title: Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Clinique Medico Chirurgicale Teissier Groupe

location_facility: Centre d'Oncologie et de Radiotherapie du Parc

location_facility: Polyclinique Du Parc Centre Maurice Tubiana

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre d'Oncologie et de Radiotherapie de Chaumont le Bois


title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

status: Unknown status

study_type: Interventional

primary_purpose: Treatment

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hopital d'Instruction des Armes Sainte-Anne

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospital General Robert Ballanger

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.

ReferenceType: result

ReferenceCitation: Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andre T, Zaniboni A, Ducreux M, Aitini E, Taieb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. doi: 10.1200/JCO.2005.06.023.


type: EudraCT Number

title: Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

acronym: D-COG

summary: As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Tours

location_facility: CHU BREST - Hôpital de la Cavale Blanche

lead_sponsor_type: academique

status_simplified: Completed


acronym: ADEQUATEartère

summary: The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.

sponsor_collaborators:
University Hospital, Tours
Astellas Pharma Inc

location_facility:
HEGP
CHU de Caen
CHU de Clermont-Ferrand
CHU de Toulouse
CHU de Strasbourg
CHU de Angers
CHRU de Tours
CHU de Rennes
CHU de Rouen
Necker
CHU de Amiens

title: Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients

source: euctr

enrollment_type: Anticipated

study_completion_date_type: Anticipated


type: Other Identifier

title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial

summary:
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.

The secondary objectives are the following:

assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
assess the improvement of exercise capacity by tests used in medical practice
assess the correlation between daily activity and exercise capacity
assess the improvement of dyspnea
assess the improvement of quality of life and psychological state

status: Terminated

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Wallaert B, Kyheng M, Labreuche J, Stelianides S, Wemeau L, Grosbois JM. Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial. Respir Med Res. 2020 Mar;77:1-7. doi: 10.1016/j.resmer.2019.10.003. Epub 2019 Oct 28.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility: Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

location_facility: Clinique des Voies Respiratoires, Hôpital Larrey

location_facility: Service de pneumologie, Hôpital Avicenne AP-HP

location_facility: Service de Pneumologie, Hôpital Victor Provo

location_facility: Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice

location_facility: Clinique des Maladies Respiratoires, CHRU de LILLE

intervention_type: Other


title: Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery

acronym: MESURE

summary:
The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.

The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.

Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.

The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.

In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.

The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.

Eleven French tertiary referral centres will enrol patients in the trial.

lead_sponsor: University Hospital, Rouen

location_facility: Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac

location_facility: Service de Gynécologie-Obstétrique CHU de NIMES

location_facility: Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE


acronym: COMARIS

summary: The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

location_facility: Médecine polyvalente, CH de SAINT NAZAIRE

title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)


title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

summary: In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Centre Hospitalier Universitaire d'Angers

intervention_type: Device


title: Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery

summary: The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Gregoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Strasbourg hospital
Lyon Hospital
Marseille Hospital
Beaujon University Hospital
Gustave Roussy institute
Saint Antoine Hospital
Bordeaux Hospital
Amiens North Hospital
Paul Brousse Hospital
Paoli calmette institute
Lille Regional Hospital

intervention_type: Procedure


acronym: TRIOCAPI

lead_sponsor: Nantes University Hospital

summary: Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

ReferenceCitation: Roze JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

version: submittedVersion

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12(12):CD013278. doi: 10.1002/14651858.CD013278.pub2.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: University Hospital (AP-HP Groupe hospitalier)

title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)


title: Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

acronym: CONSTIMOD

summary: Subjects with refractory chronic constipation are offered two conventional therapeutic strategies: either medical treatment, either surgery (in the case of medication failure). Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the sacral nerve modulation. This procedure consists in stimulating the nerves which control the contractions of the colon and so the defecation phenomenon. Several open trials have suggested that sacral nerve modulation may be effective in reducing constipation and related symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral nerve stimulation in patients with constipation.

ReferenceCitation: Zerbib F, Siproudhis L, Lehur PA, Germain C, Mion F, Leroi AM, Coffin B, Le Sidaner A, Vitton V, Bouyssou-Cellier C, Chene G; CONSTIMOD study investigators. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. 2017 Feb;104(3):205-213. doi: 10.1002/bjs.10326. Epub 2016 Oct 25.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Paris Observatory

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'hépato-gastroentérologie et oncologie digestive

location_facility: Service de gastroentérologie - hopital nord -AP-HM

location_facility: : Clinique de chirurgie digestive et endocrinienne. Institut des Maladies de l'Appareil Digestif (IMAD

location_facility: Service de physiologie digestive, urinaire, respiratoire et sportive - CHU de rouen

location_facility: Service d'hépato-gastroentérologie - CHU estaing

location_facility: Service d'hépato-gastroentérologie et explorations fonctionnelles digestives - CHU de Tours

location_facility: Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon

location_facility: Service de Chirurgie générale - CHU de Grenoble


title: A Phase III Randomized, Multicenter, Two Arms Double-blind Trial Versus Placebo, Evaluating the Interest of a Dietary Supplementation With Docosahexaenoic Acid (DHA) During Chemotherapy for Metastatic Breast Cancer

acronym: DHALYA

summary: The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).

primary_purpose: Supportive Care

sponsor_collaborators:
University Hospital, Tours
Institut Cancerologie de l'Ouest

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Institut de Cancérologie de l'Ouest (ICO)

intervention_type: Dietary Supplement


acronym: PREDICTOR

lead_sponsor: UNICANCER

summary: The purpose of this study is to identify predictive and pharmacodynamic biomarkers of activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head and neck squamous cell carcinoma patients

location_facility: Institut de cancérologie de l'Ouest - Site René Gauducheau

location_facility: Institut de cancérologie de l'Ouest - Site Paul Papin

title: Multi-centric Randomized Phase II Study of Pre-operative Afatinib (BIBW2992) Aiming at Identifying Predictive and Pharmacodynamic Biomarkers of Biological Activity and Efficacy in Untreated Non-metastatic Head and Neck Squamous Cell Carcinoma Patients


title: A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Rituximab-Aracytine High Dose-Dexamethasone (T-R-DHA) for the Treatment of Patients in Relapsed/Refractory Mantle Cell Lymphoma

acronym: T³

summary:
This is a multicenter, open label, three arms, Phase IB study.

A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL):

Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks for 6 cycles,
Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,
Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6 cycles.

design_allocation: Non-Randomized

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Groupe hospitalier Sud Hôpital Haut-Lévêque


title: Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

summary: The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

ReferenceCitation: Canis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8.

lead_sponsor: Medtronic - MITG

sponsor_collaborators:
Medtronic - MITG
Registrat-Mapi

location_facility: Béclère Hospital (Public Assistance of Paris Hospital)

location_facility: TROUSSEAU Hospital (Public Assistance of Paris Hospital)

location_facility: Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)

location_facility: TENON Hospital (Public Assistance of Paris Hospital)


title: Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up

acronym: PRNC

summary: Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because disease may generate important disability in patients including young adults. Randomized trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg) can reduce impairment on a short term period but the treatment of a chronic disease doesn't agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits to demonstrate the superiority of one treatment to the other. Long term adverse effects of corticosteroids and IVIg cost are the respective limitation of their use. The investigators scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6 months. Patients will be followed during 6 months after the treatment.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
Chu Marseille
Chu Nantes
CHU Grenoble
Chu Saint-Etienne
Centre hospitalier de Valence
CHU Nice
CHU Clermont-Ferrand
Chu Nancy
Chu Dijon
Chu Strasbourg
Hôpital Neurologique de Lyon


title: Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

acronym: EMS-Dialyse

summary:
Sport improves quality of life and health, decreasing cardiovascular risks and increasing effort tolerance. Chronic renal failure (CRF) induces many clinical and biological complications leading to less effort tolerance (strength and endurance). Renal failure patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA), diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions. Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order to counteract this, sport should be encourage in this specific hemodialysis population.

The aim of this study is to evaluate electrostimulation program during dialysis sessions for 3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).

Secondary aims will be evaluated:

Muscular strength and quadriceps diameter
Equilibrium
Quality of life.
Strength developed during maximal exercise test in a subgroup (patient undergoing dialysis in Rennes center, about 40% of the total population)
Nutritional intakes (quantitative and qualitative evaluation)

ReferenceCitation: Besnier F, Laruelle E, Genestier S, Gie S, Vigneau C, Carre F. [Effects of exercise training on ergocycle during hemodialysis in patients with end stage renal disease: relevance of the anaerobic threshold intensity]. Nephrol Ther. 2012 Jul;8(4):231-7. doi: 10.1016/j.nephro.2011.10.002. Epub 2011 Nov 18. French.

lead_sponsor: Rennes University Hospital

location_facility:
Nantes University Hospital
AUB Santé Montgermont
AUB Santé Rennes
ECHO Nantes
Cholet Hospital
AUB Santé Quimper
Rennes University Hospital
AUB Santé Fougères
AUB Santé Brest
AUB Santé Morlaix
AUB Santé Lorient


acronym: PROTOX

summary:
BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that are not fully elucidated. It is the same for symptomatology and urodynamic obstruction without clear identification of the part which is due to static phenomena (volume increase) and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and the difficulty of therapeutic indications between monitoring, medical treatment, and surgical operation. Experimental studies of BONT-A intra prostatic injection on animal and human models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the number of adrenergic α1 receptors.

Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.

PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A injection in the treatment of symptomatic BPH.

ReferenceCitation: Costa P, Ben Naoum K, Boukaram M, Wagner L, Louis JF. [Benign prostatic hyperplasia (BPH): prevalence in general practice and practical approach of French general practitioners. Results of a study based on 17,953 patients]. Prog Urol. 2004 Feb;14(1):33-9. French.

ReferenceCitation: Rhodes PR, Krogh RH, Bruskewitz RC. Impact of drug therapy on benign prostatic hyperplasia-specific quality of life. Urology. 1999 Jun;53(6):1090-8. doi: 10.1016/s0090-4295(99)00041-2.

ReferenceCitation: Isaacs JT, Coffey DS. Etiology and disease process of benign prostatic hyperplasia. Prostate Suppl. 1989;2:33-50. doi: 10.1002/pros.2990150506.

ReferenceCitation: Chute CG, Stephenson WP, Guess HA, Lieber M. Benign prostatic hyperplasia: a population-based study. Eur Urol. 1991;20 Suppl 1:11-7. doi: 10.1159/000471739.

ReferenceCitation: McConnell JD. The pathophysiology of benign prostatic hyperplasia. J Androl. 1991 Nov-Dec;12(6):356-63.

ReferenceCitation: Barrack ER, Bujnovszky P, Walsh PC. Subcellular distribution of androgen receptors in human normal, benign hyperplastic, and malignant prostatic tissues: characterization of nuclear salt-resistant receptors. Cancer Res. 1983 Mar;43(3):1107-16.

ReferenceCitation: Marcelli M, Shao TC, Li X, Yin H, Marani M, Denner L, Teng B, Cunningham GR. Induction of apoptosis in BPH stromal cells by adenoviral-mediated overexpression of caspase-7. J Urol. 2000 Aug;164(2):518-25.

ReferenceCitation: Colombel M, Vacherot F, Diez SG, Fontaine E, Buttyan R, Chopin D. Zonal variation of apoptosis and proliferation in the normal prostate and in benign prostatic hyperplasia. Br J Urol. 1998 Sep;82(3):380-5. doi: 10.1046/j.1464-410x.1998.00752.x.

ReferenceCitation: Radlmaier A, Eickenberg HU, Fletcher MS, Fourcade RO, Reis Santos JM, van Aubel OG, Bono AV. Estrogen reduction by aromatase inhibition for benign prostatic hyperplasia: results of a double-blind, placebo-controlled, randomized clinical trial using two doses of the aromatase-inhibitor atamestane. Atamestane Study Group. Prostate. 1996 Oct;29(4):199-208. doi: 10.1002/(SICI)1097-0045(199610)29:43.0.CO;2-7.

ReferenceCitation: Frick J. [Pathophysiology of benign prostatic hyperplasia]. Wien Med Wochenschr. 1996;146(8):158-60. German.

ReferenceCitation: Hieble JP, Boyce AJ, Caine M. Comparison of the alpha-adrenoceptor characteristics in human and canine prostate. Fed Proc. 1986 Oct;45(11):2609-14.

ReferenceCitation: Hieble JP, Ruffolo RR Jr. The use of alpha-adrenoceptor antagonists in the pharmacological management of benign prostatic hypertrophy: an overview. Pharmacol Res. 1996 Mar;33(3):145-60. doi: 10.1006/phrs.1996.0022.

ReferenceCitation: Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54. doi: 10.1016/j.eururo.2004.07.016.

ReferenceCitation: Wilt TJ, Ishani A, Rutks I, MacDonald R. Phytotherapy for benign prostatic hyperplasia. Public Health Nutr. 2000 Dec;3(4A):459-72. doi: 10.1017/s1368980000000549.

ReferenceCitation: Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604. Erratum In: JAMA 1999 Feb 10;281(6):515.

ReferenceCitation: Zhu YS, Imperato-McGinley JL. 5alpha-reductase isozymes and androgen actions in the prostate. Ann N Y Acad Sci. 2009 Feb;1155:43-56. doi: 10.1111/j.1749-6632.2009.04115.x.

ReferenceCitation: Crawford ED, Wilson SS, McConnell JD, Slawin KM, Lieber MC, Smith JA, Meehan AG, Bautista OM, Noble WR, Kusek JW, Nyberg LM, Roehrborn CG; MTOPS RESEARCH Group. Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol. 2006 Apr;175(4):1422-6; discussion 1426-7. doi: 10.1016/S0022-5347(05)00708-1.

ReferenceCitation: Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology. 1996 Sep;48(3):398-405. doi: 10.1016/s0090-4295(96)00353-6.

ReferenceCitation: Desgrandchamps F. [Combination therapy in benign prostatic hyperplasia (BPH)]. Ann Urol (Paris). 2004 Dec;38 Suppl 2:S24-8. doi: 10.1016/s0003-4401(04)80003-2. French.

ReferenceCitation: Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.

ReferenceCitation: Robert G, Descazeaud A, Karsenty G, Saussine C, Azzouzi AR, de la Taille A, Desgrandchamps F, Faix A, Fourmarier M, Georget A, Benard A, Barry Delongchamps N. Prostatic injection of botulinum toxin is not inferior to optimized medical therapy in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a randomized clinical trial. World J Urol. 2018 Jun;36(6):921-929. doi: 10.1007/s00345-018-2193-y. Epub 2018 Jan 30.

publisher_dissemination: Springer-Nature

location_facility: Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux

location_facility: Service d'urologie - Hôpital de la Conception - 147 boulevard Baille

location_facility: Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques

location_facility: Service d'urologie - CHRU Strasbourg - BP 426

location_facility: Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris

location_facility: Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny

location_facility: Service d'Urologie, CHU d'Angers 4, rue Larrey

location_facility: Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon

location_facility: Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King

location_facility: Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet

title: Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.


title: Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.

acronym: M-RIC

summary: The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.

lead_sponsor: Clinique Clementville

location_facility: Groupe Hospitalier Mutualiste Clinique les Eaux Claires


title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil on Demand Compared to Sildenafil Citrate on Demand on Treatment Discontinuation in Patients With Erectile Dysfunction Who Are naïve to PDE5 Inhibitors

summary: The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

ReferenceCitation: Buvat J, Buttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Portugal
United Kingdom
Romania
Spain
Greece
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

acronym: Resova

summary: The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up …) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.

location_facility: CRLC de Bourgogne Georges François Leclerc

location_facility: Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

location_facility: Centre de Lutte Contre le Cancer Léon Bérard


title: Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

acronym: COLT

summary: Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins are implicated in this process, which have never been studied prospectively in a multicentric longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist in a large database, associated with a recipient bio-collection, and specific projects using these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation. Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum, bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be also taken. T cells, known to be involved in chronic rejection will be studied, and genomic, microarray and proteomic approaches will be used to detect further predictive factors. A study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also realised from blood samples. COLT will prove molecular markers to be predictive of early OB, before the development of severe airway obstruction and will allow the identification of patients at high risk of OB. COLT will identify potential targets for future treatments of OB. This collaborative project makes research and clinical teams working together, and creates the conditions of a long term network, extendable to other laboratories with new projects and additional European transplant centres.

ReferenceCitation: Durand M, Lacoste P, Danger R, Jacquemont L, Brosseau C, Durand E, Tilly G, Loy J, Foureau A, Royer PJ, Tissot A, Roux A, Reynaud-Gaubert M, Kessler R, Mussot S, Dromer C, Brugiere O, Mornex JF, Guillemain R, Claustre J, Degauque N, Magnan A, Brouard S; COLT and SysCLAD Consortia. High circulating CD4+CD25hiFOXP3+ T-cell sub-population early after lung transplantation is associated with development of bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2018 Jun;37(6):770-781. doi: 10.1016/j.healun.2018.01.1306. Epub 2018 Mar 20.

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Artxiker

repositories: HAL univOAK

repositories_concat: HAL;univOAK

ReferenceCitation: Benmerad M, Slama R, Botturi K, Claustre J, Roux A, Sage E, Reynaud-Gaubert M, Gomez C, Kessler R, Brugiere O, Mornex JF, Mussot S, Dahan M, Boussaud V, Danner-Boucher I, Dromer C, Knoop C, Auffray A, Lepeule J, Malherbe L, Meleux F, Nicod L, Magnan A, Pison C, Siroux V; SysCLAD consortium. Chronic effects of air pollution on lung function after lung transplantation in the Systems prediction of Chronic Lung Allograft Dysfunction (SysCLAD) study. Eur Respir J. 2017 Jan 18;49(1):1600206. doi: 10.1183/13993003.00206-2016. Print 2017 Jan.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ReferenceCitation: Pison C, Magnan A, Botturi K, Seve M, Brouard S, Marsland BJ, Ernst F, Paprotka T, Deplanche K, Fritz A, Siroux V, Boissel JP, Corris PA, Auffray C, Nicod LP; SysCLAD consortium. Prediction of chronic lung allograft dysfunction: a systems medicine challenge. Eur Respir J. 2014 Mar;43(3):689-93. doi: 10.1183/09031936.00161313. No abstract available.

repository_normalized: CiteSeerX

repositories_concat: CiteSeerX

location_facility:
HEGP
CHU Nantes
CHU de Lyon
Hôpital Foch
Centre Chirurgical Marie Lannelongue
CHRU de Strasbourg
CHU de Toulouse
Hôpital Bichat
CHU de Grenoble
CHU de Marseille
CHU de Bordeaux


title: Phase II Multicenter Study Evaluating the Efficacy of Carboplatin-Etoposide Combination in Hormone-resistant Prostate Cancers With Neuroendocrine Differentiation.

summary: The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate cancer and neuro-endocrine differentiation. Eligible patients are treated with the combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater decrease from baseline serum values), objective response rate (according to RECIST criteria), and toxicity.

ReferenceCitation: Aumuller G, Leonhardt M, Janssen M, Konrad L, Bjartell A, Abrahamsson PA. Neurogenic origin of human prostate endocrine cells. Urology. 1999 May;53(5):1041-8. doi: 10.1016/s0090-4295(98)00631-1.

ReferenceCitation: Bonkhoff H, Stein U, Remberger K. Endocrine-paracrine cell types in the prostate and prostatic adenocarcinoma are postmitotic cells. Hum Pathol. 1995 Feb;26(2):167-70. doi: 10.1016/0046-8177(95)90033-0.

ReferenceCitation: Krijnen JL, Janssen PJ, Ruizeveld de Winter JA, van Krimpen H, Schroder FH, van der Kwast TH. Do neuroendocrine cells in human prostate cancer express androgen receptor? Histochemistry. 1993 Nov;100(5):393-8. doi: 10.1007/BF00268938.

ReferenceCitation: Hansson J, Abrahamsson PA. Neuroendocrine pathogenesis in adenocarcinoma of the prostate. Ann Oncol. 2001;12 Suppl 2:S145-52. doi: 10.1093/annonc/12.suppl_2.s145.

ReferenceCitation: Abrahamsson PA. Neuroendocrine differentiation in prostatic carcinoma. Prostate. 1999 May;39(2):135-48. doi: 10.1002/(sici)1097-0045(19990501)39:23.0.co;2-s.

ReferenceCitation: Oesterling JE, Hauzeur CG, Farrow GM. Small cell anaplastic carcinoma of the prostate: a clinical, pathological and immunohistological study of 27 patients. J Urol. 1992 Mar;147(3 Pt 2):804-7. doi: 10.1016/s0022-5347(17)37390-1.

ReferenceCitation: Kreis W. Current chemotherapy and future directions in research for the treatment of advanced hormone-refractory prostate cancer. Cancer Invest. 1995;13(3):296-312. doi: 10.3109/07357909509094465. No abstract available.

ReferenceCitation: Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, Armitage GR, Wilson JJ, Venner PM, Coppin CM, Murphy KC. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol. 1996 Jun;14(6):1756-64. doi: 10.1200/JCO.1996.14.6.1756.

ReferenceCitation: Moore MJ, Osoba D, Murphy K, Tannock IF, Armitage A, Findlay B, Coppin C, Neville A, Venner P, Wilson J. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol. 1994 Apr;12(4):689-94. doi: 10.1200/JCO.1994.12.4.689.

ReferenceCitation: Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748.

ReferenceCitation: Chatelut E, Canal P, Brunner V, Chevreau C, Pujol A, Boneu A, Roche H, Houin G, Bugat R. Prediction of carboplatin clearance from standard morphological and biological patient characteristics. J Natl Cancer Inst. 1995 Apr 19;87(8):573-80. doi: 10.1093/jnci/87.8.573.

ReferenceCitation: Maksymiuk AW, Jett JR, Earle JD, Su JQ, Diegert FA, Mailliard JA, Kardinal CG, Krook JE, Veeder MH, Wiesenfeld M, et al. Sequencing and schedule effects of cisplatin plus etoposide in small-cell lung cancer: results of a North Central Cancer Treatment Group randomized clinical trial. J Clin Oncol. 1994 Jan;12(1):70-6. doi: 10.1200/JCO.1994.12.1.70.

ReferenceCitation: Loehrer PJ Sr, Ansari R, Gonin R, Monaco F, Fisher W, Sandler A, Einhorn LH. Cisplatin plus etoposide with and without ifosfamide in extensive small-cell lung cancer: a Hoosier Oncology Group study. J Clin Oncol. 1995 Oct;13(10):2594-9. doi: 10.1200/JCO.1995.13.10.2594.

ReferenceCitation: Miller AA, Herndon JE 2nd, Hollis DR, Ellerton J, Langleben A, Richards F 2nd, Green MR. Schedule dependency of 21-day oral versus 3-day intravenous etoposide in combination with intravenous cisplatin in extensive-stage small-cell lung cancer: a randomized phase III study of the Cancer and Leukemia Group B. J Clin Oncol. 1995 Aug;13(8):1871-9. doi: 10.1200/JCO.1995.13.8.1871.

ReferenceCitation: Larive S, Bombaron P, Riou R, Fournel P, Perol M, Lena H, Dussopt C, Philip-Joet F, Touraine F, Lecaer H, Souquet PJ; Groupe Lyon-Saint Etienne d'Oncologie Thoracique. Carboplatin-etoposide combination in small cell lung cancer patients older than 70 years: a phase II trial. Lung Cancer. 2002 Jan;35(1):1-7. doi: 10.1016/s0169-5002(01)00288-4.

ReferenceCitation: Okamoto H, Watanabe K, Nishiwaki Y, Mori K, Kurita Y, Hayashi I, Masutani M, Nakata K, Tsuchiya S, Isobe H, Saijo N. Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standard-dose intravenous etoposide in elderly patients with small-cell lung cancer. J Clin Oncol. 1999 Nov;17(11):3540-5. doi: 10.1200/JCO.1999.17.11.3540.

ReferenceCitation: Quoix E, Breton JL, Daniel C, Jacoulet P, Debieuvre D, Paillot N, Kessler R, Moreau L, Coetmeur D, Lemarie E, Milleron B. Etoposide phosphate with carboplatin in the treatment of elderly patients with small-cell lung cancer: a phase II study. Ann Oncol. 2001 Jul;12(7):957-62. doi: 10.1023/a:1011171722175.

ReferenceCitation: Papandreou CN, Daliani DD, Thall PF, Tu SM, Wang X, Reyes A, Troncoso P, Logothetis CJ. Results of a phase II study with doxorubicin, etoposide, and cisplatin in patients with fully characterized small-cell carcinoma of the prostate. J Clin Oncol. 2002 Jul 15;20(14):3072-80. doi: 10.1200/JCO.2002.12.065.

ReferenceCitation: Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

ReferenceCitation: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-81, 1958

ReferenceCitation: Flechon A, Pouessel D, Ferlay C, Perol D, Beuzeboc P, Gravis G, Joly F, Oudard S, Deplanque G, Zanetta S, Fargeot P, Priou F, Droz JP, Culine S. Phase II study of carboplatin and etoposide in patients with anaplastic progressive metastatic castration-resistant prostate cancer (mCRPC) with or without neuroendocrine differentiation: results of the French Genito-Urinary Tumor Group (GETUG) P01 trial. Ann Oncol. 2011 Nov;22(11):2476-2481. doi: 10.1093/annonc/mdr004. Epub 2011 Mar 24.

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Départemental Les Oudairies


title: "Comparision of Diagnostic Value of Oesophagal Videocapsul (VCO) and Oeso-gastro-duodenal Fiber Endoscopy (OGDFE) for the Screening of Oesophagal Varix (OV) for Cirrhotic Patients

acronym: VCO-VO

summary: The purpose of this study is to determine the equivalence or not of diagnosis ability of oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of oesophagal varix.

primary_purpose: Diagnostic

ReferenceCitation: Cales P, Sacher-Huvelin S, Valla D, Bureau C, Olivier A, Oberti F, Boursier J, Galmiche JP; multicenter group VO-VCO. Large oesophageal varice screening by a sequential algorithm using a cirrhosis blood test and optionally capsule endoscopy. Liver Int. 2018 Jan;38(1):84-93. doi: 10.1111/liv.13497. Epub 2017 Jul 7.

ReferenceCitation: Sacher-Huvelin S, Cales P, Bureau C, Valla D, Vinel JP, Duburque C, Attar A, Archambeaud I, Benamouzig R, Gaudric M, Luet D, Couzigou P, Planche L, Galmiche JP, Coron E. Screening of esophageal varices by esophageal capsule endoscopy: results of a French multicenter prospective study. Endoscopy. 2015 Jun;47(6):486-92. doi: 10.1055/s-0034-1391393. Epub 2015 Mar 2.

publisher_dissemination: Georg Thieme

location_facility:
CH Saint Philibert
CHU Nantes
CH Avicenne
CHU Toulouse - Purpan
CH Beaujon
CH Lyon - Herriot
CH Cochin
CHU Bordeaux
CHU Strasbourg
CHU Angers
Hôpital la conception


intervention_type: Biological

acronym: MenACWY-TT-081 PRI

lead_sponsor: GlaxoSmithKline

summary: The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

ReferenceCitation: Knuf M, Romain O, Kindler K, Walther U, Tran PM, Pankow-Culot H, Fischbach T, Kieninger-Baum D, Bianco V, Baine Y, Miller J. Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 2013 May;172(5):601-12. doi: 10.1007/s00431-012-1924-0. Epub 2013 Jan 11.

title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country: Germany France

ipd_sharing: Yes


title: ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

acronym: PREPACOL

summary: The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

ReferenceCitation: Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Purpan
Hopital Nord
Institut Paoli Calmette
CHU
Hopital Saint André
CHRU Trousseau
Hôpital Beaujon
Hopital Cochin
Hopital Ambroise Paré
CRLC Val d'Aurelle


title: Injection of Concentrated Autologous Bone-marrow (IMOCA) and Bone Union of Open Tibial Shaft Fracture: Randomized Study to Assess Efficiency of IMOCA in Addition to Standard of Care.

acronym: IMOCA

summary:
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention.

In a prospective, randomized, controlled, single-blind study, 186 patients with an open tibial will be randomized to receive either the standard of care (fixation by nail or external fixator and routine soft-tissue management), or the standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow. Randomization will be stratified by severity of the open wound. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post-fracture.

lead_sponsor: University Hospital, Tours

location_facility:
UH Grenoble South Hospital
UH Tours CHRU Trousseau
UH Grenoble Michallon Hospital
UHTOURS
UH Nancy Central Hospital
UH Besançon Jean Minjoz
UH Pitié Salpétrière AH HP
UH Angers
UH Nantes Hôtel Dieu
UH Brest Cavale Blanche
UH Clermont Ferrand Gabriel Montpied


title: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

acronym: RIT in MTC

summary: Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)

location_facility:
hôpital du Cluzeau
Hôpital de la timone
CHU
Centre René Huguenin
Centre Claudius Régaud
CHU de Grenoble
Centre Paul Strauss
Centre François Baclesse
Centre René Gauducheau


title: Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome

summary: The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

ReferenceCitation: Honore S, Attalah HL, Azoulay E, Soussy CJ, Saudubray F, Harf A, Brochard L, Delclaux C. Beneficial effect of an inhibitor of leukocyte elastase (EPI-hNE-4) in presence of repeated lung injuries. Shock. 2004 Aug;22(2):131-6. doi: 10.1097/01.shk.0000126861.77543.d0.

lead_sponsor: Debiopharm International SA

location_country: Italy Tunisia Spain France

location_facility:
Laurent Brochard
Jean-François Timsit
Jean-Daniel Chiche
Jordi Mancebo D.
Jean-Michel Arnal
Jean-Yves Fagon
Samir Jaber
Claude Guerin
Alain Mercat
Fekri Abroug
Yves Castaing
Jean-Jacques Rouby
Massimo Antonelli
Jean-Christophe Richard


title: Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

summary: We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

ReferenceCitation: Ades L, Boehrer S, Prebet T, Beyne-Rauzy O, Legros L, Ravoet C, Dreyfus F, Stamatoullas A, Chaury MP, Delaunay J, Laurent G, Vey N, Burcheri S, Mbida RM, Hoarau N, Gardin C, Fenaux P. Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study. Blood. 2009 Apr 23;113(17):3947-52. doi: 10.1182/blood-2008-08-175778. Epub 2008 Nov 5.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hopital Jean-Bernard
Hopital Hotel Dieu
Hopital Archet
CHRU Hurriez
CHU Brabois
Hoiptal St Louis
Centre Henry Becquerel
Hopital Paoli Calmette
Chu Purpan
Hopital Cochin
CHU Angers


title: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer

summary: The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.

ReferenceCitation: Quoix E, Ramlau R, Westeel V, Papai Z, Madroszyk A, Riviere A, Koralewski P, Breton JL, Stoelben E, Braun D, Debieuvre D, Lena H, Buyse M, Chenard MP, Acres B, Lacoste G, Bastien B, Tavernaro A, Bizouarne N, Bonnefoy JY, Limacher JM. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol. 2011 Nov;12(12):1125-33. doi: 10.1016/S1470-2045(11)70259-5. Epub 2011 Oct 21.

lead_sponsor: Transgene

location_country: Germany Hungary Poland France

location_facility: Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie

location_facility: Hôpital Lyautey - Service de Pneumologie

location_facility: Centre Hospitalier Général, Service de Pneumologie

location_facility: Institut Paoli-Calmettes, Service d'oncologie médicale

location_facility: Klinikum Offenburg, Medizinische Klinik II

location_facility: Asklepios Fachkliniken, Zentrum für Pneumonologie

location_facility: Hôpital Pasteur - Service de médecine F- Pavillon 43


title: Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Moureau-Zabotto L, Phelip JM, Afchain P, Mineur L, Andre T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.

ReferenceCitation: Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)

summary: The purpose of the study is to assess the sensibility of the ISL questionnaire.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin

summary: The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Val d'aurelle
CHU Grenoble
Centre Léon Bérard
Institut Paoli Calmette
Institut Bergonie
Institut Claudius Regaud
Centre Paul Papin
Centre Eugène Marquis
Centre Médico-Chirurgical Foch
Centre François Baclesse
Institut Curie


title: APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation

summary: Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Hoffmann-La Roche


title: Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

summary: Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

ReferenceCitation: Cadranel J, Lavole A, Gounant V, Wislez M. [Bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features: a clinico-pathological spectrum]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S165-70. French.

ReferenceCitation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. doi: 10.1378/chest.123.6.1868.

ReferenceCitation: Garfield DH, Cadranel JL, Wislez M, Franklin WA, Hirsch FR. The bronchioloalveolar carcinoma and peripheral adenocarcinoma spectrum of diseases. J Thorac Oncol. 2006 May;1(4):344-59. Erratum In: J Thorac Oncol. 2006 Jun;1(5):405.

ReferenceCitation: Cadranel J, Quoix E, Baudrin L, Mourlanette P, Moro-Sibilot D, Morere JF, Souquet PJ, Soria JC, Morin F, Milleron B; IFCT-0401 Trial Group. IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. J Thorac Oncol. 2009 Sep;4(9):1126-35. doi: 10.1097/JTO.0b013e3181abeb5d.

ReferenceCitation: Wislez M, Antoine M, Baudrin L, Poulot V, Neuville A, Pradere M, Longchampt E, Isaac-Sibille S, Lebitasy MP, Cadranel J. Non-mucinous and mucinous subtypes of adenocarcinoma with bronchioloalveolar carcinoma features differ by biomarker expression and in the response to gefitinib. Lung Cancer. 2010 May;68(2):185-91. doi: 10.1016/j.lungcan.2009.05.021. Epub 2009 Jul 5.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: APHP - CHU Avicenne - Oncologie Medicale


title: First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

location_country: Monaco France

location_facility: Centre Hospitalier Regional Metz Thionville


title: Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.

ReferenceCitation: Bensadoun RJ, Benezery K, Dassonville O, Magne N, Poissonnet G, Ramaioli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Gery B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):983-94. doi: 10.1016/j.ijrobp.2005.09.041. Epub 2006 Jan 10.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial

acronym: HiFloWEAN

summary:
High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.

The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.

This is a open-label multicentre randomised controlled trial conducted in two parallel groups.

The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.

The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

location_facility: Intensive care unit, University Hospital, Bourg-en-Bresse

location_facility: Intensive care, University Hospital, Cholet

location_facility: Intensive care unit, University Hospital, Vannes

location_facility: Intensive care, University Hospital, Chartres

location_facility: Intensive care, University Hospital, Bourges

location_facility: Intensive care, University Hospital, Orléans

location_facility: Intensive care, University Hospital, Tours

location_facility: Intensive care, University Hospital, Le Mans,

location_facility: Intensive care, University Hospital, Dax

location_facility: Intensive care, University Hospital, Blois

status_simplified: Ongoing


title: Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

acronym: STIMU'HIS

summary:
This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique.

There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker.

Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).

status: Recruiting

lead_sponsor: University Hospital, Rouen

location_facility:
Clinique Saint Hilaire
CHI Elbeuf
CH Le Havre
CHU Rennes
Rouen University Hospital
CHU Sud Réunion
CHU Caen
Groupe Hospitalier La Rochelle Ré-Aunis
CHU Lille
Hôpital Saint Philibert


title: Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y

acronym: CAPSAPED

summary:
This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery.

It is a multicentric randomized controlled superiority trial in parallel arms :

experimental arm: Capsaicin 8% cutaneous patch
controlled arm : Hydrocolloid dressing

Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed.

Tolerance is assessed during each application and by phone call in following days until stop of cold need.

Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU d'Amiens
CHU de Marseille
CHU de Lyon
CHU de Toulouse
CHU de Brest
CHU d'Angers
CHU de Montpellier
Institut Gustave Roussy
CHU de Nantes
CHU de Bordeaux


title: Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study

acronym: EPIC-VT

summary:
Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.

First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.

For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.

The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques

location_facility: Hôpital Universitaire La Pitié-Salpêtrière - Paris

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?

summary:
Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody.

It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Limoges - Hôpital Dupuytren
CHRU de Nancy
APHP - Kremlin-Bicêtre
CHU Toulouse
CHU Nice
HCL- Croix Rousse
CHU Saint-Etienne
CHRU Strasbourg
CHU Dijon
Clinique Monticelli-Vélodrome


title: Response Profiles to High-concentration Capsaicin Desensitization in Patients With Peripheral Neuropathic Pain With or Without Allodynia: a Regional Multicenter Prospective Cohort

acronym: CAPSICAURA

summary: Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Hospices Civils de Lyon, Hôpital Pierre Wertheimer

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hospices Civils de Lyon, Hôpital de la Croix Rousse

location_facility: Clinique Mutualiste Chirurgicale de Saint Etienne

location_facility: Centre Hospitalier Universitaire Grenoble-Alpes

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

summary: This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients

lead_sponsor: MaaT Pharma

location_facility:
Hôpital Haut-Lévêque
CHU Rennes - Hôpital Pontchaillou
IUCT Toulouse
CHU Grenoble
CHU Angers
Universitätsklinikum Ulm
CHU Caen
Universitätsklinikum Bonn
CHU St Etienne
CHU Nantes Hôtel Dieu
Institut Paoli Calmettes
Hôpital St Antoine


title: Comment Diminuer Les hémocultures Inutiles : Construction et Validation d'un Score prédictif de positivité Des hémocultures en réanimation.

acronym: PROBIty

summary:
Prospective observational cohort consisting of all adult patients admitted to participating critical care units (ICU and CCU) during the study period, with blood cultures collected as part of their care, and who did not express any objection to participating.

For each patient, data will be collected prospectively for each blood culture set collected.

ReferenceCitation: Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288. Erratum In: JAMA. 2016 May 24-31;315(20):2237.

ReferenceCitation: Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.

ReferenceCitation: Goto M, Al-Hasan MN. Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe. Clin Microbiol Infect. 2013 Jun;19(6):501-9. doi: 10.1111/1469-0691.12195. Epub 2013 Mar 8.

ReferenceCitation: McNamara JF, Righi E, Wright H, Hartel GF, Harris PNA, Paterson DL. Long-term morbidity and mortality following bloodstream infection: A systematic literature review. J Infect. 2018 Jul;77(1):1-8. doi: 10.1016/j.jinf.2018.03.005. Epub 2018 May 7.

ReferenceCitation: Patel R. New Developments in Clinical Bacteriology Laboratories. Mayo Clin Proc. 2016 Oct;91(10):1448-1459. doi: 10.1016/j.mayocp.2016.06.020. Epub 2016 Aug 21.

ReferenceCitation: Leyssene D, Gardes S, Vilquin P, Flandrois JP, Carret G, Lamy B. Species-driven interpretation guidelines in case of a single-sampling strategy for blood culture. Eur J Clin Microbiol Infect Dis. 2011 Dec;30(12):1537-41. doi: 10.1007/s10096-011-1257-3. Epub 2011 Apr 18.

ReferenceCitation: Dargere S, Cormier H, Verdon R. Contaminants in blood cultures: importance, implications, interpretation and prevention. Clin Microbiol Infect. 2018 Sep;24(9):964-969. doi: 10.1016/j.cmi.2018.03.030. Epub 2018 Apr 3.

ReferenceCitation: Kirn TJ, Weinstein MP. Update on blood cultures: how to obtain, process, report, and interpret. Clin Microbiol Infect. 2013 Jun;19(6):513-20. doi: 10.1111/1469-0691.12180. Epub 2013 Mar 13.

ReferenceCitation: Opota O, Croxatto A, Prod'hom G, Greub G. Blood culture-based diagnosis of bacteraemia: state of the art. Clin Microbiol Infect. 2015 Apr;21(4):313-22. doi: 10.1016/j.cmi.2015.01.003. Epub 2015 Jan 16.

ReferenceCitation: Lamy B, Dargere S, Arendrup MC, Parienti JJ, Tattevin P. How to Optimize the Use of Blood Cultures for the Diagnosis of Bloodstream Infections? A State-of-the Art. Front Microbiol. 2016 May 12;7:697. doi: 10.3389/fmicb.2016.00697. eCollection 2016.

ReferenceCitation: Lin HH, Liu YF, Tien N, Ho CM, Hsu LN, Lu JJ. Evaluation of the blood volume effect on the diagnosis of bacteremia in automated blood culture systems. J Microbiol Immunol Infect. 2013 Feb;46(1):48-52. doi: 10.1016/j.jmii.2012.03.012. Epub 2012 Jun 26.

ReferenceCitation: Snyder SR, Favoretto AM, Baetz RA, Derzon JH, Madison BM, Mass D, Shaw CS, Layfield CD, Christenson RH, Liebow EB. Effectiveness of practices to reduce blood culture contamination: a Laboratory Medicine Best Practices systematic review and meta-analysis. Clin Biochem. 2012 Sep;45(13-14):999-1011. doi: 10.1016/j.clinbiochem.2012.06.007. Epub 2012 Jun 16.

ReferenceCitation: Caldeira D, David C, Sampaio C. Skin antiseptics in venous puncture-site disinfection for prevention of blood culture contamination: systematic review with meta-analysis. J Hosp Infect. 2011 Mar;77(3):223-32. doi: 10.1016/j.jhin.2010.10.015. Epub 2010 Dec 30.

ReferenceCitation: Dargere S, Parienti JJ, Roupie E, Gancel PE, Wiel E, Smaiti N, Loiez C, Joly LM, Lemee L, Pestel-Caron M, du Cheyron D, Verdon R, Leclercq R, Cattoir V; UBC study group. Unique blood culture for diagnosis of bloodstream infections in emergency departments: a prospective multicentre study. Clin Microbiol Infect. 2014 Nov;20(11):O920-7. doi: 10.1111/1469-0691.12656. Epub 2014 Jun 14.

ReferenceCitation: Cockerill FR 3rd, Hughes JG, Vetter EA, Mueller RA, Weaver AL, Ilstrup DM, Rosenblatt JE, Wilson WR. Analysis of 281,797 consecutive blood cultures performed over an eight-year period: trends in microorganisms isolated and the value of anaerobic culture of blood. Clin Infect Dis. 1997 Mar;24(3):403-18. doi: 10.1093/clinids/24.3.403.

ReferenceCitation: Andrews AL, Simpson AN, Heine D, Teufel RJ 2nd. A Cost-Effectiveness Analysis of Obtaining Blood Cultures in Children Hospitalized for Community-Acquired Pneumonia. J Pediatr. 2015 Dec;167(6):1280-6. doi: 10.1016/j.jpeds.2015.09.025. Epub 2015 Oct 9.

ReferenceCitation: Coburn B, Morris AM, Tomlinson G, Detsky AS. Does this adult patient with suspected bacteremia require blood cultures? JAMA. 2012 Aug 1;308(5):502-11. doi: 10.1001/jama.2012.8262. Erratum In: JAMA. 2013 Jan 23;309(4):343.

ReferenceCitation: Yamamoto S, Yamazaki S, Shimizu T, Takeshima T, Fukuma S, Yamamoto Y, Tochitani K, Tsuchido Y, Shinohara K, Fukuhara S. Body Temperature at the Emergency Department as a Predictor of Mortality in Patients With Bacterial Infection. Medicine (Baltimore). 2016 May;95(21):e3628. doi: 10.1097/MD.0000000000003628.

ReferenceCitation: Eliakim-Raz N, Bates DW, Leibovici L. Predicting bacteraemia in validated models--a systematic review. Clin Microbiol Infect. 2015 Apr;21(4):295-301. doi: 10.1016/j.cmi.2015.01.023. Epub 2015 Feb 10.

ReferenceCitation: Shapiro NI, Wolfe RE, Wright SB, Moore R, Bates DW. Who needs a blood culture? A prospectively derived and validated prediction rule. J Emerg Med. 2008 Oct;35(3):255-64. doi: 10.1016/j.jemermed.2008.04.001. Epub 2008 May 16.

ReferenceCitation: Laukemann S, Kasper N, Kulkarni P, Steiner D, Rast AC, Kutz A, Felder S, Haubitz S, Faessler L, Huber A, Fux CA, Mueller B, Schuetz P. Can We Reduce Negative Blood Cultures With Clinical Scores and Blood Markers? Results From an Observational Cohort Study. Medicine (Baltimore). 2015 Dec;94(49):e2264. doi: 10.1097/MD.0000000000002264. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6197.

ReferenceCitation: Peres Bota D, Melot C, Lopes Ferreira F, Vincent JL. Infection Probability Score (IPS): A method to help assess the probability of infection in critically ill patients. Crit Care Med. 2003 Nov;31(11):2579-84. doi: 10.1097/01.CCM.0000094223.92746.56.

ReferenceCitation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

ReferenceCitation: Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747.

ipd_sharing: Undecided

location_facility:
CH Le Mans
CHU Nantes
CHD La Roche sur Yon
CHR Orléans
CHU de Tours
CHU Rennes
CHU Poitiers
CHU Brest
CHU Dijon
CHIU Strasbourg


title: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)

acronym: TERTIO

summary: The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital BEAUJON
Hôpital Paul Brousse
Hôpital Henri Mondor
Institut Mutualiste Montsouris
Centre Hospitalier Paris St Joseph
Hôpital Nord Franche-Comté
CHU de Montpellier
CHU de Besançon
Groupe Hospitalier Paris Salpetrière
Centre Georges François Leclerc

appel_a_projets: PHRCK

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: TERTIO

titre: Evaluation de l'intérêt de combiner un vaccin inducteur de CD4-Th1 dérivé de la télomérase avec un traitement par atezolizumab et bevacizumab chez des patients avec un cancer hépatocellulaire non résécable : une étude de phase II  randomisée pour la preuve du concept.

discipline_principale: cancer

nom_porteur: BORG

prenom_porteur: Christophe


title: A Phase Ib/II Study on AsiDNA in Association With Re-irradiation in Children, Adolescents and Young Adults With High-grade Glioma

acronym: AsiDNA

summary:
HGG comprises diffuse midline gliomas (DMG), including diffuse infiltrating brainstem glioma (DIPG), characterised by histone gene mutations, as well as non-DM HGGs mainly in non-midline supratentorial areas, with distinct molecular abnormalities. First-line treatment comprises surgery when doable (non-DM HGGs), and radiotherapy in all cases. Chemotherapy or other drugs in clinical trials may be added during and/or after radiotherapy depending on the HGG subtype. The recurrence rate is nevertheless high in all paediatric and adolescent HGGs. If the time interval between the end of first-line radiotherapy and relapse is long enough, re-irradiation often provides good palliation of symptoms, delays disease progression, improves quality of life and has minimal and manageable toxicity. Nevertheless, strategies to increase efficacy without increasing toxicity in the treatment of recurrent paediatric HGG are much needed.

AsiDNA™ is a DNA repair inhibitor that increases the vulnerability of tumour cells to irradiation without increasing toxicity in healthy tissues. Its novel mechanism of action, based on perturbation of the DNA damage recognition steps in DNA repair, makes its activity specific to tumour cells. Intravenous administration of AsiDNA is currently being investigated in adults with advanced solid tumours. The MTD was not reached during the escalating dose study on the safety, pharmacokinetics and pharmacodynamics of AsiDNA administered as a 1-hour infusion, however an optimal dose range (400-600 mg) was identified for further development, based on the favourable safety and PK profiles. Preclinical studies on AsiDNA added to radiotherapy have shown increased survival and no increase in short- or long-term toxicity due to the high doses of irradiation.

The study will provide paediatric patients who have recurrent HGG with early access to innovation, even during the early drug development stage in adults.

ipd_sharing_description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

location_facility:
Chu Angers
Chu Toulouse
Gustave Roussy
Centre Leon Berard
Chu Nancy
Chu La Timone Hopital Enfants
Chru Bordeaux
Chu Strasbourg
Centre Oscar Lambret
Institut Curie


title: Cohort Study Assessing the Treatment Strategy for High-Risk Myelodysplastic

acronym: COMYRE

summary: Myelodysplastic syndromes (MDS) are bone marrow malignant diseases resulting in ineffective haematopoiesis and subsequently, blood cell count decrease. Patients have anaemia responsible of fatigue and high heart frequency, thrombocytopenia responsible of increased risk of bleeding and neutropenia responsible of increased risk of infection. The patients suffering from MDS also are at increased risk of developing acute myeloblastic leukemia (AML). Allogeneic stem cell transplantation (alloSCT) remains the only curative option for patients with aggressive MDS. However, these patients are frequently ineligible for this kind of treatment, because of, for instance, age and co-morbidities. Thus, other treatment options are needed and Azacytidine (AZA), a hypomethylating agent is then proposed. With this COMYRE observatory study, we wanted to analyse which patients undergo alloSCT, why they are not eligible to alloSCT if it is the case, the overall survival of all the patients and if there are some factors which can influence this survival. It could help us to better identify the best candidate for alloSCT and those for other treatments such as AZA.

status: Active, not recruiting

lead_sponsor: University Hospital, Bordeaux

location_facility:
Ch Villeneuve/Lot
Institut Bergonie
Chu de Bordeaux
Ch Libourne
CH PAU
CH DAX
Ch Bayonne
Ch Marmande
CH AGEN
Ch Mont de Marsan


title: Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients

acronym: Nf-Ella Loca

summary: Serum neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP) measured by single molecule array (SIMOA) are novel biomarkers of multiple sclerosis patients (MS) activity and progression. Its use is limited due to low availability and high costs. ELLA is a cheaper platform with increasing availability. Recently, we compared SIMOA and ELLA platforms to assess serum NfL levels in 203 MS patients from the OFSEP-HD study. There was a strong correlation (Spearman r = 0.86, p < 0.0001) between both platforms. As for SIMOA, serum NfL levels measured by ELLA were correlated with age and EDSS and were significantly higher in active MS, suggesting that these assays are equivalent and can be used in any center for routine care. However, the accuracy of local measures acquired with ELLA has not been determined. The aim os this study is to assess the concordance of multi-site ELLA instruments, accuracy of GFAP measures as compared to SIMOA, and the predictive value of NfL and GFAP measured by ELLA in MS.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire Pasteur 2


title: A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

acronym: DARIUS

summary: Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Bayer

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

location_facility: Sainte Catherine, Institut du Cancer Avignon-Provence

location_facility: Assitance Publique des Hôpitaux de Marseille - CHU La Timone


title: Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer - Randomized, Placebo-controlled, Double-blind Study

acronym: QISEIN

summary: This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries

lead_sponsor: Centre Francois Baclesse

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility:
Ch Cherbourg
Centre Pierre Curie
Ch Bayeux
ARCOCEA_Clinique Europe
Clinique des Dentellières
Polyclinique du Parc
Ch Calais
Centre François Baclesse
Clinique de Flandre
Centre Henri Becquerel


title: EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.

acronym: EXSUPEEP

summary:
Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.

Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.

By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.

lead_sponsor: Centre Hospitalier de Bourg en Bresse

sponsor_collaborators:
Centre Hospitalier de Bourg en Bresse
Direction Générale de l'Offre de Soins
Hospices Civils de Lyon

location_facility:
Hopital Nord
HCL Edouard Herriot
CHU Michallon
CHU La Miletrie
CH Bourg en Bresse
HCL Lyon Sud
CHU Francois Mitterand
HCL Croix Rousse
CH Victor Dupouy
CH Annecy Genevois

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CH FLEYRIAT

acronyme: ExSuPEEP

titre: Extubation en pression expiratoire positive versus extubation avec aspiration endo-trachéale chez les patients de réanimation. Étude prospective randomisée multicentrique.

discipline_principale: anesthésiologie / réanimation

nom_porteur: CATHERINE-BONNICI

prenom_porteur: Julie


title: Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care

acronym: StomaCare

summary:
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.

The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.

The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

ReferenceCitation: Becker A, Schulten-Oberborsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. doi: 10.1007/pl00012361.

ReferenceCitation: Persson E, Berndtsson I, Carlsson E, Hallen AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x.

ReferenceCitation: Neil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.

ReferenceCitation: Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Illinois at Chicago - INDIGO

evidence: oa repository (semantic scholar lookup)

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

lead_sponsor: FSK

location_facility:
Hopital Bicètre
Hopital Saint-Antoine
CHU Toulouse
Hopital Saint-Louis
ESPIC FOCH - Digestige Unit
ESPIC Foch - Urology Unit
Hopital Lyon-Sud
Hopital SAint Louis
Hopital HEGP
Hopital de la Pitié-Salpétrière


title: Impact of a Nutritional, Sensory and Culinary Support on the Improvement of the Quality of Life Related to Meals in Patients With Cancer Cancer Patients Treated With Chemotherapy

summary:
Although it has been established that the perception of food and eating and cooking habits change during cancer and its treatment, quality of life related to meals, which is an indicator of the psychobiological and physiological well-being of patients in their relationship to food, has been little studied in the pathological context, and particularly in patients undergoing chemotherapy.

Beyond its biological role, food plays a significant psychobiological and social role, as shown by a series of qualitative studies based on interviews with patients. Following a cancer diagnosis, loss of appetite, difficulty in sharing a meal with the family, and reduced pleasure in eating disrupt the patient's relationship with his or her food.

Thus, side effects such as fatigue, nausea and vomiting, and alterations in taste and smell induced by chemotherapy will affect patients' eating behavior, increasing the risk of deteriorating their quality of life with food. As these side effects are less known and therefore less expected by patients, they often lack the information and tools necessary to understand them.

The present study proposes a support for cancer patients treated by chemotherapy in order to improve their quality of life related to meals, and thus keep the pleasure of eating and reduce the risks of malnutrition. This support will consist of a guide provided to patients, in which they will have information on the functioning of the sensory systems involved in the eating experience, advice and culinary tips to adapt foods to their sensory disorders, and recipes that can be adapted in mild (for patients with hypersensitivity to tastes/smells), accentuated (for patients with hypersensitivity to tastes/smells) and enriched (for patients at risk of denutrition) versions. In addition, their sensory abilities will be assessed at the beginning of the study by psychophysical tests, then between each chemotherapy via a telephone interview (self-reported sensory abilities), and they will benefit from orientation according to the test results.

This work will be a first action to improve the quality of life related to the meal by information, follow-up, and adaptation of the meals to the sensory performances of each patient.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Louis Pradel, Service gynécologie

location_facility: Hôpital de la Croix Rousse, service pneumologie

location_facility: Centre hospitalo-universitaire de Lyon Sud, service pneumologie

location_facility: Hôpital Louis Pradel, Service pneumologie

location_facility: Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale


title: The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder

acronym: PROPRADO

summary: The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.

location_facility:
CHU Nantes
CHU Besançon
CH Le Havre
CHU Poitiers
CHU Limoges
CHU Rouen
CH Bohars
AP-HP Louis Mourier
CHU Angers
CH Guillaume Régnier

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: PROPRADO

titre: Efficacité de la modification de la mémoire traumatique au moyen d'une procédure de reconsolidation utilisant le propranolol chez l'adolescent présentant un trouble de stress post traumatique.

discipline_principale: psychiatry

nom_porteur: DAYAN

prenom_porteur: Jacques