bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral Rx & Nutrition in Pediatric Chronic Disease
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this project is to pilot test a behavioral intervention for modifying the
      diet and physical activity patterns of overweight preschool children through improved
      parenting and nutritional education(LAUNCH). This intervention will be compared to standard
      of care for preschool overweight in the primary care setting using a randomized clinical
      trial design (RCT. The results of this pilot RCT will provide data integral to estimating the
      effect size for a more definitive RCT of the intervention in the future. The primary
      hypothesis is:

      H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the
      standard of care at 12 months post-treatment.
    


Intervention name(s): LAUNCH; Pediatrician Counseling
Intervention type(s): Behavioral; Other
Intervention description(s): A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.; A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Behavioral Treatment; Preschool Children; Obesity Treatment
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)
Condition: Head and Neck Cancer; Pain; Dysfunction
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      People receiving a head and neck cancer treatment often do not find an adequate therapeutic
      response for the side effects derived from this treatment. The objective of this study is to
      assess the effectiveness of a physical recovery program based on manual therapy over these
      problems.

      Previous studies have shown the effectiveness of this type of programs on patients who have
      had cancer in other locations with clinically relevant results. There is a shortage of
      proposals for this subgroup of patients that require special attention. This project intends
      to carry out an experimental randomized controlled study with 84 patients treated of head and
      neck cancer who will be assigned randomly to the study groups: a) manual therapy program or,
      b) control group. The assessment refers to a baseline form (at the beginning of the study),
      at 6 weeks and at 6 months of patient follow-up.
    

Detailed description: 
      Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18
      appointments. Measurements are done before starting, after the last intervention and 6 months
      after finishing the treatment.
    

Intervention name(s): Manual therapy
Intervention type(s): Other
Intervention description(s): 40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Function; Quality of Life; Head and Neck Cancer
Electronic Self-management Resource Training for Mental Health
Condition: Depression; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mental health treatment disengagement may
      be mitigated by reducing barriers to self-management and enhancing self-management skills.
    

Detailed description: 
      Each year, more than four million young adults (age 18-25 years old) in the U.S. receive
      psychotropic medication or psychotherapy as treatment for a mental illness. One in every four
      of these young adults will disengage from mental health treatment before significant symptom
      remission is achieved. Mental health treatment disengagement may be mitigated by reducing
      barriers to self-management and enhancing self-management skills. Electronic self-management
      resource training for mental health (eSMART-MH) is an innovative use of avatars-virtual
      persons who tailor responses to users-to improve mental health treatment disengagement.
    

Intervention name(s): eSMART-MH intervention; Educational videos about healthy living
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Involves simulated interactions between participants and the virtual health care providers (avatars).; 20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Aggreguide A-100 ADP Assay Evaluation
Condition: Platelet Aggregation; ADP Blockers
Study type: Observational

Summary: 
      The study is to characterize the AggreGuide ADP Assay's performance.
    


Intervention name(s): platelet aggregation measurement
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Very little is known about the potential for preventing the prevalence of shoulder complaints
      in handball players, particularly younger players. The aim of this study is to evaluate the
      effect of a shoulder training program on shoulder pain during a season of team handball.
    

Detailed description: 
      Six teams, consisting of 13 to 25 players each, were randomized into two groups throughout
      their competition seasons. Three teams participated in a seven--month, three--times--a--week
      shoulder--muscle strength--training program while three teams participated in a comparable
      handball training program but did not conduct any specific upper--body strength training.
      Effects of this strength--training program were evaluated by comparing pre-- and
      post--training data from a survey on shoulder complaints based on a self--report
      questionnaire (quick DASH) and Visual Analogue Scale (VAS). The players completed the VAS on
      pain once a month. In addition to that the players were tested in a maximum push up test,
      dynamometer test for internal and external rotation strength in the shoulder and throwing
      distance in the pre- and posttest.
    

Intervention name(s): Exercise; Control group
Intervention type(s): Other; Other
Intervention description(s): Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training.; The three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise movement techniques
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      This study aimed to search whether whole body and subcutaneous adipose tissues increase in
      PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.
    

Detailed description: 
      Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass
      index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps,
      triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via
      caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via
      a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA
      was used to measure plasma adiponectin.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with PCOS witout any other metabolik diseases
      
Keywords: PCOS, Skinfold thickness, HOMA-IR
Clinical and Radiographic Outcomes of Dental Implant Therapy
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Observational

Summary: 
      900 subjects having received dental implants 9-10 years ago are invited for a clinical and
      radiographic examination. The individuals were randomly selected from the National Health
      Insurance data register in Sweden.

      The clinical and radiographic examination of the 900 selected subjects will include
      assessments of implant loss, loss of prosthesis and technical / biological complications.

      Biological complications will be assessed from the findings in the clinical and radiographic
      examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD)
      and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in
      radiographs will also be evaluated.

      The prevalence, extent and severity of peri-implantitis will hereby be determined.
      Patient-centered outcomes will also be obtained.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The register of the Swedish Social Insurance Agency was searched for subjects scheduled for
        treatment with dental implants in 2003/2004. In a first group, subjects between 65 and 75
        years old in 2003 were identified and from this pool of about 23.000 individuals, 3.000
        subjects were randomly selected. In a second group, all subjects in the age of 45-60 years
        were identified (n=1716)from the same register. Thus, the total study population in the
        present project included 4716 subjects.
      
Keywords: Cross-Sectional Studies; Prevalence; Peri-Implantitis
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to investigate the relative bioavailability of a BI 144807
      tablet formulation compared to the oral solution formulation after single dose administration
      (intermediate and high dose) under fasted conditions. Further objectives are to assess
      whether and to what extent food affects single dose pharmacokinetics of BI 144807
      administered as tablet, and to compare the relative bioavailability of two different tablet
      formulations.
    


Intervention name(s): BI 144807 high dose; BI 144807 intermediate dose; BI 144807 intermediate dose; BI 144807 intermediate dose; BI 144807 intermediate dose; BI 144807 intermediate dose; BI 144807 high dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral solution; tablet; tablet; tablet; tablet; oral solution; tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery
Condition: Orthopedic Surgery
Study type: Observational

Summary: 
      Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A
      population pharmacokinetic model of fondaparinux, based on data obtained in patients included
      in phase II/III trials, has been described. However, the validity of this model in everyday
      practice needed to be confirmed. This study was a multicenter, prospective cohort study in
      consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were
      recorded in 809 patients. Population parameters and inter-individual variability were
      estimated using NONMEM VI software. A two-compartment model with first-order absorption best
      described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual
      variability were body weight, age and creatinine clearance estimated by the simplified
      Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate
      renal failure increased drug exposure. These results suggest that fondaparinux
      pharmacokinetics need to be confirmed in patient populations not fully assessed in phase
      II/III studies
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with major orthopedic surgery who need prophylactic doses of fondaprinux
      
Biospecimen description: 
      blood sample for anti-Xaactivity measure
    
Keywords: fondaparinux; orthopedic surgery; patients with major orthopedic surgery
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The substantial range of individual responsiveness to plant sterols has important
      ramifications. Marked differences across individuals in particular aspects of the cholesterol
      metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced
      need exists to understand the genetic and metabolic factors that explain the substantial
      degree of heterogeneity in response of lipid concentrations to plant sterols across
      individuals. The primary focus of this trial is to delineate the impact of differing
      cholesterol synthesis levels on response of LDL-C and other plasma lipids to plant sterol
      consumption. Participants pre-identified as high or low endogenous cholesterol synthesizers,
      according to their screening level of lathosterol to cholesterol ratios, will be given PS or
      a placebo containing margarine to consume under supervision for 4 weeks in a crossover
      design. The trial will characterize the responsiveness of the participants' total, LDL, and
      HDL cholesterol, as well as triacylglycerol (TG) concentrations, to plant sterol consumption.
      This research will determine if cholesterol synthesis phenotype predicts the responsiveness
      of lipids to plant sterol consumption. Variations in candidate genes involved in cholesterol
      metabolism will also be investigated in order to find associations with both cholesterol
      metabolism phenotypes and responsiveness of lipids to plant sterols. The output of this
      research will be to advance the knowledge of which genetic factors influence the degree of
      cardiovascular benefit derived from plant sterols through lipid lowering.
    


Intervention name(s): Plant sterol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Cholesterol, Plant sterols, Non-response, SNPs,
Glycemic Response Testing
Condition: Glycemic Index; Glycemic Response
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether added food ingredient(s) affect glycemic
      responses to a liquid meal tolerance test (LMTT).
    


Intervention name(s): Dietary Intervention; Dietary Intervention; Dietary Intervention
Intervention type(s): Other; Other; Other
Intervention description(s): 300 ml of liquid food product; 300 ml of liquid food product; 300 ml of liquid food product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Screening for 3-D Visual Disorders in Preschool Children
Condition: Amblyopia; Strabismus; Anisometropia
MeSH terms: Amblyopia; Strabismus; Vision Disorders; Anisometropia
Study type: Interventional

Summary: 
      Visual screening is necessary among pre-school children as they found themselves in a
      critical period of visual developement. To date, there are no national vision screening
      program that has been implemented nationwide. Vision is a pilot feasibility multicentric
      cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in
      a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in
      Paris with gold-standard ophthalmic examination confirmation.
    

Detailed description: 
      Visual screening is necessary among pre-school children as they found themselves in a
      critical period of visual developement. To date, there are no national vision screening
      program that has been implemented nationwide. Methodology: The "Association Française de
      Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions
      visual screening to assess whether or not a child presents risk factors of amblyopia such as
      ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster
      study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a
      population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in
      Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume
      that a vision screening operated with the AFSOP 3 dimension screening recommendations and
      conducted by paramedical actors such as orthoptists will prove more sensitive and easier to
      implement on a national scale.
    

Intervention name(s): Instillation of cyclopentolate
Intervention type(s): Drug
Intervention description(s): Instillation of cyclopentolate of 3 drops of cyclopentolate at t0',t5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.
Intervention MeSH terms: Cyclopentolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Correlates of Physical Activity With Quality of Life in College Women of Manipal University
Condition: Physical Activity
Study type: Observational

Summary: 
      To find out the relationship between physical activity and

        -  self-esteem,

        -  sleep quality,

        -  anxiety & depression,

        -  body fat percentage,

        -  quality of life, in college females
    

Detailed description: 
      -  After receiving approval from the Institutional Research Committee and Institutional
           Ethical Committee clearance.

        -  Advertisement of the research project will be done via the Head of Department of each
           faculty of the university

        -  Subjects will be recruited on a voluntary basis and a written informed consent will be
           obtained after the research idea is explained.

        -  Demographics of each participant will be obtained

        -  Each of the following questionnaires will be administered:

      Depression, Anxiety and Stress Scale (DASS-21) Rosenberg Self-Esteem Scale Quality of Life
      Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Pittsburgh Sleep Quality
      Index (PSQI) International Physical Activity Questionnaire-Long Form (IPAQ)
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Female who all under 18 -25 yr old and are a student of Manipal University.
      
Keywords: PA,menatal health,QOL
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Condition: Corneal Neovascularization
MeSH terms: Corneal Neovascularization; Neovascularization, Pathologic
Study type: Interventional

Summary: 
      Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor,
      bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal
      neovascularization.
    


Intervention name(s): Bevacizumab (Avastin)
Intervention type(s): Drug
Intervention description(s): Bevacizumab 10mg/mL 1 drop BID x 3 weeks
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative bioavailability of zafirlukast
      tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy,
      adult, human, subjects under fasting conditions and to monitor safety of subjects.
    

Detailed description: 
      open label, randomized, two-period, two treatment, two sequence, crossover, balanced single
      dose comparative oral bioavailability study in healthy, adult, human subjects under fasting
      conditions.44 healthy, adult, human subjects.There was 11-day interval between treatments.
    

Intervention name(s): Zafirlukast
Intervention type(s): Drug
Intervention description(s): Zafirlukast tablets 20 mg
Other intervention name(s): Accolate tablets 20 mg
Intervention MeSH terms: Zafirlukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment