logiover/clinicaltrials-gov-scraper-sample-data huggingface dataset:
Role of Soy for Metabolic Health: The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
ClinicalTrials.gov ID: NCT05191160
Organization: University of Toronto
Status: UNKNOWN
Study type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Overweight and Obesity
PreDiabetes
Diabetes
Healthy Obesity, Metabolically
Overweight
Obesity
Dysglycemia
Cardiovascular Diseases
Heart Disease Risk Factors
Hypertension
Dyslipidemias
Interventions: OTHER: Soy Milk
OTHER: Cow's Milk
OTHER: Sugar Sweetened Beverages
Lead sponsor: University of Toronto (OTHER)
Collaborators: United Soybean Board
Enrollment: 186 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 75 Years
Accepts healthy volunteers: yes
Start date: 2021-11-02
Completion date: 2025-03-30
Locations:
facility: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
city: Toronto
state: Ontario
country: Canada

Summary:
Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.
Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
ClinicalTrials.gov ID: NCT06145360
Organization: SINA Health Education and Welfare Trust
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Glucose Metabolism Disorders
Diabetes Mellitus, Type 2
Hypoglycemic Agents
Empagliflozin
Interventions: DRUG: Empagliflozin 10 MG
DRUG: Insulin+Metformin+DPP4 inhibitor (DPP4I)
Lead sponsor: SINA Health Education and Welfare Trust (OTHER)
Collaborators: Horizon Pharmaceutical Pvt Ltd
Enrollment: 150 participants
Eligibility: sex ALL, minimum age 20 Years, maximum age 70 Years
Accepts healthy volunteers: no
Start date: 2023-12-01
Completion date: 2024-03-01
Locations:
facility: SINA Shireen Jinnah colony
city: Karachi
country: Pakistan

Summary:
The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.
A Single Center, Randomized, 4-Period Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Single or Repeated 3 mg Doses of Intranasally Administered Glucagon in Adults With Type 1 or Type 2 Diabetes
ClinicalTrials.gov ID: NCT02806960
Organization: Eli Lilly and Company
Status: TERMINATED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Interventions: DRUG: Nasal Glucagon
Lead sponsor: Eli Lilly and Company (INDUSTRY)
Collaborators: Locemia Solutions ULC
Enrollment: 12 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 70 Years
Accepts healthy volunteers: no
Start date: 2014-06
Completion date: 2014-08
Locations:
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mount Royal
state: Quebec
country: Canada

Summary:
This study will investigate how the body processes nasal glucagon and the effect of nasal glucagon on the body. After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods. The study is open to adults with type 1 or type 2 diabetes and is expected to last about 50 days for each participant.
Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06273124
Organization: Tandem Diabetes Care, Inc.
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type1diabetes
Interventions: DEVICE: SteadiSet Extended Wear Infusion Set
Lead sponsor: Tandem Diabetes Care, Inc. (INDUSTRY)
Collaborators: Jaeb Center for Health Research
Enrollment: 260 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2024-03-07
Completion date: 2024-12-11
Locations:
facility: Hoag Memorial Hospital Presbyterian
city: Newport Beach
state: California
country: United States
facility: Stanford University
city: Stanford
state: California
country: United States
facility: Barbara Davis Center
city: Aurora
state: Colorado
country: United States
facility: Endocrine Research Solutions
city: Roswell
state: Georgia
country: United States
facility: Rocky Mountain Clinical Research
city: Idaho Falls
state: Idaho
country: United States
facility: Northwestern University
city: Evanston
state: Illinois
country: United States
facility: Massachusetts General Hospital
city: Boston
state: Massachusetts
country: United States
facility: Henry Ford Health System
city: Detroit
state: Michigan
country: United States
facility: International Diabetes Center - HealthPartners Institute
city: Minneapolis
state: Minnesota
country: United States
facility: Mayo Clinic
city: Rochester
state: Minnesota
country: United States
facility: Icahn School of Medicine at Mt. Sinai
city: New York
state: New York
country: United States
facility: SUNY Upstate Medical University
city: Syracuse
state: New York
country: United States
facility: Texas Diabetes and Endocrinology
city: Austin
state: Texas
country: United States
facility: Rainier Clinical Research Center
city: Renton
state: Washington
country: United States
facility: University of Washington
city: Seattle
state: Washington
country: United States

Summary:
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).

Participants will be asked to:

1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
Effectiveness of High-Dose Vitamin D3 in Improving Diabetic Foot Ulcer Healing by Reducing the MMP-9 to TIMP-1 Ratio: Randomized Double-Blind Placebo-Controlled Trial
Acronym: DFU
ClinicalTrials.gov ID: NCT07139964
Organization: Universitas Sriwijaya
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Vitamin D Deficiency
Wound Healing Disorder
Interventions: DIETARY_SUPPLEMENT: Vitamin D3
OTHER: Placebo
Lead sponsor: Universitas Sriwijaya (OTHER)
Enrollment: 24 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2024-07-01
Completion date: 2025-07-31
Locations:
facility: Dr. Mohammad Hoesin General Hospital
city: Palembang
state: South Sumatra
country: Indonesia

Summary:
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of high-dose vitamin D3 supplementation in improving diabetic foot ulcer (DFU) healing. DFUs are common, serious complications of diabetes, often associated with delayed wound healing due to persistent inflammation, impaired angiogenesis, and imbalances between matrix metalloproteinase-9 (MMP-9) and its tissue inhibitor (TIMP-1). Vitamin D deficiency is prevalent among DFU patients and is linked to impaired fibroblast function, poor angiogenesis, and increased inflammation.

Participants with DFUs and serum vitamin D levels \<30 ng/mL will be randomized to receive either 10,000 IU oral vitamin D3 daily or placebo for 28 days, in addition to standard DFU care. Primary outcomes include changes in tissue MMP-9/TIMP-1 expression ratio and wound healing progression. The study will provide evidence on whether high-dose vitamin D3 can serve as a safe, effective adjunctive therapy in DFU management.
Muscle Accrual and Function in Cystic Fibrosis-Impact of Glucose Intolerance
ClinicalTrials.gov ID: NCT02776098
Organization: Children's Hospital of Philadelphia
Status: COMPLETED
Study type: OBSERVATIONAL
Conditions: Cystic Fibrosis
Lead sponsor: Children's Hospital of Philadelphia (OTHER)
Collaborators: National Institutes of Health (NIH)
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment: 54 participants
Eligibility: sex ALL, minimum age 12 Years, maximum age 
Accepts healthy volunteers: yes
Start date: 2016-05
Completion date: 2024-03-04
Locations:
facility: Children's Hospital of Philadelphia
city: Philadelphia
state: Pennsylvania
country: United States
facility: University of Pennsylvania
city: Philadelphia
state: Pennsylvania
country: United States

Summary:
This study will investigate the link between glucose abnormalities and elements critical to muscle function including mass, composition and energy metabolism. the primary goal of the study is to determine whether Cystic Fibrosis (CF) disease is associated with muscle dysfunction, especially in the presence of glucose intolerance. This is a longitudinal cohort study of 3 main groups: CF subjects without Cystic Fibrosis-related diabetes (CFRD), healthy matched controls and CF subjects with newly diagnosed CFRD started on insulin therapy.
Accuracy and Performance Evaluation of the Medtronic New Generation Enlite Glucose Sensor in Conjunction With the Medtronic 640G System Components - in Clinic and at Home
ClinicalTrials.gov ID: NCT02423798
Organization: Medtronic MiniMed, Inc.
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: DEVICE: Glucose sensor (Enlite)
Lead sponsor: Medtronic MiniMed, Inc. (INDUSTRY)
Collaborators: Profil Institut für Stoffwechselforschung GmbH
Enrollment: 24 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 74 Years
Accepts healthy volunteers: no
Start date: 2015-04
Completion date: 2015-09
Locations:

Summary:
The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components.

To evaluate the accuracy and performance of the new generation Enlite sensor. This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial.

The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home.
Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
ClinicalTrials.gov ID: NCT02589314
Organization: University of Brasilia
Status: TERMINATED
Study type: OBSERVATIONAL
Conditions: Chronic Periodontitis
Diabetes Type 2
Interventions: DEVICE: Mechanical periodontal therapy
PROCEDURE: nonsurgical periodontal therapy
Lead sponsor: University of Brasilia (OTHER)
Collaborators: Catholic University of Brasília
Brasilia University Hospital
Enrollment: 90 participants
Eligibility: sex ALL, minimum age 30 Years, maximum age 65 Years
Accepts healthy volunteers: yes
Start date: 2015-11
Completion date: 2020-08
Locations:
facility: Priscilla Farias Naiff
city: Brasília
state: Federal District
country: Brazil

Summary:
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.
A Trial to Assess the Effect of Liraglutide on Postprandial Triglyceride Levels in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00993304
Organization: Novo Nordisk A/S
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide
DRUG: placebo
Lead sponsor: Novo Nordisk A/S (INDUSTRY)
Enrollment: 20 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2009-10
Completion date: 2010-12
Locations:
facility: Novo Nordisk Investigational Site
city: Aarhus C
country: Denmark

Summary:
This trial is conducted in Europe. The aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.
Clinical Study: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
ClinicalTrials.gov ID: NCT01075347
Organization: National Taiwan University Hospital
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Corneal Epithelial Defect
Diabetic Retinopathy
Penetrating Keratoplasty
Interventions: OTHER: autologous serum
OTHER: Non-autologous serum
Lead sponsor: National Taiwan University Hospital (OTHER)
Enrollment: 165 participants
Eligibility: sex ALL, minimum age 20 Years, maximum age 70 Years
Accepts healthy volunteers: yes
Start date: 2007-03
Completion date: 2008-03
Locations:
facility: National Taiwan University Hospital, department of Ophthalmology
city: Taipei
state: Taiwan
country: Taiwan

Summary:
Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a prospective study to determine the effectiveness of topical autologous serum as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were grouped into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical autologous serum eye drops in addition to conventional postoperative eye drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately
Biological Sample Repository for Gastrointestinal Disorders
ClinicalTrials.gov ID: NCT05874726
Organization: Brigham and Women's Hospital
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Conditions: Obesity
Obesity, Morbid
Obesity, Primary
Gastro-Intestinal Disorder
Overweight and Obesity
Overweight
Overweight or Obesity
Diabetes Type 2
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Hyperlipidemias
Sleep Apnea
GERD
Gastroesophageal Reflux
Musculoskeletal Pain Disorder
Cancer
Interventions: DIAGNOSTIC_TEST: Blood Collection
DIAGNOSTIC_TEST: Urine Collection
DIAGNOSTIC_TEST: Tissue Sample Collection
Lead sponsor: Pichamol Jirapinyo, MD, MPH (OTHER)
Collaborators: Tufts University
Boston Children's Hospital
Mayo Clinic
Enrollment: 500 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2023-07-19
Completion date: 2029-04
Locations:
facility: Brigham and Women's Hospital
city: Boston
state: Massachusetts
country: United States

Summary:
The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy.
A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers
ClinicalTrials.gov ID: NCT00741026
Organization: Milton S. Hershey Medical Center
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Insulin Resistance
Diabetes Mellitus
Interventions: DRUG: Olanzapine 10 mg po qhs for 3 days
DRUG: Placebo
Lead sponsor: Milton S. Hershey Medical Center (OTHER)
Collaborators: American Medical Association
Enrollment: 15 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 30 Years
Accepts healthy volunteers: yes
Start date: 2008-08
Completion date: 2011-05
Locations:
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
city: Hershey
state: Pennsylvania
country: United States

Summary:
The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.
Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Acronym: HDL
ClinicalTrials.gov ID: NCT04532385
Organization: Centro Universitario de Ciencias de la Salud, Mexico
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Dyslipidemias
Arterial Stiffness
Interventions: DIETARY_SUPPLEMENT: Green tea extract
DIETARY_SUPPLEMENT: Placebo
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico (OTHER)
Enrollment: 20 participants
Eligibility: sex ALL, minimum age 40 Years, maximum age 65 Years
Accepts healthy volunteers: no
Start date: 2018-06-12
Completion date: 2019-01-14
Locations:
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
city: Guadalajara
state: Jalisco
country: Mexico

Summary:
The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.
Effects of Insulin Sensitizers in Subjects With Impaired Glucose Tolerance
ClinicalTrials.gov ID: NCT00108615
Organization: VA Office of Research and Development
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Glucose Metabolism Disorders
Diabetes
Interventions: DRUG: Metformin
DRUG: Pioglitazone
DRUG: Metformin
DRUG: Pioglitazone
RADIATION: CT scans
PROCEDURE: Oral glucose tolerance test
Lead sponsor: US Department of Veterans Affairs (FED)
Enrollment: 48 participants
Eligibility: sex ALL, minimum age 35 Years, maximum age 65 Years
Accepts healthy volunteers: yes
Start date: 2004-01
Completion date: 2007-12
Locations:
facility: Central Arkansas Veterans HCS
city: Little Rock
state: Arkansas
country: United States

Summary:
Subjects with impaired glucose tolerance will be randomized to receive pioglitazone or metformin for 10 weeks. Measurements of insulin sensitivity, body composition, glucose tolerance, and muscle lipid accumulation will be performed. Adipose tissue and muscle biopsies are performed. The goal of the study is to determine whether the lipotoxiciy of impaired glucose tolerance is ameliorated by pioglitazone.
A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
ClinicalTrials.gov ID: NCT05232708
Organization: Novo Nordisk A/S
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers (Diabetes Mellitus, Type 2)
Interventions: DRUG: Semaglutide B, 1.34 mg/mL
DRUG: Semaglutide D, 1.0 mg/mL
DRUG: Semaglutide D, 1.0 mg/mL
DRUG: Semaglutide B, 1.34 mg/mL
Lead sponsor: Novo Nordisk A/S (INDUSTRY)
Enrollment: 18 participants
Eligibility: sex ALL, minimum age 20 Years, maximum age 55 Years
Accepts healthy volunteers: yes
Start date: 2022-01-19
Completion date: 2022-08-30
Locations:
facility: Parexel CPRU, Level 7
city: Harrow
state: Middlesex
country: United Kingdom

Summary:
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.