title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

acronym: CONCERT

summary: The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

lead_sponsor: Medivation, Inc.

sponsor_collaborators:
Medivation, Inc.
Pfizer

location_country:
Finland
Germany
Italy
New Zealand
United Kingdom
Australia
Sweden
Belgium
United States
France


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

summary: The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Addex Pharma S.A.

location_country:
Germany
Netherlands
Switzerland
United States
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

acronym: SUNRISE

summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Poland
Russian Federation
Portugal
Slovakia
Hungary
United Kingdom
Belgium
Spain
Greece
Czech Republic
Egypt
France


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

summary: Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

study_start_date_type: Actual

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. doi: 10.1093/annonc/mdx764.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Switzerland
United States
Lebanon
China
Peru
Egypt
Italy
Norway
Singapore
Venezuela
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
Russian Federation
Israel

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)

location_facility: University of Tennessee Cancer Institute SC-2

location_facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)

location_facility: University of Vermont Office of Clinical Trials Res.

location_facility: Blue Ridge Research Center at Roanoke Neurological Center SC

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD

location_facility: Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.

location_facility: Rush University Medical Center Div. of Hematology & Oncology

location_facility: Tulane University Health Sciences Center Office of Clinical Research

location_facility: University of Pittsburgh Medical Center SC-3

location_facility: Mayo Clinic - Rochester Dept. of MayoClinic-Rochester

location_facility: Dartmouth Hitchcock Medical Center Dartmouth

location_facility: University of Virginia Health Systems SC-2

location_facility: Denver Health & Hospital Authority CACZ885M2301

location_facility: Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care

location_facility: Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)

location_facility: Wake Forest University Baptist Medical Center Dept. of WFUHS

location_facility: Washington University School of Medicine Div. of Medical Oncology

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)

location_facility: Indiana University Hospital IU Cancer Center

location_facility: Baylor College of Medicine Dept.of Baylor College of Med.

location_facility: Cancer Centers of the Carolinas Cancer Centers of Carolinas (3

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp


title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone

acronym: REGAL

summary: The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

ReferenceCitation: Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: AstraZeneca

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


lead_sponsor: Solvay Pharmaceuticals

summary: The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

ReferenceCitation: Pang PS, Mehra M, Maggioni AP, Filippatos G, Middlebrooks J, Turlapaty P, Kazei D, Gheorghiade M; RENO-DEFEND Investigators. Rationale, design, and results from RENO-DEFEND 1: a randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure. Am Heart J. 2011 Jun;161(6):1012-23.e3. doi: 10.1016/j.ahj.2011.03.004.

status: Terminated

title: A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized With Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)

type: Other Grant/Funding Number

source: euctr

location_country:
Germany
Italy
Poland
Denmark
Romania
United States
Chile
Canada
Ukraine
Russian Federation
France

status_simplified: Unknown


summary: This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.

ReferenceCitation: Chari A, Cho HJ, Dhadwal A, Morgan G, La L, Zarychta K, Catamero D, Florendo E, Stevens N, Verina D, Chan E, Leshchenko V, Lagana A, Perumal D, Mei AH, Tung K, Fukui J, Jagannath S, Parekh S. A phase 2 study of panobinostat with lenalidomide and weekly dexamethasone in myeloma. Blood Adv. 2017 Aug 21;1(19):1575-1583. doi: 10.1182/bloodadvances.2017007427. eCollection 2017 Aug 22.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Harrison SJ, Hsu AK, Neeson P, Younes A, Sureda A, Engert A, Prince HM, Li M, Savage P, Bugarini R, Williams D, Squier M, Ritchie DS. Early thymus and activation-regulated chemokine (TARC) reduction and response following panobinostat treatment in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant. Leuk Lymphoma. 2014 May;55(5):1053-60. doi: 10.3109/10428194.2013.820287. Epub 2013 Aug 5.

oa_host_type: closed

publisher_dissemination: Informa

location_facility: Karmanos Cancer Institute Div.of Hematology/Oncology

location_facility: Rush University Medical Center Divisionof Hem/Onc Research(2)

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(5)

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(2)

location_facility: The Methodist Hospital Cell & Gene Therapy Clinic

location_facility: University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3)

location_facility: Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: Dana Farber Cancer Institute Hematology / Oncology

location_facility: West Virginia University/ Mary Babb Randolph Cancer Center

location_facility: Georgia Regents University Cancer Clinical Research Unit

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

title: A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkins Lymphoma After High-dose Chemotherapy With Autologous Stem Cell Transplant

location_country:
Germany
Italy
New Zealand
Israel
Singapore
United Kingdom
Australia
Brazil
Belgium
United States
Spain
Malaysia
France


title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

summary: The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.

ReferenceCitation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

oa_host_type: repository

repository_institution: Aberdeen University - Aberdeen University Research Archive

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

repositories_concat: PubMed Central;aura.abdn.ac.uk

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Denmark
United States
Canada
France


title: Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

acronym: SIRFLOX

summary:
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

ReferenceType: result

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories_concat: irua

ReferenceCitation: Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

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

version: submittedVersion

repository_institution: University of Cambridge - Apollo

repositories_concat: University of Melbourne - Minerva Access;ora.ox.ac.uk;www.repository.cam.ac.uk

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

oa_colors: green hybrid

license: cc-by

license_normalized: cc-by

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access;archive.ugent.be;irua;ora.ox.ac.uk;orca.cardiff.ac.uk

ReferenceCitation: Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

ReferenceCitation: Gibbs P, Gebski V, Van Buskirk M, Thurston K, Cade DN, Van Hazel GA; SIRFLOX Study Group. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study. BMC Cancer. 2014 Dec 1;14:897. doi: 10.1186/1471-2407-14-897.

repository_institution: Monash University - Monash University Research Portal

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;archive.ugent.be;monash.edu

location_country:
Germany
Italy
Poland
New Zealand
Israel
Australia
Switzerland
Belgium
United States
Spain
France

location_facility: Centre Hospitalier General de Longjumeau

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Braxiskooperation Bonn, Fachartze fur Innere Medizin

location_facility: Hospitalier Universitaire de Grenoble C.H.U.

location_facility: Gemeinschaftspraxis Hamatologie und internistische Onkologie

location_facility: Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin

location_facility: Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik

location_facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

location_facility: Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie

location_facility: Praxis fur Hamatologie und Internnistische Onkologie

location_facility: Imelda Ziekenhuis GI Clinical Research Centre

location_facility: OL Vrouw Ziekenhuis Aalst Gastro-Enterologie

location_facility: VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel

location_facility: Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Schwerpunktspraxis fur Hamatologie und Internistische Onkologie

location_facility: Florida International University College of Medicine Practice

location_facility: Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl

location_facility: Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr

location_facility: Institut Jules Bordet - Centre de Tumeurs d'ULB

location_facility: Hospital de Navarra, Servicio de Ongoligia, Planta Baja

location_facility: Schwerpunktpraxis fur Hamatologie und Onkologie


title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822

summary: This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Slovakia
Hungary
Argentina
Hong Kong
Australia
Brazil
Israel
Austria
Mexico
Singapore
Switzerland
Thailand
Bulgaria
Canada
France


title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

ReferenceCitation: Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.

publisher_dissemination: American Diabetes Association

location_country:
Finland
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Canada
France
Denmark
Switzerland
United States
Ukraine
Peru
Puerto Rico
Italy
Guatemala
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel


title: Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study

summary:
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML.

The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Stone RM, Mazzola E, Neuberg D, Allen SL, Pigneux A, Stuart RK, Wetzler M, Rizzieri D, Erba HP, Damon L, Jang JH, Tallman MS, Warzocha K, Masszi T, Sekeres MA, Egyed M, Horst HA, Selleslag D, Solomon SR, Venugopal P, Lundberg AS, Powell B. Phase III open-label randomized study of cytarabine in combination with amonafide L-malate or daunorubicin as induction therapy for patients with secondary acute myeloid leukemia. J Clin Oncol. 2015 Apr 10;33(11):1252-7. doi: 10.1200/JCO.2014.57.0952. Epub 2015 Mar 2.

ReferenceCitation: Lindsley RC, Mar BG, Mazzola E, Grauman PV, Shareef S, Allen SL, Pigneux A, Wetzler M, Stuart RK, Erba HP, Damon LE, Powell BL, Lindeman N, Steensma DP, Wadleigh M, DeAngelo DJ, Neuberg D, Stone RM, Ebert BL. Acute myeloid leukemia ontogeny is defined by distinct somatic mutations. Blood. 2015 Feb 26;125(9):1367-76. doi: 10.1182/blood-2014-11-610543. Epub 2014 Dec 30.

lead_sponsor: Antisoma Research

location_country:
Germany
Poland
Argentina
Australia
Chile
Canada
France
Czech Republic
Hungary
United States
Ukraine
Romania
Belgium
Estonia
Italy
Ecuador
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: State Medical Institution Sverdlovsk Regional Clinical Hospital #1

location_facility: National Taiwan University Hospital (NTUH)

location_facility: State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development

location_facility: State Higher Educational Instution Rostov State

location_facility: State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'

location_facility: Teaching Hospital of the Medical University in Bialystok

location_facility: Sibiu County Clinical Hospital, Internal Clinic II

location_facility: Janusz Korczak Provincial Specialist Hospital

location_facility: Nicolaus Copernicus Provincial Specialist Hospital in Lodz

location_facility: Chang Gung Memorial Hospital Kao Hsiung Branch

location_facility: Chinese Medical University Hospital (CMUH)

location_facility: Institute of Haematology and Blood Transfusion Prague

location_facility: State Medical Institution Republican Hospital n.a. V.A. Baranov

location_facility: State Medical Institution Irkutsk Regional Clinical Hospital

location_facility: Northshore Hospital - Monter Cancer Center

location_facility: Brasov County Emergency Clinical Hospital

location_facility: State Medical Institution Territorial Clinical Hospital #1

location_facility: University Hospital Kralovske Vinohrady Prague

location_facility: O.F. Herbachevsky Zhytomyr Regional Clinical Hospital

location_facility: Univ of Southern California Comprehensive Cancer Center

location_facility: University of Colorado Health Sciences Center

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Poznan Stare Miasto Health Care Facility

location_facility: Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: State Medical Institution Territorial Clinical Oncological Center

location_facility: Colentina Clinical Hospital, Internal Medicine Department

location_facility: Public Institution 'Cherkasy Regional Oncology Center'

location_facility: Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department

location_facility: National Cheng Kung University Hospital (NCKUH)

location_facility: Moscow State Medical Institution Municipal

location_facility: Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

location_facility: Independent Public University Hospital No. 1 in Wroclaw

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Hospital General de Agudos "Dr. Teodoro Alvarez"

location_facility: Ivano-Frankivsk State Medical University

location_facility: Dnipropetrovsk City General Clinical Hospital #4

location_facility: Institute of Hematology and Transfusiology

location_facility: Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó

location_facility: Northwestern University School of Medicine

location_facility: Veterans General Hospital Taipei (VGH-TP)

location_facility: State Medical Institution Leningrad Regional Clinical Hospital

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk

location_facility: Municipal Medical Institution Municipal Hospital #1

location_facility: Markische Kliniken GmbH Klinikim Ludenscheid


title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

acronym: EXAM

summary:
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

ReferenceCitation: Schlumberger M, Elisei R, Muller S, Schoffski P, Brose M, Shah M, Licitra L, Krajewska J, Kreissl MC, Niederle B, Cohen EEW, Wirth L, Ali H, Clary DO, Yaron Y, Mangeshkar M, Ball D, Nelkin B, Sherman S. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017 Nov 1;28(11):2813-2819. doi: 10.1093/annonc/mdx479.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: California Digital Library - eScholarship

repositories_concat: LIRIAS (KU Leuven);PubMed Central;arpi.unipi.it;escholarship.org

ReferenceCitation: Elisei R, Schlumberger MJ, Muller SP, Schoffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3. Erratum In: J Clin Oncol. 2014 Jun 10;32(17):1864.

lead_sponsor: Exelixis

location_country:
Germany
Poland
Brazil
Chile
Canada
France
Portugal
Denmark
Switzerland
United States
India
Belgium
Peru
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Russian Federation
Israel

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: Ohio State University, James Cancer Hospital

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Center

location_facility: Netaji Subhash Chandra Bose Cancer Hospital Research Institute

location_facility: SEAROC Cancer Institute, S.K. Soni Hospital

location_facility: Washington University School of Medicine

location_facility: Hospital of the University of Pennsylvania

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen

location_facility: University of Arkansas for Medical Sciences

location_facility: Capitol Comprehensive Cancer Care Clinic and Research Institute

location_facility: Vermont Cancer Center at Fletcher Allen Health Care

location_facility: TGEN Clinical Research Service at Scottsdale Healthcare

location_facility: H. Lee Moffet Cancer Center and Research Institute

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen


lead_sponsor: Eli Lilly and Company

summary: LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).

ReferenceCitation: Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.

publisher_dissemination: Springer-Nature

ReferenceCitation: Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.

ReferenceCitation: Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: Springer

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

title: Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study

type: Other Identifier

location_country:
Finland
Germany
Italy
Portugal
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
France


acronym: EXPAND

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary:
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).

Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

location_facility:
Research site
Research Site

title: Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
France
Czech Republic
Portugal
Hungary
Hong Kong
Romania
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

summary: This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

ReferenceCitation: Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31. Erratum In: Drugs Aging. 2021 Apr 23;:

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29. Erratum In: Ann Oncol. 2018 Apr 1;29(4):1076.

lead_sponsor: Bausch Health Americas, Inc.

sponsor_collaborators:
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Brazil
Sweden
Mexico
Belgium
United States
Spain
Canada
France

location_facility:
Salix Investigational Site
Pfizer Investigational Site


summary: This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

sponsor_collaborators:
Novartis Pharmaceuticals
XOMA (US) LLC

location_facility: St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

location_facility: Wake Forest University Baptist Medical Center Dept. of Industry Research (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

title: A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Hong Kong
Singapore
Australia
Belgium
United States
Korea, Republic of
Canada
France


acronym: ASTER

summary: The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period

title: Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

location_country:
Germany
United Kingdom
Romania
Switzerland
Belgium
Czech Republic
France


acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

lead_sponsor: Boehringer Ingelheim

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.

location_facility: 1184.14.3301A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01011 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01021 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01012 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35802 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01009 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37102 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37201 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01017 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01013 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01022 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3304A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01020 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3302A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01018 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.43001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01015 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37202 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01014 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.42103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35801 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01019 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.39001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37101 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303B Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303C Boehringer Ingelheim Investigational Site

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

ipd_sharing_description:
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

location_country:
Finland
Germany
Italy
Lithuania
Slovakia
Hungary
Denmark
Sweden
Netherlands
Austria
Belgium
United States
Korea, Republic of
Latvia
Greece
Canada
Estonia
France

ipd_sharing: Yes


title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults

summary: To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

location_country:
Germany
Finland
Italy
India
Norway
United Kingdom
Netherlands
Belgium
United States
France


title: Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

acronym: VITAL

summary: The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

ReferenceCitation: Kovanda LL, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate P, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study). Antimicrob Agents Chemother. 2016 Jul 22;60(8):4568-76. doi: 10.1128/AAC.00514-16. Print 2016 Aug.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Thompson GR 3rd, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, Ostrosky-Zeichner L, Azie N, Maher R, Lee M, Kovanda L, Engelhardt M, Vazquez JA, Cornely OA, Perfect JR. Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses. Clin Infect Dis. 2016 Aug 1;63(3):356-62. doi: 10.1093/cid/ciw305. Epub 2016 May 11.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

repositories_institution: California Digital Library - eScholarship

publisher_dissemination: Oxford University Press

ReferenceCitation: Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Racil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

sponsor_collaborators:
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Chile
Canada
France
United States
India
Lebanon
Belgium
Egypt
Mexico
Korea, Republic of
South Africa
Russian Federation
Israel

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Wayne State University School of Medicine

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: Upstate Infectious Diseases Association LLP

location_facility: Fred Hutchinson Cancer Research Center, Clinical Research

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

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: American University of Beirut Medical Center

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

location_facility: University Of Colorado Health Sciences Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Republican Hospital named after V.A. Baranov

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: University of California Davis Health System

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: University of California at San Francisco

location_facility: Hospital Central Dr Ignacio Morones Prieto

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Tata Memorial Hopital, Department of Anesthesia


title: A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.

summary: The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

lead_sponsor: European Lung Cancer Working Party

location_country: Spain Greece Belgium France

location_facility: Department of Pneumology Centre Hospitalier de Mouscron

location_facility: Department of Pneumology Hôpital Saint-Joseph

location_facility: Service de Pneumologie Centre Hospitalier de Douai

location_facility: Department of Pneumology Hospital Ixelles-Molière

location_facility: Department of Pneumology Clinique Saint-Luc

location_facility: Service de Pneumologie Hôpital de Hayange

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

location_facility: Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil

location_facility: Department of Pneumology RHMS Hôpital de la Madeleine

location_facility: Department of Pneumology CHR St Joseph-Warquignies


lead_sponsor: Pharmaxis

summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.

ReferenceCitation: Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. doi: 10.1089/jam.2006.19.100.

ReferenceCitation: Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56. doi: 10.1111/j.1440-1843.2005.00659.x.

ReferenceCitation: Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. doi: 10.1089/089426802760292681.

ReferenceCitation: Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21. doi: 10.1378/chest.119.2.414.

ReferenceCitation: Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85. doi: 10.1034/j.1399-3003.1999.14c30.x.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8. doi: 10.1164/ajrccm.159.6.9809074.

ReferenceCitation: Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54. doi: 10.1183/09031936.97.10112449.

ReferenceCitation: Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouef PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.

ReferenceCitation: Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5(5):CD008649. doi: 10.1002/14651858.CD008649.pub4.

ReferenceCitation: Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.

sponsor_collaborators: Europe: KasaConsult bvba, Hoegaarden, Belgium

sponsor_collaborators: Argentina: Resolution Latin America; Buenos Aires, Argentina

location_facility: Hospital de Ninos del la Santisima Trinidad

location_facility: University of Munich Medizinischen Klinik Innenstadt

location_facility: Universitats Kinderklinik Tubungen Wurzburg

location_facility: Hospital de Ninos Superiora Sor Maria Ludovica de La Plata

location_facility: Central Connecticut Cystic Fibrosis Center

location_facility: Hospital Gral. de Ninos Pedro de Elizalde

location_facility: Hospital de Ninos Dr Ricardo Gutierrez, Pediatria

location_facility: Louisiana State University Health Sciences Center

location_facility: Nebraska Medical Center - Nebraska Regional CF Center

location_facility: Christus Santa Rosa Children's Hospital Cystic Fibrosis Center

location_facility: The Toledo Hospital and Toledo Childrens Hospital

location_facility: Batchelor Children's Research Institute - University of Miami

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Interzonal Dr Jose Penna Bahia Blanca

location_facility: Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba

title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study

location_country:
Germany
Argentina
Netherlands
Belgium
United States
Canada
France


acronym: CATNON

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

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

ReferenceCitation: Tesileanu CMS, Sanson M, Wick W, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, van Linde ME, Aldape K, Jenkins RB, Kros JM, Wesseling P, von Deimling A, Hoogstrate Y, de Heer I, Atmodimedjo PN, Dubbink HJ, Brouwer RWW, van IJcken WFJ, Cheung KJ, Golfinopoulos V, Baumert BG, Gorlia T, French PJ, van den Bent MJ. Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial. Clin Cancer Res. 2022 Jun 13;28(12):2527-2535. doi: 10.1158/1078-0432.CCR-21-4283.

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repository_institution: University of Zurich - Zurich Open Repository and Archive

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: van den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14.

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

repository_normalized: HAL

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

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

repository_institution: University of Western Australia - UWA Profiles and Research Repository

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
Pure (Denmark)
pure.rug.nl
www.zora.uzh.ch

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;Pure (Denmark);pure.rug.nl;www.zora.uzh.ch

ReferenceCitation: van den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8. Erratum In: Lancet. 2017 Oct 7;390(10103):1644.

repositories:
PubMed Central
Pure (Denmark)
www.zora.uzh.ch

location_facility: UCSF University of California San Francisco Medical Center-Mount Zion

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Cancer Centers of the Carolinas - Faris Road

location_facility: Massachussets General Hospital Cancer Center

location_facility: Cancer Centers of the Carolinas - Eastside

location_facility: ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Erasmus MC - Daniel den Hoed Cancer Center

location_facility: Akron City Hospital - Summa Health System

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino

location_facility: University Of Wisconsin Comprehensive Cancer Center

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Memorial Health University Medical Center

location_facility: University Of Utah - Huntsman Cancer Institute

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: UPMC - Heritage Valley Health System - The Medical Center

location_facility: Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Cancer Centers of the Carolinas - Seneca

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Cancer Centers of the Carolinas - Greer Radiation Oncology

location_facility: Southwest General Health Center Ireland Cancer Center

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: State University of New York Upstate Medical University

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

location_facility: University of Rochester - James P. Wilmot Cancer Center

location_facility: Dixie Medical Center Regional Cancer Center

title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

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

collaborators:
NCIC Clinical Trials Group
Radiation Therapy Oncology Group
Medical Research Council
Merck Sharp & Dohme LLC


title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils

acronym: PRET

summary: The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
United Kingdom
Japan
United States
Chile
Canada
France

location_facility: Stony Brook University Medical Center (SUNY)

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital

location_facility: CHU de Nantes - Hôpital Guillaume et René Laennec

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Kobe City Medical Center General Hospital

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

acronym: APRIL-SLE

summary: This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

ReferenceCitation: Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20. Erratum In: Ann Rheum Dis. 2016 May;75(5):946.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Birmingham - University of Birmingham Research Portal

repositories_concat: California Digital Library - eScholarship;PubMed Central;Pure (Denmark);UCL Discovery;escholarship.org

repositories_institution: University College London - UCL Discovery

publisher_dissemination: British Medical Journal

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Merck KGaA, Darmstadt, Germany

location_country:
Germany
Poland
Argentina
Australia
Croatia
Serbia
France
Czech Republic
Lithuania
Switzerland
United States
Latvia
Ukraine
India
Lebanon
Malaysia
Philippines
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Feinstein Institute for Medical Research

location_facility: University of Cincinnati Medical Center, Division of Immunology

location_facility: Division of Clinical Immunology and Rheumatology - UAB


title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

summary: This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

ReferenceCitation: Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

sponsor_collaborators:
Eli Lilly and Company
Roche Pharma AG

location_country:
Germany
Italy
Austria
United States
Puerto Rico
France

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


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

acronym: RESTORA 1

summary: A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

ReferenceCitation: Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.

lead_sponsor: Midnight Pharma, LLC

location_country:
Finland
Germany
Poland
Australia
France
Czech Republic
Slovakia
Hungary
Denmark
Switzerland
Ukraine
Belgium
Italy
United Kingdom
Sweden
Austria
Spain
South Africa
Bulgaria
Israel

location_facility: Soroka University Medical Center, Unit for Sleep Research

location_facility: Monash Adult Sleep Center, Monash Medical Centre

location_facility: Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie

location_facility: Westmead Hospital, Department of Respiratory

location_facility: The Woolcock Institute of Medical Research

location_facility: I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto

location_facility: University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine

location_facility: CH Jolimont / Sleep Disorders Center, Hospital de Jolimont

location_facility: Sleep Disorder Centre, State Health Centre

location_facility: Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa

location_facility: Oddeleni nasledne pece, Nemocnice Ceske Budejovice

location_facility: University of Vienna - Department of Neurology

location_facility: IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno

location_facility: Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology

location_facility: Hospital MAZ, Unidad de Neurofisiologia y Sueno

location_facility: Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee

location_facility: Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie

location_facility: Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris

location_facility: University of Turku, Sleep Research Unit

location_facility: Hospital La Fe, Unidad de Neurofisiologi

location_facility: National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II

location_facility: Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica

location_facility: Department of Neurology , University of Debrecen

location_facility: KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna

location_facility: Neurologicka klinika, FN L. Pasteura Kosice

location_facility: Institute for Breathing and Sleep (IBAS)

location_facility: Medical University of Innsbruck, Department of Neurology

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG

location_facility: Service de Neurologie B, Hopital Gui de Chauliac

location_facility: Örebro University Hospital, Neurology department Sleep Unit

location_facility: WITS Sleep Laboratory School of Physiology

location_facility: Technion Sleep Medicine Center, Rambam Medical Center

location_facility: Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY

location_facility: Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

location_facility: Australian Clinical Research Organisation

location_facility: Sleep Disorders Laboratory, Royal Adelaide Hospital

location_facility: Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

location_facility: Hospital Son Dureta, Unidad de Psicologia

location_facility: Centrum pro poruchy spanku a bdeni, Neurologicka klinika

location_facility: Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH

location_facility: Burnside Hospital Clinical Trials Centre

location_facility: Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu

location_facility: Laboratorium Diagnostyka Snu, Pro-Medica

location_facility: IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia

location_facility: Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.


title: A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies

summary: This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Norway
Argentina
Denmark
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Peru
France


summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

ReferenceCitation: Bateman ED, Bleecker ER, Lotvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.

ReferenceCitation: Psaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

ReferenceCitation: Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

title: A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

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.

location_country:
Germany
Poland
Russian Federation
Slovakia
Estonia
Sweden
Mexico
United States
Korea, Republic of
Peru
Bulgaria
Canada
Philippines
France


title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

summary: Adult Patients with Severe Sepsis

ReferenceCitation: Laterre PF, Macias WL, Janes J, Williams MD, Nelson DR, Girbes AR, Dhainaut JF, Abraham E. Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis. Crit Care. 2008;12(5):R117. doi: 10.1186/cc7011. Epub 2008 Sep 11.

location_country:
Finland
France
Argentina
Denmark
Australia
Brazil
Austria
Belgium
Chile
Canada
Egypt
Czech Republic

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


acronym: CATZ

lead_sponsor: Eisai Inc.

summary: The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.

title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures

location_country: Italy Poland Hungary Belgium Latvia Spain Ukraine Estonia France


title: An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis

summary: This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

location_country:
Germany
Italy
Poland
Hungary
Hong Kong
Israel
Australia
Belgium
Korea, Republic of
Spain
Thailand
Greece
Taiwan
Canada
Russian Federation
France


title: A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD

summary: This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

lead_sponsor: Novartis

sponsor_collaborators: Novartis Schering-Plough

location_country:
Germany
Ireland
Italy
Lithuania
Poland
Hungary
Argentina
Norway
Romania
United Kingdom
Belgium
Latvia
South Africa
Turkey
Chile
Peru
France

location_facility:
Novartis Investigator Site - 2 sites
Novartis investigator site
Novartis Investigator Site
Novartis Investigator site
novartis Investigator site


title: Randomized Phase II Study to Investigate the Efficacy, Safety and Tolerability of ZK 230211 (25 mg vs. 100 mg) as Second-line Endocrine Therapy for Postmenopausal Women With Hormone Receptor-positive Metastatic Breast Cancer

summary: Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.

ReferenceCitation: Jonat W, Bachelot T, Ruhstaller T, Kuss I, Reimann U, Robertson JFR. Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Ann Oncol. 2013 Oct;24(10):2543-2548. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.

lead_sponsor: Bayer

location_country:
Finland
Italy
Germany
Poland
United Kingdom
Sweden
Switzerland
Austria
Spain
France


title: Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients

summary: The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

ReferenceCitation: Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S, Brown KA, Nashan B, Rostaing L, Meadows-Shropshire S, Agarwal M, Harler MB, Garcia-Valdecasas JC. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. Am J Transplant. 2014 Aug;14(8):1817-27. doi: 10.1111/ajt.12810.

repositories_concat: California Digital Library - eScholarship;PubMed Central

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Argentina
Brazil
Austria
United States
Spain
Canada
France

location_facility: Hospital Of The University Of Pennsylvania

location_facility: University Of California San Francisco Medical Center

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Washington University School Of Medicine


acronym: ENTHUSE M1

lead_sponsor: AstraZeneca

summary:
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.

title: A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
Serbia
France
Czech Republic
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
South Africa
Taiwan
Russian Federation
Sweden