bioihbjkbjnl/mcl2 huggingface dataset:
High Dose Vitamin D3 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000
      International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's
      disease in remission.
    

Detailed description: 
      In patients with Crohn's disease in remission, the investigators hypothesized higher doses of
      vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be
      tolerated well without side effects of hypercalcemia. The investigators also wanted to
      explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's
      disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety
      symptoms. In order to determine if there is benefit from high-dose vitamin D3, the
      investigators designed a pilot randomized double-blind controlled trial comparing doses of
      oral vitamin D3 at 10,000 IU daily to 1000 IU daily.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D
ZD03 Capsule Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation
      Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy
      Volunteers in The United States
    

Detailed description: 
      ZD03 is a novel small molecular drug. It is a synthetic chemical drug candidate for treatment
      of multiple sclerosis (MS) and is proposed to be administered orally as capsules.

      This is a double-blind, randomized, placebo-controlled, single ascending dose study.
      Approximately 56 HVs will enter into the phase 1 study. The study is designed to evaluate the
      safety,tolerability and PK of ZD03 capsule at different dose cohorts when administered
      orally.

      Subjects who meet the enrollment criteria will be enrolled in one of the seven dose levels
      designated for the study, including the doses of 20, 40, 80, 120, 180, 240 and 300 mg (doses
      escalated by 100%, 100%, 50%, 50%, 33% and 25%, respectively). Each cohort will consist of 8
      subjects randomized at 3:1 to receive a single oral dose of ZD03 (n=6) or placebo (n=2) in a
      double-blind manner in a fasted state
    

Intervention name(s): ZD03; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ZD03 capsule; placebo capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
Condition: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate
      sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a
      Dose Reduction of Tacrolimus. Maximiza Study.
    


Intervention name(s): 1; 2
Intervention type(s): Drug; Drug
Intervention description(s): Continue with same dose of MMF as patient was taking before randomisation; Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the bioavailability of the Test and Reference
      products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and
      female volunteers under fed conditions and to assess the bioequivalence of these products
      based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as
      primary endpoints.
    

Detailed description: 
      An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of
      Single Doses of Test Product Metformin, prolonged-release tablets 500 mg (JSC Farmak,
      Ukraine) and Reference Product Glucophage® XR 500 mg prolonged release tablets (Merck Serono
      Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fed Conditions Single oral dose of
      Glucophage® XR 500 mg prolonged release tablets of Reference product or Metformin,
      prolonged-release tablets 500 mg of Test product will be administered to volunteers under fed
      conditions in the morning of Day 1 of each Study Period.

      Pharmacokinetic parameters of MFM were calculated from plasma concentrations determined by
      validated HPLC/MS/MS method.

      Pharmacokinetic parameters of the Test and Reference tablets were compared.

      During each period 21 samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5,
      5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0 hours
      after IMP administration in each study period.

      The study consists of two study periods with a washout period of at least 7 days between
      doses.

      Adverse events and clinically significant deviations from laboratory tests, physical
      examinations and vital signs were reported for the evaluation of safety.
    

Intervention name(s): Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine); Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the Test product was administered orally with 240 mL of water.; One tablet of the Reference product was administered orallyn with 240 mL of water.
Other intervention name(s): Diaformin® SR 500mg tablets (JSC Farmak, Ukraine); Diabufor® XR 500mg tablets (JSC Farmak, Ukraine); Glucophage® XR 500 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Metformin 500 mg Prolonged Release Tablets; Prolonged Release Tablets; oral dosage form; Metformin
Validation of a Digital Diet Method for Use With Preschoolers
Condition: Feeding Behaviors
Study type: Observational

Summary: 
      The Validation of a Digital Diet Method project is very innovative because it links three
      methods to address the gap in measuring food intake of HS preschool children. Data collection
      is based on EMA theory; participant burden is low, and the Food Image App decreases
      participant and staff burden even further. Data management and analysis are semi-automated
      and relies on advanced computer algorithms. A strength of this approach is its
      semi-automation, which allows us to leverage the strengths of human operators and computer
      automation.
    

Detailed description: 
      The goal of the proposed research is to modify the Remote Food Photography Method (RFPM) for
      use with preschoolers. Primary caregivers (the majority will be mothers) and HS assistants
      will use a Smartphone to capture 24-hour images of HS children's food selection and plate
      waste. The RFPM, Ecological Momentary Assessment (EMA). and the Food Photography Application©
      will be used to estimate the energy and nutrient intake of preschoolers. The accuracy of the
      RFPM will be examined by determining the energy and nutrient intake (collectively referred to
      as food intake [FI]) to established methods: 1) actual gram (g) weights of laboratory-based
      test meals and 2) doubly labeled water (DLW) in a natural environment.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        With an anticipated attrition rate of 15%, 62 children will be recruited, resulting in a
        sample size of 54 after attrition (14 HA boys; 14 HA girls; 13 AA boys; 13 AA girls).
      
Biospecimen description: 
      Urine samples are to be collected.
    
Keywords: nutrition assessment; children; preschool; eating behavior; Head Start; digital technology
Glycemic Load, Weight Loss and Cardiovascular Disease Risk
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the hypothesis that reducing the glycemic load of the diet will improve
      changes in body composition and cardio-vascular risk factors. The study compares a
      conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load:
      changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with
      protein, or combining both effects to produce the lowest glycemic load.
    

Detailed description: 
      Conventional low fat diets produce modest wegiht loss at best and the results are not well
      maintained. More recently there has been interest in low glycemic index and high protien
      diets wiht some evidence that these produce better fat loss and improvement in cardiovascular
      risk factors. This trial aims to evaluate these different approaches and compare the outcomes
      over 12 weeks. Major outcomes are weigth loss, body composition change, blood lipids change,
      measures of glucose homeostasis, insulin resistance, leptin and CRP.
    

Intervention name(s): high protein & low glycemic index diets
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obesity; glycemic index; glycemic load; high protein diet; blood cholesterol
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Condition: Primary Biliary Cholangitis (PBC)
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to compare the effect of daily oral administration of
      elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo
      in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).
    


Intervention name(s): Elafibranor 80 mg; Elafibranor 120 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two coated tablets daily for 12 weeks; Two coated tablets daily for 12 weeks; Two coated tablets daily for 12 weeks
Other intervention name(s): GFT505; GFT505
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elafibranor; Primary Biliary Cholangitis; Alkaline phosphatase
Atorvastatin in Moderate Active Crohns Disease
Condition: Crohns Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Open pilot study to collect information regarding the effect of atorvastatin on patients with
      active Crohns disease.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD do
      not respond to standard antidepressant therapies despite adequate dosing. An effective and
      well-tolerated antidepressant augmentation therapy would have important clinical and public
      health implications. Neuroactive steroid hormones are known to directly activate
      neurotransmitter receptors in the brain, and thus are potential candidates for augmentation
      therapies to enhance the effect of traditional antidepressants. The investigators hypothesize
      that administration of an allopregnanolone analog in women with treatment-resistant
      depression will improve depressive symptoms.
    

Detailed description: 
      Major depressive disorder (MDD) is highly prevalent and can have profoundly negative
      consequences on one's health, well-being and productivity. Women are twice as likely as men
      to experience depression during their lifetimes. In fact, it is reported that twelve million
      women in the U.S. each year will experience depression, and that one in eight women will
      experience a clinical depressive episode during their lifetimes. Additionally, nearly 70% of
      individuals with MDD do not respond to standard antidepressant therapies despite adequate
      dosing. Therefore, the identification of an effective and well tolerated antidepressant
      augmentation therapy would have important clinical and public health implications.
      Neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the
      brain, and thus are potential candidates for augmentation therapies to enhance the effect of
      traditional antidepressants. Specifically, allopregnanolone, a steroid hormone derived from
      progesterone, is a potent positive modulator of GABA action at GABA-A receptors, which are
      known to have positive effects on mood symptoms. Data suggest that depression, chronic stress
      and posttraumatic stress disorder may be associated with low central nervous system
      allopregnanolone levels. The investigators propose to administer an oral allopregnanolone
      analog to 10 postmenopausal women with treatment-resistant depression as an add-on therapy to
      their current treatment for a period of 8 weeks followed by a 2-week taper. The investigators
      hypothesize that administration of the oral allopregnanolone analog in women with
      treatment-resistant depression will improve depressive symptoms.
    

Intervention name(s): Ganaxolone
Intervention type(s): Drug
Intervention description(s): Participants received ganaxolone
Intervention MeSH terms: Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postmenopausal; women; depression
Impact of Pelvic Floor Musculature on Peripartum Outcomes
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to understand the effect of the pregnancy on the muscles in the
      pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to
      pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on
      delivery mode and if there are any injuries to the pelvic muscles.
    

Detailed description: 
      Healthy women who are pregnant with their first child will be included in the study.
      Information about their general health will be gathered. These women will be screened for
      pelvic disorders at the start and end of study. Three-dimensional ultrasound will be
      performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery. Fetal
      measurements will be included in the third trimester ultrasound for prediction of estimated
      birth weight. The relationship of the predicted fetal weight and the likelihood of having a
      successful vaginal delivery will be studied. Images will be analyzed for pelvic muscles
      function and injuries. Information regarding the length of labor, types of delivery and
      vaginal tears will be gathered. The information obtained will be analyzed to look for the
      strength of correlation of variables to the outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prenatal visits
Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal
      stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
    

Detailed description: 
      Ischemic heart disease is a major public health problem in the industrialized and developing
      world. Current research is focusing on the development of cell-based therapies using stem
      cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into
      endothelial cells and participate in the development of new blood vessels in the heart
      damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will
      evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs)
      to repair heart function in patients with myocardial ischemia.
    

Intervention name(s): MSCs injection
Intervention type(s): Procedure
Intervention description(s): MSCs cells will be injected in two aliquots of 10 ml by catheterism
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Myocardial Ischemia; Coronary Artery Disease; Heart Diseases; Coronary Disease; Ventricular Dysfunction; Arteriosclerosis
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2
      Diabetes Mellitus
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and
      efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with
      T2DM. Study medication will be administered for ninety (90) days (+2 days after the final
      assessments with half-dose of metoprolol). Following all baseline assessments, eligible
      subjects will be randomly assigned to one of the two arms (1:1).
    

Intervention name(s): Tesofensine/Metoprolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tesofensine 0.5 mg + Metoprolol 100 mg
Other intervention name(s): Tesofensine; Metoprolol
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease
Condition: Hypertension; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional

Summary: 
      A pilot, single-center, prospective, interventional study. The objective is to demonstrate
      that catheter-based renal denervation using carbon dioxide renal angiography in patients with
      moderate to severe chronic kidney disease can be performed for treatment of uncontrolled
      hypertension.
    

Detailed description: 
      Renal sympathetic denervation has been shown to be safe and effective in patients with
      uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)>45 mL/min per 1•73
      m². However, the safety and efficacy of this has not been studied in patients with more
      severe renal impairment. The investigators aim to examine safety and efficacy of renal
      denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b & 4) in a
      pilot study which may be a precursor of a large observational study in the future. Moreover,
      the current imaging protocol and procedure protocol for renal sympathetic denervation
      requires the use of iodinated contrast, which can have deleterious effects on renal function.
      The investigators have a proven track record for the use of carbon dioxide angiography in
      renal artery intervention. The investigators would like to use carbon dioxide angiography in
      this study to minimize contrast induced deterioration in renal function in this cohort which
      may again be a precursor of a farther larger study.
    

Intervention name(s): Renal Sympathetic Denervation
Intervention type(s): Device
Intervention description(s): Renal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carbon dioxide angiography; Renal sympathetic denervation; Uncontrolled hypertension; Chronic kidney disease
Patient Navigation for Medicaid Frequent ED Users
Condition: Chronic Illness
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is
      to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED)
      visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported
      health status, quality of life, access/barriers to care) among Medicaid patients who are high
      utilizers of the ED, as well as to identify best practices for engaging and providing
      healthcare services to underserved patients using patient navigation. This study will address
      needs that have been identified within the New Haven community and the local healthcare
      system, contribute to knowledge and literature surrounding the use of patient navigation to
      improve care for underserved patients and improve health system efficiency, and inform the
      design and development of programs that address these needs both locally and in other
      communities.
    


Intervention name(s): Patient Navigator; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): Patients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians.; Patients in the standard of care group will experience the usual intake process in the ED setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HEALTHCARE UTILIZATION; ED UTILIZATION; PRIMARY CARE UTILIZATION; PATIENT NAVIGATION; UNDERSERVED POPULATIONS; HEALTH DISPARITIES