title: Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"

acronym: KYPHOK

summary:
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.

This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.

Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.

The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Lariboisière-service de radiologie ostéoarticulaire

location_facility: Hôpital Henri Mondor - Service de Radiologie


title: Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture

acronym: PROME

summary:
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
UH Lille
UH Amiens
UH Caen

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

summary: This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

status: Completed

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: ERBUS

summary:
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame


title: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

summary:
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).

The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.

We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.

Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.

Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.

Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.

The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.

The study will last 3 years. The number of patient to include is 280.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique

intervention_type: Other


title: A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

summary: The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Regional - Dermatology


title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

summary:
Primary objective:

To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.

Secondary objectives:

To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.

study_start_date_type: Actual

lead_sponsor: Sanofi Pasteur, a Sanofi Company

intervention_type: Biological


title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

summary: Progressive Supranuclear Palsy (PSP) is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. The investigators thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.

lead_sponsor: Nantes University Hospital

location_facility: Service de Neurologie A, Hôpital Gabriel Montpied-BP

location_facility: Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille


title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection

summary: The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

location_facility:
Urgences pédiatriques CHU de Caen
POSU pediatrique
Urgences pédiatriques - CHU ROUEN
Urgences pédiatriques


title: Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

summary: There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Gustave Roussy
Centre Alexis Vautrin
Hôpital de la Croix Rousse
Centre Francois Baclesse

intervention_type: Procedure


title: Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial

summary: The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.

ReferenceType: derived

ReferenceCitation: Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.

lead_sponsor: Poissy-Saint Germain Hospital

location_facility:
Avignon Hospital
Poissy Saint-Germain Hospital
Poisyy Saint-Germain Hospital
André Mignot Hospital


title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

summary: The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
Centre Hospitalier Joseph Ducuing
Centre Hospitalier de Castres
Centre Hospitalier de Montauban


title: Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

acronym: DNA-EVAL

summary:
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.

Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Hoffmann-La Roche

location_facility: Service des Maladies Infectieuses et Tropicales


title: Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9

summary: Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

ReferenceType: background

ReferenceCitation: Martin JH, Begg EJ, Kennedy MA, Roberts R, Barclay ML. Is cytochrome P450 2C9 genotype associated with NSAID gastric ulceration? Br J Clin Pharmacol. 2001 Jun;51(6):627-30. doi: 10.1046/j.0306-5251.2001.01398.x.

ReferenceCitation: Martinez C, Blanco G, Ladero JM, Garcia-Martin E, Taxonera C, Gamito FG, Diaz-Rubio M, Agundez JA. Genetic predisposition to acute gastrointestinal bleeding after NSAIDs use. Br J Pharmacol. 2004 Jan;141(2):205-8. doi: 10.1038/sj.bjp.0705623. Epub 2004 Jan 5.

location_facility: Service d'hépato-gastroentérologie, Hôpital Saint Antoine

location_facility: Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière

location_facility: : Service d'hépato-gastroentérologie, Hôpital Henri Mondor

location_facility: Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE


title: Phase II Study of the Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma

summary:
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years

The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test.

The other objective is to evaluate the toxicity

ReferenceCitation: Czuczman MS, Grillo-Lopez AJ, White CA, Saleh M, Gordon L, LoBuglio AF, Jonas C, Klippenstein D, Dallaire B, Varns C. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol. 1999 Jan;17(1):268-76. doi: 10.1200/JCO.1999.17.1.268.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.

ReferenceCitation: 44. Marcus R, et al. (2003). An International Multi-Centre, Randomized, Open-Label, Phase III Trial Comparing Rituximab Added to CVP Chemotherapy to CVP Chemotherapy Alone in Untreated Stage III/IV Follicular Non-Hodgkins Lymphoma. Blood, 102, issue 11, (abstract 87).

ReferenceCitation: O'Connor O, Wright J, Moskowitz CH et al. Promising Activity of the Proteasome Inhibitor Bortezomib (Velcade) in the Treatment of Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Session Type: Poster Session 517-II. Blood, Volume 102, issue 11, November 16, 2003 (abstract 2346)

lead_sponsor: Lymphoma Study Association

collaborators: Association pour le Développement de la Recherche Clinique et Informatique en Onco-Hématologie

location_facility:
Hôpital Saint-Louis
Hôpital Lyon Sud
Hôpital Henri Mondor
Institut Gustave Roussy


type: EudraCT Number

title: A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

summary: The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
ViiV Healthcare

location_facility:
Hôpital du Bocage
Hôpital Avicenne
Hôpital Saint-Louis
Hôpital Purpan
Hôpital Gabriel Montpied
Hôpital Gui de Chaudiac
Hôpital de l'Hotel Dieu
Hôpital Pierre Zobda-Quitman
Hôpital Pontchaillou
Hôpital Pitié-Salpêtrière
Hôpital Gustave Dron
Hôpital Bichat
Centre hospitalier de Pernignan
Hôpital Saint-André
Hôpital Bretonneau
Hôpial Bicêtre
Hôpital Saint-Antoine
Hôpital Necker


title: A Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)

summary: This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Shanghai Henlius Biotech

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Singapore
Australia
United States
China
Latvia
Spain
Czechia
Bulgaria
Serbia
France

location_facility: The People's Hospital of Ningxia Hui Autonomous Region

location_facility: Bajcsy-Zsilinszky Korhaz Es Rendelointezet

location_facility: Nemocnica Poprad As Oftalmologicke Oddelenie Jzs

location_facility: Nemocnica S Poliklinikou Trebisov A.S. Ocne Oddelenie Jzs

location_facility: Irccs Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia Onlus Rome, Italy

location_facility: Special Optalmological Hospital Belgrade

location_facility: Markhot Ferenc Oktatokorhaz Es Rendelointezet

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont - Szemeszeti Klinika

location_facility: University Eye Clinic Centre Hospitalier Creteil Paris France

location_facility: Fakultna Nemocnica S Poliklinikou Zilina

location_facility: Joint Shangtou International Eye Center Of Shantou University And The Chinese University Of Hong Kong

location_facility: Retina Consultants of TEXAS - Round Rock

location_facility: Mt. Olympus Research/Museum Eye District

location_facility: University First Mhat - Sofia Sv. Joan Krastitel Ead

location_facility: Retina Consultants of Charleston: Charleston Neuroscience Institute

location_facility: Fondazione Policlinico Universitario Agostino Gemelli - Irccs Uoc Oculistica

location_facility: The Third Affiliated Hospital of Xinxiang Medical University

location_facility: Assoc. Prof. Dr. Desislava Koleva Aipsmaed Sveti Luka Eood

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Specialized Eye Hospital For Active Treatment - Burgas Ltd

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lubline

location_facility: Specialized Hospital For Active Treatment in Ophthalmology - Varna

location_facility: Clinica Oculistica Universita Vita Salute - Irccs Ospedale San Raffaele

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Fakultna Nemocnica S Poliklinikou Nove Zamky Oftalmologicke Nelozkove Oddelenie

location_facility: Retina Consultants of Charleston - Beaufort

location_facility: VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota

location_facility: Clinica Oculistica Ospedale Luigi Sacco, Universita' Degli Studi Di Milano

location_facility: Centre Hospitalier Universitaire Amiens-Picardie Service D'Ophthalmologie Amiens France

status_simplified: Ongoing


title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)

acronym: HOME-PE

summary:
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.

The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.

An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.

The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.

The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).

The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

As regards the rate of patients eventually managed as outpatients.
As regards the rate of patients, in theory, eligible for outpatient care,

primary_purpose: Other

ReferenceCitation: Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28.

ReferenceCitation: Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.

ReferenceCitation: Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available. Erratum In: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642.

ReferenceCitation: Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

ReferenceCitation: Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.

ReferenceCitation: Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: Université de Lausanne - SERVAL

repository_institution: Leiden University - Leiden Repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Angers

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

location_country: Switzerland Netherlands Belgium Spain France

location_facility: Leiden University Medical Center Leiden,

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: HOME

titre: Hospitalisation Ou prise en charge à la Maison des patients ayant une Embolie pulmonaire : essai contrôlé randomisé

discipline_principale: médecine interne

nom_porteur: ROY

prenom_porteur: Pierre Marie


title: Study of the Therapeutic Response and Survival of Patients With Metastatic Colorectal Cancer (Stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®

acronym: ONCOGRAM

summary: Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity

status: Active, not recruiting

ReferenceCitation: Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taibi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme(R). Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

sponsor_collaborators:
University Hospital, Limoges
Oncomédics

location_facility:
Clermont-Ferrand University Hospital
Limoges University Hospital
CHU de POITIERS
CHU de TOURS
Nimes University Hospital
CHU de Strasbourg
Centre Médical MGEN Alfred Leune
Clinique des Cédres
CHU d'AMIENS
Bergonié Institut
CHu de la Martinique
Hospital Center
CH de Saint Junien

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: ONCOGRAM

titre: Étude de la réponse thérapeutique et de la survie de patients atteints par un cancer colorectal avancé/métastatique (stade IV) et traités selon les directives d'un test de chimiosensibilité, l'Oncogramme®

discipline_principale: cancérologie, chirurgie digestive

nom_porteur: MATHONNET

prenom_porteur: Muriel


title: a French Observational Prospective Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer

acronym: PROWESs

summary: This French non-interventional prospective multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.

lead_sponsor: AstraZeneca


study_start_date_type: Anticipated

acronym: DICOV

lead_sponsor: Hospices Civils de Lyon

summary:
SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative clinical benefit, particularly in the initial stages facilitating viral eviction. .

Based on the mechanism of action and the available data, diltiazem, administered in the first days post-infection, could facilitate viral eradication in these patients through the stimulation of the innate immune response of cells of the infected respiratory epithelium, actor in the fight against SARS-CoV-2.

In this context, the investigators propose the DICOV trial, to demonstrate the ability of diltiazem to reduce the viral load more rapidly, in patients hospitalized for COVID-19 hypoxemic pneumonia.

sponsor_collaborators:
Hospices Civils de Lyon
Signia Therapeutics

location_facility: Médecine interne, CHMS, Hospices Civils de Lyon

location_facility: Service de Pneumologie CHU Gabriel Montpied

location_facility: Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière

location_facility: Service des Maladies Infectieuses et Tropicales

location_facility: Service des Maladies Infectieuses et du Voyageur Hôpital Gustave Dron

location_facility: de Pneumologie Groupe Hospitalier du Havre Hôpital

location_facility: Service de Maladies infectieuses et tropicales

location_facility: Clinique des Voies Respiratoires Hôpital Larrey

location_facility: Maladies infectieuses et Tropicales CHU Grenoble Rhône-Alpes

location_facility: Service de pneumologie, CHLS, Hospices Civils de Lyon

location_facility: Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne

location_facility: Médecine Interne, Hôpital de la Croix- Rousse, HOSPICES CIVILS DE LYON

location_facility: Clinique des bronches, de l'allergie et du sommeil Hôpital Nord

location_facility: Service de pneumologie Hôpital Haut-Leveque

location_facility: Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon

status: Withdrawn

title: Multicenter, Double-blind, Randomized, Placebo-controlled Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia - A Phase IIB, Proof of Concept Study

source: euctr


title: ANRS 175 RHIVIERA-01: Assessment of HIV Remission Upon Combination Antiretroviral Therapy (cART) Interruption in Early Treated Individuals From ANRS CO6 PRIMO Cohort Carrying the Major Histocompatibility Complex (MHC) B35/53Bw4TTC2 Genotype

summary:
The aim of the trial is to evaluate in ANRS CO6 PRIMO cohort participants if the presence of the MHC B35 (53) Bw4TTC2 genotype favors the control of HIV infection (defined by a viral load (VL) less than 400 cp/mL) after discontinuation of antiretroviral therapy (ART) initiated during primary HIV infection.

The trial will be a pilot "proof of concept", one arm, multicenter, nested in the ANRS CO6 PRIMO Cohort, in which the intervention is treatment interruption (of at least 6 months).

It is planned to include between 20 and 50 participants.

location_facility:
Hôpital Avicenne
Hôpital Pierre Zobda-Quitman
Institut Pasteur
Hôpital Raymond Poincaré
Hôpital Edouard HERRIOT
Hôpitaux Universitaires de Strasbourg
La Pitié Salpêtrière
Hôpital Saint-Louis
Hôpital Gui de Chauliac
Hôpital Tenon
Centre Hospitalier du Pays d'Aix
Hôpital de la Côte de Nacre
Hôtel Dieu
Hôpital de Purpan
Hôpital Gustave Dron
Hôpital Carémeau
Hôpital Sainte Marguerite
Hôpital Le Bocage
Hôpital Saint-André
Hôpital de l'Hôtel-Dieu
Hôpital Gabriel Montpied
CHD Vendée
Hôpital de la Croix Rousse
Hôpital Lariboisière
CHI Villeneuve Saint Georges
Hôpital de Bicêtre
Hôpital PELLEGRIN
Hôpital Bretonneau


title: Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') or or Authorisation for Early Access (AAP). A Prospective Cohort.

summary: This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') or authorisation for early access (AAP) delivered by the French drug agency (ANSM).

location_facility: Centre Hospitalier Sud Francilien - Hématologie

location_facility: Centre Hospitalier Sud Francilien - Néphrologie

location_facility: Hôpital Universitaire Necker Enfants Malades


title: A Randomized, Double-blind, Placebo-controlled Phase 2 (2a and 2b) Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia

acronym: POLYCOR

summary:
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3.

Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients.

A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans.

The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

oa_host_type: repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Gaborit B, Dailly E, Vanhove B, Josien R, Lacombe K, Dubee V, Ferre V, Brouard S, Ader F, Vibet MA, Le Thuaut A, Danger R, Flet L, Omnes A, Berly L, Chiffoleau A, Jobert A, Duvaux O, Raffi F; POLYCOR Trial Group. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study. Antimicrob Agents Chemother. 2021 Aug 17;65(9):e0123721. doi: 10.1128/AAC.01237-21. Epub 2021 Aug 17.

evidence: oa repository (via free pdf)

repository_normalized: medRxiv

version: submittedVersion

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, Lacombe K, Dubee V, Ader F, Ferre V, Vicaut E, Orain J, Le Bras M, Omnes A, Berly L, Jobert A, Morineau-Le Houssine P, Botturi K, Josien R, Flet L, Degauque N, Brouard S, Duvaux O, Poinas A, Raffi F; POLYCOR study group. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. Trials. 2021 Mar 9;22(1):199. doi: 10.1186/s13063-021-05132-9.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

collaborators:
BPIfrance
Xenothera SAS

sponsor_collaborators:
Nantes University Hospital
BPIfrance
Xenothera SAS

location_country: Réunion Martinique France

location_facility:
CH Avignon
CH de La Rochelle
APHP - Hôpital Tenon
CH Métropole Savoie
CHU Nice
CHU Limoges
APHP - Hôpital Avicennes
Hôpital FOCH
GHR Mulhouse Sud-Alsace
CHU Nîmes
CH Bretagne Atlantique
CHU Amiens Picardie
CHU Angers
CH de Mont de Marzan
CHU La Réunion
CH de la Côte Basque
CH Le Mans
CHU Nantes
CH Sud Francilien
CHR Orléans La Source
CHU Reims
CHRU Nancy
Hôpital Privé d'Antony
CHU Saint Etienne
CHRU Lille
CHU Caen
CHU Strasbourg
CH Colmar
CH Cornouaille
Hospices Civils Lyon
Hôpital Saint Antoine
CHU Martinique
CHD Vendée
CH René Dubos


type: Registry Identifier

title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial

acronym: PRESTO

summary:
INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.

PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.

ReferenceCitation: Petrelli F, Ghidini A, Ghidini M, Bukovec R, Trevisan F, Turati L, Indini A, Seghezzi S, Lonati V, Moleri G, Tomasello G, Zaniboni A. Better survival of patients with oligo- compared with polymetastatic cancers: a systematic review and meta-analysis of 173 studies. F1000Res. 2021 May 27;10:423. doi: 10.12688/f1000research.52546.4. eCollection 2021.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo

repositories_concat: PubMed Central;Zenodo

publisher_dissemination: Informa

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_country: Martinique France

location_facility: Gustave Roussy Cancer Campus Grand Paris

location_facility: Institut de cancérologie et d'hématologie universitaire de Saint Etienne

location_facility: Centre de radiothérapie Marie Curie de Valence

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: IUCT- Oncopole -Institut Claudius Regaud

location_facility: Institut de cancérologie Strasbourg Europe (ICANS )

location_facility: Institut de cancérologie de Seine et Marne - Clinique de Jossiny


title: Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

acronym: NeurofilMS

summary:
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Rennes
Hopital Saint Antoine
CHU de Rouen
Fondation Rothschild
CHU d'Amiens
CHU de Nancy
Hopital Timone
CHU de Lyon
CHU de Lille
CHU de Dijon
CHU de Toulouse
CHU de Strasbourg
CHU de Saint Etienne
CHU de Nimes
Hopital Pitie Salpetriere
CH de Poissy
CHU de Nice
CHU de Tours
CHU de Besancon
CHU de Montpellier
CHU de Grenoble
CHU de Potiers
CHU de Martinique
CHU de Bordeaux
CHU de Caen
CHU de Limoges
Hopital Henri Mondor
CHU de Clermont Ferrand

intervention_type: Diagnostic Test


type: Other Identifier

title: French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort

acronym: RESPONSE

summary:
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.

To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

location_facility: Centre Hospitalier de Versailles Hôpital Andre Mignot


title: Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

acronym: ALLIANCE

summary: to evalute if therapeutic alliance is related to adherence in JIA

lead_sponsor: University Hospital, Brest

location_facility:
CHRU Brest
Hôpital Nord Franche Comté
CHU Dijon
CHU Nîmes
Hôpital Femme-Mère-Enfant - HCL
CHU Martinique
Hôpital Bicêtre - APHP
CH Mulhouse
CHU Rennes
CHRU Lille
CHU Poitiers
CHU Bordeaux
CHRU Strasbourg
CHRU Besançon
Hôpital Necker-Enfants Malades - APHP
CHU Nancy
CHU Angers


title: Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB

summary: This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

lead_sponsor: Hoffmann-La Roche


acronym: FIDEL

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

summary: The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.

ReferenceCitation: Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.

oa_host_type: closed

repositories_concat: closed

location_facility: Maternité Régionale Universitaire de Nancy

location_facility: Les Hôpitaux de Chartres (Hôpital Pasteur)

location_facility: CHU de Lille, Maternité Jeanne de Flandre

location_facility: Hôpital Saint-Joseph / Pôle Parents - Enfants

title: Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery


title: Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)

acronym: OSICAT

summary:
Targeted population: Patients with heart failure causing hospitalization during the last twelve months.

Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required.

Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

ReferenceType: result

ReferenceCitation: Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.

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

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

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

repositories_concat: HAL

lead_sponsor: CDM e-Health

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Intercommunal Castres-Mazamet

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Pasteur

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale

location_facility: Centre Hospitalier Universitaire d'Amiens de Picardie

location_facility: Cabinet de Cardiologie - Pôle médical spécialisé

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Centre Hospitalier d'Avignon - Hospital Henri Duffaut

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André

location_facility: Centre Hospitalier Universitaire Caremeau

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Centre de réadaptation cardiovasculaire Midi-Gascogne

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel

location_facility: Centre Hospitalier Universitaire d'Angers


title: Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years.

acronym: D-Lay-MS

summary: The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: MAILLART Elisabeth - La Pitié Salpétrière

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: CH de Cornouaille - Site Quimper - Hôpital Laennec

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Martinique - Hôpital Pierre Zobda-Quitman

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Fondation Ophtalmologique Adolphe Rothschild


title: Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

acronym: PHRC CMV

summary: The investigators aim is to determine the incidence of cytomegalovirus resistance to antivirals in a cohort study. The patients are included at their first CMV active infection and are followed during two years thereafter. When criteria for suspected resistance are meet, blood and urine samples are collected for virus isolation and further resistance phenotype, and for resistance genotype determination. Results are compared with baseline samples. Clinical information such as treatment, immunosuppressive regimen and clinical evolution will be collected. Through this study, the investigators aim to organize a national network for the detection and identification of CMV resistant strains that will be useful when new therapeutics will be available.

ReferenceCitation: Germi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.

publisher_dissemination: Elsevier

ReferenceCitation: Hantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.

location_facility: Virologie - Hôpital La Pitié Salpétrière


title: Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study

summary:
TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

primary_purpose: Supportive Care

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

location_facility: Centre Hospitalier Intercommunal Alençon-Mamers

location_facility: Centre Hospitalier de Belfort Montbéliard


title: Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure Without Known Cardio Vascular or Renal Disease, Stratified on Blood Pressure Control.

acronym: PREVENTA

summary: Evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.

time_perspective: Cross-Sectional


title: A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

summary:
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon

+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.

c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.


title: Evaluation of the Frequency of Limitation of Activity, Depending on Gender and Age-group, in Patients With Persistent Asthma Consulting a General Practitioner

acronym: ASMAVIE

summary: Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner


title: Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not

acronym: SAISON

summary: To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not controlled) of asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is taken or not.


title: National Survey on GERD Patients (Adults and Children)

acronym: RGO à trav

summary: To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)


title: Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

acronym: ORHEO

summary: The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

ReferenceCitation: Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503. Erratum In: BMC Cancer. 2014;14:720.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer


title: Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg

summary: The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

ReferenceCitation: Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.

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


title: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

acronym: PREDICOM

summary: To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

ReferenceCitation: Sellem E, Rouland JF, Baudouin C, Bron A, Denis P, Nordmann JP, Renard JP. Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination. BMC Ophthalmol. 2010 Mar 26;10:10. doi: 10.1186/1471-2415-10-10.

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


title: Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.

summary: Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.

lead_sponsor: ATF Implants

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

acronym: EVART

summary: The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

lead_sponsor: Institut de l'Atherothrombose

location_country: Belgium France

location_facility: Office-based Specialist in vascular medecine


title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

acronym: SURVEILLANCE

summary:
RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

ReferenceCitation: Lepage C, Phelip JM, Cany L, Faroux R, Manfredi S, Ain JF, Pezet D, Baconnier M, Deguiral P, Terrebone E, Adenis A, Le Malicot K, Bedenne L, Bouche O. Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer: The FFCD PRODIGE 13 randomised phase III trial. Dig Liver Dis. 2015 Jul;47(7):529-31. doi: 10.1016/j.dld.2015.03.021. Epub 2015 Apr 2. No abstract available.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique Belgium France

location_facility: Clinique Mutualiste de l'Estuaire - Cité Sanitaire

location_facility: Centre de Radiothérapie et d'oncologie médicale

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

location_facility: Clinique du Cléret et Clinique Saint Joseph

location_facility: Centre Médical National MGEN Alfred Leune


title: Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

acronym: CPC

summary: CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

lead_sponsor: Graftys SA

sponsor_collaborators:
Graftys SA
Clinfile

location_country: Germany Italy Martinique Switzerland France


title: Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence

acronym: ADIUVO

summary:
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk.

The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection

ReferenceCitation: Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80. doi: 10.1056/NEJMoa063360.

lead_sponsor: University of Turin, Italy

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Canada
France

location_facility: Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1

location_facility: Dept. of Internal Medicine Maxima Medisch Centrum

location_facility: Endocrinologie - Institut de Cancérologie Gustave Roussy

location_facility: Medical Oncology Branch - Center for Cancer Research - National Cancer Institute

location_facility: University Hospital Campus Mitte Charitè, Berlin

location_facility: Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham

location_facility: Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer

location_facility: Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Endocrinologie - CHU Besançon Hôpital Jean Minjoz

location_facility: Endocrinologie - CHU Toulouse Hôpital Larrey

location_facility: Endocrine Oncology - University of Michigan Comprehensive Cancer Center

location_facility: University Hospital Wuerzburg, Endocrinology

location_facility: A.O.U. San Giovanni Battista - Molinette

location_facility: A.O.Universitaria Arcispedale S.Anna Ferrara


title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

acronym: OLD

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Medico-Chirurgical et Obstetrique d'Evry

location_facility: Centre Hospitalier d'Ardeche Meridionale

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne

location_facility: Centre Hospitalier Villeneuve Saint Georges


title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial

acronym: RAINBO

summary:
The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer:

p53 abnormal endometrial cancer patients to the p53abn-RED trial
mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial
no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial
POLE mutant endometrial cancer patients to the POLEmut-BLUE trial

ReferenceCitation: IMPLEMENTATION OF COLLABORATIVE TRANSLATIONAL RESEARCH (TRANSPORTEC) FINDINGS IN AN INTERNATIONAL ENDOMETRIAL CANCER CLINICAL TRIALS PROGRAM (RAINBO). T Bosse, M Powell, E Crosbie, A Leary, J Kroep, K Han, J Mcalpine, N Horeweg, S De Boer, M De Bruyn, R Nout, V Smit, HW Nijman, N Singh, H Mackay, R Edmondson, L Mileshkin, D Church, H Kitchener, CL Creutzberg. Int J Gynecol Cancer 2021;31(Suppl 3):A1-A395. DOI: 10.1136/ijgc-2021-ESGO.171

doi: implementation

ReferenceCitation: RAINBO Research Consortium. Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program. Int J Gynecol Cancer. 2022 Dec 20;33(1):109-17. doi: 10.1136/ijgc-2022-004039. Online ahead of print.

ipd_sharing: Yes

ipd_sharing_description: Following the planned translational work in the RAINBO programme and publications, the translational research (TR) committee will open up the sample collection to external researchers. Access will be granted following completion of a research proposal form and approval by the TR committee chaired by Dr. Tjalling Bosse. All external researchers will be expected to demonstrate funding for their project and ethics approval. Data will be made available as required through data sharing agreements. The following will be reviewed when considering applications for data sharing and sample access: data and sample use is in-keeping with patient consent, the proposed project has scientific value, with defined objectives and study plan, trial data are appropriate for the intended purpose, acknowledgement of the RAINBO Programme in all publications that arise from the data sharing, compliance with legal and regulatory requirements as applicable and patient confidentiality maintained at all times.

lead_sponsor: Leiden University Medical Center

collaborators: Institute Gustave Roussy (sponsor p53abn-RED trial)

collaborators: Leiden University Medical center (sponsor MMRd-GREEN trial)

collaborators: University College London (sponsor NSMP-ORANGE trial)

collaborators: Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial)

collaborators: Comprehensive Cancer Centre The Netherlands

collaborators: Cancer Research UK & UCL Cancer Trials Centre

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
United Kingdom
Canada
Netherlands
France

location_facility: The NSMP-ORANGE trial: Manchester Academic Health Science Centre, St Mary's Hospita

location_facility: The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto

location_facility: The NSMP-ORANGE trial: Barts Health NHS Trust

location_facility: The MMRd-GREEN trial: Leiden University Medical Center

location_facility: The p53abn-RED trial: Institute Gustave Roussy

location_facility: The POLEmut-BLUE trial: University of British Columbia


title: A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

lead_sponsor: BeiGene

location_country:
Germany
Italy
Poland
Argentina
Japan
Brazil
Mexico
United States
China
Spain
Turkey
France

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Beijing Chest Hospital, Capital Medical University

location_facility: Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

location_facility: Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

location_facility: Centre de Lutte Contre Le Cancer Institut Bergonie

location_facility: Complejo Hospitalario Universitario Insular Gran Canaria

location_facility: Japan Anti Tuberculosis Association Fukujuji Hospital

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Providence Medical Foundation St Jude Heritage Healthcare

location_facility: Klinikum Ludwigshafen, Medizinische Klinik A

location_facility: Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala

location_facility: Oncosite Centro de Pesquisa Clinica Em Oncologia

location_facility: University Medical Center New Orleans West Jefferson Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

location_facility: Instituto Dor de Pesquisa E Ensino Distrito Federal

location_facility: Kobe City Medical Center General Hospital

location_facility: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

location_facility: The Tumor Hospital Affiliated to Guangxi Medical University

location_facility: Baskent University Practice and Research Hospital Adana Medical Oncology Department

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

location_facility: Metro Minnesota Community Oncology Research Consortium (Mmcorc)

location_facility: Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital

location_facility: Iu C, Clinical Research Excellence Application and Research Center

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

location_facility: Centro Para La Atencion Del Paciente Oncologico (Caipo)

location_facility: Hospital Regional Universitario de Malaga

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau

location_facility: Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh

location_facility: Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng

location_facility: Christus Latam Hub Center of Excellence and Innovation Sc

location_facility: Chu Tours Hopital Bretonneau Service Pneumologie

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Nucleo de Pesquisa Da Rede Sao Camilo (Instituto Brasileiro de Controle Do Cancer)

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Instituto Dor de Pesquisa E Ensino Recife

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Tr Trakya University Health Research and Application Center (Hospital)

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: National Hospital Organization Kinki Chuo Chest Medical Center

location_facility: Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

location_facility: Centro Integrado de Oncologia de Curitiba Ss Cionc


acronym: ANRS 143

lead_sponsor: ANRS, Emerging Infectious Diseases

summary:
The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

ReferenceCitation: Esteban-Cantos A, Rodriguez-Centeno J, Barruz P, Alejos B, Saiz-Medrano G, Nevado J, Martin A, Gaya F, De Miguel R, Bernardino JI, Montejano R, Mena-Garay B, Cadinanos J, Florence E, Mulcahy F, Banhegyi D, Antinori A, Pozniak A, Wallet C, Raffi F, Rodes B, Arribas JR; NEAT001/ANRS143 Study Group. Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2021 Apr;8(4):e197-e205. doi: 10.1016/S2352-3018(21)00006-0. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.

ReferenceCitation: Ammassari A, Stohr W, Antinori A, Molina JM, Schwimmer C, Domingo P, Thalme A, Di Pietro M, Wallet C, Pozniak A, Richert L, Raffi F; NEAT001/ANRS143 Trial Study Group. Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):481-490. doi: 10.1097/QAI.0000000000001834.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bernardino JI, Mocroft A, Mallon PW, Wallet C, Gerstoft J, Russell C, Reiss P, Katlama C, De Wit S, Richert L, Babiker A, Buno A, Castagna A, Girard PM, Chene G, Raffi F, Arribas JR; NEAT001/ANRS143 Study Group. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015 Nov;2(11):e464-73. doi: 10.1016/S2352-3018(15)00181-2. Epub 2015 Sep 30.

ReferenceCitation: Raffi F, Babiker AG, Richert L, Molina JM, George EC, Antinori A, Arribas JR, Grarup J, Hudson F, Schwimmer C, Saillard J, Wallet C, Jansson PO, Allavena C, Van Leeuwen R, Delfraissy JF, Vella S, Chene G, Pozniak A; NEAT001/ANRS143 Study Group. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
NEAT - European AIDS Treatment Network

location_facility: Hospital of Infectious Diseases of Warsaw

location_facility: Klinikum der Johann Wolfgang Goethe Universität

location_facility: Istituto Naziona e per le Malattie "Lazzaro Spallanzani"

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hôpital Européen Georges Pompidou (HEGP)

title: An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

location_country:
Germany
Ireland
Italy
Poland
Portugal
Hungary
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Spain
Greece
France


title: Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

summary:
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry.

The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.

time_perspective: Other

ReferenceCitation: Bang P, Polak M, Perrot V, Sert C, Shaikh H, Woelfle J. Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex(R) Growth Forum Database Registry. Front Endocrinol (Lausanne). 2022 Feb 18;13:812568. doi: 10.3389/fendo.2022.812568. eCollection 2022.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repository_institution: Linkoping University - DiVA

publisher_dissemination: Frontiers

ReferenceCitation: Bang P, Woelfle J, Perrot V, Sert C, Polak M. Effectiveness and safety of rhIGF1 therapy in patients with or without Laron syndrome. Eur J Endocrinol. 2021 Feb;184(2):267-276. doi: 10.1530/EJE-20-0325.

evidence: open (via page says license)

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_concat: DiVA.org;PubMed Central

lead_sponsor: Ipsen

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
French Guiana
Austria
Martinique
United States
Spain
France

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Diabetologia Pediatrica Azienda Ospedaliero-Universitaria

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitätsklinikum Erlangen Kinder- und Jugendklinik

location_facility: Klinikum der Otto von Guericke Universität

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Children's Health Specialty Center West Plano

location_facility: Universitätskliniken des Saarlandes Kinderklinik

location_facility: U.O. Pediatria e Neonatologia Ospedale di Macerata

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Hospital Universitario y Politécnico La Fe


title: A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study

summary: The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Adams D, Polydefkis M, Gonzalez-Duarte A, Wixner J, Kristen AV, Schmidt HH, Berk JL, Losada Lopez IA, Dispenzieri A, Quan D, Conceicao IM, Slama MS, Gillmore JD, Kyriakides T, Ajroud-Driss S, Waddington-Cruz M, Mezei MM, Plante-Bordeneuve V, Attarian S, Mauricio E, Brannagan TH 3rd, Ueda M, Aldinc E, Wang JJ, White MT, Vest J, Berber E, Sweetser MT, Coelho T; patisiran Global OLE study group. Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study. Lancet Neurol. 2021 Jan;20(1):49-59. doi: 10.1016/S1474-4422(20)30368-9. Epub 2020 Nov 16. Erratum In: Lancet Neurol. 2021 Feb;20(2):e2.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
United States
Malaysia
Italy
Cyprus
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Sweden


title: European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

acronym: EVIDENCE

summary: The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

ReferenceCitation: Lanas A, Boers M, Nuevo J. Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice. Ann Rheum Dis. 2015 Apr;74(4):675-81. doi: 10.1136/annrheumdis-2013-204155. Epub 2013 Dec 18.

publisher_dissemination: British Medical Journal

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Norway
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
Greece
Turkey
France


acronym: The 'EMBRACE' Trial

lead_sponsor: Eisai Inc.

summary: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Miyoshi Y, Yoshimura Y, Saito K, Muramoto K, Sugawara M, Alexis K, Nomoto K, Nakamura S, Saeki T, Watanabe J, Perez-Garcia JM, Cortes J. High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study. Breast Cancer. 2020 Jul;27(4):706-715. doi: 10.1007/s12282-020-01067-2. Epub 2020 Mar 5.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

ReferenceCitation: Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w

location_facility: Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Eastern Cape Oncology Centre, GVI, St Georges Hospital

location_facility: Instituto Nacional do Cancer-Unidade III (INCA III)

location_facility: Royal Perth Hospital, Department of Medical Oncology

location_facility: GUZ YO Regional Clinical Oncology Hospital

location_facility: The Ottawa Hospital Regional Cancer Center

location_facility: Centre Hospitalier Notre-Dame - Reine Fabiola

location_facility: Krasnodar Territory Clinical Oncology Center

location_facility: Hospital Universitario de Girona Dr. Josep Trueta

location_facility: Semmelweis Medical University, III. Dep. of Internal Med.

location_facility: Centro de Pesquisas e Estudios do Centro Goiano

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: NN Petrov Research Institute of Oncology

location_facility: Centro Regional Integrado de Oncologia-CRIO

location_facility: US Oncology St. Vincent's Hospital - Bruno Cancer Center

location_facility: Hosptial Interzonal General de Mar del Plata

location_facility: Peachtree Hematology/Oncology Consultants, PC

location_facility: Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice

location_facility: State Institution of Healthcare Stavropol Region clinical Oncology dispensary

location_facility: Salzburger Landeskliniken Universitatsklinik fur Innere medizin III

location_facility: CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia

location_facility: Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii

location_facility: Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology

location_facility: North Shore Hematology/Oncology Associates

location_facility: Debrecen Medical University, Department of Oncology

location_facility: AZ Groeninge, Campus Maria's Voorzienigheid

location_facility: McGill University Health Centre, Department of Oncology, Gerald Bronfman Center

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie

title: The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

location_country:
Italy
Poland
Hungary
Argentina
Australia
Brazil
Switzerland
Austria
Belgium
United States
Spain
South Africa
Croatia
Czechia
Canada
Russian Federation
France


title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

summary: To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

lead_sponsor: H. Lundbeck A/S

sponsor_collaborators:
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.

location_country:
Finland
Italy
Poland
Sweden
United States
South Africa
Estonia
Serbia
France


title: Survey on the Expectations of Adolescents With Juvenile Idiopathic Arthritis (JIA) Regarding Knowledge and Communication With Health Care Professionals in the Field of Sexual Health, and Their Parents' Views on the Subject.

acronym: SNAPS-JIA

summary:
Sexual health is a legitimate area to explore in the care of these patients, as it has such an impact on quality of life. However, addressing sexual health in a situation of chronic disease confronts the double societal taboo of disease and sexuality. Health professionals are uncomfortable because they are not trained to talk about the subject, especially in the presence of parents and with a teenager they have watched grow up.

In this context, a needs survey among juvenile idiopathic arthritis (JIA) patients and the point of view of their parents in the field of sexual health seems necessary.

Main objective: To determine the expectations of adolescents (aged 10-19 years) with juvenile idiopathic arthritis regarding knowledge and communication with health care professionals in the field of sexual health.

time_perspective: Retrospective

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Societe Francaise de Rhumatologie

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Association Nationale de Défense contre l'Arthrite Rhumatoïde

location_facility: CHU de Strasbourg - Hôpital de Hautepierre


lead_sponsor: Astellas Pharma Global Development, Inc.

summary: This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

ReferenceCitation: Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.

oa_host_type: publisher

unpaywall_oa_status: bronze

location_facility: Saint Francis Hospital / Bon Secours - South Carolina

location_facility: Louisiana State University/ East Jefferson General Hospital

location_facility: New York University (NYU) Cancer Institute

location_facility: Georgia Cancer Specialists / Northside Hospital Cancer Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: University of California Irvine - Newport

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Ironwood Cancer & Research Centers - Chandler

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: University of California Los Angeles Medical Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Hillman Cancer Center / University of Pittsburgh Medical Center

location_facility: University of Colorado Hospital / University of Colorado

title: An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

collaborators:
Merck Sharp & Dohme LLC
Seagen Inc.


title: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe

acronym: DrEW

summary:
Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period.

Retrospective data from 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 European sites.

The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.

lead_sponsor: NEAT ID Foundation

sponsor_collaborators:
NEAT ID Foundation
Merck Sharp & Dohme LLC

location_country:
United Kingdom
France

location_facility:
CHU de Nantes
Guy's Hospital
St Louis Hospital
Hopital Universitaire Pitie-Salpetriere


title: Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up

summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

lead_sponsor: FH ORTHO

location_country: Switzerland France

location_facility: Centre hospitalier universitaire vaudois


title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects

acronym: HEART

summary: This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.

lead_sponsor: Valbiotis

sponsor_collaborators:
Valbiotis
Biofortis Mérieux NutriSciences

location_country: Germany France

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

intervention_type: Dietary Supplement