bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
Condition: Bipolar Disorder; Alcohol Abuse
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to study the effects (both good and bad) of combining
      quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of
      elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor
      judgment, reckless behavior) and to study the effects (both good and bad) of combining
      quetiapine and topiramate for reducing use of alcohol.
    

Detailed description: 
      Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of
      topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in
      adolescents with bipolar disorder.

      Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to
      greater reduction in alcohol consumption (number of drinks per day, number of drinks per
      drinking day, and number of heavy drinking days) and greater abstinence (percentage of days
      abstinent) compared with quetiapine alone.

      Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing
      manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.

      Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce
      greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.
    

Intervention name(s): quetiapine and placebo; Quetiapine and Topiramate
Intervention type(s): Drug; Drug
Intervention description(s): Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.; Dosing Schedule and Titration of Quetiapine:
open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
Dosing Schedule and Titration of Topiramate:
All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.
Other intervention name(s): Quetiapine; Topiramate
Intervention MeSH terms: Topiramate; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adolescents
Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major
      efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is
      associated with the development of weight-related comorbid conditions and increased
      morbidity.

      Regular physical activity is an important modality of obesity management. Despite
      controversies, poor exercise tolerance has frequently been reported in youth obesity and the
      cause of this limited exercise tolerance remains unknown. Several factors accompanying
      obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such
      as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary
      volumes are associated with obesity and may impact exercise intolerance in this population.
      Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to
      exercise can become constrained in obesity. A thorough understanding of the mechanisms
      underlying this exercise intolerance remains fundamental in order to favour long term
      adherence to exercise training. This is especially true in youth populations, in which the
      management of overweight and obesity must be undertaken as soon as possible, due to the early
      onset of cardiovascular risk factors.

      The main purpose of this study is to determine early-onset cardio-respiratory mortality
      factors in obese adolescents as well as their relation with exercise intolerance (i.e.
      dyspnea) when compared with age and gender-paired normal-weight volunteers.
    

Detailed description: 
      Physiopathological trial. Expected total enrollment : 20 obese adolescents + 20 control
      subjects Tested treatment: Exercise training (4 hours per week). Treatment duration: 12 weeks
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): 12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower).
Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Adolescent; Exercise training; Exercise tolerance
Placebo Modulation of Orthodontic Pain
Condition: Pain
Study type: Interventional

Summary: 
      How placebo modulates orthodontic pain remains largely unknown. The present study aimed to
      investigate the placebo modulation of brain activity associated with orthodontic pain using
      fMRI.
    

Detailed description: 
      How placebo modulates orthodontic pain remains largely unknown. The present study aimed to
      investigate the placebo modulation of brain activity associated with orthodontic pain using
      fMRI. 23 voluneers were recruited in a longitudinal fMRI experiment. At both the baseline and
      the one-month follow-up, orthodontic separators were placed between right lower molars 24
      hours before MRI scans. At baseline, the subjects were scanned without placebo while all
      subjects took placebos half an hour before the scan at follow-up. Scans include a
      bite/non-bite task fMRI and a followed resting state fMRI. A generalized linear model was
      used to identify pain-regulating network from task fMRI, and functional connectivity analysis
      of pain related brain regions was performed to study the possible modulation of placebo on
      connectivity of pain-regulating networks using resting-state fMRI.
    

Intervention name(s): placebo; orthodontic elastic separators
Intervention type(s): Other; Device
Intervention description(s): participants took placebos (pills made by starch) that were told to be an effective analgesic.; Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Yoga, Immune Function, and Health
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to examine the impact of hatha yoga on immune and hormonal functioning
      in healthy individuals.
    

Detailed description: 
      This study is designed to examine the effects of hatha yoga on autonomic, immune, and
      endocrine function. The data from both inexperienced and experienced groups will help us
      better understand how longer-term practice of yoga may be beneficial. The study consists of
      one 3-hour screening session and three 6-hour activity sessions with 30 minute follow-up
      appointments the following morning scheduled 2 - 4 weeks apart. Each participant will
      complete the 3 activity sessions, which will consist of either yoga, mild movement, or a
      neutral activity (watching a videotape), in randomly assigned order. Thus, both novices and
      experts will participate in 3 activity sessions each (yoga, movement control, video control).
      The order in which each participant goes through the activity sessions is counterbalanced.
      Data for each activity session will be aggregated by group (i.e. novice or expert). We will
      measure responses to tape stripping to assess skin barrier repair, and evaluate responses to
      computer tasks, self-report measures, and a battery of unobtrusive behavioral measures. We
      will also collect blood and saliva samples to measure immune and endocrine outcomes.
    

Intervention name(s): Hatha Yoga Classes; Movement Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Iyengar yoga, the form of hatha yoga used in this study, emphasizes the use of props to help students achieve precise postures safely and comfortably according to their particular body types and needs. The yoga activity sessions were directed by four experienced yoga teachers following a script. The poses used were (in order) Supta Baddha Konasana (Reclining Bound Angle Pose), Adho Mukha Svanasana (Downward Facing Dog), Supported Uttanasana (Intense Forward Stretch), Parsvotanasana (Intense Side Stretch Pose), Prasarita Padottanansana (Wide-Legged Forward Bend), Janu Sirsasana (Head to Knee Pose), Bharadvajasana (Simple Seated Twist Pose), Viparita Karani (Restful Inversion), Supported Setu Bandha Sarvanagasana (Bridge Pose), and Savasana (Corpse Pose). Blood draws occurred during the last two minutes of Supta Baddha Konasana (pose held 10 minutes), Viparita Karani (10 minutes), and Savasana (15 minutes).; Walking on a treadmill at .5 miles per hour was used to control for general physical movement/cardiovascular expenditure because it best approximated the heart rates during the restorative yoga session. To match the lower heart rate, women also rested supine on a bed for several minutes after walking, before and after getting their blood drawn.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: yoga; immune function; stress; health; mood; skin barrier repair
Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which
      showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow
      up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.
    

Detailed description: 
      The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in
      95 children treated with dual NRTI. The study showed almost all children to have some degree
      of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major
      mutation.

      After the study, the patients were managed based on the physician's judgment using genotyping
      results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.

        1. No viral resistance

        2. Low grade resistance with or without clinical/ immunological failure

        3. High grade resistance with or without clinical/ immunological failure.

      There are limited prospective studies evaluating outcome of decision regarding salvage
      therapy after genotyping results

      There are also new mutations that are not considered major mutation that may affect treatment
      outcome

      Knowledge learned from this study will benefit Thai children with NRTI resistance by helping
      pediatricians better choose salvage treatment options
    

Intervention name(s): salvage therapy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Intervention model description: salvage therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV children; genotypic resistance; dual NRTIs; Salvage therapy; treatment outcome; Salvage therapy based on genotyping results; Treatment Failure
Developmental Outcomes
Condition: Hypoxic-Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypoxia
Study type: Observational

Summary: 
      Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and
      in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits
      and/or death at 18-20 months.
    

Detailed description: 
      Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB
      #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The
      developmental assessment tool that will be used is called the Bayley Scales of Infant and
      Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will
      then be compared to the child's HIE biomarkers concentrations already obtained at birth.
    

Intervention name(s): Developmental Outcomes
Intervention type(s): Other
Intervention description(s): A Bayley-III developmental assessment will be performed study subjects at age 18-20 months
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children 18-20 months of age born with Hypoxic Ischemic Encephalopathy (HIE)
      
Biospecimen description: 
      Biomarkers will be compared to developmental outcomes, however these blood samples were
      already obtained through IRB#504-2011
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite
Condition: Dental Malocclusion
MeSH terms: Malocclusion; Open Bite
Study type: Interventional

Summary: 
      Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion
      and maxillary posterior dento-alveolar intrusion as regards open bite closure.
    

Detailed description: 
      Now, maxillary posterior dento-alveolar intrusion has been validated as a conservative
      treatment modality for treatment of skeletal open bite in adult patients. However, it was
      proved that mandibular posterior teeth extrusion take place during the treatment which
      results in reduction in the amount of open. bite closure. Therefore, the aim of our study is
      to compare in a randomized clinical trial methodology between maxillary posterior
      dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar
      intrusion in terms of anterior open bite closure.
    

Intervention name(s): Maxillary posterior dento-alveolar intrusion
Intervention type(s): Procedure
Intervention description(s): Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
Other intervention name(s): Bi-maxillary posterior dento-alveolar intrusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: molar intrusion; open bite; mini-screws
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will
      reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is
      hypothesized that marijuana dependent adolescents who are treated with NAC will use less
      marijuana during treatment when compared to adolescents who receive a placebo.
    

Detailed description: 
      This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment
      for cannabis dependence in adolescents. While recent advances have been made in psychosocial
      treatments for cannabis dependent adolescents, minimal work has been done to investigate the
      potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive,
      over-the-counter agent with a favorable tolerability profile in adults and children, in
      common use since FDA approval in 1963. Preclinical and preliminary clinical research in
      adults suggests a role for NAC in addiction treatment via glutamate modulation.
    

Intervention name(s): N-Acetylcysteine; placebo; Contingency Management
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 1200 mg twice daily for 8 weeks; 2 capsules twice daily for 8 weeks; rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin C Depigmenattion Versus Conventional Technique
Condition: Melanin Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      Although physiologic gingival hyperpigmentation is not a pathologic condition, it is
      considered one of the main esthetic problems in dentistry. It was found that the attached
      gingiva is the most frequently pigmented intraoral tissues followed by the papillary gingiva
      and the alveolar mucosa
    

Detailed description: 
      In addition to all of the previously mentioned actions of vitamin C, it was found to be
      involved in depigmentation due to several factors that not only depend on its direct effect
      on melanin and melanocytes but also due to the overall effect on the applied tissues. Melanin
      is one of the main reservoir for ROS, copper and calcium in the tissue cells . Once vitamin C
      is introduced to the target tissue, it binds efficiently to melanin due to the ROS, calcium
      and copper content which causes intracellular deficiency of these items and the inability of
      the cells to produce melanin. Calcium deficiency causes failure of melanocytes to perform
      cellular adhesion to keratinocytes as calcium is essential to form cadherins . Adhesion to
      keratinocytes is important stimulator to melanocytes in order to produce melanin, format
      dendrites and transfer the produced melanin to neighboring cells . Shortage of the
      intercellular copper limits the formation of tyrosin, tyrosinase enzyme and peroxidase enzyme
      which in turn stops the melanin production .

      Therefore, the aim of the present study is to compare the clinical efficiency of the
      non-surgical intraepidermal injection of vitamin C in comparison to the gold standard
      surgical technique (scalpel technique) for gingival depigmentation.
    

Intervention name(s): vitamin c depigementation
Intervention type(s): Dietary Supplement
Intervention description(s): locally injected vitamin c depigementation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
Condition: Non-24 Hour Sleep-Wake Disorder; Blindness
MeSH terms: Blindness; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™
      2 mg in improving total night sleep duration and stabilizing the circadian clock phase in
      totally blind subjects with non-24 hour sleep-wake disorder.
    

Detailed description: 
      This was a multi-center, double-blind, placebo-controlled study of a once-daily (QD) dose of
      Circadin™ 2 mg in subjects with non-24 hour sleep-wake disorder. Subjects were initially
      treated with placebo for 2 weeks and then were randomly assigned in a 1:1 ratio to receive
      Circadin™ 2 mg or placebo for 6 weeks, followed by a 2-week washout period. The primary
      objective was to assess the effect of Circadin 2 mg given once daily for 6 weeks on total
      night sleep duration. Secondary objectives were other sleep variables recorded by the diary
      like sleep latency, daytime naps and sleep offset time. Other endpoints were CGIC score for
      Severity of Illness and Global Improvement and WHO (Five) Well-Being Index score.
    

Intervention name(s): melatonin (Circadin); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg prolonged release melatonin tablets once daily 2 hours before going to bed; one tablet per day 2 hours before going to bed
Other intervention name(s): Circadin; ATC code N05CH01
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: totally blind subjects
Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients
Condition: Diabetic Nephropathy; Medication Compliance
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared
      with conventional diet.

      low GL may have more favorable effect than low GI diet.
    

Detailed description: 
      According to body weight status of participants, the investigators considered a slight
      calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed
      for all volunteers. Dietary records forms were given to all subjects and they were educated
      how to record their dietary intakes. The investigators asked subjects not to change their
      physical activity level during the study and monitored them for their physical activity level
      by 3 days physical activity records monthly.
    

Intervention name(s): low GI; low GI; conventional diet
Intervention type(s): Other; Other; Other
Intervention description(s): All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.; All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.; All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycemic index; diabetic nephropathy; low glycemic load; inflammation