title: A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

acronym: ACHIEVE

summary:
The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1).

The study consists of 4 periods: A Screening Period (up to 8 weeks), a multiple-ascending dose (MAD) Placebo-Controlled Period (24 weeks), a Treatment Period (24 weeks) and a Long-Term Extension (LTE) Period (96 weeks).

lead_sponsor: Dyne Therapeutics

location_country:
Germany
Italy
New Zealand
United Kingdom
Netherlands
France

location_facility: Ludwig Maximilians University, Munich - Friedrich Baur Institut

location_facility: Fondazione Policlinico Universitario A Gemelli-Rome

location_facility: John Walton Muscular Dystrophy Research Centre


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: BioCryst Pharmaceuticals

summary: The purpose of this study is to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH patients with residual anemia despite treatment with a C5 inhibitor.

status: Active, not recruiting

title: A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Italy
Hungary
United Kingdom
Spain
France

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Ongoing


title: IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study

summary:
Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL+ study is to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.

status: Recruiting

primary_purpose: Other

lead_sponsor: Brahms AG

location_country:
Italy
United Kingdom
Spain
France

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université

intervention_type: Device


lead_sponsor: Institut de Recherches Internationales Servier

summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S65487 with azacitidine in patients with acute myeloid leukaemia.

location_facility: Samsung Medical Center - Division of Hematology-Oncology

location_facility: C. Universidad de Navarra Servicio de Hematologia

location_facility: Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika Klinikai Farmakológiai Részleg

location_facility: Hospital 12 de Octubre Servicio de Hematología

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Klinika Transplantacji Szpiku i Onkohematologii pokoj 4.041 ul. Wybrzeze Armii Krajowej 15

location_facility: Seoul National University Hospital - Department of Hematology-Oncology

location_facility: H. Universitario La Fe Servicio de Hematologia

location_facility: University College London - Hospitals NHS Foundation Trust

title: Phase I / II, Open Label, Dose Escalation Part (Phase I) Followed by Non-comparative Expansion Part (Phase II), Multi-centre Study, Evaluating Safety, Pharmacokinetics and Efficacy of S65487, a Bcl2 Inhibitor Combined With Azacitidine in Adult Patients With Previously Untreated Acute Myeloid Leukemia Not Eligible for Intensive Treatment

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Poland
Hungary
United Kingdom
Korea, Republic of
Spain
France

ipd_sharing: Yes


title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes

summary:
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

location_country:
Spain
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Liverpool University Hospitals NHS Foundation Trust

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.

summary:
Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison.

The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose.

The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Efficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G, Mandelli F. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res. 2014 Apr;23(3):825-36. doi: 10.1007/s11136-013-0523-5. Epub 2013 Sep 13.

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country:
Germany
Italy
Iraq
Netherlands
Austria
Belgium
United States
Greece
Taiwan
France

location_facility: Policlinico S. Orsola - Malpighi, Università di Bologna

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

location_facility: Dana-Farber Cancer Institute Harvard University

location_facility: Ematologia - Sapienza Università di Roma

location_facility: Centre Hospitalier Universitaire of Poitiers

intervention_type: Other


type: Other Identifier

title: Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

summary: This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

time_perspective: Prospective

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Ireland
Italy
Poland
Portugal
Slovakia
Hungary
Argentina
United Kingdom
Iran, Islamic Republic of
Sweden
Austria
Belgium
France


title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

summary: The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

primary_purpose: Prevention

lead_sponsor: Ethicon, Inc.

sponsor_collaborators:
Ethicon, Inc.
OMRIX Biopharmaceuticals

location_country:
Finland
Germany
United Kingdom
Netherlands
Belgium
France

location_facility: Department of Neurosurgery, Klinikum Ingolstadt GmbH

location_facility: Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel

location_facility: Department of Neurosurgery, John Radcliffe Hospital

location_facility: Department of Neurosurgery, University Giessen-Marburg

location_facility: Department of Neurosurgery, Ziekenhuis Oost Limburg

location_facility: Department of Neurosciences and Rehabilitation, Tampere University Hospital

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Essen

location_facility: Department of Neurosurgery, University Hospital of Liège

location_facility: Service de Neurochirurgie B, Hopital Neurologique de Lyon

location_facility: Edinburgh Centre for Neuro-Oncology, Western General Hospital

location_facility: Department of Neurosurgery, Ninewells Hospital & Medical School


title: International Validation of Two Non-motor Scales in Parkinson's Disease: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in Parkinson's Disease (SPARK) Scale

summary: The goal of this project is to develop the international validation of two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, in order to improve the understanding of the extent and severity of non-motor symptoms in Parkinson's disease (PD).

lead_sponsor: Insel Gruppe AG, University Hospital Bern

collaborators: Michael J. Fox Foundation for Parkinson's Research

location_country:
Germany
United Kingdom
Romania
Switzerland
Spain
Greece
France

location_facility: Centre hospitalier régional universitaire de Besançon

location_facility: Insel Gruppe AG University Hospital Bern


title: Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

summary: The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.

lead_sponsor: Cook Group Incorporated

location_country:
Italy
United Kingdom
Denmark
Netherlands
Spain
Canada
France

location_facility:
Hospital Universitari de Girona
Instituto Clinico Humanitas IRCCS
Kingston General Hospital
Odense Universitetshospital
University College of London Hospital
St. Michael's Hospital
Hospital Son Llatzer
Deventer Ziekenhuis
Institut Paoli Calmettes
Hospital de Basurto


title: Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.

summary: The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.

lead_sponsor: AO Clinical Investigation and Publishing Documentation

location_country:
United States
Sweden
Germany
France

location_facility: Centre Hospitalier Universitaire d'Angers


title: AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)

acronym: DISCOVER

summary: AcQMap Registry is an observational study

status: Terminated

ipd_sharing: Undecided

lead_sponsor: Acutus Medical

location_country:
Germany
United Kingdom
Netherlands
France

location_facility: Sheffield Teaching Hospital Northern General Hospital

location_facility: Erasmus MC Cardiologie Elektrofysiologie

status_simplified: Unknown


title: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)

summary: This LIGHTSITE II study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

lead_sponsor: LumiThera, Inc.

location_country:
Germany
Italy
United Kingdom
Spain
France

location_facility: Universitätsklinikum Freiburg- Klinik für Augenheilkunde

location_facility: Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein

location_facility: Institut ophtalmologique de l'Ouest- Clinique jules VERNE


title: Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours

acronym: BoB

summary:
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.

The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks.

The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles.

The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).

design_allocation: Non-Randomized

lead_sponsor: Vall d'Hebron Institute of Oncology

sponsor_collaborators:
Vall d'Hebron Institute of Oncology
Roche Pharma AG
Iqvia Pty Ltd
Taisho Pharmaceutical Co., Ltd.
Janssen, LP

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Spain
France

location_facility: Instituto Nazionale dei Tumori di Milano


title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

summary: An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

ReferenceType: result

ReferenceCitation: Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.

ReferenceType: derived

ReferenceCitation: Eikelis N, Hering D, Marusic P, Duval J, Hammond LJ, Walton AS, Lambert EA, Esler MD, Lambert GW, Schlaich MP. The Effect of Renal Denervation on Plasma Adipokine Profile in Patients with Treatment Resistant Hypertension. Front Physiol. 2017 May 30;8:369. doi: 10.3389/fphys.2017.00369. eCollection 2017.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Monash University - Monash University Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;monash.edu

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Esler MD, Bohm M, Sievert H, Rump CL, Schmieder RE, Krum H, Mahfoud F, Schlaich MP. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J. 2014 Jul;35(26):1752-9. doi: 10.1093/eurheartj/ehu209. Epub 2014 Jun 4.

oa_host_type: repository

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

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repositories_concat: PubMed Central;ub.uni-erlangen.de-opus

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ReferenceCitation: Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Bohm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013 Jul 9;128(2):132-40. doi: 10.1161/CIRCULATIONAHA.112.000949. Epub 2013 Jun 18. Erratum In: Circulation. 2014 May 20;129(20):e502.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

ReferenceCitation: Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880.

ReferenceCitation: Ukena C, Mahfoud F, Kindermann I, Barth C, Lenski M, Kindermann M, Brandt MC, Hoppe UC, Krum H, Esler M, Sobotka PA, Bohm M. Cardiorespiratory response to exercise after renal sympathetic denervation in patients with resistant hypertension. J Am Coll Cardiol. 2011 Sep 6;58(11):1176-82. doi: 10.1016/j.jacc.2011.05.036.

ReferenceCitation: Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25.

ReferenceCitation: Schlaich MP, Straznicky N, Grima M, Ika-Sari C, Dawood T, Mahfoud F, Lambert E, Chopra R, Socratous F, Hennebry S, Eikelis N, Bohm M, Krum H, Lambert G, Esler MD, Sobotka PA. Renal denervation: a potential new treatment modality for polycystic ovary syndrome? J Hypertens. 2011 May;29(5):991-6. doi: 10.1097/HJH.0b013e328344db3a.

lead_sponsor: Medtronic Vascular

location_country:
Germany
Poland
United Kingdom
Australia
Switzerland
Austria
Belgium
Latvia
Spain
France

location_facility: Barts and the London School of Dentistry & Medicine

location_facility: Universitatsklinikum Schleswig-Holstein, Luebeck Campus

location_facility: Pauls Stradins Clinical University Hospital


summary: AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

ReferenceCitation: Parellada M, San Jose Caceres A, Palmer M, Delorme R, Jones EJH, Parr JR, Anagnostou E, Murphy DGM, Loth E, Wang PP, Charman T, Strydom A, Arango C. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. Front Psychiatry. 2021 Aug 24;12:701729. doi: 10.3389/fpsyt.2021.701729. eCollection 2021.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo
eprints.ncl.ac.uk

repositories_concat: PubMed Central;Zenodo;eprints.ncl.ac.uk

lead_sponsor: Celso Arango, MD, PhD

sponsor_collaborators:
Celso Arango, MD, PhD
UMC Utrecht

location_facility: University of Salamanca & Complejo asistencial de Zamora

location_facility: Servicio de Psiquiatría del Niño y del Adolescente, Hospital General Universitario Gregorio Marañón, SERMAS


title: A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.

acronym: BISS

summary:
The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen.

Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.

Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.

In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.

As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.

Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.

ReferenceCitation: Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9. doi: 10.1016/s0161-6420(80)35127-0.

ReferenceCitation: Tejedor J, Rodriguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7. doi: 10.1136/bjo.83.7.783.

ReferenceCitation: Tejedor J, Rodriguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4. doi: 10.1136/bjo.82.2.110.

ReferenceCitation: Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6. doi: 10.3928/0191-3913-19940901-03.

ReferenceCitation: Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5. doi: 10.1001/archopht.1990.01070120080033.

ReferenceCitation: de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.

ReferenceCitation: McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8. doi: 10.1001/archopht.1997.01100160581010.

ReferenceCitation: Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.

ReferenceCitation: Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.

ReferenceCitation: Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.

ReferenceCitation: Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5. doi: 10.3928/0191-3913-20001101-05.

ReferenceCitation: Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43. doi: 10.1016/s0161-6420(89)32776-x.

ReferenceCitation: Kushner BJ, Morton GV. A randomized comparison of surgical procedures for infantile esotropia. Am J Ophthalmol. 1984 Jul 15;98(1):50-61. doi: 10.1016/0002-9394(84)90188-0.

ReferenceCitation: Helveston EM, Ellis FD, Schott J, Mitchelson J, Weber JC, Taube S, Miller K. Surgical treatment of congenital esotropia. Am J Ophthalmol. 1983 Aug;96(2):218-28. doi: 10.1016/s0002-9394(14)77790-6.

ReferenceCitation: Scheiman M, Ciner E, Gallaway M. Surgical success rates in infantile esotropia. J Am Optom Assoc. 1989 Jan;60(1):22-31.

ReferenceCitation: Hatt SR, Leske DA, Liebermann L, Holmes JM. Comparing outcome criteria performance in adult strabismus surgery. Ophthalmology. 2012 Sep;119(9):1930-6. doi: 10.1016/j.ophtha.2012.02.035. Epub 2012 Apr 26.

ReferenceCitation: Wan MJ, Mantagos IS, Shah AS, Kazlas M, Hunter DG. Comparison of Botulinum Toxin With Surgery for the Treatment of Acute-Onset Comitant Esotropia in Children. Am J Ophthalmol. 2017 Apr;176:33-39. doi: 10.1016/j.ajo.2016.12.024. Epub 2017 Jan 3.

ReferenceCitation: Dysli M, Keller F, Abegg M. Acute onset incomitant image disparity modifies saccadic and vergence eye movements. J Vis. 2015 Mar 18;15(3):12. doi: 10.1167/15.3.12.

ReferenceCitation: Dysli M, Abegg M. Gaze-dependent phoria and vergence adaptation. J Vis. 2016;16(3):2. doi: 10.1167/16.3.2.

ReferenceCitation: Mahan M, Engel JM. The resurgence of botulinum toxin injection for strabismus in children. Curr Opin Ophthalmol. 2017 Sep;28(5):460-464. doi: 10.1097/ICU.0000000000000408.

ReferenceCitation: Pediatric Eye Disease Investigator Group; Christiansen SP, Chandler DL, Lee KA, Superstein R, de Alba Campomanes A, Bothun ED, Morin J, Wallace DK, Kraker RT. Tonic pupil after botulinum toxin-A injection for treatment of esotropia in children. J AAPOS. 2016 Feb;20(1):78-81. doi: 10.1016/j.jaapos.2015.09.011.

ReferenceCitation: Pehere N, Jalali S, Mathai A, Naik M, Ramesh K. Inadvertent intraocular injection of botulinum toxin A. J Pediatr Ophthalmol Strabismus. 2011 Jan 25;48 Online:e1-3. doi: 10.3928/01913913-20110118-06.

ReferenceCitation: Liu M, Lee HC, Hertle RW, Ho AC. Retinal detachment from inadvertent intraocular injection of botulinum toxin A. Am J Ophthalmol. 2004 Jan;137(1):201-2. doi: 10.1016/s0002-9394(03)00837-7.

ReferenceCitation: Bradbury JA, Taylor RH. Severe complications of strabismus surgery. J AAPOS. 2013 Feb;17(1):59-63. doi: 10.1016/j.jaapos.2012.10.016. Epub 2013 Jan 23.

ReferenceCitation: Ares C, Superstein R. Retrobulbar hemorrhage following strabismus surgery. J AAPOS. 2006 Dec;10(6):594-5. doi: 10.1016/j.jaapos.2006.04.005. Epub 2006 Oct 2.

ReferenceCitation: Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2017 Mar 2;3(3):CD006499. doi: 10.1002/14651858.CD006499.pub4.

ReferenceCitation: Lyons CJ, Tiffin PA, Oystreck D. Acute acquired comitant esotropia: a prospective study. Eye (Lond). 1999 Oct;13 ( Pt 5):617-20. doi: 10.1038/eye.1999.169.

ReferenceCitation: BURIAN HM, MILLER JE. Comitant convergent strabismus with acute onset. Am J Ophthalmol. 1958 Apr;45(4 Pt 2):55-64. doi: 10.1016/0002-9394(58)90223-x. No abstract available.

ipd_sharing_description: The de-identified study dataset will be made publicly available for secondary analyses by publishing the data on a data sharing platform such as Dryad or BORIS, the public online data repository from the University of Bern.

sponsor_collaborators: Insel Gruppe AG, University Hospital Bern

location_country: Switzerland France

location_facility: Institut Ophtalmologique Sourdille Atlantique


study_start_date_type: Anticipated

lead_sponsor: Gilead Sciences

summary: The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)

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

location_facility: Centre Hospitalier Régional Universitaire de Lille

status: Withdrawn

title: Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE

location_country: Italy Poland Spain France


title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

acronym: VALUE

summary: This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

ReferenceCitation: Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.

lead_sponsor: Laminate Medical Technologies

location_country:
Germany
Spain
United Kingdom
France

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Klinikum Ernst von Bergmann gemeinnützige GmbH


acronym: LIVERHOPE

lead_sponsor: Judit Pich

summary:
The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis.

The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.

ReferenceCitation: Pose E, Napoleone L, Amin A, Campion D, Jimenez C, Piano S, Roux O, Uschner FE, de Wit K, Zaccherini G, Alessandria C, Angeli P, Bernardi M, Beuers U, Caraceni P, Durand F, Mookerjee RP, Trebicka J, Vargas V, Andrade RJ, Carol M, Pich J, Ferrero J, Domenech G, Llopis M, Torres F, Kamath PS, Abraldes JG, Sola E, Gines P. Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):31-41. doi: 10.1016/S2468-1253(19)30320-6. Epub 2019 Oct 10.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

version: acceptedVersion

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;cris.unibo.it

publisher_dissemination: Elsevier

location_facility:
Hospital Clínic de Barcelona
Bologna University Hospital
Academic Medical Centre
San Giovanni Battista Hospital
Universitatsklinikum Bonn
Royal Free Hospital
Beajuon Hospital
Padova University Hospital
Hospital Universitari Vall d'Hebrón

title: Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France


title: Current Treatment of HCV Infection After HSCT

summary:
The availability of novel therapies with DAAs might prompt clinicians caring for HSCT recipients with HCV infection to prescribe the treatment more frequently and possibly earlier after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most appropriate one is not straightforward. It depends not only on its efficacy, toxicity and rate of pharmacological interactions, but also on availability (both through healthcare system and in expanded access programs), and cost.

This observational prospective study will focus on treatment strategies in HSCT recipients with HCV infection. The main focus will be the therapeutic approach, the combination of drugs chosen, the length of treatment and the outcome. The main reasons for treating or not treating HSCT recipients with HCV infection will be also explored. Compared to previous cohorts, this study might provide additional data in the area of non-invasive assessment of fibrosis, HCV-RNA levels and genotyping.

In order to get as much data as possible on HCV treatment, patients with chronic HCV infection transplanted during the last 10 years will be included.

Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016 will be reported.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Italy Spain France

location_facility:
Ospedale Civile
Ospedale Santa Maria della Misericordia
Centre Hospitalier de Meaux
Hospital Santa Creu i Sant Pau
Hospital de la Princesa
Ospedale San Raffaele s.r.l.
Policlinico G.B. Rossi


title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

acronym: TRI-REPAIR

summary: The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

ReferenceCitation: Nickenig G, Weber M, Schuler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.

repositories_concat: PubMed Central

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Nickenig G, Weber M, Schueler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Edwards Lifesciences

location_country: Germany Italy France

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Universitätsklinik Hamburg Eppendorf, Herzzentrum

location_facility: LMU Klinikum der Universität München, Medizinische Klinik I

location_facility: Bonn University - Universitätsklinikum Bonn


title: Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis

summary: This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.

primary_purpose: Diagnostic

lead_sponsor: Proactina S.A.

sponsor_collaborators:
Proactina S.A.
ConsulTech GmbH
pharmtrace
Pharmathen S.A.

location_country: Hungary France

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Országos Klinikai Idegtudományi Intézet (OKITI)

location_facility: Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière


title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

ReferenceCitation: Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.

lead_sponsor: Pierre Fabre Medicament

location_country:
Finland
Germany
Italy
Poland
Portugal
Norway
United Kingdom
Denmark
Romania
Sweden
Spain
Czech Republic
France

location_facility: KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care

location_facility: FREDERIKSBERG HOSPITAL - Clinic of Rheumatology

location_facility: KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology


title: 24-month Randomized, Double-masked, Controlled, Multicenter, Phase II Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to AMD.

summary: This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

ReferenceCitation: Ritter M, Simader C, Bolz M, Deak GG, Mayr-Sponer U, Sayegh R, Kundi M, Schmidt-Erfurth UM. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol. 2014 Dec;98(12):1629-35. doi: 10.1136/bjophthalmol-2014-305186. Epub 2014 Jul 30.

oa_host_type: closed

publisher_dissemination: British Medical Journal

ReferenceCitation: Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, Pilz S, Weisberger A; MONT BLANC Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012 May;119(5):992-1000. doi: 10.1016/j.ophtha.2012.02.002. Epub 2012 Mar 17.

lead_sponsor: Novartis

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Spain
France


title: Interventional, Randomised, Open Label, Multi-centre, Parallel-group, Controlled Study Investigating the Effects of Using the PReDicT Test to Guide the Antidepressant Treatment of Depressed Patients

summary:
Depression is a very common, serious and in some cases life-threatening condition, affecting around 350 million people globally. Approximately 11% of citizens in the European Union suffer from depression at some point in their lives. Depression is associated with significant socio-economic costs and has been predicted to become the greatest cause of disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion . Improvements in managing the treatment of depression are urgently needed to improve patient outcomes, contain rising healthcare costs, improve workplace productivity and help to address global economic and societal challenges.

While a range of effective antidepressant medications are available to treat depression, it takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working. However, surprisingly, more than 50% of patients fail to respond to the first antidepressant treatment they are prescribed. Therefore, it often takes several months to identify an effective antidepressant treatment for the majority of patients with depression. During this time a patient's ability to work and function socially is severely impaired. Individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and on healthcare resources.

ReferenceCitation: World Health Organization, The Global Burden of Disease: 2004 update. nDeneva, World Health Organization, 2008.

ReferenceCitation: Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.

ReferenceCitation: Rush AJ. STAR*D: what have we learned? Am J Psychiatry. 2007 Feb;164(2):201-4. doi: 10.1176/ajp.2007.164.2.201. No abstract available.

ReferenceCitation: Kingslake J, Dias R, Dawson GR, Simon J, Goodwin GM, Harmer CJ, Morriss R, Brown S, Guo B, Dourish CT, Ruhe HG, Lever AG, Veltman DJ, van Schaik A, Deckert J, Reif A, Stablein M, Menke A, Gorwood P, Voegeli G, Perez V, Browning M. The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial. Trials. 2017 Nov 23;18(1):558. doi: 10.1186/s13063-017-2247-2.

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: Würzburg University - Online Publication Service of Würzburg University

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

repository_institution: Radboud University - Radboud Repository

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

repository_institution: University of Nottingham - Nottingham ePrints

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

publisher_dissemination: Springer-Nature

lead_sponsor: P1vital Products Limited

location_country:
Germany
United Kingdom
Netherlands
Spain
France

location_facility: Rothwell and Desborough Healthcare Group

location_facility: University of Nottingham Health Service - Cripps Health Centre

location_facility: Dept of Psychiatry, Outpatient Clinic, University Hospital


title: Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.

summary:
Primary Objective

The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.

Secondary Objectives

To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I …) in this patient population.
To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge.

ReferenceCitation: Montalescot G, Drexler H, Gallo R, Pearson T, Thoenes M, Bhatt DL. Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study. Eur Heart J. 2009 Nov;30(22):2733-41. doi: 10.1093/eurheartj/ehp301. Epub 2009 Aug 21.

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

location_country:
Germany
Italy
Hungary
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France


title: A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

summary:
Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML) characterized by consistent clinical, morphologic, and genetic features. According to the FAB classification APL is designated as"M3 leukemia" and assigned to the WHO defined type of AML with recurrent cytogenetic abnormalities, "acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) and variants".

Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus anthracycline-based regimens, relapses still occur in approximately 20% of patients. Moreover, these regimens are associated with significant toxicities due to severe myelosuppression frequently associated with life-threatening infections and potentially serious late effects including development of secondary MDS/AML. In a recent randomized clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of arsenic trioxide (ATO) and ATRA has been shown to result into better survival with significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA) therapy. Inspired by the results of this trial the investigators intend to perform a randomized study in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard AIDA-based treatment with ATO/ATRA combination including low-doses idarubicin during induction. The investigators propose a modified ATO/ATRA protocol with the addition of two doses of IDA (50% compared to standard AIDA induction) for induction because of the anticipated need of adding anthracyclines to control hyperleukocytosis and to achieve long-term disease control in this high-risk APL population. This is followed by 4 cycles of ATO/ATRA consolidation therapy. As in the APL0406 study for low/intermediate-risk patients the investigators expect less severe hematologic toxicity and treatment-related mortality resulting in an improved outcome for patients in the experimental arm. Furthermore, from the start of consolidation, these patients (in contrast to the standard arm) can be treated on an outpatient basis, which is also considered to be associated with an improved quality of life. The study will be conducted as a European intergroup study.

lead_sponsor: Technische Universität Dresden

collaborators: Gruppo Italiano Malattie EMatologiche dell'Adulto

collaborators: HOVON - Dutch Haemato-Oncology Association

collaborators: Programa para el Tratamiento de Hemopatías Malignas

collaborators: German Federal Ministry of Education and Research

location_country: Germany Italy Netherlands Spain France

location_facility:
French-Belgian-Swiss APL study group
GIMEMA study group
AML-CG study group
OSHO study group
AML-SG study group
PETHEMA study group
HOVON study group
SAL study group


title: An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder

acronym: AQUARIUS

summary: The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.

location_country:
Argentina
Sweden
Austria
South Africa
Estonia
Russian Federation
France


title: Multi-center, Prospective, Post-market Study

summary: The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).

lead_sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

location_country: Germany Ireland Italy Switzerland France

location_facility: AP Hospital Europeen G Pompidou and Hospital Necker


title: A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease

summary: The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.

location_country:
Germany
Portugal
United Kingdom
Denmark
Sweden
Netherlands
Austria
Tunisia
Spain
South Africa
Morocco
Canada
France


title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis

summary:
The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

ReferenceCitation: van de Kerkhof PC, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol. 2009 Jan;160(1):170-6. doi: 10.1111/j.1365-2133.2008.08927.x. Epub 2008 Nov 25.

lead_sponsor: LEO Pharma

location_country:
Finland
Germany
United Kingdom
Netherlands
Belgium
Canada
France

location_facility: Hôpital Trousseau, Service de Dermatologie CHU Tours

location_facility: Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie

location_facility: Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie

location_facility: Policlinic of Dermatology, Medical Reception Centre

location_facility: Royal Gwent Hospital, Department of Dermatology

location_facility: Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie


title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment

acronym: CONTROL

summary:
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
Hungary
Hong Kong
United Kingdom
Brazil
Netherlands
Switzerland
United States
Spain
Greece
South Africa
Czech Republic
France


title: 52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy

acronym: GINGER

summary:
Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

ReferenceCitation: Fritsche A, Hahn A, Landgraf W, Haring HU. Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study. Eur Endocrinol. 2013 Mar;9(1):1-3. doi: 10.17925/EE.2013.09.01.1. Epub 2013 Apr 4.

location_country:
Germany
Italy
Poland
Portugal
Slovakia
United Kingdom
Romania
Australia
Sweden
Netherlands
Switzerland
Belgium
Spain
Czech Republic
France

location_facility: Sanofi-Aventis Sanofi-aventis


title: Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease

summary: Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.

ReferenceCitation: Boscaro M, Bertherat J, Findling J, Fleseriu M, Atkinson AB, Petersenn S, Schopohl J, Snyder P, Hughes G, Trovato A, Hu K, Maldonado M, Biller BM. Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study. Pituitary. 2014 Aug;17(4):320-6. doi: 10.1007/s11102-013-0503-3.

oa_colors: green hybrid

evidence: open (via page says license)

publisher_dissemination: Springer

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
United States
France

location_facility: Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.

location_facility: University of Pennsylvania Medical Center


title: An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

summary: This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

location_country:
United States
Italy
Germany
France

location_facility:
Novartis Investigative Site
University of Chicago
MD Anderson Cancer Center
Dana Faber Institute


title: An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study

summary: This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Japan
Latvia
Spain
South Africa
Serbia
Russian Federation
France

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

location_facility: University of the Witwatersrand Research

location_facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Clin Hospital Center - Kragujevac; Pulmonary Diseases


title: Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety Study With PA101 in Patients With Indolent Systemic Mastocytosis

summary:
This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in adult patients with indolent systemic mastocytosis (ISM).

The purpose of the study is to determine the efficacy and safety profile of PA101 delivered via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using standard treatments.

lead_sponsor: Patara Pharma

location_facility:
Hopital Necker - Enfants Malades
Hospital Universitario de Fuenlabrada
University Medical Center Mainz
Technical University München
University Medical Center of Groningen
University of Salerno
Klinikum Darmstadt
Charité - Universitätsmedizin Berlin


title: Care for Late Stage Parkinsonism

acronym: CLaSP

summary: The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

ReferenceCitation: Kruse C, Kretschmer S, Lipinski A, Verheyen M, Mengel D, Balzer-Geldsetzer M, Lorenzl S, Richinger C, Schmotz C, Tonges L, Woitalla D, Klebe S, Schrag A, Dodel R. Resource Utilization of Patients with Parkinson's Disease in the Late Stages of the Disease in Germany: Data from the CLaSP Study. Pharmacoeconomics. 2021 May;39(5):601-615. doi: 10.1007/s40273-021-01011-y. Epub 2021 Mar 19.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Balzer-Geldsetzer M, Ferreira J, Odin P, Bloem BR, Meissner WG, Lorenzl S, Wittenberg M, Dodel R, Schrag A. Study protocol: Care of Late-Stage Parkinsonism (CLaSP): a longitudinal cohort study. BMC Neurol. 2018 Nov 5;18(1):185. doi: 10.1186/s12883-018-1184-3.

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

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

lead_sponsor: University College, London

collaborators: Philipps University Marburg Medical Center

collaborators: Instituto de Medicina Molecular João Lobo Antunes

collaborators: Ludwig-Maximilians - University of Munich

location_country:
Germany
France
Portugal
United Kingdom
Netherlands
Sweden

location_facility:
Lund University
University of Munich
University College London
Radboud university medical center
Instituto de Medicina Molecular
University of Marburg
University of Bordeaux


title: Phase I/Prospective Randomized Phase II Trial Of the Safety and Efficacy of Tamoxifen in Combination With GDC-0032 Compared With Tamoxifen alONe.

acronym: Poseidon

summary:
This study is designed as a phase 1 dose escalation study followed by a randomised phase II study. The study will be performed in three different centres: Addenbrooke & Cambridge university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron Hospital (Barcelona, Spain).

Three to six patients will be followed for one completed cycle of therapy (28 days) and subsequent enrolment of new cohorts will be based on the safety assessment in that first cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alone.

lead_sponsor: The Netherlands Cancer Institute

collaborators:
Genentech, Inc.
EurocanPlatform
Rather

sponsor_collaborators:
The Netherlands Cancer Institute
Genentech, Inc.
EurocanPlatform
Rather

location_country:
Spain
Netherlands
United Kingdom
France

location_facility:
Reinier de Graaf Gasthuis
Vall d'Hebron University Hospital/VHIO
Hospital Clínic de Barcelona
Haaglanden Medisch Centrum
Hospital Germans Trias i Pujol
Gustave Roussy
Hospital Universitari Sant Joan de Reus
Hospital Arnau de Vilanova
Antoni van Leeuwenhoek
Hospital ICO-Hospitalet (Bellvitge)
University of Cambridge
MUMC
Deventer Ziekenhuis
Ziekenhuis Groep Twente


title: The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

acronym: EUROCRIPS

summary: The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

ReferenceCitation: D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefevre T, Gasparetto V, Garbo R, Omede P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.

lead_sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_country: Italy Spain France

location_facility: Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

location_facility: Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto


title: Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

ReferenceCitation: Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2. Erratum In: Eur J Cancer. 2008 Jul;44(11):1612.

ReferenceCitation: Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.

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

location_country:
Italy
Poland
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
Canada
France

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: University Hospital - Rotterdam Dijkzigt

intervention_type: Radiation


title: Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

summary: The aim of the present study is to investigate the efficacy, safety and tolerability of a therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P. vivax in endemic countries.

ReferenceCitation: Hasugian AR, Purba HL, Kenangalem E, Wuwung RM, Ebsworth EP, Maristela R, Penttinen PM, Laihad F, Anstey NM, Tjitra E, Price RN. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and posttreatment prophylaxis against multidrug-resistant Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis. 2007 Apr 15;44(8):1067-74. doi: 10.1086/512677. Epub 2007 Mar 5.

ReferenceCitation: Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.

ReferenceCitation: Sinclair D, Gogtay N, Brand F, Olliaro P. Artemisinin-based combination therapy for treating uncomplicated Plasmodium vivax malaria. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD008492. doi: 10.1002/14651858.CD008492.pub2.

lead_sponsor: Alfasigma S.p.A.

location_country: Germany Italy France Netherlands Switzerland Spain Israel

location_facility: Medizinische Klinik mit Schwerpunkt Infektiologie, Charite/Campus Virchow-Klinikum

location_facility: Centro di Malattie Tropicali - INMI Spallanzani

location_facility: 15. The Center for Geographic Medicine and Tropical Diseases, Department of Medicine C - The Chaim Sheba Medical Center

location_facility: Azienda Ospedaliera Arcispedale S. Maria Nuova IRCCS - Dip. Medicina Interna e Spec. Mediche

location_facility: Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute

location_facility: Clinica di Malattie Infettive e Tropicali, Universitá di Brescia

location_facility: Department of Infectious Diseases & Tropical Medicine, University of Munich

location_facility: Hôpital St André-CHU, Médecine interne et Maladies tropicales

location_facility: Dep. Infectious Disease, Section Travel Medicine, Leiden University Medical Centre


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)

summary: This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
United States
Korea, Republic of
New Zealand
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus

location_facility: University of Pennsylvania - Abramson Cancer Center

location_facility: Auckland District Health Board (ADHB); Auckland City Hospital (ACH)

location_facility: Yale School of Medicine - Smilow Cancer Hospital - Yale-New Haven Hospital Location


title: A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)

acronym: EU-STAR

summary: To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

lead_sponsor: DFINE Inc.

location_country: Germany Italy France

location_facility:
Otto-von-Guericke-Universität Magdeburg
Goethe-Universität Frankfurt am Main
Nouvel Höpital Civil
Ospedale di Treviso Ca' Foncello
Policlinico Tor Vergata
Universitätsklinikum Bonn
Cardarelli Hospital Naples, Italy
Universität zu Köln


lead_sponsor: PCI Biotech AS

summary: This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable cholangiocarcinomas.

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

title: A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-Induced Photochemical Internalisation (PCI) of Gemcitabine in Patients With Advanced Inoperable Cholangiocarcinomas

location_country:
Germany
United Kingdom
Norway
France


title: Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis

summary:
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.

This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational try is to identify:

The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression
The potential predictors and confounders for response to therapy

status: Unknown status

lead_sponsor: Gabriela Riemekasten

collaborators: University of Campania "Luigi Vanvitelli"

location_country:
Germany
Italy
Hungary
United Kingdom
Switzerland
France

location_facility: University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

location_facility: The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

location_facility: Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: Pecsi Tudomanyegyetem - University of Pecs

location_facility: Felix-Platter Spital, University of Basel

location_facility: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

location_facility: Centre for Pediatric Rheumatology, Klinikum Eilbek

location_facility: Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

location_facility: University of Zurich, Department of Rheumatology

location_facility: Royal Free Hospital, University College London


title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

summary: To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

ReferenceCitation: Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15. No abstract available.

ReferenceCitation: Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18.

ReferenceCitation: Messika-Zeitoun D, Nickenig G, Latib A, Kuck KH, Baldus S, Schueler R, La Canna G, Agricola E, Kreidel F, Huntgeburth M, Zuber M, Verta P, Grayburn P, Vahanian A, Maisano F. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-472. doi: 10.1093/eurheartj/ehy424.

ReferenceCitation: Nickenig G, Hammerstingl C, Schueler R, Topilsky Y, Grayburn PA, Vahanian A, Messika-Zeitoun D, Urena Alcazar M, Baldus S, Volker R, Huntgeburth M, Alfieri O, Latib A, La Canna G, Agricola E, Colombo A, Kuck KH, Kreidel F, Frerker C, Tanner FC, Ben-Yehuda O, Maisano F. Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005.

lead_sponsor: Edwards Lifesciences

location_country: Germany Italy France Netherlands Switzerland Israel

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

location_facility: Universitätskliniken zu Köln Klinik III Innere Medizin

location_facility: Zentrum für Kardiologie, Universitätsmedizin Mainz

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II


summary:
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary vascular resistance, which leads to right ventricular failure. Despite being recently the object of greater attention and despite therapeutic advances, pulmonary hypertension due to SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients prospectively followed in the "European League Against Rheumatism Scleroderma Trials and Research" (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some previous data have suggested the protective effects of calcium channel blockers on the development of pulmonary hypertension, the potential preventive effects of vasodilators for the prevention of Pulmonary hypertension have not been determined yet. In addition to be considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids, endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also be used for this indication.

This observational trial is one out of five observational trials of the collaborative project "To decipher the optimal management of systemic sclerosis" (DeSScipher).

Aim of this observational trial is:

- to compare the outcomes of adult and juvenile SSc patients who are at high risk of developing pulmonary hypertension and are receiving either different vasodilator treatments or no vasodilator treatment.

lead_sponsor: University of Paris 5 - Rene Descartes

sponsor_collaborators: University of Campania "Luigi Vanvitelli"


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

location_facility: University of California at Irvine Medical Center

location_facility: Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum

location_facility: Severance Hospital Yonsei University Health System

location_facility: Klinikum der Universität München Campus Grosshadern


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, NCT03272269) 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.

lead_sponsor: Imcyse SA

location_country:
Germany
Lithuania
United Kingdom
Denmark
Sweden
Belgium
France

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

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


title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism

acronym: PARTUM

summary: The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.

ReferenceCitation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

publisher_dissemination: Wiley

lead_sponsor: University of Calgary

collaborators: Canadian Institutes of Health Research (CIHR)

collaborators: Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

location_country: Ireland Canada Netherlands France

location_facility: British Columbia Women's Hospital & Health Centre

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

summary: To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern


title: An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Advanced Non-Small Cell Lung Cancer

summary: This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).

lead_sponsor: Achilles Therapeutics UK Limited

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: The Leeds Teaching Hospitals NHS Trust, St James's University Hospital

location_facility: Guys and St Thomas' NHS Foundation Trust, Guy's Hospital

location_facility: The Christie NHS Foundation Trust, Christie Hospital

location_facility: University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

location_facility: University Hospital Southampton NHS Foundation Trust, Southampton General Hospital

location_facility: Instituto de Investigación Sanitaria Fundación Jimenez Díaz

location_facility: Centro Integral Oncologico Clara Campal Hospital Universitario HM Sanchinarro

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Manchester University NHS Foundation Trust, Wythenshawe Hospital


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).

ReferenceCitation: Beyna T, Moreels T, Arvanitakis M, Pioche M, Saurin JC, May A, Knabe M, Agnholt JS, Bjerregaard NC, Puustinen L, Schlag C, Aabakken L, Paulsen V, Schneider M, Neurath MF, Rath T, Deviere J, Neuhaus H. Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy. Endoscopy. 2022 Dec;54(12):1147-1155. doi: 10.1055/a-1831-6215. Epub 2022 Apr 21.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Georg Thieme

lead_sponsor: Olympus Europe SE & Co. KG

location_country: Finland Germany Norway Denmark Belgium France

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


lead_sponsor: Bayer

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.

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony

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

ipd_sharing_description:
Availability of this study's data will later 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.vivli.org 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 member section of the portal.

location_country:
United States
Italy
Poland
France


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.

ReferenceCitation: Swan D, Henderson R, McEllistrim C, Naicker SD, Quinn J, Cahill MR, Mykytiv V, Lenihan E, Mulvaney E, Nolan M, Parker I, Natoni A, Lynch K, Ryan AE, Szegezdi E, Krawczyk J, Murphy P, O'Dwyer M. CyBorD-DARA in Newly Diagnosed Transplant-Eligible Multiple Myeloma: Results from the 16-BCNI-001/CTRIAL-IE 16-02 Study Show High Rates of MRD Negativity at End of Treatment. Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):847-852. doi: 10.1016/j.clml.2022.07.011. Epub 2022 Jul 21.

lead_sponsor: European Myeloma Network

sponsor_collaborators:
European Myeloma Network
Janssen Research & Development, LLC

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

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.

ReferenceCitation: White PC. Emerging treatment for congenital adrenal hyperplasia. Curr Opin Endocrinol Diabetes Obes. 2022 Jun 1;29(3):271-276. doi: 10.1097/MED.0000000000000723.

lead_sponsor: Millendo Therapeutics US, Inc.

location_country: France Brazil Spain Czechia Israel

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

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

location_facility: Hospital General Universitario Gregorio Marañón

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