title: Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit

acronym: PROMESREA

summary:
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s).

Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors.

A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown.

Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).

location_facility: Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP


title: Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis

acronym: DTS

summary:
Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary from 6 weeks to several months depending on the medical habits. The study hypothesis is that a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.

We run a prospective multi-centric, non inferiority open label trial, randomised in two parallel groups.

The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks versus 12 weeks, on the rate of cure in this indication.

The study concerns 400 patients more than 18 years, 70 centres in France are involved.

The duration of the study is 4 years.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Desoutter S, Cottier JP, Ghout I, Issartel B, Dinh A, Martin A, Carlier R, Bernard L; Duration of Treatment for Spondylodiscitis Study Group. Susceptibility Pattern of Microorganisms Isolated by Percutaneous Needle Biopsy in Nonbacteremic Pyogenic Vertebral Osteomyelitis. Antimicrob Agents Chemother. 2015 Dec;59(12):7700-6. doi: 10.1128/AAC.01516-15. Epub 2015 Oct 5.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

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)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Zervou FN, Zacharioudakis IM, Mylonakis E. ACP Journal Club. 6 weeks of antibiotics was noninferior to 12 weeks for clinical cure in pyogenic vertebral osteomyelitis. Ann Intern Med. 2015 May 19;162(10):JC7. doi: 10.7326/ACPJC-2015-162-10-007. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American College of Physicians

ReferenceCitation: Bernard L, Dinh A, Ghout I, Simo D, Zeller V, Issartel B, Le Moing V, Belmatoug N, Lesprit P, Bru JP, Therby A, Bouhour D, Denes E, Debard A, Chirouze C, Fevre K, Dupon M, Aegerter P, Mulleman D; Duration of Treatment for Spondylodiscitis (DTS) study group. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial. Lancet. 2015 Mar 7;385(9971):875-82. doi: 10.1016/S0140-6736(14)61233-2. Epub 2014 Nov 5.

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


acronym: SADR

summary:
Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.

lead_sponsor: CHU de Reims

intervention_type: Other


title: Prelimenary Observational Study of the Influence of Adherence to the Recommandations Issued by the National Nutrition and Health Program on the Risk of Overweiht and Obesity in Children : the Case of a Municipality That Has Signed the " Ville Active PNNS " Charter

acronym: KALI SANTE

summary:
Childhood obesity has been rising steadily over the past 40 years. In 2016, the World Health Organization (WHO) observed around 340 million overweight or obese children and adolescents worldwide, including one in five in France. The causes are complex, both individual (genetic, biological, behavioral) and collective (social, economic, cultural). Childhood obesity encourages the development of chronic diseases such as diabetes and hypertension, and can affect mental health. Without early treatment, the risk of obesity persisting into adulthood is high.

In the Alpes-Maritimes region, the commune of Mouans-Sartoux has been promoting a local diet in line with PNNS-4 recommendations since 2011.

We wish to study the impact of these actions on the health of Mouans children. We propose a preliminary observational study to assess the relationship between family adherence to PNNS recommendations and the prevalence of overweight and obesity in Mouans-Sartoux elementary school children.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

status_simplified: Ongoing


type: Other Identifier

title: WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

acronym: WINTHER

summary: An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Procedure


title: Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder

acronym: IMPACT

summary:
Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.

The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.

primary_purpose: Other

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

oa_host_type: repository

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Bristol - Bristol Research

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Nottingham - Repository@Nottingham

version: acceptedVersion

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral


title: Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot

summary: The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot

lead_sponsor: Sigvaris France

sponsor_collaborators:
Sigvaris France
Clin-Experts

lead_sponsor_type: industriel


title: Study Evaluating the Effect of Compression Stockings at Constant Pressure for 28 Days on the Number of Apneas/Hypopneas Per Hour of Sleep (Index of Apneas/Hypopneas) in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment

summary:
The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea).

The main symptoms of sleep apnea-hypopnea syndrome are daytime sleepiness (caused by the fragmentation and breakdown of sleep) and nocturnal snoring; possibly accompanied by the following symptoms: non-restorative sleep, difficulty concentrating, nocturia, cognitive disorders, libido disorders.

The consequences of sleep apnea-hypopnea syndrome are multiple for the patient both in the short term and in the long term.

The short-term manifestations are as follows: daytime sleepiness, reduced alertness, difficulty driving (risk of road accidents), difficulty performing tasks (risk of accidents at work), memory and concentration problems , learning difficulties (especially in children), mood disorders. In the end, there is an alteration in the quality of life of the patient.

Sleep apnea-hypopnea syndrome also has long-term consequences: a link between sleep apnea-hypopnea syndrome and cardiovascular morbidity and mortality has been explored by several cohort studies.

Nasal ventilation by continuous positive airway pressure is considered the reference treatment for sleep apnea-hypopnea syndrome. The use of nasal ventilation by continuous positive airway pressure, compared to no treatment, is not associated with a reduced risk of cardiovascular outcomes or death in patients with sleep apnea according to a recent meta-analysis.

Mandibular advancement devices are an alternative treatment for nasal ventilation by continuous positive airway pressure. The acceptability of its treatments, whether nasal ventilation by continuous positive airway pressure or mandibular advancement devices, is not very good and some patients do not start treatment or abandon it because of the constraints related to these treatments. There is therefore a need to find other treatments.

The overnight rostral fluid displacement from the legs, related to prolonged sitting can generate edema in the neck, more precisely in the upper airways, and therefore obstructive respiratory dysfunctions responsible for sleep apnea-hypopnea syndrome. Correlations between nocturnal fluid shifts and the number of apneas/hypopneas have been demonstrated Previous studies has shown a reduction in the apnea-hypopnea index by the daytime preventive wearing of medical compression, which can reduce the extent of leg edema and the displacement of nocturnal fluids.

The aim of the present study is to show that daytime wearing of medical compression developed specifically to optimize its effect in this indication for 28 days versus not wearing it reduces the number of apneas/hypopneas in patients with sleep apnea-hypopnea syndrome.

status: Recruiting

primary_purpose: Prevention

location_facility: Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière

intervention_type: Device


type: Registry Identifier

title: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial

acronym: PrevHPV

summary: This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.

ReferenceCitation: Bocquier A, Michel M, Giraudeau B, Bonnay S, Gagneux-Brunon A, Gauchet A, Gilberg S, Le Duc-Banaszuk AS, Mueller JE, Chevreul K, Thilly N; PrevHPV Study group. Impact of a school-based and primary care-based multicomponent intervention on HPV vaccination coverage among French adolescents: a cluster randomised controlled trial protocol (the PrevHPV study). BMJ Open. 2022 Mar 24;12(3):e057943. doi: 10.1136/bmjopen-2021-057943.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Secondary schools and GPs' practices of the participating municipalities


title: Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria.

acronym: TDR-PALU

summary: The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

ReferenceType: result

ReferenceCitation: Musset L, Bouchaud O, Matheron S, Massias L, Le Bras J. Clinical atovaquone-proguanil resistance of Plasmodium falciparum associated with cytochrome b codon 268 mutations. Microbes Infect. 2006 Sep;8(11):2599-604. doi: 10.1016/j.micinf.2006.07.011. Epub 2006 Aug 10.


title: Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).

acronym: Masq-Aute

summary:
The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices by healthcare personnel to limit their contamination.

However, there is currently a shortage of masks in France due to insufficient national stocks while the disease is spreading.

There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to provide care in complete safety. Contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. Caregiver protection is also intended to contain the risk of nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks provide optimal security against the risk of aerosolization of contaminated biological liquids. They are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and Chemical) atmosphere.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?

acronym: Happy-Fiv

summary:
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.

HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.

Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.

lead_sponsor: CMC Ambroise Paré


title: Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers

acronym: OROPAP

summary: The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared


title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin

summary: The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.

status: Terminated

lead_sponsor: ValoTec

sponsor_collaborators: ValoTec APHP

status_simplified: Unknown


title: Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children

acronym: COENZYME

summary:
The main purpose of this study is the comparison of frequency of vomiting episodes (number of episodes per year) observed during the year after the begin of Q10 coenzyme treatment to frequency observed during the year before the begin of this treatment in children with cyclic vomiting syndrome.

Secondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.

lead_sponsor: Central Hospital, Nancy, France


title: SyncAV Post-Market Trial

acronym: SyncAV

summary: The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

lead_sponsor: Abbott Medical Devices

location_country:
Finland
Germany
Poland
Australia
Japan
Thailand
Canada
Serbia
France
Colombia
Portugal
Hong Kong
Switzerland
United States
India
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
United Arab Emirates
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Russian Federation
Sweden

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

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Meshalkin National Medical Research Center

location_facility: Clinical Center of Serbia - Pacemaker Center

location_facility: New York Presbyterian Brooklyn Methodist Hospital

location_facility: Azienda Ospedaliera Universitaria MaterDomini

location_facility: Asian Institute of Gastroenterology (AIG) Hospital

location_facility: Helsinki University Central Hospital (HYKS)

location_facility: Keimyung University Dongsan Medical Center

location_facility: Hospital Puerta de Hierro - Hospital Universitario

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: McGill University Health Centre General Hospital

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Narayana Institute of Cardiac Sciences, Bommasandra

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Cardiac Arrhythmia Research Group Inc. (CARGI)

location_facility: Cardiovascular Associates of the Delaware Valley


title: A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

summary: The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

lead_sponsor: ImmunityBio, Inc.

location_country:
Italy
Poland
Hungary
Israel
Denmark
Australia
Netherlands
United States
Spain
Chile
Canada
Russian Federation
France

location_facility: Wake Forest University Baptist Medical Center

location_facility: University Hospitals Case Medical Center

location_facility: Sharet Institute of Oncology Hadassah Ein Karem Medical Center

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan

location_facility: Instituto Clinico Oncologica del Sur (ICOS)

location_facility: Azienda Ospedaliero-Universitaria di Bologna-Policlinico S Orsola-Malpighi

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: Centre Hospitalier Regional et Universitaire - Hospital Bretonneau

location_facility: Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: The James Cancer Hospital and Solove Research Institute


title: A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With REN001 in Patients With Primary Mitochondrial Myopathy

acronym: STRIDE

summary: This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.

lead_sponsor: Reneo Pharma Ltd

location_country:
Germany
Italy
New Zealand
Hungary
Norway
Denmark
Australia
United Kingdom
Netherlands
Belgium
United States
Spain
Czechia
Canada
France

location_facility: IRCCS Istituto delle Scienze Neurologiche

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: University of Pécs Clinical Centre, Department of Neurology

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta" UOC Genetica Medica e Neurogenetica

location_facility: Queen Square Centre for Neuromuscular Diseases

location_facility: University of Texas SouthWestern Medical Center

location_facility: Centre Hospitalier Universitaire d' Angers

location_facility: Medical Center of the University of Munich Friedrich Baur Institute at the Neurological Clinic and Polyclinic

location_facility: University Hospital Bonn Clinic and Polyclinic for Neurology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Neurophysiopathology Unit

location_facility: Rigshospitalet, University of Copenhagen

location_facility: Adult Metabolic Diseases Clinic, Vancouver General Hospital

location_facility: Centre for the Treatment of Pediatric Neurodegenerative Disease, University of Texas McGovern Medical School

location_facility: A.O.U Policlinico di Messina U.O.C Neurologia e Malattie Neuromuscolari

location_facility: Semmelweis University Insitute of Genomics and Rare Disorders

location_facility: Columbia University Irving Medical Center

location_facility: Azienda Ospedaliero-Universitaria Pisana Dipartimento di specialita' mediche UOC Neurologia

location_facility: M.A.G.I.C. Clinic (Metabolics and Genetics in Calgary)

location_facility: Myology Institute, University of Florida

location_facility: Hospital Universitari i Politècnic La Fe


title: AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

summary: This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.

status: Active, not recruiting

lead_sponsor: Syndax Pharmaceuticals

location_country:
Germany
Italy
Poland
Portugal
Israel
Singapore
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Canada
France

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: University of Oklahoma - Health Sciences Center

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Weill Medical College of Cornell University

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fondazione Policlinica Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. (IPO-Lisboa)

location_facility: CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

location_facility: Hospital Universitario Marquis de Valdecilla

location_facility: Washington University School of Medicine

location_facility: University Hospital of West Attica - Attikon - Hematology Division

location_facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: McGill University Health Center - Research Institute

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: The University of Chicago Medical Center (UCMC)

location_facility: University of Alabama at Birmingham - Children's of Alabama

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: General Hospital of Thessaloniki G. Papanikolaou - Hematology Department, BMT Unit

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii

location_facility: University of Wisconsin - Carbone Cancer Center

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Froedtert Hospital and the Medical College of Wisconsin


title: A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

acronym: SURPASS-SWITCH

summary: The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Romania
Mexico
Belgium
United States
France

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: Medizinisches Versorgungszentrum am Bahnhof Spandau

location_facility: Iowa Diabetes and Endocrinology Research Center

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

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Alliance for Multispecialty Research, LLC

location_facility: North Hills Family Medicine/North Hills Medical Research

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Unidad de Investigación Clínica y Atención Médica HEPA

location_facility: Diseno y Planeacion en Investigacion Medica


type: EudraCT Number

title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

ReferenceCitation: Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.

repository_institution: DEAKIN - Own your potential

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

lead_sponsor: AbbVie

location_country:
United States
Australia
Taiwan
France

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 154441

location_facility: HonorHealth Research Institute - Pima /ID# 155461

location_facility: South Texas Accelerated Research Therapeutics /ID# 154442

location_facility: UC Davis Comprehensive Cancer Center - Main /ID# 154439


title: A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/ Refractory Primary Central Nervous System Lymphoma

acronym: STAR CNS

summary: The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.

lead_sponsor: GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
France
New Zealand
Australia
United States
Canada
Israel

location_facility: La Pitie-Salpetriere University Hospital

location_facility: Memorial Sloan Kettering Cancer Center Main Campus

location_facility: CHU APHM la Timone / Aix Marseille University


title: Clinico-biological Study/Characterization of Rhabdomyosarcoma in AYA (Adolescents and Young Adults, 15-25-year-old Patients)

summary:
Rhabdomyosarcoma (RMS) stands for the most frequent soft tissue sarcoma in children and, adolescents and young adults (AYA, 15-25-year-old population), accounting for approximately half of the whole soft tissue sarcomas in these populations.. Conversely, RMS represents a very small proportion of the soft tissue sarcomas in adults (3%), that is less than 1% of all solid cancers of adults.

To date, previous studies undertaken among the paediatric population have pointed out several prognostic factors such as tumor localisation, tumor invasiveness at diagnosis, tumor size, histological subset, and treatment plans. Age at diagnosis remains an independent prognostic factor.

RMS management is consensual in Europe for paediatric population, essentially based on the protocol RMS 2005 within the framework of the European Paediatric Soft tissue sarcoma Study Group (EpSSG). Care in AYAs remain heterogeneous and are either achieved in paediatric department, according to EpSSG guidelines, or in oncology department, known as "adult unit", depending on ESMO (European Society for Medical Oncology), which are non-specific recommendations for the management of rhabdomyosarcoma.

No consensus has been published yet for RMS in AYA despite the growing interest in cancers in AYA population - topic.supported by the French National Cancer Institute (INCa) - and the increasing network between paediatricians and adult-oncologists. Thus management of RMS in AYA remains patchy/unequal depending on the type of care unit.

Herein, with the support of the Oscar Lambret Center, we aim at assessing and identifying clinico-biological prognostic factors of rhabdomyosarcoma in AYA. Eventually, we hope to offer a standardized treatment to this population. Data collected from medical file will be anonymised in a confidential database of which the recipient is the sponsor of the study.

The ancillary study will aim at characterizing the molecular profile of the difficult-to-classify RMS subtypes (fusiform or pleomorphic subsets) in molecular biology for ambiguous cases.

From a scientific point of view, this study aims at understanding the parameters that may influence the prognosis of RMS in AYAs by evaluating various clinical and biological factors.

Biologically, molecular profiling of RMS in AYA may improve the characterization of this tumour in this age group.

At the clinical level, the completeness of the data collected will lead to a better description of RMS in AYAs. We hope to harmonize their therapeutic management by providing therapeutic adjustments according to population subsets.

Finally, these results could also help to adapt the therapeutic management of AYAs within the framework of the European protocol that is currently under construction, and will involve both children and adults.

lead_sponsor: Centre Oscar Lambret

collaborators: Société Française de lutte contre les Cancers et les leucémies de l'Enfant et l'adolescent

location_facility: LILLE Centre Oscar Lambret/ CHRU de Lille

location_facility: NANCY Institut de Cancérologie de Lorraine

location_facility: NANTES Institut de Cancérologie de l'Ouest

location_facility: TOURS CHU-Bretonneau/Hôp G de Clocheville


title: Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Effect of a 30-week Caffeine Treatment on Cognition in Alzheimer's Disease at Beginning to Moderate Stages

acronym: CAFCA

summary:
Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available.

Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable.

The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).

lead_sponsor: University Hospital, Lille

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility: CHU Lille consultation mémoire Les Bâteliers

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: CAFCA

titre: Essai randomisé multicentrique en double aveugle, contre placebo, évaluant l'effet de la caféine pendant 26 semaines sur la cognition dans la maladie d'Alzheimer à un stade débutant à modéré.

discipline_principale: maladie d'alzheimer caféine prévention secondaire

nom_porteur: LEBOUVIER

prenom_porteur: Thibaud


title: High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial

acronym: PASTA

summary:
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.

Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.

Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.

Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.

The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.

This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

ReferenceCitation: Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.

ipd_sharing_description: It is not planned to share individual participant data to other researchers.

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_country:
Germany
United Kingdom
Australia
Switzerland
Austria
France

location_facility: Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin

location_facility: Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants

location_facility: Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie

location_facility: Universitätsklinik für Kinder und Jugendheilkunde Wien

location_facility: Luzerner Kantonsspital, Kinderspital, Neuropädiatrie

location_facility: Ospedale Regionale di Bellinzona e Valli


acronym: Hubble

lead_sponsor: Takeda

summary: The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Universitatsmedizin Rostock - Kinder und Jugendklinik

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Children's Specialty Group - Medical Center Location

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

location_facility: London Health Sciences Centre University Hospital

location_facility: University Hospitals Rainbow Babies & Children's Hospital

location_facility: Kharkiv Regional Clinical Children's Hospital

location_facility: Schneider Children's Medical Center of Israel

location_facility: The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: McGill University Health Centre Glen Site

location_facility: Nemours Childrens Specialty Care - Jacksonville

location_facility: National Scientific Center of Radiological Medicine of NAMS of Ukraine

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Children's and Women's Health Centre of British Columbia

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: Children's Center for Digestive Healthcare

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Nottingham University Hospitals NHS Trust

title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

source: euctr

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Poland
Hungary
Israel
United Kingdom
Netherlands
Belgium
United States
Canada
Ukraine
France


lead_sponsor: UNICANCER

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

publisher_dissemination: Informa

ReferenceCitation: Lui G, Treluyer JM, Fresneau B, Piperno-Neumann S, Gaspar N, Corradini N, Gentet JC, Marec Berard P, Laurence V, Schneider P, Entz-Werle N, Pacquement H, Millot F, Taque S, Freycon C, Lervat C, Le Deley MC, Mahier Ait Oukhatar C, Brugieres L, Le Teuff G, Bouazza N; Sarcoma Group of UNICANCER. A Pharmacokinetic and Pharmacogenetic Analysis of Osteosarcoma Patients Treated With High-Dose Methotrexate: Data From the OS2006/Sarcoma-09 Trial. J Clin Pharmacol. 2018 Dec;58(12):1541-1549. doi: 10.1002/jcph.1252. Epub 2018 May 23.

ReferenceCitation: Tabone MD, Brugieres L, Piperno-Neumann S, Selva MA, Marec-Berard P, Pacquement H, Lervat C, Corradini N, Gentet JC, Couderc R, Chevance A, Mahier-Ait Oukhatar C, Entz-Werle N, Blay JY, Le Deley MC. Prognostic impact of blood and urinary angiogenic factor levels at diagnosis and during treatment in patients with osteosarcoma: a prospective study. BMC Cancer. 2017 Jun 15;17(1):419. doi: 10.1186/s12885-017-3409-z.

publisher_dissemination: Springer-Nature

ReferenceCitation: Piperno-Neumann S, Le Deley MC, Redini F, Pacquement H, Marec-Berard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werle N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretiere JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugieres L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17.

sponsor_collaborators:
UNICANCER
Novartis
Chugai Pharmaceutical
National Cancer Institute, France
SFCE
Ligue contre le cancer, France

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

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

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Dijon

title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

ipd_sharing_description: IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients.


lead_sponsor: University of Birmingham

summary:
The main purpose of this study is :

To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction
To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.)
To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy.
To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients.
To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.

sponsor_collaborators:
University of Birmingham
Assistance Publique - Hôpitaux de Paris
Cancer Research UK
National Cancer Institute, France
Pfizer

location_facility: Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire Amiens - Picardie

location_facility: Centre Hospitalier Universitaire De Rouen

location_facility: John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust

location_facility: Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve

location_facility: Centre Hospitalier Universitaire De Poitiers

location_facility: Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin

location_facility: NHS Greater Glasgow and Clyde, The Royal Hospital for Children

location_facility: Southampton University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire Vaudois Chuv Lausanne

location_facility: Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants

location_facility: Centre Hospitalier Universitaire Saint-etienne

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Royal Belfast Hospital for Sick Children

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Grenoble

location_facility: Centre Hospitalier Regional Universitaire Brest - Hopital Morvan

location_facility: Great Ormond Street Hospital For Children NHS Trust

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants

location_facility: Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De NICE

location_facility: Centre Hospitalier Universitaire De Limoges

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: NHS Lothian, Royal Hospital for Sick Children

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: Centre Hospitalier Universitaire De Clermont-ferrand

location_facility: Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville

location_facility: Centre Hospitalier Universitaire De Rennes - Hopital Sud

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire D'angers

location_facility: Centre Hospitalier Universitaire De Nancy

title: International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

location_country:
Ireland
New Zealand
United Kingdom
Australia
Switzerland
France

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

titre: Etude internationale, multicentrique, randomisée, ouverte, de phase III, pour le traitement des leucémies aiguës myéloblastiques de l'enfant et de l'adolescent

discipline_principale: pediatric hematology / childhood acute myeloid leukemia

nom_porteur: LEVERGER

prenom_porteur: Guy


title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

acronym: CULTIVATE

summary: This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

collaborators: Arena is a wholly owned subsidiary of Pfizer

sponsor_collaborators: Arena is a wholly owned subsidiary of Pfizer

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Lebanon
Belgium
Malaysia
Moldova, Republic of
Puerto Rico
Egypt
Philippines
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Georgia
Russian Federation
Israel

location_facility: OCT/PFT/Endoscopy address: Ospedale San Bortolo di Vicenza

location_facility: UF Health Radiology-Jacksonville (chest x-rays)

location_facility: Houston Pulmonary Sleep and Allergy Associates (PFT)

location_facility: Salve Health Care Sp. o.o., (PFT and Endoscopy)

location_facility: Baylor St. Luke's Medical Center Endoscopy - McNair Campus

location_facility: Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)

location_facility: OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Allied Health Clinical Research Organization, LLC

location_facility: Absolute Surgical Specialist - Craig Amshel, MD

location_facility: USF Health Morsani Center For Advanced Healthcare

location_facility: Specjalistyczne Gabinety Lekarskie LANDA

location_facility: A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente

location_facility: Mitchel & Shannon Wong Eye Institute - (OCT procedure)

location_facility: Saint George University Hospital Medical Center

location_facility: Colorado Springs Imaging (Ultrasound and MRE Location)

location_facility: Retina Consultants of Southern California

location_facility: Dr. med Mayer AUGENPRAXISKLINIK IM ALLEE-CENTER REMSCHEID

location_facility: Digestive Health Specialists (Satellite Clinic Location)

location_facility: Special Hospital for Ophthalmology "Hospital Laser Center Vid"

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD

location_facility: Dr Hannes Jansen van Rensburg (PFT + DLCO)

location_facility: Ophthalmic Physicians Incorporated (OCT Only)

location_facility: Endoscopy room of Korea University Ansan Hospital

location_facility: The Catholic University of Korea, Daejeon St. Mary's Hospital

location_facility: AKH Wien- Universitatsklinik fiir Innere Medizin III

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Academician Ye.M.Neiko Chair of Internal Medicine #1, Clinical Immunology and Allergology

location_facility: Centro Oftalmologico Dr. Carlos H.Lerner(OCT)

location_facility: Akershus University Hospital Department of Gastroenterology

location_facility: Houston Eye Associates (For Eye Examination)

location_facility: Medical Eye Services LTD (Ophthalmoscopy with OCT)

location_facility: Centro de lnvestigaciones Clinicas S.A.S

location_facility: Gabinety Lekarskie Sensor (OCT and Ophthalmoscopy)

location_facility: ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD

location_facility: Theodor Bilharz Research Institute Research Ethics Committee

location_facility: Arizona Retina Institute/ Phoenix Retina Associates(OCT)

location_facility: Luis A. Serrano Torres, MD Private Office

location_facility: Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs

location_facility: Endoscopy address: Azienda Ospedaliero-Universitaria Sant' Andrea UOD Endoscopia Digestiva

location_facility: Macquarie University Hospital Clinical Trials

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: UF Health Imaging Center-Emerson (chest x-rays)

location_facility: Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

location_facility: Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)

location_facility: Newsome Eye Specialist (OCT Procedures Only)

location_facility: Optical Coherence Tomography and Ophthalmology

location_facility: Antelope Valley Eye Care - Ophthalmologist

location_facility: Baylor College of Medicine - Baylor St. Luke's Medical Center

location_facility: National Hepatology and Tropical Medicine Research Institute

location_facility: GASTRO I., s.r.o. Gastroenterologicka ambulancia

location_facility: Memorial Endoscopy Center (For Colonoscopy)

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: BHI of Omsk region "Clinical oncology dispensary"

location_facility: OCT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOD Oculistica

location_facility: ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva

location_facility: West Coast Endoscopy Center (Endoscopy Procedures)

location_facility: Pulmonary Associates (Chest X-Ray & PFT Facility)

location_facility: Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,

location_facility: Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County

location_facility: Dothan Eyecare-Dr. Brent McKinley (OCT Location)

location_facility: MARSHALL EYE SURGEONS - HUNTINGTON (OCT and OPTHALMOSCOPY ONLY)

location_facility: PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery

location_facility: CNE Lviv Clinical Emergency Hospital, Center of Therapy,Danylo Galytskyy Lviv National Medical

location_facility: Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)

location_facility: CNE Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology,

location_facility: Centre Hospitalier Universitaire UCL Namur - Site Godinne

location_facility: PFT address: Praxis fur Pneumologie und Allergologie

location_facility: Centrum Okulistyczne Sudety, Gabinet Dzierzoniow (OCT, Ophtalmoscopy)

location_facility: Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont

location_facility: KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Joloko (OCT, Ophthalmoscopy)

location_facility: Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)

location_facility: Ponce Medical School Foundation, Inc. CAIMED Center

location_facility: PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center

location_facility: Servicios Hospitalarios de México, S.A. de C.V.

location_facility: CNE Andrii Novak Transcarpathian Regional Clinical Hospital of Transcarpathian Reg Council, Departme

location_facility: Barnes-Jewish West County Hospital (Additional Endoscopy Location)

location_facility: McGill University Health Centre - Montreal General Hospital (Pharmacy)

location_facility: Johese Clinical Research, Unitas Hospital

location_facility: Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary

location_facility: OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona

location_facility: UF Health Laboratory Emerson (blood draws)

location_facility: United Surgery Center Temecula [Endoscopy Only]

location_facility: PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia

location_facility: Premier Medical Group East (Opthalmology & Optometry Facility)

location_facility: S.C Pelican Impex S.R.L, Sectia Gastroenterologie

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

location_facility: Kocaeli Universitesi Tip Fakultesi Hastanesi

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Century City Endoscopy (Colonoscopy - Nicholas Karyotakis, MD)

location_facility: Atlanta Gastroenterology Associates (endoscopy only)

location_facility: Duke Medical Plaza North Duke Street (recruitment and study activities)

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Libertyville Imaging Center (Diagnostic Imaging)

location_facility: DLCO and ophthalmology tests: Szent Borbala Korhaz

location_facility: McGill University Health Centre - Montreal General Hospital (Radiology)

location_facility: Northwood Vision (Optical Coherence Tomography)

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia (Endoscopy)

location_facility: Quadram Institute Clinical Research Facility

location_facility: Endoscopy: CHU Grenoble Alpes- Hopital Michallon

location_facility: University of the Philippines - Philippine General Hospital

location_facility: Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc

location_facility: The University of Texas Health Science Center at Houston

location_facility: Cisca Pulmonary & Critical Care (PFT Facility)

location_facility: Servicios Medicos y de lnvestigacion Clinica Inspirepharma S de RI de CV

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Medlux. Jerzy Pukaluk, (Endoscopy)

location_facility: Baylor St. Luke's Medical Center - McNair Campus (pharmacy)

location_facility: NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center

location_facility: Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv

location_facility: Weston Outpatient Surgical Center (Endoscopy)

location_facility: Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)

location_facility: Dell Seton Medical Center at The University of Texas(DSMCUT) - (PFT procedure & Endoscopy procedure)

location_facility: Florida Pulmonary Research lnstitute - Pulmonary Function Test/DLCO

location_facility: Washington University School of Medicine

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: USF Health South Tampa Center for Advanced Healthcare

location_facility: Safety Harbor Surgery (Endoscopy Procedures)

location_facility: Cabell Huntington Hospital Center for Lung Health (PFTs Only)

location_facility: OCT/ PFT/ Endoscopy address: I.R.C.C.S. Saverio De Bellis

location_facility: Centrum Medyczne PZU Zdrowie Sw. Lukasz (Ophthalmoscopy, OCT, Endoscopy)

location_facility: Borland-Groover Clinic (Endoscopy Facility)

location_facility: OCT room of Korea University Ansan Hospital

location_facility: S.C. Euroclinic Hospital S.A., Specialitatea Gastroenterologie

location_facility: Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)

location_facility: Specjalistyczne Gabinety Lekarskie Body Clinic

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta

location_facility: The University of Texas at Austin Dell Medical School - UT Health Austin

location_facility: Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno

location_facility: ENDOMED, s.r.o. Gastroenterologicka ambulancia

location_facility: Colorado Springs Pulmonary Consultants, PC

location_facility: A V Pediatrics, Allergy and Family Medicine - PFT

location_facility: Duke Health's Brier Creek Medical Pavilion (recruitment and study activities)

location_facility: PFT Facility in Kyungpook National University Hospital

location_facility: San Antonio Military Medical Center, Department of Pathology

location_facility: Larkin Community Hospital (Endoscopy Procedure)

location_facility: Lung Center (Pulmonary Function Test only)

location_facility: SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

location_facility: Morton & Partners Radiologists (Radiology)

location_facility: Alkek Eye Center Jamail Specialty Care Center (OCT)

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.

location_facility: University of Cincinnati Medical Center (PFT and Endoscopy location)

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Pulmonary Function Test CHU Lille, Institut Coeur Poumon

location_facility: Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)

location_facility: OCT/Ophtalmoscopy address: Hochkreuz Augenklinik + Laserzentrum

location_facility: University Physicians and Surgeons (DBA: Marshall Health)

location_facility: T.C. Saglik Bakanligi Ankara Sehir Hastanesi

location_facility: Lynchburg Pulmonary Associates, Inc. (PFT only)

location_facility: University General Hospital of Alexandroupoli

location_facility: Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)

location_facility: Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO

location_facility: Clinical Center " Dr Dragisa Misovic-Dedinje"

location_facility: Cairo University , Kasr Al Aini Hospital

location_facility: Memorial Hermann Memorial City Medical Digestive Health Center

location_facility: FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF

location_facility: Surgicare of Mobile (Endoscopy & Biopsy Facility)

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Health Care Institution "Mogilev Hospital #1"

location_facility: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Malattie dell'apparato digerente

location_facility: Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro

location_facility: Clinical Medical Research sp. z o.o. (OCT. ophthalmoscopy)

location_facility: Poliklinika Dabrowska PRINN (PFT, Endoscopy)

location_facility: OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Asclepiades • interna a gastroenterologie s. r. o.

location_facility: Medical Center of Limited Liability Company Harmoniia Krasy

location_facility: Clinica Privada de Ojos Santa Lucia Mar del Plata (OCT, Ophthalmoscopy)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: CNE Reg Clinical Hospital of Ivano-Frankivsk Reg Council, Dep of Gastroenterology

location_facility: OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)

location_facility: North Shore Endoscopy Center (Endoscopy)

location_facility: South Florida Center for Endoscopy and Digestive Disease, LLC

location_facility: Laboratoire de Biologie medicale Site de Flers

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg

location_facility: NYU Langone Health - Ambulatory Care Center

location_facility: NYU Langone Inflammatory Bowel Disease Center

location_facility: Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.

location_facility: Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi

location_facility: 3T Imaging of Morton Grove (Diagnostic Imaging)

location_facility: Hospital of the university of occupational and environmental health

location_facility: NYU Pulmonary and Critical Care Associates (Pulmonary)

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki (DLCO)

location_facility: Gastrointestinal Biosciences Clinical Trials,LLC

location_facility: Retina Consultants of Southwest Florida OCT only

location_facility: UT Health East Texas Physicians (pulmonary functions only)

location_facility: S.C. Centrul Medical Unirea S.R.L., Specialitatea Gastroenterologie

location_facility: Advanced Endoscopy and Pain Center - Colonoscopy

location_facility: Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)

location_facility: Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)

location_facility: LTD Academician Nikoloz Kipshidze Central University Clinic

location_facility: Orlando Health/Digestive Health Institute

location_facility: Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)

location_facility: A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"

location_facility: PFT room of Korea University Ansan Hospital

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)

location_facility: Karkonoskie Centrum Badan Medycznych - Lexmedica

location_facility: Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria

location_facility: McGill University Health Centre - Montreal General Hospital (Research Site)

location_facility: OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan

location_facility: Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)

location_facility: Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)

location_facility: Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.

location_facility: Christus Trinity Mother Frances Endoscopy Center (endoscopies only)

location_facility: CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)

location_facility: Private Enterprise Diagnostic Center "Mediscan"

location_facility: Clarunis - Universitäres Bauchzentrum Basel

location_facility: Bay Area Endoscopy and Surgery Center (Endoscopy only)

location_facility: lnstitutul Clinic Fundeni, Sectia Medicina lnterna 2

location_facility: Healthcare Institution "Vitebsk Regional Clinical Specialized Center"

location_facility: Clinica Santa Lucia (Optical Coherence Tomography, OCT)

location_facility: St. Petersburg Endoscopy Center (Endoscopy Procedures)

location_facility: Hospital de Cirugia y Cardiologia los Angeles S.A. de C.V.

location_facility: Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University

location_facility: Special Hospital for Ophthalmology Milos Clinic

location_facility: Cabell Huntington Hospital (Endoscopy Only)

location_facility: Centro de Educacion Medica e Investigacion Clinica (CEMIC)

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)

location_facility: Microcirugia Ocular SA (OCT, Ophthalmoscopy)

location_facility: Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)

location_facility: Center for Digestive Health (Endoscopy Location)

location_facility: Special Hospital for eye diseases "Veselinovic "

location_facility: Atlanta Gastroenterology Associates(IP only)

location_facility: The trustee for The RTS Unit Trust trading as Respiratory Testing Services

location_facility: OCT/Ophtalmoscopy address: Universitaetsklinikum Jena

location_facility: GASTRO LM s.r.o., Gastroenterologicka ambulancia

location_facility: MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons

location_facility: Alberto Collado Solorzano (Clinica Vision)

location_facility: S.C Policlinica CCBR S.R.L., Specialitatea Medicina lnterna

location_facility: Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care

location_facility: (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)

location_facility: The Catholic University of South Korea, Seoul St. Mary's Hospital

location_facility: Hammoud Hospital University Medical Center

location_facility: Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Therapeutic and Interventional Damas Endoscopy Center

location_facility: Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)

location_facility: Nelson R. Medina-Moreno, MD Private Office

location_facility: Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of

location_facility: UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Southern Therapy and Advanced Research, LLC

location_facility: Baylor St. Luke's Medical Center - McNair Campus

location_facility: Queen City Gastroenterology and Hepatology (Endoscopy)

location_facility: Endoscopy Facility in kyungpook National University Hospital

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Univ.-Professor Dr. Mehrdad Baghestanian

location_facility: ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva

location_facility: Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spoka Partnerska

location_facility: Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie

location_facility: Centro de Investigaciones Clinicas de la Universidad Catolica

location_facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology

location_facility: Caromont Regional Medical Center (PFT and DCLO only)

location_facility: S.C. Quantum Medical Center S.R.L., Specialitatea Gastroenterologie

location_facility: Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)

location_facility: LLC "Siberian Center for Prevention and Treatment of Myopia Eye"

location_facility: Estudio de La Vision (OCT, Ophthalmoscopy)

location_facility: Medical University Innsbruck, Internal Medicine Ⅰ

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

location_facility: Dr W Simmonds (Gastroenterology Department)

location_facility: General Hospital of Athens of Chest Diseases "Sotiria

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II (Endoscopy)

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: S.C Medlife S.A., Departamentul Gastroenterologie

location_facility: OCT Facility In kyungpook National University Hospital

location_facility: AKH Wien- Universitatsklinik fur Innere Medizin III

location_facility: OCT/Ophtalmoscopy address: Augenarzte Krefeld, Dr. med. Christopher Kallen, Behnisch Haus

location_facility: CHU de Clermont Ferrand - Hopital Estaing

location_facility: Health Care Institution "Vitebsk Regional Clinical Hospital"

location_facility: Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna

location_facility: Lee Shettle Eye & Hearing (Ophthalmoscopy Only)

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)

location_facility: United Surgery Center Murrieta [Endoscopy Only]

location_facility: Universitatsklinikum Schleswig-Holstein- Campus Kiel

location_facility: Sleep Medicine/Pulmonary Disease (PFT - Said Mostafavi, MD)

location_facility: Health care Institution "10th City Clinical Hospital"

location_facility: Klinika SAL VITA Centrum Gastroenterologii

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi

location_facility: St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)

location_facility: Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika

location_facility: FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF

location_facility: S.C. Delta Health Care S.R.L., Specialitatea Gastroenterologie

location_facility: Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.

location_facility: UCSD Clinical and Translational Research Institute

location_facility: Endoscopy room of Dong-A University Hospital

location_facility: The Endoscopy Center (Endoscopy Procedure)

location_facility: UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)

location_facility: UF Health Jacksonville Respiratory Therapy (PFT and DLCO)

location_facility: McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)

location_facility: Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro

location_facility: Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical

location_facility: SPECTRUM - Osrodek Okulistyki Klinicznej (OCT, Ophthalmoscopy)

location_facility: Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD

location_facility: CHU BESANCON, Centre d'Investigation Clinique

location_facility: UCSD lnvestigational Drug Service Pharmacy

location_facility: Duke University Medical Center (Ileocolonoscopy, PFT & DLCO)

location_facility: Gastro Florida (Regulatory Administrative Duties)

location_facility: Center for Digestive Endoscopy - Endoscopy Facility

location_facility: ETHICS Commission of Municipal City Clinical Hospital of the Emergency Medical Care

location_facility: Bay Area Chest Physicians, P.A. (Pulmonary Function Test)

location_facility: HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

location_facility: Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)

location_facility: Encore Borland-Groover Clinical Research

location_facility: Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.

location_facility: McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)

location_facility: AV Pediatrics Allergy and Family Medicine

location_facility: Anticancer-Oncology Hospital of Athens "Agios Savvas"

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)

location_facility: Joint Stock Company Medical Center "AVICENNA"

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: Egyptian Liver Research Institute and Hospital ( ELRIAH)

location_facility: Univerisity General Hospital of Heraklion

location_facility: Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)

location_facility: Osrodek okulistyczny ,,Okolek" (OCT, Ophthalmoscopy)

location_facility: CRC - Centro Ricerche Cliniche di Verona

location_facility: Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)

location_facility: Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment

location_facility: Vilnius University Hospital Santaros Klinikos


title: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

acronym: RESPIVAC

summary: This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

lead_sponsor: ANRS, Emerging Infectious Diseases

collaborators: Institut de Recherche en Santé Publique, France

location_facility:
Hôpital Gui de Chauliac
Hôpital Cochin
CHU
Groupement hospitalier Edouard Herriot
Hôpital Bichat


acronym: GLADIATOR UC

summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

location_facility: PFT(1) Facility Severance Hospital, Yonsei University Health System

location_facility: University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD

location_facility: Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk

location_facility: FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF

location_facility: Perez Eye Center(OCT & Ophthalmoscopy only)

location_facility: West Coast Endoscopy (Colonoscopy Procedures)

location_facility: CNE "Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council", Reg Specialize

location_facility: Buderim Eye Centre( OCT and Ophthalmoscopy Facility)

location_facility: OCT Charite - Universitatsmedizin Berlin

location_facility: CCR-ICTS Center for Innovative Patient Care

location_facility: Specjalistyczny Okulistyczny Niepubliczny Zaklad Opieki Zdrowotnej OCUSERVICE

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: Multidisciplinary Medical center "Clinic Park"

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Clinical Diagnostical Center "Simedgroup"

location_facility: MEDICOME- Oswiecimskie Centrum Medyczne (OCT)

location_facility: University of Calgary, Department of Medicine - Opthalmology (OCT Only)

location_facility: Charite - Universitatsmedizin Berlin, Campus Mitte (CCM)

location_facility: IRCCS Ospedale San Raffaele, Unita di Gastroenterologia

location_facility: Medical Eye Services LTD (Ophthalmoscopy with OCT)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Retina Consultants of Southwest Florida, PA "OCT"

location_facility: Arizona Retina Institute/ Phoenix Retina Associates(OCT)

location_facility: Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)

location_facility: McGill University Health Center- Montreal General Hospital (Electrocardiogram Clinic)

location_facility: Christus Trinity Mother Frances Endosopy Center ( endoscopies only)

location_facility: Endoscopy Facility in Kyungpook National University Chilgok Hospital

location_facility: UCI Health Eye Care Services (Ophthalmoscopy and OCTs)

location_facility: Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: OCT(1) Facility in Severance Hospital, Yonsei University Health System

location_facility: PFT Facility in Kyungpook National University Chilgok Hospital

location_facility: Opthalmology tests: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont,Szemeszeti Klinika

location_facility: BHI of Omsk region "Clinical oncology dispensary"

location_facility: Health Care Institution "Vitebsk Regional Clinical Specialized Center"

location_facility: Institution "Gomel Regional Specialized Clinical Hospital"

location_facility: Transcarpathian Center of Eye Microsurgery

location_facility: West Coast Endoscopy Center (Endoscopy Procedures)

location_facility: Limited Liability Company "Lookout "Medical Center"

location_facility: Dothan Eyecare-Dr. Brent McKinley (OCT Location)

location_facility: Kendall Endoscopy and Surgery Center (Endoscopy)

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: LTD Israeli-Georgian Medical Research Clinic Helsicore

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)

location_facility: Swedish Medical Center First Hill Endoscopy Center

location_facility: Endoscopy Center at Med Point (Endoscopy only)

location_facility: Barnes-Jewish West County Hospital (Additional Endoscopy Location)

location_facility: Clarin Eye Care Center (OCT/Ophthalmoscopy)

location_facility: FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF

location_facility: CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology

location_facility: University of Cincinnati College of Medicine

location_facility: United Surgery Center Temecula [Endoscopy Only]

location_facility: Chevy Chase Endoscopy Center (Endoscopy Facility Only)

location_facility: AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review)

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

location_facility: McGill University Health Center- Montreal General Hospital (IP Address)

location_facility: Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz

location_facility: UCSD Clinical and Translational Research Institute (Research Clinic)

location_facility: PFT(2) Facility Severance Hospital, Yonsei University Health System

location_facility: Libertyville Imaging Center (Diagnostic Imaging)

location_facility: DLCO and ophthalmology tests: Szent Borbala Korhaz

location_facility: Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )

location_facility: PFT Klinik fur Infektiologie & Pneumologie

location_facility: Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,

location_facility: Washington University School of Medicine

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC

location_facility: CNE Andrii Novak Transcarpathian Regional Clinical Hospital of

location_facility: Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)

location_facility: UCI Investigational Drug Services (IDSP - Pharmacy)

location_facility: Advanced Radiology Associates (x-Ray only)

location_facility: CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology

location_facility: Endoexpert EgeszsegUgyi Szolgaltato Kft.

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: Radiology Consultants of Lynchburg (X-ray only)

location_facility: Colorado Springs Pulmonary Consultants, PC

location_facility: Clinical Hospital Russian Railways - Medicina

location_facility: Larkin Community Hospital (Endoscopy Procedure)

location_facility: Lung Center (Pulmonary Function Test only)

location_facility: Dr.Shiran DeSilva Respiratory Clinic (PFT)

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)

location_facility: Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)

location_facility: GI Alliance (Patients Seen; IP Delivered)

location_facility: Lynchburg Pulmonary Associates, Inc. (PFT only)

location_facility: Health Care Institution "Grodno City Clinical Hospital #4"

location_facility: Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Koman Family Outpatient Pavilion (Endoscopy)

location_facility: Advanced Endoscopy and Pain Center (Colonoscopy)

location_facility: Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)

location_facility: OCT(2) Facility in Severance Hospital, Yonsei University Health System

location_facility: Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific

location_facility: North Shore Endoscopy Center (Endoscopy)

location_facility: University of Utah Moran Eye Center (Opthalmoscopy/OCT)

location_facility: Montreal General Hospital (MUHC-Radiology)

location_facility: University of Utah Hospitals and Clinics (PFT)

location_facility: UT Health East Texas Physicians (pulmonary functions only)

location_facility: Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)

location_facility: LTD Academician Nikoloz Kipshidze Central University Clinic

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)

location_facility: Private Institution, Educational Organization of Higher Education "Medical University "Reaviz",

location_facility: Sunshine Coast University Private Hospital

location_facility: Fondazione Policlinico Agostino Gemelli IRCCS

location_facility: McGill University Health Center- Montreal General Hospital (Endoscopy clinic)

location_facility: Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova

location_facility: Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)

location_facility: Mater Misericordiae Hospital ( Endoscopy)

location_facility: Pinnacle Health Imaging at Tristan (X-Ray only)

location_facility: Alkek Eye Center Jamail Specialtu Care Center (OCT)

location_facility: Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

location_facility: Antelope Valley Eye Care (Ophthalmologist)

location_facility: Victoria Eye Center (OCT and Opthalmoscopy)

location_facility: CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State

location_facility: LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

location_facility: ASST Rhodense - Ophthalmology Unit (For Ophthalmoscopy)

location_facility: OCT Facility In kyungpook Natioanl University Hospital

location_facility: Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)

location_facility: UCI Irvine Medical Center - Pulmonology Services - PFTs

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Hopital Estaing

location_facility: Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)

location_facility: Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic

location_facility: St. Joseph's Hospital (OCT Procedure only)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

location_facility: Endoscopy Facility in kyungpook National University Hospital

location_facility: Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)

location_facility: Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT)

location_facility: Centro Hospitalar Universitario de Sao Joao, E.P.E

location_facility: LoCicero Medical Group (PFT Procedure Only)

location_facility: ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva

location_facility: University of Utah Clinic and Endoscopy Suite - Sugarhouse

location_facility: Baylor College of Medicine-Baylor Medical Center (IP Storage)

location_facility: Coral Sea Clinical Research Institute Pty.Ltd

location_facility: OCT Facility in Kyungpook National University Chilgok Hospital

location_facility: Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,

location_facility: Center for Digestive Health (Colonoscopy Location)

location_facility: Yale New Haven Hospital - Winchester Chest Clinic - PFT

location_facility: United Surgery Center Murrieta [Endoscopy Only]

location_facility: Inter-branch scientific and technical complex "Eye microsurgery"

location_facility: Chevy Chase Pulmonary Associate (PFT Only)

location_facility: Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location)

location_facility: Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review)

location_facility: Endoscopy Facility in Severance Hospital, Yonsei University Health System

location_facility: Pulmonary Associates (Secondary PFT Location)

location_facility: Absolute Surgical Specialists - Craig Amshel, MD

location_facility: Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: UCI Health H. H. Chao Comprehensive Digestive Disease Center

location_facility: The Endoscopy Center (Endoscopy Procedure)

location_facility: McGill University Health Center- Montreal General Hospital (Research Site)

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon

location_facility: University of Calgary, Department of Medicine - Respirology (PFT Only)

location_facility: Centre Hospitalier Universitaire de Nantes - Hotel-Dieu

location_facility: Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD

location_facility: UCSD lnvestigational Drug Service Pharmacy

location_facility: Ospedale San Bortolo di Vicenza, Gastroenterologia

location_facility: Retina Group of Washington (Ophthalmoscopy and OCT Only)

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine

location_facility: Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft. (Pulmonary function)

location_facility: Northwood Vision- Optical Coherence Tomography (OCT)

location_facility: London Health Sciences Centre - University Hospital

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

location_facility: University of Utah Huntsman Cancer Hospital Endoscopy

location_facility: Regional Medical center LLC (Branchevsky's clinic)

location_facility: PFT Facility in kyungpook Natioanl University Hospital

location_facility: Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>

location_facility: Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"

title: A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

location_country:
Germany
Poland
Australia
Czechia
Canada
France
Belarus
Portugal
Hungary
United States
Ukraine
Belgium
Italy
Korea, Republic of
Spain
Bulgaria
Georgia
Russian Federation
Israel