bioihbjkbjnl/mcl2 huggingface dataset:
Vasopressin and the Social Brain
Condition: Social Psychology
Study type: Interventional
Phase: Early Phase 1

Summary: 
      It has long been established that interpersonal relationships can have a profound impact on
      health and well-being. Yet, the investigators are still learning about the complex biological
      processes that contribute to positive social interactions and the ability to develop and
      maintain social relationships. Recent research has begun to focus on vasopressin, a
      neuropeptide that is naturally produced in the hypothalamus, because administration of this
      neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g.,
      faces), and brain activity in neural regions associated with social and emotional processes.
      To date, several aspects of vasopressin's effects on social behavior have been unexplored. As
      such, the overarching goal of this project is to examine the effects of intranasal
      vasopressin on several tasks involving learning and social processes. In addition, the
      investigators will explore associated neural activity through functional magnetic resonance
      imaging (fMRI). Results from the study will inform our understanding of the neurobiology of
      socioemotional processes.

      The investigators hypothesize that compared to placebo, vasopressin will improve deception
      detection, increase empathy and altruism, enhance responses to photo stimuli of primary
      caregivers, and improve learning when the subject has a prosocial goal of teaching another
      person. These effects will manifest in behavioral and neural activity. It is also
      hypothesized that main effects will not be found for vasopressin, but rather, analyses of
      relevant moderators will elucidate these findings.
    


Intervention name(s): Intranasal vasopressin; Intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).; Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vasopressin; intranasal administration; healthy sample
Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and pharmacokinetic profiles of two different formulations
      MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen
      in healthy volunteers
    

Detailed description: 
      Part 1:

      To compare the bioavailability and pharmacokinetic profiles of two different formulations
      MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen
      in healthy volunteers; and To choose one of the two MN-166 50mg ER tablet formulations for
      evaluation in Part 2.

      Secondary: To determine the safety and tolerability of the two formulations of MN-166 ER
      tablets in a single-dose regimen in healthy volunteers.

      Part 2:

      To compare the bioavailability and steady-state pharmacokinetic profile of MN-166 50mg ER
      tablet with MN-166 10mg capsules in a multiple-dose regimen in healthy volunteers; and

      Secondary: To determine the safety and tolerability of MN-166 ER tablets in a multiple-dose
      regimen in healthy volunteers
    

Intervention name(s): MN-166
Intervention type(s): Drug
Intervention description(s): an orally available small molecule drug approved in Japan and Korea for asthma and post-stroke complications and has been prescribed for these indications for more than 25 years
Other intervention name(s): ibudilast; Pinatos® capsule
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will receive the following three treatments in a crossover fashion, administered one week apart:
ER1: Single dose (50mg) of ER Prototype 1 (one 50mg ER1 tablet),
ER2: Single dose (50mg) of ER Prototype 2 (one 50mg ER2 tablet), and
IR: Two doses of intermediate-release capsules (50mg Pinatos® capsules in two divided doses 12 hours apart, i.e., 25mg for each dose).
Masking: None (Open Label)
Primary purpose: Other
Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this trial is to determine the effects of citicoline on cognitive
      performance in healthy Men and Women with Age-Associated Memory Impairment compared to a
      placebo.
    

Detailed description: 
      This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in
      healthy men and women with Age-Associated Memory Impairment. Cognitive assessments will be
      performed to determine whether citicoline administration with supportive memory, compared to
      placebo administration.
    

Intervention name(s): Placebo supplement; Citicoline supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cellulose; Cognizin
Other intervention name(s): Placebo; Cognizin
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Social Media Intervention - Physical Activity
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of the study is to develop and test social media interventions to help young
      people increase well-being and reduce risky behaviors. The study will help us learn about
      ways to deliver wellness information in a way that is appealing and helpful to young people
      that use social media.

      Eligible participants will be enrolled after baseline survey is completed. Participants will
      be involved with the secret social media group they are assigned to for 8 weeks. In addition,
      surveys will be completed at various times during and after the 8 week social media group.
    


Intervention name(s): Physical Activity (PA) Social Media Group; Verdi plus PA Social Media Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will have access to the secret Social Media page that will deliver health information focused on increasing healthy activities and well-being. This information will be posted by e-coaches. Participants can interact with the e-coaches as well as other study members in the group.; Participants will have access to the secret Social Media page that will deliver health information focused on increasing healthy activities, well-being, and reducing risky behaviors. This information will be posted by e-coaches. Participants can interact with the e-coaches as well as other study members in the group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: social media
Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults
Condition: Obesity
Study type: Interventional

Summary: 
      Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for
      60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by
      physical activity because the increased metabolic rate during exercise is partially carried
      over even when exercise stops. Therefore, persons who are physically active maintain higher
      RMR and less body fat than do sedentary controls. It is well known that high energy intake
      stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to
      approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a
      high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age
      (RMR tends to decline progressively over the life span) and body composition (lean body mass
      is regarded as the main determinant of RMR). However, the research regarding the effect of a
      specific combination of macronutrients and exercise on RMR is scarce.

      Therefore, the aim of the current study is to assess the combined effect of a meal
      composition and physical activity on RMR in normal weight and overweight children,
      adolescents and adults.
    

Detailed description: 
      One hundred (100) healthy volunteers, 50 normal weight (NW) and 50 overweight (OW), age 6-30
      will be recruited for the current study. All participants and/or their parents will sign
      informed consent prior to their participation. Participants will visit the clinic 4 times,
      with a week's difference between them. Participants will arrive at the clinic after 12 hours
      of fasting and avoiding physical activity for 14 hours. During the first visit, their RMR
      will be measured, and 15min later they will perform 60 min of aerobic training, and 15
      minutes later they will be asked to drink 300ml of water, followed by a second RMR test. In
      the consecutive visits they will follow the same routine without the first RMR test, and
      drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a
      random order.
    

Intervention name(s): DRINK - Water, Protein, Fat, Carbohydrate
Intervention type(s): Other
Intervention description(s): Following exercise participants will consume a drink (with different composition in each visit) and than RMR will be evaluated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: RMR; Macro nutrients; Exercise
Newborn Screening for Adrenoleukodystrophy
Condition: Adrenoleukodystrophy
MeSH terms: Adrenoleukodystrophy
Study type: Observational

Summary: 
      To test if the routine newborn screening dried blood spots can be used to test if elevation
      of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy
      (ALD)
    

Detailed description: 
      Parents of newborns will be invited to test if their newborns are affected with ALD. The
      routine newborn screening dried blood spots sample will be used to test the concentration of
      C26:0-lyso-PC . If positive of a screening test, further confirmation tests including
      physical examination and other methodology for ALD confirmation will be provided. Genetic
      counseling and treatment option will be provided, too.
    

Intervention name(s): newborns testing for ALD
Intervention type(s): Procedure
Intervention description(s): Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        newborns whose parents agree to be tested
      
Keywords: adrenoleukodystrophy; C26:0-lyso-PC
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Condition: Cerebral Palsy; Paraparesis, Spastic
MeSH terms: Muscle Spasticity; Cerebral Palsy; Paraparesis; Paraparesis, Spastic
Study type: Interventional

Summary: 
      The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded
      STS exercise program on the functional strength, gross motor function, daily participation,
      exercise involvement, motor control, and gait speed for children with spastic diplegia.
    


Intervention name(s): Loaded sit-to-stand exercise; Synchronized music
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks; Synchronized music for loaded sit-to-stand exercise to guide movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise
Voice Changes During ECT
Condition: Unipolar Depression; Bipolar Depression; Bipolar Disorder, Manic
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      Depressed patients talk differently when they are depressed compared to when they are well.
      But it is hard to actually measure what the differences are. The study team will record voice
      samples from patients with mood disturbances, like depression, over the course of their
      receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or
      quantify exactly what has changed in their speech and voice. The study team will choose ECT
      as it is one of the most effective and rapid treatment for depression. The study team will
      use a service provided by a company, NeuroLex, who has complex computer programs (artificial
      intelligence, AI) to analyze the voice samples.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): 3 voice recording tasks and 1 text entry task will be performed.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing electroconvulsive therapy (ECT) at the Medical University of South
        Carolina on an outpatient or inpatient basis.
      
Keywords: VAPRE
Effectiveness of Sealants on Molars
Condition: Tooth Decay
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and
      its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary
      dentition could slow the specific development of carious lesions in early childhood. In
      addition, this non-invasive approach could delay the conventional food and thus save
      financial costs for more complex treatments. Finally, the installation of AS could afford, as
      demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the
      caries process.
    

Detailed description: 
      Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and
      its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary
      dentition could slow the specific development of carious lesions in early childhood. In
      addition, this non-invasive approach could delay the conventional food and thus save
      financial costs for more complex treatments. Finally, the installation of AS could afford, as
      demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the
      caries process.

      Main objective: To evaluate the effect of AS on caries incidence in the deciduous dentition
      obtained over a period of three years, taking into account the risk of caries established
      initially.

      Secondary objectives:

        1. To assess the prevalence and caries attack sites at the end of each year

        2. Estimate the retention rate (partial or complete) of the AS during the study

        3. Determine the cost savings of treatment during the trial period
    

Intervention name(s): decayed tooth surfaces
Intervention type(s): Other
Intervention description(s): The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: test and control tooth groups. Each patient is therefore his own witness
Masking: Single (Participant)
Primary purpose: Prevention
A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects
Condition: Refractory Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a single arm, single-center, non-randomized phase I clinical trial which is
      designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL
    

Detailed description: 
      The 3x3 dose escalation design will be adopted in order to determine the maximum tolerated
      dose (MTD). Subjects will be enrolled into low-dose group, medium-dose group and high-dose
      group as below:

      Dose CAR+ cells/kg

      Low 0.8×106

      Medium 2.5×106

      High 5.0×106

      DLT is evaluated within 30 days post C-CAR011 infusion).
    

Intervention name(s): C-CAR-011
Intervention type(s): Biological
Intervention description(s): lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene.
Other intervention name(s): CAR-CD19
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory diffuse large B-cell lymphoma; anti-CD19 chimeric antigen receptor T-cell
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
Condition: Tonsillectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will
      significantly reduce post-operative fentanyl use compared to placebo.
    


Intervention name(s): Intravenous ibuprofen; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.; Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy, Pediatric
Europe-Japan Diagnostic Study for EGFR Testing
Condition: EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      This is a non-interventional diagnostic, international, multicenter and non-comparative study
      of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with
      adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and
      Europe and will assess the concordance of EGFR mutation status derived from tumour samples
      and blood based circulating free DNA. The data generated will inform the use of less-invasive
      sample types in diagnostic practice. The study also aims to assess the current status of EGFR
      mutation testing across Japan and Europe and gaps in currently available data including EGFR
      mutation frequency in particular populations and demographic subgroups, EGFR mutation
      frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology,
      utility of multiple sample types in the assessment of EGFR mutation status, and impact of
      EGFR mutation status on therapy choice. The data may be used to drive improvements to the
      EGFR mutation testing process, ensuring that patients have access to testing and are treated
      appropriately on the basis of the molecular features of their disease.
    

Detailed description: 
      A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable
      sample types for EGFR testing,
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who are newly
             diagnosed, have not received any local or systemic chemotherapy. Locally advanced
             patients should not be eligible for curative treatment (including surgery and
             chemoradiotherapy).

          -  Patients who have newly diagnosed locally advanced (stage IIIA/B) NSCLC who are not
             eligible for curative treatment (including surgery and chemoradiotherapy) or
             metastatic NSCLC and have not received systemic chemotherapy. Previous or planned
             palliative radiotherapy is allowed.

          -  Patients who have had surgical resection with or without adjuvant chemotherapy and
             have experienced recurrent disease.
      
Biospecimen description: 
      Tumour samples (biopsy or citology) Blood (plasma) samples
    
Keywords: EGFR,; aNSCLC,; mutation status,; diagnostic study,; Europe,; Japan
Insulin Bolus Required for High Fat Foods in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.

      Subjects will have several admissions during which the investigators will apply an iterative
      dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin
      ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The
      investigators hypothesize that the incremental insulin dose required to cover dietary fat in
      patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
    

Detailed description: 
      Subjects for this study will be adults with type 1 diabetes who use an insulin pump for
      diabetes self-management.

      Subjects will be admitted to the clinical research center in the morning in the fasting
      state. Subjects will have several admissions. During the initial two admissions, subjects
      will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated
      from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not
      provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5
      admissions during which they will receive the pizza-high fat meal with progressively
      increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target
      range 80-180 mg/dL.
    

Intervention name(s): Lispro
Intervention type(s): Drug
Intervention description(s): Increasing insulin doses
Other intervention name(s): Humalog
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment