bioihbjkbjnl/mcl2 huggingface dataset:
Fatty Acids and Executive Function Development in 7-12 Year Olds
Condition: Executive Function
Study type: Observational

Summary: 
      Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related
      changes in executive functions in children and older adults.

      Participants: Eighty-four typically-developing 7-to 12-year-old children.

      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three
      sessions will consist of the screening. These sessions will be telephone calls to collect
      24-hour diet information that will be used to determine whether they are eligible for the
      fourth session. Approximately 120 participants will be screened to find 84 participants who
      are eligible for the fourth session, in which participants will complete a series of tests on
      the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that
      provides computerized versions of standardized cognitive tests. They will also complete a
      maze task in which they figure out a path through the maze by walking on the correct squares.
      Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in
        English. Every effort will be made to recruit roughly equal numbers of boys and girls.
        Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made
        to match the sample to the race and ethnicity of the region: 80% White, 15%
        African-American, and 5% Native American, Asian, and Other descent.
The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)
Condition: Obesity; Type2 Diabetes
Study type: Observational

Summary: 
      The purpose of this study is to investigate a persons dietary intake and its effect on the
      gut microbiome and the association of those two variables on weight and glucoregulation.
      Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin,
      c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2)
      with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean
      controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to
      investigate the association with diet, microbiome and weight/glucoregulation.
    


Intervention name(s): no intervention used
Intervention type(s): Other
Intervention description(s): Patients will be giving a blood sample after 8 hours of fasting.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese diabetics, obese non-diabetics and controls
      
Biospecimen description: 
      plasma/serum samples and fecal samples will be collected from each patient.
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Condition: Fascia; Inflammation; Thoracic; Rotation
MeSH terms: Fasciitis; Inflammation
Study type: Interventional

Summary: 
      Testing the effect of a specific stretch technique versus sham treatment, to objectify the
      influence of that specific technique on thoracic rotation mobility.
    

Detailed description: 
      Subjects in the experimental group will undergo a technique for stretching the intrathoracic
      fascia. Before and after, a measurement will be performed with a goniometer, to see if there
      is a difference in thoracic rotation mobility.

      Subjects in the placebo group get a different technique, where the hands of the therapists
      are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there
      is a measurement in thoracic rotation mobility.

      Data will be compared and statistical analyse will be done to see of there is a difference in
      rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic
      rotation mobility, will be accepted or rejected.
    

Intervention name(s): Measuring thoracic rotation mobility
Intervention type(s): Other
Intervention description(s): Measuring the thoracic rotation mobility with a goniometer, from a standardized position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and the dose-response relationship of
      ILT-101 to blood Tregs.
    

Detailed description: 
      In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs)
      and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).

      The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose
      interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may
      improve AID. Exploiting this potential requires i) to better target the dose with the best
      benefit / risk ratio and also ii) to better understand the mechanism of action of this
      molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes,
      multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very
      thorough immunological follow-up is carried out in order to discover biomarkers of treatment
      efficacy. Exploitation of these results will benefit both the cross-analysis of the effects
      of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a
      comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it
      possible to define the most effective dose of IL-2.
    

Intervention name(s): ILT101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks; Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
Other intervention name(s): low-dose IL-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Low dose of IL-2; Healthy volunteers; Kinetic study
Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and
      mortality. Weight restoration is a treatment priority, and better treatments are needed.
    

Detailed description: 
      This study is a 16-week randomized, double-blind, placebo-controlled trial of olanzapine in
      adult outpatients with AN. 160 individuals with AN, ages > 18, will be randomly assigned to
      receive olanzapine or placebo for 16 weeks together with a medication management treatment.
      Primary outcomes will include weight gain as well as psychological symptoms known to be
      associated with AN, including obsessionality, mood, and anxiety.

      This project is based on evidence from a recently completed 8-week pilot study comparing the
      efficacy of olanzapine to placebo in outpatients with AN (PI: Evelyn Attia, MD), as well as a
      recently published 12-week trial of olanzapine vs placebo (Bissada et al, Am J Psychiatry,
      2007) in which outpatient treatment with olanzapine was associated with weight improvement,
      improved psychological status, and no untoward metabolic effects among low-weight patients.

      The investigators hypothesize that among underweight adult outpatients with AN receiving
      olanzapine vs. placebo, together with medication management treatment: 1)patients with AN
      receiving olanzapine will gain weight at a faster rate than those receiving placebo; and 2)
      patients with AN receiving olanzapine will demonstrate greater reduction in psychological
      symptoms, including obsessionality, mood, anxiety and eating disorder symptoms, than those
      receiving placebo.
    

Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.; Control Group will receive placebo pill
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eating Disorders; Anorexia Nervosa
Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO
      80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has
      marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp®
      Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been
      performed in subjects younger than 18 years
    


Intervention name(s): LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)
Intervention type(s): Drug
Intervention description(s): Once daily application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?
Condition: Cerebral Palsy; Children
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To determine the clinical efficacy of auditory cueing using a cross over design to
      investigate whether increasing auditory cueing frequency by 20% above self paced cadence
      affects gait parameters in children with Cerebral Palsy when performing a functional task.
    

Detailed description: 
      Introduction: Cerebral Palsy is a non progressive disorder occurring in early brain
      development, resulting in inefficient ambulatory pattern. The use of sensory cues to
      facilitate loco-motor activity has been suggested as providing the necessary trigger to
      synchronise movement with greater beneficial outcomes observed at higher frequency
      intensities within the adult population. Thus auditory cueing could have the potential to
      alter gait parameters during a functional task.

      Aim: To explore if increasing auditory cueing frequency (AC20) affects gait during a
      functional task compared to auditory cueing at self-paced cadence (ACSC).

      Method: Nineteen children with CP levels 1 and 2 on the Gross Motor Function Classification
      Scale participated using paired analysis. Outcomes were compared to the mean values for
      temporal spatial gait data within the conditions using a cross over design. TS data was
      obtained by using the GAITRite® walkway system whilst walking holding a cup.
    

Intervention name(s): Auditory Cueing
Intervention type(s): Device
Intervention description(s): Auditory cueing set at different frequency rates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Auditory Cueing; Gait
Magnetic Seizure Therapy (MST) for Severe Mood Disorder
Condition: Depression
MeSH terms: Seizures; Depression; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy
      (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major
      depressive episode in the context of either unipolar or bipolar depression. The investigators
      will conduct a number of clinical and neuropsychological tests to assess clinical and
      cognitive response to treatment. The investigators hypothesize that:

        1. MST and ECT will have similar antidepressant efficacy.

        2. MST will have less post-treatment amnesia than ECT as reflected in primary measures of
           anterograde and retrograde amnesia following the acute treatment phase.

        3. At follow up, MST will show a lesser degree of persisting deficit in measures of
           retrograde amnesia than ECT.
    

Detailed description: 
      The purpose of this study is to compare the clinical efficacy and side effects of Magnetic
      Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing
      a major depressive episode in the context of either unipolar or bipolar depression. ECT is
      known to be highly effective in treating depression, but it can have some adverse cognitive
      side effects. MST is a new form of convulsive therapy that is being developed as a means of
      improving the side effect profile of ECT so that more patients may benefit without suffering
      significant detrimental effects on cognition.

      Both ECT and MST cause a seizure, but they do so in different ways. In ECT, an electrical
      stimulator is used to pass an electrical current between two electrodes placed on the
      person's head, which causes some electricity to go through the brain and cause a seizure. In
      MST, a magnetic stimulator is used to pass a magnetic field to the brain, which then creates
      a small electrical field in the brain that causes a seizure.

      In addition to the treatment sessions, this study will involve a number of assessments at
      different timepoints that are used to evaluate the person's antidepressant response and the
      physical and cognitive side effects of treatment.
    

Intervention name(s): Thymatron; Magstim Theta
Intervention type(s): Device; Device
Intervention description(s): Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks); 100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
Other intervention name(s): Thymatron, Electroconvulsive Therapy (ECT); Magstim Theta, Magnetic Seizure Therapy (MST)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MST; Magnetic Seizure Therapy; ECT; Electroconvulsive Therapy; Depression; Magnetic
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Condition: Infection Viral; Thromboses, Venous; COVID-19
MeSH terms: COVID-19; Virus Diseases; Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, dose-requirements, and exploratory
      efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in
      children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection
      (i.e., COVID-19).
    


Intervention name(s): Enoxaparin Prefilled Syringe [Lovenox]
Intervention type(s): Drug
Intervention description(s): Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
Intervention MeSH terms: Enoxaparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2
      different dupilumab drug products in adult healthy volunteers. The duration per participant
      is up to 11 weeks.
    

Detailed description: 
      Duration per participant is up to 11 weeks.
    

Intervention name(s): Dupilumab (SAR231893)
Intervention type(s): Drug
Intervention description(s): injection solution subcutaneous
Other intervention name(s): REGN668
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Simplified Diet Approach in Phenylketonuria
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      This is a study to determine if a simplified protein counting system, including the free
      usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in
      teens and adults with phenylketonuria (PKU).

      Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to
      participate in this study.

      Subjects will be educated on the simplified system upon enrollment, and historical
      phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about
      their attitudes towards their current Phe counting system.
    

Detailed description: 
      This is a study to determine if a simplified protein counting system, including the free
      usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in
      teens and adults with phenylketonuria (PKU).

      Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to
      participate in this study.

      Subjects will be educated on the simplified system upon enrollment, and historical
      phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about
      their attitudes towards their current Phe counting system.

      Upon enrollment, a 3-day food record and Phe levels over the past 12 months will be
      collected. Demographic information will be asked, as well as questions regarding their
      current Phe counting system. Patients will be educated on the new counting system, stressing
      3 key principles: 1) free use of fruits and vegetables, low in protein, 2) protein counting
      as a simpler version of Phe counting, including reinforcement of label reading, and 3) daily
      use of PKU formula for enhanced nutrient and protein intake. Patients will be given written
      educational tools to reinforce this new method.

      At the end of the 12 months, subjects will be asked to provide a 3-day food record, and
      questions will be asked about their attitudes toward the use of the new simplified system.

      Phenylalanine levels from the 12-month study period will be used to compare with historical
      data.
    

Intervention name(s): Dietary Protein Counting and Free Fruits and Vegetables
Intervention type(s): Behavioral
Intervention description(s): Subjects will be educated on new simplified diet approach and phenylalanine levels will be monitored for 1 year, and will be compared to 12 months prior to study enrollment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Observational

Summary: 
      N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing
      enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a
      nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator
      genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater
      toxicity of ATT drug. Therefore this study has been designed to analyze the genetic
      polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced
      hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1
      gene may help in predicting the high risk group of ATT induced hepatitis.
    


Intervention name(s): ATT
Intervention type(s): Drug
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cases are enrolled in the study from primary care clinic after they are diagnosed with
        pulmonary tuberculosis.
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The objective of this study is to obtain an additional 36 months of safety and effectiveness
      data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014
      clinical trial.
    

Detailed description: 
      VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the
      VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in
      the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months
      post-operatively (based on the anniversary of their first VisAbility™ surgery) with no
      planned interventions.
    

Intervention name(s): VisAbility™ Micro Insert
Intervention type(s): Device
Intervention description(s): No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.
Intervention model: Single Group Assignment
Intervention model description: A non-randomized single group design. All subjects who were implanted with the VisAbility™ Micro Insert (360 subjects) will be invited to participate. Actual sample size will be determined at the completion of enrollment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Near Vision; Reading Vision; Reading Glasses; Reading; Readers; Presbyopic