title: A Phase II Trial of Bevacizumab in Myelodysplastic Syndromes (Int-1, Int-2 and High Risk According to IPSS) With Excess of Marrow Blasts

summary:
The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on angiogenesis and erythropoiesis.

To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be administrated at the initial dose of 5 mg/kg.

The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and hematological improvement (HI) according to IWG criteria (see appendix 3).

The secondary endpoints will be survival, response duration, side effects, evaluation of angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression, HIF-1alpha expression).

The design of this study consists of three study periods: pre-treatment (screening), treatment (loading and maintenance), and follow-up. All patients will participate in the study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up unless the criteria for planned or unplanned early discontinuation are met.

location_facility: Department of clinical hematology, Robert Debré Hospital

location_facility: Department of Onco-Hematology, Caremeau Hospital, CHU Nîmes

location_facility: Department of Clinical hematology, Archet Hospital, CHU de Nice

location_facility: Department of Hematology and Oncology, CHU de Strasbourg


title: Randomized Therapeutic Study of a Treatment by Tacrolimus Adapted or Not According to the Genotype of the Cytochrome P450 3A5 After Renal Transplantation

summary:
Renal transplantation is the treatment of choice of the chronic renal insufficiency arrived at its final stage. Tacrolimus is an immunosuppressant treatment used for the prevention of episodes of acute rejection. Tacrolimus is characterized by a narrow therapeutic index and important interindividual variations of its pharmacokinetic characteristics. Proteins CYP3A4 and CYP3A5 are responsible of intestinal and hepatic metabolism of Tacrolimus. Various polymorphisms for CYP3A5 and CYP3A4 were described and several retrospective studies suggested an association between a genetic polymorphism of CYP3A5 and the pharmacokinetic parameters of Tacrolimus. In particular, we showed that the presence of an allele CYP3A5*1 was associated to the use of more important amounts of Tacrolimus to obtain the desired blood concentrations.

This study is a national, multicentric, prospective, opened, randomized on two arms of treatment. 280 receivers of a renal transplant in 12 centres will be included. The genotyping of gene CYP3A5 will be carried out in the 6 days following transplantation. During the first week, the patients will be treated by basiliximab, MMF and corticosteroids. They will be randomized (central randomization) in D6 to receive either Tacrolimus at 0.2 mg/kg/d, or at a dosage adapted to their genotype. After determination of the first residual blood concentration of Tacrolimus realized after six oral intakes, the daily amounts of Tacrolimus could be modified if necessary to reach the desired blood concentrations. The total duration of the study for a patient is 3 months after transplantation.

The objective of this study is to evaluate the impact of the adaptation, according to the genotype of the CYP3A5 of the patient, of the first amount of Tacrolimus on the first residual blood concentration of Tacrolimus, keeping in mind the aim of the individualization of dosage schedule by pharmacogenetic approach.

Principal criterion : Comparison, between the two groups, of the percentage of patients for whom the first blood concentration of Tacrolimus evaluated 3 days (D10) after the first administration of Tacrolimus ranges between 10 and 15 ng/ml.

Statistics will be carried out in intention to treat. The principal criterion will be analyzed by the test of chi-2.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Angers
CHU Limoges - Hôpital Dupuytren
CHU Strasbourg - Hospices Civils
CHU Gabriel Montpied
CHU Rouen - Hôpital de Bois-Guillaume
CHU Tours - Hôpital Bretonneau
CHU Rennes - Hôpital Pontchaillou
CHU de la côté de Nacre
CHU Poitiers- hôpital Jean Bernard
CHU Reims - Hôpital Maison Blanche

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


design_allocation: Non-Randomized

intervention_type: Radiation

status: Terminated

study_start_date_type: Actual

lead_sponsor: UNICANCER

acronym: RACCER

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

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

type: Other Identifier

type: EudraCT Number

source: euctr

title: Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.

lead_sponsor_type: industriel

status_simplified: Unknown


title: Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

summary: Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.

ReferenceType: derived

ReferenceCitation: Le Jeune F, Vérin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.

family: Le Jeune

full_name: Florence Le Jeune

given: Florence

sequence: first

family: Vérin

full_name: Marc Vérin

given: Marc

sequence: additional

family: N'Diaye

full_name: Karim N'Diaye

given: Karim

family: Drapier

full_name: Dominique Drapier

given: Dominique

family: Leray

full_name: Emmanuelle Leray

given: Emmanuelle

family: Du Montcel

full_name: Sophie Tezenas Du Montcel

given: Sophie Tezenas

family: Baup

full_name: Nicolas Baup

given: Nicolas

family: Pelissolo

full_name: Antoine Pelissolo

given: Antoine

family: Polosan

full_name: Mircea Polosan

given: Mircea

family: Mallet

full_name: Luc Mallet

given: Luc

family: Yelnik

full_name: Jérome Yelnik

given: Jérome

family: Devaux

full_name: Bertrand Devaux

given: Bertrand

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Chereau

full_name: Isabelle Chereau

given: Isabelle

family: Bourguignon

full_name: Aurélie Bourguignon

given: Aurélie

family: Peron

full_name: Julie Peron

given: Julie

family: Sauleau

full_name: Paul Sauleau

given: Paul

family: Raoul

full_name: Sylvie Raoul

given: Sylvie

family: Garin

full_name: Etienne Garin

given: Etienne

family: Krebs

full_name: Marie-Odile Krebs

given: Marie-Odile

family: Jaafari

full_name: Nematollah Jaafari

given: Nematollah

family: Millet

full_name: Bruno Millet

given: Bruno

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Biological Psychiatry

title: Decrease of Prefrontal Metabolism After Subthalamic Stimulation in Obsessive-Compulsive Disorder: A Positron Emission Tomography Study

ReferenceCitation: Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chéreau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.

title: A video clinical global impression scale (CGI) in obsessive compulsive disorder

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

title: Subthalamic Nucleus Stimulation in Severe Obsessive–Compulsive Disorder

location_facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière


title: Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy

summary: To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

ReferenceType: result

ReferenceCitation: Pénisson-Besnier I, Devillers M, Porcher R, Orlikowski D, Doppler V, Desnuelle C, Ferrer X, Bes MC, Bouhour F, Tranchant C, Lagrange E, Vershueren A, Uzenot D, Cintas P, Solé G, Hogrel JY, Laforêt P, Vial C, Vila AL, Sacconi S, Pouget J, Eymard B, Chevret S, Annane D. Dehydroepiandrosterone for myotonic dystrophy type 1. Neurology. 2008 Aug 5;71(6):407-12. doi: 10.1212/01.wnl.0000324257.35759.40.

family: Penisson-Besnier

full_name: I. Penisson-Besnier

given: I.

family: Devillers

full_name: M. Devillers

given: M.

family: Porcher

full_name: R. Porcher

given: R.

family: Orlikowski

full_name: D. Orlikowski

given: D.

family: Doppler

full_name: V. Doppler

given: V.

family: Desnuelle

full_name: C. Desnuelle

given: C.

family: Ferrer

full_name: X. Ferrer

given: X.

family: Bes

full_name: M. -C.A. Bes

family: Bouhour

full_name: F. Bouhour

given: F.

family: Tranchant

full_name: C. Tranchant

family: Lagrange

full_name: E. Lagrange

given: E.

family: Vershueren

full_name: A. Vershueren

given: A.

family: Uzenot

full_name: D. Uzenot

family: Cintas

full_name: P. Cintas

given: P.

family: Sole

full_name: G. Sole

given: G.

family: Hogrel

full_name: J. -Y. Hogrel

family: Laforet

full_name: P. Laforet

family: Vial

full_name: C. Vial

family: Vila

full_name: A. L. Vila

given: A. L.

family: Sacconi

full_name: S. Sacconi

given: S.

family: Pouget

full_name: J. Pouget

given: J.

family: Eymard

full_name: B. Eymard

given: B.

family: Chevret

full_name: S. Chevret

family: Annane

full_name: D. Annane

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility:
CHU Pouget
CHU
Institut de myologie
Raymond Poincaré Hospital


title: Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Viret

full_name: Frédéric Viret

given: Frédéric

family: Baey

full_name: Charlotte Baey

given: Charlotte

family: Ychou

full_name: Marc Ychou

given: Marc

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Mornex

full_name: Françoise Mornex

given: Françoise

family: Pignon

full_name: Jean-Pierre Pignon

given: Jean-Pierre

family: Celier

full_name: Patrice Celier

given: Patrice

family: Berille

full_name: Jocelyne Berille

given: Jocelyne

family: Ducreux

full_name: Michel Ducreux

given: Michel

currency_apc_doaj: GBP

journal_name: Radiation Oncology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

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


title: Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

summary:
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

location_facility:
Centre Antoine Lacassagne
Centre Alexis Vautrin
Centre Oscar Lambret
Centre Hospitalier Lyon Sud
Centre Paul Strauss
Hopital Saint-Louis
Centre Leon Berard
Institut Gustave Roussy
CHU Pitie-Salpetriere
Institut Bergonie


title: First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

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 combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer


title: Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study

acronym: CATAREV-B

summary: Compare two methods of managing the lack of CVC blood return : opacification using contrast media injection or radio-clinical method with a simple chest X-ray followed by a rapid infusion of physiological serum

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut du Cancer Sainte Catherine Avignon Provence

intervention_type: Procedure

status_simplified: Ongoing


title: Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)

acronym: CIRCULAR

summary: Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

primary_purpose: Screening

ipd_sharing: No

lead_sponsor: Institut Bergonié

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

intervention_type: Diagnostic Test


title: Evaluation of the Efficacy of a Single Infusion of Ketamine Combined With Magnesium Sulfate to Treat Refractory Chronic Cluster Headache

acronym: KETALGIA

summary:
Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting < 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks.

Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Hospices civils de Lyon, Hôpital Pierre Wertheimer


title: Assessment of Therapeutic Plasma Exchange to Improve Respiratory Function by Alleviating Cytokine Storm During Severe Covid-19 Infections Randomised Open-label Controlled Trial

acronym: CovidEP

summary:
Severe Covid-19 (Coronavirus Disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-IFN (Interferon) auto-antibodies, inducing acute respiratory distress syndrom (ARDS). Therapeutic plasma exchange (TPE) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series.

The study aims to remove cytokines during cytokine storm and anti-IFN auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. To that aim, the study investigates to compare a treatment using TPE plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier Porte de Valence - Montélimar

location_facility: Hôpital Pitié Salpétrière - Assistante Publique des Hôpitaux de Paris

intervention_type: Other


acronym: IMMUNOGAST

location_facility:
Bordeaux - Hopital Haut-Leveque
Hcl - Centre Hospitalier Lyon Sud
Toulouse - Iuct Rangueil-Larrey
Dijon - Centre Georges-Francois Leclerc
Aphm - Hopital La Timone
Aphp - Hopital Pitie Salpetriere
Hcl - Hopital Edouard Herriot
Aphp - Hopital Saint-Louis

title: An Umbrella Phase 2 Trial to Assess Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent Advanced/Metastatic GASTric Adenocarcinoma Patients

summary:
For patients with advanced/metastatic gastric adenocarcinomas in progression after a first line chemotherapy comprising platinum and fluoropyrimidine, the reported second line treatments are : 1) paclitaxel combined with ramucirumab (overall response rate (ORR) = 25%; median progression free survival (PFS) = 2.9 months; median overall survival (OS)= 5.9 months), or paclitaxel alone (ORR = 14%, median PFS = 2.9 months; median OS= 5.9 months); 2) docetaxel (ORR = 7%, median OS = 5.2 months) or 3) irinotecan (ORR = 0%, median OS= 4.0 months).

These numbers demonstrate the poor prognosis of this disease, and the unmet medical need for innovative therapeutic strategies.

Cancer Genome Atlas (TCGA) mapped a genomic landscape of gastric adenocarcinomas, and identified 4 sub-types:

Tumor positive for Epstein-Barr virus (EBV) (8%), which display recurrent PIK3CA mutations, extreme DNA hypermethylation, and amplification of JAK2, ErbB2, PD-L1 and PD-L2;
Microsatellite instable tumors (MSI-high) (22%), which show elevated mutation rates, including mutations of genes encoding targetable oncogenic signaling proteins (PIK3CA, ErbB2, ErbB3, and EGFR);
Genomically stable tumors (20%), which are enriched for the diffuse histological variant and mutations of RHOA or fusions involving RHO-family GTPase-activating proteins;
Tumors with chromosomal instability (50%), which show marked aneuploidy and focal amplification of receptor tyrosine kinases and VEGFA.

Most of diffuse-type gastric adenocarcinomas were classified in genomically stable tumors. This subgroup of cancers, accounting for about 20 to 30% of gastric adenocarcinomas, is associated with particularly poor prognosis and resistance to chemotherapy. A proteomic landscape of diffuse-type gastric adenocarcinomas was recently reported.

Pembrolizumab, an anti-PDL1 drug granted with an accelerated approval by FDA in September 2017, exhibited promising activity in gastric adenocarcinoma patients previously treated with 1 or 2 lines of chemotherapy (ORR=11.6%, median PFS = 2.0 months, median OS= 5.6 months), especially in those with PDL1 positive tumors (ORR=22.7%). The tumor response was particularly high in patients with MSI-high tumor (ORR=57.1%). However the preliminary outcomes of the phase III KEYNOTE-061 trial (NCT02370498) recently released in the press suggest that pembrolizumab was not superior to paclitaxel in 592 patients with advanced gastric or gastroesophageal junction adenocarcinoma whose disease progressed after first-line treatment with platinum and fluoropyrimidine doublet therapy (the hazard ratio (HR) for OS was 0.82 (95% confidence interval = 0.66-1.03; one sided P = .042) (http://www.ascopost.com/News/58377).

These outcomes suggest that, although being very promising, immunotherapy should be combined to other agents for being fully effective in gastric adenocarcinomas patients.

We propose a strategy based on molecular features to select the drugs that will be associated with atezolizumab, an anti-PDL1 drug, in patients with pre-treated advanced gastric adenocarcinomas:

Patients with tumors positive for EBV or microsatellite instable tumors (30%) will be treated with atezolizumab and ipatasertib.
Patients with genomically stable tumors (20%) will be treated with atezolizumab combined with bevacizumab.
Patients with tumors with chromosomal instability (50%) will be treated with atezolizumab combined with bevacizumab.

Expected outcomes:

IMMUNOGAST trial will provide data about the clinical feasibility of biomolecular characterization of gastric adenocarcinomas for routine treatment adjustment. Moreover it should generate information about the relevance of adjusting combined immunotherapies based on molecular subtypes, in terms of clinical efficacy. Finally, translational research project outcomes should provide important data about relationships between efficacy and tumor immune gene spatial expression, along with tumor and circulating mutational burden. These outcomes may help identify the best candidates for tested combinations in the future.


title: SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.

acronym: SPONDIMMO

summary:
Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.

The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility:
Paris University Hospital
Rennes University Hospital
Quimper Hospital
Tours University Hospital
Clermont ferrand University Hospital
Angers University Hospital
La Roche Sur Yon Hospital
Nantes University Hospital
Saint-Nazaire Hospital


title: A Multicenter, Prospective, Multi-organ Study to Evaluate the Clinical Benefit of an Exome "Complex" Analysis Versus an Exome "Simple" Analysis to Help the Therapeutic Decision for the Precision Medicine

summary:
The "simple" analysis of the exome can determine somatic and constitutional mutations. The major challenge lies in the translation of sequencing data into clinically relevant information allowing the clinician to guide his decision-making A "complex" analysis of the exome would provide access to structural DNA data, concerning mutational signatures, tumor mutational load, analysis of large deletions, loss of heterozygosity as well as amplification of certain genes which may have an impact on the management of patients.

No data available to date makes it possible to assess the clinical interest of the availability of its additional information resulting from a "complex" analysis compared to a "simple" analysis. The objective of the EXOMA2 study is to assess the proportion of patients for whom the proposed therapy is derived from its additional information (complex analysis) and would not have been possible with a classic exome analysis (simple analysis) .

We hereby formulate the hypothesis that a "complex" analysis on a population presenting a metastatic or locally advanced disease treated early (from the 1st line of treatment) will make it possible to determine therapeutic indications which could not be discovered with a "simple" analysis.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Chu Poitiers
Centre Oscar Lambret
CHU Amiens Picardie
CHRU Jean Minjoz
Institut Hospitalier Franco-Britannique
CGFL
CHU François Mitterrand
CHU Nantes
Institut Bergonie


title: Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)

acronym: DOXYVAC

summary: The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Necker-Enfants Malades
Hôpital Pitié-Salpétrière
Hôpital Tenon
Hôpital Bichat
Hôpital pitié Salpetrière
Hôpital Hôtel Dieu
Hôpital Européen Georges Pompidou
Hôpital Saint-Antoine
Hôpital Saint-Louis


title: Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS)

acronym: TAAS

summary: This project aim to correlate risk factors (genetic, therapeutic and socio-demographic factors) to anti-αIIbβ3 antibodies formation following blood products transfusion (platelets or packed red cells) or pregnancy in a national cohort of GT patients.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Bordeaux - Hôpital Pellegrin
CHU Strasbourg
CHU Toulouse
CHU Limoges
CHU Bordeaux - Hôpital Haut-Lévêque
CHU Nîmes
CHU Poitiers
Hôpital Bicêtre, APHP
Hôpital la Timone, APHM

intervention_type: Biological


title: Impact of Early Haemodynamic Assessment by Echocardiography on Organ Dysfunction of Patients Admitted in the Emergency Department for Sepsis or Septic Shock

acronym: GENESIS

summary: Acute circulatory failure that combines hypovolemia, vasoplegia and cardiac dysfunction plays a major role in the development of sepsis-related organ dysfunction. Pathophysiological mechanisms are multiple and complex. The objective of the GENESIS study is to determine the impact of early haemodynamic assessment using echocardiography in association with a therapeutic algorithm (intervention arm), when compared with standard of care based on the current Surviving Sepsis Campaign (SSC) recommendations (control arm), on the development of organ dysfunctions in patients admitted to the Emergency Department for sepsis or septic shock.

lead_sponsor: University Hospital, Limoges

location_facility:
Hospices civils de Lyon
Nice university hospital
Bordeaux university hospital
Limgoes university hospital
La réunion university hospital
Poitiers university hospital
Toulouse university hospital
Grenoble university hospital
Nantes university hospital


title: COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne

acronym: AntiCoV-HB

summary: Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)

intervention_type: Behavioral


title: COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)

summary:
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.

In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.

Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).

Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.

High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.

Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.

We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

ReferenceCitation: Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16.

family: Shakoor

full_name: Hira Shakoor

given: Hira

family: Feehan

full_name: Jack Feehan

given: Jack

family: Al Dhaheri

full_name: Ayesha S. Al Dhaheri

given: Ayesha S.

family: Cheikh Ismail

full_name: Leila Cheikh Ismail

given: Leila

family: Ali

full_name: Habiba I. Ali

given: Habiba I.

family: Alhebshi

full_name: Salma Hashem Alhebshi

given: Salma Hashem

family: Apostolopoulos

full_name: Vasso Apostolopoulos

given: Vasso

family: Stojanovska

full_name: Lily Stojanovska

given: Lily

journal_name: Maturitas

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Annweiler C, Beaudenon M, Gautier J, Simon R, Dubée V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5.

apc_source: openAPC

family: Annweiler

full_name: Cédric Annweiler

given: Cédric

name: on behalf of the COVIT-TRIAL study group

family: Beaudenon

full_name: Mélinda Beaudenon

given: Mélinda

family: Gautier

full_name: Jennifer Gautier

given: Jennifer

family: Simon

full_name: Romain Simon

given: Romain

family: Dubée

full_name: Vincent Dubée

given: Vincent

family: Gonsard

full_name: Justine Gonsard

given: Justine

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

journal_name: Trials

location_facility:
CHU Angers
CH Saumur
CHU Limoges
CH Le Mans
CHU Saint Etienne
CHU Bordeaux
CHU Tours
CHU Nantes
CHU Nice


status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

primary_purpose: Prevention

acronym: COVIDAXIS

location_facility:
CHU de Saint-Etienne
CHU de Nantes
CHU de Nancy
CHU d'Angers
CHU de Bordeaux
CHU de Clermont-Ferrand
CHU de Montpellier
CHU de Rennes
CHU de Rouen

title: Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial

summary:
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.

In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.

As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.

The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.

Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:


title: A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion

acronym: KISS

summary: KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

lead_sponsor: Ceric Sàrl

location_country:
Italy
Switzerland
France
Spain
United Kingdom
Portugal

location_facility: Freeman Hospital Newcastle Newcastle Upon Tyne, Tyne and Wear

location_facility: CHUV Centre Hospitalier Universitaire Vaudois


title: Liver and Metabolic Effects of Insulin Pump Therapy in a Population of Type 2 Diabetics With Non-alcoholic Hepatic Steatosis

acronym: STEATO-POMPE

summary:
The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. The presence of a NAFLD is positively correlated with the severity of insulin resistance and dysglycemia in this population. The presence of NAFLD worsens the prognosis of T2D with an increased cardiovascular risk. This hepatic impairment would also increase the risk of microvascular complications, especially nephropathy. Conversely, T2D increases the risk of transition from NAFLD to NASH and then to hepatic fibrosis and its related complications (cirrhosis, hepatocellular carcinoma). The risk of progression of liver steatosis to fibrosis is also more important as diabetes and insulin resistance are more severe.

In addition to diabetes and insulin resistance, other risk factors are associated with more severe liver damage such as changes in microbiota. Indeed, it has already been described a smaller amount of bacteroides in the microbiota of subjects with T2D and the most severe hepatic impairment. The treatment of NAFLD/NASH is poorly codified without approved drugs in this indication, while many phase 3 trials with candidate drugs are undergoing. Life-style measures (physical activity and low carbohydrate/calorie diet) can limit the progression from NAFLD to more severe liver fibrosis. Some bariatric surgery studies have also shown good results in this situation. Pharmacological interventions are also reported with proven efficacy of pioglitazone, vitamin E and orlistat.

The OPT2MISE study has recently shown the superiority of insulin pump (or continuous sub-cutaneous insulin infusion: CSII) compared to multiple daily insulin injections (MDI) to improve glycemic control in a population of patients with T2D in failure of well-titrated MDI. In addition, treatment with CSII showed a 45% decrease in insulin resistance (assessed by HOMA-IR) in a population of newly diagnosed T2D.

In light of these data, investigators hypothesize that the introduction of insulin pump treatment in a population of subjects with T2D and NAFLD, by improving insulin sensitivity, could reduce fatty liver content compared to standard MDI treatment.

primary_purpose: Other

location_facility:
CHU de Rennes
Nantes UH
CHU
Hospices Civils


title: Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period

acronym: DIABELOOP SP8

summary:
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.

Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.

Then, a 3-month study phase will be performed during 12 weeks:

1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

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

location_facility: Necker-Enfants Malades University Hospital

location_facility: Marseille - La Conception University Hospital

intervention_type: Device


title: Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial

acronym: ADAMOPA

summary: In emergency medicine, acute pain is a common reason for consultation. It is recommended that patients in moderate to severe pain should receive a combination of intravenous acetaminophen and morphine. However, the data are sparse to support this strategy. Thus, the purpose of our research is to test non-inferiority of IV morphine alone versus IV acetaminophen and morphine in a multicenter, randomized, controlled double blind trial in ED patients with moderate to severe acute pain.

location_facility: La Pitié-Salpêtrière University Hospital


title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

acronym: ESOLANE

summary:
DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling.

In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

lead_sponsor: Laboratoires Vivacy

location_facility:
CHU Croix-Rousse
Clinique de l'Europe
Chu Henri Mondor
Private office
Centre de la femme


title: MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study

summary: MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study

lead_sponsor: Octapharma

location_facility:
Paris Study Site - Lariboisiere
Saint Denis Study Site - Pediatrie
Clamart Study Site
Paris Study Site - Necker
Rouen Study Site
Saint-Etienne Study Site
Caen Study Site
Rennes Study Site
Saint Denis Study Site


title: Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

acronym: SCAR-AF

summary: This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

lead_sponsor: French Cardiology Society

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Saint Joseph Saint Luc


title: Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients

acronym: OPRICA

summary:
Infections on joint replacements remain one of the most serious complications of orthopaedic surgery. Despite improvements in skin preparation and antibiotic prophylaxis procedures, the risk of infection of joint prosthesis is still high, particularly for shoulder prostheses, especially in men. One of the bacteria most often involved in post-operative infections for shoulder prosthesis is Cutibacterium acnes (CA). This bacterium is one of the predominant bacteria in pilosebaceous units. Eradication of this micro-organism remains difficult despite the techniques used in the preoperative phase.

The objective of this protocol is to evaluate the efficacy of applying a 5% benzoyl peroxide topical during the 5 days preceding the procedure in the surgical skin incision area, which is based on local acne treatment, on the reduction of the CA bacterial load in the dermis of the approach to shoulder arthroplasty in men.

location_facility:
CHU de Nantes
CHU d'Angers
Institut Locomoteur de l'Ouest
CHU de Tours
Clinique Saint Michel Sainte Anne
Santé Atlantique
CHU de Rennes
CHU de Brest
CHBA


title: A GINECO Phase II Trialo Assessing the Safety and the Efficacy of the Bevacizumab (FKB238), Olaparib and Durvalumab (MEDI 4736) Combination in Patients With Advanced Epithelial Ovarian Cancer in Relapse

acronym: BOLD

summary: Assessing the safety and efficacy of the bevacizumab (FKB238), Olaparib and Durvalumab (MEDI 4736) combination in patient with high grade serous or high grade endometrioid or other high grade epithelial non mucinous ovarian tumor, with at least one previous line of platinum-taxane chemotherapy, and present with platinum resistant disease (PRR) or platinum-sensitive relapse (PSR), whatever the line of chemotherapy given at relapse.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon


title: CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

acronym: CABRAMET

summary: This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de l'Ouest-Site Paul Papin

location_facility: Institut de Cancérologie de l'Ouest-site René Gauducheau


title: Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation

acronym: ProDUCT-HF

summary: The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

location_facility:
Ch Annecy
CH PUY
CH RIOM
CHU de GRENOBLE
Ch Issoire
Ch Moulins
Ch Lyon Sud
Infirmerie Protestante de Lyon
Chu Clermont-Ferrand


title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse

acronym: TAPP

summary: The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

ReferenceCitation: Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x.

family: Lacorre

full_name: A. Lacorre

given: A.

family: Vidal

full_name: F. Vidal

given: F.

family: Campagne-Loiseau

full_name: S. Campagne-Loiseau

given: S.

family: Marin

full_name: B. Marin

given: B.

family: Aubard

full_name: Y. Aubard

given: Y.

family: Siegerth

full_name: F. Siegerth

family: Mesnard

full_name: C. Mesnard

given: C.

family: Chantalat

full_name: E. Chantalat

given: E.

family: Hocke

full_name: C. Hocke

family: Gauthier

full_name: T. Gauthier

given: T.

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_facility:
CHU de Saint-Etienne
CHU de Clermont Ferrand
CHU de Limoges
CHU de Bordeaux
CHU de Toulouse - Rangueil
CH de Tulle
CH de Gueret
CH de Brive
CHU de Toulouse - Paule de Viguier


title: A Prospective Multicenter, Comparative, Randomized, Double-blind, Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® in Patients With Moderate to Severe Dry Eye Syndrome

summary:
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices.

Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.

lead_sponsor: SIFI SpA

location_country: France Spain

location_facility:
CHU Saint Etienne/Hôpital Nord
CHU de Bordeaux - Hôpital Pellegrin
Centre Monticelli
Hopital La Timone Adultes
Hopital Bretonneau
Chu Morvan
Hospital Universitario Virgen Macarena
Hôpital de la Croix Rousse
Hospital Recoletas Campo Grande
CHU François Mitterand
Instituto Oftalmologico Fernandez-Vega
CHU de Nice - Hôpital Pasteur


title: Lung Water By Ultra-Sound Guided Treatment To Prevent Death and Cardiovascular Complications in High Risk End Stage Renal Disease Patients With Cardiomyopathy (Lust Study)

acronym: LUST

summary:
Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function.

Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.

The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

ReferenceType: background

ReferenceCitation: Kramer A, Stel V, Zoccali C, Heaf J, Ansell D, Grönhagen-Riska C, Leivestad T, Simpson K, Pálsson R, Postorino M, Jager K; ERA-EDTA Registry. An update on renal replacement therapy in Europe: ERA-EDTA Registry data from 1997 to 2006. Nephrol Dial Transplant. 2009 Dec;24(12):3557-66. doi: 10.1093/ndt/gfp519. Epub 2009 Oct 9.

ReferenceCitation: Charra B, Calemard E, Ruffet M, Chazot C, Terrat JC, Vanel T, Laurent G. Survival as an index of adequacy of dialysis. Kidney Int. 1992 May;41(5):1286-91.

ReferenceCitation: Sinha AD, Agarwal R. Can chronic volume overload be recognized and prevented in hemodialysis patients? The pitfalls of the clinical examination in assessing volume status. Semin Dial. 2009 Sep-Oct;22(5):480-2. doi: 10.1111/j.1525-139X.2009.00641.x. Epub 2009 Sep 9.

ReferenceCitation: Staub NC. Pulmonary edema. Physiol Rev. 1974 Jul;54(3):678-811. Review.

ReferenceCitation: Crandall ED, Staub NC, Goldberg HS, Effros RM. Recent developments in pulmonary edema. Ann Intern Med. 1983 Dec;99(6):808-22. Review.

ReferenceCitation: Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70.

ReferenceCitation: Picano E, Gargani L, Gheorghiade M. Why, when, and how to assess pulmonary congestion in heart failure: pathophysiological, clinical, and methodological implications. Heart Fail Rev. 2010 Jan;15(1):63-72. doi: 10.1007/s10741-009-9148-8. Review.

ReferenceCitation: Picano E, Frassi F, Agricola E, Gligorova S, Gargani L, Mottola G. Ultrasound lung comets: a clinically useful sign of extravascular lung water. J Am Soc Echocardiogr. 2006 Mar;19(3):356-63. Review.

ReferenceCitation: Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5.

ReferenceCitation: Mallamaci F, Benedetto FA, Tripepi R, Rastelli S, Castellino P, Tripepi G, Picano E, Zoccali C. Detection of pulmonary congestion by chest ultrasound in dialysis patients. JACC Cardiovasc Imaging. 2010 Jun;3(6):586-94. doi: 10.1016/j.jcmg.2010.02.005.

ReferenceCitation: Cice G, Ferrara L, Di Benedetto A, Russo PE, Marinelli G, Pavese F, Iacono A. Dilated cardiomyopathy in dialysis patients--beneficial effects of carvedilol: a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2001 Feb;37(2):407-11.

lead_sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

location_country: Italy France Poland Greece Israel Romania Spain Germany Slovenia

location_facility: IASIO Hospital - General Clinic of Kallithea

location_facility: CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension Unit

location_facility: Medical University of Silesia in Katowice

location_facility: Hôpital Ambroise Paré (Assistance-Publique Hôpitaux de Paris)


title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

summary: The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

ReferenceCitation: Denton CP, Hachulla É, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.

family: Denton

full_name: Christopher P. Denton

given: Christopher P.

name: National Referral Centre for Rare Systemic Auto-immune Diseases; Department of Internal Medicine; Hôpital Huriez; University of Lille; Lille France

family: Hachulla

full_name: Éric Hachulla

given: Éric

name: Charité University of Medicine; Berlin Germany

family: Riemekasten

full_name: Gabriela Riemekasten

given: Gabriela

name: Johannes Gutenberg University; Mainz, and ACURA Rheumatology Centre RLP; Bad Kreuznach Germany

family: Schwarting

full_name: Andreas Schwarting

given: Andreas

name: Actelion Pharmaceuticals Ltd.; Allschwil Switzerland

family: Frenoux

full_name: Jean-Marie Frenoux

given: Jean-Marie

family: Frey

full_name: Aline Frey

given: Aline

family: Le Brun

full_name: Franck-Olivier Le Brun

given: Franck-Olivier

name: The University of Manchester; Salford Royal NHS Foundation Trust and NIHR Manchester Musculoskeletal Biomedical Research Centre; Central Manchester NHS Foundation Trust; Manchester Academic Health Science Centre; Manchester UK

family: Herrick

full_name: Ariane L. Herrick

given: Ariane L.

name: on behalf of the Raynaud Study Investigators

journal_name: Arthritis & Rheumatology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Actelion

location_country:
Germany
United Kingdom
France


title: A Randomized Phase II Study of Fulvestrant in Combination With the Dual mTOR Inhibitor AZD2014 or Everolimus or Fulvestrant Alone in Estrogen Receptor-positive Advanced or Metastatic Breast Cancer

acronym: MANTA

summary:
This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014 versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment with (or within 12 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting. Patients will be randomised (2:3:3:2) to one of the four treatment arms:

Fulvestrant
Fulvestrant + AZD2014 (continuous daily schedule)
Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off)
Fulvestrant + everolimus

Randomization will be stratified by the following criteria:

Measurable disease (vs. non-measurable).
Sensitivity to prior endocrine therapy (sensitive versus resistant)

ReferenceCitation: Schmid P, Zaiss M, Harper-Wynne C, Ferreira M, Dubey S, Chan S, Makris A, Nemsadze G, Brunt AM, Kuemmel S, Ruiz I, Perelló A, Kendall A, Brown J, Kristeleit H, Conibear J, Saura C, Grenier J, Máhr K, Schenker M, Sohn J, Lee KS, Shepherd CJ, Oelmann E, Sarker SJ, Prendergast A, Marosics P, Moosa A, Lawrence C, Coetzee C, Mousa K, Cortés J. Fulvestrant Plus Vistusertib vs Fulvestrant Plus Everolimus vs Fulvestrant Alone for Women With Hormone Receptor-Positive Metastatic Breast Cancer: The MANTA Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1556-1564. doi: 10.1001/jamaoncol.2019.2526. Erratum in: JAMA Oncol. 2021 Feb 1;7(2):312.

name: Barts Cancer Institute, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, United Kingdom

name: Oncology–Clinical, Barts Health National Health Service Trust, London, United Kingdom

family: Schmid

full_name: Peter Schmid

given: Peter

name: Praxis fuer Interdisziplinaere Onkologie, Freiburg, Germany

family: Zaiss

full_name: Matthias Zaiss

given: Matthias

name: Kent Oncology Centre, Maidstone and Tunbridge Wells National Health Service Trust, Tunbridge Wells, United Kingdom

family: Harper-Wynne

full_name: Catherine Harper-Wynne

given: Catherine

name: Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal

family: Ferreira

full_name: Marta Ferreira

given: Marta

name: Oncology, Derriford Hospital, Plymouth Hospitals National Health System Trust, Plymouth, United Kingdom

family: Dubey

full_name: Sidharth Dubey

given: Sidharth

name: Oncology–Clinical, Nottingham University Hospitals National Health System Trust, Nottingham, United Kingdom

family: Chan

full_name: Stephen Chan

given: Stephen

name: Mount Vernon Cancer Centre, East & North Herts National Health System Trust, London, United Kingdom

family: Makris

full_name: Andreas Makris

name: Institute of Clinical Oncology, Tbilisi, Republic of Georgia

family: Nemsadze

full_name: Gia Nemsadze

given: Gia

name: Cancer Centre, University Hospitals of North Midlands National Health System Trust, Stoke-on-Trent, United Kingdom

family: Brunt

full_name: Adrian M. Brunt

given: Adrian M.

family: Kuemmel

full_name: Sherko Kuemmel

given: Sherko

name: Hospital Universitario Sant Joan De Reus, Tarragona, Spain

family: Ruiz

full_name: Isabel Ruiz

given: Isabel

family: Perelló

full_name: Antonia Perelló

given: Antonia

name: Cancer Services, Great Western Hospitals National Health System Foundation Trust, Swindon, United Kingdom

family: Kendall

full_name: Anne Kendall

given: Anne

name: Academic Unit of Clinical Oncology, University of Sheffield, Sheffield, United Kingdom

family: Brown

full_name: Janet Brown

given: Janet

name: Medical Oncology, Queen Elizabeth Hospital, Woolwich, Lewisham and Greenwich National Health System Trust, London, United Kingdom

family: Kristeleit

full_name: Hartmut Kristeleit

given: Hartmut

family: Conibear

full_name: John Conibear

given: John

name: Vall d’Hebron Institute of Oncology, SOLTI Breast Cancer Research Group, Vall d’Hebron University Hospital, Barcelona, Spain

family: Saura

full_name: Cristina Saura

given: Cristina

name: Institut Sainte Catherine, Avignon, France

family: Grenier

full_name: Julien Grenier

given: Julien

name: Zala County Hospital, Zalaegerszeg, Hungary

family: Máhr

full_name: Károly Máhr

given: Károly

name: Sf Nectarie Oncology Center Societate cu Raspundere Limitata, Craiova, Dolj, Romania

family: Schenker

full_name: Michael Schenker

given: Michael

name: Yonsei University Health System, Seoul, Republic of Korea

family: Sohn

full_name: Joohyuk Sohn

given: Joohyuk

name: National Cancer Center, Goyang-si Gyeonggi-do, Republic of Korea

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

name: Oncology Translational Medicine Unit, Innovative Medicines and Early Drug Development Biotech Unit, AstraZeneca, Cambridge, United Kingdom

family: Shepherd

full_name: Christopher J. Shepherd

given: Christopher J.

name: Ramon y Cajal University Hospital, Madrid, Spain

name: Baselga Oncology Institute, Institute of Oncology, QuironGroup, Madrid, Spain

repository_institution: Keele University - Keele Research Repository

title: Fulvestrant Plus Vistusertib vs Fulvestrant Plus Everolimus vs Fulvestrant Alone for Women With Hormone Receptor–Positive Metastatic Breast Cancer

location_country:
Spain
France
Georgia
Romania
Hungary
Portugal
Germany
United Kingdom
Korea, Republic of

location_facility: Antoine Lacassagne Centre De Lutte Contre Le Cancer De Nice

location_facility: Oncology Institute "Prof. Dr. Ion Chiricuta"

location_facility: Cafeteria Hospital San Pedro de Alcantara

location_facility: Klinik für Gynäkologie & Geburtshilfe/Brustzentrum

location_facility: Cluj County Clinical Emergency Hospital, Clinical Department of Medical Oncology

location_facility: Schwerpunktpraxis Hämatologie / Onkologie MVZ Lahr

location_facility: Schwarzwald Baar Klinikum, Villingen-Schwenningen

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Frauenärztliche Gemeinschaftspraxis - Onkologie

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Korea University Medical Center Guro Hospital

location_facility: University of Pecs, Institute of Oncology


title: Cryoballoon Ablation for Early Persistent Atrial Fibrillation

summary: The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Germany France Greece

location_facility:
Hôpital Henri Mondor
Charite - Universitaetsmedizin
Uniklinik Ulm
Krankenhaus Porz am Rhein
CHU de la Timone
Klinikum Nürnberg Süd
Henry Dunant Hospital Center
CHU de Grenoble
Clinique Pasteur
Cardioangiologisches Centrum Bethanien
St. Vinzenz-Hospital
Asklepios Klinik St. Georg
CHU - Hôpitaux de Rouen
Herz- und Diabeteszentrum NRW


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

acronym: AGENT-ISR

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

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

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

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

family: Hamm

full_name: Christian W. Hamm

given: Christian W.

family: Dörr

full_name: Oliver Dörr

given: Oliver

family: Woehrle

full_name: Jochen Woehrle

given: Jochen

family: Krackhardt

full_name: Florian Krackhardt

given: Florian

family: Ince

full_name: Hüseyin Ince

given: Hüseyin

family: Zeus

full_name: Tobias Zeus

given: Tobias

family: Berland

full_name: Jacques Berland

given: Jacques

family: Piot

full_name: Christophe Piot

given: Christophe

family: Roubille

full_name: Francois Roubille

given: Francois

family: Schult

full_name: Ingolf Schult

given: Ingolf

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Nef

full_name: Holger Nef

given: Holger

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

lead_sponsor: Hemoteq AG

location_country: Germany France

location_facility: CHU Montpellier, Hôpital Arnaud de Villeneuve

location_facility: Centre Hospitalier Saint Joseph Saint Luc de Lyon


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

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

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

lead_sponsor: Celgene

location_country:
United Kingdom
France

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


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

acronym: ESSBR

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

lead_sponsor: LifeCell

location_facility: Klinik der Universität München, Campus Innenstadt

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

location_facility: Wythenshawe Hospital UHSM NHS Foundation Trust

location_facility: Institut du Cancer de Montpellier Val d'Aurelle


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

acronym: EuroCTO

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

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

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

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

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

name: Klinikum Darmstadt GmbH, Medizinische Klinik I, Grafenstrasse 9, Darmstadt, Germany

family: Werner

full_name: Gerald S Werner

given: Gerald S

name: Hospital Clinic, Sección de Hemodinámica Cardíaca; Villaroel 170, Barcelona, Spain

family: Martin-Yuste

full_name: Victoria Martin-Yuste

given: Victoria

name: Royal Sussex County Hospital, Sussex Cardiac Centre, Eastern Road, Brighton, UK

family: Hildick-Smith

full_name: David Hildick-Smith

given: David

name: Hopital de Rangueil CHU Toulouse, Department of Cardiology, 1 avenue Jean Poulhès, Toulouse Cedex 9, France

family: Boudou

full_name: Nicolas Boudou

given: Nicolas

name: AHEPA University Hospital, 1st Department of Cardiology, Stilponos Kyriakidi 1, Thessaloniki, Greece

family: Sianos

full_name: Georgios Sianos

given: Georgios

name: Cardiology Clinic, MHAT “Tokuda Hospital Sofia”, 51B Nikola Vaptsarov Blvd., Sofia, Bulgaria

family: Gelev

full_name: Valery Gelev

given: Valery

name: Hospital Galdakao-Usansolo, Sección de Hemodinámica, barrio de labeaga s/n, Galdakao, Spain

family: Rumoroso

full_name: Jose Ramon Rumoroso

given: Jose Ramon

name: Pauls Stradins Clinical University Hospital, Institute of Cardiology and Regenerative Medicine, 13 Pilsonu street, Riga, Latvia

family: Erglis

full_name: Andrejs Erglis

given: Andrejs

name: Aarhus University Hospital, Department of Cardiology B, Skejby Aarhus N, Denmark

family: Christiansen

full_name: Evald Høj Christiansen

given: Evald Høj

name: Hospital Clinico San Carlos, Unidad de Cardiología Intervencionista, Profesor Martin Lagos s/n, Madrid, Spain

family: Escaned

full_name: Javier Escaned

given: Javier

name: University Hospital Careggi, Division of Structural Interventional Cardiology, Largo Brambilla 3, Florence, Italy

family: di Mario

full_name: Carlo di Mario

given: Carlo

name: Institut Jacques Cartier, 6 avenue Noyer Lambert, Massy, France

family: Hovasse

full_name: Thomas Hovasse

given: Thomas

name: Bellvitge University Hospital, Unidad de Hemodinàmica y Cardiologia, C/ Feixa Llarga s/n, L'Hospitalet de Llobregat, Barcelona, Spain

family: Teruel

full_name: Luis Teruel

given: Luis

name: HELIOS Klinik Krefeld, Medizinische Klinik I, Lutherplatz 40, Krefeld, Germany

family: Bufe

full_name: Alexander Bufe

given: Alexander

name: Zentralklinik Bad Berka, Klinik für Kardiologie, Robert-Koch-Allee 9, Bad Berka, Germany

family: Lauer

full_name: Bernward Lauer

given: Bernward

name: Leuven Biostatistics and Statistical Bioinformatics Centre, L-BioStat. Kapucijnenvoer 35, Leuven, Belgium

family: Bogaerts

full_name: Kris Bogaerts

given: Kris

name: Hospital Universitario Puerta de Hierro, Servicio de hemodinamica y arritmias, Joaquin Rodrigo, 2, Majadahonda, Spain

family: Goicolea

full_name: Javier Goicolea

name: Royal Infirmary of Edinburgh, Department of Cardiology, 51 Little France Crescent, Edinburgh, UK

family: Spratt

full_name: James C Spratt

given: James C

name: Glenfield Hospital, Leicester Cardiovascular Biomedical Research Unit, Groby Road, Leicester, UK

family: Gershlick

full_name: Anthony H Gershlick

given: Anthony H

name: Department of Clinical and Experimental Medicine, University of Catania, Via Antonello da Messina 75, Catania, Italy

family: Galassi

full_name: Alfredo R Galassi

given: Alfredo R

family: Louvard

full_name: Yves Louvard

given: Yves

journal_name: European Heart Journal

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

location_country:
Italy
United Kingdom
France
Spain
Germany
Latvia

location_facility: Unidad de Cardiología Intervencionista Hospital de Sant Pau

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

location_facility: National Heart and Lung Institute Imperial College

location_facility: Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita

location_facility: Cardiovascular Institute - Hospital Clinico San Carlos

location_facility: Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

location_facility: Department of Cardiovascular Sciences University of Leicester

location_facility: Institut Hospitalier Jacques Cartier - ICPS


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

acronym: REPARO

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

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

family: Yanai

full_name: Ryoji Yanai

given: Ryoji

family: Nishida

full_name: Teruo Nishida

given: Teruo

family: Chikama

full_name: Tai-Ichiro Chikama

given: Tai-Ichiro

family: Morishige

full_name: Naoyuki Morishige

given: Naoyuki

family: Yamada

full_name: Naoyuki Yamada

family: Sonoda

full_name: Koh-Hei Sonoda

given: Koh-Hei

journal_name: Cornea

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Dompé Farmaceutici S.p.A

location_country:
Italy
France
Poland
Spain
Germany
United Kingdom

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

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

location_facility: Hospital Clinic de Barcelona - Oftalmología

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

location_facility: Instituto Oftalmológico Fernández-Vega - Oftalmología

location_facility: "CHU Toulouse-Purpan - Service Ophtalmologie

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

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

location_facility: Azienda Ospedaliero Universitaria Careggi

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

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

location_facility: Moorfields Eye Hospital - Moorfields Eye Hospital

location_facility: Manchester Royal Eye Hospital - Manchester Royal Eye Hospital

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

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

location_facility: District Railway Hospital Katowice - Department of Ophthalmology

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

location_facility: Royal Victoria Infirmary - Dept. of Ophthalmology

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

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

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

location_facility: Vissum Corporación Oftalmológica de Alicante

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


title: Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy

summary: Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

lead_sponsor: Forest Laboratories


title: A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

summary: The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
South Africa
France
Spain


lead_sponsor: Eli Lilly and Company

location_country: Italy Germany France Spain

acronym: A Study in Patients with Non-Small Cell Lung Cancer

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: Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin With Concurrent Thoracic Radiotherapy, in Patients With Unresectable, Locally Advanced, Stage III, Nonsquamous Non-Small Cell Lung Cancer

summary: This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.


title: A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in Patients With Advanced -Stage Metastatic Malignant Melanoma

summary:
The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.

Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.

Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Italy Switzerland Spain France Poland Hungary Portugal Germany

location_facility: Azienda Ospedaliera Garibaldi, UO Oncologia Medica

location_facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3

location_facility: Klinika Onkologii Centralnego Szpitala WAM

location_facility: Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii

location_facility: Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica

location_facility: Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia

location_facility: U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"

location_facility: Instituto Catalan Oncologico, Servicio de Oncologia

location_facility: Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico

location_facility: Ospedale San Vincenzo U.O. Oncologia Medica

location_facility: Hopital Saint-Eloi Service de Dermatologie

location_facility: Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos

location_facility: Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1

location_facility: Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg

location_facility: Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia

location_facility: Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte

location_facility: Ospedale Umberto I°, Divisione di Oncologia Medica

location_facility: Hosp. Univ. de Canarias Servicio de Oncologia Medica

location_facility: Hosp. Clinic i Provincial Servicio de Oncologia

location_facility: Centre Eugene Marquis Departement d'Oncologie Medicale

location_facility: Petz Aladar Megyei Korhaz, Borgyogyaszat

location_facility: Azienda Ospedaliera S. Elia, UO di Oncologia

location_facility: UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe

location_facility: Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej

location_facility: Dermatologische Klinik der Universitat Tubingen

location_facility: Ospedale Sandro Pertini, Oncologia Medica

location_facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Orszagos Onkologiai Intezet Borgyogyaszat

location_facility: Casa di Cura San Pio X, UO Oncologia Medica

location_facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C

location_facility: IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A

location_facility: CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

location_facility: Hosp. Universitario de Jaen Servicio de Oncologia

location_facility: Ospedale Pierantoni, Divisione Oncologia Medica

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej

location_facility: Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia

location_facility: Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna

location_facility: Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie

location_facility: Istituto Europeo di Oncologia, Divisione di Chirurgia Generale

location_facility: Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva

location_facility: Hospital General Universitario de Valencia Unidad de Oncologia Medica

location_facility: Ospedale PF Calvi Dipartimento di Oncologia

location_facility: Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel

location_facility: Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano

location_facility: CHU de Limoges Hopital Dupuytren Service de Dermatologie

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica

location_facility: Klinik fur Dermatologie und Allergologie der RWTH Aachen

location_facility: Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau

location_facility: Università di Firenze Dipartimento di Scienze Dermatologiche

location_facility: Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia


title: rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

summary: This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

ReferenceCitation: Kavakli K, Makris M, Zulfikar B, Erhardtsen E, Abrams ZS, Kenet G; NovoSeven trial (F7HAEM-1510) investigators. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial. Thromb Haemost. 2006 Apr;95(4):600-5.

lead_sponsor: Novo Nordisk A/S

location_country:
France
Poland
Israel
Hungary
Spain
Turkey
United Kingdom


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

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

lead_sponsor: Tibotec BVBA

location_country:
Sweden
United Kingdom
France


title: Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial

acronym: ODS II

summary: This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).

lead_sponsor: Ethicon Endo-Surgery (Europe) GmbH

location_country:
Italy
United Kingdom
France

location_facility: Ospedale "Franchini" di Montecchio Emilia

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease

summary: This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.

ReferenceCitation: Prantera C, Lochs H, Campieri M, Scribano ML, Sturniolo GC, Castiglione F, Cottone M. Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1117-25.

ReferenceCitation: Prantera C, Lochs H, Grimaldi M, Danese S, Scribano ML, Gionchetti P; Retic Study Group (Rifaximin-Eir Treatment in Crohn's Disease). Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease. Gastroenterology. 2012 Mar;142(3):473-481.e4. doi: 10.1053/j.gastro.2011.11.032. Epub 2011 Dec 6.

family: Prantera

full_name: Cosimo Prantera

given: Cosimo

family: Lochs

full_name: Herbert Lochs

given: Herbert

family: Grimaldi

full_name: Maria Grimaldi

given: Maria

family: Danese

full_name: Silvio Danese

given: Silvio

family: Scribano

full_name: Maria Lia Scribano

given: Maria Lia

family: Gionchetti

full_name: Paolo Gionchetti

given: Paolo

journal_name: Gastroenterology

title: Rifaximin-Extended Intestinal Release Induces Remission in Patients With Moderately Active Crohn's Disease

lead_sponsor: Alfasigma S.p.A.

location_country:
Italy
France
Poland
Israel
Hungary
Russian Federation
Germany

location_facility: Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin

location_facility: Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza

location_facility: Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

location_facility: Russian Center of Functional Surgical Gastroenterology

location_facility: State Scientific Centre of Coloproctology

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej

location_facility: St. Petersburg Mechnikov State Medical Academy

location_facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika

location_facility: Novosibirsk State Medical University City Hospital #7

location_facility: Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika

location_facility: Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

location_facility: Azienda Ospedaliera Universitaria Policlinico di Torvergata

location_facility: Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat

location_facility: Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky

location_facility: Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat

location_facility: Szpital Specjalistyczny Św. Wojciecha- Adalberta

location_facility: Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

location_facility: A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: Azienda Ospedaliera "San Camillo-Forlanini"

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką

location_facility: Azienda Ospedaliera S. Giovanni Battista Molinette

location_facility: Rostov State Medical University City Hospital # 20

location_facility: Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi

location_facility: Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie