bioihbjkbjnl/mcl2 huggingface dataset:
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
Condition: Hyperglycemia; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hyperglycemia
Study type: Interventional

Summary: 
      The objective of this study is to formulate and validate a green tea confection (i.e. "gummy"
      candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular
      function. The central hypothesis is that a green tea confection will protect against vascular
      endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of
      this application will be assessed by developing a green tea-containing confection, examining
      its physiochemical properties and its inhibition of starch digestion, and then validating its
      vasoprotective activities in healthy humans by assessing its blood glucose-regulating
      activities.
    

Detailed description: 
      The study involves validating a green tea confection (i.e. "gummy" candy) as a dietary
      strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function.
      The central hypothesis is that a green tea confection will protect against vascular
      endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of
      this application will be assessed by providing research participants 75 grams of carbohydrate
      in the form of a confection that contains no green tea concentrate or green tea concentrate
      at a level equivalent to approximately 3 cups of freshly brewed tea. Blood glucose and
      brachial artery flow-mediated dilation will be assessed at regular intervals during the 3
      hour postprandial period to define the extent to which green tea attenuates postprandial
      increases in blood glucose and decreases in vascular function that otherwise occur in a
      hyperglycemia-dependent manner.
    

Intervention name(s): Green Tea Concentrate
Intervention type(s): Dietary Supplement
Intervention description(s): Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: green tea; catechins; vascular endothelial function; postprandial hyperglycemia; oxidative stress
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy
      we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48
      weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects
      in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We
      expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared
      to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity
      and biologic potency due to sustained and higher levels of a fully potent interferon protein.
    


Intervention name(s): interferon alfa-2b; interferon alfa-2b; interferon alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12 MU daily continuously subcutaneous; 9 MU daily continuously subcutaneous; 6 MU daily continuously subcutaneous
Other intervention name(s): Intron A; Intron A; Intron A
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: genotype 1 nonresponders
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting
      intervention for school-aged children with type 1 diabetes and their caregivers in a pilot
      randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes
      include glycemic control (HbA1c, % in range), improvements in parent sleep, parental
      distress, and child behavior problems.
    


Intervention name(s): Sleep Coach Jr.
Intervention type(s): Behavioral
Intervention description(s): A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial with 2 conditions (intervention and usual care).
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
Condition: Endovascular
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery
      puncture site, compared with manual compression hemostasis in patients who have undergone
      diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural
      sheath.
    

Detailed description: 
      Effectiveness: to superiority to the control group in time to hemostasis. Comparison of time
      to ambulation, procedure success rate, length of stay in hospital, device success rate.

      Safety-Major/Minor complication rate, adverse events, SAEs as compared to control.
    

Intervention name(s): MynxGrip; Manual compression
Intervention type(s): Device; Other
Intervention description(s): Vascular Closure; Manual compression is a commonly used method to achieve hemostasis of femoral artery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized parallel controlled trial, in which treatment is conducted simultaneously for both the test group and the control group, so that potential differences influencing the outcome measures between both groups can be minimized.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vascular closure
A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B)
Condition: Amyotrophic Lateral Sclerosis (Healthy Volunteers)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820
      when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl
      succinate (EES) in Part A and possibly itraconazole in Part B).

      In Part A, the objective is to assess the effects of repeated administration of EES as CYP3A4
      inhibitor, on the PK profile of a single oral dose of SAR443820 tablet in healthy male and
      female participants.

      In Part B, the objective is to assess the effects of repeated administration of itraconazole
      on the PK profile of a single oral dose of SAR443820 capsule in healthy male participants.

      Part A includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2
      (SAR443820 + EES). Part B includes a screening period, Period 1 (SAR443820), a wash-out
      period and Period 2 (SAR443820 + itraconazole). The washout period between single SAR443820
      administration in Period 1 and the start of dosing with EES (Part A) or itraconazole (Part B)
      in Period 2 is at least 4 days.

      The study duration is approximately 7 weeks for each Part A and Part B.

      The treatment duration is:

        -  For SAR443820 (both Part A and Part B): 1 day in each Period; single dose of SAR443830
           on Period 1 (P1)-Day 1 and on Period 2 (P2)-Day 6 for each Part.

        -  For EES (Part A): 9 days of treatment in Period 2 with P2-Day 1 starting at least 4 days
           after P1-Day 1.

        -  For itraconazole (Part B): the treatment duration lasts 11 days in Period 2 and it is
           fixed once the results of Part A are issued, P2-Day 1 starting at least 4 days after
           P1-Day 1.
    

Detailed description: 
      The study duration was approximately 7 weeks for each Part A and Part B.
    

Intervention name(s): SAR443820; SAR443820; Erythromycin ethyl succinate; Itraconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet by oral administration; Capsule by oral administration; Tablet by oral administration; Capsule by oral administration
Intervention MeSH terms: Itraconazole; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Auriculotherapy for Prevention of Postoperative Urinary Retention
Condition: Analgesia, Epidural
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      Urinary retention is a common complication of epidural analgesia. Auriculotherapy could
      prevent this complication. This study will be performed among men receiving thoracic epidural
      analgesia after thoracic surgery.
    


Intervention name(s): Control; Treated; Intra-venous anesthesia
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.; Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
Other intervention name(s): Sham Comparator; Auriculotherapy
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: analgesia, epidural; urinary retention
The Effect of Three Methods Used in Reducing Pain During Dressing Change
Condition: Healthy
Study type: Interventional

Summary: 
      This randomized controlled study aims to determine the effect of listening to music (LM),
      ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain
      experienced during the first dressing in children aged 8-18 with appendectomy.
    

Detailed description: 
      The sample of the study consisted of 120 children (LM:30, BS:30, MO:30, control:30). A minute
      before dressing and during dressing, the children in the LM group listened to music, the
      children in the SB group squeezed the ball, the children in the MO group performed
      mathematical operations.According to the child, parent, and nurse assessment, it was
      determined that the mean pain score of the children in the LM and MO groups was lower than
      that of the BS group and control groups (p< .05).
    

Intervention name(s): mathematical operations; ball squeezing; listening to music; kontrol grubu
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Prepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels.; For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.; Children were allowed to listen to music with headphones during dressing changes.; No application was made during dressing change in children. Routine dressing change of the clinic was applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; appendectomy; child; distraction; dressing
Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose
      tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the
      population was also evaluated.
    

Detailed description: 
      The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and
      FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2
      crossover design. The safety of FK949E in the population is also evaluated.
    

Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): extended release formulation of quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FK949E; Pharmacokinetics; Major Depressive Disorder
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELLVACCINE TRIAL
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study
      assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic
      hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will
      be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will be
      conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to
      a maximum of approximately 2 years.
    


Intervention name(s): hAd5-S-Fusion+N-ETSD; Placebo (0.9% (w/v) saline)
Intervention type(s): Biological; Biological
Intervention description(s): Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10^11 viral particles/mL.; Clear and colorless liquid.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The first 200 subjects randomized will comprise the phase 2 portion of the study.
Enrollment may continue during this period and these subjects would be included in the phase 3 portion of the study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Condition: Tracheostomized Patients
Study type: Interventional

Summary: 
      To compare lung deposition of amikacin in two settings: spontaneously breathing through a
      tracheostomy cannula and through the mouth.
    


Intervention name(s): Nebulization through the tracheostomy; Nebulization through the mouth
Intervention type(s): Other; Other
Intervention description(s): Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The first session was performed prior to tracheostomy removal. During the first nebulization, subjects inhaled the aerosol through the tracheostomy, cuff inflated and inner cannula removed.; Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The second nebulization was performed when the tracheostome was totally scarred. During the second nebulization, subjects inhaled the aerosol a mouth piece and wore a nose clip.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nebulization aerosol nebulizer tracheostomy
Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
Condition: Birth Weight; Fetal Growth Retardation; Fetal Weight; Fetal Macrosomia
MeSH terms: Fetal Growth Retardation; Fetal Macrosomia; Body Weight; Birth Weight; Fetal Weight
Study type: Observational

Summary: 
      This trial is a collaborative study between 4 sites worldwide. A total of 600 research
      subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software
      to improve on estimated fetal weight predictions over a broad range of gestational ages. The
      purpose is to compare the accuracy and precision of birth weight predictions based on this
      new technology as compared to the current 2D birth weight prediction models.
    

Detailed description: 
      Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes
      this estimation is not always similar to what the baby actually weighs. In addition to the
      regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and
      leg soft tissue may give us more precise information on how much the baby weighs. This
      measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue
      measurement of the arm or thigh that can be used to evaluate body composition. This
      measurement mostly reflects the fat and muscle development with a small amount of bone.

      The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it
      possible to efficiently and reproducibly measure semi-automated FLV using a computer guided
      technique.

      Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D
      measurements will be taken. These measurements will then be used to estimate fetal weight. We
      will compare estimated weight to actual birth weight in order to determine the accuracy and
      precision of the 5D Limb Volume technology. This data may also be used to develop new weight
      estimation models that could provide better accuracy and/or precision than what is currently
      provided using published methods.
    

Intervention name(s): Ultrasound Examination
Intervention type(s): Other
Intervention description(s): Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 28-42 weeks gestation. Fetuses will be either small for gestational
        age (estimated fetal weight < 10%), average for gestational age, or large for gestational
        age (estimated fetal weight > 90%).
Aripiprazole Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of addition of aripirazole to the treatment of bipolar depressed patients who
      are not better on the medications that they are currently receiving.
    

Detailed description: 
      Hypothesis/Objectives:

      Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar
      depression.

      Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton
      Depression Rating Scale (HAM-D) during an 8-week treatment course.

      a. Study Population:

      A total number of 10 evaluable patients will be enrolled in the study.

      c. Study Design and Method

      This proposal will use an open label design. Aripiprazole will be added to the treatment of
      patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed
      to continue their psychotropic medication, at a stable dose, as long as they meet inclusion
      criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks,
      15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a
      patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment
      response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item
      Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Condition: Raynaud Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with
      the primary Raynaud phenomenon, with regards to the frequency, duration and severity of
      vasospastic attacks.
    

Detailed description: 
      Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it
      is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s
      phenomenon are discussed and fall into the following three categories:

        -  neurological malfunction

        -  pathological blood vessel wall and blood cell interactions

        -  inflammatory and immunological responses Based on these concepts different classes of
           drugs have been tested. Although some therapies have shown effects, prolongation of the
           therapy is often difficult due to side-effects.

      Considering a prevalence of 5-10% in the general population, there is still a place and
      probably a need for the development of new treatment concepts. Ginkgo biloba has shown to
      have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in
      patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were
      shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations,
      EGb 761® may be an effective treatment for Raynaud´s phenomenon.

      Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon
      on the frequency, duration, and severity of vasospastic attacks compared to placebo.
    

Intervention name(s): Ginkgo biloba extract EGb 761
Intervention type(s): Drug
Intervention description(s): daily Ginkgo biloba extract EGb 761
Other intervention name(s): Ginkgo biloba
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Raynaud´s phenomenon; Vasospastic attacks; Ginkgo biloba