bioihbjkbjnl/mcl2 huggingface dataset:
TAFF-Psychological Treatment of Separation Anxiety Disorder
Condition: Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Anxiety, Separation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specific family based cognitive
      behavioral treatment program is effective in the treatment of children with separation
      anxiety disorder.
    

Detailed description: 
      Anxiety disorders are the most common mental disorders both in adulthood and childhood.
      Recent research indicates that anxiety disorders in childhood and in particular Separation
      Anxiety Disorder (SAD) increase the risk of mental disorders in adulthood. Despite these
      results research on SAD is still limited compared to the vast research activity on adult
      anxiety disorders. The proposed research program will close a gap of current international
      research: It will test the efficacy of a family based cognitive behavioral treatment program
      specific for SAD.

      The research program consists of two parts. One study is aimed at children with SAD aged 5 to
      7. 40 children are randomly allocated immediately to SAD-specific family-based treatment or
      to a wait list. For the second study 60 children with SAD (8 to 13 years old) are randomly
      allocated to either SAD-specific family-based treatment ("SAD-CBT") or a well established
      global CBT program for childhood anxiety disorders ("global CBT").

      In both studies treatment success is tested at the end of treatment as well as 4 weeks and 1,
      2 and 3 years after treatment.
    

Intervention name(s): family based cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SAD; treatment; cognitive behavior therapy; family; children; anxiety
Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
Condition: Caries Reduction; Caries Prevention
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Probiotics are microorganisms that when administered in adequate amounts can confer health
      benefits. In vitro and clinical studies support the idea that lactobacilli have protective
      effects on oral health. A recent study in which preschoolers consumed milk drinks enriched
      with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits
      to children.

      The aim of this study is to evaluate the effect of daily consumption of milk beverages
      enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean
      children.
    

Detailed description: 
      In this randomized controlled trial, preschool children belonging to Integra Foundation will
      be invited to participate. After obtaining parent´s informed consent, clinical and
      microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed.
      Differences in prevalence and incidence of caries, dmft and microbial diversity between
      groups will be assessed.
    

Intervention name(s): Experimental: Probiotic enriched milk
Intervention type(s): Dietary Supplement
Intervention description(s): Milk will be enriched with lactobacillus rhamnosus for the experimental group.
Other intervention name(s): probiotic: Lactobacillus rhamnosus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: caries; probiotics; lactobacilli
The Metformin-FMD Trial
Condition: Ischemia Reperfusion Injury; Endothelial Function
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      In acute myocardial infarction early restoration of coronary blood flow is the most effective
      strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial
      injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia
      and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this
      process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue.
      Recently, it has been shown that the glucose-lowering drug metformin is able to limit
      IR-injury in murine models of myocardial infarction, probably by increased formation of the
      endogenous nucleoside adenosine. In the current research proposal, the investigators aim to
      translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of
      the brachial artery as a well-validated model of (endothelial) IR-injury.
    


Intervention name(s): Metformin; Pretreatment with metformin in combination of infusion of caffeine.; No pretreatment with metformin in combination with infusion of caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): metformin 500 mg three times a day, for 3 days; Pretreatment with metformin 500 mg three times a day for 3 days, in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes) prior to FMD measurement; No pretreatment with metformin in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes).
Intervention MeSH terms: Metformin; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study
Condition: Preterm Birth; Pregnancy; Stress; Psychological Distress
MeSH terms: Premature Birth
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the present prospective study is the analysis of risk and protective factors
      of perinatal stress and psychological distress of parents with or without a preterm child.
      Stress is measured biologically by Cortisol levels and psychologically by a questionnaire.
      Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress
      disorder, burnout) are measured by various questionnaires. We analyze the influence of
      different aspects as personality traits, social support, partnership.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women either with risk of with no risk of preterm birth from the obstetric ward or
        from the antenatal class of the obstetric department and their partners
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-6950
      across ascending multiple doses in healthy adult male and female subjects. The secondary
      objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by
      measuring plasma concentrations of ONO-6950 and pulmonary function.
    


Intervention name(s): ONO-6950; ONO-6950
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg, 100 mg, 300 mg at multiple doses; Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-6950; Healthy adult subjects
Substudy - Evaluation of Patients With Iliac Vein Thrombosis
Condition: Iliac Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Observational [Patient Registry]

Summary: 
      Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry.
      Using standardized questionnaire, clinical data detailing venous thromboembolism and
      contributing VTE risk factors are recorded. Results of technical and laboratory
      investigations including screening of thrombophilic disorders were additionally entered into
      the database.
    


Intervention name(s): thrombophilia screening
Intervention type(s): Genetic
Intervention description(s): genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with previous iliofermoral thrombosis, which has been proven by objective
        measurements (Duplex sonography, phlebography, CT/MRT)
      
Biospecimen description: 
      whole blodd, serum
    
Keywords: VTE; thrombophilia screening; patients; risk factors; post-thrombotic syndrome
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      With the use of Non invasive ventilation the patients with cystic fibrosis will have better
      lung function (FEV1).
    

Detailed description: 
      3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.
    

Intervention name(s): Bilevel; PEP mask
Intervention type(s): Device; Device
Intervention description(s): 3 months; 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung function
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      The purpose of this study is to determine if taking supplemental DHA improves measures of
      processing speed and executive function in teen and adult women with PKU.
    


Intervention name(s): Docosahexaenoic Acid; Corn/soy oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules providing 10 mg DHA/kg body weight/day taken once daily; Capsules taken once daily
Other intervention name(s): DHASCO-S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Phenylketonurias; Docosahexaenoic Acids; Neuropsychological Tests; Female; Adolescent; Adult
P3 Long Term Safety Study of Once Daily SB204 in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, open label long-term safety (LTS) study to be conducted in
      approximately 600 subjects with acne vulgaris.
    

Detailed description: 
      A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily
      in the Treatment of Acne Vulgaris.
    

Intervention name(s): SB204 4%
Intervention type(s): Drug
Intervention description(s): Open label, topical SB204 4%
Other intervention name(s): NVN1000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Less Invasive Beractant Administration in Preterm Infants
Condition: Infant, Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy and feasibility of a new less invasive
      surfactant administration (LISA) technique with a specific designed cannula for surfactant
      administration using Beractant replacement in preterm infants <32 weeks of gestation and
      compare short and long term outcomes with the intubation, administration of surfactant and
      extubation method (INSURE).

      This was a single-center, prospective, open-label, non-randomized, controlled study with an
      experimental cohort of 30 patients treated with LISA and a retrospective control group
      comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was
      administered as exogenous surfactant in both groups if patients on nasal continuous positive
      airway pressure (nCPAP) during the first three days of life were needed of more than 30% of
      fraction of inspired oxygen inspired oxygen fraction (FiO2).
    


Intervention name(s): LISA; INSURE
Intervention type(s): Procedure; Procedure
Intervention description(s): All infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure.; The INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted.
After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2< 0.35; for a target Oxygen Saturation (SpO2) of >90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Beractant; Feasibility Studies; Infant, Premature; Noninvasive Ventilation
Nocturnal Parkinson's Disease Symptoms Study Group
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in
      Parkinson's disease patients and caregivers.
    


Intervention name(s): Questionaire to assess Noctural Parkinson's Disease Symptoms
Intervention type(s): Other
Intervention description(s): Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parkinson's disease patient and care givers
      
Keywords: Quality of life; Noctural Parkinson's Disease Symptoms
Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects
Condition: Normal Subjects
Study type: Interventional

Summary: 
      In vivo deposition studies of aerosol administration during noninvasive ventilation are
      scarce in the current literature.

      We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy
      aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the
      different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered
      using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive
      ventilation (NIV).
    


Intervention name(s): Mesh nebulizer; Jet nebulizer; Noninvasive ventilation-NIV
Intervention type(s): Other; Other; Other
Intervention description(s): VMN (NIVO, Respironics®, Murrysville, Pennsylvania, USA) with an MMAD of 3.0 µm was placed in the elbow adapter at the mask. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL.; The JN (Misty Max, Air Life, Yorba Linda, USA) with a particle MMAD of 5 µm (according to the manufacturer information) was positioned in the circuit using a "T" piece placed between the circuit leak and the mask, and operated with oxygen flow at 8 L/min. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL.; Bilevel positive airway pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted to12 cmH2O peak inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure. Patients were adapted to use NIV before starting measurements, pressures were titrated before reaching the established levels and just after this period masks were fitted using the straps. They were oriented to use a breathing pattern inspiring deeply and exhaling slowing to avoid ventilator-patient asynchrony.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An fMRI Study in Healthy Volunteers to Investigate the Effects of ABX-1431 on Experimental Hyperalgesia and Its Neural Correlates
Condition: Pain
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental
      hyperalgesia and its neural correlates.
    


Intervention name(s): ABX-1431; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 40 mg, single dose; Capsules, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer; Experimental hyperalgesia; fMRI
Sleep, Mood, and Behavior Study
Condition: Sleep Difficulties in Pediatric Anxiety Disorder; Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether improving sleep in children and adolescents
      with anxiety disorder will further enhance affective, clinical, and social functioning.
    

Detailed description: 
      This study is one of two interlinking protocols developed to investigate neural, affective,
      behavioral and social predictors of improvement as a critical next step in advancing the
      understanding of processes involved in the treatment response of anxiety disorders in youth.
      This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children
      ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of
      impairment in their ability to sleep. Participants will have completed a 16 session
      intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to
      assess whether improving sleep will further enhance affective, clinical, and social
      functioning.
    

Intervention name(s): Cognitive Behavioral Therapy-Sleep
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Therapy: 6 sessions of CBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep difficulties in pediatric anxiety disorder; Neural correlates of pediatric anxiety disorder; Social correlates of pediatric anxiety disorder; Generalized Anxiety Disorder in pediatric populations; Separation Anxiety Disorder in pediatric populations; Social Phobia in pediatric populations
Epidemiology of Cardiac Development in Youth
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To document normal developmental changes in cardiac structure and function during late
      childhood and adolescence.
    

Detailed description: 
      DESIGN NARRATIVE:

      The investigators documented the nature and extent of changes in cardiac structure based on
      M-mode measurements and developed corresponding reference values. They documented the nature
      and extent of changes in cardiac function based on pulse Doppler measures and indices and
      developed corresponding reference values. They also investigated clinical findings based on
      M-mode and Doppler measurements as well as changes in body size and composition, sexual
      maturation, and other covariates. They used existing data from Project HeartBeat! 's 12
      four-monthly examinations over the age range from 8 to 17 years.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      The objective of this study is to determine the effects of cerebrospinal fluid sampling rate
      on biomarker levels of young, healthy volunteers.
    


Intervention name(s): Sampling Rate
Intervention type(s): Other
Intervention description(s): Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Whole blood, plasma, cerebrospinal fluid
    
Keywords: Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
Study of ONO-2506 in Patients With Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to
      placebo in patients with acute ischemic stroke.
    


Intervention name(s): ONO-2506; ONO-2506; ONO-2506
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days; Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days; Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONO-2506; stroke; Acute ischemic stroke