bioihbjkbjnl/mcl2 huggingface dataset:
KidQuest Family-Based Weight Control
Condition: Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a family based diet and exercise program is
      helpful for extremely overweight children aged 8-12, and to compare this approach to standard
      medical management of severe pediatric obesity.
    

Detailed description: 
      The prevalence of pediatric obesity has increased significantly, and approximately 11% of
      American children and adolescents are obese. Of particular concern, the greatest increase in
      prevalence has occured among the heaviest children. Severe pediatric obesity (defined as >
      150% of ideal body weight for height) is associated with higher rates of medical and
      psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier
      than less severely obese children are to become obese adults and suffer the long-term health
      consequences of obesity. Although the efficacy of family-based behavioral weight control
      programs in the treatment of moderate pediatric obesity is well established, few studies have
      focused on the treatment of severe obesity. Thus in this application, we propose a randomized
      controlled trial to evaluate the efficacy of a family-based behavioral weight control program
      in the management of severe pediatric obesity.

      Two hundred children aged 8-12 will be randomized to a six-month family-based program or
      usual care, and will complete assessments at pre- and post- treatment and 6-month and
      12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based
      program, when compared to children who receive usual care, will show favorable changes in
      body mass index, body composition, food intake, activity level, and cardiovascular risk
      factors. 2) Children who participate in the family-based program, when compared to children
      who receive usual care, will report higher levels of self-esteem, social competence and
      health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the
      the proposed investigation is to examine the relationships among gender, race, compliance to
      diet and exercise. level of parent adherence and treatment outcome. The proposed
      investigation is significant as the first effort to systematically evaluate a treatment
      program for severely obese children. It will provide data about a serious public health
      problem and establish a foundation for programmatic research to develop effective treatments
      for an underserved population.
    

Intervention name(s): Family-based treatment
Intervention type(s): Behavioral
Intervention description(s): 20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emollient Therapy for Severe Acute Malnutrition
Condition: Child Malnutrition; Malnutrition in Children; Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The investigators hypothesize that the absorption of topically applied EFA-containing
      emollient (SSO) into the skin and thence into the bloodstream in children with SAM will
      improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond
      that possible through normal standard-of-care
    

Detailed description: 
      A child with SAM, in addition to wasting will often present with infection, hypothermia,
      dehydration and electrolyte imbalance - complications attributable, at least in part, to
      compromised skin barrier function. Essential fatty acid (EFA)-containing emollients such as
      sunflower seed oil (SSO) have been shown to augment skin barrier function, reduce
      transepidermal water loss (TEWL) and risk of bloodstream infection and mortality, and promote
      weight gain in preterm infants. Recent research from rural Bangladesh showed very low levels
      of EFAs in young children in the general population. It is believed that EFA levels will be
      further depleted in children with SAM. So the investigators aim to demonstrate the
      feasibility of topical applications of SSO to children with SAM, and to measure clinical
      impact of emollient therapy with SSO on skin barrier function, skin condition, EFA levels in
      blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute
      rehabilitation from SAM, in addition to the benefits of normal standard-of-care.
    

Intervention name(s): Topical emollient (Sun Flower seed oil)
Intervention type(s): Other
Intervention description(s): 3 g of oil per kg of infant's weight at study entry of Sunflower Seed oil (SSO) will be applied three times per day at regularly spaced intervals (8-hour intervals) for 10 days. Oil will not be applied to the face (to avoid the possibility of any accidental aspiration or ingestion), ears or under the hairline. Care will be taken to not injure the skin during the massage treatment. The child's anal area will be washed prior to application to avoid the spread fecal flora from the anal region (to which the oil will be applied to last). Prior to bathing the child a minimum of 3-4 hours should have elapsed following the application of the SSO. The amount of oil required will be calculated based on the child's weight and the required amount weighed out each time.
Intervention MeSH terms: Emollients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical Trial in two treatment arms
Masking: None (Open Label)
Primary purpose: Treatment
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
Condition: Type 1 Diabetes
MeSH terms: Pure Autonomic Failure; Hypoglycemia
Study type: Interventional

Summary: 
      Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.
    

Detailed description: 
      Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant
      counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior
      activation of GABA(A) receptors may result in blunting of counterregulatory responses during
      next day hypoglycemia.

      The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam
      will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms
      during next day hypoglycemia in T1DM and healthy man.
    

Intervention name(s): Alprazolam; control group
Intervention type(s): Drug; Other
Intervention description(s): 1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2); control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.
Other intervention name(s): Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Beetroot Juice and Postprandial Vascular Activity
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Increased postprandial lipemia may increase the risk for cardiovascular diseases. An
      important mechanistic link between lipemia following a high-fat meal and adverse
      cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to
      identify nutrients that can neutralize this acute vascular disturbance.

      The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could
      improve vascular activity during the postprandial phase.
    


Intervention name(s): Beetroot Juice with oral fat load; Carbohydrate control drink with oral fat load
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd); 140 mL (low-nitrate) carbohydrate control drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: beetroot juice; nitrate; vascular activity; postprandial state
Drug-Drug Interaction Study in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics
      of K-877 in healthy adult subjects.
    


Intervention name(s): K-877; Clarithromycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clarithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Adult Volunteers
Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment
      of chronic hepatitis C virus (HCV) infection. The purpose of this study is to investigate the
      effects of GSK2878175, at different doses in men and women infected with chronic hepatitis C
      virus. The study will investigate how much of the drug gets into the blood stream and how
      long the body takes to get rid of it. The study will also investigate if GSK2878175 has any
      important side effects. The study will also measure what effect GSK2878175 has on the
      hepatitis C virus infection after taking the study medication for 2 days. Approximately 44
      people will take part in this study. Depending on the type of chronic hepatitis C infection a
      subject will be enrolled into 1 of 4 groups randomly. Each group will participate in one
      dosing session. One dosing session consists of GSK2878175 or a placebo (sugar pill) given
      once per day for 2 days.

      Group A, B, and C is made up of 8 participants per group. In each of these groups 6
      participants will receive GSK2878175 and 2 participants will receive placebo. Group D is made
      up of 20 participants. 15 participants will receive GSK2878175 and 5 participants will
      receive placebo. The treatment groups will be dosed in sequence. Group A will be the first to
      take the study medication, then Group B, and so on. The plan is to dose subjects in Group A
      with 10 mg, Group B with 30 mg, Group C with 60 mg, and Group D with 60 mg of GSK2878175 or
      placebo. The next treatment group's actual dose will be decided after looking at the results
      from the previous group. The doses may therefore be higher or lower than planned depending on
      the previous group's results. The number of participants enrolled in the next group may also
      change depending on the results from the previous group.
    


Intervention name(s): GSK2878175; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose.; Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose visually matching GSK2878175.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: NS5B; chronic hepatitis C (CHC); antiviral activity; pharmacokinetics (PK); Safety; hepatitis C virus (HCV); GSK2878175
A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.
Condition: Malignant Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in
      subjects with solid tumours no longer responding to, or eligible for standard therapies, and
      for whom there are no additional standard therapies likely to benefit the subject.
    

Detailed description: 
      The study is an open-label, randomised, 4-period, 4-sequence crossover pharmacokinetic study
      designed to generate in vivo PK data from tablet variants with different size/geometry and
      dose, to correlate with their corresponding in vitro dissolution profiles. The duration of
      each dosing period is 7 days including the washout period. Subjects will be randomised to a
      treatment sequence, following a balanced Latin Squares design. Twelve subjects who meet
      inclusion/exclusion criteria and have provided informed consent will be randomly assigned to
      the treatment sequences: ABCD, BDAC, CADB, or DCBA.

      On Day 1 of each period, subjects will receive a single dose of either Treatment A, B, C, or
      D, according to the randomisation schedule. Serial blood samples for determination of
      olaparib in plasma will be collected for up to 72 hours.

      Cancer subjects with advanced solid tumours are required for this study, as pre-clinical
      toxicology data preclude the use of olaparib in healthy volunteers. The olaparib doses chosen
      will deliver exposure at or below that which has been previously demonstrated to be
      acceptable and tolerated in cancer subjects.
    

Intervention name(s): Olaparib Treatment A; Olaparib Treatment B; Olaparib Treatment C; Olaparib Treatment D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Olaparib Tablet 25 mg; Olaparib Tablet 100 mg; Olaparib Tablet 150 mg; Olaparib Tablet 250 mg
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumor
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis
      Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month
      schedule) in Korean adolescents aged between 11 to 17 years.
    


Intervention name(s): Meningococcal B Recombinant vaccine rMenB+OMV NZ; Placebo; Meningococcal ACWY-CRM conjugate vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.; Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.; Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Other intervention name(s): Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis, adolescents, Meningococcal B
IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Observational

Summary: 
      Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and
      bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment,
      1-2% of patients require parathyroidectomy anually. The use of an intraoperative
      paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of
      standardized protocols, the use of different assays and uneven PTH clearance. The aim of this
      study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for
      predicting successful surgery after parathyroidectomy.
    

Detailed description: 
      A prospective observational study (cohort) was performed in patients who were submitted to
      parathyroidectomy by an endocrine surgeon for SHPT. All were submitted to a bilateral neck
      exploration with a subtotal parathyroidectomy. Three IOPTH determinations were withdrawn: at
      anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion
      gland resection. Another sample was taken 24 hours after the procedure (PTH24), values
      <150pg/mL defined a successful surgery and patients were assigned to the successful or
      unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70%
      and 90% at 15 and 30 minutes.
    

Intervention name(s): Intraoperative Paratohormone
Intervention type(s): Diagnostic Test
Intervention description(s): Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values <150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic kidney disease and secondary hyperparathyroidism
      
Keywords: Secondary hyperparathyroidism; Parathyroidectomy; Intraoperative paratohormone
Build-up of Action Representation in Autism Spectrum Disorders
Condition: Healthy; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core
      feature is social and communications disorders. Motor skill impairments are frequently
      described in autism, but few studies have addressed the question of their origin and their
      specificity. Furthermore, it is not clear whether motor problems encountered in autism are
      related to dyspraxia, or if they present with specific features. This project aims at
      deciphering the origin of motor problems encountered by children who grow-up with autism in
      order to propose early interventions that could influence the other developmental
      trajectories, such as the social one.

      Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography
      (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely:
      proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory
      executive control will be correlated to brain oscillation modulation, both topographically
      and temporally. Two groups of children (aged between 7 and 12) are compared: a group of
      children with ASD and a control group of typically developing children.
    


Intervention name(s): Behavioral assessments; Magnetoencephalography (MEG); Magnetic Resonance Imaging (MRI)
Intervention type(s): Other; Other; Other
Intervention description(s): Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).; Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).; Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Autism; Sensori-motor learning; Development; Neuroimaging
Chemoreflex Sensitivity in Chronic Kidney Disease
Condition: Chronic Kidney Disease; Cardiovascular Morbidity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypersensitivity
Study type: Observational

Summary: 
      Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD)
      and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex
      sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the
      present study is to examine whether chemosensor function is altered in patients with stage 3
      and stage 4 CKD.
    

Detailed description: 
      Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD
      [glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2], in patients with stage 4 CKD [GFR
      15-29 ml/min/1.73 m2], as well as in patients without any evidence of CKD. CHRS is measured
      by determination of the venous partial pressure of oxygen and the heart rate before and after
      deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R
      intervals before and after inhalation divided by the difference in the oxygen pressures is
      calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be
      shown that using a simple clinical bedside test we provide the first evidence for impaired
      hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay
      the basis for future intervention studies assessing chemosensor function in these patients.
    

Intervention name(s): blood sampling
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Biospecimen description: 
      Measurement of the venous partial pressure of oxygen in blood samples
    
Keywords: Cardiovascular autonomic neuropathy; Chemoreflex sensitivity; Chronic kidney disease; Sudden cardiac arrest