bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Effects of Antipsychotics in Children
Condition: Aggression; Attention Deficit-Hyperactivity; Oppositional Defiant Disorder; Pervasive Development Disorders; Bipolar Disorder
MeSH terms: Bipolar Disorder; Aggression; Attention Deficit and Disruptive Behavior Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The project aims to describe and compare the outcome of 12 weeks of prospective, randomized
      treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle,
      liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for
      symptoms of aggression and non-metabolic adverse events. Children aged 6-18 will be studied,
      exploring effects of stimulant therapy and age-related differences in vulnerability to
      treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and
      lipid kinetics with stable isotope tracers, body composition with dual energy x-ray
      absorptiometry and magnetic resonance imaging (MRI), and standardized assessments of efficacy
      and adverse events. Relevant data are critically needed to target clinical therapy and basic
      research, identify medical risks, and guide regulatory decisions in this vulnerable
      population.
    

Detailed description: 
      This randomized clinical trial assesses both the safety and efficacy of atypical
      antipsychotic agents in antipsychotic-naive aggressive children with various childhood
      psychiatric disorders during 12 weeks of prospective, randomized treatment with olanzapine,
      risperidone or aripiprazole.

      Aim 1: To evaluate effects of selected antipsychotic treatments on insulin action in muscle
      (glucose disposal), liver (glucose production) and adipose tissue (lipolysis).

      Aim 2: To evaluate effects of selected antipsychotic treatments on abdominal fat mass, total
      body fat and total fat-free mass.
    

Intervention name(s): risperidone; olanzapine; aripiprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): randomized to begin 12 week trial of risperidone; randomized to begin 12 week trial of olanzapine; randomized to 12 week trial of aripiprazole
Other intervention name(s): Risperdal; Zyprexa; Abilify
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antipsychotic treatment; Insulin action/secretion; Abdominal fat mass, total body fat; Aggression; Resting metabolic rates
Nutrient-Fortified Beverage Study
Condition: Normal Controls
Study type: Interventional

Summary: 
      The objective of this study is to assess the effects of nutrient-fortified beverage on mental
      energy in healthy human subjects.
    


Intervention name(s): Anti-Oxidant Drink
Intervention type(s): Other
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Vitamin D Effects in Overweight Patients
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the study is to investigate in overweight patients who are on a telemedically
      guided weight loss program the influence of a daily vitamin D supplement on

        -  weight loss and body composition,

        -  selected inflammation markers and biochemical parameters of lipid and glucose metabolism
           .

        -  selected clinical parameters such as blood pressure, heart rate
    

Detailed description: 
      Obese patients are known to have low levels of vitamin D metabolites. There is some evidence
      that vitamin D and/or dietary calcium may influence energy metabolism and body weight. We
      therefore perform a prospective controlled trial with 200 overweight (Body mass index 27-29.9
      kg/m2) and obese subjects (Body mass index >= 30 kg/m2) who are on a telemedically guided
      weight loss program. Subjects randomly receive a daily vitamin D supplement or a placebo for
      1 year. Participants have to send their body weight data to the study office weekly. In
      addition, a nutritionist at the study office has to be contacted weekly to receive further
      support concerning the weight loss program. Dietary records have to be completed monthly.
      Clinical parameters and blood samples are collected at baseline, and after 6 and 12 months.
      It is the aim of the study to investigate the vitamin D effects on weight loss and body
      composition. In addition, possible vitamin D effects on clinical and selected biochemical
      parameters should be assessed. These parameters include heart rate, blood pressure,
      inflammation markers, and parameters of lipid and glucose metablolism.
    

Intervention name(s): vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): 6 drops of a vitamin D containing oil
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: body weight; body compostion; vitamin D; blood pressure
The Effects of Increased vs. Traditional Squat Stance Width on Performance Indices in Elite Rugby League Players
Condition: Sports Performance
Study type: Interventional

Summary: 
      The back squat is a commonly utilized resistance training exercise for the promotion of both
      performance and musculoskeletal health. There are a range of manipulations that can be made
      to the setup of this resistance exercise, with once such adaptation being the stance width
      when performing the exercise. This intervention aims to explore the effects of increasing the
      stance with on performance indices in elite rugby league players.
    


Intervention name(s): Normal stance width; Wide stance width
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Normal self-selected stance width when performing squat exercises.; Increased stance with (by 20% over their own self-selected stance width) when performing squat exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stratified to include similar number of forward and backs in each arm.
Masking: Single (Investigator)
Primary purpose: Basic Science
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      To determine the best parameters with various leads to cover back and leg pain and provide
      best pain relief
    

Detailed description: 
      Prospective double-blinded trial of patients already implanted with SCS to determine which
      programming model best controls their back and or leg pain. Baseline visit is 2 weeks after
      implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects
      NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit
      @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses
      that for the next 12 weeks. The visit @ week 20 collects NRS.
    

Intervention name(s): preset program
Intervention type(s): Device
Intervention description(s): Change to different present program using epidural and peripheral lead to cover pain
Other intervention name(s): epidural and peripheral lead to cover pain (Spinal Cord Stimulator)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; neuromodulation; spinal peripheral neuromodulation; spinal cord stimulation; postlaminectomy pain syndrome
Daclizumab Japanese PK Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019
      (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75
      mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of
      this study in this study population is to assess the safety and tolerability of BIIB019
      administered as a single SC dose (75 mg or 150 mg).
    


Intervention name(s): BIIB019 subcutaneous injection
Intervention type(s): Biological
Intervention description(s): participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
Other intervention name(s): Daclizumab High Yield Process; DAC HYP
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Renal Tubular Disorders in Egyptian Children
Condition: Renal Tubular Disorders in Children
Study type: Observational [Patient Registry]

Summary: 
      Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect
      of these functions can give rise to a host of disorders. These disorders can lead to life
      threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little
      data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion
      for diagnosis can improve the overall clinical outcome of these children.
    

Detailed description: 
      Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect
      of these functions can give rise to a host of disorders. These disorders can lead to life
      threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little
      data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion
      for diagnosis can improve the overall clinical outcome of these children. As a result,
      starting management early will help those children have a better life. Therefore awareness
      about these disorders and long-term outcome is really important. The investigators present
      the clinical characterizations of many tubular disorder and the follow up in our center.

      The aim of this study is to reveal the different clinical presentations and the main lab
      features of renal tubular disorders in children to promote early recognition and management.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        all children who have renal tubular disorders (inpatient and outpatient) in the Paediatric
        Department, Sohage University Hospital.
      
Keywords: renal tubular disorders; failure to thrive; metabolic acidosis; metabolic alkalosis; hypokalemia
Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
Condition: Preterm Newborns
MeSH terms: Premature Birth; Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the
      effect of laser acupuncture in the treatment of perioperative pain during tracheal suction
      after patent ductus arteriosus ligation in preterm infants.
    

Detailed description: 
      management of pain in preterm infants is essential because it is exposed to repetitive
      movements painful and invasive miners such as surgical treatment of the ductus arteriosus
      which is accompanied by respiratory instability, increased consumption analgesics.
      Acupuncture has shown its analgesic efficacy in numerous studies in children and adults.
      Acupuncture (laser) is a simple, fast method without side effect used in children, but no
      study exists on the effect of acupuncture in the treatment of perioperative pain in addition
      to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and
      discomfort after surgery of the ductus arteriosus in preterm infants in addition to
      pharmacologic agents

      Main objective:

      Assessing the contribution of laser acupuncture on the pain management during endotracheal
      suctioning (ETS) after surgery ductus arteriosus in preterm infants
    

Intervention name(s): Laser stimulation; Fake laser stimulation
Intervention type(s): Device; Device
Intervention description(s): Infants will be divided in 2 groups:
Placebo group: Placebo (fake laser stimulation) plus opioid treatment before ETS
Experimental group: Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment.
This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery); newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: preterm newborns; Transfontanellar ultrafast doppler; Acupuncture; perioperative pain; surgery of the ductus arteriosus
Randomized Clinical Trial of Occlusal Sealant
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on
      occlusal surfaces previously coated with intermediary bonding layer and it determined caries
      incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal
      Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.
    

Detailed description: 
      The greatest risk of sealant failure occurs soon after tooth eruption, when contamination
      with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer
      between humidity contaminated enamel and sealant can improve bond strength, reduces
      microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer
      beneath the sealant seems to be based on a combination of moisture-chasing effects of the
      hydrophilic primer, increased flow dispersion imparted by the less viscous primer and
      adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin
      complex once reaction is complete.
    

Intervention name(s): Sealant; Adhesive and Sealant
Intervention type(s): Device; Device
Intervention description(s): Application of preventive agent; Application of preventive agent and technique for control moisture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: clinical trial; pit and fissure sealants; tooth eruption; retention; adhesive system; intermediary layer
Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the
      QT/QTc interval in healthy subjects.
    


Intervention name(s): MT-7117; moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, randomized, partial double-blind, placebo and positive-controlled, three-way crossover study to evaluate the effect of a single oral dose of MT-7117, placebo, and positive control, moxifloxacin, on the QT/QTc interval in healthy subjects. The study consists of 3 treatments administered in a specific sequence as per the randomization list. Each subject will receive all 3 treatments over a specific sequence.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this research is the role of the Persumac(an Iranian traditional
      remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer
      patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting
      in acute and delayed phase.
    

Detailed description: 
      The study was a double-blind, placebo controlled, Cross-over clinical trial of Iranian
      traditional remedy (Persumac) on chemotherapy induced nausea and vomiting in breast cancer
      patients. From October 2015 to May 2016, sample selection continued to be until the full
      sample size.

      Executive steps of study:

        1. Among patients referred for breast cancer, to the oncology clinic in Imam Reza hospital
           in Mashhad University of Medical Sciences, an oncology referral center in the North East
           of Iran; patients included in study who had at least one chemotherapy session and remain
           at least three sessions of Their chemotherapy cycle and had inclusion criteria.

        2. The initial assessment of patients (Run- in): Concurrent with the visit of patient for
           chemotherapy (the first session of her/his chemotherapy in this study); during
           interview, study questionnaire was delivered to patient. It took a full explanation of
           how to complete it and return the next session.

        3. In the second session of chemotherapy (in study); after eligibility qualification and
           obtaining consent form, patients randomly allocated into intervention and control
           groups, In accordance with the study protocol, interventions take place. Questionnaire
           was delivered to the patient again.

        4. (Wash out): Sixth day after the second session of chemotherapy until a day before the
           third session of chemotherapy determined as Wash out period.

        5. In the third session of chemotherapy-in study, after obtaining the previous
           questionnaire, patient received cross over interventions. Questionnaire delivered to the
           patient again.
    

Intervention name(s): Persumac; lactose
Intervention type(s): Drug; Drug
Intervention description(s): 2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour; 2.7 grams Lactose every 8 hour
Other intervention name(s): Sumac and black Zirah; Lactose powder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Breast cancer; Traditional medicine; Chemotherapy Induced Nausea and Vomiting; Bunium Persicum; Rhus Coriaria
Weight Watchers and Families
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Research suggests that when one spouse loses weight, the other spouse does too. This study
      will examine whether a ripple effect is observed in untreated spouses and children of
      individuals participating in a nationally available weight loss program. Participants will be
      randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month
      waiting period. Participants and untreated spouses (and any children in the home) will be
      assessed at baseline, 3, and 6 months.
    


Intervention name(s): Self guided handout; Weight Watchers
Intervention type(s): Other; Behavioral
Intervention description(s): Written handout with basic weight management strategies; Access to Weight Watchers in-person meetings and online tools
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The relationship of Vitamin D levels in children and young adults to atherosclerosis.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and
        race.
      
Biospecimen description: 
      plasma, serum, PBMCs, urine
    
Keywords: Vitamin D Deficiency; HIV+ Children; HIV+ Young Adults
Phase 1 Trial of Inactivated West Nile Virus Vaccine
Condition: West Nile Viral Infection
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose
      escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine
      given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of
      age. The primary objective is to assess the safety, reactogenicity, and tolerability of the
      HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29
      at a dose of 1 mcg or a dose of 4 mcg.
    

Detailed description: 
      This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose
      escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine
      given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of
      age at a single site. The study will consist of two dosing groups of HydroVax-001 vaccine to
      be enrolled sequentially. Each dose group will consist of 20 individuals who receive
      HydroVax-001 and 5 who receive placebo. Controls will receive sterile 0.9 percent NaCl
      placebo intramuscularly at days 1 and 29. The study duration is approximately 25 months (12
      month enrollment, 13 month follow up) and subject participation duration of approximately 14
      months. The primary objective is to assess the safety, reactogenicity, and tolerability of
      the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and
      29 at a dose of 1 mcg or a dose of 4 mcg. The secondary objective is to assess WNV-specific
      plaque reduction neutralization test (PRNT50) responses after a first dose and after a second
      dose of HydroVax-001 WNV vaccine given at doses of 1 mcg and 4 mcg. This study aims to
      recruit up to 50 men and women between the ages of 18 and 50. The study duration is
      approximately 25 months at a single site and subject participation duration is approximately
      14 months.
    

Intervention name(s): HydroVax-001; Placebo
Intervention type(s): Biological; Other
Intervention description(s): HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29; 0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: dose-ranging; double blind; female; healthy; HydroVax; male; Placebo-Controlled; Vaccine; West Nile Virus