title: Value-based Healthcare for Outcomes In Breast and Lung Cancer in Europe

acronym: VOICE

summary:
VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.

The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.

The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.

The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.

status: Active, not recruiting

primary_purpose: Health Services Research

lead_sponsor: Kronikgune

location_country: Italy France Belgium Spain Portugal

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Instituto Português de Oncologia do Porto

location_facility: Hospital Universitari i Politècnic La Fe

intervention_type: Other


title: Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study

summary: The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_country:
Switzerland
Netherlands
France
Belgium
Australia
Germany
United Kingdom

location_facility:
University College London Hospital
Universitätsklinikum Augsburg
Erasmus MC - University Medical Center
Isala Clinics
Hirslanden private hospital group
UZ Gasthuisberg
Catharina Hospital
University Medical Center Groningen
MRI TUM
Westmead hospital
CHU Nantes
Barmherzige Brüder Regensburg
EVK Duesseldorf
Amsterdam UMC, location VUmc
St. Antonius Hospital
Haga Medical Center

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

summary: This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912 in adult subjects with SBS-associated intestinal failure (SBS-IF).

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Hanmi Pharmaceutical Company Limited

location_country:
United States
France
Poland
Germany
Korea, Republic of

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

intervention_type: Drug

lead_sponsor_type: industriel


type: EudraCT Number

title: Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Active Generalized Pustular Psoriasis.

summary: This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).

status: Completed

study_completion_date_type: Actual

primary_purpose: Supportive Care

enrollment_type: Actual

lead_sponsor: Boehringer Ingelheim

location_country:
France
Japan
Malaysia
Tunisia
Korea, Republic of
Taiwan

location_facility: Hedi Chaker Hospital, Department of Dermatology

status_simplified: Completed


title: SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

acronym: SUMMERTIME

summary: Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Fan K, Ritter C, Nghiem P, Blom A, Verhaegen ME, Dlugosz A, Ødum N, Woetmann A, Tothill RW, Hicks RJ, Sand M, Schrama D, Schadendorf D, Ugurel S, Becker JC. Circulating Cell-Free miR-375 as Surrogate Marker of Tumor Burden in Merkel Cell Carcinoma. Clin Cancer Res. 2018 Dec 1;24(23):5873-5882. doi: 10.1158/1078-0432.CCR-18-1184. Epub 2018 Jul 30.

ReferenceCitation: Kervarrec T, Tallet A, Miquelestorena-Standley E, Houben R, Schrama D, Gambichler T, Berthon P, Le Corre Y, Hainaut-Wierzbicka E, Aubin F, Bens G, Tabareau-Delalande F, Beneton N, Fromont G, Arbion F, Leteurtre E, Touzé A, Samimi M, Guyétant S. Diagnostic accuracy of a panel of immunohistochemical and molecular markers to distinguish Merkel cell carcinoma from other neuroendocrine carcinomas. Mod Pathol. 2019 Apr;32(4):499-510. doi: 10.1038/s41379-018-0155-y. Epub 2018 Oct 22.

ReferenceCitation: Paulson KG, Lewis CW, Redman MW, Simonson WT, Lisberg A, Ritter D, Morishima C, Hutchinson K, Mudgistratova L, Blom A, Iyer J, Moshiri AS, Tarabadkar ES, Carter JJ, Bhatia S, Kawasumi M, Galloway DA, Wener MH, Nghiem P. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: A prospective validation study. Cancer. 2017 Apr 15;123(8):1464-1474. doi: 10.1002/cncr.30475. Epub 2016 Dec 7.

ReferenceCitation: Samimi M, Molet L, Fleury M, Laude H, Carlotti A, Gardair C, Baudin M, Gouguet L, Maubec E, Avenel-Audran M, Esteve E, Wierzbicka-Hainaut E, Beneton N, Aubin F, Rozenberg F, Dupin N, Avril MF, Lorette G, Guyetant S, Coursaget P, Touzé A. Prognostic value of antibodies to Merkel cell polyomavirus T antigens and VP1 protein in patients with Merkel cell carcinoma. Br J Dermatol. 2016 Apr;174(4):813-22. doi: 10.1111/bjd.14313. Epub 2016 Feb 3.

lead_sponsor: University Hospital, Tours

location_country:
Italy
Austria
Sweden
Netherlands
Finland
France
Romania
Turkey
Germany
United Kingdom

location_facility: Department of Dermatology, Carol Davila University of Medicine and Pharmacy

location_facility: Skin Cancer and Surgery Center, Sahlgrenska University Hospital

location_facility: Dermatology Dept, Hospital University of Tours

location_facility: Department of Dermatology, Başkent University Faculty of Medicine

location_facility: University Hospital of Helsinki, Finland

location_facility: National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy

location_facility: Department of Dermatology, Medical University of Vienna


type: Other Grant/Funding Number

type: Registry Identifier

title: Early Sleep Apnea Treatment in Stroke: A Multicenter, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation

acronym: eSATIS

summary:
Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome.

To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB.

Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.

ReferenceCitation: Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23.

ReferenceCitation: Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. Review.

ReferenceCitation: Duss SB, Brill AK, Baillieul S, Horvath T, Zubler F, Flügel D, Kägi G, Benz G, Bernasconi C, Ott SR, Korostovtseva L, Sviryaev Y, Salih F, Endres M, Tamisier R, Gouveris H, Winter Y, Denier N, Wiest R, Arnold M, Schmidt MH, Pépin JL, Bassetti CLA. Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke). Trials. 2021 Jan 22;22(1):83. doi: 10.1186/s13063-020-04977-w.

ReferenceType: result

ReferenceCitation: Brill AK, Rösti R, Hefti JP, Bassetti C, Gugger M, Ott SR. Adaptive servo-ventilation as treatment of persistent central sleep apnea in post-acute ischemic stroke patients. Sleep Med. 2014 Nov;15(11):1309-13. doi: 10.1016/j.sleep.2014.06.013. Epub 2014 Aug 1.

family: Brill

full_name: Anne-Kathrin Brill

given: Anne-Kathrin

sequence: first

family: Rösti

full_name: Regula Rösti

given: Regula

sequence: additional

family: Hefti

full_name: Jacqueline Pichler Hefti

given: Jacqueline Pichler

family: Bassetti

full_name: Claudio Bassetti

given: Claudio

family: Gugger

full_name: Matthias Gugger

given: Matthias

family: Ott

full_name: Sebastian R. Ott

given: Sebastian R.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Sleep Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep. 2011 Sep 1;34(9):1271-7. doi: 10.5665/SLEEP.1254.

family: Bravata

full_name: Dawn M. Bravata

given: Dawn M.

family: Concato

full_name: John Concato

given: John

family: Fried

full_name: Terri Fried

given: Terri

family: Ranjbar

full_name: Noshene Ranjbar

given: Noshene

family: Sadarangani

full_name: Tanesh Sadarangani

given: Tanesh

family: McClain

full_name: Vincent McClain

given: Vincent

family: Struve

full_name: Frederick Struve

given: Frederick

family: Zygmunt

full_name: Lawrence Zygmunt

given: Lawrence

family: Knight

full_name: Herbert J. Knight

given: Herbert J.

family: Lo

full_name: Albert Lo

given: Albert

family: Richerson

full_name: George B. Richerson

given: George B.

family: Gorman

full_name: Mark Gorman

given: Mark

family: Williams

full_name: Linda S. Williams

title: Continuous Positive Airway Pressure: Evaluation of a Novel Therapy for Patients with Acute Ischemic Stroke

ReferenceCitation: Parra O, Sánchez-Armengol A, Bonnin M, Arboix A, Campos-Rodríguez F, Pérez-Ronchel J, Durán-Cantolla J, de la Torre G, González Marcos JR, de la Peña M, Carmen Jiménez M, Masa F, Casado I, Luz Alonso M, Macarrón JL. Early treatment of obstructive apnoea and stroke outcome: a randomised controlled trial. Eur Respir J. 2011 May;37(5):1128-36. doi: 10.1183/09031936.00034410. Epub 2010 Sep 16.

ReferenceCitation: Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schäbitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.

name: From the Department of Neurology (J.M., M.A.R., A.O., A.S., M.S., E.B.R., P.Y., R.D.), the Institute of Epidemiology and Social Medicine (H.W.), and the Institute for Clinical Radiology (A.K.), University of Münster, Münster, Germany; and EVK Bielefeld (W.R.S.), Neurologie Bethel, Bielefeld, Germany.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Continuous Positive Airway Pressure Ventilation for Acute Ischemic Stroke

ReferenceCitation: Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.

name: From the Toronto Rehabilitation Institute (C.M.R., M.B., R.G., B.J.M., T.D.B.) and the Centre for Sleep Medicine and Circadian Biology (C.M.R., B.J.M., T.D.B.), University of Toronto, Ontario, Canada; the Department of Medicine (C.M.R., T.D.B.), Toronto General Hospital of the University Health Network and Sunnybrook Health Sciences Centre (B.J.M.), Toronto, Ontario, Canada.

title: Influence of Continuous Positive Airway Pressure on Outcomes of Rehabilitation in Stroke Patients With Obstructive Sleep Apnea

ReferenceCitation: Barbé F, Durán-Cantolla J, Sánchez-de-la-Torre M, Martínez-Alonso M, Carmona C, Barceló A, Chiner E, Masa JF, Gonzalez M, Marín JM, Garcia-Rio F, Diaz de Atauri J, Terán J, Mayos M, de la Peña M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

full_name: for the Spanish Sleep and Breathing Network

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

title: Effect of Continuous Positive Airway Pressure on the Incidence of Hypertension and Cardiovascular Events in Nonsleepy Patients With Obstructive Sleep Apnea

ReferenceCitation: Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbé F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.

title: Association Between Treated and Untreated Obstructive Sleep Apnea and Risk of Hypertension

location_country:
Germany
Russian Federation
France
Switzerland

location_facility: Federal State Budgetary Institution "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation

location_facility: Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble

location_facility: Department of Neurology, Pulmonary Medicine and Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, HNO-Universitätsklinik, Klinik und Poliklinik für Neurologie

location_facility: Department and Out-Patient Care of Neurology, Charité Center Neurology, Neurosurgery and Psychiatry CC 15, Department of Neurology with Experimental Neurology, Center for Stroke Research Berlin (CSB)

location_facility: Neurology Department, Cantonal Hospital St.Gallen


title: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

summary: The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.

lead_sponsor: Bristol-Myers Squibb

location_country: France Poland


intervention_type: Biological

lead_sponsor: Alexion Pharmaceuticals

location_country:
Netherlands
France
Norway
Russian Federation
United States
United Kingdom

source: euctr

title: A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).


title: An Open Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation

summary: This study is assessing the effect of setmelanotide (RM-493) on weight and other factors in patients with Leptin Receptor (LEPR) deficiency obesity due to rare bi-allelic loss-of-function LEPR genetic mutation.

ReferenceType: derived

ReferenceCitation: Clément K, van den Akker E, Argente J, Bahm A, Chung WK, Connors H, De Waele K, Farooqi IS, Gonneau-Lejeune J, Gordon G, Kohlsdorf K, Poitou C, Puder L, Swain J, Stewart M, Yuan G, Wabitsch M, Kühnen P; Setmelanotide POMC and LEPR Phase 3 Trial Investigators. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020 Dec;8(12):960-970. doi: 10.1016/S2213-8587(20)30364-8. Epub 2020 Oct 30.

family: Clément

full_name: Karine Clément

given: Karine

family: van den Akker

full_name: Erica van den Akker

given: Erica

family: Argente

full_name: Jesús Argente

given: Jesús

family: Bahm

full_name: Allison Bahm

given: Allison

family: Chung

full_name: Wendy K Chung

given: Wendy K

family: Connors

full_name: Hillori Connors

given: Hillori

family: De Waele

full_name: Kathleen De Waele

given: Kathleen

family: Farooqi

full_name: I Sadaf Farooqi

given: I Sadaf

family: Gonneau-Lejeune

full_name: Julie Gonneau-Lejeune

given: Julie

family: Gordon

full_name: Gregory Gordon

given: Gregory

family: Kohlsdorf

full_name: Katja Kohlsdorf

given: Katja

family: Poitou

full_name: Christine Poitou

given: Christine

family: Puder

full_name: Lia Puder

given: Lia

family: Swain

full_name: James Swain

given: James

family: Stewart

full_name: Murray Stewart

given: Murray

family: Yuan

full_name: Guojun Yuan

given: Guojun

family: Wabitsch

full_name: Martin Wabitsch

given: Martin

family: Kühnen

full_name: Peter Kühnen

given: Peter

family: Pigeon-Kherchiche

full_name: Patricia Pigeon-Kherchiche

given: Patricia

family: Flaus-Furmaniuk

full_name: Anna Flaus-Furmaniuk

given: Anna

family: Bald

full_name: Martin Bald

family: Denzer

full_name: Christian Denzer

given: Christian

family: von Schnurbein

full_name: Julia von Schnurbein

given: Julia

location_country:
United States
Netherlands
France
Réunion
Germany
United Kingdom
Canada

location_facility: Institute of Cardiometabolism and Nutrition / Pitié-Salpêtrière Hospital

location_facility: University of Cambridge Metabolic Research Laboratories


title: Endoscopic Management of Patients With T1bN0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.

summary: Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

location_facility:
Radboudumc
University College London Hospital
Universitätsklinikum Augsburg
VuMC
Erasmus MC - University Medical Center
Isala Clinics
Hirslanden private hospital group
UZ Gasthuisberg
Academic Medical Center
Catharina Hospital
University Medical Center Groningen
MRI TUM
Westmead hospital
CHU Nantes
Barmherzige Brüder Regensburg
EVK Duesseldorf
St. Antonius Hospital
Haga Medical Center


title: An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

acronym: AURIGA

summary:
AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).

The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries.

Additionally, utilization and treatment regimens in routine clinical practice will be described.

Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.

time_perspective: Prospective

ipd_sharing: Undecided

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
United Arab Emirates
Saudi Arabia
Lebanon
France
Kuwait
Russian Federation
Egypt
China
Germany
Taiwan


title: Post-Market Clinical Follow-up Study With the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups

acronym: P-MAX

summary:
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.

CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.

ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.

lead_sponsor: Straub Medical AG

location_country: Italy Austria France Ireland Germany

location_facility: Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Klinikum Arnsberg, Klinik für Angiologie


lead_sponsor: OxThera

location_country:
United States
France
Tunisia
Belgium
Spain
Germany
United Kingdom

acronym: ePHex

location_facility: Centre Hospitalier Universitaire de Liège

title: A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

summary: This study will evaluate the efficacy and safety of OC5 in patients with PH.


title: A Physician-initiated, International, Multi-center, Ambispective, Observational Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

summary:
The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.

The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.

time_perspective: Other

ReferenceCitation: Greenberg RK, West K, Pfaff K, Foster J, Skender D, Haulon S, Sereika J, Geiger L, Lyden SP, Clair D, Svensson L, Lytle B. Beyond the aortic bifurcation: branched endovascular grafts for thoracoabdominal and aortoiliac aneurysms. J Vasc Surg. 2006 May;43(5):879-86; discussion 886-7.

ReferenceCitation: Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex criteria and outcomes for renal stents and stent grafts following endovascular repair of juxtarenal and thoracoabdominal aneurysms. J Vasc Surg. 2009 Apr;49(4):827-37; discussion 837. doi: 10.1016/j.jvs.2008.11.024. Epub 2009 Feb 23.

ReferenceCitation: Manning BJ, Harris PL, Hartley DE, Ivancev K. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms. J Endovasc Ther. 2010 Aug;17(4):449-55. doi: 10.1583/10-3024.1.

ReferenceCitation: Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.

ReferenceCitation: Bisdas T, Donas KP, Torsello G, Austermann M. Technical assessment of the preloaded fenestrated stent-graft in the management of pararenal aortic aneurysms. J Endovasc Ther. 2013 Aug;20(4):461-8. doi: 10.1583/13-4310.1.

lead_sponsor: IRCCS San Raffaele

location_country:
Italy
Sweden
France
United States
United Kingdom

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay

location_facility: Vascular Center Malmö, Skåne University Hospital


title: Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

acronym: SERPENTINE

summary: It is nowadays well established that the immune system can profoundly influence disease outcome in cancer patients. Increasing evidence is indeed showing that patients displaying spontaneous T cell-mediated immune response against their tumor (defined as immune surveillance) have higher chance to respond to therapies and display globally better prognosis. Conversely, patients whose tumor is characterized by immunosuppression, usually involving myeloid cells and chronic inflammation pathways, often undergo rapid progression and rarely benefit from therapy. Hence, capturing the immune features of individual tumors can help to predict disease course and tailor the therapeutic workup in clinical setting.

primary_purpose: Diagnostic

ReferenceCitation: Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018 Mar 23;359(6382):1350-1355. doi: 10.1126/science.aar4060. Epub 2018 Mar 22. Review.

ReferenceCitation: Galluzzi L, Buqué A, Kepp O, Zitvogel L, Kroemer G. Immunological Effects of Conventional Chemotherapy and Targeted Anticancer Agents. Cancer Cell. 2015 Dec 14;28(6):690-714. doi: 10.1016/j.ccell.2015.10.012. Review.

ReferenceCitation: Apetoh L, Tesniere A, Ghiringhelli F, Kroemer G, Zitvogel L. Molecular interactions between dying tumor cells and the innate immune system determine the efficacy of conventional anticancer therapies. Cancer Res. 2008 Jun 1;68(11):4026-30. doi: 10.1158/0008-5472.CAN-08-0427. Review.

ReferenceCitation: Péguillet I, Milder M, Louis D, Vincent-Salomon A, Dorval T, Piperno-Neumann S, Scholl SM, Lantz O. High numbers of differentiated effector CD4 T cells are found in patients with cancer and correlate with clinical response after neoadjuvant therapy of breast cancer. Cancer Res. 2014 Apr 15;74(8):2204-16. doi: 10.1158/0008-5472.CAN-13-2269. Epub 2014 Feb 17.

ReferenceCitation: Wilmott JS, Long GV, Howle JR, Haydu LE, Sharma RN, Thompson JF, Kefford RF, Hersey P, Scolyer RA. Selective BRAF inhibitors induce marked T-cell infiltration into human metastatic melanoma. Clin Cancer Res. 2012 Mar 1;18(5):1386-94. doi: 10.1158/1078-0432.CCR-11-2479. Epub 2011 Dec 12.

ReferenceCitation: Thorsson V, Gibbs DL, Brown SD, Wolf D, Bortone DS, Ou Yang TH, Porta-Pardo E, Gao GF, Plaisier CL, Eddy JA, Ziv E, Culhane AC, Paull EO, Sivakumar IKA, Gentles AJ, Malhotra R, Farshidfar F, Colaprico A, Parker JS, Mose LE, Vo NS, Liu J, Liu Y, Rader J, Dhankani V, Reynolds SM, Bowlby R, Califano A, Cherniack AD, Anastassiou D, Bedognetti D, Mokrab Y, Newman AM, Rao A, Chen K, Krasnitz A, Hu H, Malta TM, Noushmehr H, Pedamallu CS, Bullman S, Ojesina AI, Lamb A, Zhou W, Shen H, Choueiri TK, Weinstein JN, Guinney J, Saltz J, Holt RA, Rabkin CS; Cancer Genome Atlas Research Network, Lazar AJ, Serody JS, Demicco EG, Disis ML, Vincent BG, Shmulevich I. The Immune Landscape of Cancer. Immunity. 2018 Apr 17;48(4):812-830.e14. doi: 10.1016/j.immuni.2018.03.023. Epub 2018 Apr 5. Erratum in: Immunity. 2019 Aug 20;51(2):411-412.

ReferenceCitation: Spitzer MH, Carmi Y, Reticker-Flynn NE, Kwek SS, Madhireddy D, Martins MM, Gherardini PF, Prestwood TR, Chabon J, Bendall SC, Fong L, Nolan GP, Engleman EG. Systemic Immunity Is Required for Effective Cancer Immunotherapy. Cell. 2017 Jan 26;168(3):487-502.e15. doi: 10.1016/j.cell.2016.12.022. Epub 2017 Jan 19.

ReferenceCitation: Dumeaux V, Fjukstad B, Fjosne HE, Frantzen JO, Holmen MM, Rodegerdts E, Schlichting E, Børresen-Dale AL, Bongo LA, Lund E, Hallett M. Interactions between the tumor and the blood systemic response of breast cancer patients. PLoS Comput Biol. 2017 Sep 28;13(9):e1005680. doi: 10.1371/journal.pcbi.1005680. eCollection 2017 Sep.

ReferenceCitation: Cortez-Retamozo V, Etzrodt M, Newton A, Rauch PJ, Chudnovskiy A, Berger C, Ryan RJ, Iwamoto Y, Marinelli B, Gorbatov R, Forghani R, Novobrantseva TI, Koteliansky V, Figueiredo JL, Chen JW, Anderson DG, Nahrendorf M, Swirski FK, Weissleder R, Pittet MJ. Origins of tumor-associated macrophages and neutrophils. Proc Natl Acad Sci U S A. 2012 Feb 14;109(7):2491-6. doi: 10.1073/pnas.1113744109. Epub 2012 Jan 30.

ReferenceCitation: Gabrilovich DI. Myeloid-Derived Suppressor Cells. Cancer Immunol Res. 2017 Jan;5(1):3-8. doi: 10.1158/2326-6066.CIR-16-0297. Review.

ReferenceCitation: Groth C, Hu X, Weber R, Fleming V, Altevogt P, Utikal J, Umansky V. Immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) during tumour progression. Br J Cancer. 2019 Jan;120(1):16-25. doi: 10.1038/s41416-018-0333-1. Epub 2018 Nov 9. Review.

ReferenceCitation: Ostrand-Rosenberg S. Myeloid derived-suppressor cells: their role in cancer and obesity. Curr Opin Immunol. 2018 Apr;51:68-75. doi: 10.1016/j.coi.2018.03.007. Epub 2018 Mar 13. Review.

ReferenceCitation: Wesolowski R, Markowitz J, Carson WE 3rd. Myeloid derived suppressor cells - a new therapeutic target in the treatment of cancer. J Immunother Cancer. 2013 Jul 15;1:10. doi: 10.1186/2051-1426-1-10. eCollection 2013. Review.

ReferenceCitation: Fleming V, Hu X, Weber R, Nagibin V, Groth C, Altevogt P, Utikal J, Umansky V. Targeting Myeloid-Derived Suppressor Cells to Bypass Tumor-Induced Immunosuppression. Front Immunol. 2018 Mar 2;9:398. doi: 10.3389/fimmu.2018.00398. eCollection 2018. Review.

ReferenceCitation: Engblom C, Pfirschke C, Pittet MJ. The role of myeloid cells in cancer therapies. Nat Rev Cancer. 2016 Jul;16(7):447-62. doi: 10.1038/nrc.2016.54. Review.

ReferenceCitation: Filipazzi P, Valenti R, Huber V, Pilla L, Canese P, Iero M, Castelli C, Mariani L, Parmiani G, Rivoltini L. Identification of a new subset of myeloid suppressor cells in peripheral blood of melanoma patients with modulation by a granulocyte-macrophage colony-stimulation factor-based antitumor vaccine. J Clin Oncol. 2007 Jun 20;25(18):2546-53.

ReferenceCitation: Filipazzi P, Huber V, Rivoltini L. Phenotype, function and clinical implications of myeloid-derived suppressor cells in cancer patients. Cancer Immunol Immunother. 2012 Feb;61(2):255-263. doi: 10.1007/s00262-011-1161-9. Epub 2011 Nov 27. Review.

ReferenceCitation: Blattner C, Fleming V, Weber R, Himmelhan B, Altevogt P, Gebhardt C, Schulze TJ, Razon H, Hawila E, Wildbaum G, Utikal J, Karin N, Umansky V. CCR5(+) Myeloid-Derived Suppressor Cells Are Enriched and Activated in Melanoma Lesions. Cancer Res. 2018 Jan 1;78(1):157-167. doi: 10.1158/0008-5472.CAN-17-0348. Epub 2017 Oct 31.

ReferenceCitation: Huber V, Vallacchi V, Fleming V, Hu X, Cova A, Dugo M, Shahaj E, Sulsenti R, Vergani E, Filipazzi P, De Laurentiis A, Lalli L, Di Guardo L, Patuzzo R, Vergani B, Casiraghi E, Cossa M, Gualeni A, Bollati V, Arienti F, De Braud F, Mariani L, Villa A, Altevogt P, Umansky V, Rodolfo M, Rivoltini L. Tumor-derived microRNAs induce myeloid suppressor cells and predict immunotherapy resistance in melanoma. J Clin Invest. 2018 Dec 3;128(12):5505-5516. doi: 10.1172/JCI98060. Epub 2018 Nov 5.

ReferenceCitation: Bronte V, Brandau S, Chen SH, Colombo MP, Frey AB, Greten TF, Mandruzzato S, Murray PJ, Ochoa A, Ostrand-Rosenberg S, Rodriguez PC, Sica A, Umansky V, Vonderheide RH, Gabrilovich DI. Recommendations for myeloid-derived suppressor cell nomenclature and characterization standards. Nat Commun. 2016 Jul 6;7:12150. doi: 10.1038/ncomms12150. Review.

ReferenceCitation: De Henau O, Rausch M, Winkler D, Campesato LF, Liu C, Cymerman DH, Budhu S, Ghosh A, Pink M, Tchaicha J, Douglas M, Tibbitts T, Sharma S, Proctor J, Kosmider N, White K, Stern H, Soglia J, Adams J, Palombella VJ, McGovern K, Kutok JL, Wolchok JD, Merghoub T. Overcoming resistance to checkpoint blockade therapy by targeting PI3Kγ in myeloid cells. Nature. 2016 Nov 17;539(7629):443-447. doi: 10.1038/nature20554. Epub 2016 Nov 9.

ReferenceCitation: Welters MJ, van der Sluis TC, van Meir H, Loof NM, van Ham VJ, van Duikeren S, Santegoets SJ, Arens R, de Kam ML, Cohen AF, van Poelgeest MI, Kenter GG, Kroep JR, Burggraaf J, Melief CJ, van der Burg SH. Vaccination during myeloid cell depletion by cancer chemotherapy fosters robust T cell responses. Sci Transl Med. 2016 Apr 13;8(334):334ra52. doi: 10.1126/scitranslmed.aad8307.

ReferenceCitation: Crunkhorn S. Cancer: New path to improving immunotherapy. Nat Rev Drug Discov. 2018 Mar;17(3):164. doi: 10.1038/nrd.2018.22. Epub 2018 Feb 16.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_country: Italy France Norway Egypt Germany

location_facility: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

intervention_type: Diagnostic Test


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

design_allocation: Non-Randomized

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Spain
United States
France
Poland

location_facility: Georgia Cancer Center at Augusta University


title: Daratumumab as a Treatment for Adult Immune Thrombocytopenia (The DART Study)

summary: A multicenter clinical, open-label total dose-escalating phase II study with safety run-in to explore the clinical activity, total dosage, and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or TPO-RA.

lead_sponsor: Ostfold Hospital Trust

location_country: Denmark Norway France

location_facility:
Ostfold Hospital Trust
Haukeland University Hospital
Odense University Hospital
Oslo University Hospital
Henri Mondor University Hospital
Akershus University Hospital


title: Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study

acronym: FASTII

summary: The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.

ReferenceCitation: Masdjedi K, Tanaka N, Van Belle E, Porouchani S, Linke A, Woitek FJ, Bartorelli AL, Ali ZA, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Boersma E, Van Mieghem NM, Spitzer E, Daemen J. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention. 2021 Oct 14. pii: EIJ-D-21-00471. doi: 10.4244/EIJ-D-21-00471. [Epub ahead of print]

ipd_sharing_description: Individual participant data are needed for the final analysis which will be done by Erasmus MC.

lead_sponsor: Erasmus Medical Center

location_country:
Italy
United States
Netherlands
France
Japan
Germany

location_facility:
CHU
Erasmus Medical Center
Columbia University Medical Center
Herzzentrum Dresden
Centro Cardiologico Monzino
Tokyo Medical University


title: A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy

acronym: DENIM

summary: This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.

lead_sponsor: Amphera BV

location_country:
Italy
Netherlands
France
Belgium
United Kingdom

location_facility: Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Characterization of Acute and Long Term Response to Left Ventricle Only Pacing Combined With MultiPoint Pacing and SyncAV

summary:
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.

This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects.

Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs.

In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure.

Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire.

Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.

status: Enrolling by invitation

ipd_sharing_description: No participant data will be shared to other researchers

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Canada
United Kingdom
France

location_facility:
John Radcliffe Hospital
Policlinico Casilino
Queen Elizabeth Hospital
St. Bartholomew's Hospital
Montreal Heart Institute
CHU Rennes

intervention_type: Device

status_simplified: Unknown


title: Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

acronym: PREDICT

summary: To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.

status: Unknown status

ReferenceCitation: Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7.

ReferenceCitation: Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29.

ReferenceCitation: Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5.

ReferenceCitation: Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.

ReferenceCitation: Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4.

ReferenceCitation: Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8.

ReferenceCitation: Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.

ReferenceCitation: Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406.

lead_sponsor: Centro Hospitalar Lisboa Ocidental

location_country:
Italy
United States
France
Portugal

location_facility: Department of Cardiology, University Hospital

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz

location_facility: Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta

location_facility: Institute of Cardiology, Catholic University of the Sacred Heart

location_facility: Hospital Prof. Doutor Fernando da Fonseca


title: CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months

summary: Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

ReferenceCitation: Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10.

family: Schultheis

full_name: Paige Schultheis

given: Paige

family: Montoya

full_name: Melissa Natalie Montoya

given: Melissa Natalie

family: Zhao

full_name: Qiuhong Zhao

given: Qiuhong

family: Archer

full_name: Johanna Archer

given: Johanna

family: Madden

full_name: Tessa Madden

given: Tessa

family: Peipert

full_name: Jeffrey F. Peipert

given: Jeffrey F.

journal_name: American Journal of Obstetrics and Gynecology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

ReferenceCitation: Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljański J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.

family: Reaney

full_name: Matthew Reaney

given: Matthew

family: Mathieu

full_name: Chantal Mathieu

given: Chantal

family: Östenson

full_name: Claes-Göran Östenson

given: Claes-Göran

family: Matthaei

full_name: Stephan Matthaei

given: Stephan

family: Krarup

full_name: Thure Krarup

given: Thure

family: Kiljański

full_name: Jacek Kiljański

given: Jacek

family: Salaun-Martin

full_name: Carole Salaun-Martin

given: Carole

family: Sapin

full_name: Hélène Sapin

given: Hélène

family: Theodorakis

full_name: Michael Theodorakis

given: Michael

family: Guerci

full_name: Bruno Guerci

given: Bruno

currency_apc_doaj: GBP

journal_name: Health and Quality of Life Outcomes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

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

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


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer

acronym: XENON

summary:
Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
To assess the effects of xaliproden on the time to complete recovery from PSN
To evaluate the safety profile of xaliproden

status: Terminated

lead_sponsor: Sanofi

location_country:
Italy
United States
France
Greece
Spain
Germany
United Kingdom
Canada


title: A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

summary: To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Austria
Netherlands
Germany
France
Japan
Spain
United States
Korea, Republic of
Taiwan

location_facility: Klinikum der Universität München Campus Grosshadern

location_facility: Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of California at Irvine Medical Center


title: IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo

summary:
This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27) in which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

At the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the clinical parameters.

The study involves a follow-up of 6 months after the end of the initial participation to the IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study IMCY-T1D-001.

For each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). The patients will undergo planned assessments and procedures as outlined in the table of study procedures.

ipd_sharing_description: to be disclosed later

lead_sponsor: Imcyse SA

location_country:
Sweden
France
Lithuania
Belgium
Denmark
Germany
United Kingdom

location_facility: St. Bartholomew's Hospital (Barts Health NHS Trust)

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)


lead_sponsor: Alnylam Pharmaceuticals

location_country:
Italy
United Arab Emirates
Jordan
Lebanon
Netherlands
France
Israel
Belgium
Australia
Turkey
United States
United Kingdom

acronym: ILLUMINATE-C

title: ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (PH1)

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).


title: Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

summary: The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

primary_purpose: Device Feasibility

ReferenceCitation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.

family: Lombardi

full_name: Joseph V. Lombardi

given: Joseph V.

family: Cambria

full_name: Richard P. Cambria

given: Richard P.

family: Nienaber

full_name: Christoph A. Nienaber

given: Christoph A.

family: Chiesa

full_name: Roberto Chiesa

given: Roberto

family: Mossop

full_name: Peter Mossop

given: Peter

family: Haulon

full_name: Stéphan Haulon

given: Stéphan

family: Zhou

full_name: Qing Zhou

given: Qing

journal_name: Journal of Vascular Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: William Cook Europe

location_country:
Italy
France
Australia
Germany
Czech Republic

location_facility: Clinic of Internal Medicine, University Hospital Rostock


summary: The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

ReferenceCitation: Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex® ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.

lead_sponsor: Allergan

location_country:
Italy
France
Israel
Australia
New Zealand
Portugal
United States
United Kingdom
Korea, Republic of


title: A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.

acronym: SATIN

summary:
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).

The secondary objectives are:

to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.

location_country:
Brazil
Uruguay
France
Poland
Tunisia
Belgium
Germany
United Kingdom


title: Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry

acronym: SAMISEN

summary: The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).

lead_sponsor: Olympus Europe SE & Co. KG

location_country: Finland France Norway Belgium Denmark Germany

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


title: An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies

summary: The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
United States
France
Poland

location_facility: Szpital Wojewodzki W Szczecinie Zdunowie

location_facility: ASST Grande Ospedale Metropolitano Niguarda


ReferenceCitation: van Tilburg CM, Witt R, Heiss M, Pajtler KW, Plass C, Poschke I, Platten M, Harting I, Sedlaczek O, Freitag A, Meyrath D, Taylor L, Balasubramanian GP, Jäger N, Pfaff E, Jones BC, Milde T, Pfister SM, Jones DTW, Kopp-Schneider A, Witt O. INFORM2 NivEnt: The first trial of the INFORM2 biomarker driven phase I/II trial series: the combination of nivolumab and entinostat in children and adolescents with refractory high-risk malignancies. BMC Cancer. 2020 Jun 5;20(1):523. doi: 10.1186/s12885-020-07008-8.

family: van Tilburg

full_name: Cornelis M. van Tilburg

given: Cornelis M.

family: Witt

full_name: Ruth Witt

given: Ruth

family: Heiss

full_name: Melanie Heiss

given: Melanie

family: Pajtler

full_name: Kristian W. Pajtler

given: Kristian W.

family: Plass

full_name: Christoph Plass

given: Christoph

family: Poschke

full_name: Isabel Poschke

given: Isabel

family: Platten

full_name: Michael Platten

family: Harting

full_name: Inga Harting

given: Inga

family: Sedlaczek

full_name: Oliver Sedlaczek

given: Oliver

family: Freitag

full_name: Angelika Freitag

given: Angelika

family: Meyrath

full_name: David Meyrath

given: David

family: Taylor

full_name: Lenka Taylor

given: Lenka

family: Balasubramanian

full_name: Gnana Prakash Balasubramanian

given: Gnana Prakash

family: Jäger

full_name: Natalie Jäger

given: Natalie

family: Pfaff

full_name: Elke Pfaff

given: Elke

family: Jones

full_name: Barbara C. Jones

given: Barbara C.

family: Milde

full_name: Till Milde

given: Till

family: Pfister

full_name: Stefan M. Pfister

given: Stefan M.

full_name: David T. W. Jones

given: David T. W.

family: Kopp-Schneider

full_name: Annette Kopp-Schneider

given: Annette

full_name: Olaf Witt

given: Olaf

journal_name: BMC Cancer

ipd_sharing_description:
The pseudonymized data will be shared for transparency reasons in the context of publications and after publication with other physicians and scientists (national and international academia) to promote and accelerate research on causes and treatment development of oncological diseases.

Requests for access to pseudonymized patient data for non-INFORM-related scientific purposes will be reviewed by a Data Access Committee consisting of the INFORM Board, and the participating investigators. A positive statement of the respective ethic committee and a signed data protection commitment are requested. Requests should be addressed to the coordinating investigator Prof. Olaf Witt. Results of scientific research based on the INFORM2 NivEnt data may be used for academic teaching, research and scientific publications or presentations at scientific meetings.

location_country: Austria Sweden Switzerland Netherlands France Australia Germany

location_facility: Hopp Children's Cancer Center Heidelberg (KiTZ)

title: INFORM2 Exploratory Multinational Phase I/II Combination Study of Nivolumab and Entinostat in Children and Adolescents With Refractory High-risk Malignancies

summary: The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, high PD-L1 mRNA expression or focal MYC(N) amplification and explore activity in biomarker low tumors (low mutational load, low PD-L1 mRNA expression and non-MYC(N) amplified).


title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy

acronym: Perseus

summary: Background of the study: The combination of daratumumab with VRd is anticipated to further improve response rates in patients and may lead to improved long-term outcomes in newly diagnosed patients with multiple myeloma. Given this potential, and based upon the initial safety and efficacy observed in the ongoing Phase 2 Study MMY2004, as well as continued positive results with daratumumab in various disease settings and combination regimens, this Phase 3 study is designed to demonstrate improved outcomes for patients treated with daratumumab+VRd. The Phase 3 study will utilize the subcutaneous (SC) formulation of daratumumab instead of the IV formulation utilized in the Phase 2 study, which may limit additional toxicity to patients treated with the quadruplet regimen.

lead_sponsor: European Myeloma Network

location_country: Italy Switzerland Netherlands France Czechia Greece Poland Norway Belgium Australia Spain Turkey Denmark

location_facility: Hospital Clinic I Provincial de Barcelona

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

location_facility: Uniwersytet Jagiellonski Collegium Medicum


title: A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia

summary: This is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.

lead_sponsor: Millendo Therapeutics US, Inc.

location_country: Brazil France Czechia Israel Spain

location_facility: Universidade Federal de São Paulo, Escola Paulista de Medicina

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital das Clínicas da FMUSP - Prédio do Instituto Central

location_facility: University of Ribeirão Preto, Medicine Faculty (Faculdade de Medicina) of Ribeirão Preto


title: ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

acronym: ImpleMentAll

summary:
The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are:

To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services.
To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders.
To disseminate the validated toolkit in various healthcare contexts across Europe.

Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.

ReferenceCitation: Doukani A, Cerga Pashoja A, Fanaj N, Qirjako G, Meksi A, Mustafa S, Vis C, Hug J. Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis. JMIR Form Res. 2021 Nov 1;5(11):e29280. doi: 10.2196/29280.

family: Doukani

full_name: Asmae Doukani

given: Asmae

family: Cerga Pashoja

full_name: Arlinda Cerga Pashoja

given: Arlinda

family: Fanaj

full_name: Naim Fanaj

given: Naim

family: Qirjako

full_name: Gentiana Qirjako

given: Gentiana

family: Meksi

full_name: Andia Meksi

given: Andia

family: Mustafa

full_name: Sevim Mustafa

given: Sevim

family: Vis

full_name: Christiaan Vis

given: Christiaan

family: Hug

full_name: Juliane Hug

given: Juliane

bso_classification: Social sciences

currency_apc_doaj: USD

journal_name: JMIR Formative Research

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

title: Organisational Readiness for Implementing an Internet-Based Cognitive Behavioural Therapy Intervention for Depression across Community Mental Health Services in Albania and Kosovo: A Directed Content Qualitative Study. (Preprint)

ReferenceCitation: Bührmann L, Schuurmans J, Ruwaard J, Fleuren M, Etzelmüller A, Piera-Jiménez J, Finch T, Rapley T, Potthoff S, Aouizerate B, Batterham PJ, Calear A, Christensen H, Pedersen CD, Ebert DD, Van der Eycken E, Fanaj N, van Genugten C, Hanssen D, Hegerl U, Hug J, Kleiboer A, Mathiasen K, May C, Mustafa S, Oehler C, Cerga-Pashoja A, Pope C, Qirjako G, Rosmalen J, Sacco Y, Samalin L, Skjøth MM, Tarp K, Titzler I, Zanalda E, Zbukvic I, Smit JH, Riper H, Vis C; ImpleMentAll consortium. Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial. Trials. 2020 Oct 28;21(1):893. doi: 10.1186/s13063-020-04686-4.

family: Bührmann

full_name: Leah Bührmann

given: Leah

name: on behalf of the ImpleMentAll consortium

family: Schuurmans

full_name: Josien Schuurmans

given: Josien

family: Ruwaard

full_name: Jeroen Ruwaard

given: Jeroen

family: Fleuren

full_name: Margot Fleuren

given: Margot

family: Etzelmüller

full_name: Anne Etzelmüller

given: Anne

family: Piera-Jiménez

full_name: Jordi Piera-Jiménez

given: Jordi

family: Finch

full_name: Tracy Finch

given: Tracy

family: Rapley

full_name: Tim Rapley

given: Tim

family: Potthoff

full_name: Sebastian Potthoff

given: Sebastian

family: Aouizerate

full_name: Bruno Aouizerate

given: Bruno

family: Batterham

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

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

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

repository_institution: Northumbria University - Northumbria Research Link

ipd_sharing_description: IPD will be available on request following a standardised data accession form on relevant participant data. Note this data does not contain clinical outcomes.

location_country: Italy Netherlands France Kosovo Albania Australia Spain Denmark Germany

location_facility:
ASLTO3
ANU
UMCG
FDM
Get.On
DF
BDI
MHCPPriz
GGZ InGeest
BSA
CMHTIR
Internet Psychiatrien


lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
France
Spain
United States
United Kingdom
Canada

acronym: CAPtivate

location_facility: Hospital Clinico Universitario de Santiago

location_facility: University Hospital Cleveland Medical Center/Case Western Reserve University

location_facility: Queen Elizabeth Hospital, Department of Endocrinology

location_facility: Hospital Universitario de Cruces. Servicio de Pediatria

title: A Long-Term Follow-up Study to Evaluate Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults With Late-Onset OTC Deficiency

summary: Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.


title: Open-label, Single-arm, Multi-center Study of Intracerebral Administration of Adeno-associated Viral (AAV) Serotype rh.10 Carrying Human N-sulfoglucosamine Sulfohydrolase (SGSH) cDNA for Treatment of Mucopolysaccharidosis Type IIIA

acronym: AAVance

summary: MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients.

ReferenceCitation: Tardieu M, Zérah M, Husson B, de Bournonville S, Deiva K, Adamsbaum C, Vincent F, Hocquemiller M, Broissand C, Furlan V, Ballabio A, Fraldi A, Crystal RG, Baugnon T, Roujeau T, Heard JM, Danos O. Intracerebral administration of adeno-associated viral vector serotype rh.10 carrying human SGSH and SUMF1 cDNAs in children with mucopolysaccharidosis type IIIA disease: results of a phase I/II trial. Hum Gene Ther. 2014 Jun;25(6):506-16. doi: 10.1089/hum.2013.238. Epub 2014 May 5.

lead_sponsor: LYSOGENE

location_country:
United States
Netherlands
France
Germany
United Kingdom

location_facility: Baylor college of medicine / Texas children's hospital

location_facility: University Medical Center Hamburg-Eppendorf


title: A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

acronym: PRISM-UDR

summary: This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

lead_sponsor: Polyphor Ltd.

location_country:
Israel
United States
France
Czechia

location_facility:
Research site
Research Site


title: Open Label, Two Cohort (With and Without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients With Gaucher Disease Type 1 and Type 3

acronym: ELIKIDS

summary:
Primary Objective:

Evaluate the safety and pharmacokinetics of eliglustat in pediatric patients (≥2 to <18 years old).

Secondary Objective:

Evaluate the efficacy of eliglustat and quality of life in pediatric patients (≥2 to <18 years old).

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
Italy
Sweden
France
Japan
Argentina
Russian Federation
Spain
Turkey
Canada
United Kingdom

location_facility:
Investigational Site Number 3800001
Investigational Site Number 7920002
Investigational Site Number 8260002
Investigational Site Number 1240001
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 3920001
Investigational Site Number 8260003
Investigational Site Number 7240003
Investigational Site Number 1240002
Investigational Site Number 7520001
Investigational Site Number 3800002
Investigational Site Number 6430001
Investigational Site Number 7920004
Investigational Site Number 3920002
Investigational Site Number 0320001
Investigational Site Number 7520002
Investigational Site Number 1240003
Investigational Site Number 7240001
Investigational Site Number 6430005
Investigational Site Number 6430002
Investigational Site Number 7920003
Investigational Site Number 7240002


title: Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

summary:
Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

The objective is to compare the efficacy and safety of the different treatment regimens

lead_sponsor: LEO Pharma

location_country:
Netherlands
France
Belgium
Spain
Germany
United Kingdom
Canada

location_facility: Clatterbridge Hospital, Department of Dermatology

location_facility: Hospital Mutua de Terrassa Dermatology Service

location_facility: Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie


title: Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study

summary: This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

lead_sponsor: Zimmer Biomet

location_country:
Netherlands
Finland
France
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Royal Liverpool and Broadgreen University Teaching Hospitals


title: Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation

acronym: MCLelderly

summary:
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:

Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?

ReferenceCitation: Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. doi: 10.1056/NEJMoa1200920.

family: Kluin-Nelemans

full_name: H.C. Kluin-Nelemans

family: Hoster

full_name: E. Hoster

given: E.

family: Hermine

full_name: O. Hermine

given: O.

family: Walewski

full_name: J. Walewski

given: J.

family: Trneny

full_name: M. Trneny

given: M.

family: Geisler

full_name: C.H. Geisler

family: Stilgenbauer

full_name: S. Stilgenbauer

given: S.

family: Thieblemont

full_name: C. Thieblemont

given: C.

family: Vehling-Kaiser

full_name: U. Vehling-Kaiser

given: U.

family: Doorduijn

full_name: J.K. Doorduijn

family: Coiffier

full_name: B. Coiffier

given: B.

family: Forstpointner

full_name: R. Forstpointner

given: R.

family: Tilly

full_name: H. Tilly

given: H.

family: Kanz

full_name: L. Kanz

given: L.

family: Feugier

full_name: P. Feugier

given: P.

family: Szymczyk

full_name: M. Szymczyk

family: Hallek

full_name: M. Hallek

family: Kremers

full_name: S. Kremers

family: Lepeu

full_name: G. Lepeu

given: G.

family: Sanhes

full_name: L. Sanhes

family: Zijlstra

full_name: J.M. Zijlstra

family: Bouabdallah

full_name: R. Bouabdallah

family: Lugtenburg

full_name: P.J. Lugtenburg

family: Macro

full_name: M. Macro

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: Treatment of Older Patients with Mantle-Cell Lymphoma

ReferenceCitation: Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Geisler CH, Trneny M, Stilgenbauer S, Kaiser F, Doorduijn JK, Salles G, Szymczyk M, Tilly H, Kanz L, Schmidt C, Feugier P, Thieblemont C, Zijlstra JM, Ribrag V, Klapper W, Pott C, Unterhalt M, Dreyling MH. Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. J Clin Oncol. 2020 Jan 20;38(3):248-256. doi: 10.1200/JCO.19.01294. Epub 2019 Dec 5.

name: University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

name: University Hospital Ludwig-Maximilians-University Munich, Munich, Germany

name: Hôpital Necker, Institut Imagine, Assistance Publique–Hôpitaux de Paris, University Paris Descartes, Paris, France

name: Maria Sklodowska-Curie Institute, Warsaw, Poland

name: Charles University General Hospital, Prague, Czech Republic

name: Erasmus MC Cancer Institute, Rotterdam, the Netherlands

name: Hospices Civils de Lyon, University of Lyon, Pierre-Benite, France

name: University of Tübingen, Tübingen, Germany

name: Center Hospitalier Regional and University Nancy Vandoeuvre les Nancy, Nancy, France

name: Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands

name: University Hospital Schleswig-Holstein Campus Kiel/Christian-Albrechts University Kiel, Kiel, Germany

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.

name: Eva Hoster, Roswitha Forstpointner, Wolfgang Hiddemann, Martin H. Dreyling, and Michael Unterhalt, University Hospital Munich; Eva Hoster, University of Munich, Munich; Wolfram Klapper, University of Kiel; Christiane Pott, University Hospital Schleswig-Holstein, Kiel; Michael Hallek, Universität Köln, Köln; Stephan Stilgenbauer, University of Ulm, Ulm, Germany; Olivier Hermine, University Paris Descartes and Université Sorbonne Paris Cité; Catherine Thieblemont, Hôpital Saint Louis, Paris; Vincent Ribrag...

title: Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network

ReferenceCitation: Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Böttcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.

name: Second Medical Department, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Department of Internal Medicine III, University of Munich, Grosshadern, Germany;

name: Assistance Publique-Hopitaux de Paris, Hôpital Henri-Mondor, Immunology Department, Inserm U955, Equipe 9, Université Paris XII, Créteil, France, for the Groupe d'Etudes de Lymphomes de L'Adulte (GELA);

name: Laboratoire d'Hématologie, Hôpital Necker-Enfants-Malades, Paris, France, for the GELA;

name: Institute of Human Genetics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Service d'Hématologie Biologique, Centre Hospitalier Lyon Sud, Pierre-Bénite, France;

name: Department of Hematology, Rigshospitalet, Copenhagen, Denmark;

name: Department of Immunology, Erasmus MC, Rotterdam, The Netherlands;

name: Institute of Hematopathology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Department of Pathology, Centre Hospitalier Lyon-Sud, Lyon, France;

name: Laboratoire de Récherche Translationelle, Institut Gustave Roussy, Villejuif, France;

name: Department of Hematology, University Hospital St Jan, Brugge, Belgium;

name: First Department of Medicine, Charles University, Prague, Czech Republic;

name: Institute of Oncology, Maria Sklodowska-Curie Memorial Cancer Center, Warszawa, Poland;

name: Department of Medicine V, University of Heidelberg, Heidelberg, Germany;

name: Department of Hematology, University Medical Center, University of Groningen, Groningen, The Netherlands; and

name: Department of Clinical Hematology, University Paris Descartes, Centre National de la Recherche Scientifique Unite Mixte de Recherche 8147, Necker Hospital Paris, France, for the GELA

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

location_country:
Italy
Netherlands
France
Poland
Denmark
Germany
Czech Republic

location_facility: The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology

location_facility: General University Hospital, 1St Department of Medicine

location_facility: HOVON - Dutch Haemato-Oncology Association (HOVON-Datacenter)

location_facility: Ospedale Ferratotto, Divisione Di Ematologia

location_facility: Groupe D´Etudes des Lymphomes De l´Adulte (GELA)


title: The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

summary: The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Brazil
Mexico
Germany
France
Puerto Rico
Spain
Canada

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

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


title: A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)

summary:
Primary Objective:

To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).

Secondary Objective:

To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.

ReferenceCitation: van Sörnsen de Koste JR, Senan S, Underberg RW, Oei SS, Elshove D, Slotman BJ, Lagerwaard FJ. Use of CD-ROM-based tool for analyzing contouring variations in involved-field radiotherapy for Stage III NSCLC. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):334-9.

location_country:
Italy
Netherlands
Finland
France
Belgium
Spain
Turkey
United Kingdom


title: A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

summary: This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

lead_sponsor: Baxter Healthcare Corporation

location_country: Italy Austria Germany France

location_facility: Istituto Nationale per la Ricerca sul Cancro

location_facility: Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

location_facility: S. Luigi - S. Curro, Presidi Ospedalieri Unificati

location_facility: Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis


title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

summary: To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

family: de Velasco

full_name: Guillermo de Velasco

given: Guillermo

family: McKay

full_name: Rana R. McKay

given: Rana R.

family: Lin

full_name: Xun Lin

given: Xun

family: Moreira

full_name: Raphel B. Moreira

given: Raphel B.

family: Simantov

full_name: Ronit Simantov

given: Ronit

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

journal_name: Clinical Genitourinary Cancer

title: Comprehensive Analysis of Survival Outcomes in Non–Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Kalanovic

full_name: Daniel Kalanovic

given: Daniel

journal_name: European Urology

ReferenceCitation: Grünwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

family: Krajewski

full_name: Katherine M. Krajewski

given: Katherine M.

family: Perkins

full_name: Julia J. Perkins

given: Julia J.

title: Depth of Remission is a Prognostic Factor for Survival in Patients with Metastatic Renal Cell Carcinoma

ReferenceCitation: Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3.

name: From the Institut Gustave Roussy, Villejuif, France; Charité-Universitätsmedizin, Berlin; Klinikum rechts der Isar, Munich, Germany; Kantonsspital St Gallen, St Gallen, Switzerland; Karolinska University Hospital, Stockholm; Lund University Hospital, Lund, Sweden; Stanford University, Stanford, CA; Pfizer Global Research and Development, La Jolla, CA; Nevada Cancer Institute, Las Vegas, NV; Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; and the Papageorgiou Hospital, Thessaloniki,...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase II Study of Sunitinib Administered in a Continuous Once-Daily Dosing Regimen in Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

location_country:
United States
Sweden
Switzerland
Netherlands
France
Greece
Germany


title: An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis

summary:
Primary Objective:

The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).

Secondary Objectives:

The secondary objectives of the study are:

To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

lead_sponsor: Sanofi

location_country:
Morocco
France
Tunisia
Hungary
Belgium
Spain
Turkey
United States