acronym: UCPVax

title: Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study

ReferenceCitation: Galaine J, Borg C, Godet Y, Adotévi O. Interest of Tumor-Specific CD4 T Helper 1 Cells for Therapeutic Anticancer Vaccine. Vaccines (Basel). 2015 Jun 30;3(3):490-502. doi: 10.3390/vaccines3030490. Review.

ReferenceCitation: Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotévi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.

ReferenceCitation: Adotévi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28. Review.

ReferenceType: result

ReferenceCitation: Adotévi O, Vernerey D, Jacoulet P, Meurisse A, Laheurte C, Almotlak H, Jacquin M, Kaulek V, Boullerot L, Malfroy M, Orillard E, Eberst G, Lagrange A, Favier L, Gainet-Brun M, Doucet L, Teixeira L, Ghrieb Z, Clairet AL, Guillaume Y, Kroemer M, Hocquet D, Moltenis M, Limat S, Quoix E, Mascaux C, Debieuvre D, Fagnoni-Legat C, Borg C, Westeel V. Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study. J Clin Oncol. 2022 Sep 7:JCO2200096. doi: 10.1200/JCO.22.00096. [Epub ahead of print]

summary:
UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong TH1 CD4 T cell responses in cancer patients.

Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by using Continuous Reassessment Method (CRML) dose escalation design model.

The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to estimate its Maximum Tolerated Dose (MTD).

The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax according to the dose level.


acronym: TICTAVI

summary: Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: University Hospital, Bordeaux

location_facility:
APHP
APHM
CHRU de Nîmes
CHU de Bordeaux
CHRU de Lille

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome

acronym: JUMP

summary: Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire de La Réunion

intervention_type: Device

status_simplified: Ongoing


title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

acronym: FRACTION

summary: The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Steinmeyer Z, Gérard S, Filleron T, Lozano S, Brechemier D, Abellan Van Kan G, Mourey L, Cristol-Dalstein L, De Decker L, Rolland Y, Balardy L. Low lean mass and chemotherapy toxicity risk in the elderly: the Fraction study protocol. BMC Cancer. 2019 Nov 27;19(1):1153. doi: 10.1186/s12885-019-6377-7.

lead_sponsor: University Hospital, Toulouse

location_facility: Institut du Cancer de Montpellier Val d'Aurelle

intervention_type: Other


status: Terminated

primary_purpose: Treatment

acronym: VesiCaP

title: Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer

lead_sponsor: Center Eugene Marquis

type: EudraCT Number

source: euctr

location_facility:
Clinique Pasteur Lanroze
CH Bretagne Sud
Hôpital Saint Louis
Centre Eugene Marquis
CH Lyon Sud

summary: The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

acronym: APCext

summary:
The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and endstage liver disease has led to an increase in the gap between patients on waiting-lists and available liver grafts. In order to compensate for this scarcity, use of liver grafts harvested from extended criteria donors (ECD) has become more and more frequent.

However, these ECD grafts are known to be associated with a higher rate of primary non function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to ischemia-reperfusion injury (IRI).

During OLT, the clamping of the portal vein induces blood congestion in the splanchnic territory leading to increased gut permeability, bacterial translocation and release of endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.

Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic congestion and could therefore decrease IRI and improve liver graft function. However, TPCS remains poorly used as no randomised trial succeeds to show its benefit on liver function due to lack of power.

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility:
CHU Tours
Hospices Civils Lyon
CHU Rennes
CHU Bordeaux
CHU Toulouse

intervention_type: Procedure


title: Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track

acronym: Microsperm

summary: To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.

primary_purpose: Supportive Care

ReferenceCitation: Tsujimura A, Matsumiya K, Miyagawa Y, Tohda A, Miura H, Nishimura K, Koga M, Takeyama M, Fujioka H, Okuyama A. Conventional multiple or microdissection testicular sperm extraction: a comparative study. Hum Reprod. 2002 Nov;17(11):2924-9.

ipd_sharing: Undecided


title: VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease

acronym: VEDO-PREDIRESP

summary:
Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor) agents.

For Crohn's disease patients treated with vedolizumab, a strong association between vedolizumab serum levels and clinical response to induction and maintenance was demonstrated by anterior studies.

It could be of paramount interest to early identify Crohn's Disease patients under vedolizumab who will be responders to vedolizumab induction and to identify those who will achieve clinical remission under maintenance therapy with vedolizumab.

Researchers decided to assess the clinical response to vedolizumab induction at week 10. For clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be infused at week 10 and then every four weeks.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Lyon-Sud, Hospices Civils de Lyon, PIERRE-BENITE


title: Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

acronym: NVCI

summary:
The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.

Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV

Very low: <10% occurrence of CINV;
Low: 10 to 30% occurrence of CINV;
Average: 30 to 90% occurrence of CINV;
High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.

Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.

Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.

These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.

The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.

Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.

lead_sponsor: Hopital Foch

location_facility: Centre spécilaisé en cancérologie Paris Nord


title: Evaluation of the Effectiveness of Personalized Short and Intensive Educational SPA Therapy Prevention of Upper Limb Musculoskeletal Disorders (MSDs).

acronym: MUSKA

summary: The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives (personal or professional)

ReferenceCitation: McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. Review.

ReferenceCitation: Kamaleri Y, Natvig B, Ihlebaek CM, Bruusgaard D. Localized or widespread musculoskeletal pain: does it matter? Pain. 2008 Aug 15;138(1):41-46. doi: 10.1016/j.pain.2007.11.002. Epub 2008 Feb 20.

ReferenceCitation: Solidaki E, Chatzi L, Bitsios P, Markatzi I, Plana E, Castro F, Palmer K, Coggon D, Kogevinas M. Work-related and psychological determinants of multisite musculoskeletal pain. Scand J Work Environ Health. 2010 Jan;36(1):54-61. Epub 2009 Dec 11.

ReferenceCitation: Fan ZJ, Smith CK, Silverstein BA. Assessing validity of the QuickDASH and SF-12 as surveillance tools among workers with neck or upper extremity musculoskeletal disorders. J Hand Ther. 2008 Oct-Dec;21(4):354-65. doi: 10.1197/j.jht.2008.02.001.

ReferenceCitation: Polson K, Reid D, McNair PJ, Larmer P. Responsiveness, minimal importance difference and minimal detectable change scores of the shortened disability arm shoulder hand (QuickDASH) questionnaire. Man Ther. 2010 Aug;15(4):404-7. doi: 10.1016/j.math.2010.03.008.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Gautheron V, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Gautheron V, Revel M, Poiraudeau S. Validation of the French version of the Disability of the Arm, Shoulder and Hand questionnaire (F-DASH). Joint Bone Spine. 2008 Mar;75(2):195-200. Epub 2007 Aug 30.

ReferenceCitation: Meroni R, Scelsi M, Boria P, Sansone V. Shoulder disorders in female working-age population: a cross sectional study. BMC Musculoskelet Disord. 2014 Apr 4;15:118. doi: 10.1186/1471-2474-15-118.

ReferenceCitation: Parot-Schinkel E, Descatha A, Ha C, Petit A, Leclerc A, Roquelaure Y. Prevalence of multisite musculoskeletal symptoms: a French cross-sectional working population-based study. BMC Musculoskelet Disord. 2012 Jul 20;13:122. doi: 10.1186/1471-2474-13-122.

ReferenceType: derived

ReferenceCitation: Lanhers C, Pereira B, Gay C, Hérisson C, Levyckyj C, Dupeyron A, Coudeyre E. Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Dec 9;17(1):497.

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

acronym: TRANSFECMV

summary: Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented

primary_purpose: Basic Science

lead_sponsor: University Hospital, Limoges

location_facility: Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus

location_facility: Centre de biologie pathologie / Laboratoire de virologie


title: Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study

acronym: PR

summary:
The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.

The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance

time_perspective: Retrospective

lead_sponsor: Smith & Nephew Orthopaedics AG

location_facility:
Clinique du Renaison
Clinique la Parisière
Centre Hospitalier de Montélimar
Centre Hospitalier du Forez- Montbrison
Infirmerie Protestante de Lyon


title: Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)

summary:
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).

Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.

Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.

location_facility:
Hôpital Édouard Herriot
Chu Saint Etienne
CHU de Toulouse
Assistance Publique-Hopitaux de Paris
Ch Regional D'Orleans


title: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis

summary:
The studied pathology concerns post traumatic cervical spinal cord contusion on narrow spinal canal.

The pathophysiology remains controversial. This pathology does not enjoy consensus support. Many questions remain regarding the surgical care and its delay.

The purpose of the study was to demonstrate non-inferiority of early surgical treatment compared to the same surgery performed with a delay among patients identified as having a cervical spinal cord contusion on posttraumatic narrowed cervical canal.

In the current state of knowledge and practices, the treatment of post traumatic spinal cord contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The generally accepted delay is 15 days.

The surgical technique is a conventional cervical spinal decompression surgery. The type of decompression (anterior or posterior) is dependent on the compression and therefore the clinical radiological analysis. The choice of the technique and the surgical approach are therefore left to the discretion of the surgeon.

After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the Neurosurgery Service of the University Hospital concerned.

After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, early surgery within 48 hours of diagnosis is then considered (according to the assigned group).

The surgical technique is a conventional cervical spinal decompression surgery. Way posterior surgery, laminectomy for spinal stenosis significant if greater than or equal to 3 floors will be preferred. In other cases, the type of surgery will be at the discretion of the surgeon and the opinion of the Staff Neurosurgery.

The surgical procedure is identical in the two groups. Alone, the delay of the surgery varies : less than 48 hours for the first group and 15 days for the second.

During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following criteria will be assessed : the quality and quickness of the motor and sensory recovery, the early post-operative evolution and the long and medium term evolution but also disability and functional sequelaes.

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
CHU d'Angers
CHU de Brest
Hospital LA TIMONE
CHU de Rennes


title: Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy in the Complex Regional Pain Syndrome of the Upper Limb : a Multicentric Randomized Open Study.

acronym: AlgoMIR

summary:
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.

Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.

location_facility: Consultation Douleur de la Mutualité de la Loire

intervention_type: Behavioral


title: Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments

acronym: LIPEG

summary: The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. We evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public. A focus group drafted a new version of the letter (letter B) through these observations. The two letter models (A vs B) are compared in terms of impact through precise items (understanding and feelings) on three populations: patients, public and genetic professionals. Assumption is made that the letter B will be preferred to the letter A. Overall, we aim at giving a letter formulation accommodating as many people as possible to standardize practices.

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)

summary: This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

ReferenceCitation: Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO(2) removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: CHU CLERMONT FERRAND, Département Anesthésie Réanimation

location_facility: CHU AMIENS, Département Anesthésie Réanimation

location_facility: CHU MONTPELLIER, Département Anesthésie Réanimation

location_facility: Hopital Pitié Salpetriere, Reanimation Medicale


title: Study of cccDNA in Liver Transplant Patients With B Virus Markers

acronym: ECOGREFFE-B

summary: The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hépatologie, Hôpital de la Croix-Rousse

intervention_type: Biological


title: A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period

acronym: TERICIS

summary:
National, multicenter study:

The study consists of 3 periods:

A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria.
Treatment period with timed evaluations
Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
CHU de Strasbourg
CHU de Lille
CHU de Montpellier
CHU de Besançon


title: Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy

acronym: TelOG

summary:
There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.

The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).

External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.

However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.

The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse
Centre Hospitalier du Havre
Centre Hospitalier


title: Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

acronym: M'RHICO

summary: This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.

ReferenceCitation: Constantin JM, Jaber S, Futier E, Cayot-Constantin S, Verny-Pic M, Jung B, Bailly A, Guerin R, Bazin JE. Respiratory effects of different recruitment maneuvers in acute respiratory distress syndrome. Crit Care. 2008;12(2):R50. doi: 10.1186/cc6869. Epub 2008 Apr 16.

ReferenceCitation: Rangel-Castilla L, Gopinath S, Robertson CS. Management of intracranial hypertension. Neurol Clin. 2008 May;26(2):521-41, x. doi: 10.1016/j.ncl.2008.02.003. Review. Erratum in: Neurol Clin. 2008 Aug;26(3):xvii. Rangel-Castillo, Leonardo [corrected to Rangel-Castilla, Leonardo].

ReferenceCitation: Chesnut RM. Care of central nervous system injuries. Surg Clin North Am. 2007 Feb;87(1):119-56, vii. Review.

ReferenceCitation: Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218. Review.

location_facility:
UH Toulouse
UH Caen
UH Montpellier
UH Clermont-Ferrand
UH Nantes


title: Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

acronym: DENERV'AP

summary:
Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.

The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.

The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.

The study will run for 18 months and it will be necessary to recruit 50 patients.

All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.

The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.

location_facility:
CHU de Nice
CHU de Grenoble
CHU de Toulouse
AP-HM
AP-HP


acronym: CARPEMAN

summary: This is a Multicenter prospective diagnostic study.

location_facility:
CHU
Institut de Cancérologie de l'Ouest
Centre Françis Baclesse
Centre Henri Becquerel


type: Registry Identifier

title: Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck

acronym: TEmPoRAL

summary: Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years

location_facility: Centre d'Oncologie St Vincent - Boulevard de la Boutière

intervention_type: Radiation


title: A Randomized Phase III of Adjuvant Targeted Radionuclide Therapy With In111-Pentetreotide in Patients With Digestive Neuroendocrine Tumors After Complete Surgical Resection of Liver Metastases.

acronym: TERAVECT

summary:
TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy.

In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôptal Cochin
Hôpital Haut Lévêque - CHU Bordeaux
Hôpital Beaujon
Hôpital R. Salengro
Hôpital Hôtel Dieu


title: Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns

summary: Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are increasing. Among the actions to control resistance, one is an interesting lead: to prevent the emergence of resistant bacteria by limiting possibilities for bacteria to acquire resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few data on the dynamic of acquisition over time. Among the genetic components that disseminate resistance genes, resistance integrons (RI) play a major role in the acquisition and dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the first days of life. It thus appears to be an appropriate model to study the dynamic of resistance acquisition. This project intends to follow the NB of neonatology over time in order to study the dynamic of the digestive acquisition of RI and MRB

location_facility:
Hospital center
University Hospital
University hospital


title: Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units

summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

location_facility:
Poitiers University Hospital
Tours University Hospital
Rennes University Hospital
Angers University Hospital
Nantes University Hospital


title: A Randomized Controlled Non-inferiority Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

acronym: LIA

summary: The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Polyclinique du Plateau
Clinique Claude Bernard
Clinique Jules Verne
Hospital Ambroise Paré Paris
Institut Mutualiste Montsouris


title: An Open Label First-in-Human Adjuvant Phase I Study of a Synthetic Multiple Antigenic Glycopeptide Displaying a Tri Tn Glycotop (MAG-Tn3) Plus AS15, as a Therapeutic Vaccine Candidate in Patients With Non Metastatic, HER2 Negative Localized Breast Cancer at High-Risk of Relapse

acronym: MAGTRIVACSEIN

summary: The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks.

ReferenceCitation: Rosenbaum P, Artaud C, Bay S, Ganneau C, Campone M, Delaloge S, Gourmelon C, Loirat D, Medioni J, Pein F, Sablin MP, Tredan O, Varga A, Leclerc C. The fully synthetic glycopeptide MAG-Tn3 therapeutic vaccine induces tumor-specific cytotoxic antibodies in breast cancer patients. Cancer Immunol Immunother. 2020 May;69(5):703-716. doi: 10.1007/s00262-020-02503-0. Epub 2020 Feb 7.

lead_sponsor: Institut Pasteur

location_facility: Institut de Cancérologie de l'OUEST - Centre René Gauducheau


title: Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients

summary:
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.

Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.

The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.

ReferenceCitation: Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.

ReferenceCitation: Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.

ReferenceCitation: Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.

location_facility:
Chu de Saint Etienne
CHU Avicenne
CHRU de Strasbourg
CHU Gabriel Montpied
CHU Saint-Louis


title: The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men: a Double Blind Randomized Controlled Trial

acronym: Shock-ED

summary: The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment. The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud


title: Early Postnatal Discharge in a French Perinatal Network

acronym: SORPRISE

summary: The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

ReferenceCitation: Liu S. Rate of neonatal hospital readmission after discharge following birth. Canadian Perinatal Health Report 2003; 104-106. http://www.hc-sc.gc.ca/pphb-dgspsp/rhs-ssg/index.html

ReferenceCitation: Ellberg L, Högberg U, Lundman B, Källén K, Håkansson S, Lindh V. Maternity care options influence readmission of newborns. Acta Paediatr. 2008 May;97(5):579-83. doi: 10.1111/j.1651-2227.2008.00714.x.

ReferenceCitation: Boulvain M, Perneger TV, Othenin-Girard V, Petrou S, Berner M, Irion O. Home-based versus hospital-based postnatal care: a randomised trial. BJOG. 2004 Aug;111(8):807-13.

ReferenceCitation: Oddie SJ, Hammal D, Richmond S, Parker L. Early discharge and readmission to hospital in the first month of life in the Northern Region of the UK during 1998: a case cohort study. Arch Dis Child. 2005 Feb;90(2):119-24.

ReferenceCitation: Sainz Bueno JA, Romano MR, Teruel RG, Benjumea AG, Palacín AF, González CA, Manzano MC. Early discharge from obstetrics-pediatrics at the Hospital de Valme, with domiciliary follow-up. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):714-26.

ReferenceCitation: Johansson K, Aarts C, Darj E. First-time parents' experiences of home-based postnatal care in Sweden. Ups J Med Sci. 2010 May;115(2):131-7. doi: 10.3109/03009730903431809.

ReferenceCitation: Shaw E, Levitt C, Wong S, Kaczorowski J; McMaster University Postpartum Research Group. Systematic review of the literature on postpartum care: effectiveness of postpartum support to improve maternal parenting, mental health, quality of life, and physical health. Birth. 2006 Sep;33(3):210-20. Review.

ReferenceCitation: Bravo P, Uribe C, Contreras A. Early postnatal hospital discharge: the consequences of reducing length of stay for women and newborns. Rev Esc Enferm USP. 2011 Jun;45(3):758-63. Review.

ReferenceCitation: OCDE (2009), Panorama de la santé 2009 : Les indicateurs de l'OCDE, Éditions OCDE.doi : 10.1787/health_glance-2009-fr

ReferenceCitation: Lindsay F, Postnatal care: development of a psychometric multidimensional satisfaction questionnaire (theWOMBPNSQ) to assess women's views BrJGenPract2011; DOI:10.3399/bjgp11X601334

doi: lindsay

ReferenceCitation: Antoniotti S, Baumstarck-Barrau K, Siméoni MC, Sapin C, Labarère J, Gerbaud L, Boyer L, Colin C, François P, Auquier P. Validation of a French hospitalized patients' satisfaction questionnaire: the QSH-45. Int J Qual Health Care. 2009 Aug;21(4):243-52. doi: 10.1093/intqhc/mzp021. Epub 2009 Jun 23.

ReferenceCitation: Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.

ReferenceCitation: Edinburgh Depression Scale Translated Government of Western Australia Department of Health www.folkhalsoguiden.se/upload/Psykisk Hälsa/Edinburgh Depression Scale Translated Government of Western Australia Department of Health.pdf

ReferenceCitation: DOMECQ, S. AUSTRUY, J.VIOT, F. CADIOT, C POURIN. Evaluation de la satisfaction des correspondants externes : Rapport régional, mars 2009. CCECQA -Hôpital Xavier Arnozan -33604 Pessac www.ccecqa.asso.fr

lead_sponsor: University Hospital, Grenoble

location_facility:
Clinique des Cèdres
Clinique Belledonne
CH Voiron
Clinique Mutualiste
Hopital Couple Enfant


title: Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study

acronym: THERMALGI

summary:
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.

Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

ReferenceCitation: Adler GK, Kinsley BT, Hurwitz S, Mossey CJ, Goldenberg DL. Reduced hypothalamic-pituitary and sympathoadrenal responses to hypoglycemia in women with fibromyalgia syndrome. Am J Med. 1999 May;106(5):534-43.

ReferenceCitation: Altan L, Bingöl U, Aykaç M, Koç Z, Yurtkuran M. Investigation of the effects of pool-based exercise on fibromyalgia syndrome. Rheumatol Int. 2004 Sep;24(5):272-7. Epub 2003 Sep 24.

ReferenceCitation: Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ, Chappell AS. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry. 2009;11(5):237-44. doi: 10.4088/PCC.08m00680.

ReferenceCitation: Baranowsky J, Klose P, Musial F, Häuser W, Dobos G, Langhorst J. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int. 2009 Nov;30(1):1-21. doi: 10.1007/s00296-009-0977-5. Epub 2009 Aug 12. Review. Erratum in: Rheumatol Int. 2009 Nov;30(1):23. Haeuser, Winfried [corrected to Häuser, Winfried].. Rheumatol Int. 2009 Nov;30(1):23.

ReferenceCitation: Bellometti S, Galzigna L. Function of the hypothalamic adrenal axis in patients with fibromyalgia syndrome undergoing mud-pack treatment. Int J Clin Pharmacol Res. 1999;19(1):27-33.

ReferenceCitation: Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

ReferenceCitation: Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45.

ReferenceCitation: Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9.

ReferenceCitation: Bircan C, Karasel SA, Akgün B, El O, Alper S. Effects of muscle strengthening versus aerobic exercise program in fibromyalgia. Rheumatol Int. 2008 Apr;28(6):527-32. Epub 2007 Nov 3.

ReferenceCitation: Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.

ReferenceCitation: Burckhardt CS, Mannerkorpi K, Hedenberg L, Bjelle A. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. J Rheumatol. 1994 Apr;21(4):714-20.

ReferenceCitation: Burckhardt CS. Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des. 2006;12(1):59-66. Review.

ReferenceCitation: Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1. Review.

ReferenceCitation: Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. Review.

ReferenceCitation: Buskila D, Neumann L, Vaisberg G, Alkalay D, Wolfe F. Increased rates of fibromyalgia following cervical spine injury. A controlled study of 161 cases of traumatic injury. Arthritis Rheum. 1997 Mar;40(3):446-52.

ReferenceCitation: Carville SF, Arendt-Nielsen L, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Späth M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. Epub 2007 Jul 20. Review. Erratum in: Ann Rheum Dis. 2015 Feb;74(2):476. Arendt-Nielsen, S [corrected to Arendt-Nielsen, L].

ReferenceCitation: Cedraschi C, Desmeules J, Rapiti E, Baumgartner E, Cohen P, Finckh A, Allaz AF, Vischer TL. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management. Ann Rheum Dis. 2004 Mar;63(3):290-6.

ReferenceCitation: Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73.

ReferenceCitation: Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. Review. French.

ReferenceCitation: Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. Epub 2002 Mar 29.

ReferenceCitation: Dönmez A, Karagülle MZ, Tercan N, Dinler M, Işsever H, Karagülle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. Epub 2005 Jun 17.

ReferenceCitation: Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. Epub 2007 May 23.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

ReferenceCitation: Furlan R, Colombo S, Perego F, Atzeni F, Diana A, Barbic F, Porta A, Pace F, Malliani A, Sarzi-Puttini P. Abnormalities of cardiovascular neural control and reduced orthostatic tolerance in patients with primary fibromyalgia. J Rheumatol. 2005 Sep;32(9):1787-93.

ReferenceCitation: Giske L, Vøllestad NK, Mengshoel AM, Jensen J, Knardahl S, Røe C. Attenuated adrenergic responses to exercise in women with fibromyalgia--a controlled study. Eur J Pain. 2008 Apr;12(3):351-60. Epub 2007 Sep 10.

ReferenceCitation: Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

ReferenceCitation: Hassett AL, Radvanski DC, Vaschillo EG, Vaschillo B, Sigal LH, Karavidas MK, Buyske S, Lehrer PM. A pilot study of the efficacy of heart rate variability (HRV) biofeedback in patients with fibromyalgia. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):1-10. Epub 2007 Jan 12.

ReferenceCitation: Jentoft ES, Kvalvik AG, Mengshoel AM. Effects of pool-based and land-based aerobic exercise on women with fibromyalgia/chronic widespread muscle pain. Arthritis Rheum. 2001 Feb;45(1):42-7.

ReferenceCitation: Kazlauskaite R, Evans AT, Villabona CV, Abdu TA, Ambrosi B, Atkinson AB, Choi CH, Clayton RN, Courtney CH, Gonc EN, Maghnie M, Rose SR, Soule SG, Tordjman K; Consortium for Evaluation of Corticotropin Test in Hypothalamic-Pituitary Adrenal Insufficiency. Corticotropin tests for hypothalamic-pituitary- adrenal insufficiency: a metaanalysis. J Clin Endocrinol Metab. 2008 Nov;93(11):4245-53. doi: 10.1210/jc.2008-0710. Epub 2008 Aug 12.

ReferenceCitation: Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. Review.

ReferenceCitation: Ledingham J, Doherty S, Doherty M. Primary fibromyalgia syndrome--an outcome study. Br J Rheumatol. 1993 Feb;32(2):139-42.

ReferenceCitation: Lerma C, Martinez A, Ruiz N, Vargas A, Infante O, Martinez-Lavin M. Nocturnal heart rate variability parameters as potential fibromyalgia biomarker: correlation with symptoms severity. Arthritis Res Ther. 2011;13(6):R185. doi: 10.1186/ar3513. Epub 2011 Nov 16.

ReferenceCitation: McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the manifestations of primary fibromyalgia. Arthritis Rheum. 1988 Sep;31(9):1135-41.

ReferenceCitation: McCracken LM, MacKichan F, Eccleston C. Contextual cognitive-behavioral therapy for severely disabled chronic pain sufferers: effectiveness and clinically significant change. Eur J Pain. 2007 Apr;11(3):314-22. Epub 2006 Jun 9.

ReferenceCitation: McVeigh JG, McGaughey H, Hall M, Kane P. The effectiveness of hydrotherapy in the management of fibromyalgia syndrome: a systematic review. Rheumatol Int. 2008 Dec;29(2):119-30. doi: 10.1007/s00296-008-0674-9. Epub 2008 Aug 27. Review.

ReferenceCitation: Moldofsky H, Inhaber NH, Guinta DR, Alvarez-Horine SB. Effects of sodium oxybate on sleep physiology and sleep/wake-related symptoms in patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study. J Rheumatol. 2010 Oct;37(10):2156-66. doi: 10.3899/jrheum.091041. Epub 2010 Aug 3.

ReferenceCitation: Moldofsky H, Lue FA, Mously C, Roth-Schechter B, Reynolds WJ. The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study. J Rheumatol. 1996 Mar;23(3):529-33.

ReferenceCitation: Morley S, Williams ACC. RCTs of psychological treatments for chronic pain: progress and challenges. Pain. 2006 Apr;121(3):171-172. doi: 10.1016/j.pain.2006.01.017. Epub 2006 Mar 2.

ReferenceCitation: Mostoufi SM, Afari N, Ahumada SM, Reis V, Wetherell JL. Health and distress predictors of heart rate variability in fibromyalgia and other forms of chronic pain. J Psychosom Res. 2012 Jan;72(1):39-44. doi: 10.1016/j.jpsychores.2011.05.007. Epub 2011 Jun 30.

ReferenceCitation: Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26. Review.

ReferenceCitation: Onieva-Zafra MD, Castro-Sánchez AM, Matarán-Peñarrocha GA, Moreno-Lorenzo C. Effect of music as nursing intervention for people diagnosed with fibromyalgia. Pain Manag Nurs. 2013 Jun;14(2):e39-46. doi: 10.1016/j.pmn.2010.09.004. Epub 2010 Nov 26.

ReferenceCitation: Ozkurt S, Dönmez A, Zeki Karagülle M, Uzunoğlu E, Turan M, Erdoğan N. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study. Rheumatol Int. 2012 Jul;32(7):1949-54. doi: 10.1007/s00296-011-1888-9. Epub 2011 Apr 2.

ReferenceCitation: Pioro-Boisset M, Esdaile JM, Fitzcharles MA. Alternative medicine use in fibromyalgia syndrome. Arthritis Care Res. 1996 Feb;9(1):13-7.

ReferenceCitation: Richards SC, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial. BMJ. 2002 Jul 27;325(7357):185.

ReferenceCitation: Russell IJ, Kamin M, Bennett RM, Schnitzer TJ, Green JA, Katz WA. Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol. 2000 Oct;6(5):250-7.

ReferenceCitation: Sayar K, Aksu G, Ak I, Tosun M. Venlafaxine treatment of fibromyalgia. Ann Pharmacother. 2003 Nov;37(11):1561-5.

ReferenceCitation: Sephton SE, Salmon P, Weissbecker I, Ulmer C, Floyd A, Hoover K, Studts JL. Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: results of a randomized clinical trial. Arthritis Rheum. 2007 Feb 15;57(1):77-85.

ReferenceCitation: Tomas-Carus P, Häkkinen A, Gusi N, Leal A, Häkkinen K, Ortega-Alonso A. Aquatic training and detraining on fitness and quality of life in fibromyalgia. Med Sci Sports Exerc. 2007 Jul;39(7):1044-50.

ReferenceCitation: van Koulil S, Effting M, Kraaimaat FW, van Lankveld W, van Helmond T, Cats H, van Riel PL, de Jong AJ, Haverman JF, Evers AW. Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis. 2007 May;66(5):571-81. Epub 2006 Aug 17. Review.

ReferenceCitation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72.

ReferenceCitation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

ReferenceCitation: Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.

ReferenceCitation: Maindet C, Maire A, Vermorel C, Cracowski C, Rolland C, Forestier R, Comte A, Roques CF, Serra E, Bosson JL. Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial. J Pain. 2021 Aug;22(8):940-951. doi: 10.1016/j.jpain.2021.02.010. Epub 2021 Mar 4.

location_facility:
station thermale ALLEVARD LES BAINS
station thermale LAMALOU LES BAINS
Station thermale URIAGE LES BAINS
station thermale AIX LES BAINS
station thermale BOURBON LANCY


title: Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

acronym: PECTUS

summary: this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test

lead_sponsor: Centre Jean Perrin

location_facility: CHU de St Etienne, Hôpital Nord, Chirurgie thoracique

location_facility: CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles

location_facility: CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles

location_facility: CHU G Montpied, Service de Cardiologie et Maladies Vasculaires


title: Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study

acronym: IAHAI

summary:
Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.

ReferenceCitation: Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CH de Mâcon
CHU de DIJON
CH de METZ
CH de Chalon-sur-Saône
CHU de Besançon


title: ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

summary:
Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.

Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.

Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.

Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.

To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.

lead_sponsor: University Hospital, Caen

location_facility: Clinical Research Center University Hospital Caen


title: Inter-regional Project of the Great Western Exploration Approach for Exome Molecular Causes Severe Intellectual Disability Isolated or Syndromic

acronym: HUGODIMS

summary: Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to 4000 new cases each year. Chromosomal or molecular pathology causes are not identified in half of the cases by current techniques. Studies show that de novo mutations are common in many different genes. The "exome" approach by high-throughput sequencing (NGS) has emerged as the technique of choice for identifying and comparing the exome of the child to the parent. We wish to evaluate this approach and its contribution in the diagnostic management of 50 patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA / Biogenouest will provide technological and bioinformatics support this project.

location_facility:
Poitiers University Hospital
Tours University Hospital
Brest University Hospital
Rennes University Hospital
Angers University Hospital


ipd_sharing: Yes

title: A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

lead_sponsor: Gilead Sciences

ReferenceCitation: Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.

ReferenceCitation: Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

summary: This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.


title: Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)

acronym: AIRLESS

summary: The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).

location_facility:
CHU de Grenoble
Hôpital Arnaud de Villeneuve
Hôpital Trousseau
Hopital Barbois
Clinique Pasteur


type: Other Grant/Funding Number

title: Comparison of FDG PET-CT Estimated Testis Functional Value Between Patients Having Positive Testicular Sperm Cells Extraction and Patients With a Negative Extraction, in Men With Azoospermia

acronym: AzoPredHisto

summary: Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

ReferenceCitation: Ferretti L, Sargos P, Gross-Goupil M, Izard V, Wallerand H, Huyghe E, Rigot JM, Durand X, Benoit G, Ferriere JM, Droupy S. Testicular-sparing surgery for bilateral or monorchide testicular tumours: a multicenter study of long-term oncological and functional results. BJU Int. 2014 Dec;114(6):860-4. doi: 10.1111/bju.12549. Epub 2014 Aug 16.

lead_sponsor: University Hospital, Toulouse

location_facility:
UHToulouse
UHBordeaux
University Hospital
Centre européen Georges Pompidou


title: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease

acronym: MicroMICI

summary: The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Necker Enfants Malades
Hôpital Saint Antoine
Hôpital Robert Deré
Hôpital Saint Louis
Hôpital Beaujon


acronym: SOMELIA

title: Does Melatonin Restore Sleep Architecture in Autistic Children?

location_facility:
CHU de Caen
CHU de Tours
CHRU de Strasbourg
Centre Hospitalier du Chinonais
Hôpital Femme Mere Enfant

summary:
Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation.

Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders.

Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders.

It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings).

The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects.

The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.


title: Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression

acronym: STHYM

summary:
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important.

Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery.

Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.

lead_sponsor: Rennes University Hospital

location_facility:
APHM
CHS
CHU
APHP Pitié Salpetriere


title: Consumption of Fatty Acids, Metabolism of Adipose Tissue and Risk of Colorectal Cancer: AGARIC Case Control Study

acronym: AGARIC

summary: The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.

ReferenceCitation: Cottet V, Vaysse C, Scherrer ML, Ortega-Deballon P, Lakkis Z, Delhorme JB, Deguelte-Lardière S, Combe N, Bonithon-Kopp C. Fatty acid composition of adipose tissue and colorectal cancer: a case-control study. Am J Clin Nutr. 2015 Jan;101(1):192-201. doi: 10.3945/ajcn.114.088948. Epub 2014 Nov 12.

location_facility:
CHU Jean Minjoz
Hôpital Robert Debré
Hôpital de BRABOIS
CHU Dijon
Hôpital Hautepierre


title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up

acronym: BIO-OHS

summary:
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.

lead_sponsor: AGIR à Dom

location_facility: Hôpital Michallon, Laboratoire EFCR et Sommeil

location_facility: Laboratoire d'analyses medicales de Thuir


title: Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study

acronym: GlyCEDIA

summary: The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes

ReferenceCitation: U S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx

ReferenceCitation: Heras M, Fernández-Reyes MJ, Sánchez R, Guerrero MT, Molina A, Rodríguez MA, Alvarez-Ude F. Elderly patients with chronic kidney disease: outcomes after 5 years of follow-up. Nefrologia. 2012 May 14;32(3):300-5. doi: 10.3265/Nefrologia.pre2012.Jan.10994. Epub 2012 Feb 28. English, Spanish.

ReferenceCitation: Pieringer H, Biesenbach G. Hemodialysis in patients older than 65 years with end-stage renal failure--comparison of outcome in patients with and without diabetes. Z Gerontol Geriatr. 2008 Apr;41(2):139-45. doi: 10.1007/s00391-007-0467-x. Epub 2008 Mar 11.

ReferenceCitation: Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.

ReferenceCitation: Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500.

ReferenceCitation: Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.

ReferenceCitation: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602.

ReferenceCitation: McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. Am J Kidney Dis. 2002 Sep;40(3):566-75.

ReferenceCitation: Okada T, Nakao T, Matsumoto H, Shino T, Nagaoka Y, Tomaru R, Wada T. Association between markers of glycemic control, cardiovascular complications and survival in type 2 diabetic patients with end-stage renal disease. Intern Med. 2007;46(12):807-14. Epub 2007 Jun 15.

ReferenceCitation: Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

ReferenceCitation: ACCORD Study Group, Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.

ReferenceCitation: Riveline JP, Teynie J, Belmouaz S, Franc S, Dardari D, Bauwens M, Caudwell V, Ragot S, Bridoux F, Charpentier G, Marechaud R, Hadjadj S. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant. 2009 Sep;24(9):2866-71. doi: 10.1093/ndt/gfp181. Epub 2009 Apr 23.

ReferenceCitation: Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T, Frankel AH, Tam FW, Dornhorst A, Frost G, Turner JJ. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1137-42. doi: 10.2337/dc08-1688. Epub 2009 Feb 5.

ReferenceCitation: Vos FE, Schollum JB, Coulter CV, Manning PJ, Duffull SB, Walker RJ. Assessment of markers of glycaemic control in diabetic patients with chronic kidney disease using continuous glucose monitoring. Nephrology (Carlton). 2012 Feb;17(2):182-8. doi: 10.1111/j.1440-1797.2011.01517.x.

ReferenceCitation: Ersoy A, Ersoy C, Altinay T. Insulin analogue usage in a haemodialysis patient with type 2 diabetes mellitus. Nephrol Dial Transplant. 2006 Feb;21(2):553-4. Epub 2005 Oct 12.

ReferenceCitation: Schmitz O, Alberti KG, Orskov H. Insulin resistance in uraemic insulin-dependent diabetics. Effect of dialysis therapy as assessed by the artificial endocrine pancreas. Acta Endocrinol (Copenh). 1984 Mar;105(3):371-8.

ReferenceCitation: Simic-Ogrizovic S, Backus G, Mayer A, Vienken J, Djukanovic L, Kleophas W. The influence of different glucose concentrations in haemodialysis solutions on metabolism and blood pressure stability in diabetic patients. Int J Artif Organs. 2001 Dec;24(12):863-9.

ReferenceCitation: Biesenbach G, Raml A, Schmekal B, Eichbauer-Sturm G. Decreased insulin requirement in relation to GFR in nephropathic Type 1 and insulin-treated Type 2 diabetic patients. Diabet Med. 2003 Aug;20(8):642-5.

ReferenceCitation: Cano N. Bench-to-bedside review: glucose production from the kidney. Crit Care. 2002 Aug;6(4):317-21. Epub 2002 Jun 7. Review.

ReferenceCitation: Cersosimo E, Garlick P, Ferretti J. Renal substrate metabolism and gluconeogenesis during hypoglycemia in humans. Diabetes. 2000 Jul;49(7):1186-93.

ReferenceCitation: Abe M, Kaizu K, Matsumoto K. Evaluation of the hemodialysis-induced changes in plasma glucose and insulin concentrations in diabetic patients: comparison between the hemodialysis and non-hemodialysis days. Ther Apher Dial. 2007 Aug;11(4):288-95.

ReferenceCitation: Chujo K, Shima K, Tada H, Oohashi T, Minakuchi J, Kawashima S. Indicators for blood glucose control in diabetics with end-stage chronic renal disease: GHb vs. glycated albumin (GA). J Med Invest. 2006 Aug;53(3-4):223-8.

ReferenceCitation: Holmes G, Galitz L, Hu P, Lyness W. Pharmacokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment. Br J Clin Pharmacol. 2005 Nov;60(5):469-76.

ReferenceCitation: Rave K, Heise T, Pfützner A, Heinemann L, Sawicki PT. Impact of diabetic nephropathy on pharmacodynamic and Pharmacokinetic properties of insulin in type 1 diabetic patients. Diabetes Care. 2001 May;24(5):886-90.

ReferenceCitation: Morello CM. Pharmacokinetics and pharmacodynamics of insulin analogs in special populations with type 2 diabetes mellitus. Int J Gen Med. 2011;4:827-35. doi: 10.2147/IJGM.S26889. Epub 2011 Dec 12.

ReferenceCitation: Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007 May;9(3):418-27.

ReferenceCitation: Marshall J, Jennings P, Scott A, Fluck RJ, McIntyre CW. Glycemic control in diabetic CAPD patients assessed by continuous glucose monitoring system (CGMS). Kidney Int. 2003 Oct;64(4):1480-6.

ReferenceCitation: Tzamaloukas AH, Yuan ZY, Murata GH, Balaskas E, Avasthi PS, Oreopoulos DG. Clinical associations of glycemic control in diabetics on CAPD. Adv Perit Dial. 1993;9:291-4.

ReferenceCitation: Shurraw S, Hemmelgarn B, Lin M, Majumdar SR, Klarenbach S, Manns B, Bello A, James M, Turin TC, Tonelli M; Alberta Kidney Disease Network. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med. 2011 Nov 28;171(21):1920-7. doi: 10.1001/archinternmed.2011.537.

ReferenceCitation: Hendriksen KV, Jensen T, Oturai P, Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012 Jan;55(1):46-50. doi: 10.1007/s00125-011-2345-8. Epub 2011 Oct 16.

lead_sponsor: Centre Europeen d'Etude du Diabete

location_facility:
Sainte Anne Hospital
Regional Hospital of Mulhouse
Regional Hospital of Valenciennes
Regional Hospital of Colmar
University Hospital of Strasbourg


title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

summary: The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

lead_sponsor: EyeTechCare

location_facility:
Croix Rousse University Hospital
University Hospital
Michallon University Hospital
Huriez University Hospital
HIA - Val de Grace Hospital


title: Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration

acronym: CinBiCarn

summary: The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophies According to Fat Mass and Glucose Metabolism

summary: White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies) through aberrant distribution (lipodystrophies), these 3 different disorders being paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin resistance, low-grade fat inflammation and immune alterations are not perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to assess different cytokines, especially interleukin 7, and metabolic parameters as well as fat mass distribution with DEXA and RMN, in different models of fat distribution, including normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue bank will be constituted at the same time to improve our knowledge in disorders linking fat mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model of insulin resistance.

time_perspective: Cross-Sectional

ReferenceCitation: Lemaitre M, Chevalier B, Jannin A, Le Mapihan K, Boury S, Lion G, Labalette M, Vantyghem MC. Metabolic and immunological phenotype of rare lipomatoses: Dercum's disease and Roch-Leri mesosomatic lipomatosis. Orphanet J Rare Dis. 2021 Jun 29;16(1):290. doi: 10.1186/s13023-021-01920-3.

lead_sponsor: University Hospital, Lille

location_facility:
Lille University Hospital
Amiens University Hospital
Reims University Hospital
Caen University Hospital
Rouen University Hospital


acronym: CARLHA

title: Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'ouest/René Gauducheau

summary:
As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist.

The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.


title: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

acronym: SEWORRA

summary: To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

lead_sponsor: University Hospital, Rouen

location_facility:
Department of rheumatology
Department of Rheumatology CHG Elbeuf
Normandy
Department of Rheumatology
Department of Rheumatology, CHU de Caen


title: First in Man Safety Evaluation of the ART18Z Bioresorbable Stent for the Treatment of Single de Novo Lesion of a Native Coronary Artery.

summary: This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

lead_sponsor: Arterial Remodeling Technologies

location_facility:
Hôpital Haut Leveque
Polyclinique les Fleurs
Hôpital Européen Georges Pompidou
Hôpital Rangueil
Clinique Pasteur


title: Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors

summary:
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).

Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.

lead_sponsor: Nantes University Hospital

location_facility: Institut de Cancérologie de l'Ouest, René Gauducheau


title: Emergence of Resistance in Intestinal Microflora During Carbapenem Treatments

acronym: ERIC

summary: The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more common due to the increased prevalence in the hospital and community of extended spectrum β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure towards emergence of strains which are also resistant to carbapenems, placing patients in a catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake preventive measures to preserve their effectiveness. The aim of the study is to evaluate and describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.

ReferenceCitation: Grall N, Lazarevic V, Gaïa N, Couffignal C, Laouénan C, Ilic-Habensus E, Wieder I, Plesiat P, Angebault C, Bougnoux ME, Armand-Lefevre L, Andremont A, Duval X, Schrenzel J. Unexpected persistence of extended-spectrum β-lactamase-producing Enterobacteriaceae in the faecal microbiota of hospitalised patients treated with imipenem. Int J Antimicrob Agents. 2017 Jul;50(1):81-87. doi: 10.1016/j.ijantimicag.2017.02.018. Epub 2017 May 10.

location_facility:
Hôpital Beaujon
Hôpital Louis Mourier
Hôpital Bichat-Claude Bernard
Hôpital Saint-Louis
Hôpital Paul Brousse


title: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

acronym: MENT-APL-O

summary: The main objective of this study is to estimate the lifetime prevalence of major psychiatric disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV) in a large sample of patients with developed clinical signs of pure obstetrical antiphospholipid syndrome (suspected APS).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


acronym: CLEAN

summary:
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.

This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Mégarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

ReferenceCitation: Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.

ReferenceCitation: Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.

ReferenceCitation: Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.

ReferenceCitation: Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.

lead_sponsor: Poitiers University Hospital

location_facility:
Poitiers University Hospital
Estain University Hospital
Lyon University Hospital
Angers University Hospital
Bichat-Claude Bernard Hospital


title: A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.

ipd_sharing_description: IPD will not be shared at an individual level, those data will be part of the study database including all enrolled patients.

location_facility:
Centre Léon Berard
Centre Antoine Lacassagne
Centre Oscar Lambret
Institut Gustave Roussy
Institut Curie

summary: This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.


title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

summary: This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

ReferenceCitation: Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533.

lead_sponsor: Mead Johnson Nutrition

location_facility:
Hôpital Necker Enfants Malades
Centre médical
Médecine Infantile 1
Hôpital Armand Trousseau
Hôpital Saint Vincent de Paul


title: Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients.

acronym: USPIO-CIS

summary: While significant progress has been made on medical imagery in recent years in the individualization of different lesions in the nervous system for demyelination, axonal loss, atrophy, little progress has been made in the specific recognition the inflammatory process. Yet this point is essential since the currently available treatments have a partial impact mainly on the inflammatory component and that many uncertainties remain about the links between inflammation and tissue destruction affecting myelin and axons. The recent discovery of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the opportunity to answer important questions which one can sense that this could have a significant impact on therapeutic drug monitoring of these patients. This study will involve 50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from the earliest manifestations of the disease with clinical and MRI scheduled for the first 3 years of their disease.

ReferenceCitation: Crimi A, Commowick O, Maarouf A, Ferré JC, Bannier E, Tourbah A, Berry I, Ranjeva JP, Edan G, Barillot C. Predictive value of imaging markers at multiple sclerosis disease onset based on gadolinium- and USPIO-enhanced MRI and machine learning. PLoS One. 2014 Apr 1;9(4):e93024. doi: 10.1371/journal.pone.0093024. eCollection 2014.

location_facility:
Maison Blanche Hospital
Purpan Hospital
La Pitie-Salpaetriere Hospital (APHP)
La Timone University Hospital (APHM)
Rennes University Hospital


title: A Phase I/II Study Investigating the Combination of RAD001 and Rituximab in Patients With Non-Hodgkin's Lymphomas

summary:
This study is an open label, multicenter study with two phases:

Phase I is a dose escalation study of RAD001 in combination with one injection of Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). The purpose of the study is to assess the feasibility of the combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug interaction (DDI).
Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination at the RP2D in patients with lymphomas.

Patients with lymphomas will be treated at the RP2D established during phase I and evaluated for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR) and stable disease (SD), and time to progression using the IWG criteria for treatment response.

Induction therapy will follow the same schedule than during the phase I study.

Maintenance therapy: Monthly cycles for up to 2 years with:

Daily RAD001 at the same dose than during induction therapy.
Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual maintenance schedule for Rituximab.

Response to therapy will be assessed between day 42 and day 49, then every two months.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Service des Maladies du Sang - CHRU de Lille

location_facility: Service Hématologie - Hôtel Dieu de NANTES

location_facility: Service Hématologie - Centre Henri Becquerel

location_facility: Service Hématologie - Institut Gustave Roussy


title: A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies

summary: This study is an open label, multicenter study with a dose escalation of Asparec® administered once every two to four weeks for two administrations. The primary objective of this study is to determine the Maximum Tolerated Dose following one single dose of Asparec when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which are to evaluate the safety of Asparec and to determine the PK profile as assessed by measurement of plasma L-asparaginase enzymatic activity following single and repeated doses of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be measured.

lead_sponsor: Jazz Pharmaceuticals

location_facility:
Hôpital Henri Mondor
Hôpitaux du CHU de Nantes
Centre Henri Becquerel
Institut Claudius Regaud
Hospices Civils de Lyon


title: Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure

summary: This research project consists of a prospective diagnostic study conducted on patients with clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main objective of this study is to determine whether the plasma level of Neutrophil Gelatinase Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF) occurring within 48 hours after admission for rhabdomyolysis.

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière


title: Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates

acronym: OCN/PRF

summary: The main objective of our study is to assess, after tooth extraction, the efficacity of PRF in the prevention of healing delay and of jawbone osteochemonecrosis induced by bisphosphonates

ReferenceCitation: Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7:CD012432. doi: 10.1002/14651858.CD012432.pub3. Review.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
Chu de Reims
Scm Bally Curien
Chu de Dijon
Chu de Nancy
Chr Metz Thionville