bioihbjkbjnl/mcl2 huggingface dataset:
A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
Study type: Interventional

Summary: 
      The proposed study is to test and validate a novel intervention that integrates computerized
      cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory
      by probing the individualized neural systems underlying working memory. We will test the
      proposed intervention on children with ADHD with working memory deficits. The R61
      proof-of-concept phase will assess the target engagement, effective dose and feasibility.
    


Intervention name(s): Neurofeedback; Cognitive training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.; The Cognitive training group will receive computerized working memory training with performance feedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Working memory; functional near infrared spectroscopy (fNIRS); magnetic resonance imaging (MRI); Neurofeedback; Cognitive training; Neuromonitoring
Critical Periods of Exercise
Condition: Metabolism
Study type: Interventional

Summary: 
      Early childhood (~3-7 years of age) is an important window for determining body composition
      trajectory and may be a critical period for the development of tissue partitioning patterns
      that influence obesity risk. As adiposity accelerates during this critical period,
      deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues;
      i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of
      tissue mass accrued in early childhood has implications for metabolic profile,
      glucose/insulin homeostasis, hormone profile and resting energy expenditure.

      The interplay between fat and bone deposition represents a physiologic trait enabling the
      body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly
      the phenotype underlying obesity and diabetes risk may be determined by the differentiation
      of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development.
      In vitro studies demonstrate transdifferentiation under the influence of specific external
      stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have
      demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass
      accrual in adulthood, even when the stimulus is later removed (animals are no longer
      exercising). Children's early experiences (engagement in physical activity vs. sedentary
      behavior) may 'environmentally induce' alterations in body composition and predispose
      individuals to obesity throughout life.

      Aim 1. To examine the associations between body composition via DXA and objectively-measured
      physical activity/inactivity.

        1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.

        2. Hypothesis 1.2: There is a positive association between sedentary behavior and total fat
           mass.

           Aim2. To examine the associations between adipose tissue distribution via MRI and
           objectively-measured physical activity/inactivity.

        3. Hypothesis 2.1: There is an inverse association between physical activity and bone
           marrow adipose tissue.

        4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone
           marrow adipose tissue.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Children will be exposed to a 10-week exercise intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; bone marrow adipose tissue; bone mineral density; Children in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeks; Control treatment will be provided no intervention; All participants will be instructed not to change their current dietary habits during the study period.
A Study of Parenterally-administered Teverelix TFA in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, open-label, single centre study investigating the pharmacokinetics, safety and
      pharmacodynamics of a single dose of teverelix TFA, a gonadotrophin releasing hormone
      antagonist, via subcutaneous or intramuscular route of administration in healthy male
      volunteers
    

Detailed description: 
      The primary objective of the study is:

      • To characterise the pharmacokinetic (PK) profile of teverelix following single dose,
      subcutaneous (s.c.) and intramuscular (i.m.) administration of teverelix TFA in healthy male
      subjects

      The secondary objectives of the study are:

        -  To assess the safety and tolerability of teverelix TFA after single s.c. and i.m.
           injections in healthy male subjects

        -  To evaluate pharmacodynamics (PD) effects of teverelix following single dose, s.c. and
           i.m. administration of teverelix TFA in healthy male subjects
    

Intervention name(s): teverelix TFA
Intervention type(s): Drug
Intervention description(s): A single s.c. or i.m. injection of teverelix TFA administered on Day 1
Intervention MeSH terms: Antarelix
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This Phase I clinical study is an open-label, parallel-design, single-centre study to investigate the PK, safety and PD following subcutaneous and intramuscular administration of single doses of teverelix TFA in healthy male subjects.
Masking: None (Open Label)
Primary purpose: Basic Science
Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
Condition: Ebola Virus
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability
      and immunogenicity of an investigational Ebola vaccine in healthy adults.
      VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype 3 vector-based Ebola vaccine, encodes
      wild type (WT) glycoprotein (GP) from the Sudan strain of Ebolavirus and is administered
      intramuscularly (IM).
    

Detailed description: 
      A total of 40 participants were evenly split, with 20 in each of the two dosage groups to
      receive the investigational cAd3-EBO S vaccine at a dose of either 1x10^10 particle units
      (PU) (Group 1) or 1x10^11 PU (Group 2). The dose escalation plan included daily review of any
      new safety data by a study clinician, regular review of safety data by the protocol team and
      a staged enrollment plan with required interim safety reviews. The study began with
      enrollment of 3 participants into Group 1 (1x10^10 PU) at a rate of 1 participant per day.
      After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety
      review occurred before enrollment of additional participants into the group. No safety issues
      were identified; therefore, an additional 17 participants were enrolled to complete Group 1.
      When there was a minimum of seven days of follow-up safety data from the last enrolled
      participant in Group 1, an interim safety review occurred. No safety issues were identified,
      and enrollment of participants into the next dose level (Group 2) began with the enrollment
      of 3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for
      the first 3 vaccinated participants in Group 2 (1x10^11 PU), an interim safety review
      occurred before the enrollment of additional participants into Group 2. No safety issues were
      identified, and an additional 17 participants were enrolled to complete Group 2. Participants
      were followed for approximately 48 weeks.
    

Intervention name(s): cAd3-EBO S vaccine
Intervention type(s): Biological
Intervention description(s): The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP).
Other intervention name(s): VRC-EBOADC086-00-VP
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential Assignment Dose Escalation
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ebola virus; Ebola vaccine; cAd3-EBO S
Efficacy and Safety of the Algorithm for Enteral Nutrition Support
Condition: Nutrition Disorder, Child
MeSH terms: Nutrition Disorders; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The purpose of this trial is to evaluate the efficacy and safety of the implementation of an
      algorithm for enteral nutrition support compared with usual standard practice in children
      with malnutrition status with congenital heart disease
    

Detailed description: 
      In many developing countries, pediatric cardiac programs are not fully established, and
      nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy
      and safety of the implementation of an algorithm for enteral nutrition support compared with
      usual standard practice in children with malnutrition status with congenital heart disease.
      The usual standard practice for feeding often interrupted by retention in the gut and then
      choose the parenteral nutrition support especially in the patients with unstable hemodynamic
      status. Actually tiny and continuous feeding would improve the gut function and reach the
      adequate energy supply.
    

Intervention name(s): intervention group
Intervention type(s): Other
Intervention description(s): When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of
      NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and
      adults with Tourette Syndrome (TS).
    


Intervention name(s): Valbenazine
Intervention type(s): Drug
Other intervention name(s): NBI-98854
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Stress Reduction Techniques
Condition: Stress
Study type: Interventional

Summary: 
      There are many ways to reduce stress. This study will compare 2 different programs for
      reducing stress. In addition to looking at how well the programs reduce stress, we will also
      ask questions about how these programs may be working.
    


Intervention name(s): Program 2; Program 1
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.; A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
Condition: Tick-borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and immunogenicity of three different
      concentrations of a TBE vaccine in healthy children aged 1 to 6 years.
    


Intervention name(s): Tick-borne Encephalitis Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
Condition: Growth of Term Infants
Study type: Interventional

Summary: 
      This clinical trial will evaluate an investigational infant formula with a probiotic to
      determine if it provides normal growth and if it is well tolerated by term infants compared
      to a marketed routine infant formula.
    


Intervention name(s): An investigational infant formula containing a probiotic source; Control: Marketed routine infant formula
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Survey Tool for Screening of Anemia in Women Before Pregnancy
Condition: Anemia Complicating Pregnancy; Anemia Complicating Childbirth; Anemia Complicating the Puerperium
MeSH terms: Pregnancy Complications; Anemia
Study type: Observational

Summary: 
      The goal of this observational and cross-sectional study is to develop and validate a survey
      that can be used to identify anemia, and its severity, among pre-pregnant women allowing for
      the timely implementation of focused public health and personalized interventions.

      Participants will be asked 26 survey questions about menstrual history and provide a 5 ml
      venous blood sample to measure hemoglobin, ferritin, and transferrin saturation levels.
    

Detailed description: 
      Despite a variety of governmental campaigns and funded programs, anemia rates among
      reproductive age women in low- and middle-income countries (LMICs) have not decreased over
      the past few decades. Iron deficiency is associated with increases in morbidity and mortality
      in both non-pregnant and pregnant women, as well as their offspring.

      Up to 500 currently married women between 18 and 25 years old who are not pregnant, have
      never been pregnant, and are not using any type of contraception other than barrier methods
      will be recruited for this study from primary health centres (PHCs) in Belagavi , Karnataka,
      India.

      Accredited Social Health Activists (ASHAs) will identify potentially eligible participants
      and bring them to participating primary healthcare centers (PHCs) for screening, consent, and
      enrollment. Once enrolled, trained female interviewers will administer the PREPSA survey to
      the participant and a laboratory technician will draw a blood sample (upon completion of the
      survey or within four weeks) to analyze hemoglobin, ferritin, and transferrin saturation
      values. The survey responses that most closely align with low iron indices will be identified
      and become the basis of a scored, validated instrument which may be weighted based upon the
      strength of the associations found. Results will inform future health outcome trials.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Currently married pre-pregnant women (n=500), ages 18-25 years, in Belagavi, Karnataka,
        India
      
Keywords: Anemia
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control
      (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung
      condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine
      (PPSV23). The purpose of this study is to increase awareness of vaccination to late
      adolescents with asthma and smokers (social aspect of study), and to recommend vaccination
      (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled
      in research to determine whether late adolescents with and without asthma (smokers) have
      distinctive pneumococcal vaccine response patterns and whether such patterns are associated
      with subsequent variance in asthma outcomes.
    


Intervention name(s): Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)
Intervention type(s): Biological
Other intervention name(s): Pneumovax
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Aim of the work Impact of serum vit D level in SLE patients with COVID-19 disease on severity
      of infection, duration of COVID-19 disease course, fatigue development as a complication for
      both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes
      Patients and methods 38 SLE patients previously diagnosed and on different lines of lupus
      management. Participants were presented to chest outpatient clinic and emergency hospital,
      Mansoura University with manifestation suggesting COVID-19 infection. Serum vit D was
      measured in serum by ELISA.
    

Detailed description: 
      Primary objective: assess the impact of serum vit D level in SLE patients with COVID-19
      disease on severity of infection and pandemic treatment outcome.

      Secondary objectives:

        -  Effect of serum vit D level in SLE patients on duration of COVID-19 disease course and
           fatigue development as a complication for both SLE and COVID-19

        -  Impact of prior chloroquine on COVID-19 disease outcomes

        -  Correlation of serum vit D level with different laboratory investigations at time of
           COVID-19 outbreak
    

Intervention name(s): Vitamin D; ELISA
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): Impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection, duration of COVID-19 disease course, fatigue development as a complication for both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes; Measure vitamin D level
Other intervention name(s): Serum Vitamin D level
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        SLE patients infected with COVID-19
      
Biospecimen description: 
      Serum sample for Vitamin D level by ELISA
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Condition: De Novo Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether alefacept is effective and well tolerated
      when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a
      combination therapy of placebo, tacrolimus and steroids in the prevention of kidney
      transplant rejection.
    


Intervention name(s): Alefacept; placebo; Tacrolimus; Mycophenolate Mofetil; Steroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV and subcutaneous injection; IV and subcutaneous injection; The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.; Mycophenolic mofetil was administered as 750 mg twice per day orally; Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
Other intervention name(s): Amevive
Intervention MeSH terms: Mycophenolic Acid; Alefacept; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: kidney transplant; alefacept
Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
Condition: Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in
      treating patients with gastrointestinal stromal tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients
           with gastrointestinal stromal tumors.

      Secondary

        -  To determine the efficacy and safety of dasatinib in these patients.

        -  To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.

        -  To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.

        -  To determine the efficacy of second-line treatment with another TK-inhibitor.

      OUTLINE: This is a multicenter study.

      Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for
      26 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months for 4 years.
    

Intervention name(s): dasatinib
Intervention type(s): Drug
Intervention description(s): Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
Other intervention name(s): Sprycel
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastrointestinal stromal tumor