bioihbjkbjnl/mcl2 huggingface dataset:
A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Aim 1 - The primary aim of the study is to assess whether group counseling is a non-inferior
      intervention compared to the usual care of individual counseling in the management of
      childhood obesity. In order to achieve this aim, the investigators will compare the mean
      change in BMI after 6 months of intervention in the two study arms.

      Aim 2 - The secondary aim of the study is to determine if the change in BMI is associated
      with changes in the dietary composition, physical activity and metabolic profile.
    

Detailed description: 
      This is a non-inferiority study to determine the sample size needed for a larger study to
      explore an intervention strategy focused on nutrition counseling to maximize weight loss and
      minimize cardiovascular risk factors in obese children and adolescents. This is a prospective
      parallel arm, randomized trial, to study the impact of nutritional counseling in an
      individual vs. group setting. There will be a total of four groups. Obese pre-adolescents
      (ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions:
      individual nutrition counseling or group nutrition counseling. Subjects will receive the same
      information in both interventions. All content will be developed prior to starting the
      intervention. Each group session will have a maximum of 7 children with 1 parent/caregiver
      per child and a minimum of 5 children with a caregiver. Group sessions will be one time a
      month for 60 minutes (30 minutes for dietetic session and 30 minutes for
      discussion/questions) and individual sessions will be one time a month for 30 minutes. There
      will be 6 sessions for each group.

      All groups will receive standard of care for physical fitness counseling which includes
      recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours
      a day. All groups will be evaluated for depression and appropriately referred if found to be
      depressed. Behavioral strategies, like mindful eating, will be included in the nutrition
      education.
    

Intervention name(s): Nutritional Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes. Classes will meet one time a month. Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Nutritional counseling; Physical activity; Food diary
Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers
Condition: Prematurity
MeSH terms: Premature Birth; Birth Weight
Study type: Observational

Summary: 
      The aim of the present study is to describe the performance of very low birth-weight preterm
      toddlers regarding expressive language and cognitive development during sensorimotor and
      beginning of pre-operational periods, as well as to compare the performance presented by
      these children to that presented by their full-term peers, according to Genetic Epistemology
      theoretical principles.

      The hypothesis of this study is that very-low birth weight preterms would present a poorer
      performance, concerning expressive language and cognition development,than their full-term
      peers.
    

Detailed description: 
      Very low birth weight preterm infants are known to have risks of cognitive and behavioral
      problems, including learning difficulties, attention deficits and hyperactivity, as well as
      neuromotor deficits. Moreover, they are reported to have a high risk of speech and language
      impairments up to school age, even in cases where major neurological abnormalities are
      excluded. Impairments have been reported both in receptive and expressive language and, more
      specifically, in morphosyntax and naming.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Group:

        Very-Low Birth weight preterm newborns (mean weight: 1073g, mean gestational age: 29 3/7w),
        born in the Hospital of the University of São Paulo between March 2005 and February 2006,
        assisted in the High Risk Newborns Follow up Ambulatory of the University's Hospital.

        Control Group:

        Full-term newborns (mean weight: 3291g, mean gestational age: 39 1/7w), followed up in the
        Pediatrics Ambulatory of the University's Hospital and/or being assisted in the University'
        Hospital Nursery School.
      
Keywords: expressive language; cognition; early development; very low birt weight; prematurity
Muscle MRI in Becker Muscular Dystrophy and in Limb-girdle Muscular Dystrophy Type 2I
Condition: Becker Muscular Dystrophy; Limb-Girdle Muscular Dystrophy Type 2I
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophies, Limb-Girdle
Study type: Observational

Summary: 
      The purpose of this study is to investigate the paradoxical muscle enlargement in the calves
      and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular
      dystrophy type 2I.

      The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle
      structure on MRI and based on a calculation of muscle strength per cross-sectional area.The
      findings will be compared with results from non-affected controls.

      Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.
    

Detailed description: 
      The purpose of this study is to investigate the paradoxical muscle enlargement seen in
      patients affected by Becker muscular dystrophy and Limb-girdle muscular dystrophy type 2I.

      Becker and limb-girdle muscular dystrophies are both hereditary muscular disorders. Both
      diseases appear clinically with shrinkage and muscle weakness of the muscles around the
      shoulder girdle and pelvis, while muscle hypertrophy of the calves and tongue is seen.

      The quality of the enlarged calves has to the investigators knowledge not previously been
      described, and their hypothesis is that the normal correlation between muscle strength and
      muscle cross-section is absent in the calf muscles. Thus the investigators hypothesis
      suggests that there is no actual hypertrophy of the calf muscles, but rather a
      pseudohypertrofy with reduced force per cross-sectional area. With a picture of increased fat
      infiltration and disorganized muscle fibers.

      The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle
      structure on MRI (assessed on both T1 imaging, 3-point Dixon scans, and diffusion tension
      imaging), and based on a calculation of muscle strength per cross-sectional area. Isokinetic
      muscle dynamometry (Biodex-4) will be used to measure muscle strength. The findings will be
      compared with results from non-affected controls.

      Additionally the investigators want to describe the tongue muscle appearance on T1-weighted
      MRI.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Danish patients genetically verified with either becker muscular dystrophy or limb-girdle
        muscular dystrophy type 2I
      
Keywords: BMD; LGMD2I; Calf enlargement; Muscular dystrophy; MRI
Effects of LDX on Functioning of College Students With ADHD
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a
      prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college
      students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students
      with ADHD from two universities (University of Rhode Island and Lehigh University) completed
      a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral,
      psychosocial, and academic functioning were completed on a weekly basis across five
      conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
    

Detailed description: 
      Objective: Evaluate stimulant medication on symptoms and functioning for college students
      with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants
      included 24 college students with ADHD and 26 college students without psychopathology.
      Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases
      (no-drug baseline, placebo, 30, 50, & 70-mg LDX per day). Self-report rating scales of
      functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse
      side-effects were collected (baseline only for control students).
    

Intervention name(s): lisdexamfetamine dimesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Other intervention name(s): Vyvanse; LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking
      tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the
      tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib)
      . This type of CT scan will measure the tumor by volume and by standard measurement (length
      and width). Both methods will be compared to find out whether standard measurement or
      measurement by tumor volume is more accurate.
    

Detailed description: 
      Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor
      Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown
      to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the
      U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after
      failure of at least one chemotherapy treatment. However, it is not approved for the first
      treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.

      Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib)
      at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans
      for tumor response assessment will be obtained at baseline and after 3 weeks of treatment
      with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be
      offered to patients who had at least a 50% (half) decrease in size of their tumor after
      treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the
      receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their
      surgery.

      Post-operative chemotherapy will be administered at the discretion of the treating physician
      to patients with stages IB and II. Patients who receive post-operative chemotherapy will
      begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and
      no longer than 6 months after surgery. Follow-up for recurrence and survival will continue
      for 2 years.
    

Intervention name(s): Tarceva (Erlotinib)
Intervention type(s): Drug
Intervention description(s): Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma,non-small cell lung; preoperative; Tarceva; Response rate
Perioperative Flare in RA: Characterization of Clinical and Biological Features
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Researchers at the Hospital for Special Surgery are trying to learn more about post-operative
      rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint
      replacement surgery and what the result of flaring is for patients over the 6 weeks post
      operation.

      Through this study we aim to describe rates, characteristics, and risk factors of RA flare
      within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)
    

Detailed description: 
      The condition to be studied is worsening (flare) of rheumatoid arthritis (RA) in patients who
      have undergone arthroplasty. RA patients were recruited prior to elective THA and TKA and
      prospectively followed. Clinicians evaluated RA clinical characteristics 0-2 weeks before and
      6 weeks post surgery. Patients answered questions regarding disease activity including
      self-reported joint counts and flare status weekly for 6 weeks.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will comprise of roughly 200 patients with Rheumatoid Arthritis
        undergoing a total joint replacement.
      
Biospecimen description: 
      During surgery, the subjects' surgeon will take samples of the tissue removed as part of
      their surgery from their joint. Specifically for Total Hip Replacement (THR), the femoral
      head will be collected intraoperatively from standardized anatomic sites, (fovea and capsular
      reflection). For Total Knee replacement (TKR), tissue samples of the patella cartilage,
      distal femur and proximal tibia, and synovium from the suprapatellar pouch will be collected
      intraoperatively.
    
Keywords: Rheumatoid Arthritis; Total Hip Replacement; Flare; Perioperative Outcomes
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Condition: Vascular System Injuries; Lipid Metabolism Disorders; Endothelial Disfunction
MeSH terms: Vascular System Injuries; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Women have a natural protection that gives them greater longevity. One hypothesis most
      commonly used is the estrogen protection in the premenopausal period. However many studies of
      various forms of hormone replacement therapy proved ineffective in promoting additional
      protection for women. Thus, it is discussed other ways of protection associated with
      longevity in women. Of these, the sirtuin system was found in several animal studies to be
      associated with longevity. This system also showed, through the involvement of several
      metabolic pathways, an important protection against the process of atherosclerosis. But the
      activity of this system in humans is unknown and if it is more active in women than in men.
      The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55
      to 65 years, and their influence on the main metabolic pathways related to longevity and the
      process of atherosclerosis. The research protocol includes analysis of the influence of
      sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of
      inflammation and homeostasis, before and after the interventions with caloric restriction or
      resveratrol administration. It is expected of this study mechanistic conclusion for longevity
      and possible clinical applications in the mechanism of atherosclerosis prevention.
    

Detailed description: 
      After a washout period of 15 days without medication, men and women will be randomized to the
      group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men)
      will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12
      women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the
      washout period and before the intervention (baseline) and after 30 days of intervention
      (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.
    

Intervention name(s): Resveratrol; Caloric restriction
Intervention type(s): Drug; Behavioral
Intervention description(s): 1 pill daily containing 500 mg/d of resveratrol for 30 days; Diet of 1000kcal per day for 30 days
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sirtuin; atherosclerosis; longevity; calorie restriction; resveratrol; vascular reactivity
A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/
      infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if
      continuous delivery of levodopa and carbidopa can provide reduced variability in plasma
      concentration; to test and compare the PK profile of high and low concentrations of CD; to
      assess preliminary efficacy.
    


Intervention name(s): Levodopa and carbidopa SC solution; Oral levodopa and carbidopa
Intervention type(s): Drug; Drug
Intervention description(s): Levodopa and carbidopa SC solution; Oral levodopa and carbidopa
Other intervention name(s): ND0612
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Motor fluctuations; levodopa pharmacokinetics; levodopa and carbidopa solution; continuous subcutaneous delivery
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A
Condition: Healthy; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design:

      Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with
      Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1
      diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes
    

Detailed description: 
      The principle objectives of this study are to assess safety and tolerability and to explore
      pharmacokinetic(PK) and pharmacodynamic(PD) parameters of a single dose of a novel very-long
      acting insulin formulation (HM12460A) in comparison to a single dose of human Neutral
      Protamine Hagedorn (NPH) in healthy volunteers (part 1), subjects with type 1 diabetes (part
      2) and in subjects with type 2 diabetes (part 3).

      The study will incorporate adaptive elements to provide both PK and PD data. The dose of
      HM12460A to be administered to the subjects with type 1 diabetes and type 2 diabetes will be
      guided by PK data from part 1 of the study; the PD assessment of HM12460A in subjects with
      diabetes will also be informed by knowledge of PK gained from the healthy volunteer study.
    

Intervention name(s): HM12460A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A; Singe dose SC administration of Placebo
Other intervention name(s): LAPS-Insulin
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prophylaxis Versus On-demand Therapy Through Economic Report
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The project is a controlled observational, multicenter, prospective data collection on
      secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A
      (FVIII < 1%).

      The observational period will cover at least 5 years per patient.

      The long-term secondary prophylaxis group will be compared versus on-demand treatment group
      by the assessment of orthopedic status progression and pharmacoeconomics evaluation.
    


Intervention name(s): Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention type(s): Drug; Drug
Intervention description(s): Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly; On-demand treatment with product given only for bleeding episodes
Intervention MeSH terms: Factor VIII
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Haemophilics
Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat
      administered individually or combined three times per day for 24 weeks while on a reduced
      calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit
      (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O
      glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of
      orlistat, either combined or separate.
    


Intervention name(s): Velneperit 400 mg; Orlistat 120 mg; Orlistat Placebo; Velneperit Placebo; Reduced Calorie Diet
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Velneperit 400 mg q.d.; Orlistat 120 mg t.i.d; Orlistat Placebo t.i.d.; Velneperit Placebo q.d; Reduced calorie diet
Other intervention name(s): S-2367; Xenical
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: reduced calorie diet; orlistat; velneperit