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

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

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

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

lead_sponsor: Gabriela Riemekasten

location_country:
Italy
Switzerland
France
Hungary
Germany
United Kingdom

location_facility: Felix-Platter Spital, University of Basel

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

location_facility: Royal Free Hospital, University College London

location_facility: Pecsi Tudomanyegyetem - University of Pecs

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

location_facility: Centre for Pediatric Rheumatology, Klinikum Eilbek

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

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

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

location_facility: University of Zurich, Department of Rheumatology


ReferenceType: derived

ReferenceCitation: Ljung R, Karim FA, Saxena K, Suzuki T, Arkhammar P, Rosholm A, Giangrande P; Pioneer™1 Investigators. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors. J Thromb Haemost. 2013 Jul;11(7):1260-8. doi: 10.1111/jth.12237.

name: Department of Paediatrics and Malmö Centre for Thrombosis and Haemostasis; Lund University; Skåne University Hospital; Malmö Sweden

family: Ljung

full_name: R. Ljung

given: R.

sequence: first

name: Haemophilia Centre; National Blood Centre; Kuala Lumpur Malaysia

family: Karim

full_name: F. A. Karim

given: F. A.

sequence: additional

name: Children's Hospital Boston; Harvard Medical School; Boston MA USA

family: Saxena

full_name: K. Saxena

given: K.

name: Department of Laboratory Medicine; Tokyo Medical University; Tokyo Japan

family: Suzuki

full_name: T. Suzuki

given: T.

name: Medical and Science; Haemophilia R&D Portfolio; Novo Nordisk A/S; Søborg Denmark

family: Arkhammar

full_name: P. Arkhammar

given: P.

name: Biostatistics Biopharm; Novo Nordisk A/S; Søborg Denmark

family: Rosholm

full_name: A. Rosholm

given: A.

name: Oxford Haemophilia and Thrombosis Centre; Churchill Hospital; Oxford UK

family: Giangrande

full_name: P. Giangrande

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Thrombosis and Haemostasis

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Novo Nordisk A/S

enrollment_type: Actual

primary_purpose: Prevention

location_country:
Brazil
South Africa
Sweden
Former Serbia and Montenegro
Serbia
France
Japan
Malaysia
Turkey
United States
United Kingdom

study_completion_date_type: Actual

type: EudraCT Number

type: Registry Identifier

type: Other Identifier

source: euctr

title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of Prophylactic Administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients With Inhibitors

summary: This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.

name: Paul Sabatier University; Toulouse France

family: Paul

full_name: C. Paul

given: C.

family: Reich

full_name: K. Reich

name: Department of Dermatology; Tufts Medical Center; Boston MA USA

family: Gottlieb

full_name: A.B. Gottlieb

name: Psoriasis Center at the Department of Dermatology; University Medical Center Schleswig-Holstein; Campus Kiel Germany

family: Mrowietz

full_name: U. Mrowietz

given: U.

name: Department of Dermatology; Charité Universitätsmedizin Berlin; Berlin Germany

family: Philipp

full_name: S. Philipp

given: S.

name: Department of Dermatology; Fukuoka University Hospital; Fukuoka Japan

family: Nakayama

full_name: J. Nakayama

given: J.

family: Harfst

full_name: E. Harfst

given: E.

family: Guettner

full_name: A. Guettner

family: Papavassilis

full_name: C. Papavassilis

journal_name: Journal of the European Academy of Dermatology and Venereology

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Treatment

location_country:
United States
France
Japan
Israel
Norway
Germany
Iceland

title: A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

summary: The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).


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

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

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

Aim of this observational trial is:

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

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University of Paris 5 - Rene Descartes

lead_sponsor_type: academique

status_simplified: Unknown


ReferenceType: background

ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31.

ReferenceCitation: Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.

name: Department of Internal Medicine and Gastroenterology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, Hamburg, 20099 Germany

name: Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany

family: Pape

full_name: Ulrich-Frank Pape

given: Ulrich-Frank

name: Department of Surgery, Mount Sinai Medical Centre, New York, NY, USA

family: Iyer

full_name: Kishore R. Iyer

given: Kishore R.

name: Department of Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark

family: Jeppesen

full_name: Palle B. Jeppesen

given: Palle B.

name: Department of Nutrition and Department of General and Vascular Surgery, M. Pirogow Hospital, Lódz, Poland

family: Kunecki

full_name: Marek Kunecki

given: Marek

name: Department of Digestive System, St. Orsola Hospital, University of Bologna, Bologna, Italy

family: Pironi

full_name: Loris Pironi

given: Loris

name: Gastroentérologie et Nutrition Clinique, Université Côte D’Azur, Nice, France

family: Schneider

full_name: Stéphane M. Schneider

given: Stéphane M.

name: Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Centre Nashville, TN, USA

family: Seidner

full_name: Douglas L. Seidner

given: Douglas L.

name: Biostatistics & Statistical Programming, Shire Human Genetic Therapies, Inc., Lexington, MA, USA, a member of the Takeda group of companies

family: Lee

full_name: Hak-Myung Lee

given: Hak-Myung

name: Global Drug Safety, Shire, Cambridge, MA, USA, a member of the Takeda group of companies

family: Caminis

full_name: John Caminis

given: John

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Gastroenterology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Shire

location_country:
Italy
Germany
France
Poland
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: University Health Network - Toronto General Hospital

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik I

title: A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

summary: This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.


intervention_type: Biological

lead_sponsor: Amgen

primary_purpose: Supportive Care

location_country:
United States
South Africa
India
Mexico
France
Czechia
Bulgaria
Greece
Poland
Slovakia
Hungary
Australia
Russian Federation
New Zealand
Slovenia
Canada
Latvia
Ukraine

title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

summary: This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.


title: A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

summary: This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

design_allocation: Non-Randomized

ReferenceCitation: Miller KD, Diéras V, Harbeck N, Andre F, Mahtani RL, Gianni L, Albain KS, Crivellari D, Fang L, Michelson G, de Haas SL, Burris HA. Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. J Clin Oncol. 2014 May 10;32(14):1437-44. doi: 10.1200/JCO.2013.52.6590. Epub 2014 Apr 14.

name: Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Reshma L. Mahtani, Sylvester Comprehensive Cancer Center, Miami, FL; Kathy S. Albain, Loyola University Chicago Stritch School of Medicine, Maywood, IL; Liang Fang, Glenn Michelson, Genentech, South San Francisco, CA; Howard A. Burris, Sarah Cannon Research Institute, Nashville, TN; Véronique Diéras, Institut Curie, Paris; Fabrice Andre, Institut Gustave Roussy, Villejuif, France; Nadia Harbeck, Interdisciplinary...

family: Miller

full_name: Kathy D. Miller

given: Kathy D.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

family: Andre

full_name: Fabrice Andre

given: Fabrice

family: Mahtani

full_name: Reshma L. Mahtani

given: Reshma L.

family: Gianni

full_name: Luca Gianni

given: Luca

family: Albain

full_name: Kathy S. Albain

given: Kathy S.

family: Crivellari

full_name: Diana Crivellari

given: Diana

family: Fang

full_name: Liang Fang

given: Liang

family: Michelson

full_name: Glenn Michelson

given: Glenn

family: de Haas

full_name: Sanne L. de Haas

given: Sanne L.

family: Burris

full_name: Howard A. Burris

given: Howard A.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase IIa Trial of Trastuzumab Emtansine With Pertuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive, Locally Advanced, or Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Germany
France
Belgium
Spain
Canada


title: Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up

summary:
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

ReferenceCitation: van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.

family: van Hoof

full_name: Marc van Hoof

given: Marc

family: Wigren

full_name: Stina Wigren

given: Stina

family: Ivarsson Blechert

full_name: Johan Ivarsson Blechert

given: Johan

family: Molin

full_name: Mattias Molin

given: Mattias

family: Andersson

full_name: Henrik Andersson

given: Henrik

family: Mateijsen

full_name: D. J. M. Mateijsen

given: D. J. M.

family: Bom

full_name: Steven J. H. Bom

given: Steven J. H.

family: Calmels

full_name: M. N. Calmels

given: M. N.

family: van der Rijt

full_name: Antoon J. M. van der Rijt

given: Antoon J. M.

family: Flynn

full_name: Mark C. Flynn

given: Mark C.

family: Tongeren

full_name: Joost van Tongeren

given: Joost van

family: Hof

full_name: Janny R. Hof

given: Janny R.

family: Brunings

full_name: Jan Wouter Brunings

given: Jan Wouter

family: Anteunis

full_name: Lucien J. C. Anteunis

given: Lucien J. C.

family: Marco Algarra

full_name: Jaime Marco Algarra

given: Jaime

family: Stokroos

full_name: Robert Jan Stokroos

given: Robert Jan

family: Joore

full_name: Manuela A. Joore

given: Manuela A.

journal_name: Frontiers in Neurology

license: cc-by

license_normalized: cc-by

title: A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

location_facility: Otorhinolaryngology, Hospital Clinico Universitario De Valencia


ReferenceCitation: Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

name: Centre de Recherche et Développement Pierre Fabre; Toulouse France

family: Bouroubi

full_name: Athmane Bouroubi

given: Athmane

family: Donazzolo

full_name: Yves Donazzolo

given: Yves

family: Donath

full_name: Franck Donath

given: Franck

name: Common Cold Centre; Cardiff University; Cardiff UK

family: Eccles

full_name: Ron Eccles

given: Ron

name: Hunter Pain Clinic; Newcastle New South Wales Australia

family: Russo

full_name: Marc Russo

given: Marc

family: Harambillet

full_name: Nadine Harambillet

given: Nadine

family: Gautier

full_name: Stéphanie Gautier

given: Stéphanie

family: Montagne

full_name: Agnès Montagne

given: Agnès

journal_name: International Journal of Clinical Practice

evidence: open (via free article)

lead_sponsor: Pierre Fabre Medicament

location_country:
Germany
Latvia
France
United Kingdom

acronym: IBUPROFEN LOZENGE IN ACUTE SORE THROAT PAIN

title: Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

summary: The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.


title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

ReferenceType: result

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.

family: Loebel

full_name: Antony Loebel

given: Antony

family: Cucchiaro

full_name: Josephine Cucchiaro

given: Josephine

family: Silva

full_name: Robert Silva

given: Robert

family: Kroger

full_name: Hans Kroger

given: Hans

family: Hsu

full_name: Jay Hsu

given: Jay

family: Sarma

full_name: Kaushik Sarma

given: Kaushik

family: Sachs

full_name: Gary Sachs

given: Gary

journal_name: American Journal of Psychiatry

publisher: American Psychiatric Association Publishing

title: Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

ReferenceCitation: Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.

family: Raison

full_name: Charles L. Raison

given: Charles L.

family: Pikalov

full_name: Andrei Pikalov

given: Andrei

family: Siu

full_name: Cynthia Siu

given: Cynthia

family: Tsai

full_name: Joyce Tsai

given: Joyce

family: Koblan

full_name: Kenneth Koblan

given: Kenneth

journal_name: Brain, Behavior, and Immunity

evidence: open (via crossref license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.

family: Sajatovic

full_name: Martha Sajatovic

given: Martha

family: Forester

full_name: Brent P. Forester

given: Brent P.

ReferenceCitation: Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.

ReferenceCitation: Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.

ReferenceCitation: Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.

ReferenceCitation: McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

title: Lurasidone in the Treatment of Bipolar Depression With Mixed (Subsyndromal Hypomanic) Features

location_country:
South Africa
India
France
Romania
Russian Federation
United States
Czech Republic
Ukraine

location_facility: Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

location_facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Florida Clinical Research Center, LLC,3914 State Road 64 East

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Excell Research, Inc,3998 Vista Way,Suite 100

location_facility: Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230

location_facility: Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209

location_facility: Depression and Anxiety Disorders Research Institute

location_facility: Mental Illness Treatment Rehabilitationi Foundation

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

location_facility: FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200

location_facility: California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Seth K M School of P G Medicine & Research

location_facility: Chair of Psychiatry and Medical Psychology

location_facility: CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I

location_facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Sheppard Pratt Health System,6501 North Charles Street

location_facility: American Medical Research Inc.,1200 Harger Road Suite 415

location_facility: Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103

location_facility: University of California at Irvine Medical Center


title: A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.

family: Xu

full_name: Jane Xu

given: Jane

family: Calabrese

full_name: Joseph R. Calabrese

given: Joseph R.

publisher_dissemination: American Psychiatric Association Publishing

title: Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression

family: Rajagopalan

full_name: Krithika Rajagopalan

given: Krithika

family: Bacci

full_name: Elizabeth Dansie Bacci

given: Elizabeth Dansie

family: Ng-Mak

full_name: Daisy Ng-Mak

given: Daisy

family: Wyrwich

full_name: Kathy Wyrwich

given: Kathy

title: Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials

title: Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis

location_country:
United States
South Africa
India
France
Poland
Romania
Russian Federation
Germany
Czech Republic
Ukraine

location_facility: Midwest Clinical research Center, One Elizabeth Place, Suite G-3

location_facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209

location_facility: Capital Clinical Research,5515 Security Lane, Suite 525

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Lake Charles Clinical Trials LLC,700 Spring Forest Road

location_facility: Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie

location_facility: FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric

location_facility: Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125

location_facility: Mental Illness Treatment Rehabilitation Foundation (MITR)

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog

location_facility: Depression and Anxiety Disorders Research Institue

location_facility: CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1

location_facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

location_facility: Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy

location_facility: Moscow Medical Academy named I.M. Sechenov

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street

location_facility: American Medical Research, Inc., 1200 Harger Road Suite 415


title: European Multicenter Study Using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to Treat Chronic AF

acronym: HISTORIC-AF

summary:
Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining surgical endoscopic and transcatheter techniques in a staged fashion provides superior clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting > 1 year but > 5 years.

The proposed procedure involves the creation of cardiac lesions with epicardially applied radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.

ReferenceCitation: Bisleri G, Curnis A, Bottio T, Mascioli G, Muneretto C. The need of a hybrid approach for the treatment of atrial fibrillation. Heart Surg Forum. 2005;8(5):E326-30. Review.

ReferenceCitation: Muneretto C, Bisleri G, Rosati F, Krakor R, Giroletti L, Di Bacco L, Repossini A, Moltrasio M, Curnis A, Tondo C, Polvani G. European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):740-745. doi: 10.1093/ejcts/ezx162.

family: Muneretto

full_name: Claudio Muneretto

given: Claudio

family: Bisleri

full_name: Gianluigi Bisleri

given: Gianluigi

family: Rosati

full_name: Fabrizio Rosati

given: Fabrizio

family: Krakor

full_name: Ralf Krakor

given: Ralf

family: Giroletti

full_name: Laura Giroletti

given: Laura

family: Di Bacco

full_name: Lorenzo Di Bacco

given: Lorenzo

family: Repossini

full_name: Alberto Repossini

given: Alberto

family: Moltrasio

full_name: Massimo Moltrasio

given: Massimo

family: Curnis

full_name: Antonio Curnis

given: Antonio

family: Tondo

full_name: Claudio Tondo

family: Polvani

full_name: Gianluca Polvani

given: Gianluca

journal_name: European Journal of Cardio-Thoracic Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial†

lead_sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_country:
Italy
France
Poland
Germany
United Kingdom

location_facility:
Heart Center Brandenburg- Immanuel
Univ.Hosp. Molinette
Univ. Hosp. Spedali Civili
Louis Pradel Hospital
Royal Brompton
University Hospital
Hammersmith Hospital
Hamburg Uke
Stadtische Kliniken
Ospedale Gavazzeni


title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

acronym: ARTFORCE

summary:
This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

status: Active, not recruiting

ReferenceCitation: Heukelom J, Hamming O, Bartelink H, Hoebers F, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.

family: Heukelom

full_name: Jolien Heukelom

given: Jolien

family: Hamming

full_name: Olga Hamming

given: Olga

family: Bartelink

full_name: Harry Bartelink

given: Harry

family: Hoebers

full_name: Frank Hoebers

given: Frank

family: Giralt

full_name: Jordi Giralt

given: Jordi

family: Herlestam

full_name: Teresa Herlestam

given: Teresa

family: Verheij

full_name: Marcel Verheij

given: Marcel

family: Brekel

full_name: Michiel van den Brekel

given: Michiel van den

family: Vogel

full_name: Wouter Vogel

given: Wouter

family: Slevin

full_name: Nick Slevin

given: Nick

family: Deutsch

full_name: Eric Deutsch

given: Eric

family: Sonke

full_name: Jan-Jakob Sonke

given: Jan-Jakob

family: Lambin

full_name: Philippe Lambin

given: Philippe

family: Rasch

full_name: Coen Rasch

given: Coen

currency_apc_doaj: GBP

journal_name: BMC Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: The Netherlands Cancer Institute

location_country:
Sweden
Netherlands
France
Spain
United Kingdom

location_facility:
Christie Hospital NHS Trust
Gustave Roussy Cancer Institute
Netherlands Cancer Institute
Erasmus Medical Centre
University Hospital Vall d'Hebron
Karolinska Institute
Universitair Medisch Centrum Groningen
University Medical Centre Utrecht
Maastro Clinic

intervention_type: Radiation

status_simplified: Ongoing


title: International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

acronym: STARS

summary: Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

status: Terminated

ReferenceCitation: Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.

name: Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea

family: Park

full_name: Samina Park

given: Samina

name: Department of Radiation Oncology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea

family: Kim

full_name: Hak Jae Kim

given: Hak Jae

full_name: In Kyu Park

given: In Kyu

full_name: Young Tae Kim

given: Young Tae

family: Kang

full_name: Chang Hyun Kang

given: Chang Hyun

ReferenceCitation: Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum in: Lancet Oncol. 2015 Sep;16(9):e427.

family: Chang

full_name: Joe Y Chang

given: Joe Y

family: Senan

full_name: Suresh Senan

given: Suresh

family: Paul

full_name: Marinus A Paul

given: Marinus A

family: Mehran

full_name: Reza J Mehran

given: Reza J

family: Louie

full_name: Alexander V Louie

given: Alexander V

family: Balter

full_name: Peter Balter

given: Peter

family: Groen

full_name: Harry J M Groen

given: Harry J M

family: McRae

full_name: Stephen E McRae

given: Stephen E

family: Widder

full_name: Joachim Widder

given: Joachim

family: Feng

full_name: Lei Feng

given: Lei

family: van den Borne

full_name: Ben E E M van den Borne

given: Ben E E M

family: Munsell

full_name: Mark F Munsell

given: Mark F

family: Hurkmans

full_name: Coen Hurkmans

family: Berry

full_name: Donald A Berry

given: Donald A

family: van Werkhoven

full_name: Erik van Werkhoven

given: Erik

family: Kresl

full_name: John J Kresl

given: John J

location_facility: CyberKnife Center of WanFang Medical Hospital


title: Efficacy of Oral Alitretinoin Treatment in Patients With Palmo-plantar Pustulosis (PPP) Inadequately Responding to Standard Topical Treatment

summary: The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.

ipd_sharing: Yes

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

lead_sponsor: Stiefel, a GSK Company

location_country:
Germany
United Kingdom
France
Netherlands


title: A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterferon Alpha-2a + Ribavirin + Placebo

summary: The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.

ReferenceCitation: Ciancio A, Andreone P, Kaiser S, Mangia A, Milella M, Solà R, Pol S, Tsianos E, De Rosa A, Camerini R, McBeath R, Rizzetto M. Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role? J Viral Hepat. 2012 Jan;19 Suppl 1:52-9. doi: 10.1111/j.1365-2893.2011.01524.x.

family: Ciancio

full_name: A. Ciancio

given: A.

family: Andreone

full_name: P. Andreone

given: P.

family: Kaiser

full_name: S. Kaiser

given: S.

family: Mangia

full_name: A. Mangia

family: Milella

full_name: M. Milella

given: M.

family: Solà

full_name: R. Solà

given: R.

family: Pol

full_name: S. Pol

family: Tsianos

full_name: E. Tsianos

given: E.

family: De Rosa

full_name: A. De Rosa

family: Camerini

full_name: R. Camerini

family: McBeath

full_name: R. McBeath

family: Rizzetto

full_name: M. Rizzetto

journal_name: Journal of Viral Hepatitis

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Italy France Greece Spain Germany

location_facility: Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista


title: Performance of Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for the Non-invasive Staging of Liver Fibrosis in Patients With Chronic Hepatitis C

summary: This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.

primary_purpose: Diagnostic

lead_sponsor: Johann Wolfgang Goethe University Hospital

location_country: Germany France Netherlands

location_facility: Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern

intervention_type: Device


title: A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

acronym: PEARLII

summary: This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

ReferenceCitation: Donnez J, Tomaszewski J, Vázquez F, Bouchard P, Lemieszczuk B, Baró F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.

family: Donnez

full_name: Jacques Donnez

given: Jacques

family: Tomaszewski

full_name: Janusz Tomaszewski

given: Janusz

family: Vázquez

full_name: Francisco Vázquez

given: Francisco

family: Bouchard

full_name: Philippe Bouchard

given: Philippe

family: Lemieszczuk

full_name: Boguslav Lemieszczuk

given: Boguslav

family: Baró

full_name: Francesco Baró

given: Francesco

family: Nouri

full_name: Kazem Nouri

given: Kazem

family: Selvaggi

full_name: Luigi Selvaggi

given: Luigi

family: Sodowski

full_name: Krzysztof Sodowski

given: Krzysztof

family: Bestel

full_name: Elke Bestel

given: Elke

family: Terrill

full_name: Paul Terrill

given: Paul

family: Osterloh

full_name: Ian Osterloh

given: Ian

family: Loumaye

full_name: Ernest Loumaye

given: Ernest

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids

lead_sponsor: PregLem SA

location_country: Italy Austria Netherlands France Poland Israel Belgium Spain Germany

location_facility: Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii

location_facility: Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Hadassah University Hospital, Mount Scopus

location_facility: Hopital Erasme, Department of Obstetrics and Gynecology,

location_facility: Rabin Medical Center, Helen Schneider Hospital for Women

location_facility: Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari

location_facility: Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe

location_facility: Soroka University Medical Center, Division of Obstetrics & Gynecology

location_facility: CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique

location_facility: Policlinico Universitario "Agostino Gemelli"

location_facility: Poliklinik fur Frauenheilkunde und Geburtshilfe

location_facility: Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia

location_facility: University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine

location_facility: Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari

location_facility: Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena

location_facility: Gabinet Lekarski Specjalistyczny "Sonus"

location_facility: Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology

location_facility: Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone

location_facility: Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,

location_facility: Universita di Padova-Dip scienze ginecologiche e della riproduzione umana


title: A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial

acronym: SOFT-EST

summary:
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.

PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

ipd_sharing: No

lead_sponsor: International Breast Cancer Study Group

location_country: Italy Peru Sweden Switzerland Spain France Hungary Portugal

location_facility: INEN (Instituto de Enfermedades Neoplasicas)

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: Clinica Oncologica, Policlinico Univeritario

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Other


ReferenceCitation: Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.

family: Jolles

full_name: Stephen Jolles

given: Stephen

family: Borte

full_name: Michael Borte

given: Michael

family: Nelson

full_name: Robert P. Nelson

given: Robert P.

suffix: Jr.

family: Rojavin

full_name: Mikhail Rojavin

given: Mikhail

family: Bexon

full_name: Martin Bexon

given: Martin

family: Lawo

full_name: John-Philip Lawo

given: John-Philip

family: Wasserman

full_name: Richard L. Wasserman

given: Richard L.

journal_name: Clinical Immunology

oa_colors: green hybrid

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repository_normalized: https

version: acceptedVersion

lead_sponsor: CSL Behring

location_country:
Sweden
Switzerland
France
Poland
Romania
Spain
Germany
United Kingdom

title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)

summary: This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.


title: A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.

summary: The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

lead_sponsor: DePuy International

location_country:
Germany
United Kingdom
France
Switzerland

location_facility: Robert Jones & Agnes Hunt Orthopaedic Hospital


title: Influence of Preoperative Hemodialysis or Intraoperative Modified Ultrafiltration on Postoperative Outcome for Patients With Severe Renal Dysfunction Undergoing Open Heart Surgery: Randomized, Controlled, Multicenter Clinical Trial

acronym: SeRenaD-CPB

summary: The purpose of this study is to determine whether preoperative hemodialysis or intraoperative modified ultrafiltration are effective for patients with non-dialysis dependent severe renal dysfunction undergoing open heart surgery.

ReferenceCitation: Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23. Review.

ReferenceCitation: Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. Review.

ReferenceCitation: Levin A, Foley RN. Cardiovascular disease in chronic renal insufficiency. Am J Kidney Dis. 2000 Dec;36(6 Suppl 3):S24-30. Review.

ReferenceCitation: Anderson RJ, O'brien M, MaWhinney S, VillaNueva CB, Moritz TE, Sethi GK, Henderson WG, Hammermeister KE, Grover FL, Shroyer AL. Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery. VA Cooperative Study #5. Kidney Int. 1999 Mar;55(3):1057-62.

ReferenceCitation: Cooper WA, O'Brien SM, Thourani VH, Guyton RA, Bridges CR, Szczech LA, Petersen R, Peterson ED. Impact of renal dysfunction on outcomes of coronary artery bypass surgery: results from the Society of Thoracic Surgeons National Adult Cardiac Database. Circulation. 2006 Feb 28;113(8):1063-70. Epub 2006 Feb 20.

ReferenceCitation: Zakeri R, Freemantle N, Barnett V, Lipkin GW, Bonser RS, Graham TR, Rooney SJ, Wilson IC, Cramb R, Keogh BE, Pagano D. Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting. Circulation. 2005 Aug 30;112(9 Suppl):I270-5.

ReferenceCitation: Weerasinghe A, Hornick P, Smith P, Taylor K, Ratnatunga C. Coronary artery bypass grafting in non-dialysis-dependent mild-to-moderate renal dysfunction. J Thorac Cardiovasc Surg. 2001 Jun;121(6):1083-9.

ReferenceCitation: Ibáñez J, Riera M, Saez de Ibarra JI, Carrillo A, Fernández R, Herrero J, Fiol M, Bonnin O. Effect of preoperative mild renal dysfunction on mortality and morbidity following valve cardiac surgery. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):748-52. Epub 2007 Sep 21.

ReferenceCitation: Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Carpentier A, Adams DH. Early and late outcomes of cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):90-5. Epub 2007 Nov 22.

ReferenceCitation: Devbhandari MP, Duncan AJ, Grayson AD, Fabri BM, Keenan DJ, Bridgewater B, Jones MT, Au J; North West Quality Improvement Programme in Cardiac Interventions. Effect of risk-adjusted, non-dialysis-dependent renal dysfunction on mortality and morbidity following coronary artery bypass surgery: a multi-centre study. Eur J Cardiothorac Surg. 2006 Jun;29(6):964-70. Epub 2006 May 3.

ReferenceCitation: Kilo J, Margreiter JE, Ruttmann E, Laufer G, Bonatti JO. Slightly elevated serum creatinine predicts renal failure requiring hemofiltration after cardiac surgery. Heart Surg Forum. 2005;8(1):E34-8.

ReferenceCitation: Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203.

ReferenceCitation: Shen I, Giacomuzzi C, Ungerleider RM. Current strategies for optimizing the use of cardiopulmonary bypass in neonates and infants. Ann Thorac Surg. 2003 Feb;75(2):S729-34.

ReferenceCitation: Naik SK, Knight A, Elliott MJ. A successful modification of ultrafiltration for cardiopulmonary bypass in children. Perfusion. 1991;6(1):41-50.

ReferenceCitation: Naik SK, Knight A, Elliott M. A prospective randomized study of a modified technique of ultrafiltration during pediatric open-heart surgery. Circulation. 1991 Nov;84(5 Suppl):III422-31.

ReferenceCitation: Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9.

ReferenceCitation: Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. Epub 2006 Oct 13. Review.

ReferenceCitation: Bogă M, Islamoğlu, Badak I, Cikirikçioğlu M, Bakalim T, Yağdi T, Büket S, Hamulu A. The effects of modified hemofiltration on inflammatory mediators and cardiac performance in coronary artery bypass grafting. Perfusion. 2000 Mar;15(2):143-50.

ReferenceCitation: Capuano F, Bianchini R, Goracci M, Roscitano A, Luciani R, Simon C, Giusti L, Sinatra R. Intraoperative veno-arterial hemofiltration during miniaturized extracorporeal bypass. Ann Thorac Surg. 2007 Jun;83(6):2215-6.

ReferenceCitation: Durmaz I, Yagdi T, Calkavur T, Mahmudov R, Apaydin AZ, Posacioglu H, Atay Y, Engin C. Prophylactic dialysis in patients with renal dysfunction undergoing on-pump coronary artery bypass surgery. Ann Thorac Surg. 2003 Mar;75(3):859-64.

ReferenceCitation: Bingol H, Akay HT, Iyem H, Bolcal C, Oz K, Sirin G, Demirkilic U, Tatar H. Prophylactic dialysis in elderly patients undergoing coronary bypass surgery. Ther Apher Dial. 2007 Feb;11(1):30-5.

ReferenceCitation: Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

lead_sponsor: University Hospital, Geneva

location_country: Switzerland France Spain Turkey Germany

location_facility: University of Lyon, Hopital Cardiothoracique Louis Pradel

location_facility: Hospital Clinico, University of Barcelona, Department of Cardiovascular Surgery

location_facility: University Hospital of Geneva, Service for Cardiovascular Surgery

location_facility: Pamukkale University, Department of Cardiovascular Surgery

location_facility: Gaziantep University, Department of Cardiovascular Surgery

location_facility: Ankara University, Department of Cardiovascular Surgery

intervention_type: Procedure


title: A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, MultiCentre Study of Colesevelam as Add-on Therapy in Patients With Familial Hypercholesterolaemia

summary: This study is designed to assess whether colesevelam given as third line treatment added to a maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Sweden
Netherlands
France
Germany
United Kingdom

location_facility: Department of Medicine, University of Manchester

location_facility: Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires


ReferenceCitation: Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, Belohradsky BH, Wahn V, Neufang-Hüber J, Zenker O, Grimbacher B. Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011 Oct;141(1):90-102. doi: 10.1016/j.clim.2011.06.002. Epub 2011 Jun 12.

full_name: S. Jolles

given: S.

family: Bernatowska

full_name: E. Bernatowska

given: E.

family: de Gracia

full_name: J. de Gracia

given: J.

full_name: M. Borte

given: M.

family: Cristea

full_name: V. Cristea

given: V.

family: Peter

full_name: H.H. Peter

family: Belohradsky

full_name: B.H. Belohradsky

family: Wahn

full_name: V. Wahn

family: Neufang-Hüber

full_name: J. Neufang-Hüber

family: Zenker

full_name: O. Zenker

given: O.

family: Grimbacher

full_name: B. Grimbacher

given: B.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy

ReferenceCitation: Borte M, Pac M, Serban M, Gonzalez-Quevedo T, Grimbacher B, Jolles S, Zenker O, Neufang-Hueber J, Belohradsky B. Efficacy and safety of hizentra®, a new 20% immunoglobulin preparation for subcutaneous administration, in pediatric patients with primary immunodeficiency. J Clin Immunol. 2011 Oct;31(5):752-61. doi: 10.1007/s10875-011-9557-z. Epub 2011 Jun 15.

family: Pac

full_name: Malgorzata Pac

given: Malgorzata

family: Serban

full_name: Margit Serban

given: Margit

family: Gonzalez-Quevedo

full_name: Teresa Gonzalez-Quevedo

given: Teresa

full_name: Bodo Grimbacher

given: Bodo

full_name: Othmar Zenker

given: Othmar

family: Neufang-Hueber

full_name: Jutta Neufang-Hueber

given: Jutta

full_name: Bernd Belohradsky

given: Bernd

journal_name: Journal of Clinical Immunology

title: Efficacy and Safety of Hizentra®, a New 20% Immunoglobulin Preparation for Subcutaneous Administration, in Pediatric Patients with Primary Immunodeficiency

location_country:
Italy
Sweden
Switzerland
France
Poland
Romania
Spain
Germany
United Kingdom

title: A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

summary: The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).


title: A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

acronym: MusiQoL

summary:
This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667

ReferenceCitation: Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.

family: Baumstarck

full_name: K. Baumstarck

given: K.

family: Pelletier

full_name: J. Pelletier

family: Boucekine

full_name: M. Boucekine

family: Auquier

full_name: P. Auquier

given: P.

journal_name: Revue Neurologique

title: Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: A 2-year longitudinal study

ReferenceCitation: Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.

full_name: Mohamed Boucekine

given: Mohamed

family: Loundou

full_name: Anderson Loundou

given: Anderson

full_name: Karine Baumstarck

given: Karine

family: Minaya-Flores

full_name: Patricia Minaya-Flores

given: Patricia

full_name: Jean Pelletier

given: Jean

family: Ghattas

full_name: Badih Ghattas

given: Badih

full_name: Pascal Auquier

given: Pascal

journal_name: BMC Medical Research Methodology

lead_sponsor: EMD Serono

location_country:
Italy
Austria
Germany
France
Israel
Norway
Argentina
Australia
Spain
Turkey
United States
United Kingdom

location_facility:
Reseach site
Reseach Site
Research Site


title: Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

summary:
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

lead_sponsor: Sandoz

location_country:
Austria
India
France
Czechia
Bulgaria
Poland
Slovakia
Romania
Russian Federation
Germany

location_facility: St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

location_facility: Sozialmedizinisches Zentrum Ost Donauspital

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"

location_facility: Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

location_facility: State Healthcare Institution "Kemerova Regional Clinical Hospital"

location_facility: KfH Kuratorium für dialyse und Nierentransplantation e.V.

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: State Healthcare Institution "Reoublic Hospital named after VA Baranov"

location_facility: Municipal medical Institution "City Hospital #1"

location_facility: KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

location_facility: Pulse Diagnostix Cardiac and Medical Center

location_facility: State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"

location_facility: Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"

location_facility: State Health Care Institution City Clinical Hospital named after SP Botkin

location_facility: Municipal Healthcare Institution "City Clinical Hospital #2"

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Klinik für Nephrologie und Allgemeine Innere Medizin

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

location_facility: Schwerpunktpraxis für Diabetologie und Nephrologie

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"

location_facility: State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav

location_facility: Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

location_facility: Gemeinschaftspraxis Dr. Steffen & Dr. Perino

location_facility: Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych

location_facility: CHU de Rouen - Hopital de Bois Guillaume

location_facility: Studienzentrum Hämatologie / Onkologie / Diabetes

location_facility: Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

location_facility: Nephrologisches Zentrum an Stadtkrankenhaus

location_facility: State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

location_facility: State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

location_facility: State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"

location_facility: Russian University of Peoples Frienship (clinical base: City clinical hospital #53)

location_facility: State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"

location_facility: State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"

location_facility: Municipal Institution "City Clinical Hospital #40"

location_facility: Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

location_facility: Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner

location_facility: St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"

location_facility: Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl

location_facility: State Educational Institution of Higher Professional Education "Moscow State University of Medicine and dentistry of Federal Agency of health Care and Social Development", City Clinical Hospital #23

location_facility: Municipal healthcare Institution "City Clinical Hospital #2"

location_facility: Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Praxis Dr. Rose, Pohlmeier und Dr. Lammers

location_facility: Institutul National de DiabetNutritie si Boli Metabolice Paulescu


title: A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy

summary: This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

location_country:
Italy
Hong Kong
Netherlands
United Kingdom
Germany
France
Poland
Hungary
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
Czech Republic
Taiwan


lead_sponsor: Eisai Inc.

location_country:
United States
Chile
Netherlands
Germany
France
Argentina
Australia
Spain
Canada
United Kingdom

title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis

summary: The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.

family: Sengupta

full_name: Manjistha Sengupta

given: Manjistha

family: Cheema

full_name: Amrita Cheema

given: Amrita

family: Kaminski

full_name: Henry J. Kaminski

given: Henry J.

family: Kusner

full_name: Linda L. Kusner

given: Linda L.

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Serum Metabolomic Response of Myasthenia Gravis Patients to Chronic Prednisone Treatment

location_country:
Italy
United States
Former Serbia and Montenegro
India
Mexico
Netherlands
France
Israel
Russian Federation
Spain
Germany
United Kingdom
Canada
Ukraine


title: Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma

summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.

ReferenceCitation: Rubie H, Chisholm J, Defachelles AS, Morland B, Munzer C, Valteau-Couanet D, Mosseri V, Bergeron C, Weston C, Coze C, Auvrignon A, Djafari L, Hobson R, Baunin C, Dickinson F, Brisse H, McHugh K, Biassoni L, Giammarile F, Vassal G; Société Françaisedes Cancers de l'Enfant; United Kingdom Children Cancer Study Group-New Agents Group Study. Phase II study of temozolomide in relapsed or refractory high-risk neuroblastoma: a joint Société Française des Cancers de l'Enfant and United Kingdom Children Cancer Study Group-New Agents Group Study. J Clin Oncol. 2006 Nov 20;24(33):5259-64.

lead_sponsor: Children's Cancer and Leukaemia Group

location_country:
Ireland
France
United Kingdom

location_facility: Great Ormond Street Hospital for Children NHS Trust

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: Institute of Child Health at University of Bristol

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Royal Marsden NHS Foundation Trust - Surrey


title: Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery

summary: The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management

lead_sponsor: Codman & Shurtleff

location_country:
Germany
United Kingdom
France


title: A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

summary: This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

lead_sponsor: Pfizer

location_country:
Italy
United States
Brazil
Netherlands
Spain
Germany
France
Czechia
Poland
Norway
Belgium
Australia
Portugal
Canada
Korea, Republic of

location_facility: Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill

location_facility: Medical University of South Carolina, Department of Transplantation Surgery

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Asan Medical Center, Department of Surgery

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: California Pacific Medical Center - Pacific Campus

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

location_facility: Westmead Hospital, Department of Renal Medicine

location_facility: Department of Surgery, Yonsei University College of Medicine Severance Hospital

location_facility: Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu

location_facility: Investigational Drug Services (IDS) / UNC Healthcare

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore

location_facility: USCF Medical Center - Connie Frank Transplant Center

location_facility: UNC Department of Surgery/Abdominal Transplant Division

location_facility: CHRU de Nancy-Brabois - Service de Nephrologie

location_facility: UNC Department of Surgery, Clinical Trials Consortium

location_facility: Oslo universitetssykehus HF- Rikshospitalet

location_facility: Drexel University College of Medicine - Hahnemann University Hospital

location_facility: Hospitais da Universidade de Coimbra, EPE

location_facility: Central Northern Adelaide Renal and Transplantation Service

location_facility: Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao

location_facility: University of North Carolina, Department of Medicine/Nephrology


title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

acronym: ATAMS

summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

ReferenceCitation: Kappos L, Hartung HP, Freedman MS, Boyko A, Radü EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Freedman

full_name: Mark S Freedman

given: Mark S

family: Boyko

full_name: Alexey Boyko

given: Alexey

family: Radü

full_name: Ernst Wilhelm Radü

given: Ernst Wilhelm

family: Mikol

full_name: Daniel D Mikol

given: Daniel D

family: Lamarine

full_name: Marc Lamarine

given: Marc

family: Hyvert

full_name: Yann Hyvert

given: Yann

family: Freudensprung

full_name: Ulrich Freudensprung

given: Ulrich

family: Plitz

full_name: Thomas Plitz

given: Thomas

family: van Beek

full_name: Johan van Beek

given: Johan

journal_name: The Lancet Neurology

location_country:
Austria
United States
Sweden
Switzerland
Lebanon
Netherlands
Germany
United Kingdom
France
Lithuania
Australia
Belgium
Russian Federation
Spain
Canada
Czech Republic
Ukraine


title: MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood

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 tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.

ReferenceCitation: McDowell HP, Foot AB, Ellershaw C, Machin D, Giraud C, Bergeron C. Outcomes in paediatric metastatic rhabdomyosarcoma: results of The International Society of Paediatric Oncology (SIOP) study MMT-98. Eur J Cancer. 2010 Jun;46(9):1588-95. doi: 10.1016/j.ejca.2010.02.051. Epub 2010 Mar 24.

family: McDowell

full_name: Heather P. McDowell

given: Heather P.

family: Foot

full_name: Annabel B.M. Foot

given: Annabel B.M.

family: Ellershaw

full_name: Caroline Ellershaw

given: Caroline

family: Machin

full_name: David Machin

given: David

family: Giraud

full_name: Cécile Giraud

given: Cécile

family: Bergeron

full_name: Christophe Bergeron

given: Christophe

journal_name: European Journal of Cancer

title: Outcomes in paediatric metastatic rhabdomyosarcoma: Results of The International Society of Paediatric Oncology (SIOP) study MMT-98

lead_sponsor: Societe Internationale d'Oncologie Pediatrique

location_facility: Great Ormond Street Hospital for Children NHS Trust

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

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Meyerstein Institute of Oncology at University College of London Hospitals

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: Royal Belfast Hospital for Sick Children

location_facility: Royal Marsden NHS Foundation Trust - Surrey


title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Netherlands
Germany
France
Poland
Belgium
Argentina
Canada
United Kingdom

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins


title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

summary: Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.

ReferenceCitation: Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551. Erratum in: Crit Care Med. 2014 May;42(5):e390. multiple investigator names added.

family: Guntupalli

full_name: Kalpalatha Guntupalli

given: Kalpalatha

family: Dean

full_name: Nathan Dean

given: Nathan

family: Morris

full_name: Peter E. Morris

given: Peter E.

family: Bandi

full_name: Venkata Bandi

given: Venkata

family: Margolis

full_name: Benjamin Margolis

given: Benjamin

family: Rivers

full_name: Emanuel Rivers

given: Emanuel

family: Levy

full_name: Mitchell Levy

given: Mitchell

family: Lodato

full_name: Robert F. Lodato

given: Robert F.

family: Ismail

full_name: Preeti M. Ismail

given: Preeti M.

family: Reese

full_name: Amber Reese

given: Amber

family: Schaumberg

full_name: John P. Schaumberg

given: John P.

family: Malik

full_name: Rajesh Malik

given: Rajesh

family: Dellinger

full_name: R. Phillip Dellinger

given: R. Phillip

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: A Phase 2 Randomized, Double-Blind, Placebo–Controlled Study of the Safety and Efficacy of Talactoferrin in Patients With Severe Sepsis*

lead_sponsor: Agennix

location_country:
United States
France
Spain
Germany
Canada

location_facility: Wake Forest University Baptist Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The George Washington University Hospital

location_facility: University of Pittsburgh Medical Center Presbyterian Hospital

location_facility: Texas Tech University Health Sciences Center

location_facility: University of Oklahoma Health Science Center

location_facility: Floyd Memorial Hospital and Health Services


title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients With Advanced Solid Tumors

summary: Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.

lead_sponsor: PharmaMar

location_country:
United States
France
Spain

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: A Pan-European Prospective Interventional Cohort Study in Patients Hospitalized With Acute COPD Exacerbations With Longitudinal Follow-up

summary: The CATALINA study is a prospective interventional cohort study embedded within CICERO (Collaboration In COPD ExaceRbatiOns, a European Respiratory Society supported Clinical Research Collaboration), designed to collect standardised, longitudinal clinical data and biological samples in 20 pan-European centres.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Wim Janssens

location_country:
Italy
Sweden
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: University Medical Centre of Gießen & Marburg


title: Development and Internal Validation of a Clinical Nomogram to Diagnose Prostatic Inflammation in Men With Lower Urinary Tract Symptoms

acronym: PIN

summary:
Rationale: Histological inflammation of the prostate is a common finding in the results of the histopathological examinations after a prostate biopsy or a transurethral or open prostatectomy.

Several studies have investigated the role of prostatic inflammation in the development of prostatic enlargement and pathogenesis of Lower Urinary Tract Symptoms (LUTS). Therefore, prostatic inflammation could be a potential treatment target for men with LUTS.

Objective: The aim of the study is the development and the validation of a nomogram based on clinical parameters that could predict the presence of prostatic inflammation.

Study design: Non-interventional, multicentric, cross-sectional, observational prospective study.

Study population: Men, age ≥ 40 yrs, with LUTS who will undergo any prostatic surgery for BPH (Open, laparoscopic, robotic, transurethral resection/enucleation, laser prostatectomy) or TRUS-biopsy according to the standard clinical practice of the participating urologists

Intervention: All included males receive standard care for their symptoms according to the physician's practice. For this study, baseline demographic and clinical characteristics of the patients are recorded and correlated with the histological outcome.

Main study parameters/endpoints: Development and validation of the Prostatic Inflammation Nomogram

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional treatment or intervention related to the study is required.

Therefore no negative outcomes are expected as the standard treatment is unchanged. There is no additional burden for the patients.

status: Recruiting

ReferenceCitation: Nickel JC, Roehrborn CG, O'Leary MP, Bostwick DG, Somerville MC, Rittmaster RS. The relationship between prostate inflammation and lower urinary tract symptoms: examination of baseline data from the REDUCE trial. Eur Urol. 2008 Dec;54(6):1379-84. Epub 2007 Nov 20.

ReferenceCitation: Robert G, Descazeaud A, Nicolaïew N, Terry S, Sirab N, Vacherot F, Maillé P, Allory Y, de la Taille A. Inflammation in benign prostatic hyperplasia: a 282 patients' immunohistochemical analysis. Prostate. 2009 Dec 1;69(16):1774-80. doi: 10.1002/pros.21027.

ReferenceCitation: Irani J, Levillain P, Goujon JM, Bon D, Doré B, Aubert J. Inflammation in benign prostatic hyperplasia: correlation with prostate specific antigen value. J Urol. 1997 Apr;157(4):1301-3.

ReferenceCitation: Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. Epub 2005 Sep 12. Review. Erratum in: Circulation. 2005 Oct 25;112(17):e297. Circulation. 2005 Oct 25;112(17):e298.

ReferenceCitation: Iasonos A, Schrag D, Raj GV, Panageas KS. How to build and interpret a nomogram for cancer prognosis. J Clin Oncol. 2008 Mar 10;26(8):1364-70. doi: 10.1200/JCO.2007.12.9791. Review.

ipd_sharing: Undecided

ipd_sharing_description: Not yet decided when and what kind of IPD and supporting information will be available to researchers

lead_sponsor: Institute for Monitoring of Urogenital Diseases

location_country: Italy Spain Cyprus France Greece Portugal

location_facility: Dept of Urology, General Hospital of Larissa

location_facility: Dept of Urology, University Hospital of Florence

location_facility: Dept of Urology, University Hospital of Larissa


ReferenceCitation: Kowdley KV, Luketic V, Chapman R, Hirschfield GM, Poupon R, Schramm C, Vincent C, Rust C, Parés A, Mason A, Marschall HU, Shapiro D, Adorini L, Sciacca C, Beecher-Jones T, Böhm O, Pencek R, Jones D; Obeticholic Acid PBC Monotherapy Study Group. A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis. Hepatology. 2018 May;67(5):1890-1902. doi: 10.1002/hep.29569. Epub 2018 Jan 29.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Austria
Germany
France
Spain
United States
United Kingdom
Canada

location_facility: University Medical Centre Hamburg-Eppendorf

location_facility: Centre de Recherche du CHUM / University of Montreal

title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

summary: The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.


title: European Geriatric Emergency Departments Registry Study

acronym: EGERS

summary: Geriatric presentations to emergency services comprise a significant percentage of all emergency service presentations in Europe and it has been reported that 3-23% of all emergency service presentations from various regions of the countries. There are specific management practices for patients who are 65 years and older at emergency services. On the other hand several risk-scoring systems have been developed to define the severity class of the patient during their initial evaluation at emergency services.Only a few studies in the literature have evaluated risk-scoring systems for the geriatric patient group.Several studies have reported that risk-scoring systems, such as Identification of Seniors at Risk and Triage Risk Screening Tool, which are specifically developed for geriatric patients over 65 years who present to emergency services, are not sufficiently effective for evaluating patients in more severe conditions. Previously the TEDGeS (Turkish Emergency Departments Geriatric Scoring Study) pilot study was carried out and published by some of the investigators of this project.This pilot study enrolled all geriatric patients (age ≥ 65 years) and carried out in 13 centers from different cities of Turkey. This pilot study showed that geriatric patients not only constitute significant proportion of emergency department presentations but also these patients need more hospitalization. The predictive powers of the Modified Early Warning Score, Rapid Emergency Medicine Score and The Vital PAC Early Warning Score for hospitalization and mortality in geriatric patients those presented to emergency department are significantly high and might be concerned in the emergency department triage of these patients. Within the light of these pilot study results, the investigators have decided to execute this prospective, multinational, multicentric study with the main objective to determine the epidemiological and age related characteristics of geriatric patients presenting to the emergency department across Europe and evaluate early warning scoring systems systems regarding hospitalization, ICU admission and in-hospital mortality for geriatric patients.

ReferenceCitation: Dundar ZD, Ergin M, Karamercan MA, Ayranci K, Colak T, Tuncar A, Cander B, Gul M. Modified Early Warning Score and VitalPac Early Warning Score in geriatric patients admitted to emergency department. Eur J Emerg Med. 2016 Dec;23(6):406-412.

ReferenceCitation: Cei M, Bartolomei C, Mumoli N. In-hospital mortality and morbidity of elderly medical patients can be predicted at admission by the Modified Early Warning Score: a prospective study. Int J Clin Pract. 2009 Apr;63(4):591-5. doi: 10.1111/j.1742-1241.2008.01986.x. Epub 2009 Feb 11.

ReferenceCitation: Dundar ZD, Ayranci MK. Presenting symptoms of older emergency department patients: a single-center experience of 10,692 patients in Turkey. Acta Clin Belg. 2020 Dec;75(6):405-410. doi: 10.1080/17843286.2019.1655215. Epub 2019 Aug 12.

ReferenceCitation: Lamantia MA, Stewart PW, Platts-Mills TF, Biese KJ, Forbach C, Zamora E, McCall BK, Shofer FS, Cairns CB, Busby-Whitehead J, Kizer JS. Predictive value of initial triage vital signs for critically ill older adults. West J Emerg Med. 2013 Sep;14(5):453-60. doi: 10.5811/westjem.2013.5.13411.

ReferenceCitation: Buurman BM, van den Berg W, Korevaar JC, Milisen K, de Haan RJ, de Rooij SE. Risk for poor outcomes in older patients discharged from an emergency department: feasibility of four screening instruments. Eur J Emerg Med. 2011 Aug;18(4):215-20. doi: 10.1097/MEJ.0b013e328344597e.

ReferenceCitation: Pines JM, Mullins PM, Cooper JK, Feng LB, Roth KE. National trends in emergency department use, care patterns, and quality of care of older adults in the United States. J Am Geriatr Soc. 2013 Jan;61(1):12-7. doi: 10.1111/jgs.12072.

ReferenceCitation: Platts-Mills TF, Travers D, Biese K, McCall B, Kizer S, LaMantia M, Busby-Whitehead J, Cairns CB. Accuracy of the Emergency Severity Index triage instrument for identifying elder emergency department patients receiving an immediate life-saving intervention. Acad Emerg Med. 2010 Mar;17(3):238-43. doi: 10.1111/j.1553-2712.2010.00670.x.

ReferenceCitation: Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6.

ReferenceCitation: Wheeler I, Price C, Sitch A, Banda P, Kellett J, Nyirenda M, Rylance J. Early warning scores generated in developed healthcare settings are not sufficient at predicting early mortality in Blantyre, Malawi: a prospective cohort study. PLoS One. 2013;8(3):e59830. doi: 10.1371/journal.pone.0059830. Epub 2013 Mar 29. Erratum in: PLoS One. 2014;9(2):e91623.

lead_sponsor: Gazi University

location_country: Croatia France Greece Ireland Turkey Germany

location_facility: Necmettin Erbakan University Meram Medical Faculty


title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

summary: This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

ReferenceCitation: Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

name: Unit of Neurology Department of Medicine Florence Health Authority Firenze Italy

family: Zaccara

full_name: Gaetano Zaccara

given: Gaetano

family: Almas

full_name: Mary Almas

given: Mary

family: Pitman

full_name: Verne Pitman

given: Verne

family: Knapp

full_name: Lloyd Knapp

given: Lloyd

family: Posner

full_name: Holly Posner

given: Holly

journal_name: Epilepsia

title: Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: A randomized, double‐blind, noninferiority trial

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Peru
Greece
Belgium
Russian Federation
Taiwan
India
Costa Rica
France
Panama
Lithuania
Korea, Republic of
Colombia
Philippines
Bulgaria
Germany
Italy
Mexico
Czechia
Venezuela
Spain
Turkey


title: Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia

acronym: MEMORY

summary: This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

lead_sponsor: H. Lundbeck A/S

location_country: Italy France Poland Spain Estonia

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis

location_facility: Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: University Clinical Hospital of Valladolid

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala

location_facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk


title: Non-ischemic Preservation of the Donor Heart in Heart Transplantation - a Randomized, Controlled, Multicenter Trial

summary: The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

primary_purpose: Other

lead_sponsor: XVIVO Perfusion

location_country:
Italy
Sweden
France
Belgium
Spain
Germany
United Kingdom

location_facility: Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière