summary:
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.

Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.

Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.

ReferenceCitation: Millot F, Guilhot J, Baruchel A, Petit A, Bertrand Y, Mazingue F, Lutz P, Vérité C, Berthou C, Galambrun C, Sirvent N, Yakouben K, Schmitt C, Gandemer V, Reguerre Y, Couillault G, Mechinaud F, Cayuela JM. Impact of early molecular response in children with chronic myeloid leukemia treated in the French Glivec phase 4 study. Blood. 2014 Oct 9;124(15):2408-10. doi: 10.1182/blood-2014-05-578567. Epub 2014 Aug 28.

ReferenceCitation: Millot F, Baruchel A, Guilhot J, Petit A, Leblanc T, Bertrand Y, Mazingue F, Lutz P, Vérité C, Berthou C, Galambrun C, Bernard F, Yacouben K, Bordigoni P, Edan C, Reguerre Y, Couillault G, Méchinaud F, Cayuela JM, Guilhot F. Imatinib is effective in children with previously untreated chronic myelogenous leukemia in early chronic phase: results of the French national phase IV trial. J Clin Oncol. 2011 Jul 10;29(20):2827-32. doi: 10.1200/JCO.2010.32.7114. Epub 2011 Jun 13.

lead_sponsor: Poitiers University Hospital

location_facility:
Hôpital de Brabois - CHU de Nancy
CHU Amiens
Hôpital La Timone - CHU de Marseille


title: Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

summary: The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Nantes University Hospital

location_facility:
Institut Paoli Calmettes
CHU de Bordeaux
CHU de Nantes

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Interest of the Combination of the DaTSCAN Scintigraphy and MRI Scan in the Differential Diagnosis of Lewy Body Dementia From Alzheimer Disease in Patients With Hallucinations

acronym: DatScan

summary: The aim of this study is to improve the diagnostic of Lewy body dementia by combining the scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Limoges

location_facility: Département de Gérontologie - Chu Limoges

location_facility: Pôle de psychiatrie du sujet âgé - CH Esquirol

intervention_type: Procedure


title: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

acronym: MAUV

summary:
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.

To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.

To evaluate rate of amputations and recurrence at one year after complete cicatrisation

status: Terminated

study_completion_date_type: Anticipated

location_facility: Service de Chirurgie Thoracique, cardiovasculaire et angiologie

location_facility: Service de Médecine Interne et Pathologie Vasculaire

location_facility: Service de Chirurgie Vasculaire et Viscérale

status_simplified: Unknown


title: Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls

acronym: SUIVIREIN

summary:
Purpose of the study:

To evaluate the effect of prematurity on renal function in 5 years old children
To compare former premature children treated by ibuprofen in the neonatal period to controls

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Vieux R, Hascoët JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.

lead_sponsor: Jean Michel Hascoet

location_facility:
CHU
Maternite Regionale Universitaire
AP-HM (Néonatologie)

lead_sponsor_type: industriel


title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

acronym: ARABUL

summary:
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.

In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.

This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.

status: Unknown status

enrollment_type: Anticipated

location_facility:
Bordeaux University Hospital
Limoges University Hospital
Toulouse University Hospital


title: A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.

summary: This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius REGAUD
Institut Curie
Centre René GAUDUCHEAU


title: Af Ablation In Brady-Tachy Syndrome

acronym: Alternative

summary:
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.

The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

design_allocation: Randomized

lead_sponsor: Abbott Medical Devices

location_facility:
Hôpital St joseph
Clinique Pasteur
CHU


title: Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

acronym: PHYTOPLAQUES

summary: The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.

lead_sponsor: French Cardiology Society

location_facility: Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department

location_facility: Hôpital cardio-vasculaire et pneumologique Louis Pradel

intervention_type: Dietary Supplement


title: Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone

acronym: FIBROMAF

summary:
Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy.

Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
AP-HP Hôpital Cochin
Hôpital Claude Huriez
AP-HP Hôpital Antoine Beclere


title: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

acronym: AngioPred

summary: Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients

summary: This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.

lead_sponsor: Novartis


title: Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study

acronym: ICAR

summary: For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.

lead_sponsor: Rennes University Hospital

location_facility: Service de Chirugie Viscérale - Hôpital de Pontchaillou

location_facility: Département d'Oncologie Médicale - CRLCC Eugène Marquis

location_facility: Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes

intervention_type: Other


title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

summary: Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

lead_sponsor: Nestlé

location_facility:
Hôpital Georges Clemenceau
Hopital Emile Roux
Hopital Charles RICHET


title: An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia

summary: The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 1
Site 3
Site 2


title: Prognostic Value of Cardiac and Renal Markers in the Acute Phase of Ischemic Stroke or Transient Ischemic Attack :Albuminuria-Brain Natriuretic Peptide-Cystatine C in Stroke

acronym: ABC-AVC

summary: Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.

study_start_date_type: Actual

lead_sponsor: University Hospital, Tours

location_facility: Service de neurologie / CHU Pontchaillou


title: IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients

summary:
Medical errors that affect patient safety have generated huge concern since the publication of "To Err Is Human" 6 years ago [1]. Given the complexity of management in the intensive care unit (ICU) and the nature of human activities, critically ill patients are exposed to adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs and medical errors in ICUs [2-6], one of their main goals being to identify strategies for preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an indicator for the risk of medical error is challenging. In 2005, our group conducted a systematic literature review and presented the results to 30 national experts with clinical backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique, these experts selected 14 AEs that had the following characteristics: high frequency, easy and reproducible definition, association with morbidity and mortality, and ease of reporting without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref abstract). Preliminary evaluation of the results allowed us to choose the following AEs for the current Iatroref III study: error in insulin administration, error in anticoagulant administration, error in anticoagulant prescription, unplanned extubation, and unplanned removal of central venous catheter. Evidence suggests that guidelines alone without reinforcing strategies may be insufficient to change provider behavior and that the most effective interventions may be multifaceted rather than single-component strategies ([7]). This study will test a composite intervention program. The objectives of the study are to determine whether the introduction of a composite intervention program decreases the predefined AEs.

Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.

ReferenceCitation: Garrouste-Orgeas M, Soufir L, Tabah A, Schwebel C, Vesin A, Adrie C, Thuong M, Timsit JF; Outcomerea Study Group. A multifaceted program for improving quality of care in intensive care units: IATROREF study. Crit Care Med. 2012 Feb;40(2):468-76. doi: 10.1097/CCM.0b013e318232d94d.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Medical and surgical Intensive Care unit


title: Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

acronym: TEPARF

summary:
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the patient's response to treatment.

PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in evaluating response to treatment in patients undergoing radiofrequency ablation for lung metastases.

ReferenceCitation: Bonichon F, Palussière J, Godbert Y, Pulido M, Descat E, Devillers A, Meunier C, Leboulleux S, de Baère T, Galy-Lacour C, Lagoarde-Segot L, Cazeau AL. Diagnostic accuracy of 18F-FDG PET/CT for assessing response to radiofrequency ablation treatment in lung metastases: a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1817-27. doi: 10.1007/s00259-013-2521-9. Epub 2013 Sep 17.

lead_sponsor: Institut Bergonié

location_facility:
Centre Hospitalier de la Cote Basque
Institut Bergonie
Hopital Haut Leveque


title: IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel

summary: Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this 4-week cycle, for 6 courses.

ReferenceCitation: Brignone C, Gutierrez M, Mefti F, Brain E, Jarcau R, Cvitkovic F, Bousetta N, Medioni J, Gligorov J, Grygar C, Marcu M, Triebel F. First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity. J Transl Med. 2010 Jul 23;8:71. doi: 10.1186/1479-5876-8-71.

lead_sponsor: Immutep S.A.S.

location_facility:
Hôpital Tenon
Centre René Huguenin
Hôpital Européen Georges Pompidou

intervention_type: Biological


title: Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma

summary:
In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of 10 patients with MM who have inclusion criteria use the extended 2nd line indication, either intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule of administration of bortezomib will be the following : 1.3 mg per square meter of body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to eight cycles, either IV (group 1) or SC (group 2).

The primary objective is to characterize the pharmacokinetics of the 2 routes of administration.

The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of administration.

ReferenceCitation: Moreau P, Coiteux V, Hulin C, Leleu X, van de Velde H, Acharya M, Harousseau JL. Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. Haematologica. 2008 Dec;93(12):1908-11. doi: 10.3324/haematol.13285. Epub 2008 Sep 2.

location_facility:
Lille UH
Nancy UH
Nantes UH


title: Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab

summary: Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

ReferenceCitation: Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10.

lead_sponsor: French Innovative Leukemia Organisation

location_facility:
Regional university hospital
REgional Hospital


title: Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.

summary: The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.

primary_purpose: Prevention

location_facility:
Institut Claudius Regaud
Centre Oscar Lambret
Centre Paul STRAUSS

intervention_type: Behavioral


title: An Open Label Parallel Group Study To Investigate The Pharmacokinetics Of Intravenous Linezolid, An Oxazolidinone, Administered To Healthy Volunteers And Patients With Major Thermal Injuries

summary: Evaluation of linezolid pk profile in burns patients

lead_sponsor: Pfizer


title: Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)

acronym: LAM-RAPA

summary: These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.

ReferenceType: background

ReferenceCitation: Récher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. Epub 2004 Nov 18.

lead_sponsor: University Hospital, Toulouse

location_facility: Service d'Hématologie, Hôpital Jean Minjoz


title: Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

summary: The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

ReferenceCitation: Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. Review.

ReferenceCitation: Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital


title: Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor

summary: The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen

location_facility:
Institut Claudius Regaud
Institut Bergonie
Institut Val d'Aurelle_ Paul Lamarque


title: Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer

summary:
In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation.

Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by radiotherapy only, or by both at the same time. At advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA, treatment relies on radio-chemotherapy, either alone or pre-surgery.

The pre-therapeutic complete examination of the cervical cancer includes a clinical examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to precise the volume and the spreading of the tumour in the pelvic area.

A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a specificity for the detection of such lymph node metastasis with a sensitivity varying from 24 to 75 % and a specificity between 84 and 100 % according to the studies.

As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized so far are performed, usually, on a small number of subjects and with heterogeneous populations. However, it seems that such an examination enables a better detection of lymph nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies, sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.

We propose a prospective, multicentric and multidisciplinary study for the estimation of diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer, in comparison with the MRI. This study should enable to include 380 patients within 3 years. An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A comparison between the sensitivity and the specificity of both examinations will be established and a correlation with the histology of the lymph node dissection will be made.

ReferenceCitation: Monteil J, Maubon A, Leobon S, Roux S, Marin B, Renaudie J, Genet D, Fermeaux V, Aubard Y, Tubiana-Mathieu N. Lymph node assessment with (18)F-FDG-PET and MRI in uterine cervical cancer. Anticancer Res. 2011 Nov;31(11):3865-71.

lead_sponsor: University Hospital, Limoges

location_facility:
Médecine Nucléaire
Oncologie Médicale
Gynécologie Obstétrique


title: Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squamous Cell Carcinoma - A Randomised Phase II Study

summary: Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

ReferenceCitation: Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. doi: 10.1200/JCO.2012.42.3988. Epub 2013 Jan 22. Erratum in: J Clin Oncol. 2013 May 1;31(13):1702.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre Oscar Lambret
Centre René Gauducheau
CHU de Tours


title: A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma

summary: Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Centre Jean Perrin
Centre Alexis Vautrin
Institut Gustave Roussy


title: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

summary: Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

ReferenceCitation: Tunkel AR, Hartman BJ, Kaplan SL, Kaufman BA, Roos KL, Scheld WM, Whitley RJ. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004 Nov 1;39(9):1267-84. Epub 2004 Oct 6.

ReferenceCitation: de Gans J, van de Beek D; European Dexamethasone in Adulthood Bacterial Meningitis Study Investigators. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002 Nov 14;347(20):1549-56.

ReferenceCitation: Auburtin M, Porcher R, Bruneel F, Scanvic A, Trouillet JL, Bédos JP, Régnier B, Wolff M. Pneumococcal meningitis in the intensive care unit: prognostic factors of clinical outcome in a series of 80 cases. Am J Respir Crit Care Med. 2002 Mar 1;165(5):713-7.

ReferenceCitation: Viladrich PF, Gudiol F, Liñares J, Pallarés R, Sabaté I, Rufí G, Ariza J. Evaluation of vancomycin for therapy of adult pneumococcal meningitis. Antimicrob Agents Chemother. 1991 Dec;35(12):2467-72.

ReferenceCitation: Ricard JD, Wolff M, Lacherade JC, Mourvillier B, Hidri N, Barnaud G, Chevrel G, Bouadma L, Dreyfuss D. Levels of vancomycin in cerebrospinal fluid of adult patients receiving adjunctive corticosteroids to treat pneumococcal meningitis: a prospective multicenter observational study. Clin Infect Dis. 2007 Jan 15;44(2):250-5. Epub 2006 Dec 15.

location_facility: Service de Réanimation Médicale, CHU Bichat

location_facility: Service de Réanimation Médicale, CHU Louis Mourier

location_facility: Service de Réanimation Médicale, CHI Poissy-St-Germain


summary: Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

lead_sponsor: University Hospital, Angers

location_facility: Neurosurgical intensive care. CHU Le Kremlin Bicêtre

location_facility: Neurosurgical intensive care. CHU de Nancy


title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

summary: Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

ReferenceCitation: Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. Epub 2012 Mar 23.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Hôpital Necker service des Maladies Infectieuses

location_facility: Service de Rhumatologie hopital Pitie-Salpetriere

location_facility: Service de Medecine Interne hopital Avicenne


title: Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

ReferenceType: result

ReferenceCitation: Ducreux M, Ychou M, Laplanche A, Gamelin E, Lasser P, Husseini F, Quenet F, Viret F, Jacob JH, Boige V, Elias D, Delperro JR, Luboinski M; gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. Hepatic arterial oxaliplatin infusion plus intravenous chemotherapy in colorectal cancer with inoperable hepatic metastases: a trial of the gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol. 2005 Aug 1;23(22):4881-7. Epub 2005 Jul 11.

lead_sponsor: UNICANCER

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

acronym: Cough-IPF

summary: In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of life.

lead_sponsor: Erasmus Medical Center

location_country: Netherlands France Italy

location_facility: Erasmus MC Rotterdam, Dep. of Pulmonology

location_facility: University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel

location_facility: Regional Centre for Rare Lung Disease University of Catania.


type: EudraCT Number

title: Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

acronym: TRANSREG

summary: TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

ReferenceCitation: Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Rhumatologie - Hôpital PITIE SALPETRIERE

location_facility: Service de Gastro Entérologie - Hôpital SAINT-ANTOINE

location_facility: Service de Dermatologie - Hôpital COCHIN

location_facility: Médecine interne - Hôpital Saint-Antoine

location_facility: Service de Rhumatologie - Hôpital SAINT-ANTOINE

location_facility: Service de Médecine Interne - Hôpital PITIE SALPETRIERE

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE


title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.

acronym: BAXASSO

summary:
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.

The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

primary_purpose: Other

lead_sponsor: CMC Ambroise Paré

location_facility:
CMC Ambroise Paré
Clinique du Pré
Hôpital Privé Armand Brillard
Clinique Jouvenet
Hôpital Privé Paul D'Egine
Clinique Bizet
Clinique Rémusat


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy

summary: To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

ReferenceCitation: Dougados M, Combe B, Braun J, Landewé R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Germany France Netherlands


title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

summary:
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase

ReferenceCitation: Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85.

ReferenceCitation: Di Mario C, Dudek D, Piscione F, Mielecki W, Savonitto S, Murena E, Dimopoulos K, Manari A, Gaspardone A, Ochala A, Zmudka K, Bolognese L, Steg PG, Flather M; CARESS-in-AMI (Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction) Investigators. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008 Feb 16;371(9612):559-68. doi: 10.1016/S0140-6736(08)60268-8.

lead_sponsor: Società Italiana di Cardiologia Invasiva

location_country: Poland France Italy

location_facility: Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej

location_facility: First Dept. Cardiology - Gornoslaskiego Centrum Medycznego

location_facility: Oddzial Kardiologii - Szpital Powiatowy w Zakopane

location_facility: Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2

location_facility: Fondazione Centro San Raffaele del Monte Tabor IRCCS

location_facility: Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu

location_facility: Oddzial Wewnetrzny - Szpital Mijski w Krynicy

location_facility: Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika

location_facility: Nuovo Ospedale S. Agostino Estense - Baggiovara

location_facility: II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie

location_facility: Zaklad Hemodynamiki i Angiokardiografii Pracownia 1

location_facility: Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej

location_facility: Service de Cardiologie - Hopital St. Joseph

location_facility: Oddzial Kardiologii - Szpital Miejski w Tychach

location_facility: Szpital Powiatowy im. Jana Pawla II w Wadowicach

location_facility: Oddzial Wewneztrnj Okregowy Szpital Kolciowy

intervention_type: Device


acronym: SMILE

title: A Two-arm, Phase 2/3 Multicentre, Open-label, Randomised Study Evaluating Safety and Antiviral Effect of Current Standard Antiretroviral Therapy Compared to Once Daily Integrase Inhibitor Administered With Darunavir/Ritonavir (DRV/r) in HIV-1 Infected, Virologically Suppressed Paediatric Participants.

lead_sponsor: PENTA Foundation

type: Other Identifier

source: euctr

location_country:
Portugal
Spain
United Kingdom
Argentina
Thailand
Switzerland
Uganda
Ukraine
France
South Africa
Mexico

location_facility: Evelina Children Hospital, St Thomas's Hospital

summary: A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.


title: Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

acronym: NiloPost-STIM

summary:
Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain.

In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib.

Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM.

The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B

location_facility: CHU de Nice, Service Hématologie Clinique

location_facility: Hôpital Haut Lévêque, Service Hématologie

location_facility: Centre Hospitalier Lyon Sud, Service Hématologie


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

acronym: SURMOUNT-MMO

summary: This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

status: Recruiting

ipd_sharing: Yes

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.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University

location_facility: Tianjin Medical University General Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro de Investigaciones Clínicas Baigorria

location_facility: Brigham and Women's Hospital Diabetes Program

location_facility: Private Practice - Dr. Mercea Corina Delia

location_facility: Northeast Research Institute - St. Augustine

location_facility: Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: B_serwis Popenda Spolka Jawna Specjalistyczna Przychodnia Lekarska

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Centro Privado de Medicina Familiar / Mindout Research

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Kardiologicka ambulance MUDr. Ferkl s.r.o.

location_facility: Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

location_facility: Universität zu Lübeck - Institut für Endokrinologie und Diabetes

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: BR Trials - Ensaios Clinicos e Consultoria

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: General Practitioners Research Institute (GPRI)

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad

location_facility: Unidad de Investigación Clínica y Atención Médica HEPA

location_facility: Hebei Medical University - Harrison International Peace Hospital

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Neighborhood Healthcare Institute of Health

location_facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

location_facility: Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute

location_facility: Instituto de Pesquisa clinica de Campinas

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Seoul National University Bundang Hospital

location_facility: Encore Medical Research of Boynton Beach

location_facility: Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen

location_facility: Cardiology Consultants of Philadelphia Yardley

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Centro de Investigaciones Médicas Mar del Plata

location_facility: NSHA-QEII Health Sciences Centre-Dickson Bldg

location_facility: The People's Hospital of Liaoning Province

location_facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas

location_facility: Centro de Investigación Cardiometabólica de Aguascalientes

location_facility: Consultorio de Medicina Especilizada del Sector Privado

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: MICA - Medicina e Investigación Cardiometabólica

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre

location_facility: IBPClin - Instituto Brasil de Pesquisa Clínica

location_facility: CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C

location_facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

location_facility: Centro Periférico de Especialidades Bola Azul

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

location_facility: Complejo Asistencial Universitario de León - Hospital de León

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu

location_facility: Center for Advanced Research & Education

location_facility: Private Practice - Dr. Cristian Podoleanu

location_facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

location_facility: Centro de Salud e Investigaciones Médicas

location_facility: Centro Medico Privado San Vicente Diabetes

location_facility: SKY Clinical Research Network Group-Blake

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: SKY Clinical Research Network Group - Hall

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

location_facility: Private Practice - Dr. Francisco Gerardo Padilla

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: KLR Business Group, Inc. dba Arkansas Clinical Research

location_facility: The Second Affiliated Hospital of Zhengzhou University

location_facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

location_facility: Centro de Investigacion Cardiovascular y Metabólica

location_facility: Northeast Research Institute - Downtown Office

location_facility: University of California Irvine Medical Center

location_facility: Baker IDI Heart and Diabetes Institute - Melbourne

location_facility: American Health Network of Indiana, LLC - Avon

location_facility: Franciscus Gasthuis & Vlietland, Locatie Gasthuis

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: South Florida Clinical Research Institute

location_facility: Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

location_facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Wickersley Health Centre - Clifton Medical Centre

location_facility: Southern Adelaide Diabetes & Endocrine Services

location_facility: Florida Institute For Clinical Research, LLC

location_facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

location_facility: John Muir Physician Network Research Center

location_facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Grant Govt. Medical College null J. J. Group of Hospitals

location_facility: Centro de Investigaciones Medicas Temperley

location_facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

location_facility: Centro De Diabetes Metabolismo E Endocrinologia

location_facility: Third People's Hospital of Hainan Province

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Kingsway Hospitals (Best Multispeciality Hospital in Nagpur)

location_facility: University Hospital Coventry & Warwickshire

location_facility: Reinier de Graaf Ziekenhuis, locatie Delft

location_facility: Cardiology Associates of Fairfield County, P.C.

location_facility: American Health Network of Indiana, LLC - Greenfield

location_facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

location_facility: Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

location_facility: Yonsei University-Wonju Severance Christian Hospital

location_facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul

location_facility: Thomas Jefferson University - Clinical Research Institute

location_facility: Azienda Ospedaliero Universitaria S.Anna

location_facility: Kidney & Hypertension Center - Apple Valley

location_facility: Centre de Medecine Metabolique de Lanaudiere (CMML)

location_facility: Paratus Clinical Research Western Sydney

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: Balanced Life Health Care Solutions/SKYCRNG

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: The First People's Hospital of Yunnan Province

location_facility: Penn Medicine: University of Pennsylvania Health System

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: St. Vincent Hospital d/b/a Prevea Health

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Central de Asturias

location_facility: Sisli Etfal Training and Research Hospital

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: The National Diabetes & Obesity Research Institute

location_facility: Diabetes and Thyroid Center of Ft. Worth

location_facility: CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani

location_facility: Aydın Adnan Menderes Universitesi Hastanesi

location_facility: Centro de Investigación y Gastroenterología

location_facility: Centro de Diagnóstico y Rehabilitación (CEDIR)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: PanAmerican Clinical Research - Querétaro - Avenida Antea

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: DaVita Clinical Research - North Houston

location_facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

location_facility: Instituto Especialidades de la Salud Rosario

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Diseno y Planeacion en Investigacion Medica

location_facility: University of Sydney - Charles Perkins Centre

location_facility: Institutul de Boli Cardiovasculare Timișoara

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Hospital Universitario Fundacion ALcorcon

location_facility: Hospital General Universitario de Valencia

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Mackay Memorial Hospital -Tamshui Branch

location_facility: SN ZOZ Lege Artis Poradnia Diabetologiczna

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Centro de Investigacion Medica de Occidente, S.C.

location_facility: Fundación Cardiovascular de Aguascalientes A.C.

location_facility: Zentrum für klinische Studien Dr Hanusch Gmbh

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

location_facility: 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: CHUAC-Complejo Hospitalario Universitario A Coruña

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: West China Hospital of Sichuan University

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

location_facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: Instituto de Investigaciones Clínicas Córdoba

location_facility: Clalit Health Services - Sakhnin Community Clinic

location_facility: Valley Institute of Research - Fort Worth

location_facility: Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair

location_facility: Instituto Veracruzano en Investigación Clínica S.C.

location_facility: Wuhan University Medical College - Hubei Zhongshan Hospital

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Consultorio de Investigación Clínica EMO SRL

location_facility: North Hills Family Medicine/North Hills Medical Research

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

status_simplified: Ongoing


title: Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay

acronym: CONVERSTIM

summary:
Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date.

The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.

However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced.

Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Hospices Civils de Lyon Hôpital Edouard Herriot

location_facility: CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie

location_facility: Hôpital Saint-Antoine Service de Psychiatrie APHP

location_facility: Hôpital La Colombière Service de Psychiatrie


title: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
India
Israel
Turkey
Mexico
Singapore
Slovakia
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: The Center for Cancer and Blood Disorders

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: Regional Cancer Care Associates - Howell

location_facility: CHU de Charleroi - Hopital Civil Marie Curie

location_facility: Guangdong Maternity and Child Health Care Hospital

location_facility: University of Massachusetts Medical School

location_facility: Dalian University - The Affiliated Zhongshan Hospital

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: Victoria Hospital & Children's Hospital - London Health Sciences Centre

location_facility: Centro de Estudios Y Prevencion Del Cancer

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: Fuzhou General hospital of Nanjing Military Command

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: The University of Kansas Cancer Center - Westwood

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Laura and Isaac Perlmutter Cancer Center

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Sunnybrook Health Sciences - Odette Cancer Centre

location_facility: Cancer Hospital Chinese Academy of Medical Science

location_facility: Seoul National University Bundang Hospital

location_facility: The First People's Hospital of Changde City

location_facility: H.R.U Málaga - Hospital Materno-infantil

location_facility: Bioclinic Thessalonikis Private Clinic Single Member S.A.

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Centro de Oncología e Investigación de Buenos Aires

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou

location_facility: Capital Health Medical Center - Hopewell

location_facility: The First Afflilated Hospital of Bengbu Medical College

location_facility: Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer

location_facility: Walter Reed National Military Medical Center

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Grand Hôpital de Charleroi - Saint-Joseph

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: KLES Dr. Prabhakar Kore Hospital & M.R.C

location_facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.

location_facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncologia para Ensaios Clínicos e Estudos

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: CIO - Centro de Inmuno-Oncología de Occidente

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Summit Cancer Care DBA Candler Medical Oncology Practice

location_facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: All India Institute of Medical Sciences - Jodhpur

location_facility: Mugla Sitki Kocman Universitesi Egitim ve Arastirma Hastanesi

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: Hospital Universitari General de Catalunya

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Thomas Jefferson University, Aria Jefferson Health

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

location_facility: The Affiliated People's Hospital of Ningbo University

location_facility: Yuncheng Central Hospital - Eastern Hospital

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Grant Medical Foundation - Ruby Hall Clinic

location_facility: Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island

location_facility: The Second People's Hospital of Neijiang

location_facility: University of California Davis (UC Davis) Comprehensive Cancer Center

location_facility: Amphia Ziekenhuis, locatie Breda Molengracht

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

location_facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

location_facility: Winship Cancer Institute, Emory University

location_facility: Reinier de Graaf Ziekenhuis, locatie Delft

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: BP - A Beneficencia Portuguesa de São Paulo

location_facility: Investigaciones Clinicas Moleculares (ICM)

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: Thomas Jefferson University - Clinical Research Institute

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Centro Oncologico Estatal ISSEMyM ( COEI )

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: Xiangya Hospital Central South University

location_facility: Ankara Gülhane Eitim ve Aratrma Hastanesi

location_facility: Onkologische Schwerpunktpraxis Heidelberg, Dr. med. Andreas Karcher, Dr. med. Daniel Debatin, Dr. med. Stefan Fuxius

location_facility: zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi

location_facility: University General Hospital of Heraklion

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: PanAmerican Clinical Research - Querétaro - Avenida Antea

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur de Montréal

location_facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center

location_facility: Chemotopia - Kumamoto Breast & Gastrointestinal Surgical Hospital

location_facility: CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Mercy Health - St. Vincent Medical Center

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Banner MD Anderson Cancer Center at McKee Medical Center

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

location_facility: Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Istanbul Okmeydani Training and Research Hospital

location_facility: USO - Arizona Oncology Associates - HOPE

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Aultman Hospital - Timken Family Cancer Center

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Institut für Versorgungsforschung Dr. Michael Maasberg, Dr. med. Maria Theresia Keller, Marion Schmitz

location_facility: Jining Medical University - Affiliated Hospital

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Sawai Man Singh Medical College Hospital (SMS Hospital)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital

location_facility: Kapiolani Medical Center for Women and Children


title: TPExtreme: Randomized, Controlled Trial of Platinum-Cetuximab Combined Either With Docetaxel (TPEx) or With 5FU (Extreme) in Patients With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

acronym: TPExtreme

summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

ReferenceCitation: Guigay J, Aupérin A, Fayette J, Saada-Bouzid E, Lafond C, Taberna M, Geoffrois L, Martin L, Capitain O, Cupissol D, Castanie H, Vansteene D, Schafhausen P, Johnson A, Even C, Sire C, Duplomb S, Evrard C, Delord JP, Laguerre B, Zanetta S, Chevassus-Clément C, Fraslin A, Louat F, Sinigaglia L, Keilholz U, Bourhis J, Mesia R; GORTEC; AIO; TTCC, and UniCancer Head and Neck groups. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2021 Apr;22(4):463-475. doi: 10.1016/S1470-2045(20)30755-5. Epub 2021 Mar 5.

location_country: Germany France Spain

location_facility: Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

location_facility: Centre Hospitalier de Bretagne Sud (CHBS)

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin


type: Other Grant/Funding Number

title: National Real-life Study of Tumor Mutational Burden Assessment in First-line Lung Cancer

acronym: MUBULUC

summary: Tumor mutational burden (TMB) seems to be is an important marker for immune checkpoint inhibitors efficacy. This study aims to assess the feasibility of the TMB assessment in first-line lung cancer in routine practice both on biopsy and surgical tumor samples. Results will be an element of discussion for the generalization of the TMB implementation in cancer centers.

ipd_sharing_description:
Individual participant data (IPD) that underlie results in publication could be shared.

IPD detailed in the protocol of a planned metaanalysis could be shared.

location_facility: AP-HP - Hôpital Européen Georges-Pompidou


type: Registry Identifier

title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

acronym: PERFUSE

summary: A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and Ulcerative Colitis (UC) [adults for both treatments and children only for Flixabi].

lead_sponsor: Biogen

location_facility:
Research Site 8
Research Site 7
Research Site 3
Research Site 6
Research Site 10
Research Site 4
Research Site 1
Research Site 5
Research Site
Research Site 2
Research Site 9


title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures

acronym: TSF

summary: A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

lead_sponsor: Kuros Biosurgery AG

location_country:
Serbia
Slovenia
Italy
Finland
Czech Republic
Switzerland
Hungary
France
Romania
Germany
Bulgaria
Slovakia

location_facility: MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)

location_facility: Spitalul Universitar de Urgenta Bucuresti (87)

location_facility: MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)

location_facility: Fovarosi Onkormanyzat Szent janos Korhaza (81)


title: Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe

acronym: ABCAL

summary:
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.

The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.

The secondary objectives are:

Rates of infectious complications according to duration of preoperative antibiotic
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections)
Comparison of germs found in the bile during the postoperative infectious complications
Duration of hospitalization
Readmission rate for surgical site infections
Rate of reoperation for surgical site infection
Overall mortality rate at 30 days
Mortality rates specific to 30 days

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ReferenceCitation: Grant MD, Jones RC, Wilson SE, Bombeck CT, Flint LM, Jonasson O, Soroff HS, Stellato TA, Dougherty SH. Single dose cephalosporin prophylaxis in high-risk patients undergoing surgical treatment of the biliary tract. Surg Gynecol Obstet. 1992 May;174(5):347-54.

ReferenceCitation: Krajden S, Yaman M, Fuksa M, Langer JC, Rowan J, Burul CJ, Wooster DL, Deitel M, Borowy ZJ, Smith LC, et al. Piperacillin versus cefazolin given perioperatively to high-risk patients who undergo open cholecystectomy: a double-blind, randomized trial. Can J Surg. 1993 Jun;36(3):245-50.

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ReferenceCitation: Thompson JE Jr, Bennion RS, Roettger R, Lally KP, Hopkins JA, Wilson SE. Cefepime for infections of the biliary tract. Surg Gynecol Obstet. 1993;177 Suppl:30-4; discussion 35-40.

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ReferenceCitation: Cox MR, Wilson TG, Luck AJ, Jeans PL, Padbury RT, Toouli J. Laparoscopic cholecystectomy for acute inflammation of the gallbladder. Ann Surg. 1993 Nov;218(5):630-4.

ReferenceCitation: Eldar S, Sabo E, Nash E, Abrahamson J, Matter I. Laparoscopic cholecystectomy for the various types of gallbladder inflammation: a prospective trial. Surg Laparosc Endosc. 1998 Jun;8(3):200-7.

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ReferenceCitation: Gagic N, Frey CF, Gaines R. Acute cholecystitis. Surg Gynecol Obstet. 1975 Jun;140(6):868-74.

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lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Chirurgie viscérale et urologique Centre Hospitalier

location_facility: Service de Chirurgie Viscérale et Digestive

location_facility: Service de Chirurgie Digetsive Centre Hopsitalier Universitaire

location_facility: Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire

location_facility: Service de Chirurgie Digestive et Viscérale

location_facility: Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire

location_facility: Centre Hospitalier de Saint-Germain en Laye

location_facility: Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire


title: PROgression of FIbromuscular LEsions

acronym: PROFILE

summary: PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.

location_country: France Belgium

location_facility: Centre Hospitalier de Versailles hopital Andre Mignot

location_facility: CHU de Grenoble hopital Albert-Michallon

location_facility: CHU de Clermont-Ferrand hopital Gabriel-Montpied