bioihbjkbjnl/mcl2 huggingface dataset:
TAKing Steps for Incentives
Condition: Physical Activity; Incentives
Study type: Interventional

Summary: 
      The purpose of this study is to test the overall effects of incentives on physical activity
      among older taxi drivers, and whether mental accounting exists in this context.
    

Detailed description: 
      As part of the 4-month Randomized Controlled Trial, participating taxi drivers will be
      assigned to 1 of 2 groups where they will receive either cash or taxi rental credits for
      meeting specified monthly step goals measured via a step counter. Subsequently, for an
      additional 3 months, drivers will be incentivized to wear step counters to test if effects of
      the rewards are sustained once the reward is no longer in place. Effects will be quantified
      in terms of step activity; and in terms of changes in Body Mass Index (BMI), Resting Heart
      Rate (HR), Blood Pressure (BP), self-reported General Health, Health-Related Quality of Life
      (HR-QOL) and work productivity.
    

Intervention name(s): Incentive-based physical activity program; 3-month follow up
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Drivers will be offered rewards valued at a day's rental for meeting daily step targets over the specified number of days each month from Months 1 to 4, where steps will be tracked by a step counter. They will also be offered incentives for meeting the following criteria:
Accurately predicting step target attainment the following months (SGD10)
Wearing and providing step data over the month (SGD10 and a chance to win 1 of 3 cash prizes valued at SGD500); After the 4-month RCT, drivers will be incentivized to wear the step counter for another 3 months (i.e. Months 5 to 7) to test if effects of the rewards are sustained once the reward is no longer in place. For wearing their step counter and providing their step data, drivers will receive a modest cash incentive (amounting to SGD10) each month as well as the chance to win 1 of 3 cash prizes valued at SGD500.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical Activity; Incentives; Mental Accounting; Older adults
Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes
Condition: Diet, Reducing
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and
      athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term
      evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight
      loss to achieve a desired weight category. The purpose of this study was to investigate the
      impact of the low carbohydrate diet combined with strict calorie restriction on body
      composition and exercise performance in taekwondo athletes.
    

Detailed description: 
      This study used a randomized cross-over design. Each participant completed a low carbohydrate
      and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each
      trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The
      purpose of this study was to investigate the effect of 7-day caloric restriction with low- or
      high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and
      taekwondo-specific performance.
    

Intervention name(s): calorie restriction diet
Intervention type(s): Dietary Supplement
Intervention description(s): The 7-day low-calorie diet contained 15.8 ± 0.4 kcal/kg/d in both trials, divided into three meals a day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Beverage Choice and Lifestyle Modification in Overweight Youth
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The rise in childhood overweightness and concomitant increase in chronic disease risk
      warrants exploration into the effectiveness of interventions targeting the eating and
      activity habits of overweight youth. This research study developed and tested a "Beverage
      Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are
      at-risk for being overweight or are overweight and who consume large amounts of sugar
      sweetened beverages and juice. The overall study objectives were to test the acceptability
      and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)
      intake, beverage selections and beverage preferences of children in targeted age and BMI
      group. The investigators hypothesized that those children randomized to the BCLM group will
      show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and
      energy intake than those assigned to our Nutrition Education (NE) group.
    


Intervention name(s): Beverage Choice and Lifestyle Modification; Nutrition Education (NE)
Intervention type(s): Behavioral; Other
Intervention description(s): The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.; This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.
Other intervention name(s): NE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Child Overweight
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition
Condition: PreTerm Birth
MeSH terms: Dental Caries; Premature Birth
Study type: Observational

Summary: 
      The purpose of the study is to determine the prevalence of dental caries in preterm birth
      children aged 2-5 years in primary dentition.
    

Detailed description: 
      The purpose of the study is to determine the prevalence of dental caries in preterm birth
      children aged 2-5 years in primary dentition.

      PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University
      Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.

      Outcome (O) =prevalence of dental caries
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        population is limited to preterm birth children aged 2-5 years with primary teeth only ,
        both genders are included.
      
Keywords: pre-term children
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of the study is to determine whether blood sugar control is different between
      Lantus and a third oral anti-diabetic agent when added to patients who fail a
      thiazolidinedione and sulfonylurea or metformin combination.
    


Intervention name(s): Lantus (insulin glargine [rDNA origin] injection); Metformin; Glyburide; Thiazolidinedione
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Insulin Glargine; Glyburide; 2,4-thiazolidinedione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
Condition: People Who Are Overweight or Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether the addition of capsules containing
      soluble fibre complex emulsified with medium chain triglycerides and taken before with meals
      will lead to a significant amount of weight loss, reduced glycemic volatility and diminished
      cardio metabolic risk factors in overweight and obese individuals when compared to a placebo
      control.

      We believe that those participants taking 3-6 capsules per day of the treatment capsules over
      a 14 week period will loose a significant amount of weight compared to the placebo group.
    


Intervention name(s): soluble fibre complex and medium chain triglycerides; cellulose and soybean oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Sleep With the Far-infrared Emitting Pyjamas
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      The aim of this study is to explore the effects of a far-infrared emitting pyjamas on
      improving sleep in adults with poor sleep.
    

Detailed description: 
      Objectives: To explore the effects of a far-infrared emitting pyjamas on improving sleep in
      adults with poor sleep.

      Hypothesis: Subjects who wear the far-infrared emitting pyjamas (FIR pyjamas) will have
      greater improvement in sleep quality than the subjects in sham pyjamas control group
      (sham-pyjamas) at 2, 4 and 6 weeks.

      Design and subjects: A pilot randomized sham-controlled trial. Subjects with subjective sleep
      complaints will be recruited from the community. 40 subjects will be randomized to
      far-infrared emitting pyjamas and sham-pyjamas groups in a 1: 1 ratio. Study instrument:
      Pittsburgh Sleep Quality Index (PSQI) will be used as an overall evaluation of sleep quality.

      Interventions: Subjects in the FIR pyjamas group will received pyjamas with far-infrared
      emitting features and will wear it every night for 6 weeks; subjects in the sham-pyjamas
      group will receive pyjamas in identical appearance without far-infrared emitting features.

      Outcome measures: The primary outcome measure is the PSQI score. Other measures include
      insomnia severity index (ISI), sleep parameters derived from 7-day sleep diary, Hospital
      Anxiety and Depression Scale (HADS), Epworth Sleepiness Scale (ESS) and Satisfaction With
      Life Scale (SWLS) at 2, 4 and 6 weeks. Acceptability of the far-infrared emitting pyjamas
      will also be evaluated.

      Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be
      examined using a mixed-effects model. Clinical significance of sleep improvement between two
      groups will be compared with chi-squared test.
    

Intervention name(s): Far-infrared emitting pyjamas; Sham-pyjamas
Intervention type(s): Device; Device
Intervention description(s): Clothing made in far infrared (FIR) - based textiles could be a sustainable way for alleviating sleep problems with many advantages. Firstly, the proposed far infrared textiles are made of man-made profiled fibers without the addition of chemicals such as ceramic additives or other related coatings.; The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Acceptance of a Partially Hydrolyzed Formula
Condition: Fussy Infant (Baby)
Study type: Interventional

Summary: 
      A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to
      evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on
      infant fussiness.
    

Detailed description: 
      A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to
      evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant
      formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool
      characteristics, parental quality of life, and medically confirmed adverse events will be
      compared between i two study groups.
    

Intervention name(s): Infant Formula - Partially hydrolyzed protein; Infant Formula - Intact protein
Intervention type(s): Other; Other
Intervention description(s): Partially hydrolyzed cow's milk protein; Intact cow's milk protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Adipokines as Predictors of Foot Function, Pain, and Disability in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Healthy Control
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Significant increase in the levels of serum adiponectin, ADA, and hsCRP was reported in all
      RA patients compared to controls.

      Compared to patients with early RA, the increase in these markers significantly correlated
      with disease activity (DAS-ESR), lower f-BMD, radiographic scoring, pain, FFI, and functional
      limitations in patients with established RA.

      Adiponectin showed a negative correlation with serum levels of both ADA and hsCRP. By using
      ROC curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ADA (27.3 IU/L), and
      hsCRP (1.6 mg/L) could be used to estimate early RA in 45 % of the patients. Similarly, using
      cut-off values of adiponectin (32.8 µg/ml), ADA (26.1 IU/L ml), and hsCRP (2.5 mg/L),
      established RA could be predicted in 55 % of patients with 98-99% accuracy.
    

Detailed description: 
      The present study attempts to evaluate the efficacy of adiponectin, ADA, and foot bone
      mineral density (fBMD) as predictors of the disease progression in patients with rheumatoid
      arthritis. A total of 80 RA patients and eighty age and sex-matched healthy controls were
      included in this study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eighty patients diagnosed with Rheumatoid arthritis according to American Rheumatology
        Association criteria and radiographic analysis for at least 10 years previously were
        randomly involved in this study, and eighty age and sex matched healthy controls were
        included in the study following assignment of informed consent.
      
Biospecimen description: 
      Blood samples from all participants were obtained following an overnight fast; serum was
      separated and stored at -80oC until reused for analysis.
    
Keywords: rheumatoid arthritis, adipokines, foot function index, f-BMD
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis
      (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may
      decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of
      drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
    


Intervention name(s): Lersivirine; Rifabutin; Lersivirine; Rifabutin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg once daily for 10 days; 300 mg once daily for 10 days; 1000 mg once daily for 10 days; 300 mg once daily for 10 days
Intervention MeSH terms: Rifabutin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics HIV Tuberculosis Lersivirine UK-453; 061 Rifabutin; HIV Infections
A Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic
      nephropathy is better than the single use.
    

Detailed description: 
      The objectives of this study is:

        1. To evaluate the efficacy of Probucol on deferring nephropathy development of the
           patients with diabetic nephropathy (including: the change value of urine albumin from
           the baseline, the rate of the patients with serum creatinine reaching a doubling of the
           base-line serum creatinine, the rate of the hemodialysis-free survival).

        2. To evaluate the efficacy of Cliostazol and Probucol in combination on deferring
           nephropathy development of the patients with diabetic nephropathy

        3. To evaluate the efficacy of Cilostazol and Probucol in combination on atherosclerosis
           related biomarkers change. Atherosclerosis related biomarkers include:(a)Endothelium
           parameter: ICAM-1, vWF, VCAM-1,and McP-1. (b)Finolysis parameter: TM. (c)Inflammation
           parameter: Hs-CRP; IL-6. (d)Oxidation parameter: Ox-LDL, 8-OHdG. (e)Lipid parameter: TC,
           LDL-C, HDL-C, TG.

        4. To evaluate the efficacy of Cilostazol and Probucol in combination on the progress of
           carotid intima-media thickness (IMT) on patients with diabetic nephropathy.

        5. To evaluate the safety of Cilostazol and Probucol in combination on the patients with
           diabetic nephropathy.
    

Intervention name(s): Probucol; Probucol and Cilostazol
Intervention type(s): Drug; Drug
Intervention description(s): 250mg,Bid; 50-100mg,Bid
Intervention MeSH terms: Cilostazol; Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, non-randomized, open-label Phase 1 study to determine the
      absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a
      single oral dose of [14C] BIIB122 ([14C] DNL151) following a fast. The mass balance,
      excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): [14C] BIIB122 ([14C] DNL151)
Intervention type(s): Drug
Intervention description(s): Oral dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older
Condition: Aging
Study type: Observational

Summary: 
      This study sought to determine if the number of meals per day with an adequate protein
      content (defined as eating >30 g protein or >0.4 g protein/kg body mass each) is associated
      with presenting physical disability in Mexican adults aged 60 years and older. Physical
      disability was evaluated with self-reported questionnaires for different activities of daily
      living.
    

Detailed description: 
      Detailed dietary information was obtained for each participant to estimate dietary protein
      intake per meal (breakfast, lunch, dinner). One meal was considered with adequate protein
      content if it contained >30 g or >0.4 g/kg. Then, the number of meals with an adequate
      protein content was counted and classified as Zero meals, One meal, or Two or Three meals.

      Physical disability was assessed with two validated questionnaires. One for instrumental
      activities of daily living (Lawton) and another for activities of daily living (Barthel).
      Disability was classified for each questionnaire item according to the authors' scales. Most
      items considered a physical disability if the participant reported any difficulty performing
      that task.

      To analyze the association between the number of meals with adequate protein content
      (predictive variable) and physical disability (outcome variable), we used binomial logistic
      regression for each item. For the number of meals, we set the group of Zero meals as the
      reference. The analyses were adjusted for age, BMI categories, number of diagnosed diseases,
      sex, and inadequate protein intake per day (<1.2 g/kg/d).
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Cross-sectional
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Older aged Mexican adults attending to the Geriatrics Department at the Western General
        Hospital (Hospital General de Occidente) for their usual medical screening or first-time
        assessment.
      
Keywords: Protein intake; Older adults; Physical disability; Mexican adults
Emergency Surgery Following Pediatric Catheterization
Condition: Anesthesia
MeSH terms: Emergencies
Study type: Observational

Summary: 
      We study the outcome and prequesties of emergency surgeries that were necessary following
      accidents in the pediatric cardiac catheterization lab
    


Intervention name(s): Surgery following catheterization
Intervention type(s): Procedure
Intervention description(s): Emergency surgery following pediatric cardiac catheterization
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        190 pediatric patients presenting for either diagnostic or interventional cardiac
        catheterization
A Study of Two Macitentan Formulations in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of macitentan on the primary
      pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan
      tablet and the opsumit tablet in healthy adult participants in fasted conditions.
    


Intervention name(s): Macitentan
Intervention type(s): Drug
Intervention description(s): Macitentan dispersible and film-coated tablets will be administered orally as per assigned treatment sequence.
Other intervention name(s): Opsumit; ACT-064992; JNJ-67896062
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science