title: A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

acronym: VITAL

summary:
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

ReferenceCitation: Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G. Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol. 2012 Oct 10;30(29):3640-7. doi: 10.1200/JCO.2012.42.6932. Epub 2012 Sep 10.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Turkey
Malaysia
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Estonia
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility: sanofi-aventis Australia & New Zealand administrative office


status: Completed

primary_purpose: Treatment

acronym: CARE-MS I

intervention_type: Biological

title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

study_completion_date_type: Actual

lead_sponsor: Genzyme, a Sanofi Company

type: Registry Identifier

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: background

ReferenceCitation: Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.

ReferenceType: derived

ReferenceCitation: Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernández Ó, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9. Review.

ReferenceCitation: Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernández Ó, Havrdová EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

ReferenceCitation: Horáková D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernández Ó, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernández Ó, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

ReferenceCitation: Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.

ReferenceCitation: Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23. Erratum In: Neurology. 2018 Apr 17;90(16):755.

ReferenceCitation: Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.

enrollment_type: Actual

location_country:
Croatia
Poland
Brazil
Serbia
United Kingdom
Russian Federation
Australia
Argentina
Canada
Czech Republic
Ukraine
Sweden
United States
France
Mexico
Germany

location_facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

location_facility: University of Louisville Research Foundation

location_facility: Klinikum der Goethe Universität Frankfurt

location_facility: Clinical Centre of Vojvodina, Clinic for neurology

location_facility: Baylor College of Medicine, Maxine Mesinger MS Clinic

location_facility: Lehigh Valley Hospital Neurosciences and Pain Research

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department

location_facility: State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

location_facility: Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)

location_facility: Barrow Neurological Institute, St. Joseph's Hospital & Medical Center

location_facility: Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital

location_facility: Clinical Center Nis, Clinic for neurology

location_facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry

location_facility: Louisiana State University Health Sciences Center

location_facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic

location_facility: Hospital da Restauracao, Av Governador Agamenon Magalhaes

location_facility: Independent Public Teaching Hospital No. 4 in Lublin

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

location_facility: Clinical Centre Serbia, Institute for Neurology

location_facility: Clinique Neuro rive-sud, Recherche Sepmus, Inc.

location_facility: Hospital Angeles del Pedregal, Camino de Santa Teresa

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

location_facility: Universitätsklinik Carl Gustav Carus Dresden

location_facility: Krajska zdravotni a.s., Hospital Teplice

location_facility: Moscow State Medical Institution City Clinical Hospital #11

location_facility: Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia

location_facility: Samara Regional Clinical Hospital n.a. Kalinin

location_facility: University of Calgary and Foothills Medical Cenre

location_facility: Clinical Neurology Centre Sp. z o.o. (Ltd)

location_facility: Heliodor Swiecicki Teaching Hospital of the Poznan University of Medical Sciences

location_facility: North Central Neurology Associates, P.C.

location_facility: Danylo Halytsky Lviv National Medical University

location_facility: The Ohio State University Medical Center, Multiple Sclerosis Center

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

location_facility: Royal Melbourne Hospital, Department of Neurology, Ward 4 East

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis

summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

summary: The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis

ReferenceCitation: Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11. Review.

lead_sponsor: Nordic Bioscience A/S

location_country:
Denmark
Poland
Brazil
Hong Kong
Italy
Estonia
Lithuania
Czech Republic
United States
France
China
Romania

location_facility: Department of Internal Medicine, University of Florence

intervention_type: Drug


acronym: VENICE

title: A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer

lead_sponsor: Sanofi

ReferenceType: result

ReferenceCitation: Tannock IF, Fizazi K, Ivanov S, Karlsson CT, Fléchon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Arén O, Karyakin O, Elliott T, Birtle A, Magherini E, Hatteville L, Petrylak D, Tombal B, Rosenthal M; VENICE investigators. Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial. Lancet Oncol. 2013 Jul;14(8):760-8. doi: 10.1016/S1470-2045(13)70184-0. Epub 2013 Jun 4.

ReferenceCitation: van Soest RJ, Templeton AJ, Vera-Badillo FE, Mercier F, Sonpavde G, Amir E, Tombal B, Rosenthal M, Eisenberger MA, Tannock IF, de Wit R. Neutrophil-to-lymphocyte ratio as a prognostic biomarker for men with metastatic castration-resistant prostate cancer receiving first-line chemotherapy: data from two randomized phase III trials. Ann Oncol. 2015 Apr;26(4):743-749. doi: 10.1093/annonc/mdu569. Epub 2014 Dec 15.

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Estonia
Czech Republic
Korea, Republic of
France
Chile
Netherlands

summary:
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).

The secondary objectives were:

To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
To assess the overall safety in both treatment arms;
To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
to determine immunogenicity of IV aflibercept.


title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Güçlü SZ, Spangenthal S, Overend T, Henley M, Mizutani G, Zeldin RK. Safety and tolerability of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Pulm Pharmacol Ther. 2010 Oct;23(5):438-44. doi: 10.1016/j.pupt.2010.04.005. Epub 2010 Apr 21.

lead_sponsor: Novartis

location_country:
Spain
Netherlands
United States
France
Turkey
Germany


title: A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator

acronym: TUCSON

summary: This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

status: Terminated

enrollment_type: Anticipated

lead_sponsor: ImaRx Therapeutics

location_country:
United States
France

location_facility: Methodist Hospital Neurological Institute

location_facility: Bichat - Claude Bernard University Hospital and Medical School

location_facility: Barrow Neurology Clinics at St. Joseph's Hospital

status_simplified: Unknown


title: A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

summary: The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

lead_sponsor: PriCara, Unit of Ortho-McNeil, Inc.

location_country:
Croatia
Russian Federation
Argentina
Canada
Ukraine
United States
Chile
France
India


title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

acronym: Hypo~CAT

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).

ReferenceCitation: Ginès P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D; HypoCAT Study Investigators. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008 Jul;48(1):204-13. doi: 10.1002/hep.22293.

location_country:
Croatia
Romania
Spain
Italy
Australia
Argentina
Canada
Czech Republic
Hungary
United States
France
Belgium
Germany


title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

acronym: Normo~CAT

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

location_country:
Croatia
Romania
Spain
Italy
Australia
Argentina
Canada
Czech Republic
Hungary
France
Belgium
Germany


title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

acronym: SPA

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

ReferenceCitation: Wong F, Gines P, Watson H, Horsmans Y, Angeli P, Gow P, Minini P, Bernardi M. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010 Aug;53(2):283-90. doi: 10.1016/j.jhep.2010.02.036. Epub 2010 May 24.

location_country:
Croatia
Taiwan
Spain
Italy
Australia
Argentina
Canada
Czech Republic
France
Belgium
Germany


title: Efficacy and Safety of 2 mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study

summary: The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

location_country:
Taiwan
Brazil
Greece
Italy
Netherlands
Russian Federation
Canada
Czech Republic
Finland
Switzerland
United States
France
South Africa
Turkey
Colombia
Malaysia


title: Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency

summary: This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

lead_sponsor: Eli Lilly and Company

location_country:
United Kingdom
Italy
Puerto Rico
United States
France
Germany

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: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)

acronym: DIONYSOS

summary: The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

ReferenceCitation: Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. doi: 10.1111/j.1540-8167.2010.01764.x. Epub 2010 Apr 6.

ReferenceCitation: Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41.

location_country:
Italy
United States
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Tunisia
Turkey
Mexico
Sweden
Canada
China
Germany
Estonia
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands
Morocco


title: A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Šalek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9.

location_country:
Croatia
Poland
Brazil
Taiwan
Spain
Italy
United Kingdom
Argentina
Canada
Thailand
Hungary
United States
France
Israel
Turkey
South Africa
Japan
Malaysia

summary:
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.


title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain

lead_sponsor: Grünenthal GmbH

ReferenceCitation: Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.

ReferenceCitation: Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Dogan C, Etropolski M, Eerdekens M. Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. Eur J Pain. 2016 Oct;20(9):1513-8. doi: 10.1002/ejp.875. Epub 2016 Apr 7.

location_country:
Croatia
Poland
Serbia
Spain
Italy
Austria
Russian Federation
Sweden
Hungary
France
Romania
Germany
Bulgaria
Slovakia
Moldova, Republic of
Czechia

summary:
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR).

*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.


title: CABG Off or On Pump Revascularization Study (CORONARY)

acronym: CORONARY

summary:
I. Main Research Question:

To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings.

II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures.

III. The study will look at which of the two techniques reduce major risks associated with CABG.

ReferenceCitation: Hébert M, Lamy A, Noiseux N, Stevens LM; CORONARY Investigators. Impact of early quantitative morbidity on 1-year outcomes in coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2022 Mar 31;34(4):523-531. doi: 10.1093/icvts/ivab316.

ReferenceCitation: Conen D, Wang MK, Devereaux PJ, Whitlock R, McIntyre WF, Healey JS, Yuan F, Yusuf S, Lamy A. New-Onset Perioperative Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Risk of Adverse Events: An Analysis From the CORONARY Trial. J Am Heart Assoc. 2021 Jun 15;10(12):e020426. doi: 10.1161/JAHA.120.020426. Epub 2021 May 29.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Straka Z, Piegas LS, Avezum A, Akar AR, Lanas Zanetti F, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Gao P, Pettit S, Yusuf S; CORONARY Investigators. Five-Year Outcomes after Off-Pump or On-Pump Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Dec 15;375(24):2359-2368. Epub 2016 Oct 23.

ReferenceCitation: Lamy A, Tong W, Devereaux PJ, Gao P, Gafni A, Singh K, Taggart D, Straka Z, Akar AR, Piegas L, Ou Y, Yusuf S. The cost implications of off-pump versus on-pump coronary artery bypass graft surgery at one year. Ann Thorac Surg. 2014 Nov;98(5):1620-5. doi: 10.1016/j.athoracsur.2014.06.046. Epub 2014 Sep 24.

ReferenceCitation: Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Novick R, Cook RJ, Jain AR, Pan X, Noiseux N, Vik K, Stolf NA, Ritchie A, Favaloro RR, Parvathaneni S, Whitlock RP, Ou Y, Lawrence M, Lamy A; CORONARY Investigators. Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial. JAMA. 2014 Jun 4;311(21):2191-8. doi: 10.1001/jama.2014.4952. Erratum in: JAMA. 2014 Jul 2;312(1):97.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy SK, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Pogue J, Chrolavicius S, Yusuf S; CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med. 2013 Mar 28;368(13):1179-88. doi: 10.1056/NEJMoa1301228. Epub 2013 Mar 11.

ReferenceCitation: Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Cook RJ, Whitlock RP, Noiseux N, Novick RJ, Ou Y, Lamy A; CORONARY Investigators. Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial. BMJ Open. 2012 Apr 18;2(2):e001080. doi: 10.1136/bmjopen-2012-001080. Print 2012.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy S, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Ng J, Chrolavicius S, Yusuf S; CORONARY Investigators. Off-pump or on-pump coronary-artery bypass grafting at 30 days. N Engl J Med. 2012 Apr 19;366(16):1489-97. doi: 10.1056/NEJMoa1200388. Epub 2012 Mar 26.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Hu S, Piegas LS, Straka Z, Paolasso E, Taggart D, Lanas F, Akar AR, Jain A, Noiseux N, Ou Y, Chrolavicius S, Ng J, Yusuf S. Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery. Am Heart J. 2012 Jan;163(1):1-6. doi: 10.1016/j.ahj.2011.10.007.

lead_sponsor: Population Health Research Institute

location_country:
Poland
Brazil
United Kingdom
Italy
Argentina
Canada
Czech Republic
France
Chile
China
India
Colombia
Turkey

location_facility: Service de chirurgie thoracique et cardio-vasculaire

location_facility: Instituto do Coracao do Hospital das Clinicas da

location_facility: Amrita Institute of Medical Sciences and Research Center

location_facility: Irmande Santa Casa De Misericordia De Curtiba

location_facility: International Center of Cardiovascular and Thoracic Diseases

location_facility: Basildon and Thurrock University Hospital NHS FT

location_facility: Federal University of Sao Paulo School of Medicine

location_facility: Fakultni nemocnice Kralovske Vinohrady (FNKV)

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Hospital Sao Francisco Complexo Hospitalar Santa Casa

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Escorts Heart Institute and Research Centre

location_facility: Braile Clinica de Servicos de Assistencia Medico

intervention_type: Procedure


title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Cardiac Surgery

summary: Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

ReferenceCitation: Denault AY, Pearl RG, Michler RE, Rao V, Tsui SS, Seitelberger R, Cromie M, Lindberg E, D'Armini AM. Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery: the TACTICS trial. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1212-7. doi: 10.1053/j.jvca.2013.01.023. Epub 2013 Mar 21.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Poland
Serbia
United Kingdom
Italy
Austria
Canada
Sweden
United States
France
India
Israel
Germany
Slovakia
Czechia

location_facility: London Health Sciences Centre-University Hospital

location_facility: Montefiore Medical Center/Albert Einstein College of Medicine

location_facility: Fondazione IRCCS San Matteo Hospital, Cardiac Surgery

location_facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista", Cardiac Surgery Division

location_facility: National Institute of Cardiovascular Diseases, Clinic of Heart Surgery

location_facility: Klinika Chirurgii Serca, Naczyn I Transplantologii, Szpital Jana Pawla II

location_facility: Medical University of Silesia, 2nd Dept of Cardiac Surgery

location_facility: Zentrum der Chirugie-Zchir-des Universitatsklinikums

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Texas Heart Institute/St. Luke's Episcopal Hospital/Baylor College


title: An Open-Label Extension Study of Patients With Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704

design_allocation: Non-Randomized

location_country:
Australia
Canada
United States
France
Netherlands

summary: Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this extension study is to assess the long-term safety and efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).


title: Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction With Radioiodine for the Treatment of Multinodular Goiter.

summary: The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered with radioiodine in patients with multinodular goiter, a condition that involves the enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of radioiodine therapy alone in these patients. The goal of the treatment is to determine if there was a reduction in the size of the goiter and to study if goiter symptoms have improved after 6 months and after 36 months.

ReferenceCitation: Fast S, Hegedüs L, Pacini F, Pinchera A, Leung AM, Vaisman M, Reiners C, Wemeau JL, Huysmans DA, Harper W, Rachinsky I, de Souza HN, Castagna MG, Antonangeli L, Braverman LE, Corbo R, Düren C, Proust-Lemoine E, Marriott C, Driedger A, Grupe P, Watt T, Magner J, Purvis A, Graf H. Long-term efficacy of modified-release recombinant human thyrotropin augmented radioiodine therapy for benign multinodular goiter: results from a multicenter, international, randomized, placebo-controlled, dose-selection study. Thyroid. 2014 Apr;24(4):727-35. doi: 10.1089/thy.2013.0370. Epub 2014 Mar 4.

ReferenceCitation: Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12:CD010622. doi: 10.1002/14651858.CD010622.pub2. Review.

location_country:
Denmark
Brazil
Italy
Netherlands
Canada
United States
France
Germany

intervention_type: Other


title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

summary: This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
France

location_facility:
Dr. Larry Doehring
Dr. Max Weisfeld
Dr. Richard Pollak
Dr. Richard Scher
Novartis Investigative Site
Dr. Joseph Jorrizo
Dr. Patrick Agnew
Dr. Mark Ling
Dr. Robert P. Dunne
Dr. John Mallory
Novartis
Dr. Anne Lucky
Dr. Fred D. Youngswick
Dr. Jesse Plasencia
Dr. Anna Glaser
Dr. Jeffrey Conrow
Dr.Michael Kaye
Dr. Rich Phoebe
Dr. Jay Lifshen
Dr. Linda Stein-Gold
Dr. Patricia Westmorland
Dr. David Horowitz


title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

summary: The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

primary_purpose: Diagnostic

ReferenceCitation: Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United Kingdom
Italy
Austria
Netherlands
Canada
Czech Republic
Switzerland
United States
France
Belgium
Germany


title: Multi-Center Pivotal Study of Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)

summary:
The overall goal of this research is to delay the respiratory decline of patients with Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the diaphragm with laparoscopically placed electrodes.

This device currently holds an Investigational Device Exemption No. G040142 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Johns Hopkins, Mayo Clinic Jacksonville, California Pacific Medical Center (CPMC), Henry Ford Health System, The Methodist Hospital, and Stanford University.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Gonzalez-Bermejo J, Morélot-Panzini C, Salachas F, Redolfi S, Straus C, Becquemin MH, Arnulf I, Pradat PF, Bruneteau G, Ignagni AR, Diop M, Onders R, Nelson T, Menegaux F, Meininger V, Similowski T. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):44-54. doi: 10.3109/17482968.2011.597862. Epub 2011 Oct 24.

lead_sponsor: Synapse Biomedical

location_facility: Forbes Norris - California Pacific Medical Center (CPMC)

intervention_type: Device


title: Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients: an International, Multicentre Prevalence Study

summary: More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Rolfs A, Böttcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Löhr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. Erratum in: Lancet. 2006 Dec 23;368(9554):2210.

ReferenceCitation: Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Böttcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

ReferenceCitation: Thijs V, Grittner U, Fazekas F, McCabe DJH, Giese AK, Kessler C, Martus P, Norrving B, Ringelstein EB, Schmidt R, Tanislav C, Putaala J, Tatlisumak T, von Sarnowski B, Rolfs A, Enzinger C; Stroke in Fabry (SIFAP1) Investigators. Dolichoectasia and Small Vessel Disease in Young Patients With Transient Ischemic Attack and Stroke. Stroke. 2017 Sep;48(9):2361-2367. doi: 10.1161/STROKEAHA.117.017406. Epub 2017 Jul 28.

ReferenceCitation: Aigner A, Grittner U, Rolfs A, Norrving B, Siegerink B, Busch MA. Contribution of Established Stroke Risk Factors to the Burden of Stroke in Young Adults. Stroke. 2017 Jul;48(7):1744-1751. doi: 10.1161/STROKEAHA.117.016599. Epub 2017 Jun 15.

ReferenceCitation: von Sarnowski B, Schminke U, Grittner U, Tanislav C, Böttcher T, Hennerici MG, Tatlisumak T, Putaala J, Kaps M, Fazekas F, Enzinger C, Rolfs A, Kessler C; sifap1 Investigators. Posterior versus Anterior Circulation Stroke in Young Adults: A Comparative Study of Stroke Aetiologies and Risk Factors in Stroke among Young Fabry Patients (sifap1). Cerebrovasc Dis. 2017;43(3-4):152-160. doi: 10.1159/000454840. Epub 2017 Jan 14.

ReferenceCitation: Huber R, Grittner U, Weidemann F, Thijs V, Tanislav C, Enzinger C, Fazekas F, Wolf M, Hennerici MG, McCabe DJ, Putaala J, Tatlisumak T, Kessler C, von Sarnowski B, Martus P, Kolodny E, Norrving B, Rolfs A; Stroke in Young Fabry Patients (SIFAP) Investigators. Patent Foramen Ovale and Cryptogenic Strokes in the Stroke in Young Fabry Patients Study. Stroke. 2017 Jan;48(1):30-35. doi: 10.1161/STROKEAHA.116.013620. Epub 2016 Nov 29.

ReferenceCitation: Tatlisumak T, Putaala J, Innilä M, Enzinger C, Metso TM, Curtze S, von Sarnowski B, Amaral-Silva A, Jungehulsing GJ, Tanislav C, Thijs V, Rolfs A, Norrving B, Fazekas F, Suomalainen A, Kolodny EH. Frequency of MELAS main mutation in a phenotype-targeted young ischemic stroke patient population. J Neurol. 2016 Feb;263(2):257-262. doi: 10.1007/s00415-015-7969-z. Epub 2015 Nov 14.

ReferenceCitation: Wolf ME, Grittner U, Böttcher T, Norrving B, Rolfs A, Hennerici MG; sifap1 TM investigators. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study. Cerebrovasc Dis. 2015;40(3-4):129-35. doi: 10.1159/000434760. Epub 2015 Jul 25.

ReferenceCitation: Thijs V, Grittner U, Dichgans M, Enzinger C, Fazekas F, Giese AK, Kessler C, Kolodny E, Kropp P, Martus P, Norrving B, Ringelstein EB, Rothwell PM, Schmidt R, Tanislav C, Tatlisumak T, von Sarnowski B, Rolfs A; Stroke in Fabry Investigators. Family History in Young Patients With Stroke. Stroke. 2015 Jul;46(7):1975-8. doi: 10.1161/STROKEAHA.115.009341. Epub 2015 Jun 2.

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Grittner U, Giese AK, Hennerici MG, Huber R, Jungehulsing GJ, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Thijs V, von Sarnowski B, Norrving B, Rolfs A; SIFAP 1 Investigators. Brain magnetic resonance imaging findings fail to suspect Fabry disease in young patients with an acute cerebrovascular event. Stroke. 2015 Jun;46(6):1548-53. doi: 10.1161/STROKEAHA.114.008548. Epub 2015 Apr 21.

ReferenceCitation: Tanislav C, Kropp P, Grittner U, Holzhausen M, Fazekas F, Jungehülsing GJ, Tatlisumak T, von Sarnowski B, Putaala J, Huber R, Thijs V, Schmidt R, Kaps M, Enzinger C, Dichgans M, Norrving B, Rolfs A. Clinically relevant depressive symptoms in young stroke patients - results of the sifap1 study. Neuroepidemiology. 2015;44(1):30-8. doi: 10.1159/000371389. Epub 2015 Jan 31.

ReferenceCitation: Kaps M, Grittner U, Jungehülsing G, Tatlisumak T, Kessler C, Schmidt R, Jukka P, Norrving B, Rolfs A, Tanislav C; sifap1 Investigators. Clinical signs in young patients with stroke related to FAST: results of the sifap1 study. BMJ Open. 2014 Nov 7;4(11):e005276. doi: 10.1136/bmjopen-2014-005276.

ReferenceCitation: Tanislav C, Grittner U, Misselwitz B, Jungehuelsing GJ, Enzinger C, von Sarnowski B, Putaala J, Kaps M, Kropp P, Rolfs A, Tatlisumak T, Fazekas F, Kolodny E, Norrving B. Lessons from everyday stroke care for clinical research and vice versa: comparison of a comprehensive and a research population of young stroke patients. BMC Neurol. 2014 Mar 7;14:45. doi: 10.1186/1471-2377-14-45.

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Dichgans M, Gaertner B, Jungehulsing GJ, Hennerici MG, Heuschmann P, Holzhausen M, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Norrving B, Rolfs A; sifap1 Investigators. MRI in acute cerebral ischemia of the young: the Stroke in Young Fabry Patients (sifap1) Study. Neurology. 2013 Nov 26;81(22):1914-21. doi: 10.1212/01.wnl.0000436611.28210.ec. Epub 2013 Nov 1.

ReferenceCitation: Kropp P, Holzhausen M, Kolodny E, Becker U, Dichgans M, Diez-Tejedor E, Enzinger C, Fazekas F, Fuentes B, Karpinska A, Meyer W, Tanislav C, Böttcher T, Rolfs A; Stroke in Young Fabry Patients (sifap) Investigators. Headache as a symptom at stroke onset in 4,431 young ischaemic stroke patients. Results from the "Stroke in Young Fabry Patients (SIFAP1) study". J Neural Transm (Vienna). 2013 Oct;120(10):1433-40. doi: 10.1007/s00702-013-1014-0. Epub 2013 Jun 9.

ReferenceCitation: von Sarnowski B, Schminke U, Tatlisumak T, Putaala J, Grittner U, Kaps M, Tobin WO, Kinsella JA, McCabe DJ, Hennerici MG, Fazekas F, Norrving B, Kessler C, Rolfs A; sifap1 investigators. Prevalence of stenoses and occlusions of brain-supplying arteries in young stroke patients. Neurology. 2013 Apr 2;80(14):1287-94. doi: 10.1212/WNL.0b013e31828ab2ed. Epub 2013 Mar 6.

ReferenceCitation: Rolfs A, Fazekas F, Grittner U, Dichgans M, Martus P, Holzhausen M, Böttcher T, Heuschmann PU, Tatlisumak T, Tanislav C, Jungehulsing GJ, Giese AK, Putaala J, Huber R, Bodechtel U, Lichy C, Enzinger C, Schmidt R, Hennerici MG, Kaps M, Kessler C, Lackner K, Paschke E, Meyer W, Mascher H, Riess O, Kolodny E, Norrving B; Stroke in Young Fabry Patients (sifap) Investigators. Acute cerebrovascular disease in the young: the Stroke in Young Fabry Patients study. Stroke. 2013 Feb;44(2):340-9. doi: 10.1161/STROKEAHA.112.663708. Epub 2013 Jan 10.

ReferenceCitation: von Sarnowski B, Putaala J, Grittner U, Gaertner B, Schminke U, Curtze S, Huber R, Tanislav C, Lichy C, Demarin V, Basic-Kes V, Ringelstein EB, Neumann-Haefelin T, Enzinger C, Fazekas F, Rothwell PM, Dichgans M, Jungehulsing GJ, Heuschmann PU, Kaps M, Norrving B, Rolfs A, Kessler C, Tatlisumak T; sifap1 Investigators. Lifestyle risk factors for ischemic stroke and transient ischemic attack in young adults in the Stroke in Young Fabry Patients study. Stroke. 2013 Jan;44(1):119-25. doi: 10.1161/STROKEAHA.112.665190. Epub 2012 Nov 13.

ReferenceCitation: Steinicke R, Gaertner B, Grittner U, Schmidt W, Dichgans M, Heuschmann PU, Tanislav C, Putaala J, Kaps M, Endres M, Schmidt R, Fazekas F, Norrving B, Rolfs A, Martus P, Tatlisumak T, Enzinger C, Jungehulsing GJ. Kidney function and white matter disease in young stroke patients: analysis of the stroke in young fabry patients study population. Stroke. 2012 Sep;43(9):2382-8. doi: 10.1161/STROKEAHA.111.645713. Epub 2012 Jun 21.

ReferenceCitation: Fellgiebel A, Keller I, Martus P, Ropele S, Yakushev I, Böttcher T, Fazekas F, Rolfs A. Basilar artery diameter is a potential screening tool for Fabry disease in young stroke patients. Cerebrovasc Dis. 2011;31(3):294-9. doi: 10.1159/000322558. Epub 2010 Dec 22.

lead_sponsor: CENTOGENE GmbH Rostock

location_country:
Croatia
Poland
Portugal
Spain
Ireland
Austria
Georgia
Italy
Finland
United Kingdom
France
Malta
Belgium
Germany

location_facility: Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH

location_facility: The Adelaide and Meath Hospital, Department of Neurology

location_facility: University of Rostock, Department of Neurology

location_facility: Department of Neurology, Kreiskrankenhaus Altenburg

location_facility: Dept. of Neurology, Johann-Wolfgang-Goethe-Universität

location_facility: Department of Neurology, Universitaetsklinikum Carl Gustav Carus

location_facility: Department of Neurology, Klinik und Poliklinik fuer Neurologie

location_facility: Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

location_facility: Ludwig-Maximilians-University of Munich, Dept. of Neurology

location_facility: Department of Neurology, University Hospital Sestre Milosrdnice

location_facility: Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie

location_facility: Department of Neurology, Universitaetsklinikum Leipzig

location_facility: University of Heidelberg, Department of Neurology

location_facility: Heinrich-Heine University Duesseldorf, Dept. of Neurology

location_facility: Department of Neurology, Hospital Universitario La Paz

location_facility: Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck

location_facility: Department of Neurology, Universitaetsklinikum Jena

location_facility: Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie

location_facility: Stroke Prevention Research Unit, John Radcliffe Hospital

location_facility: Middelheim General Hospital, Dept. of Neurology/Memory Clinic

location_facility: Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

location_facility: University of Ulm, Department of Neurology

location_facility: Dept. of Neurology, Ospoedale Maggiore Policlinico

location_facility: Charite Campus Benjamin Franklin, Dept. of Neurology

location_facility: Institute of Psychiatry and Neurology, Dept. of Neurology

location_facility: Department of Neurology, Klinikum Chemnitz gGmbH

location_facility: Centro Hospitalar de Lisboa Central, Servico de Neurologia

location_facility: Helsinki University Central Hospital, Department of Neurology

location_facility: Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

location_facility: Department of Neurology, Klinikum Hohe Warte

location_facility: University of Giessen-Marburg Dept. of Neurology

location_facility: University Schleswig-Holstein, Dept. of Neurology

location_facility: Klinikum Bremen Mitte gGmbH, Neurologische Klinik

location_facility: University of Muenster, Dept. of Neurology

location_facility: Department of Neurology, University Tuebingen

location_facility: Christian-Doppler-Klinik, Department für medizin. Studien

location_facility: Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln

location_facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

location_facility: Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf

location_facility: Department of Neurology, Allgemeines Krankenhaus Celle

location_facility: Department of Neurology, Ernst-Moritz-Arndt-University

location_facility: Wagner-Jauregg Linz, Department of Neurology


type: Other Grant/Funding Number

title: Argus® II Retinal Stimulation System Feasibility Protocol

summary:
Investigational Phase of the Study:

The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.

Post-Approval Phase of the Study:

To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

ReferenceCitation: Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.

ReferenceCitation: Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.

ReferenceCitation: Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.

ReferenceCitation: Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.

ReferenceCitation: Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.

ReferenceCitation: Sabbah N, Authié CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.

ReferenceCitation: Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. Epub 2013 Apr 12.

ReferenceCitation: de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.

ReferenceCitation: Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.

ReferenceCitation: Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9.

ReferenceCitation: Ahuja AK, Behrend MR. The Argus™ II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.

ReferenceCitation: Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.

ReferenceCitation: Pérez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.

ipd_sharing: No

lead_sponsor: Second Sight Medical Products

location_country:
United Kingdom
Switzerland
United States
France
Mexico

location_facility: Puerta de Hierro, Centro Medico, Centro de Retina

location_facility: Moorfields Eye Hospital, Vitreoretinal Research Unit

location_facility: Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205

location_facility: University of Pennsylvania, Scheie Eye Institute

location_facility: Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12

location_facility: Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute


title: Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

summary: To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

location_country:
Germany
United States
Netherlands
France

location_facility: University of Muenster Hospital and Clinics

location_facility: Wake Forest University Baptist Medical Center


type: U.S. NIH Grant/Contract

title: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)

summary: The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.

ReferenceCitation: Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.

ipd_sharing: Yes

ipd_sharing_description: Findings will be published in a manuscript.

lead_sponsor: Medical College of Wisconsin

location_country:
United States
France

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Pennsylvania Cancer Center

location_facility: University Hospitals of Cleveland/Case Western

location_facility: University of Wisconsin Hospital & Clinics

location_facility: University of Florida College of Medicine (Shands)

location_facility: Ohio State, Arthur G. James Cancer Hospital

location_facility: Virginia Commonwealth University/MCV Hospital

location_facility: Washington University/Barnes Jewish Hospital

location_facility: University of Pittsburgh Cancer Institute


title: A Pan-European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Impaired Fasting Blood Glucose With or Without Other Comorbidities

acronym: PRADO

summary:
Primary objective:

To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.

Main Secondary objectives:

To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.

