title: Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year

summary: This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

ReferenceCitation: Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20.

lead_sponsor: Hoffmann-La Roche

location_facility: Hopital Victor Jousselin; Rhumatologie 4EME Sud

location_facility: Hopital Instruction Armees Begin; Rhumatologie

location_facility: Hopitaux du Leman site Thonon; Rhumatologie

location_facility: Centre medical des coteaux; Rhumatologie

location_facility: Ch Lyon Sud; Rhumato Secteur Jules Courmont

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Cabinet de Rhumatologie MSP de Beaublanc

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Hopital Pierre Nouveau;Medecine C Unite Rhumatologie

location_facility: Hopital Sud Anne de Bretagne; Rhumatologie

location_facility: Centre Hopsitalier Saint Nazaire; Medecine Polyvalente

location_facility: CH de Juvisy sur Orge; Consult. externes

location_facility: Institut Calot Helio Marin; Rhumatologie

location_facility: Infirmerie Protestante; Medecine interne Cancerologie

location_facility: Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: Ch Louis Pasteur; Rhumato Med Interne Neurologie

location_facility: Hopital Edouard Herriot; Pavillon F Rhumatologie

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Hopital Gabriel Montpied; Service de Rhumatologie


title: Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial

acronym: OXYDOPA

summary: This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lawn T, Rukavina K, Malcangio M, Howard M, Chaudhuri KR. Response to Mylius et al. Pain. 2022 Mar 1;163(3):e496-e497. doi: 10.1097/j.pain.0000000000002445. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Toulouse

location_facility:
Hospital of Aix-en-Provence
University Hospital of Nantes
University Hospital of Rennes
University Hospital of Bordeaux
Henri Mondor Hospital
University Hospital of Clermont-Ferrand
University Hospital of Lille
Chu Toulouse
Hospital Pierre Wertheimer
University Hospital of Marseille
University Hospital of Rouen
Pitié-Salpêtrière Hospital
University Hospital of Poitiers
University Hospital of Strasbourg
University Hospital of Nîmes - Caremeau
University Hospital of Nancy
University Hospital of Limoges
CHU Amiens

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: OXYDOPA

titre: Evaluation des effets antalgiques de l'OXYcodone LP et de la L-Dopa, versus placebo, dans les DOuleurs neuropathiques centrales du patient PArkinsonien : Essai OXYDOPA

discipline_principale: neurologie

nom_porteur: BREFEL COURBON

prenom_porteur: Christine


acronym: IPSI-PSO

lead_sponsor: Novartis Pharmaceuticals

summary: Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.

title: A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

source: euctr

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

ipd_sharing: No

lead_sponsor_type: industriel


title: A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice

acronym: GRAPHE

summary: Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry). Endoscopy. 2016 Dec;48(12):1084-1095. doi: 10.1055/s-0042-116148. Epub 2016 Oct 19.

publisher_dissemination: Georg Thieme

lead_sponsor: Nantes University Hospital

location_country: Monaco France

location_facility: Georges Pompidou University Hospital (AP-HP)

location_facility: Lariboisière University Hospital (AP-HP)

location_facility: Henri Mondor University Hospital (AP-HP)

intervention_type: Other


title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

acronym: PRECISE

summary: Observational study on long PR interval using the SafeR mode in bradycardia patients.

lead_sponsor: LivaNova

location_facility:
Clinique Keraudren
hôpital d'Argenteuil
Clinique des 2 Caps
CH Sens
CH Forbach
CH Thionville
Cabinet Valognes
Clinique Montpellier
CMCM Le Mans
hôpital privé Antony
CHU Brest
CH du Pays d'Aix
CMC Port Marly
CH Bourges
CH St Joseph
Clinique A. Paré
Clinique St Hilaire
CH Le Havre
CH Chartres
CH Corbeil Essonnes
CHU La Timone
CH Lomme
CMCO Evry
CH Annecy
HIA Percy
CCN St Denis
CH Valenciennes
CH Evreux
Hôpital L. Pasteur
Cabinet Cherbourg
Cabinet Creutzwald
CH Haguenau
CH Alençon
hôpital St André
Hôpital Nord
CHU Caen
NCN Nantes
CH St Malo
Cabinet Forbach
CH Dinan
CH Lannion
CH Lorient
Clinique Melun
Ch Chaumont
CH Basse Terre
CH Privé Metz
Cabinet Paris
CH Douarnenez
CH St Nazaire
Cabinet Alès
CH Orléans
CHU Poitiers
CH Poissy St Germain
CH Villefrance
Hopital Henri Mondor
CH Montfermeil
CH Helfaut
hôpital Sud

intervention_type: Device


title: A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer

acronym: CHEOPS

summary: The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

status: Terminated

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Pierre Fabre Laboratories

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier de l'Agglomération Montargoise

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Hospitalier de la Région d'Annecy

status_simplified: Unknown


title: A Randomized, Open-label, Comparative, Multicenter, Phase II Study of the Efficacy and Safety of REGorafenib Versus Tamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

acronym: REGOVAR

summary: The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Bayer

location_facility: Centre Hospitalier Universitaire Bretonneau

location_facility: Centre Hospitalier Universitaire Dupuytren


title: Multicentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: STOPECU

summary: Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults. It is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The discovery of complement alternative pathway as a major risk factor for aHUS has led to the design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab. Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS patients with a dramatic decrease in the risk of end-stage renal disease. However, the optimal duration of eculizumab therapy is still debated. The present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with aHUS.

ReferenceCitation: Fakhouri F, Fila M, Hummel A, Ribes D, Sellier-Leclerc AL, Ville S, Pouteil-Noble C, Coindre JP, Le Quintrec M, Rondeau E, Boyer O, Provot F, Djeddi D, Hanf W, Delmas Y, Louillet F, Lahoche A, Favre G, Chatelet V, Launay EA, Presne C, Zaloszyc A, Caillard S, Bally S, Raimbourg Q, Tricot L, Mousson C, Le Thuaut A, Loirat C, Fremeaux-Bacchi V. Eculizumab discontinuation in children and adults with atypical hemolytic-uremic syndrome: a prospective multicenter study. Blood. 2021 May 6;137(18):2438-2449. doi: 10.1182/blood.2020009280.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

location_facility:
Hôpital Européen Georges Pompidou
CH Dijon
CHU Nice
CH Alpes Léman
CHU toulouse
Ch Le Mans
CHU Amiens
CHU Rouen
Hopital Necker
CH Metz Thionville
CH métropole Savoie
CHU Nantes
BICHAT
CHU Montpellier
CHU lyon
Hopital FOCH
CHRU Lille
Hopital Tenon
CHU Caen
CHU Strasbourg
AP-HM
CHU Bordeaux

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: STOPECU

titre: Etude multicentrique, prospective, ouverte visant à évaluer une stratégie raisonnée d'arrêt de l'eculizumab chez les patients atteints de Syndrome Hémolytique et Urémique atypique (SHUa)

discipline_principale: néphrologie

nom_porteur: FAKHOURI

prenom_porteur: Fadi


acronym: Btx-HT

lead_sponsor: University Hospital, Clermont-Ferrand

summary:
Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses, leading to a reduction of pathological muscle movement. Very little information is available on its efficacy on HT. Two published reports suggested that local Btx A injections could be an effective and safe approach for treating HT. Given the scarcity of published data (small samples, open studies, different doses of Btx used, heterogeneous populations, several muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx injections in essential HT by a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.

Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment of head tremor.

Secondary objectives:

- To evaluate the tolerance of botulinum toxin injections in the treatment of head tremor.
- To evaluate the impact of botulinum toxin injections on the patients' quality of life and embarrassment.
To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D accelerometer wireless portable system (Xsens MTw wireless motion tracker system) (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a new video system device to analyze head tremor characteristics

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Allergan

location_facility:
CHU d'Amiens
Hopital Lariboisière
Hôpital Jean Minjoz
Hôpital Caremeau
Hôpital Haut-Levêque
CHU de Poitiers
CHU de Clermont-Ferrand
CHU de Toulouse
AP-HP
Hôptal Avicenne de Bobigny
Hôpital neurologique
CH Narbonne
Hôpital de Hautepierre
Hôpital de la Timone
Centre Hospitalier Pays D'Aix
Hôpital R Salendro
Fondation Rothschild

title: Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor by a Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study

type: EudraCT Number

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: Btx HT

titre: Evaluation de l'effet d'injections de toxine botulinique dans le traitement du tremblement du chef par une étude multicentrique, contrôlée, randomisée, en double aveugle versus placebo

nom_porteur: DURIF

prenom_porteur: Franck


title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

acronym: Esostrate

summary:
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.

The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.

Evaluation of the response 5 to 6 weeks after the RCT.

Step 2: Randomisation in patients with a complete clinical response:

Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence

Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre d'oncologie et de radiothérapie du Pays Basque


type: Other Identifier

title: A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma

acronym: NACRE

summary: The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Gustave Roussy Cancer Campus Grand Paris

location_facility: Centre Médical Oncogard Institut de cancérologie du Gard

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: UCGI 30/GERICO

titre: Etude de phase III évaluant deux traitements néoadjuvants chez les patients âgés de plus de 75 ans porteurs d'un adénocarcinome du rectum localement évolués.

discipline_principale: geriatric oncology / gastroinstestinal cancers

nom_porteur: FRANCOIS

prenom_porteur: Eric


title: A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease

acronym: ECIPE

summary: This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

primary_purpose: Supportive Care

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Hopital Beaujon
Hopital Nord
Chu Nantes
Chu Saint-Etienne
Hopital Saint Louis
Hopital Saint-Antoine
Chu Rouen
Chu Toulouse
Hopital Bicetre
Chu Montpellier
Institut Mutualiste Montsouris
Chu Tours
CHRU Lille
Chi Le Raincy Montfermeil
Hopital Louis Mourier
Hopital Tourcoing
CHU NICE

intervention_type: Procedure


acronym: SUNRISE

summary: Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.

title: A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

design_allocation: Non-Randomized


acronym: NEOPAN

summary: French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.

location_facility: Centre Hospitalier Intercommunal Aix-Pertuis

location_facility: Groupe Hospitalier du Havre Jacques Monod

location_facility: Institut de cancérologie Lucien Neuwirth

status: Active, not recruiting

title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

study_completion_date_type: Anticipated

ipd_sharing: Yes

status_simplified: Ongoing


title: Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

summary:
Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.

However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

ReferenceCitation: Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassabliere F, Reynaud-Federspiel E, Franca MC Jr, Martinez ARM, Camdessanche JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.

oa_host_type: repository

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

host_type: repository

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital BICETRE
Chu Saint-Etienne
CHU de NICE
AP-HM
CHU de Limoges
CHU Clermont-Ferrand
CHU de Grenoble
Hospices Civils de Lyon
CHU Bordeaux
Fondation Rothschild
CHU Poitiers
CHRU de Nantes
CH Cornouailles
Chu Creteil
CH Saint Denis - Hôpital Delafontaine
Chu Strasbourg
Hopital Pitie Salpetriere


acronym: CONVERCE

lead_sponsor: Center Eugene Marquis

summary: The purpose of this study is to determine wether cobimetinib + vemurafenib combination treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain metastasis

location_facility:
CHU Ambroise Paré
CHU Caen - Hôpital Clémenceau
CHU Albert Michallon
CHU Brest - Hôpital Morvan
Hôpital Henri Mondor
Hôîtal St louis
Hôpital Cochin
CHU de Dijon
Groupe Hospitalier l'Archet
Centre Eugène Marquis
Hôpital Bichat
CHU de Nantes
CHRU Lille
CHU Tours
Centre Hospitalier du Mans
CHU de Bordeaux
Centre Hospitalier Lyon Sud

title: Evaluation of Cobimetinib + Vemurafenib Combination Treatment in Patients With Brain Metastasis BRAFV600 Mutated Cutaneous Melanoma


title: Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

summary:
Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose innate or acquired character is still unknown. This segmental non atheromatous injury, leads to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly affected with 60-75% of total fibrodysplasia. Three histological subtypes have been described: intimal, medial and peri-medial. They are not mutually exclusive and can be observed in the same patient.

This is a rare blood disease, occurring in children and young adults. In this young population with long life expectancy, these aneurysmal lesion are associated with 10% risk of rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms.

To answer these questions, Cardiovascular Surgery Unit of the University Hospital of Saint-Etienne, French national reference center for renal artery surgery, in association with the Reference Center for Rare Vascular Disease in Paris, designed the first study for pathological and genetic characteristics of dysplastic renal artery aneurysms in young patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Centre Hospitalier A. Gayraud
Clinique Saint-Germain
Hôpital de la mère et de l'enfant
Hôpital Robert Schuman
CH Henri Mondor
Hôpital Gabriel Montpied
CH W. Morey
CHU Nantes
CH Niort
CH Louis Pasteur
Groupe Hospitalier Pellegrin
Hôpital Jeanne de Flandre
CH Emile Roux
CHRU Tours
CHU Saint-Jacques
Hôpital Européen Georges Pompidou
Hôpital Lapeyronie


title: Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity

summary:
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.

The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.

It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.

25 centers involved in this study.

After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.

They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.

The study will take place in 5 weeks:

During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:

moderate activity 3 hours after lunch
intense activity 3 hours after lunch
activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.

Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.

During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.

Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.

Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.

primary_purpose: Basic Science

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier Régional Universitaire


title: Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

summary:
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.

A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia.

Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.

ReferenceCitation: Dequin PF, Heming N, Meziani F, Plantefeve G, Voiriot G, Badie J, Francois B, Aubron C, Ricard JD, Ehrmann S, Jouan Y, Guillon A, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Tavernier E, Zohar S, Giraudeau B, Annane D, Le Gouge A; CAPE COVID Trial Group and the CRICS-TriGGERSep Network. Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1298-1306. doi: 10.1001/jama.2020.16761.

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Polyvalente, CH d'Argenteuil

location_facility: Service de Réanimation - Unité de Soins Continus, CH d'Angoulême

location_facility: Service de Réanimation Médicale, CHU de Brest

location_facility: Service de Réanimation Médicale Polyvalente, Hôpital G Montpied

location_facility: Service de Réanimation Médicale, CHR d'Orléans

location_facility: Service de Réanimation HIA Clermont-Tonnerre

location_facility: Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers

location_facility: Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg

location_facility: Service de Réanimation Médicale, CHU de Grenoble

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg

location_facility: Service de Réanimation Polyvalente, CHU de Limoges

location_facility: Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban

location_facility: Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres

location_facility: Service de Réanimation Médicale, CHU de Dijon

location_facility: Service de Réanimation Médicale, Hôpital Nord

location_facility: Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille

location_facility: Service de Réanimation, CHU Côte de Nacre

location_facility: Service de Réanimation Médicale, Hôpital Cochin, APHP

location_facility: Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP

location_facility: Service de Réanimation, CHR Metz-Thionville

location_facility: Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes

location_facility: Service de Réanimation Polyvalente, CH de Saint Malo

location_facility: Service de Réanimation Polyvalente, CHD La Roche sur Yon

location_facility: Service de Réanimation, Hôpital Louis Mourier

location_facility: Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes

location_facility: Service de Réanimation Médicale, CHU de Nancy

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: CAP CODE

titre: Influence de la corticothérapie à doses faibles sur l'évolution des pneumopathies aiguës communautaires graves.

discipline_principale: anesthésiologie / réanimation

nom_porteur: DEQUIN

prenom_porteur: Pierre François


title: Phase II Trial to Evaluate the Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

acronym: METIMGAST

summary: Immunotherapy with anti-PD1 antibodies provides encouraging results on a subset of patients. Capmatinib, a MET inhibitor, has shown an imunomodulatory effect and a synergy with spartalizumab a PD-1 inhibitor. The purpose of this phase II trial is to evaluate the efficacy and safety of the combination of capmatinib + spartalizumab in adult patients with advanced oesogastric adenocarcinoma.

status: Suspended

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Jean Minjoz
Centre Léon Bérard
Centre François Leclerc
Institut Universitaire du Cancer
Hôpital Haut Lévêque
Institut Gustave Roussy
AP-HP Hôpital Saint Louis


title: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department

acronym: HYPSEM

summary:
The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine.

Anteromedial dislocation is a very common Reason for admission in emergency department. Many methods for reduction have been described but there is no consensus on the optimum technique or sedation procedures.

Some pain medication and tranquilizers used during a shoulder dislocation management include hemodynamic, respiratory and behavioral adverse effects with the requirement of strengthened surveillance.

Hypnosis could provide to reduce sedative and analgesic use during the reduction of anteromedial dislocation.

The main objective of this study is to evaluate the efficacy of a hypnosis session for reducing the consumption of analgesic in patient throughout a reduction of shoulder dislocation.

The investigators also examine the effect of hypnosis on hemodynamic parameters, patient's pain, patient and practitioner satisfaction, sedative consumption, number of attempts for reduction and length of stay in the emergency department.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility: CHR Fleyriat- Hôpital de Bourg en Bresse

location_facility: Centre Hospitalier Saint Luc Saint Joseph

location_facility: Hôpital Nord-Ouest Villefranche sur Saône

location_facility: Groupement hospitalier Sud-Hôpital Lyon Sud


title: Interrupters of VAscular daMAge in Malignant Hypertension: Role of Inflammasome, Angiogenic and Vasoactive System

acronym: IVAMA

summary: The pathophysiology of malignant hypertension is poorly understood. The objective of this translational research project is to evaluate the relationship between activation of vasoactive systems (renin-angiotensin and endothelin systems), angiogenic signal deficiency (VEGF and sFlt-1) and the occurrence of malignant hypertension episodes in humans.

status: Recruiting

lead_sponsor: Centre Hospitalier de PAU

location_facility:
Hôpital Avicenne
Hôpital Européen Georges Pompidou
Hôpital Tenon
CHU de Tours
Hôpital Bichat
CHU de Bordeaux
Chu Rangueil

intervention_type: Biological


title: Efficacité du E-learning et du Jeu de rôle Pour la Formation Des Soignants Des EHPAD à l'Accompagnement de l'Agitation Dans Les Maladies neurodégénératives : Essai randomisé en Cluster

summary: This study will investigate the effects of "I-Learn cognition and behaviour" training in the care in agitation in patients with neurodegenerative diseases. This training for caregivers, aims to reduce agitation and psycho-behavioral disorders of patients living in nursing home. In addition, amount of psychotropic drugs prescribed, as well as the number of hospitalizations during the study will be assessed.

location_facility:
EHPAD Le Clos Saint-Vincent
Résidence Père Brottier
EHPAD Montconseil
EHPAD La Source
EHPAD La Bourdaisière
EHPAD Résidence du Prévot
Maison Saint Michel

appel_a_projets: PHRIP

acronyme: I-Learn

titre: Efficacité du e-Learning et du jeu de rôle pour la formation des soignants des EHPAD à l'accompagnement de l'agitation dans les maladies neurodégénératives : essai randomisé en cluster  I-Learn

discipline_principale: gériatrie

nom_porteur: LOURDEL

prenom_porteur: Céline


title: Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People

acronym: AiDiBull

summary: The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.

location_facility:
University hospital of Toulouse
AP-HM
AP-HP
Hospices Civils de Lyon
CHU de Nantes
CHU de Bordeaux
Hôpitaux Universitaires de Strasbourg


title: Impact on Duration of Antibiotic Therapy of Rapid Molecular Diagnostic Method for Rapid Analysis of Susceptibility of Peritoneal Samples in Postoperative Peritonitis in ICU Patients

acronym: DIRECTABDO

summary:
Hospitals, and more specifically Intensive Care Units (ICU), face the challenging issue of emergence and rapid spread of multi-drug resistant bacteria (MDR). In some cases, the therapeutic choice is extremely limited. Prevention and adequacy of antibiotic therapy (AB) are the key responses applied toward these threats. A delayed adequate AB is a known factor of poor prognosis. Intra-abdominal infections (IAI) are frequent, polymicrobial and life threatening diseases. Source control and adequate AB are instrumental issues in this setting. Despite technical advances, susceptibility testing of the microorganisms collected from peritoneal samples is not usually available before day two or three after surgery. In this time lapse, empiric AB might be inadequate (not targeting all the pathogens, which leads to a prolonged duration of AB and potential increased morbidity/mortality risk) or too broad (with the two issues of ecology with an increased risk of selection of MDR bacteria and additional costs). In a pilot study evaluating the potential benefit of a direct culture of peritoneal samples from resuscitation patients treated for peritonitis, we observed that conventional treatment made it possible to obtain microbiological results within a median of 3 [extremes 2-7] days whereas a direct microbiological technique by E-test gave results in 1 [1-2] days (p <0.0001). With this technique close to conventional microbiological, a change in antibiotic therapy could have been achieved within an average of 1 [1-2] days versus 4 [1-11] days with conventional management (p = 0, 0006).

The development of modern molecular techniques suggests that a large margin of improvement for the rendering and the precision of the results is possible.

primary_purpose: Other

location_facility:
Chartres Hospital
Amiens-Picardie Hospital
Saint Antoine Hospital
Charles Nicolle Hospital
Beaujon Hospital
Bichat Hospital
Lariboisiere Hospital

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: DIRECTABDO

titre: Impact sur la durée d'antibiothérapie de l'utilisation d'un antibiogramme direct par E-test pour l'analyse rapide de la sensibilité des prélèvements péritonéaux dans les péritonites postopératoires admises en réanimation

nom_porteur: MONTRAVERS

prenom_porteur: Philippe


title: Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs

acronym: CUICUI-AHD

summary: Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care

location_facility:
Intensive Care Avicenne Hsopital
Intensive Care Victor Dupouy Hospital
Intensive Care Bichat Hospital
Intensive Care Louis Mourier Hospital
Intensive Care Tours Hospital
Intensive Care Longjumeau Hospital
Intensive Care René Dubos Hospital


title: Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder for Patients Presenting at the Emergency Room: A Multi-center Cluster Randomized Cross-over Implementation Study.

acronym: SOFTERIV

summary:
Promising results of an early EMDR (Eye Movement Desensitization and Reprocessing) intervention on PCLS (PostConcussion-Like Syndrome) at three months have been shown, suggesting that the availability of psychological care in emergency departments will be useful. The real impact of such a care service remains to be measured. Several factors may modulate the impact of such a measure, leaving the extent of its public health benefit uncertain.

In the SOFTER III trial, the results suggest that high levels of self-rated stress at admission probably play a key role in the development of CPSP and psychological intervention.

The most appropriate study design for such an objective is to follow a cohort of patients in the Emergency Department and to assess the main risk factors for CPSD 4 months later. To this end, all consecutive patients should be asked to participate in a study and complete a risk factor questionnaire, regardless of their level of risk for CPSD.

SOFTER IV offers the opportunity to evaluate the impact of a psychological intervention to reduce the incidence of chronic pain. By acting on the emotions experienced in the Emergency Department, a reduction in acute pain and perhaps in the longer term in chronic pain can be expected. Its psychological aspects, and more specifically the emotional dimension, are known to be related to acute pain. As for the relationship with chronic pain, it exists, but its meaning is not clear because the emotional state is assessed when the pain has already become chronic. It is proposed to integrate the assessment of emotions at inclusion in the project, and to follow up patients 12 months after inclusion to assess the incidence of chronic pain and identify the factors that modulate it. Early intervention in the emergency department, including an early short one-hour EMDR intervention R-TEP (Recent Traumatic Episode Protocol), could thus reduce the incidence of chronic pain.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
UH Bordeaux

location_facility:
Hôpital Purpan
CH de Libourne
Hôpital Lariboisière
Hôpital Louis Mourier
Hôpital Edouard Herriot
Hôpital Beaujon
Hopital Pellegrin

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: SOFTER-IV

titre: Symptômes persistants équivalent au syndrome post-commotionnels et à l'état de stress post-traumatique chez les patients qui se présentent aux urgences: étude multicentrique d'implementation.

discipline_principale: emergency medicine

nom_porteur: GIL-JARDINÉ

prenom_porteur: Cédric


title: Personalized Circulating DNA Follow-up in Melanoma

acronym: PERCIMEL

summary: PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Institut de Cancerologie de Lorraine
Chru Nancy
Chu Dijon
Chru Lille
CHU Jean Minjoz
Ghr Mulhouse Sud Alsace
CGFL

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: INSTITUT DE CANCEROLOGIE DE LORRAINE

type_etablissement: CLCC

acronyme: PERCIMEL

titre: Suivi personnalisé de l'ADN circulant dans les mélanomes cutanés opérés de stades III et IV

discipline_principale: autre

nom_porteur: GEOFFROIS

prenom_porteur: Lionnel


title: Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer: a French Observational Multicenter Study of 259 Patients (ABCT-IMMUNOBZH)

acronym: IMMUNOBZH

summary: Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: 1. Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017 Apr;6(2):196-211. 2. Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M et al. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. The Oncologist. 2016 May;21(5):634-42. 3. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. 4. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. 5. Herbst RS, Baas P, Kim D-W, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. 2016 Apr;387(10027):1540-50. 6. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017 21;389(10066):255-65. 7. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer Oxf Engl 1990. 2009 Jan;45(2):228-47. 8. Common Terminology Criteria for Adverse Events (CTCAE) - CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf

lead_sponsor: University Hospital, Brest

location_facility:
Centre Hospitalier de Bretagne Sud
Centre hospitalier de Saint Malo
CHRU de Brest
CH de VANNES
Centre Hospitalier Yves Le Foll
CH DINAN
CHU de Rennes


title: Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army

acronym: QPROTEC

summary:
Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections:

A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal)
A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot.

The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: 101e Antenne Médicale, 13e Centre Médical des Armées

location_facility: 176e Antenne Médicale, 11e Centre Médical des Armées

location_facility: Institut de Recherche Biomédicale des Armées

location_facility: 93e Antenne Médicale, 8e Centre Médical des Armées

location_facility: 76e Antenne Médicale, 7e Centre Médical des Armées

location_facility: 119e Antenne Médicale, 14e Centre Médical des Armées


title: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding

acronym: APACHE

summary: In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

location_facility: North Val de Seine Paris University Hospital

location_facility: Georges Pompidou European University Hospital


title: Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients

acronym: EMOPTION

summary: Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

sponsor_collaborators:
University Hospital, Bordeaux
Societe Francaise de Rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: AP-HP - Hopital Cochin - service de rhumatologie

location_facility: AP-HP - Hopital Henri Mondor - service de rhumatologie

location_facility: CHU de Toulouse - service de rhumatologie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: CHU de Saint-Etienne - service de rhumatologie


title: Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study

acronym: PREV-HAP

summary:
PREV-HAP study is part of a larger project entitled 'Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia' (HAP2), funded by the European Union's H2020 research and innovation programme under grant agreement N°847782. HAP2 aims to develop stratified host-directed drugs and biomarkers to enhance the prevention and the treatment of HAP and develop precision medicine in infectious diseases. Its ambition is to revolutionize the management of HAP: capitalising on the novel concept of critical-illness related immunosuppression altering the host-pathogens interactions, the aim is to propose a complete reappraisal of the physiopathology of HAP based on the concept of respiratory dysbiosis.

The main hypothesis of the PREV-HAP study is that human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients and prevent Hospital-Acquired Pneumonia.

The hypothesesis is that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections.

The involvement of a state of critical-illness related immunosuppression in the susceptibility to hospital-acquired pneumonia is widely accepted, and an emerging trend is that the development of drugs for the treatment of this acquired immunosuppression will prevent infection and enhance outcomes of hospitalized patients.

It has been demonstrated that the productions of IFN-γ by immune cells are decreased in critically ill patients, and that these defects are associated with the susceptibility to HAP. rHuIFN-γ has neither been tested nor is recommended as adjunctive treatment of patients with HAP. Based on these specific factors identified in the host response, it is proposed in this study to use rHuIFN-γ as novel preventive approach for HAP.

lead_sponsor: Nantes University Hospital

location_country: Spain Greece France

location_facility: Aghioi Anargyroi General Oncology Hospital

location_facility: Koutlimbaneio & Triantafylleio General Hospital of Larissa

location_facility: General University Hospital of Heraklion


title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

acronym: FIAC

summary:
Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures.

The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.

This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.

ipd_sharing_description: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

location_facility:
Hôpital Annecy Genevois
Hôpitaux Universitaires de Strasbourg
Hôpital Pitié-Salpêtrière
CHU Purpan - Hôpital Pierre-Paul Riquet
CHU de Nantes
CHU Angers
APHM - Hôpital de la Conception

acronyme: FIAC

titre: Traitement chirurgical versus traitement conservateur des Fractures Intra-Articulaires du Condyle mandibulaire : essai contrôlé randomisé multicentrique.

discipline_principale: maxillofacial surgery / stomatology

nom_porteur: SCHOUMAN

prenom_porteur: Thomas


title: Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes

acronym: TELXCODIA

summary:
Telemedicine for diabetic patients is currently based simply on remotely monitoring capillary blood glucose levels. This experimental approach remains limited to insulin-treated diabetic patients with sufficient motivation and ability to use connected devices and only considers one aspect of the care required by diabetic patients. So far, telemedicine has not offered a more global approach to the therapeutic support of patients. This failing leads to recurrent hospitalizations for acute metabolic events.

This project aims to demonstrate the feasibility of an individualized care pathway based on a multidisciplinary tele-medical network on a territorial scale. This pathway will include a base program with follow-up that can be adapted and revised thanks to the regular use of collaborative tele-expertise.

The possibility of monthly multidiciplinary meetings via Tele-expertise between the different diabetes centers of the hospital groups would help to define and implement an individualized care pathway for diabetic patients hospitalized on a recurring basis (≥2 hospitalizations/year), which would be defined collegially during the multidiciplinary meetings .

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators:
University Hospital, Montpellier
Hospital Center, Alès
CH Bagnols sur Cèze
CH Béziers
HOPITAL ST CLAIR HBT SETE
Centre Hospitalier Saint Jean Perpignan
CH Narbonne HÔTEL DIEU

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population

summary: The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.

lead_sponsor: Wicab

location_facility: Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics


title: A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease

summary: This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease

lead_sponsor: Il-Yang Pharm. Co., Ltd.

location_facility:
CHRU de Lille - Hôpital Roger Salengro
Chu La Miletrie
Hôpital Pitié-Salpêtrière
CHU de Lyon HCL
Hôpital Nantes-Hotel Dieu
CHU Limoges
CHU de Rouen


title: Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration

acronym: PRIMAvera

summary: The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).

ReferenceType: background

ReferenceCitation: Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Pixium Vision SA

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France

location_facility: Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik

location_facility: Centre hospitalier intercommunal de Créteil - Service Ophtalmologie

location_facility: Instituto de Microcirugía Ocular de Barcelona

location_facility: KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach

location_facility: Universitätsklinikum Aachen, Klinik fuer Augenheilkunde

location_facility: Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

location_facility: Fondation Ophtalmologique A. De Rothschild

location_facility: Augenklinik der Ludwig-Maximilian Universität München


title: ENT Barotrauma Epidemiology Among French Army Divers

acronym: BTORL PAF

summary:
Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. One study related to recreational diving reports that ENT barotrauma concern 10% of dives with experimented divers and 30% with novice divers. Nevertheless, a low number of studies were realized on ENT barotrauma, particularly those involving middle ear and sinuses, maybe because most of them evolve favorably without sequelae.

Besides, it has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But once again no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence. Few data on military population exist either. However, operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Furthermore, therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption.

The purpose of this research is to study middle ear and sinus barotrauma thanks to questionnaires focused on those pathologies and their potential risk factors. The hypothesis is that it will allow identification of main risk factors in order to develop preventive measures as well as the characteristics and missions of concerned divers and the impact of those barotrauma on this population.

primary_purpose: Screening

ReferenceCitation: Taylor DM, O'Toole KS, Ryan CM. Experienced scuba divers in Australia and the United States suffer considerable injury and morbidity. Wilderness Environ Med. 2003 Summer;14(2):83-8. doi: 10.1580/1080-6032(2003)014[0083:esdiaa]2.0.co;2.

ReferenceCitation: Fitzpatrick DT, Franck BA, Mason KT, Shannon SG. Risk factors for symptomatic otic and sinus barotrauma in a multiplace hyperbaric chamber. Undersea Hyperb Med. 1999 Winter;26(4):243-7.

sponsor_collaborators: Direction Centrale du Service de Santé des Armées

location_facility: 1er Groupe Plongeurs Démineurs Cherbourg

location_facility: Service de médecine hyperbare et expertise de la plongée


title: Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients

acronym: PREDIBACK 2

summary:
Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being.

Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief.

FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient.

The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2.

This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process.

PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

lead_sponsor: Poitiers University Hospital

location_facility: Nice University Hospital, Cimiez Hospital


lead_sponsor: Highlight Therapeutics

summary: This is a phase 2, single arm, open label, adaptive design study to determine the preliminary anti-tumor activity and confirm the safety of IT BO-112 in combination with intravenous (IV) pembrolizumab. The study will enroll patients with advanced and/or metastatic melanoma that have progressed on anti-PD-1-containing treatment.

sponsor_collaborators:
Highlight Therapeutics
Merck Sharp & Dohme LLC

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

title: Phase 2 Single Arm Clinical Study to Evaluate the Efficacy and Safety of Intratumoral Administration of BO-112 in Combination With Pembrolizumab in Subjects That Have Progressed on Anti-PD-1-based Therapy for Stage III or IV Melanoma

type: Other Grant/Funding Number

location_country: Spain France


title: Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck

acronym: OPTINECK

summary:
Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment.

In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival.

While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.

lead_sponsor: Centre Henri Becquerel

location_facility:
Clinique du Parc
CH Beauvais
CHRU Lille
CH Saint-Quentin
Centre Guillaume le Conquérant
Centre Henri Becquerel
CHU Amiens


title: Dysautonomic Signs Among MECP2boys

summary: Dysautonomic signs are well known among girls with a Rett Syndrom. Rett syndrom is caused by a MECP2 mutation in 95% of cases. We want to search dysautonomic signs among boys with a MECP2 mutations because they are less studied than the girls and they have more varied phenotypes.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
CHU de NIMES
CHRU de Brest
CHRU de Lille
CHU de Besançon
Hôpital Robert Debre
Hospices Civiles de Lyon
Hôpital de la Timone


title: Evelopment and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT

summary:
Only 5% of patients infected with COVID-19 develop severe or critical Coronavirus disease 2019 (COVID-19) and there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.

Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients.

collaborators: Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)

location_facility: Hôpital Arnaud-de-Villeneuve CHU de Montpellier


title: Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study

acronym: COV-NI

summary: COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date, no treatment has yet demonstrated Strong efficacy in treating the infectious disease (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy with high potential,due to higher local concentrations and minimal adverse effects. Type I interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19 than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators have a decrease in viral carriage and a rapid reversal. The purpose of this project is to assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen requirements of the addition of inhaled Interferon type I compared to the control arm .

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: CH de l'Arrondissement de Montreuil-sur-mer


title: Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte

acronym: HEMATOVAC

summary: The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal injection followed 2 months later by polysaccharide 23-valent vaccine injection. General practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 70% of the patients are non-responders to vaccination, according to their anti-pneumococcal immunoglobulin G titers and the opsonophagocytic activity. To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, the investigator will measure anti-pneumococcal serotype-specific immunoglobulin G titers and opsonophagocytic activity at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the 13-valent pneumococcal injection (corresponding to 1 month after the end of the combined strategy) using immunoglobulin G titers and opsonophagocytic activity. At different time points (day 0, 1 month after the 13-valent pneumococcal injection, the day of the injection of the polysaccharide 23-valent vaccine, one month after the injection of the polysaccharide 23-valent vaccine, 3-6 months after the polysaccharide 23-valent vaccine,9-12 months after the polysaccharide 23-valent vaccine), the immunological response to vaccination will be monitored using specific-serotype immunoglobulin G titers, opsonophagocytic activity, and total anti-pneumococcal Immunoglobulin. The investigator will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received by both acute myeloblastic leukemia and lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.

ipd_sharing_description: Undecided

location_facility:
Chu Nantes
Chu Angers
Ch Perigueux
CHU Poitiers
CHU Bordeaux
CHU Limoges
CHU Tours

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

acronyme: HEMATOVAC

titre: Etude sur l'immunogénicité de la vaccination anti-pneumoccocique dans la leucémie aiguë myéloblastique et le lymphome chez l'adulte

discipline_principale: infectiologie

nom_porteur: PUYADE

prenom_porteur: Mathieu


title: An Open Label Non Randomized Access Study of Trametinib for Patients With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

summary: This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.

status: No longer available

study_type: Expanded Access

lead_sponsor: GlaxoSmithKline


title: A Multicentre, Randomised, Double-blind, Controlled, Phase IIIb Study to Assess the Efficacy and Safety of Rivaroxaban 10mg od Versus Enoxaparin 4000 UI for VTE PROphylaxis in NOn Major Orthopaedic Surgery

acronym: PRONOMOS

summary:
PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000 UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic surgeries for femoral neck and trochanteric fractures, THR, TKR)

Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24 hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization, patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started 6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH injection if needed for the intended treatment duration of 2 to 12 weeks based on medical judgment (according to immobilization). Patients allocated to the comparator arm will receive enoxaparin once daily for the same intended treatment duration. All patients will have a 30-day observational period after cessation of treatment.

ReferenceCitation: Samama CM, Laporte S, Rosencher N, Girard P, Llau J, Mouret P, Fisher W, Martinez-Martin J, Duverger D, Deygas B, Presles E, Cucherat M, Mismetti P; PRONOMOS Investigators. Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery. N Engl J Med. 2020 May 14;382(20):1916-1925. doi: 10.1056/NEJMoa1913808. Epub 2020 Mar 29.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hôpitaux Universitaires de Strasbourg C.C.O.M

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet


acronym: REGOBONE

lead_sponsor: UNICANCER

summary:
INDICATION:

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas

ReferenceCitation: Duffaud F, Italiano A, Bompas E, Rios M, Penel N, Mir O, Piperno-Neumann S, Chevreau C, Delcambre C, Bertucci F, Boudou-Rouquette P, Cancel M, Perrin C, Saada-Bouzid E, Monard L, Schiffler C, Chaigneau L, Hervieu A, Collard O, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study. Eur J Cancer. 2021 Jun;150:108-118. doi: 10.1016/j.ejca.2021.03.039. Epub 2021 Apr 22.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

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

repositories_concat: HAL

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

publisher_dissemination: Informa

ReferenceCitation: Duffaud F, Mir O, Boudou-Rouquette P, Piperno-Neumann S, Penel N, Bompas E, Delcambre C, Kalbacher E, Italiano A, Collard O, Chevreau C, Saada E, Isambert N, Delaye J, Schiffler C, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. doi: 10.1016/S1470-2045(18)30742-3. Epub 2018 Nov 23.

location_facility: Institut de cancerologie de l'ouest site Rene Gauducheau

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: Institut de cancerologie de lorraine alexis Vautrin

title: A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

ipd_sharing_description: no individual participant data is shared


title: Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers

acronym: FOLFA

summary: This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line with aflibercept +/- LV5FU2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Institut de cancérologie de Bourgogne - GRRECC


title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance

acronym: TAPAZ

summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.

ReferenceCitation: Joly F, Fabbro M, Berton D, Lequesne J, Anota A, Puszkiel A, Floquet A, Vegas H, Bourgeois H, Bengrine Lefevre L, You B, Pommeret F, Lortholary A, Spaeth D, Hardy-Bessard AC, Abdeddaim C, Kaminsky-Forrett MC, Tod M, Kurtz JE, Del Piano F, Meunier J, Raban N, Alexandre J, Mouret-Reynier MA, Ray-Coquard I, Provansal Gross M, Brachet PE. Paclitaxel with or without pazopanib for ovarian cancer relapsing during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study. Gynecol Oncol. 2022 Sep;166(3):389-396. doi: 10.1016/j.ygyno.2022.06.022. Epub 2022 Jul 26.

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Novartis

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Hospitalier Universitaire Bretonneau

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: "Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie"


title: Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

acronym: IPPACTTO

summary: The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Chu Nantes
CHU
Ch Cholet
CHD Vendée
Institut de Cancérologie de l'Ouest
Ch Le Mans

intervention_type: Behavioral

appel_a_projets: PREPS

nom_etablissement: ICO - SITE PAUL PAPIN

acronyme: IPPACTTO

titre: Intervention pharmaceutique dans le Parcours de soins coordonné du PAtient atteint de Cancer et Traité par Thérapie Orale

discipline_principale: organisation des soins

nom_porteur: GRUDE

prenom_porteur: Francoise


type: Registry Identifier

title: Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study

acronym: VVS-SAS

summary: This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.

ReferenceCitation: Puel V, Godard I, Papaioannou G, Gosse P, Pepin JL, Thoin F, Deharo JC, Roche F, Zarqane N, Gagnadoux F, Suehs CM, Molinari N. Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study. BMJ Open. 2020 Sep 30;10(9):e038791. doi: 10.1136/bmjopen-2020-038791.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

unpaywall_oa_status: gold

lead_sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)

location_facility: Public Assistance - Hospitals of Marseille


title: High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum

acronym: HAM

summary:
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.

It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.

The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.

The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Laennec
Groupe Hospitalier Pellegrin
Hôpital Pierre Paul Riquet, CHU Purpan
CHU Rennes
Fondation A De Rothschild
CHU de Rouen
Centre Hospitalier Lyon Sud


title: Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis: Study Protocol of a Randomized Double-blind Placebo-controlled Trial

acronym: GlutenSPA

summary: Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.

ReferenceCitation: Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.

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

lead_sponsor: University Hospital, Clermont-Ferrand

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

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

intervention_type: Dietary Supplement

acronyme: Gluten-SPA

titre: Impact d'un régime sans gluten sur la qualité de vie et le microbiote des patients ayant une spondyloarthrite axiale

discipline_principale: hors cancer

nom_porteur: COUDERC

prenom_porteur: Marion


title: KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology

summary: Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.

lead_sponsor: Institut Curie

location_facility:
Groupe Hospitalier Paris Saint- Joseph
Centre Hospitalier Universitaire
Centre Hospitalier Valenciennes
Institut de Cancérologie de l'Ouest
Centre République
Institut Curie

intervention_type: Diagnostic Test

nom_etablissement: CLCC  INSTITUT CURIE

titre: KDOG01: Dépistage transcutané du cancer du sein par odorologie canine

discipline_principale: cancer

nom_porteur: TARDIVON

prenom_porteur: Anne


title: A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression

acronym: GRID

summary:
The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009.

The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites.

Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Estaing 1 place Lucie et Raymond Aubrac

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: GRID

titre: Administration de GranulocyteMacrophage Colony-stimulating Factor (GmCsf) pour diminuer les infections acquises en reanimation au cours de l'immunodépression induite par le sepsis Etude multicentrique randomisée en double aveugle contre placebo

nom_porteur: FRIGGERI

prenom_porteur: Arnaud


title: Usefulness of Hair Cortisol/Cortisone Concentrations for the Monitoring of Medical Treatment in Patients With Cushing's Disease

acronym: HAIRCUSH

summary: The biochemical tools usable to assess the control of hypercortisolism in patients with Cushing's disease receiving medical treatments are debatable. The aim of the study is to compare the results of the measurement of cortisol and cortisone using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) in scalp hair (so called "Hair Cortisol") to that of 24h urinary free cortisol (UFC) and late night salivary cortisol (LNSC) for the monitoring of medical therapy in patients with Cushing's disease (CD).

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'endocirnologie, diabète, nutrition, Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - APHM

location_facility: Service d'Endocrinologie et des Maladies de la Reproduction - APHP Bicêtre

location_facility: CIC d'Endocrinologie, Maladies Métaboliques et Nutrition - CHU de Nantes


title: Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line

acronym: PANOPTIMOX

summary:
The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy.

Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin.

These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.

FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment.

The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

ReferenceCitation: Dahan L, Williet N, Le Malicot K, Phelip JM, Desrame J, Bouche O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Seitz JF, Lepage C, Francois E; PRODIGE 35 Investigators/Collaborators. Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial. J Clin Oncol. 2021 Oct 10;39(29):3242-3250. doi: 10.1200/JCO.20.03329. Epub 2021 Jul 21.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Hôpital de la Source- service d'oncologie

location_facility: Institut Daniel Hollard / Groupe Hospitalier Mutualiste

location_facility: CHU AP - HP - Hôpital Européen Georges Pompidou

location_facility: Hôpital de la Source -service HGE et cancérologie digestive


title: Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home

summary:
The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.

The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.

The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.

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

location_facility:
CHD de la Réunion
Hôpital Robert Schuman
CHU de Nancy
AP-HP Pitié-Salpêtrière
CHU de Lille
CHU de Dijon
Hôpital Edouard Rist
CHU de Toulouse
CHU de Limoges
CHU de Strasbourg
Garches
CHU d'Angers
CHU de Besançon
CHU de Grenoble
CH de Cannes
CHU de Rouen


title: Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients

acronym: CIMDREA

summary: the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.

lead_sponsor: University Hospital, Lille

location_facility:
CH LENS
Grand Hopital de L'Est Francilien
Hospices Civils de Lyon
C.H de Roubaix
Hôpital Roger Salengro, CHU
Chu Amiens Picardie
Ch Bethune


title: Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose

acronym: METROPOP

summary:
The objective of NEOPOPI is to conduct a population pharmacokinetic study of metronidazole in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

lead_sponsor: Rennes University Hospital

location_facility:
Centre Robert Debré
CH St Brieuc
CHU de Tours
CHU de Brest
CHU d'Angers
CH Vannes
CHU de Rennes

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: METROPOP

titre: Pharmacocinétique de population du Métronidazole chez le nouveau-né : évaluation et optimisation de la dose

nom_porteur: LEROUX

prenom_porteur: Stéphanie