title: An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Activity and Safety of a Combination of Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma.

summary: This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin's lymphoma (NHL).

ReferenceCitation: Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol. 1993 Oct;20(5 Suppl 5):75-88. Review.

ReferenceCitation: McLaughlin P, Hagemeister FB, Romaguera JE, Sarris AH, Pate O, Younes A, Swan F, Keating M, Cabanillas F. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J Clin Oncol. 1996 Apr;14(4):1262-8.

ReferenceCitation: Maloney DG, Grillo-López AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, Janakiraman N, Foon KA, Liles TM, Dallaire BK, Wey K, Royston I, Davis T, Levy R. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997 Sep 15;90(6):2188-95.

ReferenceCitation: McLaughlin P, Grillo-Lopez AJ, Maloney DG, Link BK, Levy R, Czuczman MS, Cabanillas F, Dallaire BK, White CA: Efficacy controls and long-term follow-up of patients treated with rituximab for relapsed or refractory, low-grade or follicular NHL. Blood 92:414a, 1998

lead_sponsor: Lymphoma Study Association

location_facility: Service d'hématologie clinique - Hôpital de Pontchaillou

location_facility: Centre régional de lutte contre le cancer Léon Bérard

location_facility: Service d'hématologie clinique - Centre Hospitalier du Dr Schaffner

location_facility: Service d'hématologie Institut Gustave Roussy

location_facility: Hôpital Claude Huriez - Sce des Maladies du Sang - Place Verdun

location_facility: Service d'Hématologie Hôpital Jean Minjoz

location_facility: Service de médecine D - Maladies du Sang CHU Angers

location_facility: Service d'hématologie Institut Paoli Calmette


title: ETAMI-Study: Early Thienopyridine Treatment to Improve Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

acronym: ETAMI

summary: Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Zeymer U, Mochmann HC, Mark B, Arntz HR, Thiele H, Diller F, Montalescot G, Zahn R. Double-blind, randomized, prospective comparison of loading doses of 600 mg clopidogrel versus 60 mg prasugrel in patients with acute ST-segment elevation myocardial infarction scheduled for primary percutaneous intervention: the ETAMI trial (early thienopyridine treatment to improve primary PCI in patients with acute myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):147-154. doi: 10.1016/j.jcin.2014.09.007. Epub 2014 Nov 4.

ipd_sharing: No

lead_sponsor: Stiftung Institut fuer Herzinfarktforschung

location_country: Germany France

location_facility: Charité Campus Benjamin Franklin, Med. Klinik II

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

acronym: ABSCESSBIOT

summary:
Aseptic abscess syndrome (AA) is a rare entity characterized by the occurrence of deep abscesses with no germ found. Antibiotic therapy is ineffective and they are sensitive to anti-inflammatory treatment with corticosteroids.

Gut microbiota is important for the development of the immune system. In Crohn's disease which is frequently associated with AA syndrome, dysbiosis is found but could also be involved in the immune response at a distance from the gut.

Stool, blood, saliva and urine samples will be taken from the patients included and their controls in the centers where they are followed. These biological samples will be transported to Clermont Ferrand using the same procedure (transporter and dry ice) where the following analyses will be performed: microbiota on stool and saliva, short chain fatty acids on stool and lymphocyte study on blood.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Assistance Publique - Hôpitaux de Marseille (AP-HM)

location_facility: Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Centre Hospitalier Intercommunal Nord-Ardennes

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study

summary:
Background of the study:

Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.

A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.

Objective of the study:

The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.

Study design:

This study is a multicenter, single-blinded, randomized, placebo-controlled trial.

Primary study parameters/outcome of the study:

The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.

Secondary study parameters/outcome of the study (if applicable):

Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)

Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)

Subject's and Physician's Global Impression

ReferenceCitation: van der Wilt AA, Giuliani G, Kubis C, van Wunnik BPW, Ferreira I, Breukink SO, Lehur PA, La Torre F, Baeten CGMI. Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence. Br J Surg. 2017 Aug;104(9):1167-1176. doi: 10.1002/bjs.10590.

lead_sponsor: Maastricht University Medical Center

location_country: Netherlands France Italy

location_facility: Università degli Studi di Roma "La Sapienza"

intervention_type: Device


title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

location_country: Germany France Italy

summary: This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.


title: A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease

acronym: MOGwAI

summary:
MOG-IgG associated disease (MOGAD) is a rare inflammatory disease of the central nervous system recently described. Initially reported as monophasic, data from incident cohorts suggests that around 50% of adult patients with MOG-Ab may relapse within the first two years of the disease, with most of relapses occurring early after disease onset.

No randomized controlled trial has ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. In short-sized and mainly retrospective study, azathioprine, an immunosuppressant drug, have showed promising results on preventing the risk of relapse in MOGAD patients.

The hypothesis is that the initiation of a treatment after a first attack of MOGAD should prevent further relapse and disability accrual. The investigators propose herein the first randomized controlled trial in MOGAD, to evaluate the efficacy of azathioprine to prevent relapses, after a first attack, in a placebo double-blinded design.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Neurology Montpellier Universitary Hospital

location_facility: Department of Neurology, Hôpital Caremeau

location_facility: Department of Neurology, Hôpital Pasteur 2

location_facility: Department of Neurology. Hôpital A. Fondation Rothschild

location_facility: Department of Neurology, Hôpital g. Et r. Laennec

location_facility: Department of Neurology, CHU de Bordeaux - GH Pellegrin

location_facility: Department of Neurology, CHU of Lille, Hospital Roger Salengro

location_facility: Department of Neurology, Hôpital Hautepierre

location_facility: Department of Neurology, Toulouse Universitary Hospital

location_facility: Service de Neurologie sclérose en plaques, pathologies de la myéline et neuro-inflammation - Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

location_facility: Department of Neurology APHP, Pitié Salpêtrière Hospital

location_facility: Department of Neurology University hospital Timone

location_facility: Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer


title: An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

summary: This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Spain
United Kingdom


title: LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS: CONSONANCE EXTENSION STUDY

acronym: CONSONANCE EX

summary:
The study duration of 4 years was considered to be sufficient to show a reliable and relevant effect of ocrelizumab on disability progression in the main study (CONSONANCE). However, given the potential long-term use of ocrelizumab in patients with progressive MS, it is critical that additional effectiveness and safety data are accrued in this patient population. In particular, understanding how ocrelizumab can prevent or delay time to major disability milestones such as the need to use an assisting device (Expanded Disability Status Scale [EDSS] 6.0) or a wheelchair (EDSS ≥7.0) is of significant relevance, given that progression to such milestones is associated with a significant reduction in patients' quality of life and an increase in cost of treatment (Kobelt et al. 2017).

In the ORATORIO trial, ocrelizumab reduced the risk of 24-week confirmed EDSS ≥7.0 by 46% (hazard ratio [HR]: 0.54, 95% CI 0.31-0.92; p = 0.022) in patients with primary progressive multiple sclerosis (PPMS). To further characterize the potential long-term impact of ocrelizumab treatment on time to 24-week confirmed EDSS ≥7.0, an analysis was used to extrapolate the observed data into the future, estimating the time at which 50% of patients were expected to have reached EDSS ≥7.0. Extrapolated median time to confirmed EDSS ≥7.0 was 12.1 years for placebo, which was similar to the actual median time observed in MSBase (12.4 years), and 19.2 years for ocrelizumab, representing a 7.1-year delay (95% CI: -4.3 to 18.4) [Butzkueven et al 2021]. A recent MSBase analysis also showed that in a cohort of patients with secondary progressive MS (SPMS), 17.9% reached a confirmed EDSS score of 7.0 from the diagnosis of SPMS, over a period of approximately 12 years (Lizak et al. 2020). Therefore, following patients who complete CONSONANCE beyond the 4-year study period is justified, to better assess the impact of ocrelizumab on these long-term disability milestones.

Another important therapeutic clinical goal in patients with progressive MS is preserving upper limb function. Patients with progressive MS with high EDSS scores, including those who are wheelchair-restricted, experience a devastating reduction in quality of life if they lose any residual function in their arms and/or hands, as this affects the level of independence and significantly limits the ability to perform activities of daily living (Kraft et al. 2014). The Nine-Hole Peg Test (9-HPT) has become one of the most frequently used measures of upper extremity function in MS (Earhart et al. 2011). A 20% worsening in test time is commonly used to define clinically meaningful worsening, as it corresponds to predefined clinically significant changes of established clinician- and patient-reported measures (Feys et al. 2017). Progression rates are lower for 9-HPT compared to EDSS or the Timed 25-Foot Walk Test (25FWT; Goldman et al. 2019). Therefore, following patients who complete CONSONANCE beyond the 4 year study period is justified, to better assess the long-term impact of ocrelizumab on preserving upper limb function.

Patients with MS who have completed the CONSONANCE study, and have a favorable benefit risk ratio, as determined by the treating neurologist, can be included in this study if they meet the inclusion and exclusion criteria.

1.1. Study design

This is a 4-year, single-arm, open-label, multicenter study for patients who have completed 192 weeks of treatment with ocrelizumab in the CONSONANCE study (NCT03523858), and enrolled under the protocol version 1 of CONSONANCE. It is estimated that the study will enroll approximately 90 patients with progressive MS. The study will consist of the following periods:

Screening period: The screening visit should be scheduled up to two weeks before the first infusion of ocrelizumab, and always after the last visit of CONSONANCE at Week 192. This period should not be exceeded.
Treatment period: The first visit of the treatment period (first infusion of ocrelizumab) will occur at the baseline visit, which should be 24 weeks (+14 days) after the last infusion of ocrelizumab in CONSONANCE. Ocrelizumab will be administered every 24 weeks up to Week 168 of this study. The last visit in the treatment period will be conducted 24 weeks after the last dose of ocrelizumab (i.e., at Week 192).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Lille University Hospital
Montpellier University Hospital
Nimes University Hospital
Amiens University Hospital
Clermont ferrand University Hospital
Marseille Univesity Hospital
Strasbourg University Hospital
Bayonne Hospital
Rennes University Hospital
Nantes University hospital
Nice University Hospital
Bordeaux University Hospital
Lyon University Hospital
Caen University Hospital
Nancy University Hospital


title: "Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

ReferenceCitation: Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

lead_sponsor: Pharmexa A/S

location_country: Germany France Spain

location_facility:
Jordi Bruix
Michel Beaugrand
Tim F. Greten

intervention_type: Biological


title: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use

acronym: PERSON-AL

summary:
The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.

The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital Toulouse - Neurology department

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Behavioral


title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

acronym: GREAT

summary: The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

ReferenceType: result

ReferenceCitation: Zähringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Bérégi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8.

lead_sponsor: Cordis Corporation

location_country: Germany France Netherlands

location_facility:
Erasmus MC Rotterdam
Universitätskliniken Köln
Hopital Européen Georges Pompidou


title: A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

summary:
This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy:

cohort 1: DLBCL patients
cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial.

Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab.

The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU Nantes
Hopital Henri Mondor
APHP - Hôpital Saint Antoine
CHU Lyon Sud
CHU de Rennes - Hôpital Pontchaillou
CHU de Clermont Ferrand
CHU Montpellier
IUCT Oncopole
APHP - Hôpital de la Pitiè Salpetrière
CHU de Bordeaux - Hôpital Haut Leveque
CHU de Dijon - Hôpital le Bocage
Hôpital Saint Louis
CHU de Brabois
CHRU Lille - Hôpital Claude Huriez
Centre Henri Becquerel


title: Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

acronym: AVATAX

summary: The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases

summary: The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.

status: Terminated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Netherlands
France
United Kingdom

location_facility:
Institut Gustave-Roussy
Birmingham Children's Hospital
Emma Kinderziekenhuis AMC

status_simplified: Unknown


title: Peri-operative Association of Immunotherapy (Pre-operative Association of Nivolumab and Ipilimumab, Post-operative Nivolumab Alone) in Localized Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR) Oeso-gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

acronym: NEONIPIGA

summary: This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.

ReferenceCitation: André T, Tougeron D, Piessen G, de la Fouchardière C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lièvre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study. J Clin Oncol. 2022 Aug 15:JCO2200686. doi: 10.1200/JCO.22.00686. [Epub ahead of print]

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CHU Nantes
CHRU Jean Minjoz
ICM Val d'Aurelle
Hôpital Européen Geroges Pompidou
Hôpital Saint Antoine
CHU Poitiers
Hôpital Saint Louis
Hôpital Privé Jean Mermoz
Centre Léon Bérard
CHU Toulouse
Institut Hospitalier Franco-Britannique
CHU Pontchaillou Rennes
Hôpital Henri Mondor
CHRU Lille
Institut Mutualiste Montsouris


title: 12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus

summary: The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.

lead_sponsor: Sanofi

location_facility:
Sanofi-aventis Administrative Office
Hospital de Rangueil


title: Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY

summary: Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.

status: Suspended

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier

location_facility: EHPAD Pierre Laroque CCAS de Montpellier

location_facility: EHPAD Résidence La Camargue, Nimes (Groue Orpéa)

location_facility: EHPAD Françoise Gauffier CCAS de Montpellier

location_facility: EHPAD Résidence Château Notre Dame (Groupe Orpéa)


title: An Open-Label Proof of Concept Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

summary: The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Brazil
United Kingdom
Italy
United States
France
Japan

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP


title: Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial

acronym: DISPATCH

summary:
Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR).

As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services.

This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene.

The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls.

The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders.

The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: Study protocol will be submitted for publication. IPD will be shared with other researcher.

lead_sponsor: University Hospital, Grenoble

location_facility: SAMU 73 - Centre Hospitalier Métropôle Savoie


title: Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

summary:
The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).

at diagnosis
after the first cycle of CHOEP (early evaluation)
at the end of treatment

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Sibon D, Fournier M, Brière J, Lamant L, Haioun C, Coiffier B, Bologna S, Morel P, Gabarre J, Hermine O, Sonet A, Gisselbrecht C, Delsol G, Gaulard P, Tilly H. Long-term outcome of adults with systemic anaplastic large-cell lymphoma treated within the Groupe d'Etude des Lymphomes de l'Adulte trials. J Clin Oncol. 2012 Nov 10;30(32):3939-46. doi: 10.1200/JCO.2012.42.2345. Epub 2012 Oct 8.

ReferenceCitation: Damm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2.

ReferenceCitation: Damm-Welk C, Pillon M, Woessmann W, Mussolin L. Prognostic factors in paediatric anaplastic large cell lymphoma: role of ALK. Front Biosci (Schol Ed). 2015 Jun 1;7(2):205-16. Review.

ReferenceCitation: Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugières L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

acronym: APACaPOp

summary:
Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.

This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Paul Strauss
Hôpital Edouard Herriot
Institut Mutualiste Montsouris
CHU de Rouen
Hôpital Cochin
Hôpital Beaujon
CHR d'Orléans
CHU de Brest
CHU de Toulouse
Hôpital Haut-Lévêque
CHU de Reims
Institut Curie
Hôpital Henri Mondor
Hôpital privé Jean Mermoz
CHU de Besançon


title: RObotic PArtial Nephrectomy National Study (RoPaN Study)

acronym: ROPAN

summary: The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU La Pitié Salpétrière/ Kremlin Bicêtre

intervention_type: Procedure


title: The SHINE Study: An Open Label, Interventional, Multicentre, Prospective Feasibility Study, Designed to Evaluate the Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects

summary: The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.

primary_purpose: Device Feasibility

lead_sponsor: Indigo Diabetes NV

location_country: France Slovenia Belgium

location_facility: Lapeyronie Montpellier University Hospital


title: Neurodevelopmental Impact of Epilepsy on Autonomic Function in Dravet Syndrome

acronym: AUTONOMIC

summary:
Dravet Syndrome (DS) is a severe epileptic encephalopathy, which main cause is mutations of SCN1A, the gene coding for the Nav1.1 voltage-gated sodium channel. DS is characterized by childhood onset, severe cognitive deficit and drug-resistant seizures, including several generalized convulsive seizures per day, frequent status epilepticus and high seizure-related mortality rate. Sudden and unexpected death in epilepsy (SUDEP) represents the major cause of premature deaths. The risk of SUDEP is thus about 9/1000-person-year in comparison with about 5/1000-person-year in the whole population of patients with drug-resistant epilepsies.

Experimental and clinical data suggest that SUDEP primarily result from a postictal central respiratory dysfunction. SUDEP in DS, might be the result of a seizure-induced fatal apnea in a patient who had developed epilepsy-related vulnerability to central autonomic and/or respiratory dysfunction. However, a key clinical issue which remains to be addressed is the temporal dynamics of the onset and evolution of the autonomic vulnerability in these patients. The main clinical risk factor of SUDEP is the frequency of convulsive seizures and the SUDEP risk can vary along the evolution of epilepsy. Although non-fatal seizure-induced ataxic breathing can be observed in patients with DS, whether or not repetition of seizures results in long-term alterations of breathing remains unclear.

In the AUTONOMIC project, it will be investigate in a homogenous population of patients with DS the exact interplay between epilepsy-related cardiac and respiratory alterations on the one hand and the relation between the underlying neurodevelopmental disease, the repetition of seizure per se and these epilepsy-related autonomic alterations on the other hand.

Autonomic functions will be investigated in the inter-ictal period (i.e. in the absence of immediate seizures, Work Package 1 (WP1)) and in the peri-ictal period, i.e. in the immediate time before, during (if possible) and after seizures (WP2). A multicenter cohort will be constituted, allowing to collect the inter-ictal and ictal cardio-respiratory data required in the 2 WP. The study will be sponsored by the Lyon's University Hospital.

Patients will be recruited over a period of 24 months in one of the three participating clinical center. All patients will first enter in a prospective baseline period of 3 to 6 months duration in order to collect seizure frequency. After this period, all patients will then undergo a 24-48 hours video-EEG recordings as part of the routine clinical care. The monitoring will also include a full-night polysomnography. This patients will be eligible for inclusion in an extension follow-up study will monitor vital status every year in order to investigate long-term mortality, including SUDEP.

The AUTONOMIC project will provide important results which will pave the way to develop and eventually validate therapeutic intervention to prevent SUDEP. By deciphering the exact interplay between epilepsy-related cardiac and respiratory alterations on the one hand and the relation between the underlying neurodevelopmental disease, the repetition of seizure per se and these epilepsy-related autonomic alterations on the other hand, the project will primarily deliver clinically relevant biomarkers.

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_country: Germany France Belgium

location_facility: Department of Paediatrics and Paediatric Neurology, Antwerp University Hospital

location_facility: Klinik und Poliklinik für Epileptologie, Universitätsklinikum

location_facility: Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon


title: Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

summary: This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.

lead_sponsor: Guerbet

location_country: Austria France Switzerland

location_facility:
CHUV
Univ.-Klinik für Radiologie
CHU-Hôpital François Mitterrand


title: A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.

acronym: PROFILER 02

summary:
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.

This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie Lucien NEUWIRTH

intervention_type: Genetic


title: FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

acronym: FEMOSEAL CLOSE

summary: The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.

lead_sponsor: Terumo Europe N.V.

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department

location_facility: Hôpital Paris St Joseph, Vascular and endovascular surgical center


title: An External Control, Observational, Retrospective Study Assessing the Effect of Pralsetinib Compared With Best Available Therapy for Patients With RET-Fusion Positive Advanced Non-Small Cell Lung Cancer

summary: This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.

status: Enrolling by invitation

lead_sponsor: Blueprint Medicines Corporation

location_country:
United States
Switzerland
France

location_facility: University Hospital Center of Toulouse - Larrey Hospital


title: A Long-term Follow-up Study of Patients With MPS IIIB From Gene Therapy Clinical Trials Involving the Administration of ABO-101 (rAAV9.CMV.hNAGLU)

lead_sponsor: Abeona Therapeutics, Inc

ipd_sharing_description: There is no plan to share data

location_country:
Germany
United States
France

location_facility:
University Hospital Hamburg-Eppendorf
Armand-Trousseau Hospital
Nationwide Children's Hospital

summary: This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).


title: Six Years of Follow-up After Extended Duration of Oral Anticoagulant Therapy for a First Episode of Idiopathic Pulmonary Embolism or Proximal Deep Vein Thrombosis.

acronym: Padis-Ext

summary: Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations. Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial).

ipd_sharing: Undecided

lead_sponsor: University Hospital, Brest

location_facility:
CH St Brieuc
CHIC Quimper
CH de Lannion
CHU de Nantes
CHU de St Etienne
CHU de Grenoble
CHRU de Brest
CHU de Clermont-Ferrand
Hôpital Européen Georges Pompidou
CH de Lorient
Hotel Dieu
CHU de Toulouse
CHU de Rennes
CHU de Tours
AP-HP Kremlin Bicetre


title: Decision Support System to Evaluate VENTilation in ARDS (DeVENT)

acronym: DeVENT

summary:
Patients with Acute Respiratory Distress Syndrome (ARDS) residing in the intensive care unit (ICU) often require support for their breathing from a mechanical ventilator to provide adequate gas exchange, and although it is life-saving in this setting, it is also known to contribute to the morbidity and mortality in the condition.

Mechanical ventilation delivers a volume and pressure of gas for each breath and can vary oxygen levels. Selecting the correct oxygen, pressure and volume levels is important, as incorrect levels can harm the patient, and result in an increased time connected to the ventilator.

Recently, a system has been developed (the Beacon Caresystem) which advises the healthcare practitioner by the bedside as to how to best set the ventilator. This system is based on mathematics which describes the patients disease and may therefore provide ventilator settings which better suit the individual.

The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care to investigate whether the use of the system results in improved ventilation in all severities and phases of ARDS and thus reducing morbidity in ARDS. The investigators plan to recruit 110 patients (50 in the UK and 30 in each of the other 2 sites). The study also aims to examine the biological and physiological factors that determine the worsening of ARDS and the processes involved in recovery from ARDS with the aim to develop new therapies to help detect the condition and improve recovery.

The investigators will utilise all raw data will be collected from the Beacon Caresystem to physiologically characterise the progression and resolution phases of ARDS.

Additionally blood and Urine samples will be taken from healthy volunteers (100 in total) as a control comparison group for the biological analyses carried out in the DeVENT study.

ReferenceCitation: Patel B, Mumby S, Johnson N, Falaschetti E, Hansen J, Adcock I, McAuley D, Takata M, Karbing DS, Jabaudon M, Schellengowski P, Rees SE; DeVENT study group. Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)-trial protocol. Trials. 2022 Jan 17;23(1):47. doi: 10.1186/s13063-021-05967-2.

lead_sponsor: Imperial College London

location_country:
Austria
France
United Kingdom

location_facility: Imperial College London, Royal Brompton Hospital campus


title: Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy

acronym: EarlyHABIT-ILE

summary: Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

ReferenceCitation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

lead_sponsor: Université Catholique de Louvain

location_country: France Italy Belgium

location_facility: Institute of Neuroscience, Université catholique de Louvain


title: Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.

acronym: INTACT

summary: The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

status: Unknown status

primary_purpose: Health Services Research

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: University Hospital of Bordeaux - Hospital Pellegrin

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital Européen Georges Pompidou - AP-HP de Paris

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Besançon


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Limb-Girdle Muscular Dystrophy 2I

summary: Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

lead_sponsor: Genethon

location_country:
Denmark
France
United Kingdom

location_facility:
Pr John Vissing
Dr Tanya Stojkovic
Pr Volker Straub


summary: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

lead_sponsor: Bioprojet

location_country:
Russian Federation
Bulgaria
France

location_facility: State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism


title: A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

acronym: PIONEER

summary: The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa

lead_sponsor: GenSight Biologics

location_country:
United States
United Kingdom
France

location_facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

location_facility: Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts

intervention_type: Combination Product


title: A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.

summary: The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

ReferenceCitation: Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyên XL, Lewis R, Campbell MC, Pételle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1). pii: 1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.

lead_sponsor: Nyxoah S.A.

location_country:
Australia
France
United Kingdom

location_facility: Royal National Throat, Nose and Ear Hospital - London

location_facility: Hollywood Private UWA Centre for Sleep Science Facility


title: Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.

summary:
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.

Lobectomy may be performed in two different ways:

Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.

The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.

This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.

Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.

ReferenceCitation: Pagès PB, Abou Hanna H, Bertaux AC, Serge Aho LS, Magdaleinat P, Baste JM, Filaire M, de Latour R, Assouad J, Tronc F, Jayle C, Mouroux J, Thomas PA, Falcoz PE, Marty-Ané CH, Bernard A. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01). BMJ Open. 2017 Jun 15;7(6):e012963. doi: 10.1136/bmjopen-2016-012963.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
APHM Hôpital Nord
CH Avignon
CHU de Montpellier
CHU de Nice - Hôpital Pasteur
CHU de Rouen
CH Victor Dupouy
APHP Hôpital Cochin
HUS Strasbourg - Nouvel Hôpital Civil
CHU de Poitiers
APHP Hôpital de Tenon
HCL - Louis Pradel
CHU Amiens
Centre Jean Perrin - Clermont-Ferrand
CHU Dijon
CHU de Rennes - Hôpital de Pontchaillou


title: Phase III Multicentric Study Evaluating the Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care

summary:
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations.

The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_facility: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Bruxelles


title: An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.

summary:
The purpose of this observational study is to determine the proportion of patients with a score greater than 3/10 to the questionnaire PALLIA-10.

This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at helping the providers of care to identify patients who would require palliative cares.

According to the notice of the questionnaire, patients with a score greater than 3 would be taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it seems that a large majority of patients would have a score greater than 3 in the context of anti cancer centers.

To date, palliative teams are not designed to take in charge such an amount of patients.

time_perspective: Cross-Sectional

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


title: Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm

acronym: OWED

summary: Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a patient is ready to be weaned from the ventilator based on breathing pattern measurements. The T-piece technique allows clinicians to calculate breathing patterns accurately but many prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern. The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt) supposedly represents what the patient really wants: without disconnecting the patient from the ventilator, it may be possible to determine what is the real need and whether the patient is able to maintain Vt without support. The aims of the study are as follows: to test whether the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical patients expected to be extubated within 12 hours will be excluded. After a baseline inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate the patient according to standard criteria and blinded to the ΔVt results. Ultimately, patients will be classified as "success" or "failure" and the ΔVt will be compared between these two groups.

ReferenceCitation: Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50.

ReferenceCitation: Bellani G, Mauri T, Coppadoro A, Grasselli G, Patroniti N, Spadaro S, Sala V, Foti G, Pesenti A. Estimation of patient's inspiratory effort from the electrical activity of the diaphragm. Crit Care Med. 2013 Jun;41(6):1483-91. doi: 10.1097/CCM.0b013e31827caba0.

lead_sponsor: Unity Health Toronto

location_country: Canada Italy France

location_facility: Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia


title: Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress

acronym: ANTIGRIPPE

summary: Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

location_facility: Hôpital de la Croix Rousse-service réanimation adulte chirurgicale

location_facility: Hôpital de la Croix Rousse-service réanimation adulte médicale

location_facility: Centre de Biologie et de Pathologie Nord


title: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

acronym: COMETE

summary: The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

ReferenceCitation: Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.

lead_sponsor: United Pharmaceuticals

location_facility:
Centre Hospitalier Régional
University of Naples Federico II
Necker Children's Hospital

intervention_type: Dietary Supplement


title: Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases

acronym: METACARDIS

summary: Supported by state-of-the-art systems medicine competences including integrative computational and functional genomics, the overarching goal of the trial is to investigate the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective will be to translate the clinical and fundamental based discoveries into new diagnosis and preventive actions paving the way to novel modes of treatment in the successive stages of CMD progression.

primary_purpose: Screening

ReferenceCitation: Belda E, Voland L, Tremaroli V, Falony G, Adriouch S, Assmann KE, Prifti E, Aron-Wisnewsky J, Debédat J, Le Roy T, Nielsen T, Amouyal C, André S, Andreelli F, Blüher M, Chakaroun R, Chilloux J, Coelho LP, Dao MC, Das P, Fellahi S, Forslund S, Galleron N, Hansen TH, Holmes B, Ji B, Krogh Pedersen H, Le P, Le Chatelier E, Lewinter C, Mannerås-Holm L, Marquet F, Myridakis A, Pelloux V, Pons N, Quinquis B, Rouault C, Roume H, Salem JE, Sokolovska N, Søndertoft NB, Touch S, Vieira-Silva S; MetaCardis Consortium, Galan P, Holst J, Gøtze JP, Køber L, Vestergaard H, Hansen T, Hercberg S, Oppert JM, Nielsen J, Letunic I, Dumas ME, Stumvoll M, Pedersen OB, Bork P, Ehrlich SD, Zucker JD, Bäckhed F, Raes J, Clément K. Impairment of gut microbial biotin metabolism and host biotin status in severe obesity: effect of biotin and prebiotic supplementation on improved metabolism. Gut. 2022 Dec;71(12):2463-2480. doi: 10.1136/gutjnl-2021-325753. Epub 2022 Jan 11.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Denmark France Germany

location_facility:
University of Leipzig
Hôpital Pitié-Salpétrière
University of Copenhagen

intervention_type: Radiation


title: Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens

summary: The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.

lead_sponsor: University Hospital, Montpellier

location_country: France Italy Czechia

location_facility: Institute for Clinical and Experimental Medicine


title: Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

summary:
Interactive games (virtual reality) have recently been the center of interest and scientific discussion in the field of cognitive and functional rehabilitation. From their entertaining and contextual aspects, off-the-shelf video games are potentially interesting tools as adjunct to the patient care, especially for maintaining instrumental activities of daily living (IADL) autonomy.

Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing health related quality of life (HRQL). This decrease in cognitive and functional abilities can be slowed down using adapted rehabilitation program.

However, there is no randomized controlled study comparing usual physical therapy to virtual reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.

Off-the-shelf gaming consoles offer a large range of games where cognitive and functional abilities from geriatric patients could be stimulated and consequently HRQL improved.

However, a better knowledge of the potential cognitive and functional improvement processes from virtual reality rehabilitation in institutional routine is needed to enhance the quality and the range of the available care in old adults.

This study will not only be a validation platform of virtual reality as stand alone rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming consoles in HRQL improvement of old adults.

The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL changes of patients with Alzheimer disease and related disorders.

•Method

This study is a randomized controlled trial that comprises two study phases :

Phase one; comparing three parallel groups where therapists and assessors will be kept blind of study objectives, and Phase two, the investigators will take the most cost-effective gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will use it as an adjunct to physical therapy compared to physical therapy alone, with respect to the same amount of rehabilitation time.

The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after intervention.

Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or physical therapy as the 'gold' standard condition.

All groups will receive the same amount of rehabilitation time. Power and sample calculation for phase two will be based on phase one results.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Australia France Netherlands

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

location_facility: Radboud University Nijmegen Medical Centre


title: A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia

summary: For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Edouard Herriot
St Antoine Hospital
IGR
Hopital Saint-Louis
Hopital Avicenne
CHU
CNLCC
CH
Hopital Percy


title: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions

acronym: EPIRMEX

summary:
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.

These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.

Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.

The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome

lead_sponsor: University Hospital, Tours

location_facility: Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE

location_facility: Service de Réanimation pédiatrique, Néonatologie

location_facility: Médecine Néonatale et Réanimation Pédiatrique

location_facility: Médecine Infantile - Néonatologie - Périnatologie

location_facility: Service de Pédiatrie Néonatale et Réanimation


title: An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma

summary: This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

lead_sponsor: Genentech, Inc.


title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

summary: Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Rekhtman G, Masliak Z, Robak P, Esseltine DL, Feng H, Deraedt W, van de Velde H, Arnulf B. Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study. Haematologica. 2015 May;100(5):e207-10. doi: 10.3324/haematol.2014.118182. Epub 2015 Jan 16.

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18. Erratum in: Lancet Oncol. 2011 Jun;12(6):522.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_facility: Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33

location_facility: Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU

location_facility: UZ Brussel Department Medical Oncology Laarbeeklaan 101


title: Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

acronym: SABATO

summary:
Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade [1]. This threat underscores the need to maximize clinical utility of existing antibiotics, through more rational prescription, e.g. optimizing duration of treatment.

Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000 cases occurring annually in Europe [2]. A course of at least 14 days of intravenous antimicrobials is considered standard therapy [3-5] in "uncomplicated" SAB. This relatively long course serves to prevent SAB-related complications (such as endocarditis and vertebral osteomyelitis) that may result from hematogenous dissemination to distant sites. However, there is insufficient evidence that a full course of intravenous antibiotic therapy is always required in patients with a low risk of SAB-related complications.

In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.

ReferenceCitation: Kaasch AJ, Rommerskirchen A, Hellmich M, Fätkenheuer G, Prinz-Langenohl R, Rieg S, Kern WV, Seifert H; SABATO trial group. Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection. Trials. 2020 Feb 12;21(1):175. doi: 10.1186/s13063-020-4102-0.

ReferenceCitation: Kaasch AJ, Fätkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Weiß V, Jung N, Rieg S, Kern WV, Seifert H; SABATO trial group (with linked authorship to the individuals in the Acknowledgements section). Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Trials. 2015 Oct 9;16:450. doi: 10.1186/s13063-015-0973-x.

lead_sponsor: Heinrich-Heine University, Duesseldorf

location_country:
Spain
United Kingdom
Netherlands
France
Germany

location_facility:
Paris 1
Tilburg
Freiburg
Leverkusen
Breda
St. Etienne
Utrecht
Lübeck
Amsterdam
Nantes
Paris 2
Paris 3
Rennes
Nottingham
Barcelona I
Krefeld
Diakonessenhuis Utrecht
Barcelona II
Sevilla
Paris 4
Hannover
Orléans
Paris 5
La Roche-sur-Yon
Groningen
UMC Groningen
Tours
Berlin
Jena
Quimper
Düsseldorf
Frankfurt
Sevilla II
VUmc Amsterdam
Annecy
Uniklinik Köln
Grenoble
Chambéry
Palma
Ulm


acronym: ANTHALYA

title: A Randomized, Open-Label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable

lead_sponsor: Hoffmann-La Roche

location_facility: Centre Jean Perrin; Chir Generale Oncologie

location_facility: Centre Val Aurelle Paul Lamarque; Chir A1

location_facility: Hop Europeen Georges Pompidou; Gynecologie

location_facility: Centre Rene Huguenin; Chir Generale Oncologique

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn

location_facility: Institut Curie; Chir Generale Gyneco Oncologique

location_facility: Centre Francois Baclesse; Chir Gynecologique

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Hopital Rangueil; CHIR Generale Et Gynecologique

summary: This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.


title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response

summary: This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

lead_sponsor: Novo Nordisk A/S


title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia

acronym: CLINPCT

summary: CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.

ReferenceCitation: Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotté T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.

lead_sponsor: Nantes University Hospital

location_facility: University Hospital of Saint Antoine Paris


title: Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

summary:
Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

ReferenceCitation: Vendrely V, Lemanski C, Gnep K, Barbier E, Hajbi FE, Lledo G, Dahan L, Terrebonne E, Manfredi S, Mirabel X, Mammar V, Cowen D, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904). Radiother Oncol. 2019 Nov;140:84-89. doi: 10.1016/j.radonc.2019.05.018. Epub 2019 Jun 8.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Cario - HPCA - Hôpital privé des Côtes D'Armor

location_facility: Centre d'oncologie et de radiothérapie du Parc


title: Phase 2 Study of a Reduced-toxicity Myeloablative Conditionning Regimen Using Fludarabine and Full Doses of iv Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens

summary: The purpose of this study is to assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced toxicity myeloablative" conditioning regimen in young patients (children and adolescents) with hematologic malignancies.

ReferenceCitation: Rialland F, Grain A, Labopin M, Michel G, Gandemer V, Paillard C, Pochon C, Clement L, Brissot E, Jubert C, Sirvent A, Rohrlich PS, Plantaz D, Dalle JH, Mohty M. Reduced-toxicity myeloablative conditioning regimen using fludarabine and full doses of intravenous busulfan in pediatric patients not eligible for standard myeloablative conditioning regimens: Results of a multicenter prospective phase 2 trial. Bone Marrow Transplant. 2022 Nov;57(11):1698-1703. doi: 10.1038/s41409-022-01769-5. Epub 2022 Aug 26.

location_facility:
University Hopsital
University Hospital


title: Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter

acronym: PAF CRIOBLAF

summary:
- Background:

Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these patients after several years of follow-up. However, the latter arrhythmia is associated with significant morbidity and mortality. The problem of atrial fibrillation occurrence after successful ablation of typical atrial flutter remains physicians primary concern in monitoring these patients.

Objectives:

The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon cryotherapy technology performed at the time of flutter ablation, significantly reduces the risk of developing atrial fibrillation in the two year period following the procedure.

Selection Criteria:

Patients referred for ablation of typical atrial flutter with an history of at least one documented episode of atrial fibrillation (atrial flutter remaining the predominant arrhythmia)will be enrolled in the study.

Study Methods:

This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial fibrillation occurrence over a two years period following either an ablation procedure of typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18 months.

Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then be regularly followed up clinically and by long-term ECG recordings.

Evaluation Criteria:

The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation, documented by an ECG or an R-test, occurring between M3 and M24

Number of patients:

170 patients will be enrolled in the study

Number of centers:

Four French and three German centers will participate.

Perspective:

The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the patient group with pulmonary vein isolation, could lead to a modification of atrial arrhythmia treatment indication.

lead_sponsor: University Hospital, Rouen

location_facility:
Clinique Saint Gatien
AP-HM - Hôpital Nord
CHU de Nantes
Polyclinique Vauban
Hôpital Privé de Clairval
CHU de Tours
CHU de Strasbourg
Nouvelles Cliniques Nantaises
CHU Grenoble
CHU de Brest
CHU de Rennes
University Hospital of Rouen
Clinique Saint Joseph
Clinique Pasteur
CH La Rochelle


title: Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

summary:
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.

In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades

location_facility: Service de Neurologie Pédiatrique, Hôpital Robert-Debré

location_facility: Centre Référent des Epilepsies Rares, Hôpital de Hautepierre

location_facility: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer

location_facility: Service de Neurologie pédiatrique, Hôpital de la Timone

location_facility: Service de Neurologie pédiatrique, CHU d'Amiens

location_facility: Service de Neurologie pédiatrique, CHU de Besançon

location_facility: Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin

location_facility: Service de Neurologie Pédiatrique, Hôpital des Enfants

location_facility: Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant

location_facility: Service de Neurologie Pédiatrique, CHU de Tours

location_facility: Service d'épileptologie pédiatrique, CHR de Chambéry

location_facility: Service de Neurologie Pédiatrique, CHU d'Angers


title: Medico-economic Evaluation Comparing Conformal Radiotherapy With Intensity Modulation (IMRT) Performed by, Helical Tomotherapy (Hi Art) and Dynamic Arc Therapy (RapidArc, VMAT) in Cancers With Pelvic Lymph Node Irradiation (Prostate, Cervix, Anal Canal)

acronym: RCMI PELVIS

summary: The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Assistance publique des Hôpitaux de Marseille


title: Comparative Efficacy of DuodartTM Versus Watchful Waiting With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Symptomatic BPH

acronym: CONDUCT

summary:
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH).

Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.

After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.

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

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
Greece
Netherlands
United Kingdom
France
Romania
Germany


title: A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.

acronym: GLYCEMIA

summary: The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin

ReferenceCitation: Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.

lead_sponsor: Novartis

location_facility:
Novartis Investigative Site
Novartis Investigative Site #2


acronym: FRENCH

title: Randomized Placebo Controlled Double-blind Trial in CKD Patients Not on Dialysis to Evaluate the Effect of Sevelamer Carbonate in the Control of FGF-23 Serum Levels and Its Consequences in the Evolution of PTH, Calcitriol and Mineral Metabolism Parameters Levels

lead_sponsor: Centre Hospitalier Universitaire, Amiens

ReferenceCitation: Voormolen N, Noordzij M, Grootendorst DC, Beetz I, Sijpkens YW, van Manen JG, Boeschoten EW, Huisman RM, Krediet RT, Dekker FW; PREPARE study group. High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients. Nephrol Dial Transplant. 2007 Oct;22(10):2909-16. Epub 2007 May 21.

ReferenceCitation: Levin A, Djurdjev O, Beaulieu M, Er L. Variability and risk factors for kidney disease progression and death following attainment of stage 4 CKD in a referred cohort. Am J Kidney Dis. 2008 Oct;52(4):661-71. doi: 10.1053/j.ajkd.2008.06.023.

ReferenceCitation: Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, Sherrard DJ, Andress DL. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):520-8. Epub 2004 Dec 22.

ReferenceCitation: Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell AT, McCullough PA, Norris KC; Kidney Early Evaluation Program Investigators. Trends in mineral metabolism: Kidney Early Evaluation Program (KEEP) and the National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S56-68. doi: 10.1053/j.ajkd.2007.12.018.

ReferenceCitation: Danziger J. The bone-renal axis in early chronic kidney disease: an emerging paradigm. Nephrol Dial Transplant. 2008 Sep;23(9):2733-7. doi: 10.1093/ndt/gfn260. Epub 2008 May 9.

ReferenceCitation: Inaba M, Okuno S, Imanishi Y, Yamada S, Shioi A, Yamakawa T, Ishimura E, Nishizawa Y. Role of fibroblast growth factor-23 in peripheral vascular calcification in non-diabetic and diabetic hemodialysis patients. Osteoporos Int. 2006 Oct;17(10):1506-13. Epub 2006 Aug 5.

ReferenceCitation: Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group, Kuen E, König P, Kraatz G, Mann JF, Müller GA, Köhler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. Epub 2007 Jul 26.

ReferenceCitation: Gutiérrez OM, Mannstadt M, Isakova T, Rauh-Hain JA, Tamez H, Shah A, Smith K, Lee H, Thadhani R, Jüppner H, Wolf M. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. N Engl J Med. 2008 Aug 7;359(6):584-92. doi: 10.1056/NEJMoa0706130.

ReferenceCitation: Jean G, Terrat JC, Vanel T, Hurot JM, Lorriaux C, Mayor B, Chazot C. High levels of serum fibroblast growth factor (FGF)-23 are associated with increased mortality in long haemodialysis patients. Nephrol Dial Transplant. 2009 Sep;24(9):2792-6. doi: 10.1093/ndt/gfp191. Epub 2009 Apr 25.

ReferenceCitation: Peiskerová M, Kalousová M, Kratochvílová M, Dusilová-Sulková S, Uhrová J, Bandúr S, Malbohan IM, Zima T, Tesar V. Fibroblast growth factor 23 and matrix-metalloproteinases in patients with chronic kidney disease: are they associated with cardiovascular disease? Kidney Blood Press Res. 2009;32(4):276-83. doi: 10.1159/000243050. Epub 2009 Oct 1.

ReferenceCitation: JP Cristol, AS Bargnoux, AM Dupuy, M Morena, A Avignon and B Canaud. Biological markers of vascular calcifications in uremia. Médecine Nucléaire 2009; 33, 53-61.

ReferenceCitation: Stubbs JR, Quarles LD. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Nephrol News Issues. 2009 May;23(6):33-4, 36-7. Review.

ReferenceCitation: Westerberg PA, Linde T, Wikström B, Ljunggren O, Stridsberg M, Larsson TE. Regulation of fibroblast growth factor-23 in chronic kidney disease. Nephrol Dial Transplant. 2007 Nov;22(11):3202-7. Epub 2007 Jun 13.

ReferenceCitation: Shigematsu T, Kazama JJ, Yamashita T, Fukumoto S, Hosoya T, Gejyo F, Fukagawa M. Possible involvement of circulating fibroblast growth factor 23 in the development of secondary hyperparathyroidism associated with renal insufficiency. Am J Kidney Dis. 2004 Aug;44(2):250-6.

ReferenceCitation: Tanaka H, Hamano T, Fujii N, Tomida K, Matsui I, Mikami S, Nagasawa Y, Ito T, Moriyama T, Horio M, Imai E, Isaka Y, Rakugi H. The impact of diabetes mellitus on vitamin D metabolism in predialysis patients. Bone. 2009 Nov;45(5):949-55. doi: 10.1016/j.bone.2009.07.016. Epub 2009 Jul 23.

ReferenceCitation: Urena Torres P, Friedlander G, de Vernejoul MC, Silve C, Prié D. Bone mass does not correlate with the serum fibroblast growth factor 23 in hemodialysis patients. Kidney Int. 2008 Jan;73(1):102-7. Epub 2007 Oct 17.

ReferenceCitation: Nagano N, Miyata S, Abe M, Kobayashi N, Wakita S, Yamashita T, Wada M. Effect of manipulating serum phosphorus with phosphate binder on circulating PTH and FGF23 in renal failure rats. Kidney Int. 2006 Feb;69(3):531-7.

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location_facility: Hôpital Européen Georges Pompidou Service de Nephrologie

location_facility: CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie

location_facility: CHU St Etienne Hopital Nord Service de néphrologie

location_facility: Néphrologie - Dialyse Centre de Rein Artificiel

summary: The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary phosphate. In addition, the investigators will describe the impact of the FGF23 level monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid hormone (iPTH), serum calcitriol and phosphaturia.