title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery

acronym: ThermoD-PAC

summary:
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. The investigators currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. the investigators chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann Thorac Surg 1999).

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. The investigators conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


type: EudraCT Number

title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving

summary: The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Pierre Fabre Medicament

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia

summary:
The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation.

Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Behavioral

lead_sponsor_type: academique


title: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

acronym: DIALOG

summary:
This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

study_type: Observational

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Cariou B, Fontaine P, Eschwege E, Lievre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Novo Nordisk A/S


title: Efficacy Of A Removable Intraductal Stent In Duct-To-Duct Biliary Reconstruction To Prevent Biliary Complications In Liver Transplantation: A Randomized Controlled Trial

acronym: BILIDRAINT

summary:
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.

Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.

study_start_date_type: Actual

status: Terminated

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: National Institutes of Health Consensus Development Conference Statement: liver transplantation--June 20-23, 1983. Hepatology. 1984 Jan-Feb;4(1 Suppl):107S-110S. No abstract available.

ReferenceCitation: Consensus conference: Indications for Liver Transplantation, January 19 and 20, 2005, Lyon-Palais Des Congres: text of recommendations (long version). Liver Transpl. 2006 Jun;12(6):998-1011. doi: 10.1002/lt.20765. No abstract available.

ReferenceCitation: Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg. 1994 Apr;219(4):426-34. doi: 10.1097/00000658-199404000-00014.

ReferenceCitation: Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10.

ReferenceCitation: Roberts MS, Angus DC, Bryce CL, Valenta Z, Weissfeld L. Survival after liver transplantation in the United States: a disease-specific analysis of the UNOS database. Liver Transpl. 2004 Jul;10(7):886-97. doi: 10.1002/lt.20137.

ReferenceCitation: Jain A, Reyes J, Kashyap R, Dodson SF, Demetris AJ, Ruppert K, Abu-Elmagd K, Marsh W, Madariaga J, Mazariegos G, Geller D, Bonham CA, Gayowski T, Cacciarelli T, Fontes P, Starzl TE, Fung JJ. Long-term survival after liver transplantation in 4,000 consecutive patients at a single center. Ann Surg. 2000 Oct;232(4):490-500. doi: 10.1097/00000658-200010000-00004.

ReferenceCitation: Sharma S, Gurakar A, Jabbour N. Biliary strictures following liver transplantation: past, present and preventive strategies. Liver Transpl. 2008 Jun;14(6):759-69. doi: 10.1002/lt.21509.

ReferenceCitation: Duailibi DF, Ribeiro MA Jr. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc. 2010 Mar;42(2):517-20. doi: 10.1016/j.transproceed.2010.01.017.

ReferenceCitation: Park JB, Kwon CH, Choi GS, Chun JM, Jung GO, Kim SJ, Joh JW, Lee SK. Prolonged cold ischemic time is a risk factor for biliary strictures in duct-to-duct biliary reconstruction in living donor liver transplantation. Transplantation. 2008 Dec 15;86(11):1536-42. doi: 10.1097/TP.0b013e31818b2316.

ReferenceCitation: Marubashi S, Dono K, Nagano H, Kobayashi S, Takeda Y, Umeshita K, Monden M, Doki Y, Mori M. Biliary reconstruction in living donor liver transplantation: technical invention and risk factor analysis for anastomotic stricture. Transplantation. 2009 Nov 15;88(9):1123-30. doi: 10.1097/TP.0b013e3181ba184a.

ReferenceCitation: Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8. doi: 10.1002/lt.20693.

ReferenceCitation: Shaked A. Use of T tube in liver transplantation. Liver Transpl Surg. 1997 Sep;3(5 Suppl 1):S22-3. No abstract available.

ReferenceCitation: Rolles K, Dawson K, Novell R, Hayter B, Davidson B, Burroughs A. Biliary anastomosis after liver transplantation does not benefit from T tube splintage. Transplantation. 1994 Feb;57(3):402-4. doi: 10.1097/00007890-199402150-00015.

ReferenceCitation: Ben-Ari Z, Neville L, Davidson B, Rolles K, Burroughs AK. Infection rates with and without T-tube splintage of common bile duct anastomosis in liver transplantation. Transpl Int. 1998;11(2):123-6. doi: 10.1007/s001470050115.

ReferenceCitation: Vougas V, Rela M, Gane E, Muiesan P, Melendez HV, Williams R, Heaton ND. A prospective randomised trial of bile duct reconstruction at liver transplantation: T tube or no T tube? Transpl Int. 1996;9(4):392-5. doi: 10.1007/BF00335701.

ReferenceCitation: Scatton O, Meunier B, Cherqui D, Boillot O, Sauvanet A, Boudjema K, Launois B, Fagniez PL, Belghiti J, Wolff P, Houssin D, Soubrane O. Randomized trial of choledochocholedochostomy with or without a T tube in orthotopic liver transplantation. Ann Surg. 2001 Mar;233(3):432-7. doi: 10.1097/00000658-200103000-00019.

ReferenceCitation: Weiss S, Schmidt SC, Ulrich F, Pascher A, Schumacher G, Stockmann M, Puhl G, Guckelberger O, Neumann UP, Pratschke J, Neuhaus P. Biliary reconstruction using a side-to-side choledochocholedochostomy with or without T-tube in deceased donor liver transplantation: a prospective randomized trial. Ann Surg. 2009 Nov;250(5):766-71. doi: 10.1097/SLA.0b013e3181bd920a.

ReferenceCitation: Zalinski S, Soubrane O, Scatton O. Reducing biliary morbidity in full graft deceased donor liver transplantation: is it really a matter of T-tube? Ann Surg. 2010 Sep;252(3):570-1; author reply 571-2. doi: 10.1097/SLA.0b013e3181f07a6b. No abstract available.

ReferenceCitation: Lopez-Andujar R, Oron EM, Carregnato AF, Suarez FV, Herraiz AM, Rodriguez FS, Carbo JJ, Ibars EP, Sos JE, Suarez AR, Castillo MP, Pallardo JM, De Juan Burgueno M. T-tube or no T-tube in cadaveric orthotopic liver transplantation: the eternal dilemma: results of a prospective and randomized clinical trial. Ann Surg. 2013 Jul;258(1):21-9. doi: 10.1097/SLA.0b013e318286e0a0.

ReferenceCitation: Sherman S, Jamidar P, Shaked A, Kendall BJ, Goldstein LI, Busuttil RW. Biliary tract complications after orthotopic liver transplantation. Endoscopic approach to diagnosis and therapy. Transplantation. 1995 Sep 15;60(5):467-70. doi: 10.1097/00007890-199509000-00011.

ReferenceCitation: Ostroff JW. Post-transplant biliary problems. Gastrointest Endosc Clin N Am. 2001 Jan;11(1):163-83.

ReferenceCitation: Vandenbroucke F, Plasse M, Dagenais M, Lapointe R, Letourneau R, Roy A. Treatment of post liver transplantation bile duct stricture with self-expandable metallic stent. HPB (Oxford). 2006;8(3):202-5. doi: 10.1080/13651820500501800.

ReferenceCitation: Chaput U, Scatton O, Bichard P, Ponchon T, Chryssostalis A, Gaudric M, Mangialavori L, Duchmann JC, Massault PP, Conti F, Calmus Y, Chaussade S, Soubrane O, Prat F. Temporary placement of partially covered self-expandable metal stents for anastomotic biliary strictures after liver transplantation: a prospective, multicenter study. Gastrointest Endosc. 2010 Dec;72(6):1167-74. doi: 10.1016/j.gie.2010.08.016.

ReferenceCitation: Farhat S, Bourrier A, Gaudric M, Dousset B, Scatton O, Chaussade S, Prat F. Endoscopic treatment of biliary fistulas after complex liver resection. Ann Surg. 2011 Jan;253(1):88-93. doi: 10.1097/SLA.0b013e3181f9b9f0.

ReferenceCitation: Tranchart H, Zalinski S, Sepulveda A, Chirica M, Prat F, Soubrane O, Scatton O. Removable intraductal stenting in duct-to-duct biliary reconstruction in liver transplantation. Transpl Int. 2012 Jan;25(1):19-24. doi: 10.1111/j.1432-2277.2011.01339.x. Epub 2011 Sep 29.

ReferenceCitation: Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.

ReferenceCitation: Gastaca M. Biliary complications after orthotopic liver transplantation: a review of incidence and risk factors. Transplant Proc. 2012 Jul-Aug;44(6):1545-9. doi: 10.1016/j.transproceed.2012.05.008.

ReferenceCitation: CATTELL RB, BRAASCH JW. An eveluation of the long T-tube. Ann Surg. 1961 Aug;154(2):252-4. doi: 10.1097/00000658-196108000-00009. No abstract available.

ReferenceType: derived

ReferenceCitation: Goumard C, Boleslawski E, Brustia R, Dondero F, Herrero A, Lesurtel M, Barbier L, Lecolle K, Soubrane O, Bouyabrine H, Mabrut JY, Salame E, Cachanado M, Simon T, Scatton O. Duct-to-duct biliary reconstruction with or without an intraductal removable stent in liver transplantation: The BILIDRAIN-T multicentric randomised trial. JHEP Rep. 2022 Jul 6;4(10):100530. doi: 10.1016/j.jhepr.2022.100530. eCollection 2022 Oct.

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: HAL

version: publishedVersion

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: green

ReferenceCitation: Goumard C, Cachanado M, Herrero A, Rousseau G, Dondero F, Compagnon P, Boleslawski E, Mabrut JY, Salame E, Soubrane O, Simon T, Scatton O. Biliary reconstruction with or without an intraductal removable stent in liver transplantation: study protocol for a randomized controlled trial. Trials. 2015 Dec 30;16:598. doi: 10.1186/s13063-015-1139-6.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

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

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device

status_simplified: Unknown

appel_a_projets: PHRCI

titre: Essai comparatif randomisé évaluant l'efficacité de la mise en place d'un drain biliaire interne au cours de la reconstruction biliaire dans la prévention des complications biliaires après transplantation hépatique


acronym: ENVOL

summary:
Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.

time_perspective: Prospective

ReferenceCitation: Tellouck L, Durieux M, Coupe P, Cougnard-Gregoire A, Tellouck J, Tourdias T, Munsch F, Garrigues A, Helmer C, Malet F, Dartigues JF, Dousset V, Delcourt C, Schweitzer C. Optic Radiations Microstructural Changes in Glaucoma and Association With Severity: A Study Using 3Tesla-Magnetic Resonance Diffusion Tensor Imaging. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6539-6547. doi: 10.1167/iovs.16-19838.

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

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

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

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

lead_sponsor: University Hospital, Bordeaux

collaborators: Union National des Aveugles et DEficients Visuels

location_facility: Service d'ophtalmologie Hôpital Pellegrin


title: Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

acronym: VOSETEP

summary:
Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.

lead_sponsor: Centre Henri Becquerel


lead_sponsor: Bioprojet

summary: Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

title: Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo

source: euctr


title: Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.

acronym: HLS

summary:
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).

Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.

The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.

The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Hospices Civils de Lyon


title: Thérapie Cellulaire au Cours Des Syndromes d'Insuffisance en Cellules Souches Limbiques

summary: Transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human amniotic membrane with no feeders in eyes with total limbal deficiency. Prospective non-comparative monocentric study.

ReferenceCitation: Borderie VM, Ghoubay D, Georgeon C, Borderie M, de Sousa C, Legendre A, Rouard H. Long-Term Results of Cultured Limbal Stem Cell Versus Limbal Tissue Transplantation in Stage III Limbal Deficiency. Stem Cells Transl Med. 2019 Dec;8(12):1230-1241. doi: 10.1002/sctm.19-0021. Epub 2019 Sep 5.

ipd_sharing: No

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

intervention_type: Procedure


title: Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function

summary: This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.

design_allocation: Non-Randomized


title: LEft Atrial Pacing in Diastolic Heart Failure

acronym: LEAD

summary: The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

acronym: EnteroLarc

summary: The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients

acronym: RRR

summary: COPD is characterized by exagerated decline FEV1 related to obstructive non reversible airflow. This could be the consequence of structural changes and inflammatory pattern of the bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD including a decrease in Club cells number and function.There is no treatment actually available targeted to a normal repair of the epithelium. The objective of this work is to identify potential targets for reprograming bronchial epithelial cells I order to achieve a good repair.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier


title: Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision

acronym: CATPAR

summary: Upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a recognized tool for measuring the diaphragmatic function.The purpose of this study is to evaluate the effectiveness of parietal analgesia with continuous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our secondary outcomes are the evaluation of the effect of continuous parietal analgesia with ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and post operative recovery. This prospective study will determine if the pre peritoneal local infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.

lead_sponsor: University Hospital, Rouen


title: Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

acronym: OTOPHOS

summary: The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis


title: Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient

summary: The decision to extubate a patient after acute respiratory failure is based on clinical observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume, respiratory frequency...) lack of specificity. The best way to evaluate and predict patients breathing abilities after extubation is to challenge him to a spontaneous breathing trial (SBT) with endotracheal tube in place immediately before extubation to predict the patient's ability to breathe spontaneously after extubation. The intention is to approximate, while the patient is still intubated, the work of breathing that will be required of the patient after extubation. Different approaches of ventilatory settings are currently used for the preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all supported by literature with different benefits. To the investigators knowledge, few studies define which mode of ventilation most closely approximates the work of breathing during spontaneous respiration after extubation, and none have studied a specific population of obese patient in respiratory weaning. The main objective of the investigators study is to determine, between five different SBT, which one is the best to approximate the work of breathing of obese patient after extubation.

ReferenceCitation: Mahul M, Jung B, Galia F, Molinari N, de Jong A, Coisel Y, Vaschetto R, Matecki S, Chanques G, Brochard L, Jaber S. Spontaneous breathing trial and post-extubation work of breathing in morbidly obese critically ill patients. Crit Care. 2016 Oct 27;20(1):346. doi: 10.1186/s13054-016-1457-4.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Limoges

repositories:
HAL
PubMed Central
localhost

repositories_concat: HAL;PubMed Central;localhost

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_pmh: HAL europepmc.org localhost

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


title: Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)

acronym: TELEGRAFT

summary: The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.

primary_purpose: Other


title: Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy

summary:
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.

Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.

Methods: 330 patients are planned to be included and followed for 2 years

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)

acronym: TEP-GVH

summary:
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.

PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.

Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.

The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen


title: Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study

summary: The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)

primary_purpose: Supportive Care

ReferenceCitation: Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21. Erratum In: United European Gastroenterol J. 2017 Mar;5(2):304.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

lead_sponsor: Lesaffre International

collaborators:
BioFortis
University of Nottingham

sponsor_collaborators:
Lesaffre International
BioFortis
University of Nottingham

intervention_type: Dietary Supplement


title: Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

acronym: CHLORHEX

summary:
Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.

ReferenceCitation: D'Journo XB, Falcoz PE, Alifano M, Le Rochais JP, D'Annoville T, Massard G, Regnard JF, Icard P, Marty-Ane C, Trousse D, Doddoli C, Orsini B, Edouard S, Million M, Lesavre N, Loundou A, Baumstarck K, Peyron F, Honore S, Dizier S, Charvet A, Leone M, Raoult D, Papazian L, Thomas PA. Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial. Intensive Care Med. 2018 May;44(5):578-587. doi: 10.1007/s00134-018-5156-2. Epub 2018 Apr 18.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.

acronym: PROCOPES

summary:
The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.

Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)

summary: The aim of this study was to validate functions for estimating energy expenditure in controlled and free-living conditions. This method was based on accelerometry data acquired from smartphones worn in a trouser pocket. The developed functions have been compared to the estimations provided by three research devices named Fitmate, Armband and Actiheart.

ReferenceCitation: Rousset S, Fardet A, Lacomme P, Normand S, Montaurier C, Boirie Y, Morio B. Comparison of total energy expenditure assessed by two devices in controlled and free-living conditions. Eur J Sport Sci. 2015;15(5):391-9. doi: 10.1080/17461391.2014.949309. Epub 2014 Aug 21.

ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Centre de Recherche en Nutrition Humaine d'Auvergne


title: Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy

summary:
For patients relapsing after platinum-based therapy, few data are available. The current use of cetuximab associated with radiotherapy in localized disease and associated with platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based on a clinical review, show encouraging antitumour activity and an acceptable safety profile. Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen after platinum failure.

The present study has been designed as a multicenter, randomised phase III study which will compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN patients having failed platinum-based therapy.

lead_sponsor: Pierre Fabre Medicament


title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial

acronym: SPACING

summary: Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.


title: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

ReferenceCitation: Rat C, Hild S, Gaultier A, Khammari A, Bonnaud-Antignac A, Quereux G, Dreno B, Nguyen JM. Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma. BMJ Open. 2017 Oct 5;7(10):e016071. doi: 10.1136/bmjopen-2017-016071.

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

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

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

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

publisher_dissemination: British Medical Journal

ReferenceCitation: Rat C, Grimault C, Quereux G, Dagorne M, Gaultier A, Khammari A, Dreno B, Nguyen JM. Proposal for an annual skin examination by a general practitioner for patients at high risk for melanoma: a French cohort study. BMJ Open. 2015 Jul 29;5(7):e007471. doi: 10.1136/bmjopen-2014-007471.

ReferenceCitation: Rat C, Quereux G, Grimault C, Gaultier A, Khammari A, Dreno B, Nguyen JM. Melanoma incidence and patient compliance in a targeted melanoma screening intervention. One-year follow-up in a large French cohort of high-risk patients. Eur J Gen Pract. 2015 Jun;21(2):124-30. doi: 10.3109/13814788.2014.949669. Epub 2014 Aug 20.


title: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

summary: The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

time_perspective: Other

location_facility: APHP Robert-Debré, Department of Pediatric Nephrology

intervention_type: Genetic


title: Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

acronym: REHAB

summary: Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

location_facility: Service de chirurgie Colorectale / Hôpital Beaujon


title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

summary: Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.


title: IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer

acronym: IClyCO

summary:
In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.

The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.

lead_sponsor: Rennes University Hospital


title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

summary: This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.

sponsor_collaborators:
Lesaffre International
Eurofins Optimed


title: ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients

summary: The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensitivity to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

ReferenceCitation: Matheron S, Descamps D, Gallien S, Besseghir A, Sellier P, Blum L, Mortier E, Charpentier C, Tubiana R, Damond F, Peytavin G, Ponscarme D, Collin F, Brun-Vezinet F, Chene G; France REcherche Nord&Sud Sida-Hiv Hepatites (ANRS) 159 HIV-2 Trial Study Group. First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2). Clin Infect Dis. 2018 Sep 28;67(8):1161-1167. doi: 10.1093/cid/ciy245.

evidence: open (via crossref license)

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

publisher_dissemination: Oxford University Press

lead_sponsor: ANRS, Emerging Infectious Diseases

collaborators:
Gilead Sciences
Merck Sharp & Dohme LLC

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Gilead Sciences
Merck Sharp & Dohme LLC


title: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo

acronym: TAPlastie

summary:
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.

The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.

location_facility: CHU de Bordeaux, Centre François-Xavier Michelet


title: Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.

acronym: BACLOVILLE

summary: The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.

ReferenceCitation: Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Société de Formation Thérapeutique du Généraliste

collaborators: Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist


title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial

summary: Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.

ReferenceCitation: Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.

location_facility: Service d'urologie, Hôpital Edouard Herriot


title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

acronym: NMDA

summary:
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.

In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.

ReferenceCitation: Pickering G, Pereira B, Morel V, Tiberghien F, Martin E, Marcaillou F, Picard P, Delage N, de Montgazon G, Sorel M, Roux D, Dubray C. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients. Contemp Clin Trials. 2014 Jul;38(2):314-20. doi: 10.1016/j.cct.2014.06.004. Epub 2014 Jun 16.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital

collaborators: Dr Marc Sorel, Pain Clinic, Nemours Hospital

collaborators: Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital

collaborators: Dr Monique Belon, Pain Clinic, Aurillac Hospital

collaborators: Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital

collaborators: Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital

collaborators: Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital


title: Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients

acronym: PIRATE

summary: The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.


title: Comparative Study of Different Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis

acronym: MUCO-FIBRO

summary:
Non-invasive methods of the quantification of fibrosis may help to assess the development of fibrosis at a specific moment of the evolution of the disease, in the order to decide the initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic cirrhosis:

FibroTest,
The ultrasound impulse elastography, Fibroscan (FS)
Ultrasound Elastography by ShearWave (SWE)
Magnetic resonance elastography (MRE). The purpose of this study is to assess the contribution of these methods in the diagnosis of hepatic fibrosis during the evolution of the cystic fibrosis.

primary_purpose: Screening

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose


acronym: SEMAINE

summary: The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.

sponsor_collaborators:
Hospices Civils de Lyon
University of Konstanz


title: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003

summary: PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.

ReferenceCitation: Sabatier R, Garnier S, Guille A, Carbuccia N, Pakradouni J, Adelaide J, Provansal M, Cappiello M, Rousseau F, Chaffanet M, Birnbaum D, Mamessier E, Goncalves A, Bertucci F. Whole-genome/exome analysis of circulating tumor DNA and comparison to tumor genomics from patients with heavily pre-treated ovarian cancer: subset analysis of the PERMED-01 trial. Front Oncol. 2022 Jul 29;12:946257. doi: 10.3389/fonc.2022.946257. eCollection 2022.

publisher_dissemination: Frontiers

ReferenceCitation: Bertucci F, Goncalves A, Guille A, Adelaide J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pecheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, Andre F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

lead_sponsor: Institut Paoli-Calmettes

sponsor_collaborators:
Institut Paoli-Calmettes
Cancer Research Center of Marseille


title: AVEC-TC : Post-traumatic Behavioral Disorders : Analysis and Valuation of the Expertise of Use of the Close Relations of People Victims of Traumatic Brain Injury

acronym: AVEC-TC

summary: Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.

ReferenceCitation: Saout V, Gambart G, Leguay D, Ferrapie AL, Launay C, Richard I. Aggressive behavior after traumatic brain injury. Ann Phys Rehabil Med. 2011 Jun;54(4):259-69. doi: 10.1016/j.rehab.2011.04.003. Epub 2011 May 5. English, French.

ReferenceCitation: Bayen E, Pradat-Diehl P, Jourdan C, Ghout I, Bosserelle V, Azerad S, Weiss JJ, Joel ME, Aegerter P, Azouvi P; Steering Committee of the PariS-TBI study. Predictors of informal care burden 1 year after a severe traumatic brain injury: results from the PariS-TBI study. J Head Trauma Rehabil. 2013 Nov-Dec;28(6):408-18. doi: 10.1097/HTR.0b013e31825413cf.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Fugate LP, Spacek LA, Kresty LA, Levy CE, Johnson JC, Mysiw WJ. Measurement and treatment of agitation following traumatic brain injury: II. A survey of the Brain Injury Special Interest Group of the American Academy of Physical Medicine and Rehabilitation. Arch Phys Med Rehabil. 1997 Sep;78(9):924-8. doi: 10.1016/s0003-9993(97)90051-4.

ReferenceCitation: Osiurak F, Jarry C, Allain P, Aubin G, Etcharry-Bouyx F, Richard I, Bernard I, Le Gall D. Unusual use of objects after unilateral brain damage: the technical reasoning model. Cortex. 2009 Jun;45(6):769-83. doi: 10.1016/j.cortex.2008.06.013. Epub 2008 Nov 8.

lead_sponsor: University Hospital, Angers


type: Registry Identifier

title: Exploration by NMR Spectroscopy of the Choline Concentrations in the Insular Cortex of Patients Suffering of Neuropathic Pain Induced by Oxaliplatin

acronym: INSULOX

summary:
Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling neuropathic pain that can last for months or even years after the end of chemotherapy. Currently, there is no effective neuroprotective treatment to prevent or relieve this pain. The only strategy is the reduction of oxaliplatin doses or premature discontinuation of therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding of the pathophysiology of these iatrogenic neuropathies appears necessary in order to discover new potential therapeutic targets.

Preclinical works were able to demonstrate important metabolic changes in certain brain structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of choline concentration has been found in the posterior insular cortex of neuropathic animals compared with control animals. Furthermore, the concentrations of choline were positively correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would involve the posterior insular cortex and would be associated with an increase in choline concentration at this level. Clinical translation of these preclinical results is feasible in practice since choline concentration can be determined in the brain by non-invasive magnetic resonance spectroscopy.


title: Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)

acronym: LymphoSeq

summary: This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment

ReferenceCitation: Camus V, Sarafan-Vasseur N, Bohers E, Dubois S, Mareschal S, Bertrand P, Viailly PJ, Ruminy P, Maingonnat C, Lemasle E, Stamatoullas A, Picquenot JM, Cornic M, Beaussire L, Bastard C, Frebourg T, Tilly H, Jardin F. Digital PCR for quantification of recurrent and potentially actionable somatic mutations in circulating free DNA from patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2016 Sep;57(9):2171-9. doi: 10.3109/10428194.2016.1139703. Epub 2016 Feb 17.

publisher_dissemination: Informa

lead_sponsor: Centre Henri Becquerel

sponsor_collaborators:
Centre Henri Becquerel
U918 ( Inserm unit)


title: Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study

acronym: SIMBIOSE

summary: The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.

ReferenceCitation: Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyere E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.

evidence: oa repository (via OAI-PMH title and first author match)

publisher_dissemination: Springer

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

location_facility: Claude Huriez Hospital, University hospital


title: Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

acronym: NICOM-MAP

summary: Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

lead_sponsor: Hopital Foch


title: Phase 2, Monocentric, Single Blind Study, Comparing the Efficacy and Tolerance of a Dipyridamole/Adenosine Combination Given Intravenously, as a Slow Bolus and at Low Doses to Adenosine Alone for Coronary Flow Reserve Assessment (in Patients With Stable Ischemic Heart Disease) Using Transthoracic Echodoppler

summary: The purpose of this study is to evaluate the efficacy and tolerance of a dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using transthoracic echodoppler

lead_sponsor: Adenobio N.V


title: Evaluation of States in Major Depressive Patients With Cancer, Hospitalized in a Hospital Palliative

acronym: DECAPAL

summary: The investigators propose a study that aims to develop a methodology for assessing this risk and the psychological consequences of the malignancy in the palliative phase.

lead_sponsor: Centre Francois Baclesse


title: Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

acronym: IVT NonVent

summary: The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial

acronym: FISCLOSE

summary:
Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common and generally associated with pain, anal incontinence, impaired quality of life and work incapacity. The therapeutic management of this disease has a double objective: heal the suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000 in the normal population, with a difference in prevalence between men and women (1.23 per 10 000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et al., 2012).

In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses' anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an abscess between the internal and external sphincters, which in turn can spread to other parts of the perianal region. The infection can follow many directions from this point in the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula therefore has always an intraductal origin, cryptic, with a primary port at this level, and the disregard of which causes the recurrence of the fistula; and usually a secondary port in the skin.

Fistulas are usually divided into two groups. The first group contains fistulas called "simple", which are intersphincteric fistulas or trans-sphincteric involving only the lower third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group contains fistulas called "complex". These are intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric fistulas.

For many years, the treatment of choice was to open the fistula (fistulotomy), but this procedure was associated with a risk of incontinence, the consequences could be potentially devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and advancement flap technique to cover internal opening of the fistula. The success of these therapies remains variable.

The advancement flap technique remains a strategy of choice in the treatment of anal fistulas and particularly in the case of complex fistulas. The success rate of the advancement flap technique remains variable across studies but a recent meta-analysis finds a success rate of around 60%.

A new technique for closing anal fistula is currently in development with the use of a closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners). This new technique has been validated in a porcine model of anal fistula, ensuring the safety of the device. A first case was published in a patient with complex anal fistula (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after surgery, the fistula was healed and the clip was removed by cutting with special pliers. This technique is currently being broadcast and dozens of patients were treated with this clip without any further scientific validation of the process.

To date, this innovative technique of the closure clip has not yet been assessed in a randomized controlled trial. It is therefore essential to carry out a prospective evaluation in order to determine the effectiveness and safety of this new device in the case of complex anal fistulas.

ReferenceCitation: Dubois A, Carrier G, Pereira B, Gillet B, Faucheron JL, Pezet D, Balayssac D. Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial--FISCLOSE. BMJ Open. 2015 Dec 16;5(12):e009884. doi: 10.1136/bmjopen-2015-009884.


title: Metabolic Intervention Using Resveratrol in Patients With Huntington Disease

acronym: REVHD

summary: The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the caudate volume in HD patients, using volumetric MRI.

location_facility: Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: REV HD

titre: Etude de phase IIa dans la maladie de Huntington visant à évaluer le potentiel thérapeutique du resvératrol

discipline_principale: génétique

nom_porteur: MOCHEL

prenom_porteur: Fanny


title: Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

acronym: DERENEDIAB

summary: The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized, controlled study of the effectiveness of renal denervation in addition to standardized medical treatment compared to medical treatment alone in diabetic subjects with diabetic nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.


title: Impact of DYSpnea on the ouTcome of Patients Admitted for an Acute RESpiratory Failure in the intenSive Care Unit

acronym: DYSTRESS

summary: Although pain has been extensively studied in ICU patients, only a few studies have focused on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of the present study is to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorders.

ReferenceCitation: Demoule A, Hajage D, Messika J, Jaber S, Diallo H, Coutrot M, Kouatchet A, Azoulay E, Fartoukh M, Hraiech S, Beuret P, Darmon M, Decavele M, Ricard JD, Chanques G, Mercat A, Schmidt M, Similowski T; REVA Network (Research Network in Mechanical Ventilation). Prevalence, Intensity, and Clinical Impact of Dyspnea in Critically Ill Patients Receiving Invasive Ventilation. Am J Respir Crit Care Med. 2022 Apr 15;205(8):917-926. doi: 10.1164/rccm.202108-1857OC.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

publisher_dissemination: American Thoracic Society


title: Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function

acronym: Hyper-Cor

summary: Identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. Hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial

summary: Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages & Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.

ReferenceCitation: Meziere A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canoui-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.

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

lead_sponsor: Ages et Vies Association

collaborators: Caisse Nationale de Solidarité pour l'Autonomie


title: Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.

acronym: ACTIVIH

summary: Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).

lead_sponsor: University Hospital, Montpellier

intervention_type: Biological


title: Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®

acronym: EVOSKIN

summary: Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

lead_sponsor: University Hospital, Limoges


title: Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy

acronym: PEEPSO

summary: This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
Université de Lille


title: Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study

acronym: SANIBA

summary: It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
MAYZAUD


title: Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain

acronym: PARAJUG

summary: This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.

ReferenceCitation: Pickering G, Moustafa F, Macian N, Schmidt J, Pereira B, Dubray C. A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial. Pain Physician. 2015 May-Jun;18(3):249-57.


title: Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.

acronym: CEVOREM

summary: To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.

appel_a_projets: PHRCK

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: CEVOREM

titre: Association de l'everolimus et de l'octréotide dans les méningiomes agressifs et évolutifs, non accessibles à la chirurgie ou la radiothérapie.

discipline_principale: neurooncology

nom_porteur: GRAILLON

prenom_porteur: Thomas


title: Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents

summary: This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

primary_purpose: Health Services Research

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval


title: Can Diaphragm Pacing Delay Non Invasive Ventilation in Amyotrophic Lateral Sclerosis ? a Randomized Controlled Study

acronym: RespiStimALS

summary: ALS is is characterized by a progressive degeneration of motor neurons, leading to progressive weakness of muscles, including respiratory muscles, the diaphragm. Although specific therapy is lacking, correct respiratory therapy improves quality of life and increases survival. Substituting the failing respiratory muscles by non invasive mechanical ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic nerve stimulation is a new treatment and has been the object of a preliminary international proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve stimulation in one group and a sham stimulation in the other group. Although, all the patients will be implanted, thus, at the end of the study, all the patients will receive effective stimulation.

ReferenceCitation: Guimaraes-Costa R, Similowski T, Rivals I, Morelot-Panzini C, Nierat MC, Bui MT, Akbar D, Straus C, Romero NB, Michel PP, Menegaux F, Salachas F, Gonzalez-Bermejo J, Bruneteau G; RespiStimALS team; contributors to the RespiStimALS study were:. Human diaphragm atrophy in amyotrophic lateral sclerosis is not predicted by routine respiratory measures. Eur Respir J. 2019 Feb 14;53(2):1801749. doi: 10.1183/13993003.01749-2018. Print 2019 Feb.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Gonzalez-Bermejo J, Morelot-Panzini C, Tanguy ML, Meininger V, Pradat PF, Lenglet T, Bruneteau G, Forestier NL, Couratier P, Guy N, Desnuelle C, Prigent H, Perrin C, Attali V, Fargeot C, Nierat MC, Royer C, Menegaux F, Salachas F, Similowski T. Early diaphragm pacing in patients with amyotrophic lateral sclerosis (RespiStimALS): a randomised controlled triple-blind trial. Lancet Neurol. 2016 Nov;15(12):1217-1227. doi: 10.1016/S1474-4422(16)30233-2. Epub 2016 Oct 11. Erratum In: Lancet Neurol. 2016 Dec;15(13):1301.

collaborators: ARSla (Association pour la recherche sur la SLA)


title: Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

acronym: ANOSOGNOSIA

summary:
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.

Secondary objectives are :

identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
explore the links between the anosognosia manifestations and the psychological manifestations

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

summary: This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

ReferenceCitation: Borson-Chazot F, Chabre O, Salenave S, Klein M, Brac de la Perriere A, Reznik Y, Kerlan V, Hacques E, Villette B. Adherence to growth hormone therapy guidelines in a real-world French cohort of adult patients with growth hormone deficiency. Ann Endocrinol (Paris). 2021 Feb;82(1):59-68. doi: 10.1016/j.ando.2020.11.007. Epub 2020 Dec 5.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

lead_sponsor: Novo Nordisk A/S


title: A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

acronym: Nutri-DPC

summary:
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits.

The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition.

A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively).

Hypothesis :

The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).

lead_sponsor: Hospices Civils de Lyon

location_facility: Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot


title: French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

summary: This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)


title: A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT

acronym: PAZOGLIO

summary: A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)

status: Recruiting

lead_sponsor: Centre Antoine Lacassagne

sponsor_collaborators:
Centre Antoine Lacassagne
GlaxoSmithKline

status_simplified: Ongoing


title: Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies

summary: The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.

ReferenceCitation: Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;open-archive.highwire.org

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Non Opioid Treatment for Experimental Dyspnea

acronym: Nefopel

summary: The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease

acronym: OculoMacl

summary:
The aim of this study is to determine whether saccadic eye movement recording may help in the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the disease.

Study type: Interventional Study design: Intervention Model: Single group assignment Primary purpose: Diagnostic

location_facility: Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital


title: Hypothalamus Connectivity in Chronic and Episodic Migraine in Headache-free Period: A Resting State Functional Magnetic Resonance Imaging Study

acronym: HYPOTHAMIG

summary: The purpose is to compare, using functional magnetic resonance imagery in resting-state, the connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of chronic migraineurs, studied outside a migraine attack and is compared to gender- and age- matched episodic migraineurs with very few attacks per month and studied in the attack-free period. The primary outcome will be the connectivity index of the hypothalamus to brainstem areas activated during migraine attacks and to the trigeminal-cervical complex.

ReferenceCitation: Denuelle M, Fabre N. Functional neuroimaging of migraine. Rev Neurol (Paris). 2013 May;169(5):380-9. doi: 10.1016/j.neurol.2013.02.002. Epub 2013 Apr 18.

ReferenceCitation: Lerebours F, Boulanouar K, Barege M, Denuelle M, Bonneville F, Payoux P, Larrue V, Fabre N. Functional connectivity of hypothalamus in chronic migraine with medication overuse. Cephalalgia. 2019 Jun;39(7):892-899. doi: 10.1177/0333102419833087. Epub 2019 Mar 5.

publisher_dissemination: SAGE Publications

lead_sponsor: University Hospital, Toulouse


title: Phase II Study of the Efficacy and Safety of a Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Identified by F-miso PET/CT in Patients With Stage III Non-small-cell Lung Cancer (NSCLC) Not Amenable to Curative Surgical Resection Who Are Candidate for Curative Radio-chemotherapy

summary:
This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy.

Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach.

The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.

ReferenceCitation: Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.

ReferenceCitation: Thureau S, Dubray B, Modzelewski R, Bohn P, Hapdey S, Vincent S, Anger E, Gensanne D, Pirault N, Pierrick G, Vera P. FDG and FMISO PET-guided dose escalation with intensity-modulated radiotherapy in lung cancer. Radiat Oncol. 2018 Oct 23;13(1):208. doi: 10.1186/s13014-018-1147-2.

ReferenceCitation: Vera P, Thureau S, Chaumet-Riffaud P, Modzelewski R, Bohn P, Vermandel M, Hapdey S, Pallardy A, Mahe MA, Lacombe M, Boisselier P, Guillemard S, Olivier P, Beckendorf V, Salem N, Charrier N, Chajon E, Devillers A, Aide N, Danhier S, Denis F, Muratet JP, Martin E, Riedinger AB, Kolesnikov-Gauthier H, Dansin E, Massabeau C, Courbon F, Farcy Jacquet MP, Kotzki PO, Houzard C, Mornex F, Vervueren L, Paumier A, Fernandez P, Salaun M, Dubray B. Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients with Non-Small Cell Lung Carcinoma (RTEP5 Study). J Nucl Med. 2017 Jul;58(7):1045-1053. doi: 10.2967/jnumed.116.188367. Epub 2017 Mar 2.

publisher_dissemination: Society of Nuclear Medicine

lead_sponsor: Centre Henri Becquerel

intervention_type: Radiation


title: Past Pain Experience and Perception of Experimental Pain

summary:
Differences in pain perception between subjects with and without psychiatric illness may be influenced by the individual experience, and not primarily by the pathology, although the pathological frame may amplify it.The aim of this study is to establish if the characteristics of experimental pain feeling are influenced by the past pain experience, anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated by an inventory of the potentially painful situations that one can come across through the life, to determine the following points : Number of painful events in the past, number of painful points during the last 6 months, number of painful events lasting more than 6 months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly affective, mostly sensorial, or both).

Schizophrenic, depressed and control participants will be recruited, and their pain experience throughout life will be put it in relation to experimental pain tests results (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR) variation, Blood Pressure (BP) variation.

ReferenceCitation: Girard M, Plansont B, Bonnabau H, Malauzat D. Experimental pain hypersensitivity in schizophrenic patients. Clin J Pain. 2011 Nov-Dec;27(9):790-5. doi: 10.1097/AJP.0b013e31821d904c.

lead_sponsor: Centre Hospitalier Esquirol


title: Development and Validation of a Limb Volumetry Technique Applicable in Daily Clinical Practice Using Self Positioning 3D Laser Scanning:Reproductibility and Comparison to the Reference Method

summary:
Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3D laser scanner.

Water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. The most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured.

Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3D reconstruction.

Its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. This approach will ultimately provide data that will used for designing personalized limb compression ortheses.


title: Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.

summary: The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.

lead_sponsor: Pierre Fabre Medicament


title: Behavioural and Metabolic Consequences of Increasing Eating Frequency

acronym: SAFRAN

summary:
In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :

the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
eating behavior during an ad libitum buffet test meal

location_facility: Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine


title: Influence of Sleep Apnea Syndrome and Its Treatment by Positive Airway Pressure Therapy on Transcutaneous Oxygen Tension (PtcO2) in Patients With Foot Wound or at Risk for Foot Wound

acronym: SAS-FOOT

summary: Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.The secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

time_perspective: Cross-Sectional

lead_sponsor: AGIR à Dom

location_facility: Diabetes and Endocrinology Unit, Grenoble University Hospital