title: A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients

summary: The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy

ReferenceCitation: Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.

family: Lu

full_name: Qin Lu

given: Qin

family: Zhang

full_name: Mao Zhang

given: Mao

family: Girardi

full_name: Cassio Girardi

given: Cassio

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Kesecioglu

full_name: Jozef Kesecioglu

given: Jozef

family: Rouby

full_name: Jean-Jacques Rouby

given: Jean-Jacques

journal_name: Critical Care

repository_institution: PubMed Central - Europe PMC

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

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.

family: Beale

full_name: Richard Beale

given: Richard

family: Stewart

full_name: Thomas E. Stewart

given: Thomas E.

family: Findlay

full_name: George P. Findlay

given: George P.

family: Holzapfel

full_name: Laurent Holzapfel

given: Laurent

family: Bruins

full_name: Peter Bruins

given: Peter

family: Steenken

full_name: Edmee J. Steenken

given: Edmee J.

family: Jeppesen

full_name: Ole K. Jeppesen

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Exogenous Natural Surfactant for Treatment of Acute Lung Injury and the Acute Respiratory Distress Syndrome

location_country:
Austria
Sweden
Netherlands
Germany
Finland
France
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Mount Sinai Hospital, Critical Care Unit

location_facility: St Thomas Hospital, Adult Intensive Care

location_facility: Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation

location_facility: Ullevål University Hospital, INtensive Care Department

location_facility: University Hospital of Lund, Department of Intensive Care

location_facility: Kuopio University Hospital, Intensive Care Unit

location_facility: Klinik für Anästhesiologie der RWTH Aachen

location_facility: Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin


ReferenceType: result

ReferenceCitation: Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

sequence: first

family: Aronson

full_name: Ronnie Aronson

given: Ronnie

sequence: additional

family: Home

full_name: Philip Home

given: Philip

family: Marre

full_name: Michel Marre

given: Michel

family: Niemoeller

full_name: Elisabeth Niemoeller

given: Elisabeth

family: Miossec

full_name: Patrick Miossec

given: Patrick

family: Ping

full_name: Lin Ping

given: Lin

family: Ye

full_name: Jenny Ye

given: Jenny

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by Established Basal Insulin

ReferenceType: derived

ReferenceCitation: Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

family: Davidson

full_name: Jaime A. Davidson

given: Jaime A.

family: Stager

full_name: William Stager

given: William

family: Paranjape

full_name: Sachin Paranjape

given: Sachin

family: Berria

full_name: Rachele Berria

given: Rachele

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

currency_apc_doaj: GBP

journal_name: Clinical Diabetes and Endocrinology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

journal_name: Journal of Diabetes and its Complications

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

repository_institution: University of Leicester - Leicester Research Archive

location_country:
Italy
Brazil
Chile
India
Mexico
Germany
France
Korea, Republic of
Puerto Rico
Russian Federation
Egypt
Turkey
United States
United Kingdom
Canada

title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.


title: A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis

location_country:
Sweden
India
Costa Rica
Germany
Finland
France
Norway
Argentina
Australia
Russian Federation
Spain
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin®) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25.

name: Department of Paediatric Endocrinology; Universitair Ziekenhuis Brussel; Brussels Belgium

family: De Schepper

full_name: Jean De Schepper

given: Jean

name: Faculty of Psychology and Educational Sciences; Vrije Universiteit Brussel; Brussels Belgium

family: Vanderfaeillie

full_name: Johan Vanderfaeillie

given: Johan

name: Division of Paediatric Endocrinology; Inselspital; University Children's Hospital; Bern Switzerland

family: Mullis

full_name: Primus-E. Mullis

given: Primus-E.

name: Department of Paediatrics; Universitair Ziekenhuis Antwerp; Antwerpen Belgium

family: Rooman

full_name: Raoul Rooman

given: Raoul

family: Robertson

full_name: Anna Robertson

given: Anna

family: Dilleen

full_name: Maria Dilleen

given: Maria

family: Gomez

full_name: Roy Gomez

given: Roy

family: Wollmann

full_name: Hartmut A. Wollmann

given: Hartmut A.

journal_name: Clinical Endocrinology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Pfizer

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Belgium
Spain
Germany
Czech Republic

acronym: EGN

location_facility: Policlinico Universitario, Istituto di Clinica Pediatrica

location_facility: Fakultni nemocnice Ostrava, Detska klinika

location_facility: CHU Toulouse, Hôpital des Enfants, Service Endocrinologie

location_facility: Drottning Silvias Barn och Ungdomssjukhus

location_facility: Dipartimento di Medicina Pediatrica, UO di Endocrinologia e Diabetologia

location_facility: Dipartimento Materno Infantile, UO di Pediatria e Neonatologia

location_facility: Universitair Ziekenhuis Antwerpen / Pediatrie

location_facility: Centro di Endocrinologia Pediatrica, Dipartimento di Pediatria

location_facility: Universitaetsklinikum Erlangen, Kinder- und Jugendklinik

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)

summary: To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.


title: Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of AT1001 in Patients With Fabry Disease

summary: Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease

study_start_date_type: Actual

status: Terminated

lead_sponsor: Amicus Therapeutics

location_country:
Brazil
France
Australia
United States
United Kingdom

status_simplified: Unknown


title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

summary: The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

lead_sponsor: Genmab

location_country:
Netherlands
France
Belgium
United States
United Kingdom

location_facility: The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust

location_facility: CHU Sart-Tilman Domaine Universitaire du Sart-Tilman

intervention_type: Radiation


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately Severe Crohn's Disease

ReferenceType: background

ReferenceCitation: Mansfield JC, Parkes M, Hawthorne AB, Forbes A, Probert CS, Perowne RC, Cooper A, Zeldis JB, Manning DC, Hawkey CJ. A randomized, double-blind, placebo-controlled trial of lenalidomide in the treatment of moderately severe active Crohn's disease. Aliment Pharmacol Ther. 2007 Aug 1;26(3):421-30.

lead_sponsor: Celgene Corporation

location_country:
Israel
United States
United Kingdom
France

location_facility: Department of Medicine A, Liver & Gastroenterology Units

location_facility: Department of Gastroenterology and Hepatology

location_facility: Washington Hospital Center Physicians Office Building


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

summary:
Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin.

Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.

lead_sponsor: Sanofi

location_country:
Italy
South Africa
Chile
Netherlands
France
Poland
Belgium
Argentina
Australia
Denmark
Germany


title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

summary:
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

location_country:
United States
South Africa
United Kingdom
Lebanon
France
Poland
Argentina
Australia
Turkey
Canada
Czech Republic


title: Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth. A Clinical, Multi-center, Prospective, Non-Randomized Study

summary:
This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-procedure. All patients will have a repeat angiography at 6 months follow-up.

The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions. The Genous stent received CE mark for the intended indication in August 2005

design_allocation: Non-Randomized

ReferenceCitation: den Dekker WK, Houtgraaf JH, Onuma Y, Benit E, de Winter RJ, Wijns W, Grisold M, Verheye S, Silber S, Teiger E, Rowland SM, Ligtenberg E, Hill J, Wiemer M, den Heijer P, Rensing BJ, Channon KM, Serruys PW, Duckers HJ. Final results of the HEALING IIB trial to evaluate a bio-engineered CD34 antibody coated stent (Genous™Stent) designed to promote vascular healing by capture of circulating endothelial progenitor cells in CAD patients. Atherosclerosis. 2011 Nov;219(1):245-52. doi: 10.1016/j.atherosclerosis.2011.06.032. Epub 2011 Jun 25.

family: den Dekker

full_name: Wijnand K. den Dekker

given: Wijnand K.

family: Houtgraaf

full_name: Jaco H. Houtgraaf

given: Jaco H.

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

family: Benit

full_name: Edouard Benit

given: Edouard

family: de Winter

full_name: Robbert J. de Winter

given: Robbert J.

family: Wijns

full_name: William Wijns

family: Grisold

full_name: Manfred Grisold

given: Manfred

family: Verheye

full_name: Stephan Verheye

given: Stephan

family: Silber

full_name: Sigmund Silber

given: Sigmund

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Rowland

full_name: Stephen M. Rowland

given: Stephen M.

family: Ligtenberg

full_name: Erik Ligtenberg

given: Erik

family: Hill

full_name: Jonathan Hill

given: Jonathan

family: Wiemer

full_name: Marcus Wiemer

given: Marcus

family: den Heijer

full_name: Peter den Heijer

given: Peter

family: Rensing

full_name: Benno J. Rensing

given: Benno J.

family: Channon

full_name: Keith M. Channon

given: Keith M.

family: Serruys

full_name: Patrick W.J.C. Serruys

given: Patrick W.J.C.

family: Duckers

full_name: Henricus J. Duckers

given: Henricus J.

journal_name: Atherosclerosis

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: OrbusNeich

location_country:
Austria
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

intervention_type: Device


title: A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12)

acronym: CALYPSO

summary: The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

location_country:
South Africa
Serbia
Mexico
Finland
Croatia
Bulgaria
France
Poland
Slovakia
Romania
Argentina
Russian Federation
Czech Republic


title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/Day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin

summary:
Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes

Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability

location_country:
Italy
United States
Chile
South Africa
Netherlands
Germany
France
Argentina
Australia
Russian Federation
Canada
United Kingdom


title: A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients With Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

summary:
This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate

Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®)
Immediate treatment following prostatectomy versus deferred treatment at the time of relapse

Using a 2x2 factorial design participants will therefore be randomized to

Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy)
Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy)
Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy)
Deferred treatment with leuprolide acetate alone (hormonal therapy)

Primary Objective:

The primary objective of the study is to compare progression-free survival using a 2x2 factorial design

Secondary Objectives:

To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups
To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone.
To evaluate quality of life as measured by the FACT-P questionnaire.

Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized.

The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

location_country:
Italy
Austria
United States
Brazil
India
South Africa
Mexico
Netherlands
Germany
France
Poland
Israel
Australia
Russian Federation
Turkey
Canada
United Kingdom


title: A Randomized, Double-blind, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of 2 Doses of Oral Liarozole (75 mg od and 150 mg od) Given During 12 Weeks in Lamellar Ichthyosis

summary: Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The primary activity of liarozole is considered to be the inhibition of the degradation of a substance called retinoic acid, which is the principal endogenous regulator of growth and differentiation of epithelial tissues in mammals. The current study intends to evaluate the efficacy and safety in patients with lamellar ichthyosis.

ReferenceCitation: Van Wauwe JP, Coene MC, Goossens J, Cools W, Monbaliu J. Effects of cytochrome P-450 inhibitors on the in vivo metabolism of all-trans-retinoic acid in rats. J Pharmacol Exp Ther. 1990 Jan;252(1):365-9.

ReferenceCitation: Van Wauwe J, Van Nyen G, Coene MC, Stoppie P, Cools W, Goossens J, Borghgraef P, Janssen PA. Liarozole, an inhibitor of retinoic acid metabolism, exerts retinoid-mimetic effects in vivo. J Pharmacol Exp Ther. 1992 May;261(2):773-9.

ReferenceCitation: Van Wauwe J, Coene MC, Cools W, Goossens J, Lauwers W, Le Jeune L, Van Hove C, Van Nyen G. Liarozole fumarate inhibits the metabolism of 4-keto-all-trans-retinoic acid. Biochem Pharmacol. 1994 Feb 11;47(4):737-41.

ReferenceCitation: Kang S, Duell EA, Kim KJ, Voorhees JJ. Liarozole inhibits human epidermal retinoic acid 4-hydroxylase activity and differentially augments human skin responses to retinoic acid and retinol in vivo. J Invest Dermatol. 1996 Aug;107(2):183-7.

ReferenceCitation: Dockx P, Decree J, Degreef H. Inhibition of the metabolism of endogenous retinoic acid as treatment for severe psoriasis: an open study with oral liarozole. Br J Dermatol. 1995 Sep;133(3):426-32.

ReferenceCitation: Berth-Jones J, Todd G, Hutchinson PE, Thestrup-Pedersen K, Vanhoutte FP. Treatment of psoriasis with oral liarozole: a dose-ranging study. Br J Dermatol. 2000 Dec;143(6):1170-6.

ReferenceCitation: Bhushan M, Burden AD, McElhone K, James R, Vanhoutte FP, Griffiths CE. Oral liarozole in the treatment of palmoplantar pustular psoriasis: a randomized, double-blind, placebo-controlled study. Br J Dermatol. 2001 Oct;145(4):546-53.

ReferenceCitation: Lucker GP, Heremans AM, Boegheim PJ, van de Kerkhof PC, Steijlen PM. Oral treatment of ichthyosis by the cytochrome P-450 inhibitor liarozole. Br J Dermatol. 1997 Jan;136(1):71-5.

ReferenceCitation: Vahlquist A, Blockhuys S, Steijlen P, van Rossem K, Didona B, Blanco D, Traupe H. Oral liarozole in the treatment of patients with moderate/severe lamellar ichthyosis: results of a randomized, double-blind, multinational, placebo-controlled phase II/III trial. Br J Dermatol. 2014 Jan;170(1):173-81. doi: 10.1111/bjd.12626.

name: Department of Medical Sciences Uppsala University SE‐751 85 Uppsala Sweden

family: Vahlquist

full_name: A. Vahlquist

given: A.

family: Blockhuys

full_name: S. Blockhuys

given: S.

name: Maastricht University Medical Center Maastricht the Netherlands

family: Steijlen

full_name: P. Steijlen

given: P.

name: Stiefel, a GSK company Research Triangle Park NC U.S.A

family: Rossem

full_name: K. Rossem

given: K.

name: Istituto Dermopatico dell'Immacolata Rome Italy

family: Didona

full_name: B. Didona

given: B.

name: Instituto Dermatológico Santo Domingo Dominican Republic

family: Blanco

full_name: D. Blanco

given: D.

name: University Hospital Münster Münster Germany

family: Traupe

full_name: H. Traupe

given: H.

journal_name: British Journal of Dermatology

oa_colors: green hybrid

title: Oral liarozole in the treatment of patients with moderate/severe lamellar ichthyosis: results of a randomized, double‐blind, multinational, placebo‐controlled phase II / III trial

lead_sponsor: Stiefel, a GSK Company

location_country:
Italy
Sweden
Netherlands
Dominican Republic
France
Norway
Belgium
Germany
Canada

location_facility: Academisch Ziekenhuis Vrije Universiteit Brussel

location_facility: Fondazione Policlinico Mangiagalli e Regina Elena


title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer

summary: The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Serbia
Netherlands
Finland
France
Montenegro
Romania
Belgium
Russian Federation
Germany
United Kingdom

location_facility: Level 7, Urology Research Unit, Derriford Hospital

location_facility: Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur

location_facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: Mount Vernon Cancer Centre, Marie Cuire Research Wing

location_facility: "Centrul Medical Privat" Prof. Dr. Ioiart Ioan"

location_facility: Helsinki University Hospital, Maria Hospital, Building 11

location_facility: Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans

location_facility: Clinical Center of Serbia, Institute of Urology and Nephrology

location_facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department

location_facility: Pavlov State Medical University, Urology Department

location_facility: Clinical Center Novi Sad, Clinic of Urology


title: An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

acronym: SIADH Safety

summary:
To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH.

Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.

location_country:
United States
Brazil
Hong Kong
Switzerland
Germany
France
Hungary
Belgium
Australia
Russian Federation
Canada

location_facility:
sanofi-aventis Canada
Sanofi-Aventis Administrative Office


title: Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study

acronym: ODYSSEY

summary: To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

location_country:
Italy
Chile
United Kingdom
Mexico
Netherlands
Spain
France
Poland
Belgium
Australia
Portugal
Canada
Czech Republic

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

acronym: TRACE

summary: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

location_country:
Italy
United States
Chile
South Africa
Hong Kong
Switzerland
Germany
France
Poland
Singapore
Hungary
Argentina
Australia
New Zealand
Spain
Canada
Taiwan

location_facility: sanofi-aventis New Zealand administrative office


title: Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

summary: Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

ReferenceCitation: Petersenn S, Farrall AJ, De Block C, Melmed S, Schopohl J, Caron P, Cuneo R, Kleinberg D, Colao A, Ruffin M, Hermosillo Reséndiz K, Hughes G, Hu K, Barkan A. Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study. Pituitary. 2014 Apr;17(2):132-40. doi: 10.1007/s11102-013-0478-0. Erratum in: Pituitary. 2014 Apr;17(2):141. Block, Christophe [corrected to De Block, Christophe].

family: Petersenn

full_name: Stephan Petersenn

given: Stephan

family: Farrall

full_name: Andrew J. Farrall

given: Andrew J.

family: Block

full_name: Christophe Block

given: Christophe

family: Melmed

full_name: Shlomo Melmed

given: Shlomo

family: Schopohl

full_name: Jochen Schopohl

given: Jochen

family: Caron

full_name: Philippe Caron

given: Philippe

family: Cuneo

full_name: Ross Cuneo

given: Ross

family: Kleinberg

full_name: David Kleinberg

given: David

family: Colao

full_name: Annamaria Colao

given: Annamaria

family: Ruffin

full_name: Matthieu Ruffin

given: Matthieu

family: Hermosillo Reséndiz

full_name: Karina Hermosillo Reséndiz

given: Karina

family: Hughes

full_name: Gareth Hughes

given: Gareth

family: Hu

full_name: Ke Hu

given: Ke

family: Barkan

full_name: Ariel Barkan

given: Ariel

journal_name: Pituitary

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_country:
Italy
Switzerland
Germany
France
Belgium
Australia
United States

location_facility: Cedars Sinai Medical Center Dept. of Pituitary Ctr.

location_facility: University of Michigan Health System StudyCoordinatorCSOM230B2201E1


summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

ReferenceCitation: Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.

lead_sponsor: Allergan

location_country:
Austria
United States
South Africa
Mexico
Philippines
Germany
France
Czechia
Israel
Australia
Portugal
Canada
Taiwan

intervention_type: Other


title: A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)

summary: The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

status: Withdrawn

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
United States
Netherlands
France
Belgium
New Zealand
Germany
United Kingdom


title: Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy and Pharmacokinetics of Myozyme in Patients With Late-Onset Pompe Disease.

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 overall objective is to evaluate the safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe disease as compared to placebo.

ReferenceCitation: Forsha D, Li JS, Smith PB, van der Ploeg AT, Kishnani P, Pasquali SK; Late-Onset Treatment Study Investigators. Cardiovascular abnormalities in late-onset Pompe disease and response to enzyme replacement therapy. Genet Med. 2011 Jul;13(7):625-31. doi: 10.1097/GIM.0b013e3182142966.

family: Forsha

full_name: Daniel Forsha

given: Daniel

family: Li

full_name: Jennifer S Li

given: Jennifer S

family: Smith

full_name: P Brian Smith

given: P Brian

family: van der Ploeg

full_name: Ans T van der Ploeg

given: Ans T

family: Kishnani

full_name: Priya Kishnani

given: Priya

family: Pasquali

full_name: Sara K Pasquali

given: Sara K

journal_name: Genetics in Medicine

evidence: open (via free pdf)

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_normalized: Springer

ReferenceCitation: van der Ploeg AT, Clemens PR, Corzo D, Escolar DM, Florence J, Groeneveld GJ, Herson S, Kishnani PS, Laforet P, Lake SL, Lange DJ, Leshner RT, Mayhew JE, Morgan C, Nozaki K, Park DJ, Pestronk A, Rosenbloom B, Skrinar A, van Capelle CI, van der Beek NA, Wasserstein M, Zivkovic SA. A randomized study of alglucosidase alfa in late-onset Pompe's disease. N Engl J Med. 2010 Apr 15;362(15):1396-406. doi: 10.1056/NEJMoa0909859.

full_name: Ans T. van der Ploeg

given: Ans T.

family: Clemens

full_name: Paula R. Clemens

given: Paula R.

family: Corzo

full_name: Deyanira Corzo

given: Deyanira

family: Escolar

full_name: Diana M. Escolar

given: Diana M.

family: Florence

full_name: Julaine Florence

given: Julaine

family: Groeneveld

full_name: Geert Jan Groeneveld

given: Geert Jan

family: Herson

full_name: Serge Herson

given: Serge

full_name: Priya S. Kishnani

given: Priya S.

family: Laforet

full_name: Pascal Laforet

given: Pascal

family: Lake

full_name: Stephen L. Lake

given: Stephen L.

family: Lange

title: A Randomized Study of Alglucosidase Alfa in Late-Onset Pompe's Disease

location_facility: University of Pittsburgh, Dept. of Neurology


status: Unknown status

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

enrollment_type: Anticipated

location_country:
Italy
Austria
Netherlands
Spain
France
Belgium
Portugal
United Kingdom

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Erasmus MC - Daniel den Hoed Cancer Center

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

title: Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.


title: A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody (Herceptin) In Women With c-erbB2 Positive Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with trastuzumab may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer.

ReferenceCitation: Neskovic-Konstantinovic Z, Nooij M, Khaled H, et al.: Safety and efficacy of combined trastuzumab and CMF therapy in women with metastatic breast cancer: EORTC protocol 10995. [Abstract] J Clin Oncol 25 (Suppl 18): A-1040, 2007.

ReferenceCitation: Tryfonidis K, Marreaud S, Khaled H, De Valk B, Vermorken J, Welnicka-Jaskiewicz M, Aalders K, Bartlett JMS, Biganzoli L, Bogaerts J, Cameron D; EORTC- Breast Cancer Group. Cardiac safety, efficacy, and correlation of serial serum HER2-extracellular domain shed antigen measurement with the outcome of the combined trastuzumab plus CMF in women with HER2-positive metastatic breast cancer: results from the EORTC 10995 phase II study. Breast Cancer Res Treat. 2017 Jun;163(3):507-515. doi: 10.1007/s10549-017-4203-y. Epub 2017 Mar 21.

family: Tryfonidis

full_name: Konstantinos Tryfonidis

given: Konstantinos

family: Marreaud

full_name: S. Marreaud

given: S.

family: Khaled

full_name: H. Khaled

given: H.

family: De Valk

full_name: B. De Valk

given: B.

family: Vermorken

full_name: J. Vermorken

given: J.

family: Welnicka-Jaskiewicz

full_name: M. Welnicka-Jaskiewicz

given: M.

family: Aalders

full_name: K. Aalders

given: K.

family: Bartlett

full_name: J. M. S. Bartlett

given: J. M. S.

family: Biganzoli

full_name: L. Biganzoli

given: L.

family: Bogaerts

full_name: J. Bogaerts

family: Cameron

full_name: David Cameron

given: David

name: On behalf of the EORTC- Breast Cancer Group

journal_name: Breast Cancer Research and Treatment

oa_host_type: repository

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_country:
South Africa
Serbia
Netherlands
France
Poland
Belgium
Egypt
Denmark
United Kingdom

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Herlev Hospital - University Hospital of Copenhagen

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


title: International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective for treating infants with acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.

ReferenceCitation: Hempel G, Relling MV, de Rossi G, Stary J, De Lorenzo P, Valsecchi MG, Barisone E, Boos J, Pieters R. Pharmacokinetics of daunorubicin and daunorubicinol in infants with leukemia treated in the interfant 99 protocol. Pediatr Blood Cancer. 2010 Mar;54(3):355-60. doi: 10.1002/pbc.22266.

family: Hempel

full_name: Georg Hempel

given: Georg

family: Relling

full_name: Mary V. Relling

given: Mary V.

family: de Rossi

full_name: Giulio de Rossi

given: Giulio

family: Stary

full_name: Jan Stary

given: Jan

family: De Lorenzo

full_name: Paola De Lorenzo

given: Paola

family: Valsecchi

full_name: Maria Grazia Valsecchi

given: Maria Grazia

family: Barisone

full_name: Elena Barisone

given: Elena

family: Boos

full_name: Joachim Boos

given: Joachim

family: Pieters

full_name: Rob Pieters

given: Rob

journal_name: Pediatric Blood & Cancer

ReferenceCitation: Mann G, Attarbaschi A, Schrappe M, De Lorenzo P, Peters C, Hann I, De Rossi G, Felice M, Lausen B, Leblanc T, Szczepanski T, Ferster A, Janka-Schaub G, Rubnitz J, Silverman LB, Stary J, Campbell M, Li CK, Suppiah R, Biondi A, Vora A, Valsecchi MG, Pieters R; Interfant-99 Study Group. Improved outcome with hematopoietic stem cell transplantation in a poor prognostic subgroup of infants with mixed-lineage-leukemia (MLL)-rearranged acute lymphoblastic leukemia: results from the Interfant-99 Study. Blood. 2010 Oct 14;116(15):2644-50. doi: 10.1182/blood-2010-03-273532. Epub 2010 Jun 30.

name: Berlin-Frankfurt-Münster Study Group, Austria;

family: Mann

full_name: Georg Mann

family: Attarbaschi

full_name: Andishe Attarbaschi

given: Andishe

name: Berlin-Frankfurt-Münster Study Group, Germany;

family: Schrappe

full_name: Martin Schrappe

given: Martin

name: Interfant-99 Trial Data Center, Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy;

family: Peters

full_name: Christina Peters

given: Christina

name: United Kingdom Children's Cancer Study Group, United Kingdom;

family: Hann

full_name: Ian Hann

given: Ian

name: Associazione Italiana Ematologia Oncologia Pediatrica, Italy;

family: De Rossi

full_name: Giulio De Rossi

name: Argentinean Group of Pediatric Hematology and Oncology, Buenos Aires, Argentina;

family: Felice

full_name: Maria Felice

given: Maria

name: Nordic Society of Pediatric Hematology and Oncology, Norway, Sweden, Denmark, Finland, and Iceland;

family: Lausen

full_name: Birgitte Lausen

given: Birgitte

name: French Acute Lymphoblastic Leukemia Study Group, France;

family: LeBlanc

full_name: Thierry LeBlanc

given: Thierry

name: Polish Pediatric Leukemia and Lymphoma Study Group, Poland;

family: Szczepanski

full_name: Tomasz Szczepanski

given: Tomasz

name: Children's Leukemia Group, France, Belgium, and Portugal;

family: Ferster

full_name: Alina Ferster

given: Alina

name: Cooperative Acute Lymphoblastic Leukemia Study Group, Germany;

name: St Jude Children's Research Hospital, Memphis, TN;

name: Dana-Farber Cancer Institute ALL Consortium, Boston, MA;

name: Czech Pediatric Haematology, Czech Republic;

name: Programa Infantil Nacional de Drogas Antineoplásicas, Chile;

name: Hong Kong Pediatric Hematology and Oncology Study Group, Hong Kong, China;

name: Australian and New Zealand Children's Haematology and Oncology Study Group, Australia; and

name: Dutch Childhood Oncology Study Group, Erasmus MC-Sophia Children's Hospital, The Netherlands

name: on behalf of the Interfant-99 Study Group

title: Improved outcome with hematopoietic stem cell transplantation in a poor prognostic subgroup of infants with mixed-lineage-leukemia (MLL)–rearranged acute lymphoblastic leukemia: results from the Interfant-99 Study

ReferenceCitation: Lönnerholm G, Valsecchi MG, De Lorenzo P, Schrappe M, Hovi L, Campbell M, Mann G, Janka-Schaub G, Li CK, Stary J, Hann I, Pieters R; Interfant-99 study group. Pharmacokinetics of high-dose methotrexate in infants treated for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 May;52(5):596-601. doi: 10.1002/pbc.21925.

ReferenceCitation: van der Linden MH, Valsecchi MG, De Lorenzo P, Möricke A, Janka G, Leblanc TM, Felice M, Biondi A, Campbell M, Hann I, Rubnitz JE, Stary J, Szczepanski T, Vora A, Ferster A, Hovi L, Silverman LB, Pieters R. Outcome of congenital acute lymphoblastic leukemia treated on the Interfant-99 protocol. Blood. 2009 Oct 29;114(18):3764-8. doi: 10.1182/blood-2009-02-204214. Epub 2009 Aug 5.

name: Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands;

name: University Medical Center Schleswig-Holstein, Kiel, Germany;

name: Cooperative Study Group for Treatment of ALL, University Hospital Hamburg-Eppendorf, Hamburg, Germany;

name: French ALL Group, Hôpital Saint-Louis, Paris, France;

name: Argentina Hospital de Pediatría, Buenos Aires, Argentina;

name: Associazione Italiana Ematologia Oncologia Pediatrica, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy;

name: Programa Infantil Nacional de Drogas Antineoplásicas, Hospital Roberto del Rio, Santiago, Chile;

name: UK Children's Cancer Study Group, Great Ormond Street Hospital for Children, London, United Kingdom;

name: Czech Paediatric Haematology, University Hospital Motol and 2nd Medical School, Charles University Prague, Prague, Czech Republic;

name: Polish Paediatric Leukemia and Lymphoma Study Group, Medical University of Silesia, Zabrze, Poland;

name: Sheffield Children's Hospital, Sheffield, United Kingdom;

name: Children's Leukemia Group, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium;

name: Nordic Society of Paediatric Haematology and Oncology, University of Helsinki, Helsinki, Finland;

name: Dana-Farber Cancer Institute, Boston, MA; and

name: Dutch Childhood Oncology Group, The Hague, The Netherlands

ReferenceCitation: Van der Velden VH, Corral L, Valsecchi MG, Jansen MW, De Lorenzo P, Cazzaniga G, Panzer-Grümayer ER, Schrappe M, Schrauder A, Meyer C, Marschalek R, Nigro LL, Metzler M, Basso G, Mann G, Den Boer ML, Biondi A, Pieters R, Van Dongen JJ; Interfant-99 Study Group. Prognostic significance of minimal residual disease in infants with acute lymphoblastic leukemia treated within the Interfant-99 protocol. Leukemia. 2009 Jun;23(6):1073-9. doi: 10.1038/leu.2009.17. Epub 2009 Feb 12.

ReferenceCitation: Pieters R, Schrappe M, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary J, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG. A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial. Lancet. 2007 Jul 21;370(9583):240-250. doi: 10.1016/S0140-6736(07)61126-X.

ReferenceCitation: Pieters R, Schrappe M, de Lorenzo P, et al.: Outcome of infants less than one year of age with acute lymphoblastic leukemia treated with the Interfant-99 protocol. [Abstract] Blood 108 (11): A-145, 2006.

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
Germany
France
Ireland
Belgium
United States
Czech Republic

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Southampton University Hospital NHS Trust

location_facility: Nuovo Ospedale San Gerardo at University of Milano-Bicocca

location_facility: Sir James Spence Institute of Child Health

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Central Manchester and Manchester Children's University Hospitals NHS Trust

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Institute of Child Health at University of Bristol

location_facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Royal Marsden NHS Foundation Trust - Surrey


title: Neuropsychological Evaluation of Psychiatric and Neurological Patients

summary:
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries.

The goals of this research study are to;

Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions.
Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.

study_type: Observational

ReferenceCitation: Johnstone EC, Owens DG, Bydder GM, Colter N, Crow TJ, Frith CD. The spectrum of structural brain changes in schizophrenia: age of onset as a predictor of cognitive and clinical impairments and their cerebral correlates. Psychol Med. 1989 Feb;19(1):91-103.

lead_sponsor: National Institute of Mental Health (NIMH)

location_country:
United States
Russian Federation
France

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma

summary: The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Italy
Austria
Sweden
Germany
Finland
France
Norway
Turkey
Denmark
Canada
United Kingdom

location_facility:
Rikshospitalet
Uni. Modena, Policlinico
Medizinische Universität Wien
Helsinki University Central Hospital
University Faculty of Medicine
University of Leipzig
CHU Lapeyronie
Rigshospitalet
University of Milano
Sahlgrenska University Hospital
IRCCS, Casa Sollievo della Sofferenza
University Hospital
Turku University
Huddinge University Hospital
Royal Marsden Hospital
University of Heidelberg
Tampere University Hospital
Herlev Hospital
Ospedale di Careggi
Ospedale Ferrarotto

intervention_type: Procedure


title: Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

summary: The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Eiger BioPharmaceuticals

location_country:
Italy
United States
France
Bulgaria
Israel
Romania
Belgium
Russian Federation
Spain
Turkey
Moldova, Republic of
Germany
Ukraine

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: ISMP Spitalul Clinic Republican "Timofei Mosneaga"

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Medical Center 'Ok!Clinic+' of International Institute of Clinical Studies LLC

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital" of Ivano-Frankivsk Regional Council, Departments # 2 and 3, Ivano-Frankivsk National Medical University, Department of Infectious Diseases and Epidemiology

location_facility: Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: ZIM 1, Gastroenterologie, University Hospital Frankfurt

location_facility: State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH

status_simplified: Ongoing


title: HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies

acronym: HONEST-PREPS

summary:
Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) pose a significant burden to patients admitted to the Intensive Care Unit (ICU). Reported incidence ranges from 10-16% in all ICU patients (including HAP and VAP) and around 20-30% in ventilated patients (VAP). Patients with HAP/VAP have a high mortality rate. The estimated attributable mortality of VAP is 6-13%.

Randomized Controlled Trials (RCTs) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. Several preventive and therapeutic treatment options are being developed that will require evaluation in phase-III trials. These trials are challenging due to the relatively low incidence of the outcome (e.g. HAP/VAP) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. There is a need for a well-organized and well-trained international RCT network that enables efficient execution of a series of RCTs in this population.

The aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of HAP/VAP in ICUs in several European countries. Site personnel will be trained to obtain a GCP (Good Clinical Practice) certification (if not already done), to timely identify and enroll patients at risk of HAP/VAP, to timely identify occurrence of HAP/VAP, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. Site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. Where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. Furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. E.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.

status: Recruiting

time_perspective: Prospective

lead_sponsor: UMC Utrecht

location_country: Serbia France Croatia Czechia Albania Romania Hungary Latvia

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Markusovszky Teaching Hospital Szombathely

location_facility: General Hospital Dr Josip Bencevic Slavonski Brod

location_facility: Paul Stradins Clinical University Hospital

location_facility: Central Military Emergency University Hospital "Dr. Carol Davila "


title: A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

acronym: SOPRANINO

summary: This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.

primary_purpose: Other

ipd_sharing: Yes

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

lead_sponsor: Hoffmann-La Roche

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique


title: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma

acronym: MANTRA

summary: Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

lead_sponsor: Rain Therapeutics Inc.

location_country:
Austria
France
Poland
Spain
United States

location_facility: Abramson Cancer Center at Pennsylvania Hospital

location_facility: M. Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma

location_facility: University Hospital Foundation Jimenez Diaz


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

acronym: ALLEGORY

summary: This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

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

location_country:
South Africa
Peru
Mexico
France
Argentina
Russian Federation
Spain
United States

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Winelands Medical Research; Medical Research

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Rheumatology Associates of Central Florida

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: HOPITAL COCHIN; Internal Medicine Department

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: Netcare Umhlanga Medical Centre; Rheumatology

location_facility: Northwell Health Division of Rheumatology

location_facility: FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

location_facility: SBHI of Yaroslavl Region Clinical Hospital #3

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"

location_facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova


title: A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

summary:
Due to different study designs, the sponsor separated Part C into this separate registration (NCT number to be assigned), leaving Parts A/B in NCT02534844. The trial's final results for the primary outcome measure of Adverse Events will be reported here.

The primary and study completion dates are based on the anticipated last date safety data will be collected from Part C participants.

This study is to find out how safe and effective adrabetadex is for patients with Niemann-Pick Type C1 (NPC1) disease who have neurologic symptoms (listed under Keywords).

In Parts A/B (NCT02534844), two out of every three patients will receive the study drug. The third patient will receive 1 to 2 small needle pricks at the location where the IT injection is normally made (sham control).

In Part C, all participants will receive study drug.

status: Active, not recruiting

lead_sponsor: Mandos LLC

location_country:
United States
Switzerland
France
Singapore
Australia
New Zealand
Turkey
Germany
United Kingdom

location_facility: National University Hospital (Singapore) Pte, Ltd

location_facility: Children's Hospital of Orange County: CHOC Children's

location_facility: Eunice Kennedy Shriver National Institute of Child Health and Human Development

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: CHU Paris Est - Hopital d'Enfants Armand-Trousseau

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Multicare Institute for Research and Innovation


title: A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

summary:
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

status: Enrolling by invitation

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Netherlands
France
Spain
Germany
United Kingdom
Canada

location_facility:
LEO Investigational Sites
LEO Investigational Site


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Mexico
France
Poland
Israel
Australia
Russian Federation
New Zealand
Spain
Turkey
Canada
Korea, Republic of
Taiwan
Ukraine

acronym: Phase 2a Study of Efinopegdutide (MK-6024) in Individuals With NAFLD

location_facility: Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)

location_facility: Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)

location_facility: Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)

location_facility: Sweet Hope Research Specialty, Inc ( Site 1902)

location_facility: Christchurch Hospital-Gastroenterology Research ( Site 1002)

location_facility: Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)

location_facility: Heritage Medical Research Clinic ( Site 0302)

location_facility: American Research Corporation at Texas Liver Institute ( Site 1920)

location_facility: Catalina Research Institute, LLC ( Site 1939)

location_facility: Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)

location_facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)

location_facility: CHUS - Hospital Clinico Universitario ( Site 1403)

location_facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)

location_facility: Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)

location_facility: Floridian Clinical Research, LLC ( Site 1950)

location_facility: Sheba Medical Center-The Liver Diseases Center ( Site 0700)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)

location_facility: Centro de Investigación y Gastroenterología ( Site 0902)

location_facility: Auckland City Hospital-Liver Research Unit ( Site 1003)

location_facility: Korea University Guro Hospital ( Site 1300)

location_facility: Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)

location_facility: Soon Chun Hyang University Bucheon Hospital ( Site 1304)

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)

location_facility: Humanitas-Medicina interna ed Epatologia ( Site 0800)

location_facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent

location_facility: New Technologies of Medicine Clinic ( Site 1204)

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)

location_facility: Texas Clinical Research Institute ( Site 1910)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)

location_facility: Severance Hospital, Yonsei University Health System ( Site 1305)

location_facility: Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)

location_facility: Avix Investigación Clinica, S.C. ( Site 0907)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)

location_facility: Hacettepe Universitesi-internal diseases ( Site 1602)

location_facility: Ukrainian Research Institute of Therapy ( Site 1704)

location_facility: Rambam Health Care Campus-Liver disease unit ( Site 0704)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site

location_facility: Gazi Universitesi-gastroenterology ( Site 1605)

location_facility: Shaare Zedek Medical Center-Liver Unit ( Site 0703)

location_facility: National Taiwan University Hospital ( Site 1501)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1105)

location_facility: Clinical Trials of Texas, Inc. ( Site 1906)

location_facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 1107)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (

title: A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

summary: The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.


title: A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

summary: This study will evaluate the efficacy and safety of multiple biomarker-driven treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

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

location_country:
Italy
Switzerland
Germany
France
Czechia
Belgium
Australia
Russian Federation
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hôpitaux Universitaires de Genève; Département d'oncologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

location_facility: Western General Hospital; Edinburgh Cancer Center


title: Natural History of the Progression of X-Linked Retinitis Pigmentosa

acronym: XOLARIS

summary: The objective of the study is to gain a better understanding of disease progression over time in participants with X-linked retinitis pigmentosa (XLRP).

lead_sponsor: NightstaRx Ltd, a Biogen Company

location_country:
United States
Netherlands
Finland
France
Germany
United Kingdom
Canada


title: A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients.

summary: A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Vir Biotechnology, Inc.

location_country:
United States
France
Ukraine

location_facility:
Investigative Site
Investigative Sites

intervention_type: Biological


type: Registry Identifier

title: A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

summary:
Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with cemiplimab.

Secondary Objectives:

To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
To assess other indicators of antitumor activity
To assess the concentrations of SAR444245 when given in combination with cemiplimab
To assess the immunogenicity of SAR444245
To assess active concentrations of cemiplimab when given in combination with SAR444245

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country: Italy Chile France Australia Spain

location_facility:
Investigational Site Number :1520002
Investigational Site Number :7240002
Investigational Site Number :1520001
Investigational Site Number :2500001
Investigational Site Number :7240003
Investigational Site Number :0360001
Investigational Site Number :0360002
Investigational Site Number :7240004
Investigational Site Number :1520005
Investigational Site Number :1520003
Investigational Site Number :3800001
Investigational Site Number :1520004


title: A Phase 2 Study of Pembrolizumab (MK-3475) Every 6 Weeks (Q6W) in Participants With Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

summary: The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W.

location_country:
Italy
South Africa
France
Czechia
Poland
Russian Federation
Turkey
United States
Ukraine

location_facility: Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)

location_facility: Ankara University Department of Hematology, Clinical Research Unit ( Site 1101)

location_facility: The National Medico-Surgical Center N.I. Pirogov ( Site 0801)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503)

location_facility: CNPE Regional Center of Oncology ( Site 1305)

location_facility: Ege University Medicine of Faculty ( Site 1105)

location_facility: Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)

location_facility: Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)

location_facility: Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0803)

location_facility: Almazov National Medical Research Centre ( Site 0807)

location_facility: Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902)

location_facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S


title: A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period

summary: The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
United States
France
Poland
Belgium
Spain
Canada
United Kingdom


ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Italy
United States
Brazil
Sweden
Germany
France
Japan
Poland
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

acronym: ATLAS

location_facility: Washington University School of Medicine

location_facility: Holy Cross Hospital Phil Smith Neuroscience Institute

title: A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

summary: The primary objective of this study is to evaluate the efficacy of BIIB067 when initiated in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB067 and to evaluate the effect of BIIB067 on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).


lead_sponsor: Galderma R&D

location_country:
United States
Canada
France

acronym: START

location_facility:
Galderma Investigational Site #8838
Galderma Investigational Site #8367
Galderma Investigational Site #6167
Galderma Investigational Site #8189
Galderma Investigational Site #9928
Galderma Investigational Site #8881
Galderma Investigational Site #8608
Galderma Investigational Site #9936
Galderma Investigational Site #8601
Galderma Investigational Site #8108
Galderma Investigational Site #8295
Galderma Investigational Site #8883
Galderma Investigational Site #8886
Galderma Investigational Site #9920
Galderma Investigational Site #9918
Galderma Investigational Site #8447
Galderma Investigational Site #9927
Galderma Investigational Site #8873

title: Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

summary: The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.


title: A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence

summary: The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

lead_sponsor: Ethicon, Inc.

location_country:
Austria
Sweden
France
Denmark
United States

location_facility:
UPMC
Karolinska Institute
Institute for Female Pelvic Medicine
LKH Hochsteiermark
Hopital Jeanne de Flandres
Duke University
Ordensklinikum Linz
Herlev Hospital


title: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

acronym: ADAPT

summary: DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

time_perspective: Retrospective

lead_sponsor: Keya Medical

location_country:
Italy
Austria
France
Poland
United States

location_facility:
University of Ferrara
Holy Cross Health
University of Milan
University of Kansas Medical Center
Medical University Innsbruck
Medical University of South Carolina
National Institute of Cardiology
Institute of Arnualt Tzanck
Oregon Health & Science University
Vanderbilt University Medical Center


title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

summary: This is a Phase III, open label, randomized, two-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone in locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) participants who have progressed following prior HCC treatment with atezolizumab and bevacizumab combination.

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

location_country:
Malaysia
Greece
Belgium
Russian Federation
Taiwan
Costa Rica
Croatia
France
Japan
Thailand
Canada
Korea, Republic of
Chile
Switzerland
China
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

location_facility: Sourasky Medical Center; Oncology Department

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia

location_facility: Beacon International Specialist Centre; Clinical Research Department, Level 2

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: I.M.Sechenov First Moscow State Medical University (1st MSMU)

location_facility: Inselspital Bern Medizin Gastroenterologie

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia

location_facility: Anticancer Hospital of Thessaloniki " Theagenio"

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Universitätsspital Zürich Medizin Gastroenterologie; Klinik für Gastroenterologie und Hepatologie

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Medipol Mega Üniversite Hastanesi Göztepe

location_facility: Pontificia Universidad Catolica de Chile; Clinica San Carlos de Apoquindo

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Fondazione Pascale; U.O. Sperimentazioni Cliniche

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hepatologia

location_facility: Agioi Anargiroi Hospital of Kifissia; University Internal Medicine Clinic

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Hospital Universitario Reina Sofia; Servicio de Hepatologia

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Uni Malaya Medical Center; Clinical Oncology Unit, Menara Timur

location_facility: National Taiwan University Hospital; Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hammersmith Hospital; Clinical trials unit

location_facility: Harbin Medical University Cancer Hospital

location_facility: Moscow City Oncology Hospital #62; Outpatient Care Center


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

acronym: COAST

summary: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

lead_sponsor: Opthea Limited

location_country:
Greece
Australia
Denmark
Taiwan
India
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Netherlands
Philippines
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Estonia
Latvia

location_facility:
COAST
COAST Investigational Site
COAST Investigational site


title: Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

summary: This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

lead_sponsor: Kyowa Kirin, Inc.

location_country:
Italy
France
Spain
United States
United Kingdom

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

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

location_facility: University of Pittsburgh School of Medicine

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


title: Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection

summary: Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.

lead_sponsor: Verici Dx

location_facility: University Hospital Vall d'Hebron, Barcelona


title: A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors

summary: The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.

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

lead_sponsor: Amgen

location_country:
United States
Germany
France
Japan
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: University Hospitals Cleveland Medical Center

location_facility: Henry Ford Hospital, Henry Ford Health Systems

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: University of Texas MD Anderson Cancer Center


title: Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)

summary: The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

lead_sponsor: Medtronic

location_country:
Switzerland
Netherlands
United Kingdom
France
Czechia
Belgium
Spain
Slovenia

location_facility: Enschede Middlesbrough Nottwil Maastricht Ljubljana Morges Marseille Badalona Brugge Wilrijk Madrid Sint-Niklaas Roeselare Leuven Praha


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

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

lead_sponsor: Advanced Accelerator Applications

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

acronym: NETTER-P

location_facility: University of Iowa Carver College of Medicine

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

title: A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

summary: This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.