logiover/clinicaltrials-gov-scraper-sample-data huggingface dataset:
Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Acronym: HFDM
ClinicalTrials.gov ID: NCT01213784
Organization: University of Aarhus
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE2
Conditions: Type 2 Diabetes
Heart Failure
Interventions: OTHER: all antidiabetic drugs will be appliable
Lead sponsor: University of Aarhus (OTHER)
Collaborators: The Danish Diabetes Association
Enrollment: 40 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 90 Years
Accepts healthy volunteers: no
Start date: 2010-09
Completion date: 2012-11
Locations:
facility: Dept. of cardiology, Aarhus university hospital Skejby
city: Aarhus
state: Central Jutland
country: Denmark

Summary:
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.
A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus and Patients With Non-Alcoholic Fatty Liver Disease
ClinicalTrials.gov ID: NCT03060538
Organization: Genentech, Inc.
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 2
Non-Alcoholic Fatty Liver Disease
Interventions: DRUG: BFKB8488A
OTHER: Placebo
Lead sponsor: Genentech, Inc. (INDUSTRY)
Enrollment: 154 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 75 Years
Accepts healthy volunteers: no
Start date: 2017-03-05
Completion date: 2019-12-13
Locations:
facility: Pinnacle Research Group Cullman
city: Anniston
state: Alabama
country: United States
facility: Pinnacle Research Group; Llc, Central
city: Anniston
state: Alabama
country: United States
facility: Southern California Research Center, Inc.
city: Coronado
state: California
country: United States
facility: Stanford Health Care
city: Stanford
state: California
country: United States
facility: Diabetes Research Center
city: Tustin
state: California
country: United States
facility: MD Clinical
city: Hallandale
state: Florida
country: United States
facility: Premier Research Associate, Inc
city: Miami
state: Florida
country: United States
facility: Agile Clinical Research Trials
city: Atlanta
state: Georgia
country: United States
facility: MidWest Clinical Research
city: Overland Park
state: Kansas
country: United States
facility: Hassman Research Institute
city: Berlin
state: New Jersey
country: United States
facility: Carolina Research Center at Jones Family Practice
city: Shelby
state: North Carolina
country: United States
facility: New Orleans Center for Clinical Research
city: Knoxville
state: Tennessee
country: United States
facility: Texas Clinical Research Institute, LLC
city: Arlington
state: Texas
country: United States
facility: Dallas Diabetes & Endocrine Center
city: Dallas
state: Texas
country: United States
facility: Clinical Trials of Texas Incorporated
city: San Antonio
state: Texas
country: United States
facility: Northeast Clinical Research of San Antonio LLC
city: San Antonio
state: Texas
country: United States
facility: Consano Clinical Research
city: Shavano Park
state: Texas
country: United States
facility: inVentiv Health Clinical
city: Montreal
state: Quebec
country: Canada

Summary:
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT02675855
Organization: Osiris Therapeutics
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Foot Ulcer, Diabetic
Interventions: OTHER: GrafixPRIME®
PROCEDURE: Dressing Application
DEVICE: Off-loading (walking boot)
Lead sponsor: Osiris Therapeutics (INDUSTRY)
Enrollment: 75 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2016-01
Completion date: 2017-07
Locations:
city: Arizona City
state: Arizona
country: United States
city: California City
state: California
country: United States
city: New Mexico
state: New Mexico
country: United States

Summary:
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
ClinicalTrials.gov ID: NCT01185743
Organization: Medical University of Vienna
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Schizophrenia
Diabetes
Interventions: DRUG: olanzapine
DRUG: ziprasidone
DRUG: placebo
Lead sponsor: Medical University of Vienna (OTHER)
Enrollment: 16 participants
Eligibility: sex MALE, minimum age 18 Years, maximum age 45 Years
Accepts healthy volunteers: yes
Start date: 2010-07
Completion date: 2017-01-01
Locations:
facility: Medical University of Vienna
city: Vienna
state: State of Vienna
country: Austria

Summary:
Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.

Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.
Adaptive Study of IL-2 Dose on Regulatory T Cells in Type 1 Diabetes (DILT1D)
Acronym: DILT1D
ClinicalTrials.gov ID: NCT01827735
Organization: Cambridge University Hospitals NHS Foundation Trust
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Interventions: DRUG: Aldesleukin (Proleukin)
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust (OTHER)
Collaborators: University of Cambridge
Juvenile Diabetes Research Foundation
National Institute for Health Research, United Kingdom
Wellcome Trust
Enrollment: 40 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 50 Years
Accepts healthy volunteers: no
Start date: 2013-03
Completion date: 2014-05
Locations:
facility: Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
city: Cambridge
country: United Kingdom

Summary:
Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia. Currently, medical management of type 1 diabetes focuses on intensive insulin replacement therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that can arrest the autoimmune process and thereby preserve residual insulin production leading to fewer complications and better clinical outcomes.

The vast majority of genes that contribute to susceptibility to type 1 diabetes have been found to encode proteins involved in immune regulation and function. In particular, several susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using genetically engineered E. coli stain containing an analog of the human interleukin-2 gene. There is substantial nonclinical, preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the autoimmune mediated destruction of pancreatic beta cells by induction of functional T regulatory cells. However, prior to embarking on large proof of concept trials in type 1 diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The objective of this study is to establish in patients with type 1 diabetes the optimal dose of IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.
Acute Effects of a Low-AGE vs. High-AGE Meal on Postprandial Endothelial Function in People With Type 2 Diabetes Mellitus. Protective Effects of Benfotiamine
Acronym: AGE-Benfo
ClinicalTrials.gov ID: NCT00437008
Organization: Ruhr University of Bochum
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Endothelial Dysfunction
Type 2 Diabetes Mellitus
Interventions: DRUG: Benfotiamine 1050mg, 3 days
BEHAVIORAL: high-AGE vs. low-AGE meal
Lead sponsor: Ruhr University of Bochum (OTHER)
Enrollment: 21 participants
Eligibility: sex ALL, minimum age 35 Years, maximum age 70 Years
Accepts healthy volunteers: no
Start date: 2004-11
Completion date: 2006-01
Locations:
facility: Heart and Diabetes Center NRW
city: Bad Oeynhausen
country: Germany

Summary:
The purpose of the study is to determine whether there are differences in postprandial endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days protects against the postulated deterioration of endothelial function after a high-AGE meal in people with type 2 diabetes mellitus.
A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
ClinicalTrials.gov ID: NCT05452525
Organization: Chong Kun Dang Pharmaceutical
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: CKD-379 I
DRUG: CKD-379 II
DRUG: D759+D745+D150
Lead sponsor: Chong Kun Dang Pharmaceutical (INDUSTRY)
Enrollment: 24 participants
Eligibility: sex ALL, minimum age 19 Years, maximum age 50 Years
Accepts healthy volunteers: yes
Start date: 2022-07-26
Completion date: 2022-09-21
Locations:
facility: Seoul National University Hospital
city: Seoul
state: Jongno-gu
country: South Korea

Summary:
A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination
Diagnostic Value of Serum Cathepsin S and Chromogranin A in Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT06069076
Organization: Assiut University
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Conditions: Diabetic Kidney Disease
Interventions: DIAGNOSTIC_TEST: cathepsin S and chromogranin A
Lead sponsor: Assiut University (OTHER)
Enrollment: 92 participants
Eligibility: sex ALL, minimum age 20 Years, maximum age 80 Years
Accepts healthy volunteers: yes
Start date: 2023-11-01
Completion date: 2026-10-01
Locations:

Summary:
1. Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.
2. To correlate the levels of serum Cathepsin S and chromogranin A with HbA1c and eGFR in type 2 diabetic patients based on urinary Albumin- Creatinine Ratio.
Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
Acronym: SmartAge
ClinicalTrials.gov ID: NCT04841668
Organization: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Status: COMPLETED
Study type: OBSERVATIONAL
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (OTHER)
Enrollment: 50 participants
Eligibility: sex ALL, minimum age 65 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2021-04-10
Completion date: 2024-12-03
Locations:
facility: Institut d'Investigació Biomèdica de Girona (IDIBGI)
city: Girona
state: Girona
country: Spain

Summary:
Cognitive disorders increase with age and in the presence of metabolic diseases such as Type 2 Diabetes Mellitus (T2DM). In addition, digestive disorders, changes in dietary pattern and decreased activity negatively influence the microbiome.

The hypothesis is that pharmacological intervention with metformin will modify the composition of the gut microbiota and cognition.

The study has a pilot longitudinal design, where each patient with T2DM will be followed for one year. Two groups will be recruited:

1. Group A: The aim will be to evaluate the associations between glucose (measured by continuous glucose monitoring (CGM)), cognitive function (by means of cognitive tests and magnetic resonance imaging (MRI)), physical activity (recorded by activity and sleep tracker devicer), metformin, diet (evaluated by nutritional survey) and composition of the microbiota (evaluated by metagenomics), during 12 months (6 months without metformin and 6 months with metformin treatment).
2. Group B: The aim will be to evaluate the associations between glucose, diet (evaluated by nutritional survey), cognitive function (by means of cognitive tests), physical activity (measured by activity and sleep tracker device), the treatment and composition of the microbiota (evaluated by metagenomics), during 12 months.
Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic
ClinicalTrials.gov ID: NCT03353376
Organization: Rabin Medical Center
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Group Meetings
Interventions: BEHAVIORAL: group care with Empowerment model
Lead sponsor: Rabin Medical Center (OTHER)
Enrollment: 60 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2010-09-13
Completion date: 2014-01-02
Locations:

Summary:
In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.
Stress, Coping Strategies and Quality of Life Among Patients With Chronic Conditions: Implications of Stress Management Program
ClinicalTrials.gov ID: NCT04978974
Organization: University of Gujrat
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Conditions, Multiple
Interventions: BEHAVIORAL: Stress Management Program
Lead sponsor: University of Gujrat (OTHER)
Enrollment: 110 participants
Eligibility: sex ALL, minimum age 31 Years, maximum age 60 Years
Accepts healthy volunteers: no
Start date: 2019-05-03
Completion date: 2020-12-29
Locations:
facility: Jhelum Poly Clinic
city: Jhelum
state: Punjab Province
country: Pakistan

Summary:
Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. The main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. Patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. Total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. Perceived stress scale, WHOQOL and Coping strategies questionnaire were administered at the pre and post-levels of the program. Further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. The stress Management program consisted of 10 session which were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had the duration 90 minutes and two sessions were conducted in one week.
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial
ClinicalTrials.gov ID: NCT00283218
Organization: University of Aarhus
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: DRUG: NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
Lead sponsor: University of Aarhus (OTHER)
Collaborators: Novo Nordisk A/S
Enrollment: 24 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2006-01
Completion date: 2006-08
Locations:
facility: Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
city: Aarhus
state: C
country: Denmark

Summary:
The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes.

OBJECTIVE:

The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.
Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial)
Acronym: VARIATION 2 SA
ClinicalTrials.gov ID: NCT03819790
Organization: LMC Diabetes & Endocrinology Ltd.
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Basal insulin glargine and lixisenatide
DRUG: Basal insulin Basaglar/Lantus + gliclazide MR
DRUG: Metformin
Lead sponsor: LMC Diabetes & Endocrinology Ltd. (OTHER)
Enrollment: 119 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2018-10-02
Completion date: 2019-11-19
Locations:
facility: LMC Brampton
city: Brampton
state: Ontario
country: Canada
facility: LMC Etobicoke
city: Etobicoke
state: Ontario
country: Canada
facility: LMC Scarborough
city: Toronto
state: Ontario
country: Canada

Summary:
The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).
Observational Study of a Specialized Dietary Supplements on the Healing of Diabetic Foot Ulcers and Prevention of Amputations
ClinicalTrials.gov ID: NCT07442110
Organization: Amar Zireg
Status: COMPLETED
Study type: OBSERVATIONAL
Conditions: Limb Salvage
Diabetes Complication
Dietary Supplements
Healed Ulcer
Wound Closure
At Home Setting
Diabetes Mellitus, Type 1, Type 2
Wound Healing
Diabetic Foot Ulcer
Interventions: DIETARY_SUPPLEMENT: Diabetic foot ulcer treatment by dietary supplements
Lead sponsor: Amar h Zireg (OTHER)
Collaborators: Self funded
Enrollment: 35 participants
Eligibility: sex ALL, minimum age 25 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2025-07-05
Completion date: 2025-09-30
Locations:
facility: Amar hocine Zireg
city: Bordj Bou Arreridj
state: Wilaya de Bordj Bou Arréridj
country: Algeria

Summary:
This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting.
Milk as Treatment for Hypoglycemia
ClinicalTrials.gov ID: NCT00643110
Organization: Creighton University
Status: WITHDRAWN
Study type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: DRUG: D50 glucose
Lead sponsor: Creighton University (OTHER)
Enrollment: 0 participants
Eligibility: sex ALL, minimum age 19 Years, maximum age 
Accepts healthy volunteers: yes
Start date: 2008-04
Completion date: 2009-01
Locations:
facility: Creighton Diabetes Center
city: Omaha
state: Nebraska
country: United States

Summary:
Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.
Cardiovascular Disease and Diabetes in Silesian Patients
ClinicalTrials.gov ID: NCT05626413
Organization: Medical University of Silesia
Status: UNKNOWN
Study type: OBSERVATIONAL
Conditions: Diabetes Mellitus
Lead sponsor: Medical University of Silesia (OTHER)
Collaborators: Silesian University of Technology
Liverpool Heart and Chest Hospital NHS Foundation Trust
Enrollment: 4000 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2015-01-01
Completion date: 2026-01-31
Locations:
facility: Department of Internal Diseases, Diabetology and Nephrology
city: Zabrze
country: Poland

Summary:
The project is an observational one which undertakes different, easy to obtain in everyday clinical practice, demographical, laboratory and clinical parameters of patients with diabetes in Silesian Region in Poland to predict cardiovascular disease, cardiovascular events and neuropathy using machine learning approach.
Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
Acronym: EMPA-AF
ClinicalTrials.gov ID: NCT04583813
Organization: Miulli General Hospital
Status: UNKNOWN
Study type: INTERVENTIONAL
Phases: PHASE4
Conditions: Atrial Fibrillation
Heart Failure
Obesity
Diabetes Mellitus
Interventions: DRUG: Empagliflozin
OTHER: Placebo
Lead sponsor: Miulli General Hospital (OTHER)
Enrollment: 400 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 80 Years
Accepts healthy volunteers: no
Start date: 2021-09
Completion date: 2024-04
Locations:
facility: Miulli General Hospital
city: Acquaviva delle Fonti
state: Bari
country: Italy

Summary:
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.