title: Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

ReferenceCitation: Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.

ReferenceCitation: Herling CD, Cymbalista F, Groß-Ophoff-Müller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Leprêtre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Döhner H, Leblond V, Kneba M, Letestu R, Böttcher S, Stilgenbauer S, Hallek M, Levy V. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020 Aug;34(8):2038-2050. doi: 10.1038/s41375-020-0747-7. Epub 2020 Feb 18.

lead_sponsor: German CLL Study Group

location_country: Austria Germany France

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Klinikum Schwaebisch Gmuend Stauferklinik

location_facility: Krankenhaus Siloah - Medizinische Klinik II

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

location_facility: Internistische Gemeinschaftspraxis - Friedberg

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Internistische Gemeinschaftspraxis - Halle

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Universitaetsklinik fuer Innere Medizin I

location_facility: Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

location_facility: Burkhard and Reimann Gemeinschaftspraxis

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

location_facility: Internistische Gemeinschaftspraxis - Forchheim

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Haematologische Praxis - Moenchengladbach

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Praxis fuer Innere Medizin Haematologie und Internistische Onkologie

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen


type: Other Identifier

type: EudraCT Number

title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

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

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Fizazi K, Pagliaro L, Laplanche A, Fléchon A, Mardiak J, Geoffrois L, Kerbrat P, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Malhaire JP, Linassier C, Habibian M, Martin AL, Journeau F, Reckova M, Logothetis C, Culine S. Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial. Lancet Oncol. 2014 Dec;15(13):1442-1450. doi: 10.1016/S1470-2045(14)70490-5. Epub 2014 Nov 13.

ipd_sharing: No

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

lead_sponsor: UNICANCER

location_country:
United States
Slovakia
France

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

location_facility: M. D. Anderson Cancer Center at University of Texas

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence

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

PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.

status: Terminated

study_completion_date_type: Actual

location_country: France Belgium

location_facility: Centre Hospitalier Universitaire de Dijon

intervention_type: Procedure

status_simplified: Unknown


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.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: ADDMEDICA SASA

location_country:
Guadeloupe
Martinique
Côte D'Ivoire
France
Mali
Senegal

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

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

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

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

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Drug


title: Validation of a Predictive Risk Equation for Type 2 Diabetes in Children With Diabetes to Achieve a Predictive Diagnostic Biochip for the Early Detection of Individuals at Risk in Families.

acronym: DESCENDANCE

summary:
Considering its epidemic-like development worldwide, associated with modifications in lifestyle, as well as its enormous social and economic weight, the prevention of type II diabetes is certain to be a central concern of health systems within the developed countries in the decades to come. However, while simple obesity concerns the entire population, type 2 diabetes affects only one sub-population at high genetic risk. To be effective and realistic in economic terms, efforts at prevention must be thus targeted towards these subjects at high risk. The key issue involves identifying such subjects early enough so that a strategy of effective prevention can be organized in good time.

Until now, efforts have been concentrated on individuals at risk for diabetes readily identifiable within the general population, typically subjects in the second half of adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive lifestyle and dietary measures are proposed but are constrictive and difficult to maintain over time, and the results, although they may be significant, remain disappointing, with mere postponement of an outcome which at this stage appears inevitable. The reason is ascribable to excessively tardy intervention, when the pathogenic process has already been ongoing for some ten years and the endocrine function of the pancreas is probably already irreparably impaired.

The alternative thus is earlier intervention, in childhood, adolescence or early adulthood. The problem is to identify individuals at high risk of becoming diabetic at a time when they are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The familial character of type 2 diabetes is now well established, and future diabetic subjects are themselves above all the children of diabetic subjects. However, the prevalence of the disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive tools are needed to combat diabetes in these high-risk families.

We propose to create a risk equation using an algorithm to reliably predict children most likely to develop diabetes later in life.

The algorithm will include 3 classes of data:

The genotype stemming from the genetic characterization of individuals and those their parents;
Environmental data concerning childhood, especially eating habits and physical activity;
Data of the mother who was eventually diabetic during pregnancy.

From a methodological standpoint, it would be rather difficult to take blood samples from children and wait some 50 years to determine whether or not they develop diabetes. To circumvent this difficulty, we will recruit subjects in families with a history of type II diabetes:

Parents alive, including at least one type 2 diabetic subject
Adult children (aged over 35 years), some of whom are already presenting type II diabetes, and healthy brothers and sisters, who form the control population. Test will be done to determine whether healthy subjects are really safe from the risk of diabetes (HbA1c measurement and glucose load test).

The Descendence study will include 500 families at risk involving about 3000 subjects (1000 subjects with diabetes and 2000 healthy subjects). It is expected to answer the following question: for a child born in such families at risk, what is the probability of developing diabetes later in life, so that early preventive action may be taken

status: Completed

design_allocation: Non-Randomized

primary_purpose: Prevention

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

location_facility:
CHU de Caen
Centre Hospitalier Strasbourg
CHU Jean Minjoz
CHU de Nantes
CHU Bichat
CHU Marseille Hôpitaux Sud
CHU Avicenne
CHU de Bicetre
CHU Sart Tilman Liège
CH Sud Francilien
CHU de Nancy
CHU Toulouse
University Hospital Grenoble
CHU de REIMS
CHRU Lille
CHU de Bondy
CHU de BREST

intervention_type: Other

status_simplified: Completed


type: Registry Identifier

title: A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF

acronym: SAA-G-CSF

summary: The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

ReferenceCitation: Tichelli A, de Latour RP, Passweg J, Knol-Bout C, Socié G, Marsh J, Schrezenmeier H, Höchsmann B, Bacigalupo A, Samarasinghe S, Rovó A, Kulasekararaj A, Röth A, Eikema DJ, Bosman P, Bader P, Risitano A, Dufour C; SAA Working Party of the EBMT. Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation. Haematologica. 2020 May;105(5):1223-1231. doi: 10.3324/haematol.2019.222562. Epub 2019 Oct 3.

ReferenceCitation: Tichelli A, Schrezenmeier H, Socié G, Marsh J, Bacigalupo A, Dührsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Höchsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
United Kingdom
Italy
Greece
Netherlands
Czech Republic
Switzerland
Sweden
France
Germany

location_facility: St George's Hospital/ St George's University of London


title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

acronym: AMBLED

summary: This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

lead_sponsor: Prexton Therapeutics

location_country:
Spain
Italy
Austria
United Kingdom
France
Germany

location_facility: Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Hospital Universitari General de Catalunya

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum

location_facility: Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica

location_facility: CHU Grenoble - Pôle Psychiatrie et Neurologie

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: University Hospital Erlangen - Abteilung fur Molekulare Neurologie

location_facility: Clinical Ageing Research Unit, Campus for Ageing and Vitality

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: IRCCS Fondazione Ospedale San Camillo (SC)

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Hospital Universitari i Politècnic La Fe


title: Phase I-II Study of Association of Deferasirox, Vitamin D and Azacytidine as Treatment of High Risk MDS (IPSS Int-2 and High)

acronym: GFM-EXVD-AZA

summary:
Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine in treatment of high risk MDS

Deferasirox Exjade:

The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is scheduled during the phase I, with 5 additional patients per group.

The maximal tolerated dose of Deferasirox will be required for the phase II of the study.

The first dose will be assigned according to the ferritin level of the patient at time of inclusion:

5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin is ≥1000ng/ml) in Group 2

Group 1 : Ferritin 300 to 1000ng /ml:

cohort 1 : 5 mg/kg/d
cohort 2 : 10mg/kg/d
cohort 3 : 15 mg/kg/d

Group 2 : Ferritin > 1000ng /ml:

cohort 1 : 10 mg/kg/d
cohort 2 : 15mg/kg/d

cohort 3 : 20 mg/kg/d

5 patients will be treated by cohort. In absence of toxicity (extra-hematological toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included in the next cohort.

Deferasirox will be administrated once daily during all the study period. Uvedose will be administrated once weekly during all the study period (100.000 UI P.O).

Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each cycles(One cycle is 28 days)

During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine

Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment.

No dose modification of deferasirox will be done after 3 cycles of treatment except in case of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with the same dose of Deferasirox until progression .

status: Unknown status

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Nantes
Centre Hospitalier de La Cote Basque
CHU Brabois
Centre Hospitalier de Boulogne sur Mer
Centre Catherine de Sienne
CHU Poitiers
Hôpital cochin
CHU Le Mans
GENT
CHU Limoges
IUCT Oncopole Toulouse
Hôpital Necker
Hôpital Avicenne
Hôpital Saint Vincent de Paul
Hôpital saint Louis


title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function

acronym: TUTOR

summary: The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

primary_purpose: Diagnostic

lead_sponsor: LivaNova

location_country: Portugal Italy France Belgium Germany

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Ccn: Centre Cardiologique Du Nord St Denis

location_facility: Praxis Westend Studien GbR, Medianzentrum Haus 9

location_facility: Hospital de Santa Cruz - Carnaxide (Adragão)

location_facility: HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen

location_facility: CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON

intervention_type: Device


title: TRIAGE: TRIage of Sepsis At emerGency dEpartment

acronym: TRIAGE

summary:
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.

Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Yes

lead_sponsor: BioMérieux

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: Centre d'Investigation Clinique (CIC)-CHU Limoges

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: Centre Hospitalier Universitaire Edouard Herriot

location_facility: Assistance publique - Hôpitaux de Paris Hopital de Cochin

location_facility: Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon

location_facility: Centre Hospitalier Regional Universitaire de Besançon

location_facility: Centre Hospitalier Régional Universitaire de Tours


title: European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma

acronym: OPERA

summary:
The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery.

The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%).

Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma.

Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.

lead_sponsor: Centre Antoine Lacassagne

location_country:
Denmark
France
United Kingdom
Sweden

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud

intervention_type: Radiation


title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

acronym: ANSWER

summary:
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: Hospital Clinico universitario de Santiago

location_facility: Complejo Hospitalario Arquitecto Marcide


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up

summary: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

lead_sponsor: Steba Biotech S.A.

location_country:
Spain
Italy
United Kingdom
Netherlands
Finland
Sweden
France
Germany

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

location_facility: Department of Urology-Tampere University Hospital-

location_facility: University College London Hospital (UCLH)

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: Centre Hospitalier Universitaire Lyon Sud


acronym: CaboPoint

title: A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.

lead_sponsor: Ipsen

source: euctr

ReferenceCitation: Albiges L, Schmidinger M, Taguieva-Pioger N, Perol D, Grünwald V, Guemas E. CaboPoint: a phase II study of cabozantinib as second-line treatment in patients with metastatic renal cell carcinoma. Future Oncol. 2022 Mar;18(8):915-926. doi: 10.2217/fon-2021-1006. Epub 2021 Dec 16.

ipd_sharing_description: Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available

location_country:
Spain
United Kingdom
Austria
Netherlands
Switzerland
France
Germany

location_facility: Otto-von-Guericke-Universität University hospital Magdeburg

location_facility: The Netherlands Cancer Institute - Oncology

location_facility: Western General Hospital - Edinburgh Cancer Centre

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: CHU de Nîmes - Institut de Cancérologie du Gard

location_facility: Caritas Krankenhaus St.Josef Klinik für Urologie

location_facility: Klinikum Der Friedrich-Schiller-Universitaet Jena

location_facility: University Cancer Center Hamburg Eppendorf

location_facility: Royal Cornwall Hospital (RCH) - Sunrise Centre

location_facility: University Hospital Carl Gustav Carus Dresden

summary: The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.


title: Optimization With SonR Method in the ClinicAl pRactice

acronym: OSCAR

summary: Evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus rhythm

location_country: Portugal Spain Italy Austria France Germany

location_facility: Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria


title: Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations

acronym: MAV-RAPA

summary:
The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).

Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Tours
CHU Strasbourg
UCL
CHU Montpellier
HCL Lyon
CHU Bordeaux
APHP
APHM
CHU Dijon
CHU Nancy
CHU Nice
CHU Amiens
CHRU Lille

lead_sponsor_type: academique


title: Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml

lead_sponsor: Sanofi

ReferenceCitation: Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.

location_country: Netherlands Sweden France Belgium

location_facility:
Investigational Site Number 250-012
Investigational Site Number 250-004
Investigational Site Number 250-003
Investigational Site Number 250-009
Investigational Site Number 752-001
Investigational Site Number 250-010
Investigational Site Number 250-002
Investigational Site Number 528003
Investigational Site Number 250-007
Investigational Site Number 528001
Investigational Site Number 250-008
Investigational Site Number 528002
Investigational Site Number 250-001
Investigational Site Number 250-011
Investigational Site Number 250-006
Investigational Site Number 250-005
Investigational Site Number 056-001

summary:
Primary Objective:

To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).

Secondary Objective:

To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases


title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

summary: The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

time_perspective: Cross-Sectional

lead_sponsor: Janssen-Cilag International NV

location_country:
Spain
Italy
United Kingdom
Hungary
France
Belgium
Germany

location_facility: Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Centre Medico Psychologique Le Rembrandt

location_facility: Centre Médico Psychologique De Courbevoie


title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register

summary:
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).

This study aims to assess performance, clinical outcomes and safety

lead_sponsor: Medicrea International

location_facility:
CH WAPI
La pitié Salepetrière Hospital
Hopital Saint Philibert
Hopital la Timone
Les Massues
Orthopôle
Polyclinique
Saint Etienne Hospital
Hopitaux pediatriques - CHU Lenval
CHU Estaing
Hopital Trousseau
Centre Orthopédique Santy


title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

summary:
Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

Progression Free Survival
Overall Survival
Response Duration

location_country: Austria France Norway

location_facility:
Investigational Site Number 250011
Investigational Site Number 250003
Investigational Site Number 040002
Investigational Site Number 578001
Investigational Site Number 250002
Investigational Site Number 250007
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 250006
Investigational Site Number 250009
Investigational Site Number 250001
Investigational Site Number 250008
Investigational Site Number 250010


title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

summary:
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.

ReferenceCitation: Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taillé S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-219. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Canada Italy Tunisia France

location_facility: Réanimation du Service Pneumologie - Hôtel Dieu

location_facility: Réanimation Polyvalente - CHU Fatima Bourguiba

location_facility: Réanimation Médicale, Hôpital Charles Nicolle

location_facility: Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli

location_facility: Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy

location_facility: Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon

location_facility: Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi

location_facility: Département d'Anesthésie - Hôpital de l'Enfant Jésus

location_facility: Réanimation Médicale - Hôpital Louis Mourier

location_facility: Réanimation pneumologique, Hôpital Pitié Salpétrière


title: Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)

summary: This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma

ReferenceType: background

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. Epub 2005 May 2.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Brière J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. Epub 2003 Aug 14.

ReferenceCitation: Ghesquières H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

ReferenceCitation: Copie-Bergman C, Cuillière-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

ReferenceCitation: Fitoussi O, Belhadj K, Mounier N, Parrens M, Tilly H, Salles G, Feugier P, Ferme C, Ysebaert L, Gabarre J, Herbrecht R, Janvier M, Van Den Neste E, Morschhauser F, Casasnovas O, Ghesquieres H, Anglaret B, Brechignac S, Haioun C, Gisselbrecht C. Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA. Haematologica. 2011 Aug;96(8):1136-43. doi: 10.3324/haematol.2010.038109. Epub 2011 May 5.

lead_sponsor: Lymphoma Study Association

location_country: France Switzerland Belgium

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


title: Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study

acronym: POCUSCO

summary:
COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.

While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.

Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.

Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.

Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

ReferenceType: result

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Rodriguez-Morales AJ, Cardona-Ospina JA, Gutiérrez-Ocampo E, Villamizar-Peña R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramírez-Vallejo E, Suárez JA, Zambrano LI, Villamil-Gómez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar - Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.

ReferenceCitation: Lichtenstein DA, Mezière GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10. Erratum in: Chest. 2013 Aug;144(2):721.

ReferenceCitation: Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.

ReferenceCitation: Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aubé C, Riou J, Dubée V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.

lead_sponsor: University Hospital, Angers

location_facility:
Florence DUPRIEZ
JOLY Luc-Marie
FLAMENT Thomas
SOULAT Louis
COUTURAUD Francis
LE CONTE Philippe
MARJANOVIC Nicolas
TAZAROURTE Karim
MORIN François
BAUDIN Laure
DELOMAS Thomas


title: A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease

acronym: SKY

summary: The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

lead_sponsor: ApoPharma

location_country:
Germany
Canada
United Kingdom
France

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre

location_facility: CHU de Bordeaux, Centre Expert Parkinson

location_facility: Universitätsklinikum Gießen und Marburg GmbH


title: Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction

lead_sponsor: Pierre Fabre Medicament

location_country: Lithuania Estonia France Latvia

summary: The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.


title: A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants With Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)

summary: The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Amylyx Pharmaceuticals Inc.

location_country:
Poland
Portugal
Spain
Italy
Ireland
Netherlands
United Kingdom
Sweden
France
Belgium
Germany

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC)

location_facility: Salford Royal Hospital Barnes Clinical Research Team

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Hopital Gabriel Montpied Service de Neurologie

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Trinity College Dublin/Beaumont Hospital

location_facility: Hospital Universitari de Bellvitge-IDIBELL

location_facility: Biodonostia Health Research Institute; Hospital Universitario Donostia

location_facility: Le Centre Hospitalier Régional Universitaire de Tours

location_facility: Sheffield Institute for Translational Neuroscience (SITraN)

location_facility: Università degli Studi di Bari Aldo Moro


title: Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®

acronym: C-CURVE

summary:
This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.

The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.

This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.

ReferenceCitation: Alimi M, Njoku I, Hofstetter CP, Tsiouris AJ, Kesavabhotla K, Boockvar J, Navarro-Ramirez R, Härtl R. Anterior Cervical Discectomy and Fusion (ACDF): Comparison Between Zero Profile Implants and Anterior Cervical Plate and Spacer. Cureus. 2016 Apr 17;8(4):e573. doi: 10.7759/cureus.573.

ReferenceCitation: Azab W, Abdel-Razek M, Ali A, Abdelrahman A, Salaheldin W, Nasim K, Attia H, Soliman D. Outcome evaluation of a zero-profile implant for anterior cervical diskectomy with fusion. Turk Neurosurg. 2012;22(5):611-7. doi: 10.5137/1019-5149.JTN.5646-11.2.

ReferenceCitation: Barbagallo GM, Romano D, Certo F, Milone P, Albanese V. Zero-P: a new zero-profile cage-plate device for single and multilevel ACDF. A single institution series with four years maximum follow-up and review of the literature on zero-profile devices. Eur Spine J. 2013 Nov;22 Suppl 6:S868-78. doi: 10.1007/s00586-013-3005-0. Epub 2013 Sep 24. Review.

ReferenceCitation: Bucci MN, Oh D, Cowan RS, Davis RJ, Jackson RJ, Tyndall DS, Nehls D. The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes. Med Devices (Auckl). 2017 Apr 18;10:61-69. doi: 10.2147/MDER.S127133. eCollection 2017.

ReferenceCitation: Chen Y, Liu Y, Chen H, Cao P, Yuan W. Comparison of Curvature Between the Zero-P Spacer and Traditional Cage and Plate After 3-Level Anterior Cervical Discectomy and Fusion: Mid-term Results. Clin Spine Surg. 2017 Oct;30(8):E1111-E1116. doi: 10.1097/BSD.0000000000000440.

ReferenceCitation: De Leo-Vargas RA, Muñoz-Romero I, Mondragón-Soto MG, Martínez-Anda JJ. Locking Stand-Alone Cage Constructs for the Treatment of Cervical Spine Degenerative Disease. Asian Spine J. 2019 Apr 10;13(4):630-637. doi: 10.31616/asj.2018.0234. Print 2019 Aug.

ReferenceCitation: Lee YS, Kim YB, Park SW. Does a zero-profile anchored cage offer additional stabilization as anterior cervical plate? Spine (Phila Pa 1976). 2015 May 15;40(10):E563-70. doi: 10.1097/BRS.0000000000000864.

ReferenceCitation: Li Z, Zhao Y, Tang J, Ren D, Guo J, Wang H, Li L, Hou S. A comparison of a new zero-profile, stand-alone Fidji cervical cage and anterior cervical plate for single and multilevel ACDF: a minimum 2-year follow-up study. Eur Spine J. 2017 Apr;26(4):1129-1139. doi: 10.1007/s00586-016-4739-2. Epub 2016 Aug 23.

ReferenceCitation: Lu Y, Bao W, Wang Z, Zhou F, Zou J, Jiang W, Yang H, Zhang Z, Zhu X. Comparison of the clinical effects of zero-profile anchored spacer (ROI-C) and conventional cage-plate construct for the treatment of noncontiguous bilevel of cervical degenerative disc disease (CDDD): A minimum 2-year follow-up. Medicine (Baltimore). 2018 Feb;97(5):e9808. doi: 10.1097/MD.0000000000009808.

ReferenceCitation: Nambiar M, Phan K, Cunningham JE, Yang Y, Turner PL, Mobbs R. Locking stand-alone cages versus anterior plate constructs in single-level fusion for degenerative cervical disease: a systematic review and meta-analysis. Eur Spine J. 2017 Sep;26(9):2258-2266. doi: 10.1007/s00586-017-5015-9. Epub 2017 Mar 10. Review.

ReferenceCitation: Scholz M, Schelfaut S, Pingel A, Schleicher P, Kandziora F. A cervical "zero-profile" cage with integrated angle-stable fixation: 24-months results. Acta Orthop Belg. 2014 Dec;80(4):558-66.

location_country: France Belgium

location_facility: Centre de consultations spécialisées de la Sauvegarde


title: Intracranial Aneurysms Treatment With the OPTIMA Coil System

acronym: INSTANT

summary: International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy

lead_sponsor: Balt Extrusion

location_country: Spain Latvia Austria Italy Switzerland France Germany

location_facility: University of Latvia, Faculty of Medicine

location_facility: CHU de Brest - Hôpital La Cavale Blanche

location_facility: Hospices Civils de Lyon - Hôpital Neurologique

location_facility: HUG Hôpital cantonal universitaire de geneva


acronym: CONDUCT

title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

lead_sponsor: InDex Pharmaceuticals

ReferenceCitation: Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hébuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

location_country:
Poland
Serbia
Spain
Russian Federation
Ukraine
Sweden
Hungary
France
Germany
Czechia

summary: The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.


title: Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

summary: This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

time_perspective: Retrospective

location_country:
United Kingdom
Italy
France
Turkey
Germany
Czechia

location_facility: Klinikum der Johann Wolfgang, Goethe-Universität

location_facility: İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi

location_facility: Groupement hôspitalier est Federation d'endocrinologie.


title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study

acronym: Maverick

summary: The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

lead_sponsor: Medtronic Spinal and Biologics

location_country: Germany Canada France

location_facility: Praxis für Orthopädie und Neurochirurgie Potsdam

location_facility: CH Lariboisière, Service de Neurochirurgie

location_facility: Clinique de Neurochirurgie Hôpital Roger Salengro

location_facility: Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon

location_facility: CH de Meulan - Service de Chirurgie Orthopédique

location_facility: CH Antoine Béclère - Service de Chirurgie Orthopédique


title: A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

summary: This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United Kingdom
Italy
Austria
Netherlands
France
Germany


title: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

summary:
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

ReferenceCitation: Romera I, Pérez V, Menchón JM, Schacht A, Papen R, Neuhauser D, Abbar M, Svanborg P, Gilaberte I. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol. 2012 Aug;32(4):479-86. doi: 10.1097/JCP.0b013e31825d9958.

lead_sponsor: Eli Lilly and Company

location_country: Denmark Slovenia Italy Greece Spain Sweden Hungary France Turkey Romania Netherlands

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: Sensitivity of Echography in Arthritis

acronym: SEA

summary:
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).

An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).

It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.

In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.

Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).

ReferenceCitation: Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chalès G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
CHU Nancy-Brabois
CHU A. Michallon
CHU de la Cavale Blanche
Hôpital Bicêtre
Hôpital Cochin
Hôpital Ambroise Paré
CHU de RENNES - Hôpital Sud
CHU Côte de Nacre
CHU-Brugmann
Hôpital de la Pitié


title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

summary: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Greece
Russian Federation
Estonia
France
Norway
Germany


title: Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 0)

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205.

ReferenceCitation: Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6.

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. Epub 2005 May 2.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. Epub 2003 Aug 14.

ReferenceCitation: Copie-Bergman C, Cuillière-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Centre Pluridisciplinaire d'Oncologie, CHUV


title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI).

ReferenceCitation: Dumontet C, Mounier N, Munck JN, Bosly A, Morschauser F, Simon D, Marit G, Casasnovas O, Reman O, Molina T, Reyes F, Coiffier B. Factors predictive of early death in patients receiving high-dose CHOP (ACVB regimen) for aggressive non-Hodgkin's lymphoma: a GELA study. Br J Haematol. 2002 Jul;118(1):210-7.

ReferenceCitation: Ghesquières H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

ReferenceCitation: Molina TJ, Canioni D, Copie-Bergman C, Recher C, Brière J, Haioun C, Berger F, Fermé C, Copin MC, Casasnovas O, Thieblemont C, Petrella T, Leroy K, Salles G, Fabiani B, Morschauser F, Mounier N, Coiffier B, Jardin F, Gaulard P, Jais JP, Tilly H. Young patients with non-germinal center B-cell-like diffuse large B-cell lymphoma benefit from intensified chemotherapy with ACVBP plus rituximab compared with CHOP plus rituximab: analysis of data from the Groupe d'Etudes des Lymphomes de l'Adulte/lymphoma study association phase III trial LNH 03-2B. J Clin Oncol. 2014 Dec 10;32(35):3996-4003. doi: 10.1200/JCO.2013.54.9493. Epub 2014 Nov 10.

ReferenceCitation: Récher C, Coiffier B, Haioun C, Molina TJ, Fermé C, Casasnovas O, Thiéblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquières H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.

location_facility: Groupe d'étude des lymphomes de l'adulte


title: Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

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

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

ReferenceCitation: Huguet F, André T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31.

ReferenceCitation: Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, André T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.

ReferenceCitation: Louvet C, André T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hopital Drevon
Polyclinique De Courlancy
Hopital Beaujon
Clinique Saint Jean
American Hospital of Paris
Hopital Saint Antoine
Centre Paul Papin
Institut Jules Bordet
Hopital Tenon
Centre Hospitalier Victor Dupouy


title: A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)

acronym: Catalyst

summary: This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.

ReferenceCitation: Gibney GT, Weiner LM, Atkins MB. Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol. 2016 Dec;17(12):e542-e551. doi: 10.1016/S1470-2045(16)30406-5. Review.

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

ReferenceCitation: Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.

ReferenceCitation: Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971. Review.

ReferenceCitation: Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Vesely MD, Schreiber RD. Cancer immunoediting: antigens, mechanisms, and implications to cancer immunotherapy. Ann N Y Acad Sci. 2013 May;1284:1-5. doi: 10.1111/nyas.12105.

ReferenceCitation: Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005. Review. Erratum in: Cancer Cell. 2018 Oct 8;34(4):690.

ReferenceCitation: Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litière S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2. Review. Erratum in: Lancet Oncol. 2019 May;20(5):e242.

ReferenceCitation: Goldmacher GV, Khilnani AD, Andtbacka RHI, Luke JJ, Hodi FS, Marabelle A, Harrington K, Perrone A, Tse A, Madoff DC, Schwartz LH. Response Criteria for Intratumoral Immunotherapy in Solid Tumors: itRECIST. J Clin Oncol. 2020 Aug 10;38(23):2667-2676. doi: 10.1200/JCO.19.02985. Epub 2020 Jun 18. Review.

ipd_sharing: Undecided

lead_sponsor: Cytovation AS

location_country:
Spain
Italy
United States
France
Netherlands

location_facility: Azienda Ospedaliero Universitaria Senese


title: Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation

acronym: MARSHALL-PLAN

summary: In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan).

lead_sponsor: University Hospital, Bordeaux

location_facility:
Clinique Saint Augustin
Toulouse University Hospirtal
Centre Cardiologique du Nord
AZ Sint Jan Brugge
Ambroise Paré Hospital
Bordeaux University Hospital
Clinique Pasteur
Clermont-Ferrand University Hospital
Les Franciscaines Hospital


title: A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

summary: The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Limited

location_country:
Denmark
Portugal
Spain
Italy
Russian Federation
France
Germany

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Moscow State Medical Stomatological University n.a. A.I. Evdokimov

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Regional Treatment and Rehabilitation Center

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

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

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Centre de consultations Saint-Jean Bâtiment A

location_facility: Hospital Universitari Sagrat Cor Quironsalud

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Russian National Research Medical University n.a. N.I.Pirogov


title: Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

acronym: ENTRACT

summary:
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.

The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.

We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study

ReferenceCitation: Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pène F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.

ReferenceCitation: Dumas F, Cariou A, Manzo-Silberman S, Grimaldi D, Vivien B, Rosencher J, Empana JP, Carli P, Mira JP, Jouven X, Spaulding C. Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) registry. Circ Cardiovasc Interv. 2010 Jun 1;3(3):200-7. doi: 10.1161/CIRCINTERVENTIONS.109.913665. Epub 2010 May 18.

ReferenceCitation: Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pène F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.

ReferenceCitation: Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

ReferenceCitation: Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. Epub 2004 Sep 9.

ReferenceCitation: Laurent I, Monchi M, Chiche JD, Joly LM, Spaulding C, Bourgeois B, Cariou A, Rozenberg A, Carli P, Weber S, Dhainaut JF. Reversible myocardial dysfunction in survivors of out-of-hospital cardiac arrest. J Am Coll Cardiol. 2002 Dec 18;40(12):2110-6.

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8.

ReferenceCitation: Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. Review.

ReferenceCitation: Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2. Review.

ReferenceCitation: Kawai T, Akira S. TLR signaling. Semin Immunol. 2007 Feb;19(1):24-32. Epub 2007 Feb 1. Review.

ReferenceCitation: Suffredini AF, Fromm RE, Parker MM, Brenner M, Kovacs JA, Wesley RA, Parrillo JE. The cardiovascular response of normal humans to the administration of endotoxin. N Engl J Med. 1989 Aug 3;321(5):280-7.

ReferenceCitation: Balija TM, Lowry SF. Lipopolysaccharide and sepsis-associated myocardial dysfunction. Curr Opin Infect Dis. 2011 Jun;24(3):248-53. doi: 10.1097/QCO.0b013e32834536ce. Review.

ReferenceCitation: Zhou J, Huang WQ, Li C, Wu GY, Li YS, Wen SH, Lei WL, Liu KX. Intestinal ischemia/reperfusion enhances microglial activation and induces cerebral injury and memory dysfunction in rats. Crit Care Med. 2012 Aug;40(8):2438-48. doi: 10.1097/CCM.0b013e3182546855.

ReferenceCitation: Marshall JC, Foster D, Vincent JL, Cook DJ, Cohen J, Dellinger RP, Opal S, Abraham E, Brett SJ, Smith T, Mehta S, Derzko A, Romaschin A; MEDIC study. Diagnostic and prognostic implications of endotoxemia in critical illness: results of the MEDIC study. J Infect Dis. 2004 Aug 1;190(3):527-34. Epub 2004 Jul 2.

ReferenceCitation: Korth U, Krieter H, Denz C, Janke C, Ellinger K, Bertsch T, Henn C, Klein J. Intestinal ischaemia during cardiac arrest and resuscitation: comparative analysis of extracellular metabolites by microdialysis. Resuscitation. 2003 Aug;58(2):209-17.

ReferenceCitation: Gill RS, Lee TF, Sergi C, Bigam DL, Cheung PY. Early versus delayed cyclosporine treatment in cardiac recovery and intestinal injury during resuscitation of asphyxiated newborn piglets. Intensive Care Med. 2012 Jul;38(7):1215-23. doi: 10.1007/s00134-012-2577-1. Epub 2012 May 10.

ReferenceCitation: Albrecht M, Gruenewald M, Zitta K, Zacharowski K, Scholz J, Bein B, Meybohm P. Hypothermia and anesthetic postconditioning influence the expression and activity of small intestinal proteins possibly involved in ischemia/reperfusion-mediated events following cardiopulmonary resuscitation. Resuscitation. 2012 Jan;83(1):113-8. doi: 10.1016/j.resuscitation.2011.06.038. Epub 2011 Jul 18.

ReferenceCitation: Gill RS, Manouchehri N, Lee TF, Cho WJ, Thiesen A, Churchill T, Bigam DL, Cheung PY. Cyclosporine treatment improves mesenteric perfusion and attenuates necrotizing enterocolitis (NEC)-like intestinal injury in asphyxiated newborn piglets during reoxygenation. Intensive Care Med. 2012 Mar;38(3):482-90. doi: 10.1007/s00134-011-2436-5. Epub 2011 Dec 6.

ReferenceCitation: Bedell SE, Fulton EJ. Unexpected findings and complications at autopsy after cardiopulmonary resuscitation (CPR). Arch Intern Med. 1986 Sep;146(9):1725-8.

ReferenceCitation: Piton G, Barbot O, Manzon C, Moronval F, Patry C, Navellou JC, Belle E, Capellier G. Acute ischemic pancreatitis following cardiac arrest: a case report. JOP. 2010 Sep 6;11(5):456-9.

ReferenceCitation: Gaussorgues P, Gueugniaud PY, Vedrinne JM, Salord F, Mercatello A, Robert D. Bacteremia following cardiac arrest and cardiopulmonary resuscitation. Intensive Care Med. 1988;14(5):575-7.

ReferenceCitation: Grootjans J, Lenaerts K, Derikx JP, Matthijsen RA, de Bruïne AP, van Bijnen AA, van Dam RM, Dejong CH, Buurman WA. Human intestinal ischemia-reperfusion-induced inflammation characterized: experiences from a new translational model. Am J Pathol. 2010 May;176(5):2283-91. doi: 10.2353/ajpath.2010.091069. Epub 2010 Mar 26.

ReferenceCitation: Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.

ReferenceCitation: Crenn P, Messing B, Cynober L. Citrulline as a biomarker of intestinal failure due to enterocyte mass reduction. Clin Nutr. 2008 Jun;27(3):328-39. doi: 10.1016/j.clnu.2008.02.005. Epub 2008 Apr 28. Review.

ReferenceCitation: Grimaldi D, Guivarch E, Neveux N, Fichet J, Pène F, Marx JS, Chiche JD, Cynober L, Mira JP, Cariou A. Markers of intestinal injury are associated with endotoxemia in successfully resuscitated patients. Resuscitation. 2013 Jan;84(1):60-5. doi: 10.1016/j.resuscitation.2012.06.010. Epub 2012 Jun 26.

ReferenceCitation: L'Her E, Cassaz C, Le Gal G, Cholet F, Renault A, Boles JM. Gut dysfunction and endoscopic lesions after out-of-hospital cardiac arrest. Resuscitation. 2005 Sep;66(3):331-4.

ReferenceCitation: Jacobs I, Nadkarni V, Bahr J, Berg RA, Billi JE, Bossaert L, Cassan P, Coovadia A, D'Este K, Finn J, Halperin H, Handley A, Herlitz J, Hickey R, Idris A, Kloeck W, Larkin GL, Mancini ME, Mason P, Mears G, Monsieurs K, Montgomery W, Morley P, Nichol G, Nolan J, Okada K, Perlman J, Shuster M, Steen PA, Sterz F, Tibballs J, Timerman S, Truitt T, Zideman D; International Liason Committee on Resusitation. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries. A statement for healthcare professionals from a task force of the international liaison committee on resuscitation (American Heart Association, European Resuscitation Council, Australian Resuscitation Council, New Zealand Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa). Resuscitation. 2004 Dec;63(3):233-49.

ReferenceCitation: Savoye G, Ben Soussan E, Hochain P, Lerebours E. [How and how far to investigate ischemic colitis?]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B12-23. Review. French.

ReferenceCitation: Grimaldi D, Legriel S, Pichon N, Colardelle P, Leblanc S, Canouï-Poitrine F, Ben Hadj Salem O, Muller G, de Prost N, Herrmann S, Marque S, Baron A, Sauneuf B, Messika J, Dior M, Creteur J, Bedos JP, Boutin E, Cariou A. Ischemic injury of the upper gastrointestinal tract after out-of-hospital cardiac arrest: a prospective, multicenter study. Crit Care. 2022 Mar 14;26(1):59. doi: 10.1186/s13054-022-03939-9.

lead_sponsor: Versailles Hospital

location_facility: Henri Mondor Hospital, Medical Intensive care unit

location_facility: Dupuytren hospital, Medical intensive care unit

location_facility: André Mignot Hospital, Intensive care unit

location_facility: Cotentin Hospital, Medical intensive care unit

location_facility: Orléans Hospital, Medical intensive care unit

location_facility: Sud Francilien Hospital, Medicla care unit

location_facility: Cochin Hospital, Médical intensive care unit


title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

summary: The aim of the investigation was to investigate the performance and safety of a new ostomy product.

primary_purpose: Supportive Care

lead_sponsor: Coloplast A/S

location_country:
Denmark
United Kingdom
France
Norway
Germany

location_facility: Sanitäts- und gesundheitshaus Carqueville GmbH


title: Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis

acronym: BASALT

summary: The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.

lead_sponsor: University Hospital, Limoges

location_facility: Service de Pneumologie - CHU de Strasbourg

location_facility: Service de Pneumologie - Phtisiologie - Hôpital Bichat

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou

location_facility: Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,


title: Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

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

PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Portugal Italy Austria Greece Switzerland France Israel Netherlands

