title: Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), "Vulnerable" or "Frail" , as Defined by the Criteria of the International Society of Geriatric Oncology (SIOG)

summary:
The objective of this study is to evaluate the feasibility of two different chemotherapy protocols with adjusted doses for patients aged 75 and over who often have medical problems other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In both cases, chemotherapy is combined with prednisone. The protocol will be considered feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks).

Additionally to this primary objective, efficacy will also be evaluated for both protocols as well as tolerance to treatment, quality of life and evolution of geriatric data.

location_facility: Centre Hospitalier de La Region D'Annecy


title: National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)

summary: This study describes the elevation of CPK in patient treated for solid tumors by TKI

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Oscar Lambret

location_facility:
CHU Robert Debré
Institut Jean Godinot
Hôpital Edouard Herriot
CHU Bordeaux
Institut de Cancérologie de la Loire
Centre Oscar Lambret
Centre François Baclesse
Hôpital Tenon - APHP
Centre Jean Perrin
Centre Antoine Lacassagne
Centre Léon Bérard
Institut Gustave Roussy
Hôpital Saint-Louis - APHP
Institut Bergonié
Hôpital Cochin - APHP
Centre René Huguenin
Hôpital Henri Mondor - APHP
Institut Curie
Centre Val d'Aurelle
Centre Alexis Vautrin
Institut Paoli Calmettes
Hôpital Jean Minjoz
Institut Claudius Régaud
CHU Limoges
Centre Paul Papin
Centre Henri Becquerel
Centre Eugène Marquis

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)

acronym: LIGALONGO

summary: This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Woaye-Hune P, Hardouin JB, Lehur PA, Meurette G, Vanier A. Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes. Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 10.1186/s12955-020-01398-w.

ReferenceCitation: Venara A, Podevin J, Godeberge P, Redon Y, Barussaud ML, Sielezneff I, Queralto M, Bourbao C, Chiffoleau A, Lehur PA; LigaLongo Study Group. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis. 2018 Oct;33(10):1479-1483. doi: 10.1007/s00384-018-3093-8. Epub 2018 May 28.

lead_sponsor: Nantes University Hospital

location_facility: Lille University Hospital "Claude Huriez"

location_facility: Marseille University Hospital "La Timone"

location_facility: Marseille University Hospital "Hôpital Nord"

intervention_type: Device

lead_sponsor_type: academique


ipd_sharing: Yes

status: Terminated

acronym: SOLAR

intervention_type: Drug

title: An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

lead_sponsor: Astellas Pharma Global Development, Inc.

type: EudraCT Number

source: euctr

study_start_date_type: Actual

ReferenceCitation: Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.

ipd_sharing_description:
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com

:

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Romania
Belgium
Japan
Portugal
Russian Federation
Australia
Malaysia
Singapore
Canada
Hungary
Germany
Taiwan
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility:
Site DE49007
Site RO40001
Site JP81022
Site NL31001
Site FR33003
Site TW88608
Site UA38007
Site KR82003
Site KR82004
Site MY60004
Site US10012
Site TH66012
Site TH66006
Site RO40004
Site US10031
Site RU70016
Site IT39002
Site JP81002
Site HU36006
Site KR82009
Site AU61008
Site FR33007
Site FR33006
Site IT39012
Site FR33004
Site ES34016
Site HU36003
Site US10003
Site JP81001
Site KR82013
Site KR82016
Site US10050
Site US10013
Site TW88601
Site IT39008
Site JP81021
Site IT39015
Site US10009
Site TW88609
Site KR82017
Site JP81014
Site IT39003
Site FR33010
Site SG65002
Site DE49004
Site UA38005
Site IT39014
Site RO40006
Site MY60001
Site US10027
Site AU61003
Site DE49003
Site KR82001
Site JP81025
Site KR82007
Site IT39013
Site JP81013
Site TH66011
Site US10036
Site US10051
Site RO40012
Site US10023
Site RU70008
Site KR82006
Site US10052
Site JP81005
Site PT35104
Site AU61005
Site ES34015
Site US10025
Site TW88611
Site TH66004
Site HU36001
Site UA38003
Site KR82015
Site KR82008
Site GB44001
Site BE32002
Site JP81016
Site DE49005
Site JP81018
Site ES34010
Site PT35101
Site US10029
Site US10021
Site JP81023
Site JP81024
Site PT35102
Site IT39009
Site JP81012
Site US10045
Site KR82014
Site RO40007
Site ES34002
Site AU61004
Site TW88606
Site US10030
Site RU70009
Site US10046
Site RU70017
Site TW88607
Site UA38006
Site DE49006
Site KR82011
Site RU70012
Site FR33011
Site UA38009
Site GB44002
Site CL56001
Site PT35103
Site PE51008
Site HU36004
Site JP81006
Site ES34008
Site US10011
Site US10018
Site TH66001
Site JP81015
Site GB44003
Site US10042
Site HU36007
Site JP81020
Site ES34003
Site FR33012
Site NL31006
Site SG65001
Site ES34006
Site US10047
Site IT39004
Site JP81010
Site JP81004
Site ES34004
Site UA38008
Site RU70001
Site US10048
Site CA15006
Site RO40008
Site PE51001
Site UA38001
Site HU36002
Site RO40010
Site CL56007
Site CA15002
Site KR82005
Site MY60002
Site UA38004
Site IT39011
Site AU61002
Site DE49008
Site JP81017
Site CL56002
Site JP81019
Site KR82002
Site TW88605
Site US10037
Site FR33009
Site TH66002
Site JP81008
Site US10033
Site TW88603
Site KR82010
Site TW88604
Site PE51004
Site US10034
Site ES34017
Site AU61007
Site ES34005

summary:
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.

status_simplified: Unknown


title: Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

acronym: ESSEA

summary:
Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up.

Patients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.

primary_purpose: Diagnostic

ReferenceCitation: Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Caen - Service de Chirurgie Vasculaire

location_facility: CHU de Strasbourg - Service de Chirurgie Vasculaire

location_facility: CHU de St Etienne - Service de Chirurgie Vasculaire

location_facility: AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire

location_facility: CHRU Lille Service de Chirurgie Vasculaire

location_facility: CHU de Montpellier - Service de Chirurgie Vasculaire

location_facility: CHU d'Angers - Service de Chirurgie Vasculaire

location_facility: CHU de Grenoble - Service de Chirurgie Vasculaire

location_facility: CHU de Besançon - Service de Chirurgie Vasculaire

location_facility: APHM - Hôpital Nord - Service de Chirurgie Vasculaire

location_facility: CHU de Toulouse - Service de Chirurgie Vasculaire

location_facility: CHU Clermont-ferrand - Service de Chirurgie Vasculaire

location_facility: CHU de Rouen - Service de Chirurgie Vasculaire

location_facility: CHU de Bordeaux - Service de Chirurgie Vasculaire

location_facility: CHU de Nice - Service de chirurgie vasculaire

location_facility: CHU de Dijon - Service de Chirurgie Vasculaire

location_facility: CHU de Nantes - Service de Chirurgie Vasculaire

location_facility: AP-HP Créteil - Service de chirurgie vasculaire

location_facility: CHU d'Amiens - Service de Chirurgie Vasculaire

intervention_type: Procedure


title: Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study

summary: The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.

enrollment_type: Anticipated

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Bichat Claude Bernard

location_facility: Centre Hospitalier Universitaire d'Orléans

location_facility: Centre Hospitalier de Châlons-en-Champagne

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier Universitaire Antoine Beclere

location_facility: Centre Hospitalier Mémorail France Etats Unis Saint Lo

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire Lariboisiere


title: Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

summary:
Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.

We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.

GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle


acronym: MK-4482 Ph 2/3 Study in Hospitalized Adults with COVID-19

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Mexico
United Kingdom
Canada
Ukraine
Korea, Republic of
United States
Chile
France
Israel
Colombia
Philippines
South Africa

location_facility: Clinical Projects Research Centre ( Site 1205)

location_facility: Volyn Regional Clinical Hospital ( Site 1613)

location_facility: Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)

location_facility: Moscow Clinical Hospital #52 ( Site 1103)

location_facility: Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1

location_facility: Odesa City Clinical Infectious Hospital ( Site 1611)

location_facility: Hospital Universitario San Ignacio ( Site 0401)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1302)

location_facility: Cedars-Sinai Medical Center ( Site 1822)

location_facility: Chungnam National University Hospital ( Site 2202)

location_facility: Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: Clinica Universidad de los Andes ( Site 0301)

location_facility: Hopital Bichat - Claude Bernard ( Site 0503)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: Kaiser Foundation Hospital - South Bay ( Site 1832)

location_facility: Krasnogorsk City Hospital Number 1 ( Site 1119)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: Hospital Universitari Vall d Hebron ( Site 1305)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0403)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)

location_facility: Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)

location_facility: University of New Mexico, Health Sciences Center ( Site 1806)

location_facility: University of Mississippi Medical Center ( Site 1846)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2103)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0100)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1204)

location_facility: CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)

location_facility: Wellstar Kennestone Hospital ( Site 1801)

location_facility: University of Nebraska Medical Center ( Site 1835)

location_facility: Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)

location_facility: CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: Complejo Hospitalario San Jose ( Site 0306)

location_facility: C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

location_facility: Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)

location_facility: FSBI Central Hospital with Policlinics ( Site 1105)

location_facility: University of the Philippines-Philippine General Hospital ( Site 0900)

location_facility: North Manchester General Hospital ( Site 1701)

location_facility: University of California Davis Health ( Site 1809)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.


title: Safety and Efficacy of a Strategy of Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Chemosensitive Relapsed Follicular Lymphoma

acronym: RITALLO

summary: This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease.

ReferenceType: background

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

ReferenceCitation: Khouri IF, Saliba RM, Giralt SA, Lee MS, Okoroji GJ, Hagemeister FB, Korbling M, Younes A, Ippoliti C, Gajewski JL, McLaughlin P, Anderlini P, Donato ML, Cabanillas FF, Champlin RE. Nonablative allogeneic hematopoietic transplantation as adoptive immunotherapy for indolent lymphoma: low incidence of toxicity, acute graft-versus-host disease, and treatment-related mortality. Blood. 2001 Dec 15;98(13):3595-9.

ReferenceCitation: Khouri IF, McLaughlin P, Saliba RM, Hosing C, Korbling M, Lee MS, Medeiros LJ, Fayad L, Samaniego F, Alousi A, Anderlini P, Couriel D, de Lima M, Giralt S, Neelapu SS, Ueno NT, Samuels BI, Hagemeister F, Kwak LW, Champlin RE. Eight-year experience with allogeneic stem cell transplantation for relapsed follicular lymphoma after nonmyeloablative conditioning with fludarabine, cyclophosphamide, and rituximab. Blood. 2008 Jun 15;111(12):5530-6. doi: 10.1182/blood-2008-01-136242. Epub 2008 Apr 14. Erratum in: Blood. 2009 Feb 12;113(7):1613.

ReferenceCitation: Vigouroux S, Michallet M, Porcher R, Attal M, Ades L, Bernard M, Blaise D, Tabrizi R, Garban F, Cassuto JP, Chevalier P, Facon T, Ifrah N, Renaud M, Tilly H, Vernant JP, Kuentz M, Bourhis JH, Bordigoni P, Deconinck E, Lioure B, Socié G, Milpied N; French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Long-term outcomes after reduced-intensity conditioning allogeneic stem cell transplantation for low-grade lymphoma: a survey by the French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Haematologica. 2007 May;92(5):627-34.

ReferenceCitation: Christopeit M, Schütte V, Theurich S, Weber T, Grothe W, Behre G. Rituximab reduces the incidence of acute graft-versus-host disease. Blood. 2009 Mar 26;113(13):3130-1. doi: 10.1182/blood-2009-01-200527.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Service Hématologie Clinique, Hôpital Archet 1

location_facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu


status: Recruiting

acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 Refractory MEL

title: A Phase 1/2 Open-label Rolling-arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02A

study_completion_date_type: Anticipated

location_country:
Italy
Australia
Switzerland
United States
Israel
France

location_facility: Melanoma Institute Australia ( Site 1402)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1355)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 1107)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 1404)

location_facility: West Cancer Center - East Campus ( Site 1014)

location_facility: Rambam Health Care Campus-Oncology ( Site 1704)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 1008)

location_facility: Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 1012)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1377)

location_facility: Providence Saint John's Health Center ( Site 1010)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1702)

location_facility: Tasman Oncology Research Pty Ltd ( Site 1403)

location_facility: Universitaetsspital Zuerich ( Site 1601)

location_facility: Inova Schar Cancer Institute ( Site 1011)

location_facility: Oregon Health & Science University ( Site 1013)

location_facility: Istituto Europeo di Oncologia ( Site 1301)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)

location_facility: The Angeles Clinic and Research Institute ( Site 1009)

location_facility: University of Texas MD Anderson Cancer Center ( Site 1006)

summary:
Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

status_simplified: Ongoing


title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

acronym: ELA

summary:
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):

manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.

Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceCitation: Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10.

ReferenceType: result

ReferenceCitation: Lindholm ML, Träff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c.

ReferenceCitation: Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

ReferenceCitation: Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.

lead_sponsor: Hopital Foch

location_facility: Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne


title: A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

lead_sponsor: Advanced Accelerator Applications

ReferenceCitation: Strosberg JR, Caplin ME, Kunz PL, Ruszniewski PB, Bodei L, Hendifar A, Mittra E, Wolin EM, Yao JC, Pavel ME, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Mariani MF, Demange A, Mutevelic S, Krenning EP; NETTER-1 investigators. (177)Lu-Dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1752-1763. doi: 10.1016/S1470-2045(21)00572-6. Epub 2021 Nov 15. Erratum in: Lancet Oncol. 2022 Feb;23(2):e59.

ReferenceCitation: Strosberg J, Kunz PL, Hendifar A, Yao J, Bushnell D, Kulke MH, Baum RP, Caplin M, Ruszniewski P, Delpassand E, Hobday T, Verslype C, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Paganelli G, Severi S, Morse M, Metz DC, Ansquer C, Courbon F, Al-Nahhas A, Baudin E, Giammarile F, Taïeb D, Mittra E, Wolin E, O'Dorisio TM, Lebtahi R, Deroose CM, Grana CM, Bodei L, Öberg K, Polack BD, He B, Mariani MF, Gericke G, Santoro P, Erion JL, Ravasi L, Krenning E; NETTER-1 study group. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with (177)Lu-Dotatate: an analysis of the NETTER-1 study. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2372-2382. doi: 10.1007/s00259-020-04709-x. Epub 2020 Mar 2.

ReferenceCitation: Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With (177)Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

ReferenceCitation: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

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

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

location_country:
Portugal
Spain
Italy
United Kingdom
United States
France
Belgium
Germany

location_facility: Cedars-Sinai Medical Center Samuel Oschin Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Imperial College Healthcare Trust, Hammersmith Hospital

location_facility: Excel Diagnostics and Nuclear Oncology Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Charité, Virchow-Klinikum, Gastroentrology, Hepatology & Endocrinology

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Istituto Oncologico Romagnolo per lo Studio dei Tumori

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliero - Universitaria Pisana (Presidio Ospedaliero S. Chiara)

location_facility: Digestive Oncology, Leuven Cancer Institute

location_facility: Università "Sapienza" di Roma, Facoltà di Medicina e Psicologia, Ospedale S. Andrea-Roma

location_facility: Universitätsmedizin Mainz, Medizinische Klinik I Schwerpunkt Endokrinologie

summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.


title: Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age

summary: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).

ReferenceCitation: Langerhorst P, Noori S, Zajec M, De Rijke YB, Gloerich J, van Gool AJ, Caillon H, Joosten I, Luider TM, Corre J, VanDuijn MM, Dejoie T, Jacobs JFM. Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow. Clin Chem. 2021 Nov 26;67(12):1689-1698. doi: 10.1093/clinchem/hvab187.

ReferenceCitation: Samur MK, Aktas Samur A, Fulciniti M, Szalat R, Han T, Shammas M, Richardson P, Magrangeas F, Minvielle S, Corre J, Moreau P, Thakurta A, Anderson KC, Parmigiani G, Avet-Loiseau H, Munshi NC. Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group. J Clin Oncol. 2020 Sep 20;38(27):3107-3118. doi: 10.1200/JCO.20.00461. Epub 2020 Jul 20.

ReferenceCitation: Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M. Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Jun;61(6):1323-1333. doi: 10.1080/10428194.2020.1719091. Epub 2020 Feb 22.

ReferenceCitation: Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, Arnulf B, Macro M, Belhadj K, Garderet L, Roussel M, Payen C, Mathiot C, Fermand JP, Meuleman N, Rollet S, Maglio ME, Zeytoonjian AA, Weller EA, Munshi N, Anderson KC, Richardson PG, Facon T, Avet-Loiseau H, Harousseau JL, Moreau P; IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017 Apr 6;376(14):1311-1320. doi: 10.1056/NEJMoa1611750.

ReferenceCitation: Dunavin NC, Wei L, Elder P, Phillips GS, Benson DM Jr, Hofmeister CC, Penza S, Greenfield C, Rose KS, Rieser G, Merritt L, Ketcham J, Heerema N, Byrd JC, Devine SM, Efebera YA. Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma. Leuk Lymphoma. 2013 Aug;54(8):1658-64. doi: 10.3109/10428194.2012.751528. Epub 2012 Dec 31.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre Hospitalier Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Départemental - La réunion St Denis

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Centre hospitalier départemental - La Roche sur Yon cedex


title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

acronym: ESPOIR Ext

summary:
Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

lead_sponsor: Laboratoires Thea

location_facility: Hopital d'instruction des armées LAVERAN


title: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects

acronym: ORACLES

summary: This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.

location_country: France Monaco

location_facility: Centre: Clinique Armoricaine de Radiologie


title: Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)

acronym: MUTACT

summary: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

lead_sponsor: AstraZeneca


acronym: SATURNE

title: A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)

lead_sponsor: Federation Francophone de Cancerologie Digestive

ReferenceCitation: Turpin A, de Baere T, Heurgué A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21.

location_facility:
CHU Robert Debré
CH Conception
CAC
CHRU Saint Eloi
Hôpital Privé Jean Mermoz
CHU Côte de Nacre
CH
CHU Jean Bernard
CHU Nord
Clinique des Cèdres
CHU
Groupe Hospitalier Paris St Joseph
Hôpital Claude Huriez
Institut Gustave Roussy
CHU -Hôpital de l'Archet II
Institut Bergonié
Hôpital Saint Joseph
Hôpital Européen Georges Pompidou
CHU J Minjoz
Hopital Tenon
CHR
CHU Bocage
Institut Sainte Catherine
CHU La Timone
CHBS
Hopital Dupuytren
CH Ambroise Paré

summary:
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.

PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.


title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

lead_sponsor: Grünenthal GmbH

location_facility:
Site 35
Site 19
Site 24
Site 31
Site 22
Site 12
Site 14
Site 27
Site 20
Site 36
Site 39
Site 18
Site 21
Site 33
Site 15
Site 38
Site 17
Site 26
Site 23
Site 28
Site 30
Site 34

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.


title: A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

acronym: EPCORE FL-1

summary:
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Argentina
Puerto Rico
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: East Carolina University Brody School of Medicine /ID# 227192

location_facility: Long Beach Memorial Medical Ct /ID# 228997

location_facility: University of Maryland School of Medicine /ID# 227191

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 228116

location_facility: Universitaetsklinikum Giessen /ID# 234245

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182

location_facility: Keimyung University Dongsan Medical Center /ID# 229800

location_facility: Peking University Third Hospital /ID# 230885

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366

location_facility: Seoul National University Hospital /ID# 228446

location_facility: Univerzitna nemocnica Martin /ID# 240827

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 228984

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 230043

location_facility: Universitaetsklinikum Tuebingen /ID# 229663

location_facility: Assaf Harofeh Medical Center /ID# 228037

location_facility: General University Hospital of Thessaloniki AXEPA /ID# 226630

location_facility: National Cancer Center Hospital East /ID# 232423

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121

location_facility: AZ Turnhout - Campus Sint-Elisabeth /ID# 231628

location_facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 227322

location_facility: Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124

location_facility: University of Arizona Cancer Center - North Campus /ID# 228862

location_facility: Universitair Ziekenhuis Leuven /ID# 247780

location_facility: St. Vincent Frontier Cancer Center /ID# 251220

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 229289

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 228110

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 227384

location_facility: Icahn School of Medicine at Mount Sinai /ID# 227181

location_facility: Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228619

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 230356

location_facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400

location_facility: The First Affiliated Hospital of Nanchang University /ID# 231047

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 228447

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 228107

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130

location_facility: Admiraal de Ruyter Ziekenhuis /ID# 247692

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399

location_facility: Hospital Universitario 12 de Octubre /ID# 228109

location_facility: Hospital Universitario Virgen del Rocio /ID# 228118

location_facility: Taichung Veterans General Hospital /ID# 227383

location_facility: Tel Aviv Sourasky Medical Center /ID# 228529

location_facility: South Tyneside and Sunderland NHS Foundation Trust /ID# 230039

location_facility: Hospital Italiano de Buenos Aires /ID# 229699

location_facility: Univerzitna nemocnica L. Pasteura Kosice /ID# 240175

location_facility: Fakultni nemocnice Hradec Kralove /ID# 228269

location_facility: Fujian Medical University Union Hospital /ID# 233919

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 229287

location_facility: Sutter Health Alta Bates Summit Medical Center /ID# 229428

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153

location_facility: National Cheng Kung University Hospital /ID# 227381

location_facility: Cape Fear Valley Medical Center /ID# 246915

location_facility: Sun Yat-Sen University Cancer Center /ID# 231463

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855

location_facility: The Fourth Hospital of Hebei Medical University /ID# 238657

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 232203

location_facility: IEO -Istituto Europeo di Oncologia /ID# 227396

location_facility: Ege University Medical Faculty /ID# 227792

location_facility: NHS Greater Glasgow and Clyde /ID# 230027

location_facility: University of Arkansas for Medical Sciences /ID# 227198

location_facility: Royal Prince Alfred Hospital /ID# 239272

location_facility: Peking University First Hospital /ID# 250517

location_facility: Nanfang Hospital of Southern Medical University /ID# 230383

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123

location_facility: Taipei Veterans General Hosp /ID# 227380

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 234093

location_facility: The First Affiliated Hospital of Soochow University /ID# 232511

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402

location_facility: National Cancer Center Hospital /ID# 230004

location_facility: Hospital Universitario Ramon y Cajal /ID# 228113

location_facility: Massachusetts General Hospital /ID# 245233

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 248138

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 246475

location_facility: Kagoshima University Hospital /ID# 232251

location_facility: EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129

location_facility: Tianjin Medical University Cancer Institute and Hospital /ID# 230876

location_facility: Baptist MD Anderson Cancer Center - Jacksonville /ID# 227270

location_facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602

location_facility: Universitaetsklinikum St. Poelten /ID# 234015

location_facility: Seoul National University Bundang Hospital /ID# 228448

location_facility: CHU NIMES - Hopital Caremeau /ID# 230351

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362

location_facility: UW, Cancer Ctr ProHealth Care /ID# 228746

location_facility: Universitaetsmedizin Goettingen /ID# 230411

location_facility: Albert Schweitzer Ziekenhuis /ID# 247740

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 228565

location_facility: China Medical University Hospital /ID# 227379

location_facility: Istanbul Florence Nightingale Hastanesi /ID# 229546

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402

location_facility: Augusta University Georgia Cancer Center /ID# 227313

location_facility: Medical University of South Carolina /ID# 227351

location_facility: General Hospital of Athens Laiko /ID# 226626

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 230035

location_facility: Ankara Universitesi Fakultesi /ID# 227790

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157

location_facility: Hospital Universitario de Salamanca /ID# 228117

location_facility: Akdeniz Universitesi Tip Fakul /ID# 227791

location_facility: Alliance for Multispecialty Research (AMR) - Kansas City /ID# 231075

location_facility: Kocaeli University Med Faculty /ID# 227854

location_facility: University of Southern California /ID# 227195

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 230415

location_facility: Aichi Cancer Center Hospital /ID# 230134

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino /ID# 229820

location_facility: Hospital Universitario Reina Sofia /ID# 228122

location_facility: Centrum Medyczne Pratia Poznan /ID# 229299

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 248202

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 245928

location_facility: Leids Universitair Medisch Centrum /ID# 247742

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 228896

location_facility: Saddleback Memorial Medical Center /ID# 229633

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 230347

location_facility: Hospital Santa Creu i Sant Pau /ID# 229859

location_facility: ASST Spedali civili di Brescia /ID# 227397

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 230353

location_facility: University Hospitals of North Midlands NHS Trust /ID# 230042

location_facility: Klinikum Mutterhaus der Borromäerinnen /ID# 232354

location_facility: University Hospital Plymouth NHS Trust /ID# 230038

location_facility: Guangdong Provincial People's Hospital /ID# 232512

location_facility: Hospital Parc de Salut del Mar /ID# 228106

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 227211

location_facility: The Chaim Sheba Medical Center /ID# 228322

location_facility: Hospital San Pedro de Alcantara /ID# 248845

location_facility: Hospital Universitario Austral /ID# 230865

location_facility: Centro di Riferimento Oncologico /ID# 227395

location_facility: Saint John Regional Hospital /ID# 233548

location_facility: Universitaetsklinikum Leipzig /ID# 242907

location_facility: Theageneio Anticancer Hospital /ID# 226627

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754

location_facility: Fudan University Shanghai Cancer Center /Id# 250475

location_facility: Linkoping University Hospital /ID# 233520

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 230471

location_facility: The First Hospital of China Medical University /ID# 232509

location_facility: Hospital de Clinicas da Universidade Federal do Parana /ID# 228123

location_facility: Hematology and Oncology Institute /ID# 230056

location_facility: University College London Hospitals NHS Foundation Trust /ID# 249468

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390

location_facility: Portsmouth Hospitals University NHS Trust /ID# 230044

location_facility: Ondokuz mayis University Facul /ID# 227794

location_facility: East Suffolk and North Essex NHS Foundation Trust /ID# 230040

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 231250

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 228706

location_facility: Townsville University Hospital /ID# 231124

location_facility: Universitaetsklinikum Wuerzburg /ID# 229278

location_facility: Hospital Privado Univesitario /ID# 229701

location_facility: Roswell Park Comprehensive Cancer Center /ID# 239128

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 228564

location_facility: University General Hospital Attikon /ID# 226629

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 241595

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 230403

location_facility: Inje University Busan Paik Hospital /ID# 230293

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 229894

location_facility: The First Affiliated Hospital of Xiamen University /ID# 238427

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 247510

location_facility: University General Hospital of Ioannina /ID# 226628

location_facility: Pusan National University Hospital /ID# 229798

location_facility: Haemalife Inc. Netcare Kuilsrivier Hospital /ID# 243392

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 229290

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 230036

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108

location_facility: East Kent Hospitals University NHS Foundation Trust /ID# 230152

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286

location_facility: Universitair Medisch Centrum Groningen /ID# 247741

location_facility: Goshen Center for Cancer Care /ID# 227189

location_facility: Hokkaido University Hospital /ID# 231443

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 228127

location_facility: CHU Reims - Hôpital Robert Debre /ID# 248710

location_facility: Franciscus Gasthuis & Vlietland /ID# 248139

location_facility: Jeonbuk National University Hospital /ID# 228908

location_facility: Boca Raton Regional Hospital /ID# 242769

location_facility: Pan American Center for Oncology Trials, LLC /ID# 230055

location_facility: Yamagata University Hospital /ID# 230005

location_facility: University of Rochester Cancer Center /ID# 227870

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 229122

location_facility: The Affiliated Hospital of Xuzhou Medical University /ID# 232513


title: Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact

acronym: ALGOS

summary:
The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to define univocal strategies of prevention of suicide repetition, during the emergency stay, i.e. almost in general population. One find 23 clinical trials in this topic in the past 25 years, and 18 are negative. The majority of the positive trials have the concern of being dissociated from an assumption of responsibility of care strictly speaking, to adopt a position "méta", nearer to the concept of "case management": how to remain in contact with the suicide attempter, without forcing it in this every day life, replacing a possible proposing, but assumption of responsibility resources reliable and quickly accessible in the event of at risk situation? Each one of these studies tests devices which seem more appropriate to such or such characteristic of this population, by retaining only simple criteria like the sex, the number of former suicide attempts, the proposal or not for an assumption of responsibility of care, the observance or not with the plan of care. Thus, it would seem interesting to combine these approaches in an algorithm entitled "ALGOS".

Main aim: To test the effectiveness of this algorithm of case management, named "ALGOS", in reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the number of loss of contact patients in the ALGOS group during 6 months period, compared to a control group of suicide attempters treated as usual (i.e. primarily transmitted to the attending physician).

Secondary objectives: To evaluate, according to the method validated by Beecham in 1992, direct medico-economic impact in the year which follows the introduction of algorithm ALGOS. Reduction of the other suicidal behaviors in 6 months (reduction in the full number of suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To evaluate the effect of the algorithm, at the 13th month. To study the possible differences within the time in terms of suicidal repetitions in the 2 groups. To propose different profiles of answers according to psychopathology, the number of suicide attempts, suicidal character, the sex,…

Methodology: Comparative simple blind prospective multicentric controlled study

primary_purpose: Supportive Care

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5.

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. Epub 2005 Sep 23.

ReferenceCitation: Evans J, Evans M, Morgan HG, Hayward A, Gunnell D. Crisis card following self-harm: 12-month follow-up of a randomised controlled trial. Br J Psychiatry. 2005 Aug;187:186-7.

ReferenceCitation: Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.

ReferenceCitation: Demesmaeker A, Chazard E, Vaiva G, Amad A. Risk Factors for Reattempt and Suicide Within 6 Months After an Attempt in the French ALGOS Cohort: A Survival Tree Analysis. J Clin Psychiatry. 2021 Feb 18;82(1). pii: 20m13589. doi: 10.4088/JCP.20m13589.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

ReferenceCitation: Vaiva G, Berrouiguet S, Walter M, Courtet P, Ducrocq F, Jardon V, Larsen ME, Cailhol L, Godesense C, Couturier C, Mathur A, Lagree V, Pichene C, Travers D, Lemogne C, Henry JM, Jover F, Chastang F, Prudhomme O, Lestavel P, Gignac CT, Duhem S, Demarty AL, Mesmeur C, Bellivier F, Labreuche J, Duhamel A, Goldstein P. Combining Postcards, Crisis Cards, and Telephone Contact Into a Decision-Making Algorithm to Reduce Suicide Reattempt: A Randomized Clinical Trial of a Personalized Brief Contact Intervention. J Clin Psychiatry. 2018 Sep 25;79(6). pii: 17m11631. doi: 10.4088/JCP.17m11631.

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris

intervention_type: Behavioral


title: SLEEP DISORDERED BREATHING DURING CARDIAC REHABILITATION A Study of the Improvement in Physical Performance of Patients With Heart Failure During Cardiac Rehabilitation Due to the Correction of Sleep Disordered Breathing

acronym: SATELIT-HF

summary: Sleep disordered breathing (SDB) is a frequent comorbidity for heart failure patients. Its prevalence varies according to the seriousness of the condition of the patients, but it is present in approximately 50% of patients. Screening patients for SDB and managing them by providing adapted ventilation therapy should improve their quality of life or even their prognosis. Moreover, SDB lowers nocturnal cardiovascular recovery abilities and leads to an increase in fatigability and, as a result, exercise intolerance in patients with heart failure. Physical training as part of a cardiac rehabilitation programme provides many benefits, including improving patients' exercise capacities. Our hypothesis is that adapted sleep disordered breathing therapy during rehabilitation will lead to an improvement in rehabilitation results.

primary_purpose: Prevention

lead_sponsor: French Cardiology Society

location_facility: Centre de réadaptation cardiaque Leopold Bellan

location_facility: Hôpital Intercommunal Sud Léman Valserine

location_facility: Clinique de réadaptation cardiaque Cardiocéan

intervention_type: Other


title: Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance

acronym: SCAVANCE

summary: To study compliance with secondary prevention during the first months following discharge from the cardiac intensive care unit (CIC) of patients experiencing a first episode of acute coronary syndrome : quantitative compliance over 3 months with the two principal treatments of the prescription (a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor - clopidogrel, Plavix®), using an electronic measure system ("intelligent blister" pack®);


intervention_type: Radiation

title: Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

ReferenceCitation: Aupérin A, Le Péchoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. Review.

ReferenceCitation: Tredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.

location_facility: Hôpitaux Universitaires - Nouvel Hôpital Civil

summary: Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.


acronym: SELECT-GCA

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Portugal
Austria
Australia
Russian Federation
Israel
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
New Zealand
France
Netherlands

location_facility: VA Long Beach Healthcare System /ID# 203833

location_facility: Cabinet Medical Dr. Avram S.R.L /ID# 224336

location_facility: University of Rochester Medical Center /ID# 213527

location_facility: Clinical Research of West Florida, Inc /ID# 201901

location_facility: Duplicate_Vastmanlands Sjukhus /ID# 171429

location_facility: General Hospital of Athens Gennimatas /ID# 210129

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151

location_facility: St. Marianna University Hospital /ID# 218692

location_facility: Wayne State University Health Center /ID# 212755

location_facility: Universitair Ziekenhuis Leuven /ID# 202779

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 202834

location_facility: Sahlgrenska University Hospital /ID# 171405

location_facility: Medallion Clinical Research Institute, LLC /ID# 168666

location_facility: Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 201853

location_facility: Precision Comprehensive Clinical Research Solutions /ID# 201798

location_facility: Haukeland universitetssjukehus /ID# 201602

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761

location_facility: Hopital de la Cavale Blanche /ID# 171549

location_facility: Duplicate_West Michigan Rheumatology /ID# 168647

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 201604

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781

location_facility: Arthritis Associates of Kingsport /ID# 212756

location_facility: 424 General MILITARY Hospital /ID# 210973

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454

location_facility: CHU Toulouse - Hopital Purpan /ID# 171547

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 171544

location_facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887

location_facility: Medizinische Universitaet Innsbruck /ID# 201786

location_facility: Western Connecticut Health Network- Germantown Rd /ID# 205071

location_facility: Torbay and South Devon Nhs Foundation Trust /Id# 224689

location_facility: Duplicate_Jichi Medical University Hosp /ID# 200169

location_facility: The Chaim Sheba Medical Center /ID# 241041

location_facility: Unidade Local de Saúde da Guarda, EPE /ID# 224878

location_facility: Karolinska University Hospital Solna /ID# 204945

location_facility: CHRU Tours - Hopital Trousseau /ID# 245232

location_facility: UPMC Lupus Center of Excellence /ID# 240784

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 200079

location_facility: Liverpool University University Hospitals NHS Foundation Trust /ID# 240391

location_facility: Universitaetsklinikum Tuebingen /ID# 223854

location_facility: Hospital Clinic de Barcelona /ID# 201878

location_facility: Lovelace Scientific Resources /ID# 169041

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 208950

location_facility: Hospital General Universitario Gregorio Maranon /ID# 201326

location_facility: Radboud Universitair Medisch Centrum /ID# 212925

location_facility: Piedmont Arthritis Clinic, PA /ID# 212431

location_facility: Institute of Arthritis Research /ID# 168490

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201526

location_facility: Hospital Universitario Basurto /ID# 224730

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643

location_facility: West Tennessee Research Institute /ID# 209256

location_facility: Hospital Clinico Universitario San Carlos /ID# 204871

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 213529

location_facility: Physician Research Collaboration, LLC /ID# 168610

location_facility: Japanese Red Cross Kumamoto Hospital /ID# 203507

location_facility: Rheum Assoc of North Alabama /ID# 168668

location_facility: The Center for Rheumatology and Bone Research /ID# 168652

location_facility: Universitaetsklinikum Wuerzburg /ID# 213340

location_facility: St.Luke's International Hospital /ID# 200170

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 171543

location_facility: CHU UCL Namur - site Godinne /ID# 224334

location_facility: Rheumatology Associates PA - Portland /ID# 225011

location_facility: Hospital Universitario La Paz /ID# 241848

location_facility: Froedtert Memorial Lutheran Hospital /ID# 224557

location_facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946

location_facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702

location_facility: Hospital Universitario Virgen de las Nieves /ID# 224726

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 202836

location_facility: Szent Imre Egyetemi Oktatokorhaz /ID# 201838

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 171199

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040

location_facility: Omega Research Maitland, LLC /ID# 201903

location_facility: HFR Fribourg - Hôpital cantonal /ID# 201114

location_facility: University of Vermont Medical Center /ID# 211179

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 171200

location_facility: West Texas Clinical Research /ID# 204834

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 203673

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 224731

location_facility: Medizinische Hochschule Hannover /ID# 200632

location_facility: Kemerovo State Medical University /ID# 203676

location_facility: Hospital Universitario Canarias /ID# 224928

location_facility: Timaru Medical Specialists Ltd /ID# 201943

location_facility: IRIS Research and Development, LLC /ID# 169406

location_facility: Clinical Research of West Florida - Tampa /ID# 201899

location_facility: Inselspital, Universitätsspital Bern /ID# 201364

location_facility: Arthritis and Rheumatology Institute, PLLC /ID# 214612

location_facility: Portsmouth Hospitals University NHS Trust /ID# 225002

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 224266

location_facility: General Hospital of Athens Ippokratio /ID# 202181

location_facility: Centre de Recherche Musculo-Squelettique /ID# 201224

location_facility: Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081

location_facility: AA Medical Research Center - Grand Blanc /ID# 201854

location_facility: Wake Forest Baptist Health (Shepherd) /ID# 225157

location_facility: University Clinical Research Center /ID# 202504

location_facility: The Queen Elizabeth Hospital /ID# 201939

location_facility: University of Michigan Hospitals /ID# 168645

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186

location_facility: HCL - Hopital de la Croix-Rousse /ID# 211184

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018

location_facility: Practicheskaya Medicina Clinic /ID# 224612

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 168667

location_facility: University of Alberta Hospital - Division of Hematology /ID# 208629

location_facility: Universitair Medisch Centrum Groningen /ID# 201715

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539

location_facility: Rush University Medical Center /ID# 224581

location_facility: The Lady Davis Carmel Medical Center /ID# 240731

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530

summary: This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.


acronym: ReChiVe

title: Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: INSTITUT CLAUDIUS REGAUD - CRLC Toulouse

location_facility: APHM - Marseille - Hôpital de la Conception

summary:
Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma. But the removal of the bladder reservoir has a major impact of the Quality of life. Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in combination with an optimal transurethral bladder resection, in a strategy of bladder preservation, provided a complete response being obtained (about 50% in every trial using neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation rate at 5 years.

The feasibility and the efficacy of such an attitude in a multicentric trail using the most active regimen (in term of complete response in metastatic patients) is unknown. The chosen regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and vinblastine dose-intensity.

The efficacy and safety confirmation of such an approach could lead to consider it in patients motivated to retain a functional bladder.


title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

summary:
Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007).

Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q.

In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).

Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose).

For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response.

In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Institut Paoli-Calmette, Département d'hématologie


acronym: CERTITEM

title: Prospective, Multicenter, Randomized Open Study to Evaluate the Progression of Renal Graft Fibrosis According to the Epithelial-mesenchymal Transition (EMT) in de Novo Renal Transplant Recipients Treated Either by a CNI Free Immunosuppressive Regimen With Everolimus and Enteric-coated Mycophenolate Sodium or a CNI Based Regimen With Cyclosporine and Enteric-coated Mycophenolate Sodium

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Böhmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

summary: Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin into their cytoplasm. These markers, when present, suggest that the epithelial cell undergoes a phenomenon well known as "epithelial to mesenchymal transition" (EMT) and could behaves like a myo-fibroblast. EMT is highly instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has not only been demonstrated that these markers are detectable in the renal graft at an early time point post-transplant (i.e. as soon as three months), but also that the intensity of their expression correlates with the progression of interstitial fibrosis of the graft between 3 and 12 months


title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

summary: To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

lead_sponsor: Pfizer


title: Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

acronym: Tutomesh

summary:
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.

The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.

lead_sponsor: Centre Hospitalier Régional Universitaire Montpellier

location_facility:
CHU Nantes
CH Avignon
CHU Archet II
CHU Hôtel Dieu
CH Nimes
CHU Rangueil
CH St Eloi
CH Aix en Provence
CHU Amiens
Hôpital Nord
CH Hautepierre
CHU Grenoble
CHU Jean Verdier
CH Salon de Provence
Ch Antibes-Juan les pins
Clinique de la Casamance
CHU Fréjus
CHG Beziers
CHU Trousseau


title: A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

summary: Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Hôpitaux Drôme Nord - Site de Romans-sur-Isère


title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation.

acronym: RITUX-ERAH

summary: Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

status: Unknown status

lead_sponsor: University Hospital, Tours

location_facility:
Hospital Pitié-Salpêtrière
Hospital Edouard Herriot
Hospital Nord
Hospital Bicêtre
Hospital Bocage
Hospital Tenon
Hospital Sud
Hospital Gabriel Montpied
Hospital Nancy-Brabois
Hospital Saint Louis
Hospital Bois-Guillaume
Hospital Pellegrin
Hospital Calmette
Hospital Foch
Hospital
Hospital Saint-Jacques
Hospital Bretonneau
Hospital Milétrie Jean Bernard
Hospital Necker
Hospital Dupuytren
Hospital Civil
Hospital Pasteur
Hospital Conception
Hospital Hôtel Dieu
Hospital Lapeyronie
Hospital Henri Mondor
Hospital Maison Blanche
Hospital Lyon Sud


title: Evaluation of Target Organs Damage in Hypertensive Patients Followed in General Practice With no Known Cardiovascular (CV) or Renal Disease, Stratified According to Blood Pressure Control

acronym: PreVENT-A GP

summary: Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV) or renal disease, stratified according to level of blood pressure control

time_perspective: Cross-Sectional


title: A Multicenter Randomized Open Label Phase II Study of Pomalidomide and Dexamethasone in Relapse and Refractory Multiple Myeloma Patients Who Are Progressive and Did Not Achieve at Least a Partial Response to Bortezomib and Lenalidomide

ReferenceCitation: Leleu X, Attal M, Arnulf B, Moreau P, Traulle C, Marit G, Mathiot C, Petillon MO, Macro M, Roussel M, Pegourie B, Kolb B, Stoppa AM, Hennache B, Bréchignac S, Meuleman N, Thielemans B, Garderet L, Royer B, Hulin C, Benboubker L, Decaux O, Escoffre-Barbe M, Michallet M, Caillot D, Fermand JP, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myélome. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02. Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

location_facility: Service d'Hématologie, Centre Hospitalier Lyon Sud

location_facility: Service des Maladies du Sang, Hôpital Haut-Levèque

location_facility: Onco-Hématologie, CHRU- Hôpital Bretonneau

location_facility: Service Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Maladies du Sang, CHU - Hôpital St Antoine

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

summary: The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily treated characterized with adverse prognostic and that are in desperate need of novel therapeutics.


title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

acronym: RECO

summary: Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.

ReferenceCitation: Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.

ReferenceCitation: Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.

lead_sponsor: University Hospital, Grenoble


title: A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy

acronym: BVD

summary:
The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint.

The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio.

ReferenceCitation: Rodon P, Hulin C, Pegourie B, Tiab M, Anglaret B, Benboubker L, Jardel H, Decaux O, Kolb B, Roussel M, Garderet L, Leleu X, Fitoussi O, Chaleteix C, Casassus P, Lenain P, Royer B, Banos A, Benramdane R, Cony-Makhoul P, Dib M, Fontan J, Stoppa AM, Traullé C, Vilque JP, Pétillon MO, Mathiot C, Dejoie T, Avet-Loiseau H, Moreau P. Phase II study of bendamustine, bortezomib and dexamethasone as second-line treatment for elderly patients with multiple myeloma: the Intergroupe Francophone du Myelome 2009-01 trial. Haematologica. 2015 Feb;100(2):e56-9. doi: 10.3324/haematol.2014.110890. Epub 2014 Nov 14.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: Centre Hospitalier de la Région d'Annecy