acronym: STRIVE-EU

lead_sponsor: Novartis Gene Therapies

summary: Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.

ReferenceCitation: Mercuri E, Muntoni F, Baranello G, Masson R, Boespflug-Tanguy O, Bruno C, Corti S, Daron A, Deconinck N, Servais L, Straub V, Ouyang H, Chand D, Tauscher-Wisniewski S, Mendonca N, Lavrov A; STR1VE-EU study group. Onasemnogene abeparvovec gene therapy for symptomatic infantile-onset spinal muscular atrophy type 1 (STR1VE-EU): an open-label, single-arm, multicentre, phase 3 trial. Lancet Neurol. 2021 Oct;20(10):832-841. doi: 10.1016/S1474-4422(21)00251-9.

ReferenceCitation: Day JW, Mendell JR, Mercuri E, Finkel RS, Strauss KA, Kleyn A, Tauscher-Wisniewski S, Tukov FF, Reyna SP, Chand DH. Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy. Drug Saf. 2021 Oct;44(10):1109-1119. doi: 10.1007/s40264-021-01107-6. Epub 2021 Aug 12. Erratum In: Drug Saf. 2022 Feb;45(2):191-192.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

location_facility: Carlo Besta Neurological Research Institute

location_facility: The John Walton Muscular Dystrophy Research Centre MRC Centre for Neuromuscular Diseases at Newcastle

location_facility: Great Ormond Street Hospital for Children

location_facility: University Hospital Ghent Neuromuscular reference center

location_facility: Neuropédiatrie - Centre de Référence des Maladies Neuromusculaires

title: Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

location_country:
Italy
United Kingdom
Belgium
France


study_start_date_type: Actual

intervention_type: Biological

lead_sponsor: Alexion Pharmaceuticals, Inc.

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

ReferenceType: result

ReferenceCitation: Kulagin A, Chonat S, Maschan A, Bartels M, Buechner J, Punzalan R, Richards M, Ogawa M, Hicks E, Yu J, Baruchel A, Kulasekararaj AG. Pharmacokinetics, pharmacodynamics, efficacy, and safety of ravulizumab in children and adolescents with paroxysmal nocturnal hemoglobinuria: interim analysis of a phase 3, open-label study. Presented at the European Hematology Association 2021 Virtual Congress, June 9-17, 2021.

status: Completed

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

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Norway
United Kingdom
Netherlands
United States
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


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

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

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

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

location_country:
Germany
United Kingdom
Australia
Netherlands
Switzerland
Belgium
France

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

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"

summary: Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.

ReferenceCitation: Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
France
Germany
Italy
Portugal
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Spain
Czech Republic

intervention_type: Drug


lead_sponsor: Bayer

summary: The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)

location_country:
Germany
Poland
Portugal
Hungary
Israel
Netherlands
Switzerland
Belgium
Spain
Canada
Czech Republic
Russian Federation
France


intervention_type: Other

acronym: ePHex

lead_sponsor: OxThera

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

location_facility: Centre Hospitalier Universitaire de Liège

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

location_country:
Germany
United Kingdom
Tunisia
Belgium
United States
Spain
France


type: Other Grant/Funding Number

type: Other Identifier

title: A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

acronym: DCIS

summary:
Hypotheses:

The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.

Overall Objectives:

To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Chua BH, Link EK, Kunkler IH, Whelan TJ, Westenberg AH, Gruber G, Bryant G, Ahern V, Purohit K, Graham PH, Akra M, McArdle O, O'Brien P, Harvey JA, Kirkove C, Maduro JH, Campbell ID, Delaney GP, Martin JD, Vu TTT, Muanza TM, Neal A, Olivotto IA; BIG 3-07/TROG 07.01 trial investigators. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study. Lancet. 2022 Aug 6;400(10350):431-440. doi: 10.1016/S0140-6736(22)01246-6.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

version: publishedVersion

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: King MT, Link EK, Whelan TJ, Olivotto IA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH; BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1. Epub 2020 Mar 20.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Trans Tasman Radiation Oncology Group

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

location_country:
Ireland
Italy
New Zealand
United Kingdom
Singapore
Australia
Netherlands
Switzerland
Belgium
Canada
France

location_facility: McGill University Department of Oncology

location_facility: Sandwell and West Birmingham Hospitals NHS Trust

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Genesis Cancer Care (previously Premion) - Tugun

location_facility: William Buckland Radiotherapy Centre, Alfred Hospital

location_facility: Imperial College Healthcare Charing Cross

location_facility: Cancer Institute Antoni Van Leeuwenhoekziekenhuis

location_facility: AZ Groeninghe - Campus Maria's Voorzienigheid

location_facility: Centro Di Riferimento Oncologico - Aviano

location_facility: Maastricht Radiation Oncology Maastro Clinic

location_facility: Gloucestershire Royal & Cheltenham General Hospitals

location_facility: Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Genesis Cancer Care (previously Premion) - Nambour

location_facility: The Shrewsbury and Telford Hospital NHS Trust

intervention_type: Radiation


lead_sponsor: Novartis Pharmaceuticals

summary: This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.

title: A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

design_allocation: Non-Randomized

location_country:
Denmark
United States
Canada
Russian Federation
France


title: A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

summary: The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

ReferenceCitation: Abdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14.

repository_institution: University of Nottingham - Nottingham ePrints

repository_institution: Nottingham Trent Repository - Nottingham Trent University's Institutional Repository

repository_institution: University of Nottingham - Repository@Nottingham

license: cc-by

license_normalized: cc-by

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Russian Federation
India
United Kingdom
Argentina
Singapore
Austria
United States
Korea, Republic of
Spain
Taiwan
Peru
Philippines
France

location_facility: Northwest Oncology & Hematology Associates


title: A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer

summary: This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Brazil
France
Hungary
Denmark
United States
India
Romania
Belgium
China
Puerto Rico
Italy
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation

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


title: A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

summary: The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

ReferenceCitation: Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.

publisher_dissemination: Springer-Nature

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

sponsor_collaborators:
Astellas Pharma Inc
Basilea Pharmaceutica

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Chile
Canada
France
Hungary
Switzerland
United States
India
Lebanon
Belgium
China
Malaysia
Philippines
Italy
Singapore
Mexico
Spain
South Africa
Russian Federation
Israel

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Apollo Hospitals Educational & Research Foundation

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: University Health Network - Toronto General Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Hospital General de Agudos Dr. Cosme Argerich

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerai

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Kasturba Medical College K. M. C. Hospital

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: University of Maryland School of Medicine

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: University of California Davis Health System

location_facility: Hospital General de Agudos Dr. Carlos G. Durand

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: University of California at San Francisco

location_facility: De La Salle Health Sciences Institute- DLSUMC

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde


lead_sponsor: Abbott

summary: The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Radboud University - Radboud Repository

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

unpaywall_oa_status: hybrid

ReferenceCitation: Ruemmele FM, Rosh J, Faubion WA, Dubinsky MC, Turner D, Lazar A, Eichner S, Maa JF, Alperovich G, Robinson AM, Hyams JS. Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2. J Crohns Colitis. 2018 Nov 9;12(10):1249-1254. doi: 10.1093/ecco-jcc/jjy087.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

ReferenceCitation: Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA Jr, Colletti RB, Dubinsky M, Kierkus J, Rosh J, Wang Y, Huang B, Bittle B, Marshall M, Lazar A. Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children. Gastroenterology. 2012 Aug;143(2):365-74.e2. doi: 10.1053/j.gastro.2012.04.046. Epub 2012 May 2.

location_facility:
Site Reference ID/Investigator# 4950
Site Reference ID/Investigator# 6073
Site Reference ID/Investigator# 10284
Site Reference ID/Investigator# 6700
Site Reference ID/Investigator# 5901
Site Reference ID/Investigator# 4317
Site Reference ID/Investigator# 4984
Site Reference ID/Investigator# 6798
Site Reference ID/Investigator# 14750
Site Reference ID/Investigator# 4912
Site Reference ID/Investigator# 6072
Site Reference ID/Investigator# 7640
Site Reference ID/Investigator# 16501
Site Reference ID/Investigator# 4914
Site Reference ID/Investigator# 5109
Site Reference ID/Investigator# 5892
Site Reference ID/Investigator# 4316
Site Reference ID/Investigator# 4909
Site Reference ID/Investigator# 6071
Site Reference ID/Investigator# 3734
Site Reference ID/Investigator# 4983
Site Reference ID/Investigator# 6430
Site Reference ID/Investigator# 4285
Site Reference ID/Investigator# 4913
Site Reference ID/Investigator# 5223
Site Reference ID/Investigator# 6257
Site Reference ID/Investigator# 7744
Site Reference ID/Investigator# 6182
Site Reference ID/Investigator# 5904
Site Reference ID/Investigator# 13622
Site Reference ID/Investigator# 3826
Site Reference ID/Investigator# 5102
Site Reference ID/Investigator# 5676
Site Reference ID/Investigator# 8801
Site Reference ID/Investigator# 8391
Site Reference ID/Investigator# 4916
Site Reference ID/Investigator# 5222
Site Reference ID/Investigator# 6354
Site Reference ID/Investigator# 4911
Site Reference ID/Investigator# 10287
Site Reference ID/Investigator# 5169
Site Reference ID/Investigator# 6428
Site Reference ID/Investigator# 7742
Site Reference ID/Investigator# 6065
Site Reference ID/Investigator# 5570

title: A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

location_country:
Poland
United Kingdom
Netherlands
Belgium
United States
Canada
Czech Republic
France


title: A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

acronym: LUMINATE

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

lead_sponsor: Lux Biosciences, Inc.

location_country:
Germany
India
United Kingdom
Austria
United States
Canada
France

location_facility: Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute

location_facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

location_facility: Bristol Eye Hospital and University of Bristol

location_facility: Vittala International Institute of Ophthalmology

location_facility: Klinik für Augenheilkunde, Dept. of Ophthalmology

location_facility: UMDNJ-New Jersey Medical School, Ophthalmology Dept.

location_facility: Massachusetts Eye Research and Surgery Institute

location_facility: Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,

location_facility: Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences

location_facility: Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie

location_facility: Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)

location_facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie


title: A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis


acronym: STEM

lead_sponsor: Evgen Pharma

summary:
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.

sponsor_collaborators:
Evgen Pharma
Premier Research Group plc

location_facility: Grand Hopital de Charleroi, Service D'Oncologie-Hematologie

location_facility: University Hospitals Birmingham NHS Foundation

location_facility: Royal Bournemouth & Christchurch Hospitals NHS

title: STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant

location_country:
Spain
United Kingdom
Belgium
France


acronym: REFLEX

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary:
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.

ReferenceCitation: Battaglini M, Vrenken H, Tappa Brocci R, Gentile G, Luchetti L, Versteeg A, Freedman MS, Uitdehaag BMJ, Kappos L, Comi G, Seitzinger A, Jack D, Sormani MP, Barkhof F, De Stefano N. Evolution from a first clinical demyelinating event to multiple sclerosis in the REFLEX trial: Regional susceptibility in the conversion to multiple sclerosis at disease onset and its amenability to subcutaneous interferon beta-1a. Eur J Neurol. 2022 Jul;29(7):2024-2035. doi: 10.1111/ene.15314. Epub 2022 Apr 4.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher_dissemination: Wiley

ReferenceCitation: Freedman MS, De Stefano N, Barkhof F, Polman CH, Comi G, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Lehr L, Stubinski B, Jack DL, Kappos L. Patient subgroup analyses of the treatment effect of subcutaneous interferon beta-1a on development of multiple sclerosis in the randomized controlled REFLEX study. J Neurol. 2014 Mar;261(3):490-9. doi: 10.1007/s00415-013-7222-6. Epub 2014 Jan 12.

evidence: open (via page says license)

publisher_dissemination: Springer

ReferenceCitation: De Stefano N, Comi G, Kappos L, Freedman MS, Polman CH, Uitdehaag BM, Hennessy B, Casset-Semanaz F, Lehr L, Stubinski B, Jack DL, Barkhof F. Efficacy of subcutaneous interferon beta-1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes. J Neurol Neurosurg Psychiatry. 2014 Jun;85(6):647-53. doi: 10.1136/jnnp-2013-306289. Epub 2013 Nov 29.

publisher_dissemination: British Medical Journal

ReferenceCitation: Comi G, De Stefano N, Freedman MS, Barkhof F, Polman CH, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Moraga MS, Rocak S, Stubinski B, Kappos L. Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial. Lancet Neurol. 2012 Jan;11(1):33-41. doi: 10.1016/S1474-4422(11)70262-9. Epub 2011 Dec 4. Erratum In: Lancet Neurol. 2012 Feb;11(2):125.

title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)

primary_purpose: Prevention

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Croatia
Canada
Serbia
France
Czech Republic
Portugal
Slovakia
Latvia
Morocco
Romania
Lebanon
Belgium
Estonia
Italy
Austria
Saudi Arabia
Spain
Greece
Bulgaria
Russian Federation
Israel


title: Belatacept Conversion Trial in Renal Transplantation

summary: The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

ReferenceCitation: Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyo J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.

location_country:
Germany
Poland
India
Argentina
Australia
Brazil
Mexico
Belgium
United States
Spain
Canada
France

location_facility: University Of North Carolina School Of Medicine


lead_sponsor: Puma Biotechnology, Inc.

summary: The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center

location_facility: University of Maryland, University of Maryland Medical Center

location_facility: Duke University, Duke University Medical Center

location_facility: 307 Hospital of Chinese People's Liberation Army

location_facility: Cancer Hospital, Academy of Med Science and Peking Union Med

title: A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer

location_country:
United States
China
Switzerland
France


title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

summary: The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

ReferenceCitation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Teesside University - TeesRep

repository_institution: Teesside University - Teesside University Research Portal

repositories:
PubMed Central
Pure (Denmark)
research.tees.ac.uk/ws/oai

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Norway
Romania
Australia
Brazil
Sweden
Mexico
United States
Canada
France


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur

summary: The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Hungary
Norway
United Kingdom
Australia
Sweden
United States
Canada
France


title: A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

summary: The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.

status: Terminated

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

lead_sponsor: UCB Pharma

location_country:
France
Germany
Italy
United Kingdom
Brazil
Netherlands
Belgium
United States
Spain
Canada
Czech Republic

status_simplified: Unknown


title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

summary: Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

status: Withdrawn

location_country:
France
Germany
Italy
Slovakia
Hungary
United Kingdom
Brazil
Netherlands
Belgium
United States
Spain
Canada
Czech Republic


title: A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study

acronym: EYEGUARD-X

summary: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.

ReferenceCitation: Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.

publisher_dissemination: Informa

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Tunisia
Austria
Korea, Republic of
Spain
Greece
Turkey
Taiwan
France

location_facility: Moorfields Eye Hospital NHS Foundation Trust


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 Administered Orally in Patients With Myelofibrosis

summary: This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including changes in spleen volume, JAK2V617F allele burden, and hematologic response.

primary_purpose: Health Services Research

location_country:
Germany
Italy
United Kingdom
Singapore
Australia
Netherlands
Canada
France


lead_sponsor: Shire

summary: This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy of the study drug.

location_facility: Hospital Universitario Vall D'hebron - Ppds

location_facility: Azienda Socio Sanitaria Territoriale - Asst di Monza

location_facility: University of North Carolina at Chapel Hill

title: An Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Mucopolysaccharidosis Type IIIA Disease

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

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Spain
France


title: Long-term Experience With Abatacept SC in Routine Clinical Practice

acronym: ASCORE

summary: The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Alten R, Mariette X, Flipo RM, Caporali R, Buch MH, Patel Y, Marsal S, Sanmarti R, Nurmohamed MT, Griffiths H, Peichl P, Bannert B, Chartier M, Connolly SE, Lozenski K, Rauch C. Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study. Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

collaborators:
inVentiv Health Clinical
PharmaNet

sponsor_collaborators:
Bristol-Myers Squibb
inVentiv Health Clinical
PharmaNet

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Austria
Switzerland
Spain
Greece
Monaco
France


title: A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

summary: This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.

location_country:
Germany
Italy
Australia
Japan
Netherlands
United States
France


title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA

summary:
Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.

status: Unknown status

ReferenceCitation: Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.

ReferenceCitation: Rudwaleit M, Sieper J. Positive and negative predictive values from published studies can be misleading for decision-making in clinical practice. Rheumatology (Oxford). 2006 Jun;45(6):779-80; author reply 780-1. doi: 10.1093/rheumatology/kel083. Epub 2006 Apr 4. No abstract available.

ReferenceCitation: Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum In: Ann Rheum Dis. 2019 Jun;78(6):e59.

lead_sponsor: Charite University, Berlin, Germany

location_country:
Germany
Ireland
Brazil
Turkey
Canada
France
Colombia
Hungary
Denmark
Switzerland
United States
Indonesia
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Spain
Taiwan

location_facility: Hvidovre Hospital, University of Copenhagen

location_facility: Glasgow Royal Infirmary, Queen Elizabeth Building

location_facility: Third Affiliated Hospital of Sun Yat-sen University

location_facility: Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30

location_facility: Case Western Reserve University at MetroHealth Medical Centre


title: Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers

acronym: RAPIDS 2 OL

summary: The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

lead_sponsor: Actelion

location_country:
Germany
Italy
United Kingdom
Switzerland
Austria
United States
Canada
France

location_facility:
Murray Baron, MD
Inselspital, Universitatspital Bern
Naomi Rothfield, MD
Nadera Sweiss, MD
Jerry Molitor, MD
Ospedale Maggiore
Edwin Smith, MD
Universitatsklinikum
Frederick Wigley, MD
Peter Lee, MD
Thomas Osborn, MD
Policlinico Umberto 1
Vivien Hsu, MD - UMDNJ
Universitatsklinik
Royal Free Hospital
Selly Oak Hospital
CHRU Claude Huriez
Mittie Doyle, MD
Daniel Furst, MD
Avram Goldberg, MD
Eric Rich, MD
AKH Universitatsklinik
Mary Ellen Csuka, MD
Medical Universtiy of South Carolina
Janet Pope, MD
Thomas Medsger, MD
Howard Kenney, MD
David Collier, MD
Instituto di Clinica, Villa Monna Tessa
Barri Fessler, MD
Maureen Mayes, MD
Peter Merkel, MD
Centre Hospitalier Universitaire
Bashar Kahaleh, MD
Freeman Hospital


title: Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)

acronym: BENEFIT OL

summary: The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

location_country:
France
Germany
Italy
Poland
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Canada
Czech Republic

location_facility: Charles University, Internal Medicine Department, (PAH unit)

location_facility: Centre de Pneumologie de L'Hopital Laval

location_facility: Mayo Clinic, Division of Cardiovascular Diseases and Internal Medicine


title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

ReferenceCitation: Jais X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

location_facility: Toronto General Hospital Pulmonary & Critical Care Medicine

location_facility: Centre de Pneumonologie de L'Hospital Laval


title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

summary: Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

ReferenceCitation: Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR

ReferenceCitation: Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. doi: 10.1681/ASN.2006060606. Epub 2006 Nov 8.

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
Slovakia
Israel
Norway
Denmark
United Kingdom
Netherlands
Belgium
Spain
Greece
Canada
France


title: A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of PD 0348292 in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement

summary: To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery

lead_sponsor: Pfizer

location_country:
France
Italy
Poland
Colombia
Portugal
Slovakia
United Kingdom
Denmark
Australia
United States
Spain
South Africa
Chile
Canada
Russian Federation
Czech Republic


title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.

summary: The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

ReferenceCitation: Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1. doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8.

lead_sponsor: Sheba Medical Center

location_country:
France
Italy
Korea, Republic of
China
Greece
Serbia
Israel

location_facility: Zvezdara University Clinical Center, Gastroenterology Department

location_facility: Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

location_facility: Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University

location_facility: 6th affiliated hospital of Sun yat-sen university

location_facility: nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

location_facility: Department of Gastroenterology, University Hospital & Medical School of Ionnina

location_facility: Gastroenterology department, Soroka medical center


title: Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma

acronym: VINILO

summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Innovative Therapies For Children with Cancer Consortium

location_country:
Italy
United Kingdom
Denmark
Netherlands
Austria
Switzerland
Spain
France

location_facility: Cancer Research UK Clinical Trials Unit School of Cancer Sciences University of Birmingham


title: PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

ReferenceCitation: Vairy S, Le Teuff G, Bautista F, De Carli E, Bertozzi AI, Pagnier A, Fouyssac F, Nysom K, Aerts I, Leblond P, Millot F, Berger C, Canale S, Paci A, Poinsignon V, Chevance A, Ezzalfani M, Vidaud D, Di Giannatale A, Hladun-Alvaro R, Petit FM, Vassal G, Geoerger B, Le Deley MC, Grill J. Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma. Neurooncol Adv. 2020 Jun 9;2(1):vdaa075. doi: 10.1093/noajnl/vdaa075. eCollection 2020 Jan-Dec.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

summary: To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Poland
Japan
Sweden
Belgium
Spain
Turkey
Czech Republic
Russian Federation
France


title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

summary: The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

ReferenceCitation: Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: C. R. Bard

sponsor_collaborators:
C. R. Bard
Bard Ltd

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Austria
Belgium
Spain
Greece
France

location_facility: Azienda Ospedaliera della Valtellina e dalla Valchiavenna

location_facility: Szpital Kliniczny Przemienienia Panskiego

intervention_type: Device


title: Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure

summary: This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
United Kingdom
Australia
Austria
France

location_facility:
Duesseldorf University Hospital
The Heart and Diabetes Center NRW
Uniklinik Hamburg Eppendorf (UKE)
Freeman Hospital
University of Leipzig Heart Center
St. Vincents Hospital
Papworth Hospital NHS Foundation
Hannover Medical School MHH
Medical University AKH Vienna
Hospitalier Pitié-Salpétrière
German Heart Institute Berlin DHZB


title: A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

summary: A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

lead_sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
France

location_facility: Memorial Sloan Kettering Cancer Center Dept of Onc..


title: A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate

acronym: SERUM

summary: The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

location_country:
France
Hong Kong
Australia
Belgium
Spain
Russian Federation
Israel

location_facility: GBOU VPO Moscow State University of Medicine and Dentistry

location_facility: Cliniques Universitaires Saint-Luc / Service de Rhumatologie

location_facility: Scientific Institute of Rheumatology of Russian Academy of Medical Science

location_facility: LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7

location_facility: Hospital Regional Universitario Carlos Haya. Hospital Civil

location_facility: LLC "Alliance Biomedical - Russian Group"


title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

acronym: RAPID

summary: The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

ReferenceCitation: Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

lead_sponsor: CTI BioPharma

location_country:
Germany
Italy
United States
Canada
France

location_facility: UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division

location_facility: Center for Cancer and Blood Disorders, P.C.

location_facility: New Mexico Hematology/Oncology Consultants

location_facility: Hopitaux Universitaires de Strabourg - Hopital Hautepierre

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research

location_facility: Berks Hematology-Oncology Associates Ltd.

location_facility: Western Kentucky Hematology/Oncology Group

location_facility: London Health Science Center Regional Care Program

location_facility: Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center

location_facility: Hematology/Oncology Group of Orange County

location_facility: Cancer Treatment & Research Mid-Dakota Clinic

location_facility: Southeast Nebraska Hematology and Oncology Consultants, P.C.

location_facility: Instituto di Ematologia "Lorenzo e Ariosto"

location_facility: Hazel Hawkins Hospital, Dept. of Medical Oncology

location_facility: Farmacia Osepdaliera, Odpedale Umberto I

location_facility: Consultants in Blood Disorders and Cancer

location_facility: Watson Clinic for Cancer Care and Research

location_facility: Mid-Illinois Hematology & Oncology Associates

location_facility: Multicare Oncology Hematology Specialists

location_facility: Oncology Hematology Associates of West Broward

location_facility: Our Lady of the Lake Regional Medial Center, Hematology Oncology

location_facility: Maryland Hematology/Oncology Associates, PA

location_facility: The Center for Cancer and Blood Disorders

location_facility: Oncology Hematology of Northern Illinois

location_facility: Frederick Memorial Hospital Cancer Center

location_facility: North Missssppi Hematology Oncology Associates


title: A Phase II, Multicenter, Randomized, Double-blind, "Sham" Pheresis-controlled, Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological Agents

summary:
Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint damage.

As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the opportunity to target specific inflammatory processes with new therapies has improved. Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies, including newer experimental therapies, which target either the activation of T cells or the neutralization of their effector mechanisms. These newer therapies have shown benefit in human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T cell mediated diseases including graft versus-host disease, rejection after organ transplantation, and selected autoimmune diseases.

This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine if ECP treatment can reduce the signs and symptoms of RA in this refractory patient population.

lead_sponsor: Mallinckrodt

location_country:
Germany
Italy
Slovakia
Australia
Austria
Belgium
Mexico
United States
South Africa
Canada
France

location_facility: Universita de Genova - Ospedale S. Martino

location_facility: Abt. Rheumatologie und Klinische Immunologie

location_facility: OPD- Hospital Civil "Dr. Jaun I. Menchaca"

location_facility: Carroll County Arthritis and Osteoporosis Center

location_facility: Arthritis and Osteoporosis Center of South Texas

location_facility: University of Charite Clinic for Rheumatology and Immunology

location_facility: D6 Rheumatology Clinic and E5 Hematology Unit

location_facility: Medizinische Klinik des Evangelischen Kranken

location_facility: Benaroya Research Institute at Virginia Mason


title: A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation

summary: Assessment of efficacy and safety UK-390,957.

location_country:
Germany
Italy
Poland
Israel
Norway
Australia
Sweden
Netherlands
Austria
Spain
Turkey
Canada
Czech Republic
France


acronym: The ONE Study Reference Group Trial

lead_sponsor: University of Regensburg

summary: To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.

ReferenceCitation: Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7. Erratum In: Lancet. 2020 Jun 27;395(10242):1972.

repository_institution: King's College London - Research Portal

version: submittedVersion

repository_institution: University of California - eScholarship University of California

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

sponsor_collaborators:
University of Regensburg
European Commission

location_facility: Churchill Hospital in affiliation with the University of Oxford

location_facility: Guy's Hospital in affiliation with King's College London

title: Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation

primary_purpose: Basic Science

location_country:
Germany
Italy
United Kingdom
United States
France


title: Randomized, Long-Term Administration of pH-Neutral PD Solutions Containing Lactate (BALANCE) or Bicarbonate (BICAVERA) in Children

acronym: BIOKID

summary:
Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved for the European market. Short term administration suggests comparable clearance rates compared with conventional solutions. In vitro studies demonstrate an improved local immune defense system. To compensate for metabolic acidosis, the available solutions either contain lactate or bicarbonate, the impact of either buffer on long term acidosis control and peritoneal membrane integrity, however, is unknown.

The prospective, European multi-center study will provide the first long term administration of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end point will be the effect of either PD-solution on peritoneal transport characteristics (D/P Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants of the peritoneal transporter status and of the continued morphological transformation of the peritoneum will be assessed.

After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution, the patients will be randomized to a 10 month study period using BicaVera and Balance, respectively. Dialysis regime and follow up in the out-patient clinic will be performed according to clinical needs (every 4 weeks); episodes of peritonitis will be treated according to international guidelines. Bicarbonate supplements will be prescribed at a dose of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3, 6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained at any time of abdominal surgery. Adverse events will be screened meticulously. The trial will be carried out in accordance with the German medicines act (AMG) and other local requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and the declaration of Helsinki. At study end, the patients will decide together with the responsible physician which PD-fluid should be used further one.

ReferenceCitation: Nau B, Schmitt CP, Almeida M, Arbeiter K, Ardissino G, Bonzel KE, Edefonti A, Fischbach M, Haluany K, Misselwitz J, Kemper MJ, Ronnholm K, Wygoda S, Schaefer F; European Pediatric Peritoneal Dialysis Study Group. BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991]. BMC Nephrol. 2004 Oct 14;5:14. doi: 10.1186/1471-2369-5-14.

ReferenceCitation: Schmitt CP, Nau B, Gemulla G, Bonzel KE, Holtta T, Testa S, Fischbach M, John U, Kemper MJ, Sander A, Arbeiter K, Schaefer F. Effect of the dialysis fluid buffer on peritoneal membrane function in children. Clin J Am Soc Nephrol. 2013 Jan;8(1):108-15. doi: 10.2215/CJN.00690112. Epub 2012 Nov 2.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Heidelberg University

location_country: Finland Italy Germany Austria France

location_facility:
University Children's Hospital
University Children´s Hospital


acronym: PARTITA

summary: The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.

ReferenceCitation: Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.

ReferenceCitation: Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.

ReferenceCitation: Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2.

ReferenceCitation: Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.

ReferenceCitation: Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.

ReferenceCitation: Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.

ReferenceCitation: Gilliam FR, Hayes DL, Boehmer JP, Day J, Heidenreich PA, Seth M, Jones PW, Stein KM, Saxon LA. Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study. J Cardiovasc Electrophysiol. 2011 Sep;22(9):1023-9. doi: 10.1111/j.1540-8167.2011.02086.x. Epub 2011 May 31.

ReferenceCitation: Carbucicchio C, Santamaria M, Trevisi N, Maccabelli G, Giraldi F, Fassini G, Riva S, Moltrasio M, Cireddu M, Veglia F, Della Bella P. Catheter ablation for the treatment of electrical storm in patients with implantable cardioverter-defibrillators: short- and long-term outcomes in a prospective single-center study. Circulation. 2008 Jan 29;117(4):462-9. doi: 10.1161/CIRCULATIONAHA.106.686534. Epub 2008 Jan 2.

ReferenceCitation: Della Bella P, Baratto F, Tsiachris D, Trevisi N, Vergara P, Bisceglia C, Petracca F, Carbucicchio C, Benussi S, Maisano F, Alfieri O, Pappalardo F, Zangrillo A, Maccabelli G. Management of ventricular tachycardia in the setting of a dedicated unit for the treatment of complex ventricular arrhythmias: long-term outcome after ablation. Circulation. 2013 Apr 2;127(13):1359-68. doi: 10.1161/CIRCULATIONAHA.112.000872. Epub 2013 Feb 25.

ReferenceCitation: Vergara P, Trevisi N, Ricco A, Petracca F, Baratto F, Cireddu M, Bisceglia C, Maccabelli G, Della Bella P. Late potentials abolition as an additional technique for reduction of arrhythmia recurrence in scar related ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2012 Jun;23(6):621-7. doi: 10.1111/j.1540-8167.2011.02246.x. Epub 2012 Apr 4.

ReferenceCitation: Della Bella P, Baratto F, Vergara P, Bertocchi P, Santamaria M, Notarstefano P, Calo L, Orsida D, Tomasi L, Piacenti M, Sangiorgio S, Pentimalli F, Pruvot E, De Sousa J, Sacher F, Tritto M, Rebellato L, Deneke T, Romano SA, Nesti M, Gargaro A, Giacopelli D, Peretto G, Radinovic A. Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial. Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3.

ReferenceCitation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

lead_sponsor: IRCCS San Raffaele

location_country: Germany Italy Portugal Switzerland Belgium Czechia France

location_facility: Azienda Ospedaliera Valtellina e Valchiavenna

location_facility: Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria


title: Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations

summary: The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

lead_sponsor: Spirig Pharma Ltd.

location_country:
Ireland
Germany
United Kingdom
Netherlands
Austria
Switzerland
Turkey
Czech Republic
France

location_facility: Klinikum der Charité Universitätsmedizin

location_facility: Universitätsspital Zürich, Dermatologische Klinik

location_facility: Hautklinik am Nationalen Zentrum für Tumorerkrankungen


title: A Phase III Randomized Study of TH (Paclitaxel and Trastuzumab) Versus THL (Paclitaxel, Trastuzumab and Lapatinib) in First Line Treatment of HER2-positive Metastatic Breast Cancer

acronym: TH V THL

summary: The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

lead_sponsor: Cancer Trials Ireland

location_country: Finland Ireland Germany France Portugal Norway Spain Israel

location_facility: Complejo Hospitalario Xeral Calde / Hospital Lucus Augusti

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Hospital Clinico Universitario 'Lozano Blesa'

location_facility: Interdisziplinäre Onkologische Zentrum München (IOZ München)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital General Universitario de Valencia


title: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial

acronym: WAKE-UP

summary: WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.

ReferenceCitation: Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.

evidence: open (via free article)

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: LIRIAS (KU Leuven);eprints.gla.ac.uk

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Barow E, Quandt F, Cheng B, Gelderblom M, Jensen M, Konigsberg A, Boutitie F, Nighoghossian N, Ebinger M, Endres M, Fiebach JB, Thijs V, Lemmens R, Muir KW, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G. Association of White Blood Cell Count With Clinical Outcome Independent of Treatment With Alteplase in Acute Ischemic Stroke. Front Neurol. 2022 Jun 13;13:877367. doi: 10.3389/fneur.2022.877367. eCollection 2022.

repository_institution: DZNE - DZNE Pub

repositories_concat: LIRIAS (KU Leuven);PubMed Central;eprints.gla.ac.uk;pub.dzne.de

publisher_dissemination: Frontiers

ReferenceCitation: Schlemm L, Braemswig TB, Boutitie F, Vynckier J, Jensen M, Galinovic I, Simonsen CZ, Cheng B, Cho TH, Fiehler J, Puig J, Thijs V, Fiebach J, Muir K, Nighoghossian N, Ebinger M, Pedraza S, Thomalla G, Gerloff C, Endres M, Lemmens R, Nolte CH; WAKE-UP Investigators. Cerebral Microbleeds and Treatment Effect of Intravenous Thrombolysis in Acute Stroke: An Analysis of the WAKE-UP Randomized Clinical Trial. Neurology. 2022 Jan 18;98(3):e302-e314. doi: 10.1212/WNL.0000000000013055. Epub 2021 Nov 15.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
Pure (Denmark)
eprints.gla.ac.uk
pub.dzne.de

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;Pure (Denmark);eprints.gla.ac.uk;pub.dzne.de

ReferenceCitation: Lettow I, Jensen M, Schlemm E, Boutitie F, Quandt F, Cheng B, Ebinger M, Endres M, Fiebach JB, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G; WAKE-UP Investigators. Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial. Stroke. 2021 Dec;52(12):3768-3776. doi: 10.1161/STROKEAHA.120.033425. Epub 2021 Aug 26.

ReferenceCitation: Barow E, Boutitie F, Cheng B, Cho TH, Ebinger M, Endres M, Fiebach JB, Fiehler J, Nickel A, Puig J, Roy P, Lemmens R, Thijs V, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G. 24-hour blood pressure variability and treatment effect of intravenous alteplase in acute ischaemic stroke. Eur Stroke J. 2021 Jun;6(2):168-175. doi: 10.1177/23969873211014758. Epub 2021 Jun 18.

ReferenceCitation: Scheldeman L, Wouters A, Dupont P, Christensen S, Boutitie F, Cheng B, Ebinger M, Endres M, Fiebach JB, Gerloff C, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Ringelstein EB, Chamorro A, Grond M, Laage R, Schneider A, Thomalla G, Thijs V, Lemmens R. Reversible Edema in the Penumbra Correlates With Severity of Hypoperfusion. Stroke. 2021 Jul;52(7):2338-2346. doi: 10.1161/STROKEAHA.120.033071. Epub 2021 May 13.

ReferenceCitation: Konigsberg A, Sehner S, Arlt S, Cheng B, Simonsen CZ, Boutitie F, Serena J, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C, Thomalla G; WAKE-UP investigators. Effect of intravenous alteplase on post-stroke depression in the WAKE UP trial. Eur J Neurol. 2021 Jun;28(6):2017-2025. doi: 10.1111/ene.14797. Epub 2021 Mar 22.

repository_institution: Universitat de Girona - Universitat de Girona Digital Repository

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

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

repositories_concat: HAL;LIRIAS (KU Leuven);Pure (Denmark);University of Melbourne - Minerva Access;dugi-doc.udg.edu

ReferenceCitation: Grosch AS, Kufner A, Boutitie F, Cheng B, Ebinger M, Endres M, Fiebach JB, Fiehler J, Konigsberg A, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Siemonsen CZ, Thijs V, Wouters A, Gerloff C, Thomalla G, Galinovic I. Extent of FLAIR Hyperintense Vessels May Modify Treatment Effect of Thrombolysis: A Post hoc Analysis of the WAKE-UP Trial. Front Neurol. 2021 Feb 4;11:623881. doi: 10.3389/fneur.2020.623881. eCollection 2020.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: LIRIAS (KU Leuven);PubMed Central;University of Melbourne - Minerva Access;refubium.fu-berlin.de

ReferenceCitation: Barow E, Pinnschmidt H, Boutitie F, Konigsberg A, Ebinger M, Endres M, Fiebach JB, Fiehler J, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G, Cheng B; WAKE-UP investigators. Symptoms and probabilistic anatomical mapping of lacunar infarcts. Neurol Res Pract. 2020 Aug 3;2:21. doi: 10.1186/s42466-020-00068-y. eCollection 2020.

ReferenceCitation: Schlemm L, Kufner A, Boutitie F, Nave AH, Gerloff C, Thomalla G, Simonsen CZ, Ford I, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Ebinger M, Endres M. Current Smoking Does Not Modify the Treatment Effect of Intravenous Thrombolysis in Acute Ischemic Stroke Patients-A Post-hoc Analysis of the WAKE-UP Trial. Front Neurol. 2019 Nov 22;10:1239. doi: 10.3389/fneur.2019.01239. eCollection 2019.

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dnet;eprints.gla.ac.uk;pub.dzne.de;refubium.fu-berlin.de

ReferenceCitation: Barow E, Boutitie F, Cheng B, Cho TH, Ebinger M, Endres M, Fiebach JB, Fiehler J, Ford I, Galinovic I, Nickel A, Puig J, Roy P, Wouters A, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G; WAKE-UP investigators. Clinical Characteristics and Outcome of Patients with Lacunar Infarcts and Concurrent Embolic Ischemic Lesions. Clin Neuroradiol. 2020 Sep;30(3):511-516. doi: 10.1007/s00062-019-00800-5. Epub 2019 Jun 3.

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Nighoghossian N, Pedraza S, Lemmens R, Roy P, Muir KW, Heesen C, Ebinger M, Ford I, Cheng B, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C. Effect of informed consent on patient characteristics in a stroke thrombolysis trial. Neurology. 2017 Sep 26;89(13):1400-1407. doi: 10.1212/WNL.0000000000004414. Epub 2017 Aug 25.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;eprints.gla.ac.uk

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Pedraza S, Lemmens R, Nighoghossian N, Roy P, Muir KW, Ebinger M, Ford I, Cheng B, Galinovic I, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C. Clinical characteristics of unknown symptom onset stroke patients with and without diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch. Int J Stroke. 2018 Jan;13(1):66-73. doi: 10.1177/1747493017706245. Epub 2017 Apr 20.

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Nighoghossian N, Pedraza S, Lemmens R, Roy P, Muir KW, Ebinger M, Ford I, Cheng B, Galinovic I, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C; WAKE-UP Investigators. Stroke With Unknown Time of Symptom Onset: Baseline Clinical and Magnetic Resonance Imaging Data of the First Thousand Patients in WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke: A Randomized, Doubleblind, Placebo-Controlled Trial). Stroke. 2017 Mar;48(3):770-773. doi: 10.1161/STROKEAHA.116.015233. Epub 2017 Feb 7.

location_country:
Germany
United Kingdom
Denmark
Belgium
Spain
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Institut d'Investigacio Biomedica de Girona Doctor Josep Trueta

location_facility: Aarhus Universitetshospital, Aahrhus Sygehus


title: A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

summary: The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Lovell DJ, Ruperto N, Mouy R, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Huppertz HI, Job Deslandre C, Minden K, Punaro M, Block AJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

repository_institution: PubMed Central - Europe PMC

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

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

ReferenceCitation: Ruperto N, Lovell DJ, Li T, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Alcala JO, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace C, Alessio M, Quartier P, Cortis E, Eberhard A, Simonini G, Lemelle I, Chalom EC, Sigal LH, Block A, Covucci A, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1542-51. doi: 10.1002/acr.20283. Epub 2010 Jul 1.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Horneff G, Huppertz HI, Job-Deslandre C, Loy A, Minden K, Punaro M, Nunez AF, Sigal LH, Block AJ, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010 Jun;62(6):1792-802. doi: 10.1002/art.27431.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH; Paediatric Rheumatology INternational Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. doi: 10.1016/S0140-6736(08)60998-8. Epub 2008 Jul 14.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Portugal
Brazil
Switzerland
Austria
Mexico
United States
Spain
Peru
France


title: A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

summary: The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Lithuania
Poland
Portugal
Hungary
Israel
Romania
United Kingdom
Netherlands
United States
Latvia
Spain
South Africa
Ukraine
Bulgaria
Estonia
Serbia
Russian Federation
France


title: Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

summary: This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Australia
Mexico
United States
Spain
Canada
France


title: A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up

summary: Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
United Kingdom
Austria
Belgium
Taiwan
France


title: A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES

summary:
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.

HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.

Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

ReferenceCitation: Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.

ReferenceCitation: Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16. Erratum In: N Engl J Med. 2008 Jun 5;358(23): 2530.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Australia
Switzerland
Belgium
United States
Canada
France


title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis

summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

ReferenceCitation: Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Pfizer

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Netherlands
Austria
Switzerland
United States
Spain
Russian Federation
France

location_facility: Academisch Ziekenhuis Vrije Universiteit

location_facility: Thomas Jefferson University Physicians Dept of Neurology

location_facility: Neurology Health Care Service / Fletcher Allen Health Care

location_facility: The MS Treatment Center at Griffin Hospital

location_facility: Dept of Neurology Universitatsklinikum Munster

location_facility: Chair of Nuerological Diseases and Medical Genetics

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Dept of Neurological Sciences University La Sapienza Rome

location_facility: SUNY At Stony Brook U Hospital - Department of Neurology

location_facility: Albany Medical College Dept of Neurology MC-70

location_facility: Dept of Neurology St Petersburg State Medical University

location_facility: Dept Of Neurology and Neurosurgery, Russian State Med Univ

location_facility: Servicio de Neurologia Departmento Enfermedades Desmielinizantes

location_facility: Division of Clinical Neurology Medical School Universtity Hopsital

location_facility: Dept of Neurology Medical Clinic of Russian MoH

location_facility: Department of Neurology City Hospital #33

location_facility: Dept of Neurosciences Oftamology and Genetics Univ of Genoa

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Neuroinmunologia Clinica Hospital Vall d'Hebron

location_facility: Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo

location_facility: State Instituion Central Clinical Milatary Hospital

location_facility: Dept of Neurological and Psychiatric Sciences University of Bari

location_facility: SUNY Upstate Medical University Dept of Neurology

location_facility: Dept of MS Institute for Human Brain of R.A.Sci

location_facility: University of Minnesota Medical School, Dept of Neurology

location_facility: Dept Neurologia Sanatorio Britanico de Rosario

location_facility: Div of Clinical Neurology B Floor Medical School Univ Hospital

location_facility: Unidad de EM Neurologia Hospital Virgen Macarena

location_facility: Servicio de Neurologia Hospital Bellvitge

location_facility: Department Of Neurology Royal London Hospital

location_facility: Dept of Neurology Johannes Gutenberg University

location_facility: Scientific Research Center of Neurology Russian MOH