acronym: SOLTI NEOPARP

lead_sponsor: Sanofi

summary:
Primary Objective:

- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.

Secondary objectives are:

pCR rate in the breast and axilla,
Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
Safety profiles of study combinations and of the single agent reference treatment,
Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

ReferenceCitation: Llombart-Cussac A, Bermejo B, Villanueva C, Delaloge S, Morales S, Balmana J, Amillano K, Bonnefoi H, Casas A, Manso L, Roche H, Gonzalez-Santiago S, Gavila J, Sanchez-Rovira P, Di Cosimo S, Harbeck N, Charpentier E, Garcia-Ribas I, Radosevic-Robin N, Aura C, Baselga J. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):351-7. doi: 10.1007/s10549-015-3616-8. Epub 2015 Nov 4.

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

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

sponsor_collaborators:
Sanofi
SOLTI Breast Cancer Research Group

location_facility:
Investigational Site Number 724013
Investigational Site Number 724010
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 724017
Investigational Site Number 250004
Investigational Site Number 276003
Investigational Site Number 724006
Investigational Site Number 724007
Investigational Site Number 250006
Investigational Site Number 276002
Investigational Site Number 724012
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 724001
Investigational Site Number 724011
Investigational Site Number 724018
Investigational Site Number 724009
Investigational Site Number 276001
Investigational Site Number 276004
Investigational Site Number 724015
Investigational Site Number 724003
Investigational Site Number 724005
Investigational Site Number 250003
Investigational Site Number 724016

title: Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)

location_country: Germany Spain France


type: Other Identifier

title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

summary: Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

location_country: Germany Hungary France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: Plerixafor and G-CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) - Safety Study in a General Autologous Transplant Population

acronym: PREDICT

summary: This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Spain
France

location_facility: L. & A. Seragnoli, University of Bologna


acronym: BVT. BSSL - 021

lead_sponsor: Swedish Orphan Biovitrum

summary: The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

ReferenceType: derived

ReferenceCitation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

location_facility: Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"

location_facility: Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria

location_facility: CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville

title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

source: euctr

location_country: Italy France


title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

status: Terminated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

lead_sponsor: University Hospital, Grenoble

location_country: Switzerland France

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital, Department of Surgery

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


lead_sponsor: Bayer

summary:
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

title: A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

location_country:
Germany
Italy
Poland
United Kingdom
France


acronym: REVERBREZ

lead_sponsor: Novartis Pharmaceuticals

summary: In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

ReferenceCitation: Burgel PR, Le Gros V, Decuypere L, Bourdeix I, Perez T, Deslee G. Immediate salbutamol responsiveness does not predict long-term benefits of indacaterol in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2017 Jan 31;17(1):25. doi: 10.1186/s12890-017-0372-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

title: Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD


title: Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

acronym: GRECCAR 5

summary: After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu

location_facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon

location_facility: Département de Chirurgie Oncologique - Institut Paoli Calmette

location_facility: Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux

location_facility: Service de Chirurgie Digestive - Hôpital A. Michallon

location_facility: Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy

location_facility: Service de Chirurgie Digestive - CHU Charles Nicolle

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon

location_facility: Service de Chirurgie Digestive et Générale - Brabois

location_facility: Service de Chirurgie Digestive et Viscérale - CHU Timone

location_facility: Département de Chirurgie Oncologique - Centre Oscar Lambret

location_facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle

location_facility: Service de Chirurgie Viscérale - CHU Pontchaillou


title: Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma

acronym: OTOHTPF

summary: The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre Hospitalier de Vendée
Clinique Armoricaine
Centre Antoine Lacassagne
Institut Jean Godinot
Centre Hospitalier
Centre Eugene Marquis
Centre Leon Berard
Groupe Hospitalier Pitié Salpétrière
Centre Hospitalier Bretonneau
Centre René Gauducheau
Centre Oscar Lambret
Institut Sainte Catherine
Centre Guillaume le Conquerant
Centre Hospitalier Universitaire
Centre Jean Perrin
Polyclinique de Bordeaux Nord


lead_sponsor: UNICANCER

summary:
GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in combination with trastuzumab.

Due to the minimal participation of older people in clinical trials, there is a lack of data to make evidence-based decisions regarding chemotherapy in this indication.

The study is designed to investigate whether elderly patients with locally advanced or metastatic breast cancer over-expressing HER2 could take advantage of the combination lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no detrimental impact on functional status (part of geriatric assessment).

The main objective is to assess clinical benefit (defined at 4 months as complete response, partial response or stable disease), safety and preserved geriatric independence (main objective is a "bi-criteria" or composite criteria).

sponsor_collaborators: UNICANCER GlaxoSmithKline

location_facility: Institut Cancérologie- CENTRE HOSPITALIER BREST

title: PHASE II STUDY Evaluating the Toxicity and Activity of the Combination Lapatinib + Capecitabine in Elderly Patients Aged 70 and Over With Metastatic Breast Cancer Over Expressing HER2


acronym: ESOGIA

summary:
This is a phase III randomized multicenter study involving subjects over 70 years of age with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a screening tool. If the SGS results are normal, the patient will be treated with dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale, who will receive either monotherapy (docetaxel) or best supportive care.

The strategy based on the SGS will be compared with a treatment algorithm based on standard criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia, repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the CGE, that will be administered systematically at enrollment. All the SGS items are included in the CGE.

Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL questionnaires), overall survival, the objective response rate, and toxicity. The investigators will also study the predictive power of nutritional indices such as the PINI and the Buzby score with respect to survival, the treatment response, and tolerability.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Corre R, Greillier L, Le Caer H, Audigier-Valette C, Baize N, Berard H, Falchero L, Monnet I, Dansin E, Vergnenegre A, Marcq M, Decroisette C, Auliac JB, Bota S, Lamy R, Massuti B, Dujon C, Perol M, Daures JP, Descourt R, Lena H, Plassot C, Chouaid C. Use of a Comprehensive Geriatric Assessment for the Management of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Phase III Randomized ESOGIA-GFPC-GECP 08-02 Study. J Clin Oncol. 2016 May 1;34(13):1476-83. doi: 10.1200/JCO.2015.63.5839. Epub 2016 Feb 16.

oa_host_type: closed

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Général de la Fontonne Antibes

location_facility: Centre Hospitalier De Villefranche sur Saone

location_facility: Centre Hospitalier Général Salon de Provence

location_facility: Centre Hospitalier Universaitaire de Brest

location_facility: Centre Hospitalier Universitaire d'Angers


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.

study_start_date_type: Actual

location_facility: Centre Hospitalier de La Region D'Annecy


summary:
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) .

Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed

title: A Randomized, Open Label, Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFG316 in Patients With Transplant Associated Microangiopathy After Hematopoietic Precursor Cell Transplantation

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:
United States
Germany
France

ipd_sharing: Yes


title: ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs

acronym: ERYTHRO

summary: The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Retrospective

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators: AstraZeneca CernerEnviza

location_country:
France
Italy
Portugal
United Kingdom
Spain
Greece
Israel

intervention_type: Other

status_simplified: Ongoing


title: An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)

summary:
This is an international, prospective study to assess the impact of concomitant early use of liquid biopsy (FoundationOne® Liquid CDx) within the diagnostic pathway, compared with the standard of care diagnostic pathway, on the timing of routine cancer care in treatment-naïve participants presenting with a clinical diagnosis of advanced cancer, where the pathologic diagnosis has not yet been confirmed. Participants with one of the following two clinical presentations will be included: participants with evidence of de novo metastatic lung cancer or participants with evidence of de novo metastatic gastrointestinal cancer.

Participants may have undergone different levels of diagnostic workup prior to enrollment. Participants who have not had tissue biopsy performed prior to enrollment will be classified as 'basic workup' and those who have had tissue biopsy performed prior to enrollment will be classified as 'extended workup'.

During the diagnosis period, eligible participants will undergo liquid biopsy (FoundationOne® Liquid CDx assay; as per label) on blood samples. Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. In parallel, participants will undergo the standard of care diagnostic pathway, including tissue biopsy and histology workup, if not already done before enrollment, and molecular workup according to ESMO guidelines or national guidelines for each tumor type included in this study.

Once a complete pathologic diagnosis has been made, the investigator (or multidisciplinary team) can complete an anti-cancer treatment recommendation assessment. Anti-cancer treatment recommendation should follow current practice and professional guidelines based on the results provided by either liquid biopsy (as per label) or tissue biopsy/standard of care.

primary_purpose: Diagnostic

ipd_sharing: No

ipd_sharing_description:
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Foundation Medicine

location_country: Germany Italy Spain France

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Asklepios Klinik Gauting; Onkologisches Studienzentrum

location_facility: Ospedale Papardo- Piemonte;Oncologia Medica

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Universität Mannheim; Personalisierte Onkologie

location_facility: Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU

intervention_type: Diagnostic Test


acronym: SELF

lead_sponsor: UCB Pharma

summary:
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility

ReferenceCitation: Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.

publisher_dissemination: Wiley

title: A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses


title: A Randomised, Placebo-controlled, Multicentre Phase IIb Study Evaluating the Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease

summary: This is a Phase 2b study investigating the efficacy and safety of pirepemat as adjunct therapy on falls frequency in patients with Parkinson disease. Pirepemat is taken for 84 days.

lead_sponsor: Integrative Research Laboratories AB

location_country: Germany Poland Sweden Netherlands Spain France

location_facility: Skane University Hospital - Division of Neurology

location_facility: Institute of Neuroscience and Physiology

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm Klinik für Neurologie

location_facility: Hôpital Laennec - Centre d'investigation clinique de Neurologie

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Klinik für Neurologie - Alexianer St. Joseph-Krankenhaus

location_facility: Charite Universitatsmedizin Berlin - Klinik fuer neurologie mit experimenteller neurologie

location_facility: Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Neurologie

location_facility: Karolinska Universitetssjukhuset - Neurologiska kliniken

location_facility: Universitysklinikum Münster - Klinik für neuroligie

location_facility: Universitätsmedizin Göttingen - Klinik für Neurologie

location_facility: Praxis Dr.med. Christian Oehlwein Facharzt für Neurologie und Psychiatrie

location_facility: Radboud Universitair Medisch Centrum (Radboudumc)


title: How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA

acronym: ASSIST

summary:
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.

This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.

This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

status: Unknown status

time_perspective: Cross-Sectional

ipd_sharing: Undecided

ipd_sharing_description: Available on reasonable request

lead_sponsor: University of Oxford

sponsor_collaborators:
University of Oxford
Amgen

location_country:
Germany
Italy
United Kingdom
Spain
France

location_facility: Oxford University Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: MVZ für Rheumatologie Dr. Martin Welcker GmbH

location_facility: Manchester University NHS Foundation Trust

location_facility: Midlands Partnership NHS Foundation Trust

location_facility: Hospital Universitario Central de Asturias


title: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

acronym: ABDO-MIX

summary: The purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from septic shock.

ReferenceCitation: Payen DM, Guilhot J, Launey Y, Lukaszewicz AC, Kaaki M, Veber B, Pottecher J, Joannes-Boyau O, Martin-Lefevre L, Jabaudon M, Mimoz O, Coudroy R, Ferrandiere M, Kipnis E, Vela C, Chevallier S, Mallat J, Robert R; ABDOMIX Group. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med. 2015 Jun;41(6):975-84. doi: 10.1007/s00134-015-3751-z. Epub 2015 Apr 11.

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Meditor SAS

location_facility:
Clermont-Ferrand University Hospital
La Source Hospital
Limoges University Hospital
Dieppe Hospital
Saint-Malo Hospital
Saint Louis Hospital
Roanne Hospital
Saint Jean Hospital
Poitiers University Hospital
Rouen University Hospital
Tours University Hospital
Lille University Hospital
Vendée Hospital
Strasbourg University Hospital
Lariboisière University Hospital
Pontchaillou University Hospital
Bordeaux University Hospital
Dr Schaffner Hospital

intervention_type: Device


acronym: JUVE-BRIGHT

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

ReferenceCitation: Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5.

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hamburger Zentrum für Kinder und Jugendrheumatologie

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

status: Active, not recruiting

title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.


title: European HIV&STI Prevention Network Study

summary:
The University Hospital Essen is sponsoring the Multicenter human immunodeficiency virus (HIV) and sexually transmitted infections Prevention Network Study (STIPnet) which is funded by Janssen, Pharmaceutical Companies of Johnson & Johnson.

STIPnet study is a prospective observational cohort study aiming to determine the incidence and point prevalence of HIV infection and the most common sexually transmitted infections (STIs) in individuals with sexual risk behavior. In addition, the University Hospital Essen will examine whether individuals at risk for HIV and STI infections would retain in such a study (retention rate) and would be willing to participate in potential HIV and STI prevention trials (willingness to participate).

ipd_sharing_description: The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analysed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study.Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.

lead_sponsor: Hendrik Streeck

sponsor_collaborators:
Hendrik Streeck
Janssen, LP

location_country: Italy Poland Hungary Spain France

location_facility: Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment

location_facility: National Institute for Infectious Diseases L. Spallanzani

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire de Bordeaux

intervention_type: Behavioral


type: Registry Identifier

title: A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination With Other Anti-cancer Therapies in Participants With Lymphoma

summary:
Primary Objectives:

Phase 1

-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).

Phase 2

Cohort A1 (anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab.
Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab.

Secondary Objectives:

To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab.
To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in participants with cHL.
To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination.
To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination.
To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.

ReferenceType: background

ReferenceCitation: Carlo-Stella C, Zinzani PL, Sureda A, Araujo L, Casasnovas O, Carpio C, Yeh SP, Bouabdallah K, Cartron G, Kim WS, Cordoba R, Koh Y, Re A, Alves D, Chamuleau M, Le Gouill S, Lopez-Guillermo A, Moreira I, van der Poel MWM, Abbadessa G, Meng R, Ji R, Lepine L, Saleem R, Ribrag V. A phase 1/2, open-label, multicenter study of isatuximab in combination with cemiplimab in patients with lymphoma. Hematol Oncol. 2023 Feb;41(1):108-119. doi: 10.1002/hon.3089. Epub 2022 Oct 31.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Italy
Portugal
Netherlands
Korea, Republic of
Spain
Taiwan
France

location_facility:
Investigational Site Number :3800006
Investigational Site Number :4100001
Investigational Site Number :5280002
Investigational Site Number :6200002
Investigational Site Number :1580002
Investigational Site Number :5280001
Investigational Site Number :2500005
Investigational Site Number :4100002
Investigational Site Number :3800003
Investigational Site Number :2500002
Investigational Site Number :2500001
Investigational Site Number :2500004
Investigational Site Number :3800002
Investigational Site Number :7240005
Investigational Site Number :7240002
Investigational Site Number :2500007
Investigational Site Number :6200004
Investigational Site Number :6200003
Investigational Site Number :7240003
Investigational Site Number :7240004


title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.

acronym: PREVENU

summary:
The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

ReferenceCitation: Roy PM, Rachas A, Meyer G, Le Gal G, Durieux P, El Kouri D, Honnart D, Schmidt J, Legall C, Hausfater P, Chretien JM, Mottier D; PREVENU study group. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial. PLoS One. 2016 May 26;11(5):e0154832. doi: 10.1371/journal.pone.0154832. eCollection 2016.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: University Hospital, Angers

location_facility:
H Bobigny
H Bethune
UH Grenoble
UH Marseille
UH Besançon
UH Nimes
H Cochin
H Chateauroux
UH La Reunion
UH Agen
UH Dijon
UH Ambroise Pare
UH Poitiers
UH Hotel Dieu
UH Nantes
UH la pitié salpetriere
UH Brest
UH Rennes
UH Metz Thionville
H Argenteuil
UH Bichat
H Clermont Ferrand
H Compiegne


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.

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. doi: 10.1200/JCO.2006.09.2403. 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. doi: 10.1182/blood.v98.13.3595.

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, Socie 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. doi: 10.3324/haematol.10924.

ReferenceCitation: Christopeit M, Schutte 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. No abstract available.

sponsor_collaborators:
University Hospital, Bordeaux
Roche Pharma AG

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

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Service Hématologie Clinique, Hôpital Archet 1

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

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

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu

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


acronym: FUO-TEP

lead_sponsor: University Hospital, Limoges

summary: Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.

location_facility: Médecine Interne - AP-HP - Hôpital Bichat

location_facility: Médecine Interne - AP-HP - Hôpital Hôtel Dieu

location_facility: Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

location_facility: Médecine Nucléaire et Imagerie Fonctionnelle - CHU

location_facility: Médecine Interne - AP-HP - Hôpital Cochin

location_facility: Médecine Nucléaire - AP-HP - La Pitié Salpétrière

location_facility: Médecine Interne - AP-HP - La Pitié Salpétrière

location_facility: Département de Médecine pour adulte - CHU

location_facility: Service des Isotopes - CRLCC Centre Eugène Marquis

location_facility: Médecine Nucléaire - AP-HP - Hôpital Bichat

title: Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients


acronym: RIALTO

summary: To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

title: An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

location_country:
Italy
Poland
Korea, Republic of
Thailand
France


summary: This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial compares the change in disease activity (as assessed by Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from randomization to Week 24 post-randomization, in participants with stable low disease activity [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been randomized to either continue or taper prednisone in a double-blinded fashion.

ReferenceCitation: Burmester GR, Buttgereit F, Bernasconi C, Alvaro-Gracia JM, Castro N, Dougados M, Gabay C, van Laar JM, Nebesky JM, Pethoe-Schramm A, Salvarani C, Donath MY, John MR; SEMIRA collaborators. Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial. Lancet. 2020 Jul 25;396(10246):267-276. doi: 10.1016/S0140-6736(20)30636-X.

publisher_dissemination: Elsevier

location_facility: SchlossPark-Klinik Berlin; Int. Med. II, Rheum. Osteo

location_facility: Rheumazentrum Ratingen - Studienambulanz

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Rheumatologische Schwerpunktpraxis am Feuersee

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Irccs Policlinico San Matteo; Reumatologia Adulti

location_facility: Rheumatologische Facharztpraxis Maren Sieburg

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Special hospital for rheumatic diseases Novi Sad

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Med.Klinik III

location_facility: Hopital Farhat Hached; Service Rhumatologie

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: FSBI Scientific Research Institute of Clinical and Experimental Lymphology of SB of RAMS

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi

location_facility: SMO.MD GmbH, Zentrum für klinische Studien

location_facility: Military Medical Academy; Clinic of Rheumatology

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Rheumatologische Gemeinschaftspraxis Grafschaft, Dr. med. Dorothea Pick, Dr. med. Christopher Amberg

title: Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients

location_country:
Germany
Italy
Tunisia
Serbia
Russian Federation
France


title: A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp

acronym: SAKOS

summary: The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

lead_sponsor: Vexim SA

sponsor_collaborators:
Vexim SA
ACES Ing.-GmbH

location_country: Germany Italy Switzerland Spain France

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Krankenhaus NEUWERK Sankt Augustinus kliniken

location_facility: Hospital Clinico Universitario de Valladolid,

location_facility: Hôpital Jean Minjoz Service Neurochirurgie

location_facility: Klinik und Poliklinik fur Orthopädie Universitatsklinikum

location_facility: CHU Hôtel Dieu Service Neuro traumatologie


title: Phase II Biomarker Study Evaluating The Upfront Combination Of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus The Combination After Eight Weeks Of Monotherapy With Dabrafenib Or Trametinib In Patients With Metastatic And Unresectable Stage III Or IV Melanoma Harbouring An Activating BRAF Mutation

summary: This is a three-arm, open-label, randomised Phase II study to evaluate whether the different sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an impact on translational or clinical activity in subjects with BRAF mutant metastatic unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However, duration of responses seem to be limited due to acquired drug resistance. The goal of this protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and tumour biomarkers and to study the correlation between biomarkers and response to treatment and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the ratio of 1:1:1 to one of the three treatment arms.

lead_sponsor: GlaxoSmithKline

location_country: Spain France


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.

evidence: open (via crossref license)

repository_institution: Radboud University - Radboud Repository

publisher_dissemination: Oxford University Press

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.

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

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

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

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.

publisher_dissemination: Informa

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.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

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.

sponsor_collaborators:
University Hospital, Toulouse
Dana-Farber Cancer Institute
Celgene Corporation
Janssen-Cilag Ltd.

location_facility: Centre hospitalier départemental - La Roche sur Yon cedex

location_facility: Centre Hospitalier Départemental - La réunion St Denis

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Centre Hospitalier Argenteuil Victor Dupouy


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.

lead_sponsor: Centre Oscar Lambret

location_country: Monaco France

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.


acronym: SATURNE

lead_sponsor: Federation Francophone de Cancerologie Digestive

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.

ReferenceCitation: Turpin A, de Baere T, Heurgue 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:
Hôpital Européen Georges Pompidou
CHU -Hôpital de l'Archet II
Hôpital Saint Joseph
Hopital Dupuytren
CH Conception
CHU Jean Bernard
Institut Sainte Catherine
CHBS
CHU La Timone
CHU Nord
Hôpital Privé Jean Mermoz
CHU Robert Debré
Institut Gustave Roussy
CHU Bocage
CH
CHU J Minjoz
Hopital Tenon
CHRU Saint Eloi
Groupe Hospitalier Paris St Joseph
CHU Côte de Nacre
CAC
Institut Bergonié
Clinique des Cèdres
CH Ambroise Paré
CHU
CHR
Hôpital Claude Huriez

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)


title: A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)

acronym: AGENT-ISR

summary:
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).

The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.

Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.

ReferenceCitation: Hamm CW, Dorr O, Woehrle J, Krackhardt F, Ince H, Zeus T, Berland J, Piot C, Roubille F, Schult I, Allocco DJ, Nef H. A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis. EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: Hemoteq AG

location_country: Germany France

location_facility: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility: CHU Montpellier, Hôpital Arnaud de Villeneuve


title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Thalidomide Following Multiple Oral Dosing in Subjects With Multiple Myeloma

summary: Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

ReferenceCitation: Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frolund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.

lead_sponsor: Celgene

location_country:
United Kingdom
France

location_facility:
CHU Grenoble
Royal Marsden Hospital
CHRU Hopital Brabois
CHRU-Hopital Claude Huriez
CHRU Hopital Bretonneau
Christie Hospital NHS Foundation Trust
Hopital Augustin Morvan


title: A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

acronym: ESSBR

summary: The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

lead_sponsor: LifeCell

location_country:
Germany
United Kingdom
France

location_facility: Institut du Cancer de Montpellier Val d'Aurelle

location_facility: St Luke's hospital / Bradford Royal Infirmary (BRI)

location_facility: Klinik der Universität München, Campus Innenstadt

location_facility: Wythenshawe Hospital UHSM NHS Foundation Trust


title: A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

acronym: EuroCTO

summary:
CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.

Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.

While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.

Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO

ReferenceCitation: Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.

repository_institution: University of Florence - Florence Research

ReferenceCitation: Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.

lead_sponsor: Euro CTO Club

sponsor_collaborators:
Euro CTO Club
NHS Research and Development
Biosensors International
Asahi Intecc Co., Ltd.

location_country:
Germany
Italy
United Kingdom
Spain
Latvia
France

location_facility: Cardiovascular Institute - Hospital Clinico San Carlos

location_facility: Department of Cardiovascular Sciences University of Leicester

location_facility: Unidad de Cardiología Intervencionista Hospital de Sant Pau

location_facility: Royal Sussex County Hospital - Brighton and Sussex University Hospitals

location_facility: Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita

location_facility: National Heart and Lung Institute Imperial College

location_facility: Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

location_facility: Institut Hospitalier Jacques Cartier - ICPS


title: An 8-week Phase I/II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study to Evaluate the Safety and Efficacy of Two Doses of Recombinant Human Nerve Growth Factor in Patients With Stage 2 and 3 of NK

acronym: REPARO

summary: This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

ReferenceCitation: Yanai R, Nishida T, Chikama T, Morishige N, Yamada N, Sonoda KH. Potential New Modes of Treatment of Neurotrophic Keratopathy. Cornea. 2015 Nov;34 Suppl 11:S121-7. doi: 10.1097/ICO.0000000000000587.

lead_sponsor: Dompé Farmaceutici S.p.A

location_country:
Germany
Italy
Poland
United Kingdom
Spain
France

location_facility: Università G. D' Annunzio - Clinica Oftalmologica - Centro regionale di Eccellenza in Oftalmologia

location_facility: University of Southampton Southampton General Hospital - MP104, Eye Unit

location_facility: "CHU Toulouse-Purpan - Service Ophtalmologie

location_facility: Hospital Clinic de Barcelona - Oftalmología

location_facility: Universität zu Köln - Zentrum für Augenheilkunde am Universitätsklinikum Köln

location_facility: Royal Victoria Infirmary - Dept. of Ophthalmology

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: "Fondation Ophtalmologique Adolphe de Rothschild - "Unité de Recherche Clinique

location_facility: "SPKSO Szpital Okulistyczny ul. - SPKSO Szpital Okulistyczny

location_facility: Manchester Royal Eye Hospital - Manchester Royal Eye Hospital

location_facility: Vissum Corporación Oftalmológica de Alicante

location_facility: University of Birmingham - Academic Unit of Ophthalmology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham

location_facility: Azienda ospedaliera di Padova - Clinica Oculistica Policlinico 7° Piano

location_facility: Instituto Oftalmológico Fernández-Vega - Oftalmología

location_facility: Klinikum der Universität München - Augenklinik der Ludwig-Maximilians-Universtiät München

location_facility: Dipartimento di Scienze Neurologiche Oftalmologia e Genetica - Universtità di Genova

location_facility: Azienda Ospedaliero Universitaria di Messina - Dipartimento Specialità Chirurgiche Ambulatorio Studio delle Malattie dela Superficie Oculare Unità Operativa Complessa di Oftalmologia

location_facility: Moorfields Eye Hospital - Moorfields Eye Hospital

location_facility: Azienda Ospedaliera San Paolo - U.O. Oculistica

location_facility: District Railway Hospital Katowice - Department of Ophthalmology

location_facility: Hospital Clínico San Carlos - Oftalmología. Unidad de Superficie Ocular

location_facility: Johannes-Gutenberg-Universität Augenklinik und Poliklinik - Department of Ophthalmology

location_facility: Centre Hospitalier National d'Ophtalmologie - Service d'ophtalmologie


title: A Phase 2A, Open-label Dose Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With BETA(b)-THALASSEMIA.

summary: Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

ReferenceCitation: Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.

ReferenceCitation: Cappellini M, et al. A Phase 2a, Open-Label, Dose-Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta ( )-Thalassemia: Interim Results. Presented at the 55th Annual Meeting of the American Society of Hematology (ASH), December 7-10, 2013, New Orleans, LA. Abstract No. 3448

ReferenceCitation: "Porter J, et al. Interim Results From a Phase 2A, Open-Label, Dose-Finding Study To Determine The Safety, Efficacy, And Tolerability of Sotatercept (ACE-001) In Adults with Beta-Thalassemia. Presented at the 19thCongress of the European Hematology Association, June 12-15, 2015, Milan, Italy. Abstract No. S622 "

location_country:
Italy
Greece
United Kingdom
France

location_facility: Universita degli Studi di Cagliari - ASL8

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico


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.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
ResMed
ResMed Foundation
Adep Assistance

location_facility: Clinique de réadaptation cardiaque Cardiocéan

location_facility: Hôpital Intercommunal Sud Léman Valserine

location_facility: Centre de réadaptation cardiaque Leopold Bellan


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®);

lead_sponsor: AstraZeneca


lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

ReferenceCitation: Auperin A, Le Pechoux 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.

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

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


title: Evaluation of the Effect of Probiotic Lactobacillus Paracasei Lp-33 for the Management of Rhinitis in People Sensitized to Allergens. A Double Blind Randomized Parallel Placebo Controlled Study. (GA2LEN STUDY) BIONATLANTA Project

acronym: BionAtlanta

summary: The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.

primary_purpose: Supportive Care

lead_sponsor: Merck Medication Familiale

sponsor_collaborators:
Merck Medication Familiale
Chr Hansen

location_facility:
Alain GIACOMINO
Claude BRUNAUD
Marc BUR
Sonia COURTOIS
Jean Roch ALEA
Jean-Yves DOERR
Jean Baptiste THIBERT
Luc ECHINARD
Pascal MABIRE
Maurice GAY
Jean-Louis WURTZ
Monique LESCOUTE
Natacha HEITZ
Catherine MERCEY
Chantal MARTIN
Philippe CAYRON
Frédéric RENOU
Alain GUERRI
Sabine GRUTTER
Olivier BISCH
Philippe GRUJARD
Gérard BOURREL
Nicole FERRIER
Florian KOMAC
Alain LION
Gérard DUGNY
Eric LIOTARD
Stéphane BOURGHOL
COSTA
Alain FAUDIN
Claude BERNAT
Maxime BOUMANDIL
Laurent TENNEZE
Sophie ROSENBERG
Sylvie OLLIVIER
Nathan ABENHAIM
Christian DAUGENET
Hélène STURCHLER
Sylvie CHABROL-RIVIERE
Jean DEFLAUX
Nasser GOUCHENE
Patrick DUTILLEUL
MONGIN
Raymond ATTUIL
Bruno DAUBIN
Guy BIRRY
Yves MERCEY
Philippe MARMOR
Cécile BELIN-SAUGET
Léa ABOAF
Dominique EDET
Jean-Philippe RICHTER
Jacques GRAVES
Jean François GUILLEM
Corinne SION
Laurence DAGES
Olivier CHAIX
Georgios MARKIDIS
Claire PFRUNNER-SCHNEIDER
Bernard GABBAI
Joël ETIENNEZ
Emmanuel DEJOUX
Raymond WESTERFELD
François LE HINGRAT
Jacques RAMBAUD
Yves-Olivier SCHLECHT
Hervé MOREL
Gabriel VENTURINI
Robert COMBET
Thierry STEFANAGGI
Patrick OLOMBEL
Georges BINET
Bernard CLARY
Philippe IMBERT
François BAYLE
Claire ROLLAND-JACQUEMIN
Bernadette CHAUFFAILLE
Marie Pascale DEMOLY
Gérard TELLIER
Baudoin PINSON
Gregoire MARTOCQ
Marc GARCIA
Daniel FERET
Bernard PRIJAC
Marie Christine BONS-GALLET
Chantal MALZAC
Gladys HAVARD
Dominique GENOUD
Béatrice LOGNOS-FOLCO
Charles LOUSQUI
Sébastien CONVENT
Roland BENEDIC
Judah TOLEDANO
Patrick KORMANN
Serge ELIE
Christian GIRARD
Reinhard RENNER
Christian FLAISSIER
Catherine AYRAL
Irène LAFONT
Thierry AUTARD
Paul REGNIER-VIGOUROUX
Jean-Baptiste DE LEMOS
Philippe HEUZE
Jean Pierre CANO
Michel CHASSAGNE
Michel AMOUYAL
Thierry CANALI
Nicolas BRETON
Philippe PIAT
Catherine BRUNET-CAZOT
Olivier BAISSAS
Gil MEYRAND
Dominique BLOT
Jean Pascal SASTOURNE
Patrick VOGT
Martine FERRE
Victor BASTIDE
Patrick VERDAVOINE
Philippe BOISSON
Geneviève DURANT
Didier CADINOT
Véronique PEREZ
Marcel RUETSCH
Hervé VILAREM

intervention_type: Dietary Supplement


title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection

summary: The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

lead_sponsor: Tibotec BVBA

location_country:
United Kingdom
Sweden
France


acronym: ReChiVe

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

location_facility: APHM - Marseille - Hôpital de la Conception

location_facility: INSTITUT CLAUDIUS REGAUD - CRLC Toulouse

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


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

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Institut Paoli-Calmette, Département d'hématologie


title: Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

acronym: GENOMGUS

summary: The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Intergroupe Francophone du Myelome

location_facility: Service d'Hématologie - Hôpital de Brabois

location_facility: Service de Médecine interne - Centre Hospitalier

location_facility: Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie

intervention_type: Genetic


title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

summary:
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

lead_sponsor: Eli Lilly and Company

location_country: Germany Spain France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

summary: The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Sweden
Netherlands
Switzerland
Spain
South Africa
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.


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


title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

lead_sponsor: UNICANCER

location_country: Italy Switzerland France

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Istituto Nazionale Di Riposo e Cura per Anziani


title: A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination With Induction Chemotherapy, or Azacitidine and Idarubicin as Salvage Therapy and Idarubicin With Cytarabine or Azacitidine as Maintenance Therapy in Older Patients With Acute Myeloblastic Leukemia (AML)

summary:
A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML).

To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

status: Withdrawn

lead_sponsor: Acute Leukemia French Association

sponsor_collaborators:
Acute Leukemia French Association
Assistance Publique - Hôpitaux de Paris

location_facility:
Ch Dunkerque
Ch Rene Dubos
Chu Boulogne Sur Mer
Centre Antoine Lacassagne
CHU
Hopital Saint-Louis
CH
Hopital Pitie-Salpetriere
Chu Amiens Sud
Ch Sud Francilien
St Antoine Hospital
IGR
Hopital Avicenne
Hopital Henri Mondor
Hopital Edouard Herriot
Hopital Percy
CNLCC
Necker Hospital


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"

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
Roche Pharma AG

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


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


lead_sponsor: University Hospital, Lille

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.

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, Brechignac 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 Myelome. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myelome 2009-02. Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
University Hospital, Lille
Celgene Corporation

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

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

location_facility: Maladies du Sang, CHU - Hôpital St Antoine

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

location_facility: Service Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Onco-Hématologie, CHRU- Hôpital Bretonneau

location_facility: Service d'Hématologie, Centre Hospitalier Lyon Sud

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


title: Multicentre Randomized Double-blind Placebo-controlled Study to Evaluate the Effect on Albuminuria of 6 Months Treatment With Hydroxycarbamide (Siklos®) or a Placebo in Adults With Sickle Cell Disease:

acronym: SIKAMIC

summary: The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.

lead_sponsor: ADDMEDICA SASA

location_country:
Guadeloupe
Côte D'Ivoire
Mali
Senegal
Martinique
France

location_facility: Service de biothérapie, consultation hématologie-drépanocytose hôpital Necker

location_facility: Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD)

location_facility: Service d'Hématologie Clinique, Centre National de Transfusion sanguine, Université Cheikh Anta Diop

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)


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, Traulle C, Vilque JP, Petillon 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. No abstract available.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: Centre Hospitalier de la Région d'Annecy


acronym: ALIAS

lead_sponsor: Novartis

summary: This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

oa_host_type: repository

unpaywall_oa_status: green

location_facility:
Novartis Investigative Site
Novartis Investigator Site
Investigative Site

title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients