louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01276938: Exclusive Intraoperative Radiation Therapy for Breast Cancer
Official title: Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Neoplasms
Toxicity
Keywords: Breast cancer
Intra Operative Radiation Therapy
Toxicity
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy


Eligibility criteria: Inclusion Criteria:

* Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
* Age ≥ 45 and \< 85
* Tumor major diameter ≤ 2.5 cm
* Negative surgical margins (≥ 5 mm)
* Willingness to undergo follow up examinations
* Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
* Signed informed consent

Exclusion Criteria:

* Ductal carcinoma in situ or lobular carcinoma
* Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
* Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
* Collagen vascular disorders

Primary outcomes:
measure: Early toxicity
timeFrame: 6 months
measure: Late toxicity
timeFrame: 5 years
measure: Cosmetic outcome
timeFrame: 5 years
Secondary outcomes:
measure: Local Relapse Free Survival (LRFS)
timeFrame: 10 years
measure: Disease Free Survival (DFS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS AOU San Martino- IST
Study officials:
affiliation: IRCCS AOU SanMartino IST
name: Marina Guenzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvo R. A two-step selection of breast cancer patients candidates for exclusive IORT with electrons: a mono-institutional experience. Anticancer Res. 2012 Apr;32(4):1533-6.
citation: Bonzano E, Belgioia L, Fregatti P, Friedman D, Agostinelli S, Cavagnetto F, Bevegni M, Corvo R, Guenzi M. Tumor Size-driven Dose of Intraoperative Radiotherapy for Breast Cancer: 18 Gy Versus 21 Gy. Anticancer Res. 2018 Sep;38(9):5475-5479. doi: 10.21873/anticanres.12880.
Clinical trial NCT00756938: Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Official title: A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.


Eligibility criteria: Inclusion Criteria:

* Participant is determined to be hypertensive

Exclusion Criteria:

* Participant has a history of severe or symptomatic hypertension
* Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
* Participant has started taking hypertensive medications within the past 30 days
* Participant has a known sensitivity to losartan or history of angioneurotic edema

Primary outcomes:
measure: Mean Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline and Day 21
measure: Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
timeFrame: up to 12 weeks (Base Study); up to 24 months (Extension)
measure: Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
timeFrame: up to 12 weeks (Base Study); up to 24 months (Extension)
Secondary outcomes:
measure: Mean Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline and Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Webb NJ, Wells TG, Shahinfar S, Massaad R, Dankner WM, Lam C, Santoro EP, McCrary Sisk C, Blaustein RO. A randomized, open-label, dose-response study of losartan in hypertensive children. Clin J Am Soc Nephrol. 2014 Aug 7;9(8):1441-8. doi: 10.2215/CJN.11111113. Epub 2014 May 29.
Clinical trial NCT06240338: Acute Pancreatitis : Comparison of Various Scores in Predicting Severity and Outcome
Official title: Acute Pancreatitis : Comparison of Various Scores in Predicting Severity and Outcome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Pancreatitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * age \<18 years old,
* patients with metastatic tumor
* late stage of liver cirrhosis
* active tuberculosis
* refractory heart failure
* previous transplantation
* immunosuppressive therapy
* pregnancy
* patients with chronic pancreatitis or pancreas carcinoma

Brief summary: The study will make a comparison between Various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis

Detailed description: the study will evaluate the relationship between homeostatic model assessment of insulin resistance , bedside index of severity score and the harmless acute pancreatitis score and prognosis of acute pancreatitis ,will compare of these scores in predicting severity of acute pancreatitis and will compare of these scores in predicting outcome of acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

* Any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison of various scores in predicting severity and outcome in patients with acute pancreatitis. 1.Homeostatic model assessment of insulin resistance. 2.The harmless acute pancreatitis score.
timeFrame: within 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00747838: A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias
Official title: Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Keywords: Afib
Atrial Fibrillation
Maze
Mini-Maze
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2008-09-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.

Brief summary: Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
2. \> 18 years of age

Exclusion Criteria:

1. Patients unable to give adequate informed consent
2. Patients who are known to be pregnant, plan to become pregnant or are lactating
3. Inability to return for follow up
4. Patients who are prison inmates or institutionalized
5. Patients in an emergency state
6. Patients under the age of 18

Primary outcomes:
measure: Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Vigneshwar Kasirajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Kenneth Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saini A, Hu YL, Kasirajan V, Han FT, Khan MZ, Wolfe L, Gunda S, Koneru JN, Ellenbogen KA. Long-term outcomes of minimally invasive surgical ablation for atrial fibrillation: A single-center experience. Heart Rhythm. 2017 Sep;14(9):1281-1288. doi: 10.1016/j.hrthm.2017.04.029. Epub 2017 Apr 22.
citation: Kasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
citation: Kron J, Kasirajan V, Wood MA, Kowalski M, Han FT, Ellenbogen KA. Management of recurrent atrial arrhythmias after minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation. Heart Rhythm. 2010 Apr;7(4):445-51. doi: 10.1016/j.hrthm.2009.12.008. Epub 2009 Dec 16.
Clinical trial NCT02638038: This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years
Official title: A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing Remitting
Lead sponsor: InteKrin Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized double blind parallel group study with 3mg, 1mg or placebo
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.

Detailed description: This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..

Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent before any study procedures
2. Male and female subjects aged 18-50
3. Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
4. At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart

Exclusion Criteria:

1. Subjects with a history or presence of chronic disease of the immune system other than RRMS
2. Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
3. Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2

Primary outcomes:
measure: The number of new gadolinium CE T1 weighted lesions
timeFrame: asline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Coherus BioSciences (parent company for Zao InteKrin)
name: Barbara K. Finck, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT00494338: Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
Official title: A Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic Androgen Independent Prostate Cancer (MAIPC)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed MAIPC
* Documented progressive disease in bone, soft tissue or PSA despite castrate levels of testosterone
* If LHRH agonist were used previously it must be kept
* Previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
* Previous DES should be held for at least 4 weeks before partcipating in the trial
* Chemotherapy naive patients
* No prior radioisotope
* Less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
* KPS\> 70%
* Adequate hematologic, hepatic and renal function

Exclusion Criteria:

* Patients with serious medical illness
* History of significant active cardiac disease
* History of gastrointestinal ulceration, bleeding or perforation
* History of myocardial infarctin within past 12 months
* Allergy to sulfonamides or to celecoxib or history of urticaria to any NSAID

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Efficacy of docetaxel and celecoxib by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart
timeFrame: two consecutive evaluations at least 4 weeks apart
Secondary outcomes:
measure: Response in measurable disease by response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.
timeFrame: response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02216838: Treatment of Facial Flushing With Botulinum Toxin A Injections
Official title: Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Facial Flushing
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria: Inclusion Criteria:

1. Patients 18-65 years of age with persistent facial flushing
2. Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.

Exclusion Criteria:

1. Unable to understand the protocol or give informed consent
2. Younger than 18 or older than 65 years of age
3. Females who are pregnant or lactating
4. Known hypersensitivity to BTX-A
5. Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
6. Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma
7. Botulinum toxin injections in the past 6 months
8. Ablative laser procedure in the past 6 months
9. Radiofrequency device treatment in the past 6 months
10. Ultrasound device treatment in the past 6 months
11. Medium to deep chemical peel in the past 6 months
12. Temporary soft tissue augmentation material in the area to be treated in the past year
13. Semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
14. Permanent soft tissue augmentation material in the area to be treated
15. Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
16. Is planning to use tretinoin or retinoic acid in the next 6 months
17. Has an active infection in the forehead or glabellar region (excluding mild acne)
18. Is allergic to cow's milk protein
19. Is allergic to albumin
20. Is currently using anticoagulation therapy
21. Has a history of bleeding disorders

Primary outcomes:
measure: Spectrophotometer measurement
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00516438: Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
Official title: A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Tumors
Keywords: malignant solid tumours
Poly(ADP ribose)
polymerases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: KuDOS Pharmaceuticals Limited
First posted: 2007-08-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
* Evaluable disease
* Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

* Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
* Heavily pre treated patient \> 2 previous chemotherapy regimens for metastatic disease
* Co-existing active infection

Primary outcomes:
measure: To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
timeFrame: assessed at each visit
Secondary outcomes:
measure: To identify the dose limiting toxicity of the combination therapy
timeFrame: assessed at each visit
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Beaston Oncology Centre, Glasgow, UK
name: James Cassidy
role: PRINCIPAL_INVESTIGATOR
affiliation: KuDOS Pharmaceutical Ltd
name: James Carmichael, BSc MBChB MD FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT01952938: Outcome EnduRo Versus LINK SL Rotating Hinge Knee
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthrosis,
Keywords: knee revision surgery,
rotating hinge prosthesis
Lead sponsor: Orthopaedische Klinik Koenig-Ludwig-Haus
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients need hinged knee prosthesis

Brief summary: Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters


Eligibility criteria: Inclusion Criteria:

* rotating hinge knee indicated

Exclusion Criteria:

* infection,
* malignant tumor,
* rheumatism

Primary outcomes:
measure: Oxford knee score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Orthopeadische Klinik KLH
state: Bavaria
Study officials:
References:
Clinical trial NCT02522338: Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance
Official title: Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.


Eligibility criteria: Inclusion Criteria:

* Patients infected with HIV, and included in the cohort NADIS

Exclusion Criteria:

* Patient with a known allergy
* Patients treated with metformin
* Patients with severe hepatic impairment defined as a TP spontaneously below 50%
* Patients with a history of dysthyroidism
* Patient with active neoplasia other than skin cancer
* Degradation recent (not older than 3 months) in renal function defined as the deterioration of GFR over 25%.
* Estimated GFR less than 15 mL/min/1, 73m2
* Pregnant or lactating
* Subjects under the protection of justice

Primary outcomes:
measure: Patient with a predictive performance range -30% to +30%
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Frédéric LUCHT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: