bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Resvida, a Comparison With Calorie Restriction Regimen
Condition: Obesity; Metabolic Syndrome; Diabetes; Aging
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of the antioxidant "resveratrol" to a
      diet intervention (Calorie Restriction) to determine how each of them affects the following:
      gene expression profile, cholesterol (lipids), how well the hormone insulin works to control
      your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.

      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have
      health benefits such as improving fat metabolism, insulin action, and possibly extending
      lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant
      "resveratrol". Resvida™ will be supplied by DSM Nutritional Products, Ltd.

      Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the
      Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
      Administration does not strictly regulate herbs and dietary supplements. The makers of
      Resvida™ make no claim that this supplement is meant to treat any ailment.

      Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American
      Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health
      benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.

      This study is designed to compare the health benefits of both resveratrol and CR and to
      determine if resveratrol mimics some of the health benefits shown with CR.
    


Intervention name(s): resveratrol; placebo; Calorie Restriction
Intervention type(s): Dietary Supplement; Other; Behavioral
Intervention description(s): one pill of resveratrol (Resvida™) 75 mg once a day with breakfast; one placebo pill taken once a day with breakfast; supervised calorie restriction diet: 30% reduction in caloric intake
Other intervention name(s): Resvida™
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: obesity; metabolic syndrome; diabetes; aging; calorie restriction; resveratrol; antioxidant
Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas
Condition: Perianal Fistula; Cryptoglandular Perianal Fistula; Crohn's Perianal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an extension to re-treat partial and non-responders from the previously
      approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and
      15-003200 (cryptoglandular perianal fistulas).
    

Detailed description: 
      This study is an extension to re-treat partial and non-responders from the previously
      approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and
      15-003200 (cryptoglandular perianal fistulas). This study will enroll patients that have
      persistent symptomatic perianal disease despite being treated with an MSC coated fistula
      plug, and also treat patients that have had recurrence of their perianal fistula.

      As per the previously approval treatment under IND 15356, patients will have a single
      affected fistula treated, which is the same fistula that was treated in the original
      protocol. The matrix for delivering the cells is a Gore Bio-A Fistula Plug.

      Subjects will be screened at outpatient clinic visits and interested qualified subjects will
      be offered participation in the trial and consented. At the first study visit (Visit 1;
      Screening visit), the patient will be evaluated and assessment will be made if an EUA is
      clinically necessary to assess the fistula. As this is a re-treatment trial, patients with
      incomplete response to initial plug placement typically have close follow up, recent MRI
      imaging, and may have a seton in place. If an EUA is clinically indicated, this would be by a
      colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard
      clinical care for perianal fistula.

      Patients will return on: Day 1, Week 4, Week 12, and Week 24.
    

Intervention name(s): MSC-AFP
Intervention type(s): Drug
Intervention description(s): Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.
Other intervention name(s): mesenchymal stromal cell coated fistula plug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques.
Condition: Small Vessel Disease of Diabetes Mellitus
MeSH terms: Diabetic Angiopathies
Study type: Observational

Summary: 
      To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals
      using advanced MRI techniques. With this the investigators want to document progression of
      disease both radiologically and clinically.
    

Detailed description: 
      The investigators will use a paradigm developed at Yale University called Cognitive
      Predictive Modelling (CPM) which takes connectivity data and reduces it to two smaller
      network which predict higher and lower performance in a particular task for which these
      networks have been optimized. Vascular measures will complement this measure.
    

Intervention name(s): MRI including cf-MRI, DTI, ASL and CVR.
Intervention type(s): Diagnostic Test
Intervention description(s): A paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures.
Other intervention name(s): Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSF
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Our study population are those with type 2 diabetes in mid-life and old age, who may or may
        not have cognitive deficits, whose cognitive deficits (when present) cannot be better
        explained by other factors. We exclude those who are unable to have MRI or cognitive
        testing due to a variety of reasons.
      
Biospecimen description: 
      Blood tests are performed on all participants at three time points. When permission exists we
      are banking CSF and blood products.
Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
Condition: Frenulum; Hypertrophy, Lip
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The aim of this randomized controlled parallel-designed study was to evaluate clinical
      healing and patient comfort after conventional and diode laser assisted frenectomy operations
      in case of high papillary frenulum attachment. Forty-eight patients with high papillary
      frenulum attachments were included in the study. Patients were randomly divided into three
      groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser
      (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum
      (Group L+P). Postoperative pain, difficulty in speaking and eating scores were assessed
      postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS).
      Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to
      the surface using a dental injector at postoperative 7, 14, 21 and 45 days. Plaque index,
      gingival index, bleeding on probing and probing depth were assessed at baseline and
      postoperative 7, 14, 21 and 45 days. All data were compared between groups and within each
      group.
    


Intervention name(s): Gigaa Cheese 810 nm Diode Laser; Conventional Frenectomy Operation
Intervention type(s): Device; Procedure
Intervention description(s): Diode Laser assisted frenectomy operation.; Frenectomy operation performed by surgical blades with suturing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of
      CKD-355.
    

Detailed description: 
      An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics,
      safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
    

Intervention name(s): CKD-355A (D797/Memantine HCl 20mg); CKD-355B (D797/Memantine HCl 20mg); D797; D324 (Memantine HCl 10mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once a day; once a day; once a day; twice a day
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; CKD-355
The Effect of Virtual Reality Application on Pain Severity, Anxiety Level and Patient Satisfaction
Condition: Anxiety; Pain
MeSH terms: Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      In this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program
      on Pain Severity, Anxiety Level and Patient Satisfaction in Patients Who Will Be Applied
      Angiography.
    

Detailed description: 
      Beginning 1 minute before the start of the procedure, the patients will be watched (30-45
      minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars
      Glasses, with a music background, licensed product "Secret Garden", during the procedure
      (30-45 minutes).
    

Intervention name(s): Virtual reality glasses
Intervention type(s): Other
Intervention description(s): Beginning 1 minute before the start of the procedure, the patients will be watched (30-45 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30-45 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: virtual reality glasses; Pain; Anxiety; Angiography.
Familial Clustering of Vitamin D Deficiency Via Shared Environment: The Korean National Health And Nutrition Examination Survey 2008-2012
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation
      of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based
      studies, mostly from Caucasian parent-offspring pairs. However, data on the familial
      association of 25(OH)D in extended family structure and the relative contribution of genetic
      and shared environmental factors on serum 25(OH)D level are limited in Asian populations. In
      this study, the investigators aimed to assess the relative contribution of additive genetic
      and environmental components on serum 25(OH)D level by variance components method in a
      nationwide family-based cohort. Further, the investigators will evaluate the association of
      vitamin D status of index individual with prevalent vitamin D deficiency of each family
      member including spouse, offspring, sibling, and grand-offspring. Additive influences of
      paternal and maternal vitamin D status on offspring will be also investigated.
    

Detailed description: 
      From the Korean National Health and Nutritional Examination Survey (KNHANES) conducted
      between 2008 and 2012, familial correlations for 25(OH)D will be estimated in different types
      of family relation pairs in 28551 subjects from 10882 families. The relative contribution of
      additive genetic and shared or individual environmental factors for variance of 25(OH)D level
      will be calculated using variance component method. Interactions between paternal and
      maternal vitamin D status for 25(OH)D level of offspring will be evaluated.
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study was based on data from the Korean National Health and Nutrition Examination
        Survey (KNHANES) (IV-2, 3 and V), conducted from 2008 to 2012. The KNHANES is a nationwide
        cross-sectional survey performed by the Division of Chronic Disease Surveillance, Korea
        Centers for Disease Control and Prevention (CDC), which assessed the health, nutritional
        status, and socioeconomic status of the non-institutionalized civilian population of South
        Korea. Subjects were selected using a stratified multistage clustered probability sampling
        design. Families, including at least two family members with serum 25(OH)D measurements and
        whose family relationships could be accurately identified were selected for the study.
        After the selection process, a total of 28,551 subjects from 10,882 families were included
        in our study.
Effects of Different Mode of Exercise Training on Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Randomized study on the comparison between aerobic training versus progressive resistance
      training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that
      progressive resistance training is just as effective as aerobic training on Hba1c and could
      be an alternative training for those older diabetic patients who cannot participate in
      aerobic exercise.
    

Detailed description: 
      Many studies have shown the importance of aerobic training with respect to management of
      diabetes. However adoption of aerobic activities may be challenging for some individuals with
      diabetes, especially the elderly and the obese. There is increasing interest in resistance
      training and no study have looked at direct comparison between the two.

      Subjects with diabetes but is generally sedentary (determined by means of a questionnaire)
      were recruited and randomized in one of the two groups. Subjects are supervised in a group
      and a completer is defined as one who completed 18 sessions within 8 weeks.
    

Intervention name(s): Aerobic Training; Progressive resistance training
Intervention type(s): Other; Other
Intervention description(s): 18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate; 18 sessions completed in 2 months. each session consists of 50 minutes of resistance training which is made up of 3 sets of 10 repetitions of nine resistive exercises using machines and free weights at 65-70% of 1-repetitive maximum.
Other intervention name(s): Treadmill; Cross trainer; Cycling; Weight training; Circuit training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Randomized control trial; Exercise; Hemoglobin A, Glycosylated
Characteristics of Plant Sterols Consumers in France
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The purpose of this study is to describe the cardiovascular risk profile in subjects who
      consume a marketed drinkable low fat fermented milk enriched with plant sterol.
      Investigations are lead prospectively and retrospectively among adults enrolled from general
      practitioners' database.
    


Sampling method: Non-Probability Sample
Study population: 
        adults followed by general practitionners
      
Keywords: cardiovascular risk; dairy enriched product with plant sterols; general practitioners; adults followed by general practitioners
Fasting Study of Levothyroxine Sodium Tablets 300 Mcg to Synthroid® Tablets 300 Mcg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
      sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600
      mcg dose (2 × 300 mcg) administered under fasting conditions.
    


Intervention name(s): LEVOTHYROXINE SODIUM TABLETS,; SYNTHROID® 300 mcg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 2x300mcg, single dose fasting; 2x300mcg, single dose fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
Condition: Bone Marrow Transplantation; Graft Versus Host Disease; Graft-Versus-Host Disease; Graft-Vs-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who
      are eligible for the administration after 100 days post transplant (up to 1 year)
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Immunosuppression; Bone Marrow Transplantation; Graft versus Host Disease
Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy
Condition: Aminophylline; Pain; Ureterocopic Lithotripsy
MeSH terms: Pain
Study type: Interventional

Summary: 
      This study will be conducted to evaluate the effect of intraoperative systemic aminophylline
      infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with
      ureteric stent placement at the end of the procedure.
    


Intervention name(s): Aminophylline group; Control group
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.; Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.
Intervention MeSH terms: Aminophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aminophylline; Postoperative Pain; Ureterocopic Lithotripsy
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test lot consistency of three different manufacturing lots and to
      generate safety and immunogenicity data of the investigational vaccine administered via the
      ID route.

      Primary Objective:

        -  To demonstrate lot consistency of the Fluzone ID manufacturing process.

        -  To provide information concerning the immune response of Fluzone ID.

      Secondary Objectives:

      Safety

        -  To describe the safety profile of subjects who receive of Fluzone ID.
    

Detailed description: 
      Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere
      formulation will be administered intradermally (ID) using the Becton Dickinson Micro
      Injection System.
    

Intervention name(s): Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B; Influenza Virus Vaccine USP Trivalent Types A and B
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.1 mL, Intradermal; 0.1 mL, Intradermal; 0.1 mL, Intradermal; 0.5 mL, Intramuscular
Other intervention name(s): Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Fluzone®; Adults
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to evaluate the influence of simvastatin and atorvastatin on
      vitiligous lesions in patients with non-segmental vitiligo.
    

Detailed description: 
      According to available data, statins act through several immunological pathways, potentially
      reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. A study has been
      designed as a single-center, randomized, double-blind, placebo-controlled pilot study with
      the enrollment of at least 20 active non-segmental vitiligo patients presenting with
      vitiligous lesions on both upper and lower limbs. Clinical effects of ointments containing 1%
      simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb
      will be assessed in comparison with vehicle ointment applied on the opposite limb. All study
      participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area
      Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise
      assessment of skin lesions will be performed using photographic documentation obtained during
      each study visit and processed with NIS-Elements software.
    

Intervention name(s): 1% simvastatin-acid sodium salt ointment; 1% atorvastatin calcium salt ointment
Intervention type(s): Drug; Drug
Intervention description(s): 1% simvastatin-acid sodium salt ointment applied onto a predefined limb; 1% atorvastatin calcium salt ointment applied onto a predefined limb
Other intervention name(s): simvastatin; atorvastatin
Intervention MeSH terms: Atorvastatin; Simvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment