louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06909331: Accuracy of Current Techniques in Quantifying Ketone Levels
Official title: Accuracy of Current Techniques in Quantifying Ketone Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placebo - Control
Exogenous Ketone Salt
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.


Eligibility criteria: Inclusion Criteria:

* 18-35 years

Exclusion Criteria:

* taking medications that affect blood pressure, insulin, or renal function, having meta-bolic syndrome factors such as type 2 diabetes, being pregnant, and/or indicating a pre-existing health condition on the health history questionnaire

Primary outcomes:
measure: Circulating beta-hydroxybutyrate
timeFrame: 30 minutes after consuming the drink
measure: Circulating acetoacetate levels
timeFrame: 30 minutes after consuming the drink
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References:
Clinical trial NCT03556631: Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
Official title: Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Diabetes-Related Outcomes in People With Type 1 Diabetes:a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Probiotics
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Detailed description: Design A randomized, single-blind, parallel-group, controlled clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 30 participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention and between groups.

Eligibility criteria: Inclusion Criteria:

type 1 diabetes patients ,age 18-60years old,18 Kg/m2≤BMI≤30Kg/m2, 7.0mmol/L\<fasting blood glucose \<13.0mmol/L；HbA1c≤10%，ketonuria (-)；

Exclusion Criteria:

pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs

Primary outcomes:
measure: hemoglobin A1c in percentage
timeFrame: 3 months
Secondary outcomes:
measure: weight in kilograms
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
Study officials:
affiliation: associate chief physician
name: Ping Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097331: Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: multiple sclerosis
relapsing
remitting
Relapsing-Remitting MS (RRMS)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-11-23
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.


Eligibility criteria: Inclusion criteria:

* Diagnosis of multiple sclerosis (MS).
* Expanded Disability Status Score 0 - 6.5.
* One or more relapse of MS in previous 12 months.
* Currently not taking any medications for MS (apart from those used to treat symptoms).

Exclusion criteria:

* Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
* Subjects who cannot have MRI scans.
* Women who are pregnant, breast feeding or planning to become pregnant during the study.

Primary outcomes:
measure: Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary outcomes:
measure: Number of other lesion types on MRI
measure: Number of relapses during treatment
measure: Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
measure: Circulating lymphocyte and neutrophil counts
measure: Health Outcomes: MSIS-29, Employment status
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Fraiture en Condroz
country: Belgium
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Polanki 117
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00397631: Initial Combination With Pioglitazone Study (0431-064)
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.


Eligibility criteria: General Inclusion Criteria:

* Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
* Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x.
citation: Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17.
Clinical trial NCT02731131: A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
Official title: A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis D, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.


Eligibility criteria: Inclusion Criteria:

* Positive hepatitis B surface antigen (HBsAg) for the prior 6 months
* Positive anti-delta for the prior 3 months
* Positive HDV RNA at Screening
* Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
* Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
* Negative pregnancy and adequate contraceptive use

Exclusion Criteria:

* Antiviral therapy for CHD within previous 3 months
* Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
* Increased risk of metabolic liver disease
* Decompensated liver disease
* Elevated bilirubin
* Poor hematologic or renal function
* Drug/alcohol abuse within 1 year prior to study
* History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
* Organ transplantation with existing functional graft
* Retinopathy or other ophthalmologic complication of diabetes or hypertension
* Inclusion in another investigational trial within previous 12 weeks

Primary outcomes:
measure: Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
timeFrame: Week 96
Secondary outcomes:
measure: Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
timeFrame: Week 48
measure: Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
timeFrame: Week 96
measure: Number of Participants With ALT Normalization at End of Treatment
timeFrame: Week 48
measure: Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
timeFrame: Week 96
measure: Number of Participants With Negative HDV RNA at End of Treatment
timeFrame: Week 48
Other outcomes:
Locations:
city: Cagliari
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01871831: Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency
Official title: Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2013-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can be affected by the partial pressure of oxygen of the blood sample. In this study, we investigate the influence of different partial pressure of oxygen in blood samples on measurement results. Systems with labelled oxygen-dependency as well as systems without labelled oxygen-dependency are evaluated.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* male or female subjects with type 1 or type 2 diabetes or healthy subjects
* signed informed consent form

Exclusion Criteria:

* pregnancy or lactation period
* severe acute illness that, in the opinion of the investigator, might pose additional risk to the subject
* severe chronic illness that, in the opinion of the investigator, might pose additional risk to the subject

Primary outcomes:
measure: Influence of the blood sample's partial pressure on blood glucose measurement results
timeFrame: For each sample, preparation and measurment procedure have an expected duration of about 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Study officials:
affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
name: Cornelia Haug, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumstark A, Schmid C, Pleus S, Haug C, Freckmann G. Influence of partial pressure of oxygen in blood samples on measurement performance in glucose-oxidase-based systems for self-monitoring of blood glucose. J Diabetes Sci Technol. 2013 Nov 1;7(6):1513-21. doi: 10.1177/193229681300700611.
Clinical trial NCT05049031: Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk
Official title: Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients who had T1-T3, N0-N2, M0 breast cancer
* Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 "Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast "
* Patient who has given her consent for the study (written or verbal) after clear and fair information

Exclusion Criteria:

* Metastatic breast tumor
* Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors
* Patients who have died since the last assessment
* Protected adult patient (guardianship, curatorship, safeguard of justice)

Primary outcomes:
measure: Evaluate the bone impact of hormone therapy remotely
timeFrame: Inclusion day (day 0)
measure: Evaluate the cardiovascular impact of hormone therapy remotely
timeFrame: Inclusion day (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Anna Gosset, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02847273: Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery
Official title: Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conventional Cardiac Surgery With Bypass
Keywords: NIRS
Regional oxygen saturation
cardiac surgery with bypass
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Were included 20 caucasian adult patients scheduled for conventional elective cardiac surgery with cardiopulmonary bypass.

Brief summary: Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass
* Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)
* Patient agreement

Exclusion Criteria:

* Age\<18 years
* Black skin
* Emergencies
* Patient refusal

Primary outcomes:
measure: Peripheral absolute rSO2 values
timeFrame: at conventional cardiac surgery (Day 1)
Secondary outcomes:
measure: Arterial pressure
timeFrame: at conventional cardiac surgery (Day 1)
measure: heart rate
timeFrame: at conventional cardiac surgery (Day 1)
measure: pulse oxygen saturation
timeFrame: at conventional cardiac surgery (Day 1)
measure: bispectral index
timeFrame: at conventional cardiac surgery (Day 1)
measure: Inotrope drugs doses
timeFrame: at conventional cardiac surgery (Day 1)
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon
Study officials:
affiliation: Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon
name: Jean-Luc Fellahi, Pr, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799873: Alpha-1-Antitrypsin-Deficiency in COVID-19
Official title: Individual Treatment of COVID-19 by Application of Alpha-1-antitrypsin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COVID-19 patients without need for invasive ventilation

Brief summary: The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored.

Detailed description: The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Clinical outcomes, blood inflammatory markers, and virus load are monitored.

Eligibility criteria: Inclusion Criteria:

* Infection with SARS-COV2
* Age over 18 years

Exclusion Criteria:

* Unability to consent
* Invasive ventilation

Primary outcomes:
measure: Clinical course
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University
state: Saarland
Study officials:
affiliation: UDS
name: Robert Bals
role: PRINCIPAL_INVESTIGATOR
References: