bioihbjkbjnl/mcl2 huggingface dataset:
A Virtual Reality Videogame for E-cigarette Prevention in Teens
Condition: E-Cig Use; Vaping
Study type: Interventional

Summary: 
      The use of the Invite Only VR, with the aim to prevent the initiation of e-cigarette use in
      teens by increasing their knowledge, decreasing their intentions to use e-cigarettes,
      influencing their harm perceptions and attitudes associated with e-cigarettes, and increasing
      self-efficacy associated with refusing peers involving e-cigarettes.
    

Detailed description: 
      Specific Aim #1: DEVELOPMENT: The researcher will update our current VR prototype into a
      polished videogame intervention using input from 4 focus groups of 5 adolescents each (n =
      20), aged 12-17 and the extant literature. These focus groups will inform the development of
      the VR videogame intervention, Invite Only VR, for e-cigarette prevention among teens.

      Specific Aim #2: EVALUATION: Conduct a pilot non-randomized cluster trial with 295 teens ages
      11-14 comparing the Invite Only VR intervention vs. an attention/control non-health-related
      VR videogame, collecting assessment data at baseline, post-gameplay, three months and six
      months to determine:

        1. the preliminary impact of the intervention on e-cigarette use behaviors, knowledge,
           nicotine addiction knowledge, perceived addictiveness of e-cigarettes, perceived
           likelihood of using e-cigarettes, perceptions of harm, self-efficacy to refuse, social
           approval of e-cigarettes, and e-cigarette social perceptions

        2. the intervention's acceptability and feasibility by collecting quantitative and
           qualitative data on teens' satisfaction and gameplay experience of the intervention.

        3. preliminary evidence of the impact of Invite Only VR on players' perception and
           experience of social pressure and social norm development
    

Intervention name(s): videogame; treatment as usual
Intervention type(s): Device; Other
Intervention description(s): Invite Only VR videogame; treatment as usual
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: non-equivalent control groups design with 285 teens ages 12-15 comparing the Invite Only VR intervention vs. treatment as usual
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: prevention; intervention
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare the bioavailable fraction of epinastine and pseudoephedrine when
      administered as a fixed dose combination in tablet form (new pharmaceutical formulation),
      with that obtained with each of these drugs when administered separately to healthy
      volunteers.
    


Intervention name(s): Epinastine; Pseudoephedrine; Epinastine + Pseudoephedrine combination
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Epinastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Screening Method in Sacral Neuromodulation
Condition: Overactive Bladder; Urinary Retention
MeSH terms: Urinary Bladder, Overactive; Urinary Retention
Study type: Observational

Summary: 
      The purpose of this study was to evaluate whether there is a difference in long-term outcome
      between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined
      lead procedure (TLP).
    

Detailed description: 
      Purpose: To evaluate if there is a difference in long-term outcome of sacral neuromodulation
      (SNM) between patients screened with the percutaneous nerve evaluation (PNE) and first stage
      tined lead procedure (TLP). Furthermore, we wanted to evaluate the outcome in patients who
      only responded to screening with TLP after failure of initial PNE.

      Materials and methods: We evaluated all patients screened for eligibility to receive SNM
      treatment since the introduction of the tined lead technique in our centre in 2002. In May
      2009, all implanted patients were asked to keep a voiding diary to record the effect of SNM
      on urinary symptoms. Success was defined as more than 50% improvement in at least one of the
      relevant voiding diary parameters compared to baseline. Chi square analysis was used to
      evaluate differences in long-term outcome for the separate screening methods.

      Results: In total, 92 patients were screened for SNM. Of the 76 patients who were screened
      with PNE, 35 (46%) met the criteria for permanent implantation, whereas 11 of the 16 patients
      (69%) who underwent direct screening with TLP had permanent stimulators placed. Of the 41
      patients who failed PNE and subsequently underwent screening with TLP, 18 (44%) were
      implanted with an INS after showing a successful response. The mean follow-up was 53 months
      (range 35-77 months) at the time of voiding diary analysis. Statistical analysis showed no
      difference between type of screening and long-term success (p=0.94).

      Conclusion: Although first stage TLP is a more reliable screening tool than PNE, the
      long-term success rate does not seem to be dependent on the screening method. Furthermore,
      patients who initially failed PNE but responded to prolonged screening with TLP, appear to be
      at least as successful in the long-term as patients who directly responded to PNE or TLP.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have been treated with sacral neuromodulation in our centre between 2002 and
        2009
      
Keywords: Sacral neuromodulation; Screening; Percutaneous nerve evaluation; Tined lead
Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be
      obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision
      of the McDonald criteria.

      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity
      numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient
      in different centers were counted only once.
    

Detailed description: 
      Patients' records review procedure and sampling strategies. The medical records,
      administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS,
      NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini
      Multiple Sclerosis Unit (KAMSU) registry.

      An assigned coordinator from each center was requested to facilitate data collection from
      site-specific records. In cases of incomplete documentation or unclear information,
      verification was done by on-site data coordinator either by phone contact or face-to-face
      interview with the patients, whether during the routine follow up or in an unscheduled visit.

      Several measures were taken to ensure the confidentiality of the collected information. No
      patient names were included in the database presented by site coordinator, and the study
      staff signed a confidentiality agreement for non-disclosure.
    

Intervention name(s): medical records review
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the
        McDonald criteria, and patients were classified according to the course of the disease into
        relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis
        (SPMS) and primary-progressive multiple sclerosis (PPMS). Patients with first demyelinating
        event, before 2010, were re-assessed by on-site coordinators to label them clinically
        isolated syndrome (CIS), whenever applicable, according to McDonalds 2010, and
        neuromyelitis optica (NMO) cases diagnosis was verified according to the 2015 diagnostic
        criteria. Those with typical brain Magnetic Resonant Imaging (MRI) MS like lesions without
        related clinical manifestations were diagnosed as radiologically isolated syndrome (RIS).
Effects of Infant Formula Composition on Infant Feeding Behaviors
Condition: Healthy Infants
Study type: Observational

Summary: 
      There is a paucity of information on whether and how the composition of formulas fed to
      infants influences their short-term feeding behaviors during the first few months of life.
      The purpose of this study is to investigate whether the composition of infant formula affects
      infants' feeding behaviors, in particular, how much formula is consumed within a given feed
      (i.e., measure of satiation) and how much time elapses after the feed until the infant
      exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the
      relationship between the composition of infant formula consumed and infant temperature,
      activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.
    

Detailed description: 
      This is a within-subject, 3-day study. Each mother-infant dyad will visit the Monell Center
      three times, for 5 hours each time. The protocol during the three visits will be identical.
      Upon arrival, the infant will be changed into a light-weight cotton body suit. Infants and
      mothers will be weighed and measured for height. An activity sensor will be placed on the
      infant and temperature sensors will be placed on both the infant and the mother. When the
      infant signals hunger, he/she will be fed one of three formulas in randomized order:

        1. cow milk based-formula (Enfamil)

        2. protein hydrolysate formula (Nutramigen)

        3. cow milk-based formula with glutamate level similar to Nutramigen (Enfamilg)

      Intake will be monitored and all feeds will be videotaped. In between feedings, infants will
      rest or sleep on their backs in a crib and mothers will fill out questionnaires.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mothers with healthy infants who are between the ages of 1 to 4 months and are exclusively
        feeding cows milk-based formulas will be recruited from the Philadelphia area for this
        within-subject experimental research study.
      
Biospecimen description: 
      DNA collected for analysis of taste receptor and obesity-related genes
    
Keywords: Healthy Infants; Satiation; Satiety; Intake Regulation; Infant Feeding; Infant Formula Feeding
Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)
Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determinate the effect of a pre-treatment with centrally
      acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of
      3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that
      clonidine will attenuate the subjective and cardiovascular response to MDMA.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), norepinephrine (NE), and dopamine. It is
      unknown which of these monoamines mainly contributes to the subjective and physiological
      effects of MDMA in humans. Clonidine is a centrally acting alpha2-receptor agonist and
      sympatholytic which attenuates the release of NE from presynaptic nerve terminals and also
      lowers NE plasma concentration. To determine the role of NE in the response to MDMA in humans
      we test the effects of a clonidine pretreatment on the pharmacodynamics and pharmacokinetics
      of MDMA. We use a randomized double-blind placebo-controlled cross-over design with four
      experimental sessions. Clonidine (150 μg) or placebo will be administered 1 h before the
      administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective and
      cardiovascular responses will be repeatedly assessed throughout the experiments and plasma
      samples are collected for pharmacokinetics. We hypothesize that clonidine will significantly
      attenuate predominantly the cardiovascular response to MDMA.
    

Intervention name(s): 3,4-Methylenedioxymethamphetamine; Clonidine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg, single dose; 150 μg per os; capsules identical to MDMA or clonidine
Other intervention name(s): MDMA; Ecstasy
Intervention MeSH terms: Clonidine; N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MDMA; norepinephrine; alpha2 receptor; Ecstasy; stimulant
The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
Condition: Intestinal Atresia; Necrotizing Enterocolitis; Hirschsprung Disease; Gastroschisis; Intestinal Obstruction; Incarcerated Hernia; Intussusception; Malrotation; Volvulus; Meconium Ileus; Intestinal Perforation; Trauma
MeSH terms: Gastroschisis; Enterocolitis; Enterocolitis, Necrotizing; Hirschsprung Disease; Intestinal Obstruction; Intussusception; Intestinal Perforation; Intestinal Atresia; Meconium Ileus
Study type: Interventional

Summary: 
      Background: Intestinal resections are commonly performed in the pediatric population.
      Perfusion of the bowel is one of the most important factors determining the viability of an
      intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven
      its superiority.

      Objectives:

      Primary: The aim of this study is to establish the feasibility and impact of the use of
      indocyanine green technology on intestinal resection margins during elective and emergency
      pediatric surgeries.

      Secondary: The secondary outcomes of interest include collection of adverse events and
      difficulties encountered with the use of the indocyanine green (ICG) technology.
      Postoperative surgical complications will also be recorded.

      Study Design: An open observational clinical study will be performed by using a clinical drug
      (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively
      intestinal perfusion in a specific pediatric population.
    


Intervention name(s): SPY imaging; Indocyanine Green
Intervention type(s): Device; Drug
Intervention description(s): Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.; Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
Other intervention name(s): SPY PinPoint; ICG; IC-Green
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SPY imaging; indocyanine green; pediatric surgery; ICG; intestinal resections; intestinal perfusion
Cardiac Repercussion of Systemic Sclerodermias
Condition: Systemic Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional

Summary: 
      Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in
      particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension
      (PAHT).

      In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the
      other hand, the tracking and the analysis of its effects on the right ventricular function
      are difficult with the conventional techniques.

      So, the analysis of the right ventricular function appears capital, because:

        -  it is recognized like an essential determinant of the symptoms and effort capacity,

        -  its prevalence, physiopathology and prognostic values remain unknown in this pathology,

        -  its interest in the starting of the treatment remains to be specified.

      The aim of this trial is to identify in a population of 150 patients presenting a systemic
      scleroderma without PAHT:

        -  the incidence of a right ventricular dysfonction, evaluated by the analysis of the
           myocardic regional function with myocardial tissular Doppler mode,

        -  the physiopathology of this damage by correlation with the tests of respiratory function
           and the not invasive hemodynamic datas at rest and exercise.

        -  the prognosis value of the abnormalities of the right ventricular function by a
           follow-up of these patients over a 5 years period.

      This trial should allowed to define the place of the new right ventricular function markers
      in the evaluation of the functional consequences, the forecast and perhaps the care of
      systemic sclerodermic patients.
    


Intervention name(s): Echocardiography with myocardial tissular Doppler mode
Intervention type(s): Procedure
Intervention description(s): Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Systemic Scleroderma; Echocardiography
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether doxazosin will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants
      will participate in a smoking cessation attempt after the laboratory sessions.
    


Intervention name(s): Doxazosin 4mg/day; Placebo; Doxazosin 8mg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.; Placebo; 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other intervention name(s): Cardura; Cardura
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking lapse behavior; smoking cessation; doxazosin; medication effect on smoking lapse behavior; medication effect on smoking cessation; stress
Improving Resilience With Whole Grain Wheat
Condition: Healthy; Metabolism
Study type: Interventional

Summary: 
      This study investigates the health benefits of whole grain wheat on cardiovascular/
      cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal
      challenge. This study also investigates the health benefits of whole grain wheat (WGW) on
      liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices
      in quantifying health effects in a nutritional intervention study.
    

Detailed description: 
      The study is a randomized controlled, double blind, parallel trial. A 4-week run-in period
      with refined wheat (RW) products will be included prior to the intervention for all subjects.
      Thereafter, two different treatments will be evaluated e.g. a 12-week intervention with whole
      grain wheat (WGW) products (98g of WGW per day) and a 12-week control intervention with RW
      products. Two experimental visits will be planned before and two experimental visits will be
      planned after the 12-week intervention period. In the first experimental visit the
      investigators will determine liver fat and abdominal fat distribution by magnetic resonance
      spectroscopy (MRS) and magnetic resonance imaging (MRI). In the second experimental visit the
      investigators will comprehensively phenotype the participants which will include the response
      to a mixed meal challenge test.
    

Intervention name(s): whole grain wheat; refined wheat
Intervention type(s): Other; Other
Intervention description(s): A twelve week intervention of 98g whole grain wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).; A twelve week control intervention of refined wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: resilience; challenge test; whole grain wheat; metabolic flexibility; cardio-metabolic; liver and adipose tissue
Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
Condition: Chronic Pancreatitis; Diabetes Mellitus
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of closed loop insulin pump
      therapy to control blood sugar following total pancreatectomy and islet auto-transplantation
      (TPIAT).
    

Detailed description: 
      OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop
      insulin system can successfully achieve tighter blood sugar control than the current multiple
      daily injection regimen. The investigators hypothesize that the average blood glucose will be
      lower in the closed loop group than the control group, there will be less glucose variability
      in the closed loop group than the control group, and there will be less total time spent in
      hyperglycemia and hypoglycemia in the closed loop group than in the control group. The
      investigators also will investigate insulin requirements and islet function in the first 6
      months post-transplant in the closed loop group The investigators hypothesize that the
      insulin requirements will be lower and the C-peptide levels higher in the closed loop group
      than in the control group.
    

Intervention name(s): Closed Loop Insulin
Intervention type(s): Device
Intervention description(s): The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
Other intervention name(s): Medtronic ePID 2.0 system; Medtronic Paradigm REAL-Time Insulin Pump (MMT-722); Enlite Glucose Sensor (MMT-7008X); MiniLink REAL-Time Transmitter (MMT-7703XNA); ComLink Device (MMT-7304)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Pancreatectomy; Islet Auto-Transplantation; Closed Loop Insulin Pump