bioihbjkbjnl/mcl2 huggingface dataset:
Triple P With Pediatric Residents
Condition: Psychosocial Problem; Problematic Behavior in Children; Parenting
Study type: Interventional

Summary: 
      The objective of this study is to conduct a randomized control trial to evaluate the impact
      of Triple P on the clinic practice of pediatric residents and on select parent and child
      outcomes. This study will accomplish that overarching goal through addressing two specific
      aims.

      Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P
      training on practice of pediatric residents in addressing and managing psychosocial problems.

      Hypothesis 1: At the completion of the trial, residents assigned to the intervention group,
      compared to residents exposed to the control condition, will have:

        1. increased skill levels,

        2. increased confidence, and

        3. increased satisfaction in dealing with and managing psychosocial issues

      Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P
      interventions on parent's feelings of self efficacy, parent's discipline strategies and on
      children's externalizing behavior.

      Hypothesis 2: At the completion of the intervention, parents and children receiving the
      intervention, compared to those receiving the control condition, will have:

        1. greater reduction in targeted child behavior problems,

        2. greater reduction in dysfunctional parenting practices,

        3. increased use of appropriate discipline and positive parenting strategies, and

        4. greater confidence in parenting ability.
    


Intervention name(s): Training in PC Triple P; Care As Usual
Intervention type(s): Behavioral; Other
Intervention description(s): PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.; Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Triple P
Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases
Condition: Muscle Disease
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      To evaluate physical activity levels and factors associated with physical activity levels in
      adult patients with muscle diseases.
    

Detailed description: 
      The same protocol will be applied all of the patients and healthy subjects. Individuals will
      be informed in detail about the study and demographic and physical properties will recorded
      after receiving approval. Evaluation programme that consisting of pain, fatigue, falls,
      activity limitations, quality of life, muscle strength assessment and functional assessment
      will be applied. After the evaluation, individuals will be given detailed information on the
      use of SenseWear activity monitors. Individuals will wear SenseWear activity monitors on
      right triceps muscle for 5 days. The data stored on the device will be recorded in computer
      using the software. Individuals will be given information of the resulting data (total number
      of steps, total energy expenditure, the number of daily steps and energy expenditure,
      physical activity duration in different intensity). Physical activity levels will be assessed
      by subjective aspects of physical activity questionnaire.
    

Intervention name(s): SenseWear activity monitor
Intervention type(s): Device
Intervention description(s): Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
Condition: Sleep Deprivation; Healthy Volunteers; Skeletal Muscle
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The investigator showed that a night of sleep deprivation halved the duration of an
      inspiratory endurance test and that this loss of endurance could be secondary to a lack of
      activation of the pre-motor cortex. However, the inspiratory endurance test is associated
      with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is
      complex, both automatic and voluntary. The investigator can reproduce this results on a
      simpler drive.

      During the execution of an exercise involving repeated contractions of the hand it is
      possible to record the activation of the pre-motor cortex corresponding to the phase of
      preparation of the movement. The amplitude of these premotor potentials is proportional to
      the developed motive force.

      The purpose of this study is to assess the impact of sleep deprivation on the muscular
      endurance of non-dominant in healthy subjects.

      Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing
      cortical pre-motor control.

      Main objective: To compare the motor endurance of healthy subjects after a night's sleep and
      after a sleepless night.

      Secondary objective: To compare the amplitude of premature cortical control at the beginning
      of the endurance test after a night's sleep and after a sleepless night.
    


Intervention name(s): Normal sleep night; Sleepless night
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Usual hours of sleep; Total sleep deprivation the first night
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: To compare the motor endurance of healthy subjects after a normal sleep night and after a sleepless night.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
Condition: Metastatic Cancer; Radiation Toxicity; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      melatonin may make tumor cells more sensitive to radiation therapy and may protect normal
      cells from the side effects of radiation therapy.

      PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with
      radiation therapy in treating patients who have brain metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of melatonin, used as radiosensitization/radioprotection, on
           overall survival and clinical deterioration in patients with brain metastases who are
           undergoing radiotherapy.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1
      of 2 treatment arms.

        -  Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks.
           Patients receive oral melatonin once daily every morning.

        -  Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral
           melatonin once daily every evening.

      All patients continue on melatonin for 6 months in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this
      study within 5 months.
    

Intervention name(s): therapeutic melatonin; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Melatonin
Allocation: Randomized
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific; tumors metastatic to brain; radiation toxicity
ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients
Condition: Old Age
Study type: Interventional

Summary: 
      As people age, the incidence of prostate hyperplasia increases. So patients under
      Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP)
      are mostly ole age people. Most old age patient has several underlying disease. So patients
      can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken
      under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes,
      old age patients can develop severe complication after spinal anesthesia. So we started this
      study to know the adequate drug concentration for Spinal anesthesia taken for Prostate
      Resection surgery.
    

Detailed description: 
      As people age, the incidence of prostate hyperplasia increases. So patients under
      Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP)
      are mostly ole age people. Most old age patient has several underlying disease. So patients
      can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken
      under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes,
      old age patients can develop severe hypotension and vital unstability due to unintentional
      high sensory and motor blocks. These complications are due to the decreased cerebrospinal
      fluid volume with increase of age. So we started this study to know the adequate drug
      concentration for Spinal anesthesia taken for Prostate Resection surgery.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): bupivacaine dose
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal anesthesia in old age
Urdu Version Of ProFitMap-Neck Questionnaire In Population With Chronic Neck Pain A Reliability And Validity Study
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The aim of this study is to translate or culturally adapt ProFitMap-neck into Urdu language
      and to investigate the reliability and validity of the ProFitMap-neck in Pakistani population
      having chronic neck pain. Also check it's correlation with Neck Disability Index.
    

Detailed description: 
      As with prior suggestions, the English version of the ProFitMap-neck will be translated and
      culturally modified.In population having Chronic Neck Pain ProFitMap-neck will be distributed
      among one hundred and thirty six participants selected by a convenience sampling technique
      based on pre-defined inclusion and exclusion criteria.The questionnaire will be filled out by
      two observers on the same day to examine inter and intra-observer reliability of the final
      ProFitMap-neck and neck disability index. For the inter-observer evaluation, there will be a
      2 hour delay between the first and second application. After 7 days, observer-1 will conduct
      a third assessment (re-testing) for intra-observer evaluation.The Statistical Package of
      Social Sciences program will be used to examine the data.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani Population with non-specific Chronic Neck Pain.
      
Keywords: Urdu Version of ProFitMap-neck; Non-specific Chronic Neck Pain; Psychometric Properties; Validity; Functional Limitations; Reliability
Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
Condition: Smoking
MeSH terms: Burns
Study type: Interventional

Summary: 
      This study will assess environmental emissions of selected compounds in a test chamber after
      cigarette smoking or e-cigarette vaping.
    

Detailed description: 
      Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and
      sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different
      from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with
      common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and
      secondhand vapor from e-cigarettes.

      The goals of this study are to 1) increase understanding of the composition of SHS from
      e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a
      market sample of commercial e-cigarettes to leading brand styles of commercial
      tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including
      the market-sample e-cigarettes.
    

Intervention name(s): Leading U.S. non-menthol cigarette; Leading U.S. menthol cigarette; Electronic cigarette #1; Electronic cigarette #2; Electronic cigarette #3; U.S. Market-sample electronic cigarettes
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Tobacco-burning non-menthol cigarette; Tobacco-burning menthol cigarette; Electronic cigarette; Electronic cigarette; Electronic cigarette; Marketed electronic cigarettes
Other intervention name(s): Marlboro Gold Pack Box; Newport Box; VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine); blu™ (any variety) and NJOY® (any variety)
Intervention MeSH terms: Menthol; Nicotine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: electronic cigarettes; e-cigarettes; combustible cigarettes; second-hand smoke; environmental tobacco smoke; tobacco-burning
Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)
Condition: Pancreatic Tumors
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth
      in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of
      cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple
      attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of
      the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails
      to sample the cancer cells. The fanning technique is a method where the needle moves in
      multiple directions within a mass and therefore there is a better chance of the cancer cells
      being sampled compared to the standard technique where the needle moves in only one
      direction. The diagnostic performance of both these techniques has not been compared in a
      randomized fashion.
    

Detailed description: 
      Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a
      mass.

      Standard technique: FNA performed in unidirectional fashion.
    

Intervention name(s): Standard; Fanning
Intervention type(s): Procedure; Procedure
Intervention description(s): FNA in a single plane; FNA in multiple planes
Other intervention name(s): Standard Versus Fanning Techniques for EUS-FNA; Standard Versus Fanning Techniques for EUS-FNA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Condition: Glucosephosphate Dehydrogenase Deficiency; Favism
MeSH terms: Glucosephosphate Dehydrogenase Deficiency; Favism
Study type: Interventional

Summary: 
      This study will evaluate a new and safe testing method for identifying medicines that can
      cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are
      looking for volunteers with G6PD deficiency who would be willing to donate blood samples.
    


Intervention name(s): Primaquine
Intervention type(s): Drug
Intervention MeSH terms: Primaquine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: G6PD; Favism; G6PD Deficiency; hemolysis; drug reaction; drug-induced hemolysis
Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric
      Bypass.

      Primary aim : To study the intra individual evolution of phenotypical markers of different
      drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and
      P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.
    

Detailed description: 
      Principal Judgement criteria :

      Phenotypical markers of enzymes and transporter activity before, at 5-8 weeks and 25-30 weeks
      following surgery.

      Secondary judgement criteria :

        -  Genetic polymorphisms known to affect expression and/or activity of enzymes and
           transporter.

        -  Intestinal and hepatic expression and activity of the enzymes and transporter of
           interest.

        -  Markers of inflammation Methodology, study design : open-labelled monocentric study.

      Sample size : It will be a descriptive experimental study involving 12 subjects.

      Study design : In centre 1: Inclusion at least 2 weeks prior to surgery (V0)

      In centre 2: Three studies of 12 hours each will occur (in addition with the usual clinical
      and surgical follow up) at three times periods: in the 8 weeks period before surgery (V1), at
      5-8 weeks after surgery (V2) and at 25-30 weeks after surgery (V3).

      In centre 3: the patients will undergo gastric bypass surgery (corresponding to the usual
      clinical and surgical follow up) and samples of jejunum and liver will be obtain during the
      surgery (J0).

      Centres 4 and 5 are involved in samples analysis.Hence, patients will attend 3 visits, in
      addition to the usual clinical and surgical follow-up.

      Study duration: 26 months (with duration of inclusion of 18 months)

      Duration for a patient: 38 weeks at maximum (8 months)

      Investigating center and participating units: one center enrolling the patients and three
      centers involving in the others investigations.
    

Intervention name(s): phenotypical approach
Intervention type(s): Drug
Intervention description(s): each visit : CAFEINE : (solution orale) 2 ampoules de 2 ml = 100 mg de CAFEINE DEXTROMETHORPHANE : 15 ml de sirop contains 20 mg =>22,5 ml = 30mg Midazolam : (solution injectable, ampoule 1 ml = 1 mg) : deux ampoules = 2 mg Digoxine nativelle (solution injectable, ampoule de 0.5mg) : 1 ampoule per os = 0.5 mg Losartan 50 mg : 1cp de 50mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug metabolizing enzymes and drug transporter; Roux-en Y-Gastric Bypass; Obesity; Drug Availability; BMI over 35kg/m² and comorbidities or >40kg/m²
Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in
      much of the developed world. Historically several different dietary fibers have been used as
      means of reducing body weight and the related development of type 2 diabetes. These studies
      have generated mixed, if not inconsistent, results suggesting that none of these fibers
      promise a solution to either of these two conditions. We are proposing to investigate the
      effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be called Y288 in this
      study), into the diet of adult overweight volunteers.
    

Detailed description: 
      The overall aim is to investigate the effectiveness of a soluble dietary fiber, FBCx®, on
      weight loss and/or weight management, and blood lipid levels in overweight humans.
    

Intervention name(s): Y288; Y288
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal; Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
Other intervention name(s): FBCx®; FBCx®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Diabetes; Soluble Fiber; Overweight