bioihbjkbjnl/mcl2 huggingface dataset:
Change of Fructose to Fat in South Asians
Condition: Elevated Triglycerides; Diabetes; Cardiovascular Disease; Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias; Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in
      response to the ingestion of a mixture of glucose and fructose is greater in South Asians
      compared to controls (Caucasians).
    

Detailed description: 
      South Asians, who originate from the Indian subcontinent and make up one-fifth of the world's
      population, are among the highest number who suffer from heart disease and diabetes. The
      results of many research studies suggest that genes play a role in developing heart disease
      and diabetes that is made worse by the diet in the United States. Fructose is a sugar widely
      used in the American diet, and when consumed, it is taken up by the liver and changed into
      fats through a process called de novo lipogenesis (DNL). The current study will compare this
      change into fats in the liver between South Asians and Caucasians. The participants will be
      screened on the initial visit, and on the second visit, the DNL response will be measured in
      the blood over four hours after drinking one sweetened beverage, containing half glucose,
      half fructose, similar to a soft drink. We expect that DNL in response to fructose intake is
      higher in South Asians when compared to Caucasians and may partially explain why South Asians
      have earlier heart disease and diabetes.
    

Intervention name(s): Fructose + Glucose Beverage
Intervention type(s): Other
Intervention description(s): Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Elevated triglycerides; Diabetes Mellitus; Dyslipidemia; Lipid Metabolic Disorders; Body Weight
Ex Vivo Human Thrombosis Chamber Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of study is to evaluate a thrombosis chamber model
    


Intervention name(s): Clopidogrel; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 75 mg, Once daily, 8 days; Tablets, Oral, 325 mg, Once daily, 8 days
Other intervention name(s): Plavix
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ziprasidone in Pediatric Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to
      determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric
      bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus
      slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on
      ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators
      hypothesize that slower titration of ziprasidone will result in lesser side effects which
      will assist in medication compliance as measured by patient report and pill count.
    

Detailed description: 
      This study will enroll approximately 60 children and adolescents aged 10-17 years who have
      been diagnosed with bipolar disorder. Their participation will last about 8 weeks (2 weeks of
      screening and 6 weeks of medication management) and enrollment will last for two years. After
      the screening period, all subjects who meet inclusion/exclusion criteria will be randomized
      to either rapid or slow dose titration of ziprasidone. Subjects in the rapid titration group
      will reach their maximum dose of study drug over 2 weeks, subjects in the slow titration
      group over 4 weeks. The study doctor may deviate from the dosing schedule if clinically
      indicated. The primary data analysis of this pilot study will examine the effect of rapid-
      versus slow-dose titration of ziprasidone on manic symptoms.
    

Intervention name(s): Ziprasidone; Ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.; Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
Other intervention name(s): Geodon; Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Children; Adolescents; Treatment
Effect of the Beetroot Juice in Portuguese Swimmers
Condition: Ergogenics
Study type: Interventional

Summary: 
      Objective: To investigate whether an acute intake of beet juice (BJ) improved the factors of
      total and split times (performance), stroke frequency and CMJ (biomechanics), lactate and HR
      (physiology) and RPE-TQR (psychophysiological) in a repeated (performance), stroke frequency
      and CMJ (biomechanics), lactate and HR (physiology) and RPE-TQR (psychophysiological) in a
      repeated maximal speed swimming effort in elite swimmers.

      Methods: A total of 18 elite swimmers participated in this randomized, double-blind study. In
      2 different trials, swimmers ingested a Beet-It injection (70 ml placebo (PL) or a Beet-It
      injection of 70 ml beet juice (BJ)) 3 hours before undergoing a 2x6x100 m intermittent
      maximal speed crawl performance test.
    


Intervention name(s): Beetroot Juice; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): The swimmers drank 3 hours before the test, mL70 of BJ (containing mmol6.4 of NO-3) (Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) or PLA (0.04 mmol of NO-3); The swimmers drank 3 hours before the test, mL70 of BJ (containing mmol6.4 of NO-3) (Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) or PLA (0.04 mmol of NO-3)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel allocation was carried out in the two groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: swimming; beet; swim; nitrate; intermittent sports; ergogenic aids
Physiological Changes With High-Flow Nasal Cannula
Condition: Respiratory Distress Syndrome in Premature Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on
      high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
    

Detailed description: 
      After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7
      cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device
      will be enrolled.

      All subjects will have physiologic data and electrical impedance tomography collected at:

        1. Baseline nCPAP for 15 minutes

        2. Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is
           obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour
           period

        3. Then upon return to baseline NCPAP for a final 15 minutes of data collection.
    

Intervention name(s): High flow nasal cannula; Nasal CPAP
Intervention type(s): Procedure; Procedure
Intervention description(s): 8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.; Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: high flow nasal cannula; nasal cpap
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether atazanavir powder combined with ritonavir
      is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6
      years of age.
    


Intervention name(s): Atazanavir powder; Ritonavir oral solution; Atazanavir capsules; Ritonavir capsules
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Powder, oral, dosed by weight. Participants who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.; Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
Other intervention name(s): Reyataz; BMS-232632; Norvir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV, Pediatric
Dichoptic Video Treatment for Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      1. To determine whether watching contrast-rebalanced dichoptic videos is effective in
           improving visual acuity and reducing interocular suppression in amblyopic children

        2. To compare the amount of visual acuity improvement achieved with the videos to tha
           amount achieved with patching (standard treatment for amblyopia)
    

Detailed description: 
      Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been
      shown to be an effective treatment for amblyopia. However, the games can be challenging for
      some of the youngest children and boring for some of the older children with amblyopia. To
      provide additional treatment options using the same contrast-rebalancing approach, we have
      processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic
      eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch
      dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care
      amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the
      patching group will cross over to the videos and return for a secondary outcome visit at 4
      weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
    

Intervention name(s): patching; Dichoptic videos
Intervention type(s): Other; Other
Intervention description(s): covering the fellow eye with an eyepatch to force use of the amblyopic eye; watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
Other intervention name(s): occlusion therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel for primary outcome; crossover for longterm effectiveness
Masking: None (Open Label)
Primary purpose: Treatment
Extended Work Schedules, Sleep Loss and Health
Condition: Sleep
Study type: Interventional

Summary: 
      This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk
      of diabetes, independently of the amount of sleep loss.
    


Intervention name(s): Fixed restricted bedtimes; Sleep restriction with circadian misalignment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sleep restricted to 5 hours per night for 8 nights; Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: shift work; diabetes; Affects of shift work and sleep loss on health
Molecular Pathology Research Project of Glioma
Condition: Glioma, Malignant
MeSH terms: Glioma
Study type: Observational

Summary: 
      Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend
      the application of the diagnostic algorithm to surgical practice
    

Detailed description: 
      A total of 976 gliomas were enrolled in this study. First, in order to evaluate the
      diagnostic value of TERT promoter mutation in differ glioma subtypes, we conducted a
      retrospective cohort study included 753 frozen tissue samples of patients with different
      grades of glioma. According to WHO CNS5, all recommended alteration including IDH, 1p/19q,
      TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis
      was obtained for each patient. Exploring the feasibility of the molecular pathology model of
      patients with glioma via retrospective research. Compare with the existing molecular
      pathology system, analyze the combination of IDH and TERT mutations and the feasibility of
      stratifying the prognosis of patients with glioma.

      Moreover, to expend the application of the diagnostic algorithm to surgical practice, we
      developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT
      within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a
      minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate
      the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another
      retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.
    

Intervention name(s): Detection of IDH and TERT mutation
Intervention type(s): Diagnostic Test
Intervention description(s): Detection of IDH and TERT mutation using frozen glioma tissues
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Glioma patient from Huashan Hospital with Informed Consent Form
      
Keywords: Molecular pathology
A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
Condition: Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to study the efficacy and safety of low dose of estradiol
      valerate in the prevention and treatment of postmenopausal osteoporosis.
    

Detailed description: 
      Research purposes: To assess the Impact of hormone therapy on quality of life in early
      post-menopausal women; To assess the Impact of hormone therapy on cardiovascular system in
      early post-menopausal women; To assess the Impact of hormone therapy on cognitive function in
      early post-menopausal women; To assess the Impact of hormone therapy on osteoporosis in early
      post-menopausal women.

      Study Design:

      The clinical trial research was divided into 2 groups. Treatment group given estradiol
      valerate 1mg/d, periodic application of medroxyprogesterone 6mg/d for 10 days, calcium
      900mg/d, VitD200iu/d and exercise(Brisk walking every day 2 times, continued for 10 minutes
      each time). Control group given placebo, calcium,VitD and exercise were same with treatment
      group.
    

Intervention name(s): Placebo; estradiol valerate
Intervention type(s): Drug; Drug
Intervention description(s): Placebo, calcium 900mg/d, VitD200iu/d and exercise; estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: estradiol valerate; Medroxyprogesterone; menopause; Lipid; Bone mineral density; Body Composition
Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Condition: Type 2 Diabetes; Secondary Drug Failure
MeSH terms: Neoplasm Metastasis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Pioglitazone and insulin glargine are equally effective in achieving glycemic control in
      secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
    

Detailed description: 
      The present study was undertaken to assess differences in how insulin glargine vs.
      pioglitazone affect:

        -  Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for
           insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test

        -  Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin
           resistance (HOMA-IR) and insulin tolerance test and

        -  Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma
           lipid profile as add-on therapy in patients with T2D and secondary drug failure. The
           patients' satisfaction with each treatment was also surveyed.
    

Intervention name(s): pioglitazone; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): tablet, 30 mg, once daily, 26 weeks; subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
Other intervention name(s): Actos; Lantus
Intervention MeSH terms: Insulin Glargine; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of RLIC on Motor Learning in Middle-aged and Older Adults
Condition: Adults; Older Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to determine if the beneficial effects of remote limb
      ischemic conditioning on learning seen in young adults are found in middle-aged and older
      adults.
    

Detailed description: 
      Ischemic conditioning is an endogenous phenomenon in which exposing a target organ or tissue
      to one or more brief episodes of ischemia results in protection of that organ against
      subsequent ischemia. The effects of ischemic conditioning are not confined within an organ
      but can be can be transferred from one organ to another, a technique called remote ischemic
      conditioning. A clinically feasible method for this is remote limb ischemic conditioning
      (RLIC), where episodes of ischemia and perfusion are induced with a blood pressure cuff
      placed on the arm.

      The overall goal of this line of work is to use ischemic conditioning to enhance learning and
      outcomes in persons with neurologic injuries. Two previous studies have shown that remote
      limb ischemic conditioning (RLIC) can enhance learning a motor task in healthy young adults.
      The next step is to determine which individuals would receive maximum benefit from RLIC
      before applying these findings to clinical rehabilitation populations such as stroke.
      Numerous factors, such as age, body mass index (BMI), sex, and cardiovascular comorbidities
      may influence the response. The current study determines if RLIC can enhance learning in
      middle-aged and older adults with their burden of co-morbidities.
    

Intervention name(s): RLIC; Sham conditioning; Balance training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.; See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.; All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded, randomized, controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: remote ischemic conditioning, motor learning
A Clinical Study for Inactivated Vaccine Against EV71
Condition: Enterovirus 71 Human
MeSH terms: Enterovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in
      health children and infants aged from 2 months to <12yrs.
    


Intervention name(s): EV71 with adjuvant aluminium phosphate; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two arms, EV71 with aluminium phosphate; Phosphate Buffer Saline with adjuvant aluminium phosphate
Intervention MeSH terms: Aluminum phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: EV71 Vaccine
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings
Condition: Small Intestine Bacterial Overgrowth
Study type: Observational

Summary: 
      The purpose of this study is to assess the impact of small intestine bacterial overgrowth
      (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka
      
Biospecimen description: 
      Blood, stool, and urine.
    
Keywords: oral vaccination; nutrition