To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

location_country:
Luxembourg
Spain
Italy
United Kingdom
Lithuania
Belgium
Portugal
Austria
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
Bulgaria
Denmark
Greece
Ireland
Finland
Czech Republic
France
Netherlands


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 Anterior Uveitis

acronym: LUMINATE

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

lead_sponsor: Lux Biosciences, Inc.

location_country:
United Kingdom
Austria
Canada
United States
France
India
Germany

location_facility: Klinik für Augenheilkunde, Dept. of Ophthalmology

location_facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

location_facility: Massachusetts Eye Research and Surgery Institute

location_facility: Vittala International Institute of Ophthalmology

location_facility: Bristol Eye Hospital and University of Bristol

location_facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie

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


title: A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms

acronym: MAPS

summary:
Primary Objectives:

To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause.
To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies.

Secondary Objectives:

To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities.
To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.

ReferenceCitation: McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Massó Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.

ReferenceCitation: Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.

lead_sponsor: Stryker Neurovascular

location_country:
Spain
United Kingdom
Australia
Canada
United States
France
China
Turkey
Mexico
Norway
Germany

location_facility: Barnes Jewish Mallinckrodt Institute of Radiology

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Washington Harborview Medical Center

location_facility: Istanbul University Cerrahpaşa Tıp Fakültesi

location_facility: University of Wisconsin Hospital and Center

location_facility: Clinica Ntra Sra Del Rosario Hospital Ruber Internacional

location_facility: Instituto Nacional de Neurologia e Neurocirurgia

location_facility: Newcastle General Hospital Department of Neuroradiology

location_facility: University of New Mexico Department of Neurosurgery

location_facility: University of Texas Southwestern Medical Center

location_facility: Carolina Neurosurgery & Spine Associates, PA

location_facility: St. Joseph's Hospital Barrow Neurological Institute


acronym: CLARINET

title: International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

lead_sponsor: Sanofi

ReferenceCitation: Wessel DL, Berger F, Li JS, Dähnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Argentina
India
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Egypt
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Thailand
Korea, Republic of
France
Netherlands

location_facility:
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administraive Office
Sanofi-Aventis Admnistrative Office

summary:
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.

The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).

The secondary objective was to assess the safety of Clopidogrel in the study population.


title: A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.

summary: Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

location_country:
Italy
Australia
Canada
United States
France
Germany

location_facility:
Mayo Clinic
Novartis Investigative Site
UC Irvine/Long Beach
Rochester General Hospital
Ohio State University Medical Center
St. Louis University
Carolinas Medical Center
Three Medical Park
University of Connecticut Health Center
Henry Ford Health System


title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

summary: This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

location_country:
Singapore
United States
United Kingdom
France


title: A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

summary: This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

lead_sponsor: Actelion

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

location_facility: Royal Prince Alfred Hospital - Central Clinical School

location_facility: Scottish Vascular Unit - Western Infirmary

location_facility: Unidad Medico Quirurgica de Cardiologia - Edificio General

location_facility: Universitatsklinikum fur Innere Medizin II


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

ReferenceCitation: Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Ginès P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

location_country:
Serbia
Spain
United States
Romania
Belgium
Poland
Russian Federation
Australia
Argentina
Turkey
Mexico
Malaysia
Singapore
Bosnia and Herzegovina
Brazil
Canada
Germany
Bulgaria
Czech Republic
France
Chile


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Portugal
Australia
Argentina
Israel
Malaysia
Singapore
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Taiwan
Czech Republic
Korea, Republic of
France


title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone

acronym: IMSIII

summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

ReferenceCitation: van der Ende NA, Roozenbeek B, Broderick JP, Khatri P, Lingsma HF, Dippel DW. Blinding of outcome assessors and its association with outcome in a randomized open-label stroke trial. Int J Stroke. 2022 Oct 19:17474930221131706. doi: 10.1177/17474930221131706. [Epub ahead of print]

ReferenceCitation: Chalos V, van der Ende NAM, Lingsma HF, Mulder MJHL, Venema E, Dijkland SA, Berkhemer OA, Yoo AJ, Broderick JP, Palesch YY, Yeatts SD, Roos YBWEM, van Oostenbrugge RJ, van Zwam WH, Majoie CBLM, van der Lugt A, Roozenbeek B, Dippel DWJ; MR CLEAN Investigators. National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke. Stroke. 2020 Jan;51(1):282-290. doi: 10.1161/STROKEAHA.119.026791. Epub 2019 Dec 4.

ReferenceCitation: Simpson KN, Simpson AN, Mauldin PD, Palesch YY, Yeatts SD, Kleindorfer D, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Broderick JP; Interventional Management of Stroke (IMS) III Investigators. Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III. J Am Heart Assoc. 2017 May 8;6(5). pii: e004513. doi: 10.1161/JAHA.116.004513.

ReferenceCitation: Venema E, Mulder MJHL, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Emmer BJ, Roos YBWEM, Majoie CBLM, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DWJ, Lingsma HF. Selection of patients for intra-arterial treatment for acute ischaemic stroke: development and validation of a clinical decision tool in two randomised trials. BMJ. 2017 May 3;357:j1710. doi: 10.1136/bmj.j1710.

ReferenceCitation: Mulder MJ, Venema E, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Roos YB, Majoie CB, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DW, Lingsma HF. Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid. BMJ Open. 2017 Mar 22;7(3):e013699. doi: 10.1136/bmjopen-2016-013699.

ReferenceCitation: Broderick JP, Berkhemer OA, Palesch YY, Dippel DW, Foster LD, Roos YB, van der Lugt A, Tomsick TA, Majoie CB, van Zwam WH, Demchuk AM, van Oostenbrugge RJ, Khatri P, Lingsma HF, Hill MD, Roozenbeek B, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson CS, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson KN; IMS III Investigators; MR CLEAN Investigators. Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data. Stroke. 2015 Dec;46(12):3416-22. doi: 10.1161/STROKEAHA.115.011397. Epub 2015 Oct 20. Erratum in: Stroke. 2016 Jan;47(1):e21. IMS II [corrected to IMS III Investigators].

ReferenceCitation: Abou-Chebl A, Yeatts SD, Yan B, Cockroft K, Goyal M, Jovin T, Khatri P, Meyers P, Spilker J, Sugg R, Wartenberg KE, Tomsick T, Broderick J, Hill MD. Impact of General Anesthesia on Safety and Outcomes in the Endovascular Arm of Interventional Management of Stroke (IMS) III Trial. Stroke. 2015 Aug;46(8):2142-8. doi: 10.1161/STROKEAHA.115.008761. Epub 2015 Jul 2.

ReferenceCitation: Al-Ali F, Elias JJ, Tomsick TA, Liebeskind DS, Broderick JP; IMS Study Groups. Relative Influence of Capillary Index Score, Revascularization, and Time on Stroke Outcomes From the Interventional Management of Stroke III Trial. Stroke. 2015 Jun;46(6):1590-4. doi: 10.1161/STROKEAHA.115.009066. Epub 2015 May 7.

ReferenceCitation: Palesch YY, Yeatts SD, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson A, Simpson KN, Broderick JP; Interventional Management of Stroke III Investigators. Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1321-7. doi: 10.1161/STROKEAHA.115.009180. Epub 2015 Apr 9.

ReferenceCitation: Menon BK, Qazi E, Nambiar V, Foster LD, Yeatts SD, Liebeskind D, Jovin TG, Goyal M, Hill MD, Tomsick TA, Broderick JP, Demchuk AM; Interventional Management of Stroke III Investigators. Differential Effect of Baseline Computed Tomographic Angiography Collaterals on Clinical Outcome in Patients Enrolled in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1239-44. doi: 10.1161/STROKEAHA.115.009009. Epub 2015 Mar 19.

ReferenceCitation: Tomsick TA, Yeatts SD, Liebeskind DS, Carrozzella J, Foster L, Goyal M, von Kummer R, Hill MD, Demchuk AM, Jovin T, Yan B, Zaidat OO, Schonewille W, Engelter S, Martin R, Khatri P, Spilker J, Palesch YY, Broderick JP; IMS III Investigators. Endovascular revascularization results in IMS III: intracranial ICA and M1 occlusions. J Neurointerv Surg. 2015 Nov;7(11):795-802. doi: 10.1136/neurintsurg-2014-011318. Epub 2014 Oct 23.

ReferenceCitation: Simpson KN, Simpson AN, Mauldin PD, Hill MD, Yeatts SD, Spilker JA, Foster LD, Khatri P, Martin R, Jauch EC, Kleindorfer D, Palesch YY, Broderick JP; IMS III Investigators. Drivers of costs associated with reperfusion therapy in acute stroke: the Interventional Management of Stroke III Trial. Stroke. 2014 Jun;45(6):1791-8. doi: 10.1161/STROKEAHA.113.003874. Epub 2014 May 13.

ReferenceCitation: Goyal M, Almekhlafi MA, Fan L, Menon BK, Demchuk AM, Yeatts SD, Hill MD, Tomsick T, Khatri P, Zaidat OO, Jauch EC, Eesa M, Jovin TG, Broderick JP. Evaluation of interval times from onset to reperfusion in patients undergoing endovascular therapy in the Interventional Management of Stroke III trial. Circulation. 2014 Jul 15;130(3):265-72. doi: 10.1161/CIRCULATIONAHA.113.007826. Epub 2014 May 9.

ReferenceCitation: Yeatts SD, Martin RH, Coffey CS, Lyden PD, Foster LD, Woolson RF, Broderick JP, Di Tullio MR, Jungreis CA, Palesch YY; IMS III Investigators. Challenges of decision making regarding futility in a randomized trial: the Interventional Management of Stroke III experience. Stroke. 2014 May;45(5):1408-14. doi: 10.1161/STROKEAHA.113.003925. Epub 2014 Apr 3.

ReferenceCitation: Liebeskind DS, Tomsick TA, Foster LD, Yeatts SD, Carrozzella J, Demchuk AM, Jovin TG, Khatri P, von Kummer R, Sugg RM, Zaidat OO, Hussain SI, Goyal M, Menon BK, Al Ali F, Yan B, Palesch YY, Broderick JP; IMS III Investigators. Collaterals at angiography and outcomes in the Interventional Management of Stroke (IMS) III trial. Stroke. 2014 Mar;45(3):759-64. doi: 10.1161/STROKEAHA.113.004072. Epub 2014 Jan 28.

ReferenceCitation: Hill MD, Demchuk AM, Goyal M, Jovin TG, Foster LD, Tomsick TA, von Kummer R, Yeatts SD, Palesch YY, Broderick JP; IMS3 Investigators. Alberta Stroke Program early computed tomography score to select patients for endovascular treatment: Interventional Management of Stroke (IMS)-III Trial. Stroke. 2014 Feb;45(2):444-9. doi: 10.1161/STROKEAHA.113.003580. Epub 2013 Dec 12.

ReferenceCitation: Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7. Erratum in: N Engl J Med. 2013 Mar 28;368(13):1265.

lead_sponsor: Joseph Broderick

location_country:
Spain
Australia
Netherlands
Canada
Switzerland
United States
France
Germany

location_facility: Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400

location_facility: St Luke's West Hospital, 7380 Turfway Rd.

location_facility: Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue

location_facility: University of Miami Miller School of Medicine

location_facility: Riverside Methodist Hospital, 3535 Olentangy River Road

location_facility: Henry Ford Hospital, 2799 W Grand Blvd, CFP-260

location_facility: The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd

location_facility: Bethesda North Hospital, 10500 Montgomery Rd.

location_facility: OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital

location_facility: University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520

location_facility: Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd

location_facility: UCLA Medical Center, 924 Westwood Blvd., Suite 300

location_facility: Massachusetts General Hospital, 55 Fruit Street

location_facility: Johns Hopkins University, 1500 Orleans St. 3M South

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: St. Luke's Hospital East, 85 N. Grand Ave.

location_facility: Good Samaritan Hospital, 375 Dixmyth Ave.

location_facility: University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400

location_facility: Morton Plant Mease Health Care, 300 Pinellas Street MS 49

location_facility: Santa Monica-UCLA Medical Center, 1250 16th Street

location_facility: Michigan State University, Sparrow Hospital, B 401 Clinical Center

location_facility: University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508

location_facility: University Medical Center at Brackenridge Hospital

location_facility: University of Mississippi Medical Center

location_facility: Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.

location_facility: University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044

location_facility: University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295

location_facility: PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212

location_facility: The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue

location_facility: Stroke Center at Hartford, 80 Seymour St. Rm JB603

location_facility: Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206

location_facility: St. Elizabeth Medical Center South, One Medical Village Drive

location_facility: The University Hospital, 234 Goodman Ave.

location_facility: Alexian Brothers Medical Center, 800 Biesterfield Rd.

location_facility: Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404

location_facility: University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor

location_facility: Mercy Hospital, Western Hills, 3131 Queen City Ave.

location_facility: Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville

location_facility: Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.

location_facility: Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue

location_facility: Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.

location_facility: Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton

location_facility: Mercy Hospital, Mt Airy, 2446 Kipling Ave.

location_facility: University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW

location_facility: St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst


title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

acronym: CATS

summary:
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

ReferenceCitation: Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Ginès P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Sweden
Brazil
Canada
Hungary
Denmark
France
Chile
Netherlands


title: Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infusion (CI) Versus Intermittent Bolus Infusion (BI) in Subjects With Severe or Moderately Severe Hemophilia A Undergoing Major Orthopedic Surgery

summary: The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or animal proteins, in previously treated patients with severe or moderately severe hemophilia A (baseline factor VIII level <= 2% of normal) who are undergoing unilateral major orthopedic surgery that requires drain placement. The total study period per subject (from consent to study completion) will vary from approximately 9 to 26 weeks and will involve clinical and laboratory assessments.

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.

lead_sponsor: Baxalta now part of Shire

location_country:
Poland
Portugal
Romania
Spain
Italy
Austria
Russian Federation
Sweden
Hungary
United States
France
Belgium
Norway
Netherlands

location_facility: State Health Centre, National Hemophilia Centre

location_facility: Russian Research Institute of Hematology and Transfusiology, Department of Surgical Hematology and Angiology

location_facility: University Hospital for Internal Medicine I (Hematology/Hemostaseology)

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: AMC Medical Research BV, Department of Vascular Medicine

location_facility: The University of Texas Health Science Center at Houston Medical School

location_facility: Centro Emofilia e Trombosi "Angelo Bianchi Bonomi"

location_facility: Department of Clinical & Experimental Medecine, AOU Federico II

location_facility: Hospital Vall d´Hebron, Servei d´Hemofilia

location_facility: University of Debrecen, 2nd Dept of Internal Medicine

location_facility: Hematology Research Center under Russian Academy of Medical Sciences, Department of Reconstructive Orthopedic Surgery for Hemophilia Patients

location_facility: Cliniques Universitaires St. Luc, Haematology Department

location_facility: University Hospital MAS, Department for Coagulation Disorders

location_facility: Fundeni Clinical Institute, Clinical Laboratory "St. Berceanu" Hematology and Bone Marrow Transplantation Department

location_facility: PTE ÁOK I. Internal Medical Clinic, Dept of Hematology

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: "Louis Turcanu" Emergency Clinical Children´s Hospital, 3rd Pediatrics Department, Hemophilia Center


title: A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents

summary: The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.

ReferenceCitation: Blanche S, Bologna R, Cahn P, Rugina S, Flynn P, Fortuny C, Vis P, Sekar V, van Baelen B, Dierynck I, Spinosa-Guzman S. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009 Sep 24;23(15):2005-13. doi: 10.1097/QAD.0b013e328330abaa.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
Spain
Argentina
Canada
United States
France
South Africa
Romania


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

summary: The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.

ReferenceCitation: Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

ReferenceCitation: Rutgeerts P, Reinisch W, Colombel JF, Sandborn WJ, D'Haens G, Petersson J, Zhou Q, Iezzi A, Thakkar RB. Agreement of site and central readings of ileocolonoscopic scores in Crohn's disease: comparison using data from the EXTEND trial. Gastrointest Endosc. 2016 Jan;83(1):188-97.e1-3. doi: 10.1016/j.gie.2015.06.018. Epub 2015 Jul 30.

ReferenceCitation: Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.

lead_sponsor: Abbott

location_country:
Italy
Austria
Netherlands
Canada
United States
France
Belgium
Germany


title: An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

acronym: CASSIOPEA

summary: Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

ReferenceCitation: Büller HR, Gallus AS, Pillion G, Prins MH, Raskob GE; Cassiopea Investigators. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet. 2012 Jan 14;379(9811):123-9. doi: 10.1016/S0140-6736(11)61505-5. Epub 2011 Nov 28.

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Philippines
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Egypt
Brazil
Canada
China
Bulgaria
Denmark
Belarus
Greece
Estonia
Czech Republic
France
Chile
Colombia
Netherlands

location_facility: sanofi-aventis Australia & New Zealand administrative office


summary: The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.

ReferenceCitation: Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17. Review.

ReferenceCitation: Kroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.

ReferenceCitation: Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Brazil
Greece
Italy
Canada
Sweden
United States
France
Germany

location_facility: Karolinska Institute St. Gorans Hospital

location_facility: North Shore Long Island Jewish Health System


title: Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.

summary: The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

ReferenceCitation: CURRENT-OASIS 7 Investigators, Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475. Erratum in: N Engl J Med. 2010 Oct 14;363(16):1585.

ReferenceCitation: Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. doi: 10.1056/NEJMe1008891.

ReferenceCitation: Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.

ReferenceCitation: Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Oct 9;376(9748):1203-5. doi: 10.1016/S0140-6736(10)61262-7.

ReferenceCitation: Bossard M, Gao P, Boden W, Steg G, Tanguay JF, Joyner C, Granger CB, Kastrati A, Faxon D, Budaj A, Pais P, Di Pasquale G, Valentin V, Flather M, Moccetti T, Yusuf S, Mehta SR. Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease. Heart. 2021 Nov;107(21):1739-1747. doi: 10.1136/heartjnl-2020-318045. Epub 2021 Jan 27.

ReferenceCitation: Bossard M, Granger CB, Tanguay JF, Montalescot G, Faxon DP, Jolly SS, Widimsky P, Niemela K, Steg PG, Natarajan MK, Gao P, Fox KAA, Yusuf S, Mehta SR. Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Nov 3;6(11). pii: e006577. doi: 10.1161/JAHA.117.006577.

ReferenceCitation: Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. Am Heart J. 2008 Dec;156(6):1080-1088.e1. doi: 10.1016/j.ahj.2008.07.026. Epub 2008 Nov 1.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Romania
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Greece
Ireland
Estonia
Latvia
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands


summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

ReferenceCitation: Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.

ReferenceCitation: Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.

ReferenceCitation: Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.

lead_sponsor: Allergan

location_country:
Poland
Brazil
Portugal
Spain
Greece
Austria
Australia
United Kingdom
Canada
Czech Republic
Switzerland
Korea, Republic of
United States
France
India
Israel
South Africa
Germany