title: External Pancreatic Duct Stent After Pancreaticoduodenectomy: a Prospective Randomized Multicenter Trial

summary:
Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Unfortunately, there is not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common sequelae of PF which have been associated with a high mortality rate. While many different risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct have been most consistently linked to high rates of PF. A number of methods for reducing the incidence of PF have been proposed and analysed. Many of these involve technical features of the anastomosis, including site of reconstruction, anastomotic technique, use of biologic glue, and prophylactic use of somatostatin analogue. The placement of a stent through the pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter prospective randomized trial was designed to compare the outcome after PD with external drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a diameter of wirsung <3mm).

Analysis:The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P < 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.

ReferenceCitation: Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Fédération de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.

family: Pessaux

full_name: Patrick Pessaux

given: Patrick

family: Sauvanet

full_name: Alain Sauvanet

given: Alain

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Paye

full_name: François Paye

given: François

family: Muscari

full_name: Fabrice Muscari

given: Fabrice

family: Cunha

full_name: Antonio SA Cunha

given: Antonio SA

family: Sastre

full_name: Bernard Sastre

given: Bernard

family: Arnaud

full_name: Jean-Pierre Arnaud

given: Jean-Pierre

journal_name: Annals of Surgery

title: External Pancreatic Duct Stent Decreases Pancreatic Fistula Rate After Pancreaticoduodenectomy

lead_sponsor: University Hospital, Angers


type: Registry Identifier

title: Blood Pressure Control and Arterial Properties After Surgical Treatment of Type A Thoracic Aortic Dissection or Haematoma

summary:
A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque rupture via imaging in almost 50% of cases. AH occurs in older patients than those with AD and develops on atheromatous lesions with parietal ulcers, most often in cases of poorly managed, pre-existing hypertension (HTN). Type A AHs, which affect the ascending aorta, frequently progress towards an AD with a high risk of mortality, and represent a surgical indication.

Patients who have presented AD or AH, whether they have been operated or not, must undergo prolonged monitoring. This involves both clinical and radiological checks to ensure that blood pressure is properly monitored, that the parietal lesions have receded and that there are no complications.

HTN is a recognized risk factor for the onset of AD and systolic blood pressure must be brought down to between 100 and 120 mmHg perioperatively. Furthermore, HTN is also a risk factor for the rupture of unoperated type B AD. Despite this, only two studies have looked at BP management in AD patients. The first, carried out among chronic type A or B AD patients revealed that closer monitoring of blood pressure levels at home led to a better long-term prognosis. Another study revealed a 60% prevalence of non-managed clinical HTN among 40 chronic AD patients.

Whilst frequent, regular aortic wall monitoring via imaging methods (CT or MRI) is recommended after thoracic AD surgery, there is no precise recommendation as to the method of BP monitoring in very high-risk patients. A BP level of 135/80 mmHg has been suggested as a maximum limit for patients having been operated for AD. In order to achieve this, antihypertensives of several therapeutic classes must be used, with beta-blockers as a priority. The same can be said for AH, as it has been demonstrated that the absence of beta-blocker treatment is a predictive factor for poor progress.

Increased aortic stiffness can cause increased systolic blood pressure and is recognized as an independent cardiovascular risk factor. This stiffness can be detected by measuring the carotid-to-femoral pulse wave velocity (PWV). No study has as yet focused on assessing aortic stiffness in patients who have undergone AD or AH surgery.

Obstructive sleep apnea syndrome (OSAS) in thoracic AD patients is highly prevalent, and respiratory events that occur are more severe. This has prompted some to suggest that systematic detection of OSAS after AD should be carried out. No findings have yet been published about patients who have undergone AH surgery.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging

acronym: ADEM

summary:
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.

At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.

In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.

family: Ferrero

full_name: Stéphanie Ferrero

given: Stéphanie

sequence: first

family: Wittoek

full_name: Ruth Wittoek

given: Ruth

sequence: additional

family: Allado

full_name: Edem Allado

given: Edem

family: Cruzel

full_name: Coralie Cruzel

given: Coralie

family: Fontas

full_name: Eric Fontas

given: Eric

family: Breuil

full_name: Veronique Breuil

given: Veronique

family: Ziegler

full_name: Liana Ziegler

given: Liana

family: Kremer

full_name: Joel Kremer

given: Joel

family: Loeuille

full_name: Damien Loeuille

given: Damien

family: Roux

full_name: Christian H. Roux

given: Christian H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Seminars in Arthritis and Rheumatism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.

family: Albuisson

full_name: Eliane Albuisson

given: Eliane

full_name: Stephanie Ferrero

given: Stephanie

family: Chenuel

full_name: Bruno Chenuel

given: Bruno

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

given: Isabelle

full_name: Christian Roux

given: Christian

journal_name: Rheumatology International

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Nice University Hospital, Rheumatology Department

intervention_type: Drug


title: Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741

summary: The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Orion Corporation, Orion Pharma

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective, Multicenter Randomized Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in Children and Young Adults (<35 Years) With Acute Leukemia Remission

summary: Unrelated cord blood transplantation (UCBT) has been used for several years when there is no HLA identical sibling or unrelated donor.Since the recent publication of encouraging results after transplantation of two UCB units, the number of these double-transplantations increases in a very significant way.However, there is currently no prospective study comparing in a reliable way the double-transplantation to single-transplantation results.The investigators propose a prospective and randomized study comparing the results of single versus double unit UCBT in children and young adults (< 35 yrs) with acute leukemia in remission. This is an open, multicenter study carried out in the allogeneic transplant centers from the French society for hematopoietic stem cell transplantation and cell therapy. The primary objective is to compare the incidence of transplantation failure in the two treatment arms. Transplantation failure, the primary endpoint of the study, is defined by the occurrence of one of the following events : transplant-related death, second allogeneic transplantation or autologous backup infusion for primary engraftment failure, autologous recovery. The financial impact of these double-transplantations being to date unknown, the project also includes a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence. The secondary clinical endpoints are: overall survival and disease-free survival, relapse incidence, transplant-related mortality, incidence of severe infections and GvHD. The secondary biological endpoints are: hematological and immunological recovery, post transplant chimerism.

ReferenceCitation: Michel G, Galambrun C, Sirvent A, Pochon C, Bruno B, Jubert C, Loundou A, Yakoub-Agha I, Milpied N, Lutz P, Marie-Cardine A, Gandemer V, Blaise D, Michallet M, Rialland F, Renard C, Oudin C, Esmiol S, Seux M, Baumstarck K, Mohty M, Rocha V, Dalle JH. Single- vs double-unit cord blood transplantation for children and young adults with acute leukemia or myelodysplastic syndrome. Blood. 2016 Jun 30;127(26):3450-7. doi: 10.1182/blood-2016-01-694349. Epub 2016 Apr 20.

name: Department of Pediatric Hematology-Oncology, Assistance Publique–Hôpitaux de Marseille, La Timone Hospital, Aix-Marseille University, Marseille, France;

name: Department of Public Health, Laboratoire de Santé Publique (EA 3279) Research Unit, Marseille University Hospital, Aix-Marseille University, Marseille, France;

family: Michel

full_name: Gérard Michel

given: Gérard

family: Galambrun

full_name: Claire Galambrun

given: Claire

name: Department of Pediatric Hematology-Oncology, Montpellier University Hospital, Montpellier, France;

family: Sirvent

full_name: Anne Sirvent

given: Anne

name: Department of Pediatric Hematology-Oncology, Nancy University Hospital, Nancy, France;

family: Pochon

full_name: Cecile Pochon

given: Cecile

name: Department of Pediatric Hematology, Jeanne de Flandre Hospital, Lille Nord de France University, Lille, France;

family: Bruno

full_name: Benedicte Bruno

given: Benedicte

name: Department of Pediatric Hematology-Oncology, Bordeaux University Hospital, Bordeaux, France;

family: Jubert

full_name: Charlotte Jubert

given: Charlotte

family: Loundou

full_name: Anderson Loundou

given: Anderson

name: Department of Hematology, Huriez Hospital, Lille Nord de France University, Lille, France;

family: Yakoub-Agha

full_name: Ibrahim Yakoub-Agha

given: Ibrahim

name: Department of Hematology, Haut-Leveque Hospital, Bordeaux University Hospital, Pessac, France;

family: Milpied

full_name: Noel Milpied

given: Noel

name: Department of Pediatric Hematology-Oncology, Strasbourg University Hospital, Strasbourg, France;

family: Lutz

full_name: Patrick Lutz

given: Patrick

name: Department of Pediatric Hematology-Oncology, Rouen University Hospital, Rouen, France;

family: Marie-Cardine

full_name: Aude Marie-Cardine

given: Aude

name: Department of Pediatric Hematology-Oncology, Rennes University Hospital, Rennes, France;

family: Gandemer

full_name: Virginie Gandemer

given: Virginie

name: Department of Hematology-Oncology, Transplant and Cellular Therapy Unit, Paoli-Calmettes Institute, Centre de Recherche en Cancérologie de Marseille and Aix-Marseille University, Marseille, France;

family: Blaise

full_name: Didier Blaise

given: Didier

name: Department of Hematology, Edouard Herriot Hospital, Lyon University Hospital, Lyon, France;

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

name: Department of Pediatric Hematology-Oncology, Nantes University Hospital, Nantes, France;

family: Rialland

full_name: Fanny Rialland

given: Fanny

name: Institute of Pediatric Hematology-Oncology, Lyon University Hospital, Lyon, France;

family: Renard

full_name: Cecile Renard

family: Oudin

full_name: Claire Oudin

family: Esmiol

full_name: Sophie Esmiol

given: Sophie

name: Clinical Research and Innovation Direction, Assistance Publique–Hôpitaux de Marseille, Marseille, France;

family: Seux

full_name: Mylene Seux

given: Mylene

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

name: Department of Hematology, Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Université Pierre and Marie Curie, Inserm Unité 938, Paris, France;

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

name: Eurocord, Hôpital Saint Louis AP-HP, University Paris VII, Paris, France; and

family: Rocha

full_name: Vanderson Rocha

given: Vanderson

name: Department of Pediatric Hematology, AP-HP, Robert Debré Hospital, Paris Diderot University, Paris, France

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer

summary:
The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

status: Terminated

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. Review.

ReferenceCitation: Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy: part 1, pathogenesis and prophylaxis of mucositis. Head Neck. 2003 Dec;25(12):1057-70. Review.

ReferenceCitation: Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8.

ReferenceCitation: Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy. Part 2: diagnosis and management of mucositis. Head Neck. 2004 Jan;26(1):77-84. Review.

ReferenceCitation: Lapeyre M, Charra-Brunaud C, Kaminsky MC, Geoffrois L, Dolivet G, Toussaint B, Maire F, Pourel N, Simon M, Marchal C, Bey P. [Management of mucositis following radiotherapy for head and neck cancers]. Cancer Radiother. 2001 Nov;5 Suppl 1:121s-130s. Review. French.

ReferenceCitation: Worthington HV, Clarkson JE, Eden OB. Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2004;(2):CD001973. Review. Update in: Cochrane Database Syst Rev. 2007;(2):CD001973.

ReferenceCitation: Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD000978. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD000978.

ReferenceCitation: Trotti A, Garden A, Warde P, Symonds P, Langer C, Redman R, Pajak TF, Fleming TR, Henke M, Bourhis J, Rosenthal DI, Junor E, Cmelak A, Sheehan F, Pulliam J, Devitt-Risse P, Fuchs H, Chambers M, O'Sullivan B, Ang KK. A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):674-81.

ReferenceCitation: El-Sayed S, Nabid A, Shelley W, Hay J, Balogh J, Gelinas M, MacKenzie R, Read N, Berthelet E, Lau H, Epstein J, Delvecchio P, Ganguly PK, Wong F, Burns P, Tu D, Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J Clin Oncol. 2002 Oct 1;20(19):3956-63.

ReferenceCitation: Dodd MJ, Miaskowski C, Greenspan D, MacPhail L, Shih AS, Shiba G, Facione N, Paul SM. Radiation-induced mucositis: a randomized clinical trial of micronized sucralfate versus salt & soda mouthwashes. Cancer Invest. 2003;21(1):21-33.

ReferenceCitation: Stokman MA, Spijkervet FK, Burlage FR, Dijkstra PU, Manson WL, de Vries EG, Roodenburg JL. Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial. Br J Cancer. 2003 Apr 7;88(7):1012-6.

ReferenceCitation: Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):479-85.

ReferenceCitation: Warde P, O'Sullivan B, Aslanidis J, Kroll B, Lockwood G, Waldron J, Payne D, Bayley A, Ringash J, Kim J, Liu FF, Maxymiw W, Sprague S, Cummings BJ. A Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):9-13.

ReferenceCitation: Epstein JB, Silverman S Jr, Paggiarino DA, Crockett S, Schubert MM, Senzer NN, Lockhart PB, Gallagher MJ, Peterson DE, Leveque FG. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001 Aug 15;92(4):875-85.

ReferenceCitation: Ertekin MV, Koç M, Karslioglu I, Sezen O. Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):167-74.

ReferenceCitation: Maiche AG, Gröhn P, Mäki-Hokkonen H. Effect of chamomile cream and almond ointment on acute radiation skin reaction. Acta Oncol. 1991;30(3):395-6.

ReferenceCitation: Fidler P, Loprinzi CL, O'Fallon JR, Leitch JM, Lee JK, Hayes DL, Novotny P, Clemens-Schutjer D, Bartel J, Michalak JC. Prospective evaluation of a chamomile mouthwash for prevention of 5-FU-induced oral mucositis. Cancer. 1996 Feb 1;77(3):522-5.

lead_sponsor: Centre Leon Berard


type: Other Identifier

title: Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age

summary:
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age.

The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.

primary_purpose: Health Services Research

lead_sponsor: Yves Boirie

intervention_type: Other


title: Collaborative Study to Assess the Effects of Treatment With Recombinant Growth Hormone Saizen® in the Prevention of Short Stature in Young Girls Suffering From Turner Syndrome Before the Age of 4 Years. Original French Title: Etude Collaborative Pour apprécier Les Effets du Traitement Par l'Hormone de Croissance Recombinante SAIZEN® Dans le Retard de Croissance de la Fillette Atteinte de Syndrome de Turner Avant l'âge de 4 Ans

summary: The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Linglart A, Cabrol S, Berlier P, Stuckens C, Wagner K, de Kerdanet M, Limoni C, Carel JC, Chaussain JL; French Collaborative Young Turner Study Group. Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome. Eur J Endocrinol. 2011 Jun;164(6):891-7. doi: 10.1530/EJE-10-1048. Epub 2011 Mar 11.

family: Linglart

full_name: A Linglart

given: A

family: Cabrol

full_name: S Cabrol

given: S

family: Berlier

full_name: P Berlier

given: P

family: Stuckens

full_name: C Stuckens

given: C

family: Wagner

full_name: K Wagner

given: K

family: de Kerdanet

full_name: M de Kerdanet

given: M

family: Limoni

full_name: C Limoni

family: Carel

full_name: J-C Carel

given: J-C

family: Chaussain

full_name: J-L Chaussain

given: J-L

journal_name: European Journal of Endocrinology

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation

summary:
Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :

DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment

Secondary objectives shared by the 3 observatories:

Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
Estimate the resources consumption according to the medical and non medical management of these patients,
Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice

Secondary objectives specific shared by DB and AF registries :

- Analyze the geriatric pharmaco-genetic aspects

Specific secondary objectives for each observatory :

DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
CP : Evaluate pain consequences on Daily Living Activities and patient autonomy

ReferenceCitation: Hanon O, Vidal JS, Pisica-Donose G, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Derumeaux G, Falissard B, Forette F, Pasquier F, Pinget M, Ourabah R, Becquemont L, Danchin N; S.AGES Investigators. Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort. J Nutr Health Aging. 2015 Feb;19(2):219-27. doi: 10.1007/s12603-015-0444-9.

family: Hanon

full_name: O. Hanon

given: O.

family: Vidal

full_name: J. S. Vidal

given: J. S.

family: Pisica-Donose

full_name: G. Pisica-Donose

given: G.

family: Benattar-Zibi

full_name: L. Benattar-Zibi

given: L.

family: Bertin

full_name: P. Bertin

given: P.

family: Berrut

full_name: G. Berrut

family: Corruble

full_name: E. Corruble

given: E.

family: Derumeaux

full_name: G. Derumeaux

family: Falissard

full_name: B. Falissard

given: B.

family: Forette

full_name: F. Forette

given: F.

family: Pasquier

full_name: F. Pasquier

family: Pinget

full_name: M. Pinget

given: M.

family: Ourabah

full_name: R. Ourabah

given: R.

family: Becquemont

full_name: L. Becquemont

family: Danchin

full_name: N. Danchin

given: N.

journal_name: The journal of nutrition, health & aging

title: Therapeutic management in ambulatory elderly patients with atrial fibrillation: The S.AGES cohort

ReferenceCitation: Bucher S, Bauduceau B, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Danchin N, Delespierre T, Derumeaux G, Doucet J, Falissard B, Forette F, Hanon O, Ourabah R, Pasquier F, Piedvache C, Pinget M, Ringa V, Becquemont L; S.AGES Investigators. Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort - Baseline data. Prim Care Diabetes. 2015 Aug;9(4):267-74. doi: 10.1016/j.pcd.2014.07.004. Epub 2014 Jul 31.

family: Bucher

full_name: Sophie Bucher

family: Bauduceau

full_name: Bernard Bauduceau

given: Bernard

full_name: Linda Benattar-Zibi

given: Linda

full_name: Philippe Bertin

given: Philippe

full_name: Gilles Berrut

given: Gilles

full_name: Emmanuelle Corruble

given: Emmanuelle

title: Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort – Baseline data

ReferenceCitation: Bertin P, Becquemont L, Corruble E, Derumeaux G, Falissard B, Hanon O, Pinget M, Forette F. The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data. J Nutr Health Aging. 2013;17(8):681-6. doi: 10.1007/s12603-013-0338-7.

title: The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES cohort. Baseline data


title: Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education

acronym: POPART

summary: Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.

lead_sponsor: Rennes University Hospital


title: Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)

acronym: MAIVAX

summary: The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

ReferenceCitation: Kostianovsky A, Charles P, Alves JF, Goulet M, Pagnoux C, Le Guern V, Mouthon L, Krivine A, Villiger P, Launay O, Guillevin L; French Vasculitis Study Group. Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases: a prospective, monocentre trial on 199 patients. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S83-9. Epub 2012 May 11.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological


title: Evaluation of the Structure-modifying Effect and Safety of Avocado-Soybean Unsaponifiable (Piascledine 300) in Hip Osteoarthritis (OA) a 3 Years Multicenter Randomized, Double Blind, Placebo Controlled Trial

acronym: ERADIAS

summary: This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.

ReferenceCitation: Maheu E, Cadet C, Marty M, Moyse D, Kerloch I, Coste P, Dougados M, Mazières B, Spector TD, Halhol H, Grouin JM, Lequesne M. Randomised, controlled trial of avocado-soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study. Ann Rheum Dis. 2014 Feb;73(2):376-84. doi: 10.1136/annrheumdis-2012-202485. Epub 2013 Jan 23.

family: Maheu

full_name: Emmanuel Maheu

given: Emmanuel

family: Cadet

full_name: Christian Cadet

given: Christian

family: Marty

full_name: Marc Marty

given: Marc

family: Moyse

full_name: Dominique Moyse

given: Dominique

family: Kerloch

full_name: Isabelle Kerloch

given: Isabelle

family: Coste

full_name: Philippe Coste

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Mazières

full_name: Bernard Mazières

family: Spector

full_name: Tim D Spector

given: Tim D

family: Halhol

full_name: Hafid Halhol

given: Hafid

family: Grouin

full_name: Jean-Marie Grouin

given: Jean-Marie

family: Lequesne

full_name: Michel Lequesne

given: Michel

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Randomised, controlled trial of avocado–soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study

lead_sponsor: Laboratoires Expanscience S.A.


title: Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

summary: The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.

time_perspective: Cross-Sectional

ReferenceCitation: Jacob S, Michel M, Spaulding C, Boveda S, Bar O, Brézin AP, Streho M, Maccia C, Scanff P, Laurier D, Bernier MO. Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? Radiation-induced cataracts and lens opacities. BMC Public Health. 2010 Sep 8;10:537. doi: 10.1186/1471-2458-10-537.

family: Jacob

full_name: Sophie Jacob

given: Sophie

family: Michel

full_name: Morgane Michel

given: Morgane

family: Spaulding

full_name: Christian Spaulding

family: Boveda

full_name: Serge Boveda

given: Serge

family: Bar

full_name: Olivier Bar

given: Olivier

family: Brézin

full_name: Antoine P Brézin

given: Antoine P

family: Streho

full_name: Maté Streho

given: Maté

family: Maccia

full_name: Carlo Maccia

given: Carlo

family: Scanff

full_name: Pascale Scanff

given: Pascale

family: Laurier

full_name: Dominique Laurier

family: Bernier

full_name: Marie-Odile Bernier

given: Marie-Odile

currency_apc_doaj: GBP

journal_name: BMC Public Health

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Sophie JACOB


title: Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

summary:
JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder.

However, in many cases, this JJ stent is not well tolerated and can even be unbearable.

This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.

lead_sponsor: Poitiers University Hospital

location_facility: Poitiers University Hospital - 2 rue de la Milétrie


summary:
Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet.

In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins.

It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.

location_facility: Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale


summary: Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria

ReferenceCitation: Boisson M, Grégoire N, Cormier M, Gobin P, Marchand S, Couet W, Mimoz O. Pharmacokinetics of nebulized colistin methanesulfonate in critically ill patients. J Antimicrob Chemother. 2017 Sep 1;72(9):2607-2612. doi: 10.1093/jac/dkx167.

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

family: Grégoire

full_name: Nicolas Grégoire

given: Nicolas

family: Cormier

full_name: Marielle Cormier

given: Marielle

family: Gobin

full_name: Patrice Gobin

given: Patrice

family: Marchand

full_name: Sandrine Marchand

given: Sandrine

family: Couet

full_name: William Couet

given: William

family: Mimoz

full_name: Olivier Mimoz

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

summary: The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.

primary_purpose: Diagnostic

ReferenceCitation: Chanson P, Cailleux-Bounacer A, Kuhn JM, Weryha G, Chabre O, Borson-Chazot F, Dubois S, Vincent-Dejean C, Brue T, Fedou C, Bresson JL, Demolis P, Souberbielle JC. Comparative validation of the growth hormone-releasing hormone and arginine test for the diagnosis of adult growth hormone deficiency using a growth hormone assay conforming to recent international recommendations. J Clin Endocrinol Metab. 2010 Aug;95(8):3684-92. doi: 10.1210/jc.2010-0295. Epub 2010 May 19.

family: Chanson

full_name: Philippe Chanson

given: Philippe

family: Cailleux-Bounacer

full_name: Anne Cailleux-Bounacer

given: Anne

family: Kuhn

full_name: Jean-Marc Kuhn

given: Jean-Marc

family: Weryha

full_name: Georges Weryha

given: Georges

family: Chabre

full_name: Olivier Chabre

family: Borson-Chazot

full_name: Françoise Borson-Chazot

given: Françoise

family: Dubois

full_name: Séverine Dubois

given: Séverine

family: Vincent-Dejean

full_name: Caroline Vincent-Dejean

given: Caroline

family: Brue

full_name: Thierry Brue

given: Thierry

family: Fedou

full_name: Christine Fedou

given: Christine

family: Bresson

full_name: Jean-Louis Bresson

given: Jean-Louis

family: Demolis

full_name: Pierre Demolis

given: Pierre

family: Souberbielle

full_name: Jean-Claude Souberbielle

given: Jean-Claude

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Comparative Validation of the Growth Hormone-Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency Using a Growth Hormone Assay Conforming to Recent International Recommendations

location_facility: CHU Bicêtre, Endocrinology and Reproductive Diseases Department


summary: The aim of the study is to explore the distribution of antibiotics in the brain after an acute brain injury because brain infections treatment is still an health care problem.


ReferenceCitation: Delyon J, Porcher R, Battistella M, Meyer N, Adamski H, Bertucci F, Guillot B, Jouary T, Leccia MT, Dalac S, Mortier L, Ghrieb Z, Da Meda L, Vicaut E, Pedeutour F, Mourah S, Lebbe C. A Multicenter Phase II Study of Pazopanib in Patients with Unresectable Dermatofibrosarcoma Protuberans. J Invest Dermatol. 2021 Apr;141(4):761-769.e2. doi: 10.1016/j.jid.2020.06.039. Epub 2020 Sep 18.

family: Delyon

full_name: Julie Delyon

given: Julie

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Battistella

full_name: Maxime Battistella

given: Maxime

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

family: Adamski

full_name: Henri Adamski

given: Henri

family: Bertucci

full_name: François Bertucci

given: François

family: Guillot

full_name: Bernard Guillot

given: Bernard

family: Jouary

full_name: Thomas Jouary

given: Thomas

family: Leccia

full_name: Marie-Thérèse Leccia

given: Marie-Thérèse

family: Dalac

full_name: Sophie Dalac

given: Sophie

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Ghrieb

full_name: Zineb Ghrieb

given: Zineb

family: Da Meda

full_name: Laetitia Da Meda

given: Laetitia

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Pedeutour

full_name: Florence Pedeutour

given: Florence

family: Mourah

full_name: Samia Mourah

given: Samia

family: Lebbe

full_name: Celeste Lebbe

given: Celeste

journal_name: Journal of Investigative Dermatology

acronym: DFSP-PAZO

location_facility: Hôpital Saint-Louis - Service de Dermatologie (Pole POPS)

type: EudraCT Number

source: euctr

title: A Phase IIa Open Multicenter, Trial, of Treatment With Pazopanib (Multi Tyrosine Kinase Inhibitor) in Dermatofibrosarcomas (DFSP), Unresectable Locally Advanced (Potentially Mutilating Surgery), Primary or Relapsing , Transformed or Not.

summary: In relation to the activation of PDGF-mediated signalization due to the fusion gene COL1A1-PDGFb in DFSP, imatinib (800mg/day) has shown activity in advanced DFSP and has became the reference treatment option for these patients. Yet the activity observed does not allow for a downstaging compatible with successful resection in a number of patients and does not prevent subsequent tumour progression in case of residual tumour.Pazopanib in relation to 1) its multi tyrosine kinase inhibiting activity (VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β and c-kit with IC50 values of 10, 30, 47, 71, 84, and 74 nM, respectively) involving in particular PDGFR, and VEGFR which has been shown to be activated in DFSP, 2) its antitumour activity in sarcomas patients, and 3) its acceptable safety profile, is a logical candidate for therapeutic trials in DFSP both in patients not expected to derive a sufficient benefit from imatinib and in patients failing imatinib mesylate. Moreover, using quantitative RT-PCR and immunohistochemistry we have recently demonstrated high levels of VEGF and VEGFR2 expression in dermatofibrosarcoma.


title: Aldosterone Lethal Effects Blocked in AMI Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up: THE ALBATROSS TRIAL

acronym: ALBATROSS

summary:
Study hypothesis : An early blockade of aldosterone receptors initiated at the first medical contact after acute myocardial infarction may reduce major cardiovascular events within 6 months after the occurrence of the myocardial infarction.

Primary efficacy criterion : The 6 month rate of the composite of death, resuscitated cardiac arrest, potentially lethal ventricular arrhythmia, indication for implantation of an implantable cardioversion device, occurrence or aggravation of heart failure.

Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon as possible within 72 hours after the onset of acute myocardial infarction on top of standard therapy, compared to standard therapy alone, with or without reperfusion therapy.

Study design : Prospective, multi-centre randomised, open labeled with 2 parallel study arms.

ReferenceCitation: Beygui F, Cayla G, Roule V, Roubille F, Delarche N, Silvain J, Van Belle E, Belle L, Galinier M, Motreff P, Cornillet L, Collet JP, Furber A, Goldstein P, Ecollan P, Legallois D, Lebon A, Rousseau H, Machecourt J, Zannad F, Vicaut E, Montalescot G; ALBATROSS Investigators. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial. J Am Coll Cardiol. 2016 Apr 26;67(16):1917-27. doi: 10.1016/j.jacc.2016.02.033.

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Roule

full_name: Vincent Roule

given: Vincent

family: Roubille

full_name: François Roubille

family: Delarche

full_name: Nicolas Delarche

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Van Belle

full_name: Eric Van Belle

family: Belle

full_name: Loic Belle

given: Loic

family: Galinier

full_name: Michel Galinier

given: Michel

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Cornillet

full_name: Luc Cornillet

given: Luc

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Furber

full_name: Alain Furber

given: Alain

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Ecollan

full_name: Patrick Ecollan

family: Legallois

full_name: Damien Legallois

given: Damien

family: Lebon

full_name: Alain Lebon

family: Rousseau

full_name: Hélène Rousseau

given: Hélène

family: Machecourt

full_name: Jacques Machecourt

given: Jacques

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Beygui F, Vicaut E, Ecollan P, Machecourt J, Van Belle E, Zannad F, Montalescot G. Rationale for an early aldosterone blockade in acute myocardial infarction and design of the ALBATROSS trial. Am Heart J. 2010 Oct;160(4):642-8. doi: 10.1016/j.ahj.2010.06.049.

location_facility: Hôpital PITIE-SALPETRIERE - Institut de Cardiologie


title: Comparison of Occlusive Dressings, Salicylate Ointment, Cryotherapy, Topical 5-fluoro-uracil and Imiquimod in Immunocompetent Patients Presenting Plantar Warts in Office-based Settings: a Randomized Clinical Trial

acronym: VRAIE

summary: The principal objective of the study is to compare 5 usual strategies in the management of plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the trial. The trial will include immunocompetent patients coming from the community and should help the office-based dermatologists and hospital in the decision-making therapeutic process.


title: Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.

summary: The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.

lead_sponsor: Laboratoires Genévrier


title: Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study

acronym: Hydro-Echo

summary:
The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.

The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.

In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.

ReferenceCitation: Dufour E, Donat N, Jaziri S, Kurdi O, Couturier C, Dreyfus JF, Fischler M. Ultrasound-guided perineural circumferential median nerve block with and without prior dextrose 5% hydrodissection: a prospective randomized double-blinded noninferiority trial. Anesth Analg. 2012 Sep;115(3):728-33. doi: 10.1213/ANE.0b013e31825fa37d. Epub 2012 Jun 28.

family: Dufour

full_name: Eric Dufour

given: Eric

family: Donat

full_name: Nicolas Donat

given: Nicolas

family: Jaziri

full_name: Souhail Jaziri

given: Souhail

family: Kurdi

full_name: Okba Kurdi

given: Okba

family: Couturier

full_name: Christian Couturier

given: Christian

family: Dreyfus

full_name: Jean-François Dreyfus

given: Jean-François

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Ultrasound-Guided Perineural Circumferential Median Nerve Block With and Without Prior Dextrose 5% Hydrodissection

lead_sponsor: Hopital Foch


title: High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms

summary: The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.

location_facility: Assistance Publique Hopitaux de Marseille


title: A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

summary: The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.

lead_sponsor: Centre Jean Perrin


title: Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia

summary: The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.

ReferenceCitation: Papazian L, Roch A, Charles PE, Penot-Ragon C, Perrin G, Roulier P, Goutorbe P, Lefrant JY, Wiramus S, Jung B, Perbet S, Hernu R, Nau A, Baldesi O, Allardet-Servent J, Baumstarck K, Jouve E, Moussa M, Hraiech S, Guervilly C, Forel JM; STATIN-VAP Study Group. Effect of statin therapy on mortality in patients with ventilator-associated pneumonia: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1692-700. doi: 10.1001/jama.2013.280031.

family: Papazian

full_name: Laurent Papazian

given: Laurent

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Statin Therapy on Mortality in Patients With Ventilator-Associated Pneumonia


title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.

acronym: EFFIVAC

summary: The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.

lead_sponsor: University Hospital, Rouen


title: Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain

acronym: PhyDoNe

summary:
Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy.

The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Placebo Effect of Paracetamol in Healthy Volunteers

acronym: HOP

summary:
Paracetamol is one of the most commonly used drugs in the world, indicated for the symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug used to relieve pain and reduce fever. The objective of this study is to analyze whether a placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of paracetamol is partly due to the simple fact of taking a drug.

Moreover, during the study you propose to do a saliva sample, optional, for biological research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your body..


title: Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function

summary: This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.

ReferenceCitation: Filaire M, Tardy MM, Richard R, Naamee A, Chadeyras JB, Da Costa V, Bailly P, Eisenmann N, Pereira B, Merle P, Galvaing G. Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials. Chin Clin Oncol. 2015 Dec;4(4):40. doi: 10.3978/j.issn.2304-3865.2015.11.05.


title: Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol -

acronym: KTcol

summary:
Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo.

Abstract:

The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care.

A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection ("single shot") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours.

The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo (physiological serum).

ReferenceCitation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11:CD001159. doi: 10.1002/14651858.CD001159.pub3.

name: Teaching and Research Unit, Health Sciences; University of Quebec in Abitibi-Temiscamingue; Rouyn-Noranda Canada

name: Department of Anesthesiology and Critical Care, Faculty of Medicine; Laval University; Quebec City Canada

name: Department of Anesthesiology and Critical Care; Faculty of Medicine, Laval University; Quebec City Canada

family: Guay

full_name: Joanne Guay

given: Joanne

name: Department of Anesthesiology and Perioperative Medicine; Mayo Clinic College of Medicine; Rochester MN USA

family: Kopp

full_name: Sandra Kopp

given: Sandra

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Angers


title: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research

summary:
Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and other dementias. Irrespective of the severity of the disease, the most frequently encountered symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and psychiatric conditions. Apathy is a disorder of motivation, defined as "the direction, intensity and persistence of goal-directed behaviour". Most of the current descriptions acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour, cognition or emotion. The classical neuropsychiatric symptom assessments are subjective structured interview-based, using input from the caregiver and/or the patient. New technologies are likely to provide us with a more objective measure. An example is ambulatory actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in three dimensions.

The aim of the present study is to assess using actigraphy and video recording signal, AD patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an activity of daily living scenario .

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: A Multicenter Open-label, Phase I/II Dose Escalation Study of Oral Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

acronym: LapDoc

summary: The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.

lead_sponsor: Centre Georges Francois Leclerc


title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-period Cross-over Study to Evaluate the Scopolamine Cognition Model in Healthy Male Subjects Using AZD1446 and Donepezil Versus Placebo

summary: The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.

lead_sponsor: AstraZeneca


title: A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

summary: This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.

lead_sponsor: Hoffmann-La Roche


title: Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI

summary:
Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI), able to reduce infarct size ?

In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic compounds, when given during reperfusion, after cardiac ischemia. In humans, post-conditioning offers such a protection, as the investigators have previously showed (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).

Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic complications) and finally, morbidity and even mortality. This protection depends on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or difficult to manage (insulin, morphin). One of the most promising agent could then be erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion injury. This impact could rely on anti-apoptotic properties.

ReferenceCitation: Roubille F, Micheau A, Combes S, Thibaut S, Souteyrand G, Cayla G, Bonello L, Lesavre N, Sportouch-Dukhan C, Klein F, Berboucha S, Cade S, Cung TT, Raczka F, Macia JC, Gervasoni R, Cransac F, Leclercq F, Barrère-Lemaire S, Paganelli F, Mottref P, Vernhet Kovacsik H, Ovize M, Piot C. Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial. Arch Cardiovasc Dis. 2013 Mar;106(3):135-45. doi: 10.1016/j.acvd.2012.12.001. Epub 2013 Feb 1.

family: Roubille

full_name: François Roubille

given: François

family: Micheau

full_name: Antoine Micheau

given: Antoine

family: Combes

full_name: Stéphane Combes

given: Stéphane

family: Thibaut

full_name: Séverine Thibaut

given: Séverine

family: Souteyrand

full_name: Géraud Souteyrand

given: Géraud

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Bonello

full_name: Laurent Bonello

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

family: Sportouch-Dukhan

full_name: Catherine Sportouch-Dukhan

given: Catherine

family: Klein

full_name: François Klein

family: Berboucha

full_name: Samir Berboucha

given: Samir

family: Cade

full_name: Stéphane Cade

family: Cung

full_name: Thien-Tri Cung

given: Thien-Tri

family: Raczka

full_name: Franck Raczka

given: Franck

family: Macia

full_name: Jean-Christophe Macia

given: Jean-Christophe

family: Gervasoni

full_name: Richard Gervasoni

given: Richard

family: Cransac

full_name: Frédéric Cransac

given: Frédéric

family: Leclercq

full_name: Florence Leclercq

given: Florence

family: Barrère-Lemaire

full_name: Stéphanie Barrère-Lemaire

given: Stéphanie

family: Paganelli

full_name: Franck Paganelli

family: Mottref

full_name: Pascal Mottref

given: Pascal

family: Vernhet Kovacsik

full_name: Hélène Vernhet Kovacsik

family: Ovize

full_name: Michel Ovize

given: Michel

family: Piot

title: Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: Results of the randomized Intra-Co-EpoMI trial


title: Pain and Emotional Expression in Children With Autism or Mental Retardation

summary: The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). Children will be videotaped before, during and after a venepuncture. Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).

time_perspective: Retrospective

lead_sponsor: University Hospital, Montpellier


title: A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.

lead_sponsor: LEO Pharma


title: Rapid Bacterial Antibiograms Determined by Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia: a Prospective Comparison With Standard Culture Methods

summary:
Background: Ventilator-acquired pneumonia (VAP) is the most prevalent nosocomial infection in intensive care units (ICUs). Early microbiological diagnosis and initial administration of appropriate antimicrobial therapy are associated with a better outcome. Broad-spectrum antibiotics should therefore be administered initially. However, inconsiderate antibiotic use can increase the prevalence of multi-resistant bacteria.
Purpose: A rapid antimicrobial susceptibility method is required to decrease the unnecessary use of empirical broad-spectrum antibiotics. The aim of this study is to compare the efficiency of a rapid antibiogram, provided by E-test strips directly applied to bronchoalveolar lavage (BAL) samples and analysed at 24 h, to that obtained with standard methods of culture which provide a later result.
Study design: This will be an open-label, prospective cohort study of consecutive patients with VAP, conducted in a medical ICU. In addition to standard culture methods, an E-test will be performed directly on BAL samples and analysed at 24 h. Each standard BAL culture will be used as a control for the E-test method.
Primary outcome: The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.
Secondary outcomes: The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method).

Eligibility criteria:

Inclusion criteria: all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) undergoing BAL will be eligible.
Exclusion criteria: contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
Interventions:

BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures. At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method. The final E-test results will be compared with the standard MIC cultures.

ReferenceCitation: Boyer A, Medrano J, Mzali F, Balick-Weber CC, Bessède E, Picard W, Clouzeau B, Bébéar CM, Vargas F, Hilbert G, Rogues AM, Gruson D. Direct testing of bronchoalveolar lavages from ventilator-associated pneumonia patients. Diagn Microbiol Infect Dis. 2012 Jun;73(2):107-10. doi: 10.1016/j.diagmicrobio.2012.02.017. Epub 2012 Apr 5.

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Medrano

full_name: José Medrano

given: José

family: Mzali

full_name: Fatima Mzali

given: Fatima

family: Balick-Weber

full_name: Claude-Charles Balick-Weber

given: Claude-Charles

family: Bessède

full_name: Emilie Bessède

given: Emilie

family: Picard

full_name: Walter Picard

given: Walter

family: Clouzeau

full_name: Benjamin Clouzeau

given: Benjamin

family: Bébéar

full_name: Cécile M Bébéar

given: Cécile M

family: Vargas

full_name: Frédéric Vargas

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Rogues

full_name: Anne Marie Rogues

given: Anne Marie

family: Gruson

full_name: Didier Gruson

given: Didier

journal_name: Diagnostic Microbiology and Infectious Disease

lead_sponsor: Université Victor Segalen Bordeaux 2


title: Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

acronym: Lymphoscreen

summary: The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).

lead_sponsor: Nantes University Hospital


title: Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial

summary: The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

ReferenceCitation: Anota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil JP, Minello A, Jouve JL, Paoletti X, Bedenne L, Guiu B, Bonnetain F. An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma. BMJ Open. 2016 Jun 24;6(6):e010696. doi: 10.1136/bmjopen-2015-010696.

family: Anota

full_name: Amélie Anota

given: Amélie

family: Boulin

full_name: Mathieu Boulin

given: Mathieu

family: Dabakuyo-Yonli

full_name: Sandrine Dabakuyo-Yonli

given: Sandrine

family: Hillon

full_name: Patrick Hillon

given: Patrick

family: Cercueil

full_name: Jean-Pierre Cercueil

given: Jean-Pierre

family: Minello

full_name: Anne Minello

given: Anne

family: Jouve

full_name: Jean-Louis Jouve

given: Jean-Louis

family: Paoletti

full_name: Xavier Paoletti

given: Xavier

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

family: Guiu

full_name: Boris Guiu

given: Boris

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

journal_name: BMJ Open

ReferenceCitation: Boulin M, Hillon P, Cercueil JP, Bonnetain F, Dabakuyo S, Minello A, Jouve JL, Lepage C, Bardou M, Wendremaire M, Guerard P, Denys A, Grandvuillemin A, Chauffert B, Bedenne L, Guiu B. Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial. Aliment Pharmacol Ther. 2014 Jun;39(11):1301-13. doi: 10.1111/apt.12746. Epub 2014 Apr 16.

name: INSERM U866; University of Burgundy; Dijon France

name: Department of Pharmacy; University Hospital; Dijon France

full_name: M. Boulin

given: M.

name: Department of Hepatogastroenterology; University Hospital; Dijon France

full_name: P. Hillon

given: P.

name: Department of Interventional Radiology; University Hospital; Dijon France

full_name: J. P. Cercueil

given: J. P.

name: Methodology and Quality of Life in Oncology Unit (EA 3181) & Quality of Life and Cancer Clinical Research Platform; University Hospital Besançon; Besançon France

full_name: F. Bonnetain

given: F.

name: Methodological and Biostatistics Unit; Georges Francois Leclerc Anticancer Center; Dijon France

family: Dabakuyo

full_name: S. Dabakuyo

given: S.

name: CIC-P INSERM 803; University Hospital; Dijon France

name: Department of Pharmacology-Toxicology; University Hospital; Dijon France

name: Department of Interventional Radiology; University Hospital Vaudois; Lausanne Switzerland

name: Department of Pharmacovigilance; University Hospital; Dijon France

name: Department of Oncology; University Hospital Amiens; Amiens France

location_facility: Centre Hospitalier Universitaire de DIJON


title: Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients

acronym: ANRS 2H

summary:
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.

Definitions:

Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.

Design:

Survey sampling for estimating H1N1v influenza-like illness incidence.
Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.

Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.

Nested case-control study for the determination of risk factors for serious forms:

Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.

Exhaustivity check:

The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.

primary_purpose: Other

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study

acronym: APO-TEP

summary:
In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.

Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.

lead_sponsor: Rennes University Hospital


title: A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer

acronym: CURIEBOOST

summary: The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.

lead_sponsor: Centre Francois Baclesse

intervention_type: Radiation


title: Accelerated Aging, HIV Infection, Antiretroviral Therapies

acronym: EP 45

summary: The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing that antiretroviral therapies induce an accelerated aging through the same mechanisms than genetic laminopathies or than "physiological " aging, that is through the synthesis and persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV infection and of antiretroviral therapies on markers of cell ageing (proteasome, mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using the same drug combination that will be used in few weeks in Marseille to treat children suffering from progeria

ReferenceCitation: Perrin S, Cremer J, Faucher O, Reynes J, Dellamonica P, Micallef J, Solas C, Lacarelle B, Stretti C, Kaspi E, Robaglia-Schlupp A, Nicolino-Brunet C, Tamalet C, Lévy N, Poizot-Martin I, Cau P, Roll P. HIV protease inhibitors do not cause the accumulation of prelamin A in PBMCs from patients receiving first line therapy: the ANRS EP45 "aging" study. PLoS One. 2012;7(12):e53035. doi: 10.1371/journal.pone.0053035. Epub 2012 Dec 28. Erratum in: PLoS One. 2013;8(8). doi:10.1371/annotation/f02cdfd3-b271-46fd-a78f-5a030f0b416d. Tamalet, Corine Nicolino-Brunet Catherine [corrected to Nicolino-Brunet, Corinne]; [ corrected to Tamalet, Catherine].

family: Perrin

full_name: Sophie Perrin

given: Sophie

family: Cremer

full_name: Jonathan Cremer

given: Jonathan

family: Faucher

full_name: Olivia Faucher

given: Olivia

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Dellamonica

full_name: Pierre Dellamonica

given: Pierre

family: Micallef

full_name: JoÃ«lle Micallef

given: JoÃ«lle

family: Solas

full_name: Caroline Solas

given: Caroline

family: Lacarelle

full_name: Bruno Lacarelle

given: Bruno

family: Stretti

full_name: Charlotte Stretti

given: Charlotte

family: Kaspi

full_name: Elise Kaspi

given: Elise

family: Robaglia-Schlupp

full_name: AndrÃ©e Robaglia-Schlupp

given: AndrÃ©e

family: Tamalet

full_name: Corine Nicolino-Brunet Catherine Tamalet

given: Corine Nicolino-Brunet Catherine

family: LÃ©vy

full_name: Nicolas LÃ©vy

given: Nicolas

family: Poizot-Martin

full_name: Isabelle Poizot-Martin

given: Isabelle

family: Cau

full_name: Pierre Cau

family: Roll

full_name: Patrice Roll

given: Patrice

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

version: acceptedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Correction: HIV Protease Inhibitors Do Not Cause the Accumulation of Prelamin A in PBMCs from Patients Receiving First Line Therapy: The ANRS EP45 “Aging” Study

ReferenceCitation: Perrin S, Cremer J, Roll P, Faucher O, Ménard A, Reynes J, Dellamonica P, Naqvi A, Micallef J, Jouve E, Tamalet C, Solas C, Pissier C, Arnoux I, Nicolino-Brunet C, Espinosa L, Lévy N, Kaspi E, Robaglia-Schlupp A, Poizot-Martin I, Cau P. HIV-1 infection and first line ART induced differential responses in mitochondria from blood lymphocytes and monocytes: the ANRS EP45 "Aging" study. PLoS One. 2012;7(7):e41129. doi: 10.1371/journal.pone.0041129. Epub 2012 Jul 19.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

title: HIV-1 Infection and First Line ART Induced Differential Responses in Mitochondria from Blood Lymphocytes and Monocytes: The ANRS EP45 “Aging” Study

location_facility: ANRS center from Marseille, Timone and Montpellier and Nice


title: Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

acronym: VERNIS

summary: This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Randomized Directed Immuno Nutrition by L-arginine for Critically Ill Patients

acronym: Immunolarg

summary: The main objective of this proof-of-concept study is to demonstrate that the only administration of L-arginine, based on a suspected deficit monitored by nasal nitric oxide measurement, can improve immune functions in critically ill patients at high risk of nosocomial infection.

ReferenceCitation: Marik PE, Zaloga GP. Immunonutrition in critically ill patients: a systematic review and analysis of the literature. Intensive Care Med. 2008 Nov;34(11):1980-90. doi: 10.1007/s00134-008-1213-6. Epub 2008 Jul 15. Review.

family: Marik

full_name: Paul E. Marik

given: Paul E.

family: Zaloga

full_name: Gary P. Zaloga

given: Gary P.

journal_name: Intensive Care Medicine

ReferenceCitation: Tadié JM, Cynober L, Peigne V, Caumont-Prim A, Neveux N, Gey A, Guerot E, Diehl JL, Fagon JY, Tartour E, Delclaux C. Arginine administration to critically ill patients with a low nitric oxide fraction in the airways: a pilot study. Intensive Care Med. 2013 Sep;39(9):1663-5. doi: 10.1007/s00134-013-2984-y. Epub 2013 Jun 19.

family: Tadié

full_name: Jean-Marc Tadié

given: Jean-Marc

family: Cynober

full_name: Luc Cynober

given: Luc

family: Peigne

full_name: Vincent Peigne

given: Vincent

family: Caumont-Prim

full_name: Aurore Caumont-Prim

given: Aurore

family: Neveux

full_name: Nathalie Neveux

given: Nathalie

family: Gey

full_name: Alain Gey

given: Alain

family: Guerot

full_name: Emmanuel Guerot

given: Emmanuel

family: Diehl

full_name: Jean-Luc Diehl

given: Jean-Luc

family: Fagon

full_name: Jean-Yves Fagon

given: Jean-Yves

family: Tartour

full_name: Eric Tartour

given: Eric

family: Delclaux

full_name: Christophe Delclaux

given: Christophe

location_facility: Medical Intensive Care Unit, Pompidou Hospital


title: Evaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot Study

summary:
The role of oxytocin (OT) is already known in the regulation of satiety but some clinical studies demonstrated that OT participates also in the regulation of social behavior by its implication on a better comprehension of emotion which plays a role on theory of mind and empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in 1995 showed a significant reduction in number and in volume of neurons expressing OT in the paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients with autism which showed a link between the deregulation of OT and the autistic pathology. Clinical and imaging studies obtained with PWS and autistic populations make us believe that some mechanisms are common between these two pathologies.

The objectives of this project are:

to look for an influence on the understanding of the social codes of the PWS patients,
to look for an influence on the behavior of stress and anxiety and on the regulation of eating habits when patients receive a nasal pulverizing of OT.

ReferenceCitation: Tauber M, Mantoulan C, Copet P, Jauregui J, Demeer G, Diene G, Rogé B, Laurier V, Ehlinger V, Arnaud C, Molinas C, Thuilleaux D. Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients. Orphanet J Rare Dis. 2011 Jun 24;6:47. doi: 10.1186/1750-1172-6-47.

family: Tauber

full_name: Maïthe Tauber

given: Maïthe

family: Mantoulan

full_name: Carine Mantoulan

given: Carine

family: Copet

full_name: Pierre Copet

given: Pierre

family: Jauregui

full_name: Joseba Jauregui

given: Joseba

family: Demeer

full_name: Genevieve Demeer

given: Genevieve

family: Diene

full_name: Gwenaëlle Diene

given: Gwenaëlle

family: Rogé

full_name: Bernadette Rogé

given: Bernadette

family: Laurier

full_name: Virginie Laurier

given: Virginie

family: Ehlinger

full_name: Virginie Ehlinger

family: Arnaud

full_name: Catherine Arnaud

given: Catherine

family: Molinas

full_name: Catherine Molinas

family: Thuilleaux

full_name: Denise Thuilleaux

given: Denise

journal_name: Orphanet Journal of Rare Diseases

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

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study

acronym: EP 44

summary: HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.


title: Randomized, Double-Blind, Placebo-Controlled Trial Assessing Norfloxacin in the Prevention of Complications in Patients With Cirrhosis and Severe Liver Failure

acronym: NORFLOCIR

summary: Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that this translocation may worsen the underlying liver disease. Thus, the aim of this trial was to assess the effects of the oral administration of norfloxacin (an antibiotic that suppresses intestinal Gram-negative bacteria) on the development of complications of cirrhosis.

ReferenceCitation: Moreau R, Elkrief L, Bureau C, Perarnau JM, Thévenot T, Saliba F, Louvet A, Nahon P, Lannes A, Anty R, Hillaire S, Pasquet B, Ozenne V, Rudler M, Ollivier-Hourmand I, Robic MA, d'Alteroche L, Di Martino V, Ripault MP, Pauwels A, Grangé JD, Carbonell N, Bronowicki JP, Payancé A, Rautou PE, Valla D, Gault N, Lebrec D; NORFLOCIR Trial Investigators. Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis. Gastroenterology. 2018 Dec;155(6):1816-1827.e9. doi: 10.1053/j.gastro.2018.08.026. Epub 2018 Aug 23.

apc_source: openAPC

family: Moreau

full_name: Richard Moreau

given: Richard

family: Elkrief

full_name: Laure Elkrief

given: Laure

family: Bureau

full_name: Christophe Bureau

family: Perarnau

full_name: Jean-Marc Perarnau

given: Jean-Marc

family: Thévenot

full_name: Thierry Thévenot

given: Thierry

family: Saliba

full_name: Faouzi Saliba

given: Faouzi

family: Louvet

full_name: Alexandre Louvet

given: Alexandre

family: Nahon

full_name: Pierre Nahon

family: Lannes

full_name: Adrien Lannes

given: Adrien

family: Anty

full_name: Rodolphe Anty

given: Rodolphe

family: Hillaire

full_name: Sophie Hillaire

given: Sophie

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

family: Ozenne

full_name: Violaine Ozenne

given: Violaine

family: Rudler

full_name: Marika Rudler

given: Marika

family: Ollivier-Hourmand

full_name: Isabelle Ollivier-Hourmand

given: Isabelle

family: Robic

full_name: Marie Angèle Robic

given: Marie Angèle

family: d'Alteroche

full_name: Louis d'Alteroche

given: Louis

family: Di Martino

full_name: Vincent Di Martino

given: Vincent

family: Ripault

full_name: Marie-Pierre Ripault

given: Marie-Pierre

family: Pauwels

full_name: Arnaud Pauwels

given: Arnaud

family: Grangé

full_name: Jean-Didier Grangé

given: Jean-Didier

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre


title: In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir: Prospective Multicenter Randomized Trial Versus Placebo

acronym: CYMEVAL

summary: The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.


title: A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase

summary: To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

lead_sponsor: Bioprojet


title: In Vivo Discrimination of Hip Fracture With Quantitative Computed Tomography

acronym: FEMFRACT

summary:
Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).

Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.


title: Epidemiological Study of Trisomy 21 With Research of Correlations Between Phenotype (Physical, Psychometrical) and Genotype (Genome, Transcriptome, Proteome)

acronym: INTREPID

summary: The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in order to identify the biochemical reactions involved in their mental retardation and their other phenotypic characteristics.

lead_sponsor: Institut Jerome Lejeune


title: Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

summary: The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

ReferenceCitation: Chéret A, Durier C, Mélard A, Ploquin M, Heitzmann J, Lécuroux C, Avettand-Fenoël V, David L, Pialoux G, Chennebault JM, Müller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.

family: Chéret

full_name: Antoine Chéret

given: Antoine

family: Durier

full_name: Christine Durier

given: Christine

family: Mélard

full_name: Adeline Mélard

given: Adeline

family: Ploquin

full_name: Mickaël Ploquin

given: Mickaël

family: Heitzmann

full_name: Julia Heitzmann

given: Julia

family: Lécuroux

full_name: Camille Lécuroux

given: Camille

family: Avettand-Fenoël

full_name: Véronique Avettand-Fenoël

given: Véronique

family: David

full_name: Ludivine David

given: Ludivine

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Chennebault

full_name: Jean-Marie Chennebault

given: Jean-Marie

family: Müller-Trutwin

full_name: Michaela Müller-Trutwin

given: Michaela

family: Goujard

full_name: Cécile Goujard

given: Cécile

family: Rouzioux

full_name: Christine Rouzioux

family: Meyer

full_name: Laurence Meyer

given: Laurence

name: on behalf of the ANRS OPTIPRIM study group

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Chéret A, Nembot G, Mélard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoën B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.


summary:
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.

The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.

Its contribution in obstetric must be estimated to improve patients minimum fare.

The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

ReferenceCitation: Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.

family: Sabiani

full_name: Laura Sabiani

given: Laura

family: Haumonte

full_name: Jean-Baptiste Haumonte

given: Jean-Baptiste

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Caro

full_name: Anne-Sophie Caro

given: Anne-Sophie

family: Brunet

full_name: Julie Brunet

given: Julie

family: Cocallemen

full_name: Jean-Francois Cocallemen

given: Jean-Francois

family: D’ercole

full_name: Claude D’ercole

given: Claude

family: Bretelle

full_name: Florence Bretelle

given: Florence

journal_name: European Journal of Obstetrics & Gynecology and Reproductive Biology

oa_host_type: repository

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

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Evaluation of CNAP During Induction and Maintenance of General Anesthesia

acronym: CnapEval

summary:
The purpose of this study is to compare

the non invasive measurement of arterial pressure (CNAP monitor)
with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia

lead_sponsor: Hopital Foch


title: Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury : a Comparative Study on the Effects on PtiO2 and Microdialysis Values

summary: The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

ReferenceCitation: Vialet R, Albanèse J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7.

ReferenceCitation: Sakowitz OW, Stover JF, Sarrafzadeh AS, Unterberg AW, Kiening KL. Effects of mannitol bolus administration on intracranial pressure, cerebral extracellular metabolites, and tissue oxygenation in severely head-injured patients. J Trauma. 2007 Feb;62(2):292-8.

ReferenceCitation: Soustiel JF, Vlodavsky E, Zaaroor M. Relative effects of mannitol and hypertonic saline on calpain activity, apoptosis and polymorphonuclear infiltration in traumatic focal brain injury. Brain Res. 2006 Jul 26;1101(1):136-44. Epub 2006 Jun 19.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Respiratory Muscle Endurance Training in Obese Patients

summary: Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.

primary_purpose: Supportive Care

lead_sponsor: Fondation Edith Seltzer