bioihbjkbjnl/mcl2 huggingface dataset:
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be
      administered annually to all children aged 6 months to 18 years as well as women who are
      pregnant during the influenza season. Nevertheless, targeting and mobilizing these
      populations has been difficult and influenza immunization rates nationwide remain low.
      Immunization reminder-recalls have been shown to be effective, but have had limited ability
      to rapidly identify and reach large target populations in a cost-effective manner. Evidence
      on how to optimally design these systems is not yet available and thus text message
      immunization alerts have not been widely implemented. The investigators propose to implement
      and evaluate tailored, targeted influenza text message reminders in urban pediatric and
      pregnant populations.
    


Intervention name(s): Text Message; automated call
Intervention type(s): Other; Other
Intervention description(s): Text message vaccine reminders; Automated call
Other intervention name(s): Health services; Health services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Influenza, text message, vaccination
Treatment of Social Anxiety Disorder and Selective Mutism
Condition: Social Anxiety Disorder; Selective Mutism
MeSH terms: Mutism; Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for
      Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive
      Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting
      criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient
      Program and participants will be randomized to either the Taming Sneaky Fears group or a
      parent psycho-education and child socialization group. Trained clinicians blinded to all
      measures and treatment assignment will administer pre, post and 6-month follow-up outcome
      measures. Investigators assess within-the-child and within-the-parent/environment factors
      that predict treatment outcomes.
    

Detailed description: 
      This study utilizes a repeated measures, longitudinal, randomized controlled trial design to
      compare the efficacy of two interventions in the treatment of children aged 4 to 7 years with
      SM and/or SAD. Participants are randomized into either the:

        1. Taming Sneaky Fears for SAD and/or SM parent and child group CBT treatment, or

        2. the Parent Psycho-education and Child Socialization comparison program.

      Both programs run for 10 consecutive weeks (plus one additional introduction week). To
      control for the nonspecific factors associated with treatment, such as the support, attention
      and expectation of improvement, parents and children in both treatment protocols receive
      comparable levels of attention from therapists (i.e., same duration of group sessions and
      total number of sessions with a therapist) and comparable opportunities for socialization
      (e.g., for the children: invitation to discuss how the previous week went, snack time, story
      time; for the parents: discussion of specific topics at each session). However, parents and
      children in the comparison group are not taught CBT strategies.
    

Intervention name(s): Taming Sneaky Fears; Parent Psycho-education and Child Socialization
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.; Parents receive psycho-education in parent group and children receive socialization skills in child group.
Other intervention name(s): Cognitive Behavioral Therapy (CBT); Psycho-education and Socialization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Selective Mutism; CBT; preschool anxiety disorders
Antecedent Picky Eating Behaviour in Young Children
Condition: Child Behavior; Child Rearing; Eating Behavior; Parent-Child Relations; Parenting; Feeding and Eating Disorders of Childhood
MeSH terms: Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
Study type: Observational

Summary: 
      Picky eating behaviour in young children is a very common concern for parents. The aim of the
      study is to investigate factors during early life which are associated with a child becoming
      a picky eater.
    

Detailed description: 
      Singleton children from the Avon Longitudinal Study of Parents and Children will be studied
      prospectively (n=5758-6608). Parental-completion questionnaires will be used to define 'picky
      eating' status at age 3 years, and child and parental feeding behaviours and practices
      throughout the first 2 years of the child's life. Multinomial logistic regression models with
      3 levels of picky eating status (not, somewhat and very picky) as the dependant variables
      will be used to test associations with antecedent variables, first assessing variables from
      pregnancy, and the first and second year of life, separately, then combining all significant
      variables in a final model.
    

Intervention name(s): None - observational
Intervention type(s): Other
Intervention description(s): No intervention - observational only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women in the former Avon Health Authority with an expected delivery date
        between April 1991 and December 1992 were eligible for the study; 14,541 pregnant women
        were initially enrolled, resulting in a cohort of 14,062 live births with 13,988 alive at 1
        year of age. Parents/caregivers were sent a questionnaire when the child was 3 years old
        that included a question on picky eating behaviour. Singleton children whose
        parents/caregivers answered this question were included in the study.
      
Keywords: Picky eater; Fussy eater; Faddy eater; Nutrition
Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study
Condition: Congenital Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Approximately 40,000 infants are born each year in the United States with congenital heart
      defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the
      United States. While advances in surgical treatment, cardiac bypass, and post-operative
      management have improved mortality for children born with heart defects, these children
      continue to have significant morbidity related to post-operative malnutrition, multiple organ
      dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via
      loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity.

      The purpose of this multi-center observational cohort study is to understand the extent to
      which practice variation for routine post-operative care might worsen intestinal barrier
      dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical
      correction of left sided cardiac obstructive defects. We will enroll 80 children with left
      sided obstructive congenital cardiac lesions across several US congenital cardiac centers to
      obtain clinical data and biological specimens. We will leverage existing differences in
      nutritional and antibiotic strategies at these centers to better understand how intestinal
      barrier function and the intestinal microbiome may contribute to post-operative multiple
      organ dysfunction syndrome.
    


Intervention name(s): Congenital Heart Disease Surgery
Intervention type(s): Procedure
Intervention description(s): Stool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of infants and young children who are diagnosed with left
        sided obstructive congenital heart disease and are scheduled for corrective surgery.
        Investigators will enroll a total of 80 patients in this multi-center trial. Investigators
        anticipate that local enrollment will be about 1-2 patients per month, or 12-24 per year
        when the cardiac program is active.
      
Biospecimen description: 
      Stool samples, blood samples with permission of family
    
Keywords: Heart; multiple organ dysfunction syndrome; pediatric critical care; congenital heart disease
Bilateral Movement Training for People With Stroke
Condition: Stroke; Cerebrovascular Accident; Cardiovascular Disease; Brain Injury
MeSH terms: Stroke; Brain Injuries; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators hypothesized that bilateral handgrip force training would result in
      significant improvements in paretic hand, arm movements and daily functional performances. In
      order to investigate whether the improvement of paretic hand could facilitate the motor
      recovery of paretic arm and functional performances, the investigators also hypothesized that
      motor recovery and functional performances improvements of paretic arm and hand have strongly
      correlation.
    

Detailed description: 
      Objective: To investigate the training effects of interlimb force coupling training on
      paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the
      relationship between motor recovery of paretic hand, arm and functional abilities.

      Design: A double-blind randomized controlled trial with outcome assessment at baseline and
      after 4 weeks intervention.

      Setting: Department of physical medicine and rehabilitation in Taipei Veterans General
      Hospital.

      Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were
      recruited and randomized assigned to training (n=16) and control group (n=17).

      Interventions: Interlimb force coupling training task included different gripforce generation
      on the both hands.

      Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of
      Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function
      Test (WMFT). All assessment was executed by a blinded evaluator, and data management and
      statistical analysis was also conducted by a blinded statistic researcher.
    

Intervention name(s): Bilateral movement training
Intervention type(s): Procedure
Intervention description(s): Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
Other intervention name(s): Coupling movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
Laxation and Satiety Response of Novel Dietary Fibers
Condition: Healthy
Study type: Interventional

Summary: 
      Dietary fibers have previously been shown to affect laxation and satiety. Due to differences
      in structure and physical properties of dietary fibers, these effects may not be consistent
      across all fibers. Therefore as new dietary fibers are created or discovered the laxative and
      satiating effects should be investigated in order to verify these effects.
    

Detailed description: 
      This study was designed to test the laxative effects of two fibers a resistant starch made
      from corn and a glucose polymer fiber. The secondary aim of this study was to examine the
      satieting effects of these fibers. This trial was double-blind and placebo controlled. On the
      first day of the study subjects consumed the breakfast cereal and milk and were instructed to
      complete visual analog scales periodically to test acute satiety. Subjects also completed
      diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects
      completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time,
      fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and
      collecting every fecal sample for the 5 days thereafter.
    

Intervention name(s): Glucose polymer fiber; Fiber made from corn starch; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin; 20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin; low fiber breakfast cereal and muffin
Other intervention name(s): Dietary fiber made from corn starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy adults
Return to Sport After Posterior Spinal Fusion
Condition: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The primary purpose of this prospective study is to determine when adolescent athletes with
      idiopathic scoliosis are able to return to sports participation after posterior spinal fusion
      surgery.
    

Detailed description: 
      The investigators aim to determine at what time subjects return to athletic activity, and how
      long after surgery they are performing at pre-surgical levels. The investigators will enroll
      adolescent athletes that meet the inclusion criteria below, and follow their postoperative
      activity level with standardized activity questionnaires on a monthly basis until the subject
      reaches their baseline pre-surgical performance level. The investigators primary aim is to
      determine at what time patients return to sports without any restrictions to contact level or
      type of play. The investigators secondary aim is to quantitatively assess when patients are
      able to compete at their prior level of play as determined by self-assessment surveys, as
      well as identify any post-operative complications in these patients after return to sports.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All enrolled subjects will be competitive athletes with a diagnosis of adolescent
        idiopathic scoliosis and plans to undergo posterior spinal fusion.
      
Keywords: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion; Return to Sport
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Intracoronary abciximab administration during primary percutaneous coronary intervention
      (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was
      to assess whether abciximab administration route could influence its anti-inflammatory
      effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an
      intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of
      inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.
    

Detailed description: 
      BACKGROUND: intracoronary abciximab administration during primary percutaneous coronary
      intervention (pPCI) could offer clinical advantages over the intravenous route. Besides
      antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with
      GPIIb/IIIa, avb3, and aMb2 receptors. The aim of this study was to assess whether abciximab
      administration route could influence its anti-inflammatory effects.

      METHODS: 87 consecutive STEMI patients candidate to pPCI were randomized to receive
      intracoronary (Group A, 47 patients) or intravenous (Group B, 42 patients) abciximab bolus.
      The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP),
      VCAM-1 and ICAM-1 levels.
    

Intervention name(s): Intracoronary administration of an abciximab bolus during primary PCI; Intravenous administration of an abciximab bolus during primary PCI
Intervention type(s): Drug; Drug
Intervention description(s): Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI; Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammation; thrombosis; platelets; adhesion molecules; endothelium
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
Condition: Myopia-Night Blindness
MeSH terms: Blindness; Myopia; Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      Reduced quality of vision and glare in twilight or night are frequently mentioned complaints
      within the optometric examination. A reason for these problems could be a myopic refractive
      shift in dark light conditions, commonly known as night myopia or twilight myopia.

      The aim of this study was to investigate whether quality of vision in twilight or night could
      be improved by a spectacle correction optimized for mesopic light conditions. Moreover,
      objective refraction in large pupils measured by aberrometry was compared to subjective
      mesopic refraction.
    

Detailed description: 
      After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux).
      Subjective photopic refraction and visual acuity were measured before light was turned off
      and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally,
      frames and lenses were fitted by a centration system. Lens grinding was executed centralized
      by a grinding workshop. In the course of this study, subjects were randomly assigned to wear
      two glasses double-masked in turn. One with photopic subjective refraction data and another
      with mesopic subjective refraction data. Both were worn for 14 ± 2 days each.

      Follow Up 1:

      After two weeks, participants were asked for their subjective experiences with the first
      correction by a visual analogue scale questionnaire. After the evaluation, glasses were
      changed.

      Follow Up 2:

      Two weeks later, subjective experiences were evaluated again. After visual analogue scale
      questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic
      vision and subjective safety level during night driving.
    

Intervention name(s): Spectacle/Glasses
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: night vision; mesopic visual acuity; aberrometry; mesopic spectacle correction; night myopia
Healthy Volunteer Study of the Pharmacokinetics of Oral Piperaquine With OZ439 + TPGS Formulation in the Fasted State
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in
      Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained
      using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet
      been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder
      in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate ~ 70%
      due to a small drug drug interaction).

      This study investigates the exposure of piperaquine and OZ439 when co-administered as
      piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of
      Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The
      reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat milk
    

Detailed description: 
      Objectives:

        1. To evaluate the piperaquine and OZ439 pharmacokinetics when administered as a
           combination of piperaquine phosphate tablets with OZ439 / TPGS formulation in the fasted
           state

        2. To evaluate the piperaquine and OZ439 pharmacokinetics of a reference free combination
           formulation: piperaquine phosphate tablets with OZ439 powder in bottle (PIB) given with
           full fat milk

        3. To determine safety and tolerability of OZ439 and piperaquine phosphate when
           co-administered.
    

Intervention name(s): PQP tablets 960mg; PQP tablets 1440mg; OZ439+TPGS 800mg; OZ439 PIB 800mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Piperaquine phosphate tablets 960mg; Piperaquine phosphate tablets 1440mg; OZ439+TPGS prototype formulation 800mg; OZ439 Powder in Bottle Aqueous Solution 800mg
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; safety; tolerability; bioavailability