adapted to adults and
      children) so that they learn to cook in an easy, enjoyable and family-friendly way, with
      tools to eat healthier in a simple and quick way.

      The main objective is to evaluate the feasibility of the culinary-nutritional intervention.
      The intervention will be carried out with 15 families (one of the parents and one of the
      children of the family aged between 10 and 14 years), through the measurement of
      anthropometric parameters and questionnaires on eating habits and lifestyles (both individual
      and family). In addition, questionnaires specific to the research will be collected in order
      to study the feasibility of the intervention.
    


Intervention name(s): nutritional and culinary intervention
Intervention type(s): Behavioral
Intervention description(s): Each family will attend a total of 4 culinary-nutritional workshops between April and June 2021. Workshops 1 and 2 will be held in the kitchen located at the Science Building of the University of Navarra and will be given individually to each family.
Workshops 3 and 4 will be online (Zoom) and will be held in groups of 5 families. These workshops will be held from 5.30 pm to 7.30 pm on Fridays or from 11.30 am to 1.30 pm on Saturdays.
Finally, a meeting will be organized with all the families (parents and children) where the recipes prepared by the children for the n-CHEF challenge will be shared and prizes will be awarded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: culinary medicine; home cooking; feasibility study
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly
      dosed with a placebo, in reducing serious behavioral problems in children and adolescents
      with a diagnosis of autistic disorder (AD).
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks; Tablets, Oral, once daily, 8 weeks
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Serious behavioral problems in children and adolescents with AD; Behavioral Problems
A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and
      1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the
      topical treatment in subjects with plaque psoriasis. Results from this study will be
      considered when selecting the most appropriate concentration of GSK2894512 cream and dosing
      frequency in future clinical safety and efficacy studies. This is a multicenter (United
      States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,
      6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and
      1%) and a vehicle control cream will be equally randomized and evaluated following
      application to all psoriasis lesions (except on the scalp) once daily (evening) or twice
      daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks
      screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total
      duration of subject participation will be approximately 16 to 20 weeks. Approximately 270
      adult males and females subjects with plaque psoriasis will be screened in order to have at
      least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and
      approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in
      Japan to achieve at least 24 evaluable Japanese subjects.
    


Intervention name(s): GSK2894512 1% Cream; GSK2894512 0.5% Cream; Vehicle cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically; 0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically; White to off-white vehicle cream base to be applied topically
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Double blind; Dose-finding; Vehicle-Controlled; GSK2894512; Plaque Psoriasis
Objective Sleep Disturbances in Orthostatic Intolerance
Condition: Postural Tachycardia Syndrome; Chronic Orthostatic Intolerance
MeSH terms: Dyssomnias; Parasomnias; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance; Tachycardia
Study type: Observational

Summary: 
      We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will
      test the null hypothesis that there is no difference in time during the various phases of
      sleep between patients and healthy control subjects.
    


Intervention name(s): Polysomnography
Intervention type(s): Procedure
Intervention description(s): Overnight Sleep Study
Other intervention name(s): Sleep Study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with chronic orthostatic intolerance by the Vanderbilt Autonomic
        Dysfunction Center
      
Keywords: postural tachycardia syndrome; sleep; insomnia
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Condition: Abdominal Obesity; Physical Activity
MeSH terms: Overweight; Obesity, Abdominal
Study type: Interventional

Summary: 
      In this randomized controlled trial, we will examine the effect of a 3-month exercise
      training (aerobic exercise versus resistance exercise) without calorie restriction on total
      and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2
      diabetes in overweight girls.
    


Intervention name(s): Control; Resistance Exercise; Aerobic exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Standard care control (no exercise); Supervised resistance exercise using stack weight equipments.; Supervised aerobic exercise using treadmills, bikes, and ellipticals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Visceral fat; Insulin resistance; Liver fat; Skeletal muscle lipid; Regular exercise
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The overarching goal of this project is to develop and test a behavioral intervention
      delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
    

Detailed description: 
      The goal of the proposed research is to compare two evidence-based strategies for preventing
      type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC)
      among Latinas in a "real world" setting. The aims of this study are to 1) develop a
      protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk
      Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic
      markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between
      at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC)
      groups; and 3) understand the social and cultural context surrounding weight-related
      behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas
      assigned to PLI and metformin will have greater weight loss (primary outcome) and greater
      improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
    

Intervention name(s): Promotora-led Intervention; Metformin Therapy; Usual Care
Intervention type(s): Behavioral; Drug; Other
Intervention description(s): Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.; Participants in this group will receive metformin 850 mg bid for one year.; Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Other intervention name(s): ILI; Metformin; Control
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Calcium Metabolism in Caucasian and Asian Postmenopausal Women of Chinese Descent and the Use of Strontium as a Qualitative Marker of Calcium Metabolism
Condition: Calcium Metabolism
Study type: Interventional

Summary: 
      This study aims to: 1) quantitatively assess parameters of bone calcium balance in healthy
      postmenopausal Asian women of Chinese descent; 2) assess possible ethnic differences in
      calcium metabolism by direct comparison of acquired data in Chinese postmenopausal women with
      those acquired earlier in Caucasian postmenopausal women using the same methodology; 3)
      assess differences in calcium and strontium metabolism in parallel to evaluate if strontium
      stable isotopes can be used for tracing bone calcium metabolism qualitatively
    

Detailed description: 
      The study will follow closely the protocol that was used previously by the PI at ETH Zurich
      to study calcium metabolism in healthy postmenopausal women. Calcium metabolism will be
      studied after a single oral administration of a calcium tracer (Ca-41) and by following the
      excretion of the tracer in urine over 6 months. Obtained data will be used to assess
      parameters of calcium metabolism (flux rates and sizes of body calcium compartments) by
      kinetic modelling. A strontium tracer (Sr-84) will be administered in parallel and its
      urinary excretion pattern compared to Ca-41 excretion to determine if strontium tracers can
      be used to assess calcium metabolism qualitatively. Subjects will be supplemented with Vit D
      throughout the study. Vit D supplementation will commence 1 month before isotope
      administration.
    

Intervention name(s): Ca-41(isotope tracer); Sr-84 (isotope tracer); Vitamin D
Intervention type(s): Other; Other; Dietary Supplement
Intervention description(s): Ca-41 is given orally in the form of (Ca-41)Cl3 in citrate-buffered solution. Tracer will be used to determine parameters of calcium metabolism based on tracer excretion data.; Sr-84 is given orally in the form of (Sr-84)Cl2 in aqueous solution.Tracer will be used to determine parameters of strontium metabolism based on tracer excretion data.; One tablet daily (400IU per tablet)
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Calcium metabolism; Osteoporosis; Postmenopausal women
Body Temperature Changes and Early Postoperatıve Pressure Sore
Condition: Pressure Sore; Orthopedic Disorder; Hypothermia; Nursing Caries
MeSH terms: Musculoskeletal Diseases; Pressure Ulcer; Hypothermia; Body Temperature Changes
Study type: Interventional

Summary: 
      This study aims to determine effect of body temperature changes during total knee
      arthroplasty surgery on early postoperative pressure sore formation.
    

Detailed description: 
      BACKGROUND: Intraoperative hypothermia for a prolonged period increases the risk of
      hospital-acquired pressure sores.

      PURPOSE: This study aims to determine effect of body temperature changes during total knee
      arthroplasty surgery on early postoperative pressure sore formation.

      METHODS: This experimental study was performed with experimental-control group (N=122)
      patients. Data were collected with "Personal Information Form", "Body and Ambient Temperature
      Record Form", "Braden Risk Assessment Scale". Experimental group participants were covered
      with a wool blanket, and control group was given standard care.
    

Intervention name(s): woolen blanket
Intervention type(s): Procedure
Intervention description(s): Woolen blanket: The people in the experimental group were treated with a standard hospital woolen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults
Condition: Memory Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether scopolamine-induced cognitive impairment is
      attenuated by the administration of roflumilast in combination with donepezil.
    

Detailed description: 
      The drug being tested in this study is called roflumilast. Roflumilast is being tested as a
      potential treatment for Alzheimer's disease. This study will look at roflumilast combined
      with a medication called donepezil, and their ability to reverse mimicked Alzheimer's disease
      symptoms that have been brought on by administration of a drug called scopolamine.

      The study will enroll up to 28 participants. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of four treatment groups-which will remain undisclosed
      to the participant and study doctor during the study (unless there is an urgent medical
      need). All participants will receive the following treatments at varying time points
      throughout the study:

        -  Roflumilast Dose A tablets

        -  Donepezil 10 mg capsules

        -  Placebo (dummy inactive pill) - this is a tablet or capsule that looks like the study
           drug but has no active ingredient

        -  Scopolamine 0.5 mg subcutaneous injection.

      All participants will be asked to take 2 tablets and 1 capsule and will receive a scopolamine
      subcutaneous injection on the first day of 4 separate study periods. Participants will then
      be assessed for how the scopolamine affects their mental processes and whether the study drug
      improves this.

      This single-center trial will be conducted in England. The overall time to participate in
      this study is up to 95 days. Participants will make 7 visits to the clinic, including 4
      separate periods of 2 days confinement to the clinic, and a follow-up assessment 14 days
      after the last treatment period.
    

Intervention name(s): Roflumilast; Roflumilast placebo; Donepezil; Donepezil placebo; Scopolamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Roflumilast tablets; Roflumilast placebo-matching tablets; Donepezil overencapsulated tablets; Donepezil placebo-matching overencapsulated tablets; Scopolamine subcutaneous injection
Other intervention name(s): Daxas; Aricept; Hyoscine hydrobromide
Intervention MeSH terms: Scopolamine; Donepezil; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy