bioihbjkbjnl/mcl2 huggingface dataset:
Improving Outcomes After PICU Admission: A Pilot Study
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      1. Evaluate the feasibility and acceptability of an information based intervention
           delivered to parents following their child's admission to paediatric intensive care;

        2. Evaluate the feasibility and acceptability of the study design and procedures;

        3. Explore the effects of the intervention on parent and child psychological outcomes 3-6
           months post discharge from PICU;

        4. Explore the effects of parental stress experienced during PICU admission on the
           effectiveness of the intervention;

        5. To provide data that, combined with results from other studies, could inform the sample
           size for a future multi-site RCT.
    

Detailed description: 
      Most children are now expected to make a complete medical recovery following admission to
      PICU. However, research suggests that some children will go on to develop psychological
      difficulties, such as problems with emotions, behaviour, and learning. In addition, parents
      themselves may suffer with emotional difficulties. Although the follow-up of survivors is
      recommended, there are currently no specific guidelines in place. Intervention in the early
      stages of recovery could help families pull through without long lasting after-effects.
    

Intervention name(s): Psycho-education
Intervention type(s): Other
Intervention description(s): The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: PICU; Critical illness; Outcomes; Mental health; Education; Randomized Controlled Trial (RCT); Pilot; Feasibility
Molar Potency Study of HM12460A in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in
      healthy subjects.
    


Intervention name(s): HM12460A
Intervention type(s): Biological
Intervention description(s): HM12460A is a long-acting insulin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in
      healthy male and female subjects
    


Intervention name(s): ACT541468; ACT541468 placebo; Citalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg; film-coated tablet for oral use; film-coated tablet for oral use; 20 mg; tablet tor oral use; for single- or repeated dosing
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of
      MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The
      primary hypotheses are that the duration of action, pharmacodynamic profile, and
      pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.
    


Intervention name(s): MK-1293; EU-Lantus™; Novolog™
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-1293 0.4 units/kg administered subcutaneously; EU-Lantus™ 0.4 units/kg administered subcutaneously; Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements
Intervention MeSH terms: Insulin Aspart; MK-1293
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Dark Chocolate Implementation in Elite Athletes
Condition: Oxidative Stress; Athletes Heart; Physical Activity
Study type: Interventional

Summary: 
      Dark chocolate (DC) is rich in epicatechin which augments nitric oxide (NO) production
      through endothelium-dependent influences. The increased bioavailability and activity of NO
      have been demonstrated to statistically increase flow-mediated dilation in healthy subjects
      and in hypertensive patients. DC supplementation has been hailed for its positive effects on
      cardiovascular health and it has been proposed as a booster of physical performance in
      athletes, however the mechanisms by which DC improves oxidative stress, vascular function and
      athletic performance are not fully understood. The investigators designed a human study
      assessing how DC improves NO bioavailability and activity in elite athletes. Twenty-four
      elite soccer players (aged 18-35 years old, all males) are divided in 2 groups and randomly
      assigned to receive DC (85% cocoa), 40g per day or white/milk chocolate (<35% cocoa) for 30
      days. The primary outcome measure is the evaluation of Soluble NOX2-derived peptide
      (sNOX2-dp), a direct marker of NADPH oxidase activation. The secondary outcome measures are
      other markers of oxidative stress, as the soluble P-selectin (sPs), Vitamin E, soluble CD40
      Ligand (sCD40L), a marker of in vivo platelet activation and flow-mediated dilation assessed
      by vascular ultrasound. All parameters are assessed at baseline and after 30 days in both
      groups.
    


Intervention name(s): Dark Chocolate (85% cocoa); White/Milk chocolate (<35% cocoa)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dark chocolate (85% cocoa) in tablet; white or milk chocolate (<35% cocoa) in tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional and Neurochemical Brain Changes Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of the research is to study brain structure, function and chemistry of patients
      with bipolar disorder who are receiving quetiapine or lithium, in order to better understand
      who benefits from treatment and why they respond to medications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        You are being asked to take part in this research study because you have been diagnosed
        with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder
        is an illness characterized by recurrent mood swings including mania, (periods of elation,
        excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor
        judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of
        interest in activities and disruption of sleep, appetite and energy). To participate in
        this study you must be at least 12 years old, and no older than 35.
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
Condition: Menopause
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to
      evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe
      symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy
      and/or oophorectomy.
    

Detailed description: 
      The study will include a screening period up to 4 weeks and a 12-week treatment period. The
      overall study duration for participants will be approximately 16 weeks. Study participants
      will undergo physical and gynecological exams, and blood tests for clinical laboratory
      assessments. All patients with a uterus will undergo transvaginal ultrasound.
    

Intervention name(s): Synthetic Conjugated estrogens, B; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1 (0.3mg) tablet daily; 1 tablet daily
Other intervention name(s): Enjuvia
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A; Estrogens, conjugated synthetic B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vaginal atrophy; vaginal dryness; vaginal itching; vaginal pain; dyspareunia
A Drug-drug Interaction Trial of Loperamide Pharmacokinetics Effect on Pyrotinib Maleate
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the effect of repeated oral doses of
      Loperamide on the pharmacokinetic profile of a single dose of Pyrotinib Maleate.

      The secondary objective of the study was to assess the safety of Pyrotinib Maleate given
      alone versus Fluzoparib coadministered with Loperamide.
    


Intervention name(s): pyrotinib maleate; Loperamide
Intervention type(s): Drug; Drug
Intervention description(s): a single oral dose of pyrotinib maleate on day 1 & day10 .; Loperamide 4 mg bid from day 7 to day 13
Intervention MeSH terms: Loperamide; Antidiarrheals
Intervention model: Single Group Assignment
Intervention model description: single arm, open and fixed sequence
Masking: None (Open Label)
Primary purpose: Basic Science
Arterial Endothelial Function--An Epidemiologic Study
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Arteriosclerosis; Carotid Artery Diseases
MeSH terms: Carotid Artery Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To determine if risk factors measured in childhood can predict the development of
      atherosclerotic coronary and carotid artery disease in adulthood.
    

Detailed description: 
      BACKGROUND:

      Many young adult subjects have some degree of atherosclerotic coronary and carotid artery
      disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and
      only limited therapeutic process begins in youth, a measure of the early manifestations of
      atherosclerosis may have the potential of identifying subjects at risk for premature coronary
      and carotid occlusive vascular disease when therapeutic options can be administered. Impaired
      brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children
      and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who
      smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial
      function, which is an early manifestation of the atherosclerotic process. If impaired
      brachial artery FMD is a predictor of the process, then it may be used to non-invasively
      assess atherosclerosis early in its development and to evaluate the effect of therapeutic
      interventions.

      DESIGN NARRATIVE:

      In this longitudinal study using previously studied members of the Muscatine study,
      measurements are made of contemporaneous risk factors, and brachial artery FMD, along with
      coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the
      latter two established measures of early atherosclerosis) and again three years later. The
      effort is designed to examine the following hypotheses: 1) Established risk factor levels
      measured in childhood, adulthood and across the years form childhood through adulthood are
      predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk
      factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and
      carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults;
      and 4) Brachial artery FMD is predictive of increased carotid artery IMT.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Muscatine Study Longitudinal Adult Cohort - representative sample of childhood participants
        from the 1970s
      
Biospecimen description: 
      Stored plasma and DNA samples
Improving Latent Tuberculosis (TB) Diagnosis in Thai Children
Condition: Latent Tuberculosis; HIV Infections
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Observational

Summary: 
      The study is a prospective study to improve the diagnosis and management of latent TB in
      HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the
      sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB
      Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in
      diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to
      evaluate the influence of age, nutritional and immune status on children's response to the
      IGRAs. These children will be screened for TB with a detailed TB contact history,
      symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal
      ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast
      bacilli stain and culture. A diagnostic algorithm will be generated using the combination of
      test modalities with the highest sensitivity and specificity results.
    

Detailed description: 
      Study Objectives

        -  To compare the utility of IGRAs, T-Spot®.TB and QuantiFERON®-TB Gold In-Tube, and TST
           for screening of latent TB in HIV-infected children

        -  To compare these different screening modalities in HIV-infected children to HIV
           uninfected children

        -  To assess the influence of age, nutritional and immune status, prior BCG and TST status
           on children's response to IGRAs

        -  To assess the prognostic value of IGRAs vs. TST in predicting development of active TB
           in children over 9 months

      Research questions:

      Primary:

      What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in
      HIV-infected and HIV uninfected children in Thailand?

      Secondary:

      How do age, nutritional and immune status, prior BCG and PPD status influence children's
      response to IGRAs? What is the prognostic value of IGRAs vs. TST in predicting development of
      active TB in children over 9 months?

      This is a prospective cohort study conducted at two sites in Bangkok, Thailand: HIV
      Netherlands Australia Thailand (HIV-NAT) Clinic/Chulalongkorn Hospital and Queen Sirikit
      National Institute of Child Health.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thai children between the ages of 2 months and 16 years with exposure to active TB adult
        cases will be referred to the two study sites for eligibility screening.
      
Keywords: Latent tuberculosis; HIV; Children; Interferon gamma release assays; Thailand; QuantiFERON TB Gold In-tube; T-Spot.TB
Safety and Efficacy of HB-1 for Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of HB-1 versus placebo in
      male and female adult patients aged 18 to 60 years, inclusive, with Panic Disorder.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled trial. All patients with
      Panic Disorder, with or without specified co-morbidities, who meet all of the inclusion and
      none of the exclusion criteria will be eligible. Patients and researchers will be blinded to
      their treatment group.

      The study will enroll approximately 80 adult patients who meet the diagnosis of panic
      disorder.

      The patients will be treated for 12 weeks including a 1 week safety follow up visit following
      the last dose of study drug.
    

Intervention name(s): HB-01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.; HB-1 matched placebo
Other intervention name(s): Active Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A sample size of 80 patients is planned for the study to be randomized in a 1:1 ratio of active to control.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: panic; mental illness
NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Sedentary behavior is associated with an increased risk of mortality and many health
      conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic
      syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity
      (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that
      individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent
      experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥
      20 minutes) with either light or moderate intensity activity for 2 minutes reduces
      postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity
      activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health
      consequences of sedentary behavior. The purpose of this study is to develop a smartphone
      application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in
      prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be
      refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in
      conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary
      behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will
      trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least
      2 minutes. Following the development, testing, and refining of the application, a sample of
      10 sedentary adults with type 2 diabetes will be recruited to participate in a one month
      trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the
      first study to design and examine the acceptability of a smartphone application that will
      target interrupting sedentary behavior with NEAT using objectively measured sedentary time in
      a diabetic population.
    


Intervention name(s): NEAT!
Intervention type(s): Behavioral
Intervention description(s): Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel
      after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use
    


Intervention name(s): Once Daily Application of TFV RG 1% Gel - Vaginal; Once Daily Application of TFV RG 1% gel - Rectal; Once Daily Application of TFV RG 1% gel - Rectal; Once Daily Application of TFV RG 1% Gel - Vaginal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vaginal application; Rectal application; Rectal application; Vaginal application
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microbicides; Tenofovir; Reduced-glycerin; Vaginal use; Rectal use; Pharmacokinetics
Galactose Mediated Glycogen Resynthesis
Condition: Exercise
Study type: Interventional

Summary: 
      This study will compare short-term post-exercise muscle glycogen synthesis following combined
      galactose-glucose, glucose alone or galactose alone ingestion.
    

Detailed description: 
      Lactose, the sugar contained within milk, consists of glucose and galactose. Post-exercise
      consumption of a carbohydrate mixture containing glucose with galactose has been shown to
      accelerate liver glycogen repletion as compared to glucose-only provision. However, the
      extent to which galactose-glucose combinations influence post-exercise muscle glycogen
      storage has yet to be determined.

      Therefore, this study will investigate whether short-term muscle glycogen storage after
      strenuous endurance exercise is enhanced by combined galactose-glucose or glucose only
      ingestion as compared to the ingestion of galactose alone.
    

Intervention name(s): Glucose alone; Galactose alone; Glucose and galactose
Intervention type(s): Other; Other; Other
Intervention description(s): Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.; Young men or women will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.; Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science