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Schneider Children's Medical Center of Israel

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

acronym: fAMHOPE

summary: This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

lead_sponsor: Erasme University Hospital

location_country: France Italy Belgium

location_facility:
CHC-Saint Vincent
CHIREC- Hospital Delta
CUB-Hôpital Erasme
Centre Oscar Lambret
Ospedale San Martino
CHRU Lille


title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

summary: The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
United States
France

location_facility: The University Of Texas MD Anderson Cancer Center


title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation

summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

ReferenceCitation: Jaïs P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clémenty J, Haïssaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24. Erratum in: Circulation. 2009 Sep 8;120(10):e83.

lead_sponsor: Biosense Webster, Inc.

location_country:
United States
Switzerland
France

location_facility:
University of Alabama, Birmingham
Hopital Cantonal de Geneve
Hopital Lariboisiere
Hôpital Haut Lèvêque
Mid-Ohio Cardiology
Massachusetts General Hospital


title: Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

summary:
The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.

Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.

ReferenceCitation: Dreno B, Urosevic-Maiwald M, Kim Y, Guitart J, Duvic M, Dereure O, Khammari A, Knol AC, Derbij A, Lusky M, Didillon I, Santoni AM, Acres B, Bataille V, Chenard MP, Bleuzen P, Limacher JM, Dummer R. TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial. PLoS One. 2014 Feb 24;9(2):e83670. doi: 10.1371/journal.pone.0083670. eCollection 2014.

ReferenceCitation: Accart N, Urosevic-Maiwald M, Dummer R, Bataille V, Kehrer N, Niculescu C, Limacher JM, Chenard MP, Bonnefoy JY, Rooke R. Lymphocytic infiltration in the cutaneous lymphoma microenvironment after injection of TG1042. J Transl Med. 2013 Sep 25;11:226. doi: 10.1186/1479-5876-11-226.

lead_sponsor: Transgene

location_facility:
Northwestern University Medical School
Hopital Lapeyronie
Stanford University School of Medicine
M.D. Anderson Cancer Center
Hopital de l'Hotel-Dieu
University Hospital of Zurich

intervention_type: Genetic


title: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

summary: Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

lead_sponsor: Ferring Pharmaceuticals

location_country:
Netherlands
France
Czech Republic

location_facility: Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159

location_facility: Centre d'Endocrinologie Pediatrique, 25 rue Boudet

location_facility: Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057

location_facility: Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert

location_facility: Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,

location_facility: Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a


title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

ReferenceCitation: Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26. Erratum in: Circulation. 2011 Sep 6;124(10):e279. Dosage error in article text.

location_country:
United States
Italy
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 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

acronym: ADORE

summary: Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.

lead_sponsor: Ferrer Internacional S.A.

location_country:
Poland
Portugal
Spain
Italy
Ireland
Netherlands
United Kingdom
Sweden
France
Belgium
Germany

location_facility: University of Padua - Azienda Ospedaliera di Padova

location_facility: Azienda Ospedaliera Universitaria Cagliari

location_facility: University of Torino - Rita Levi Montalcini Department of Neuroscience

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Trinity College Dublin/Beaumont Hospital

location_facility: Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania "Luigi Vanvitelli"

location_facility: Centre Hospitalo-Universitaire La Timone

location_facility: Hospital Universitario La Paz-Carlos III


title: Phase II Trial of Nivolumab for Pediatric and Adult Relapsing/Refractory Anaplastic Large Cell Lymphoma, for Evaluation of Response in Patients With Progressive Disease Cohort 1 or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse Cohort 2

acronym: NIVO-ALCL

summary: Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark France Netherlands

location_facility:
CHU Toulouse Hopital des enfants
CHU de nancy
IUC Toulouse
Centre Léon Berard Lyon
Rigshospitalet
CHU Bordeaux Hopital Pellegrin
Princess Maxima center
Hopital Saint Louis
Gustave Roussy


acronym: PHERGain

title: Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy. The PHERGain Study

lead_sponsor: MedSIR

ReferenceCitation: Perez-Garcia JM, Gebhart G, Borrego MR, Schmid P, Marme F, Prat A, Dalenc F, Kerrou K, Colleoni M, Braga S, Malfettone A, Sampayo-Cordero M, Cortes J, Llombart-Cussac A. Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study. Future Oncol. 2022 Oct 27. doi: 10.2217/fon-2022-0663. Online ahead of print.

ReferenceCitation: Perez-Garcia JM, Gebhart G, Ruiz Borrego M, Stradella A, Bermejo B, Schmid P, Marme F, Escriva-de-Romani S, Calvo L, Ribelles N, Martinez N, Albacar C, Prat A, Dalenc F, Kerrou K, Colleoni M, Afonso N, Di Cosimo S, Sampayo-Cordero M, Malfettone A, Cortes J, Llombart-Cussac A; PHERGain steering committee and trial investigators. Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):858-871. doi: 10.1016/S1470-2045(21)00122-4. Epub 2021 May 18.

location_country:
Portugal
Spain
Italy
United Kingdom
France
Belgium
Germany

location_facility: Städtisches Klinikum "St. Georg" Leipzig

location_facility: Hospital Clínic Universitari de Valencia

location_facility: Clinical of Nuclear Medicine Technical University Munich

location_facility: Centro Hospitalaer de Tras-os-Montes e Alto Douro

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital General Universitari de Valencia

location_facility: Hospital Universitario Virgen de la Victoria

summary:
The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response (pCR) in the breast and axilla.

And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.