title: Penumbral Rescue by Normobaric O=O Administration in Patients With Ischemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial

acronym: PROOF

summary: The main objective of the PROOF trial is to investigate efficacy and safety of normobaric hyperoxygenation (NBHO) as a neuroprotective treatment in patients with acute ischemic stroke due to large vessel occlusion likely to receive endovascular mechanical thrombectomy (TBY) in a randomized controlled clinical phase IIb trial.

lead_sponsor: University Hospital Tuebingen

collaborators: Coordination Centre for Clinical trials (KKS), 69120 Heidelberg, Germany

collaborators: European Clinical Research Infrastructure Network (ECRIN), 10559 Berlin, Germany

collaborators: CORE IMAGING LABORATORY: Eppdata GmbH, 22529 Hamburg, Germany

collaborators: CORE BIOMARKER LABORATORY: Fundatio Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain

location_country: Finland Germany Belgium Spain France

location_facility: Fundacio Hospital Universitari Vall D'Hebron

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: academique


study_start_date_type: Actual

acronym: ANGEL

intervention_type: Drug

lead_sponsor: Elevar Therapeutics

summary: The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).

location_facility: Chang Gung Memorial Hospital - Linko Branch

location_facility: Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)

location_facility: Chungbuk National University Medical Center

location_facility: Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department

location_facility: State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine", Department of oncology based on Municipal Institution "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly

location_facility: Centre Hospitalier Franco-Britannique; Oncologie Médicale

location_facility: State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

location_facility: Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

location_facility: Municipal Institution "Kyiv City Clinical Oncological Center"

location_facility: Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Communal Institution "Transcarpathian Regional Clinical Oncological Center"

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Kyungpook National University Medical Center

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

location_facility: Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Saint Constantin Hospital (TEO HEALTH SA)

location_facility: Fondazione IRCCS-Istituto Nazionale Tumori

location_facility: Magna Graecia University- Department of Experimental and Clinical Medicine

location_facility: Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie

location_facility: Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej

location_facility: Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Heaithcare of the Russian Federation

location_facility: Ospedale di Piacenza - Oncology and heamatology

location_facility: Seoul National University Bundang Hospital

location_facility: "Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt

location_facility: Institut Regional du Cancer Montpellier (ICM)

location_facility: Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

location_facility: Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie

location_facility: Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology

location_facility: Dnipropetrovsk Medical Academy, Department of Oncology

location_facility: Communal Institution "Ivano-Frankivsk Regional Oncological Center"

location_facility: State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"

location_facility: Severence Hospital, Yonsei University Health System

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala

location_facility: Veterans Health Service (VHS) Medical Center

location_facility: Chi Mei Medical Center - LiouYing Branch

location_facility: Ospedali Riuniti di Ancona - SOD Clinica Oncologica

location_facility: Saku Central Hospital Advanced Care Center

status: Completed

title: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
United Kingdom
Romania
Japan
United States
Korea, Republic of
Taiwan
Ukraine
Russian Federation
France

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed


title: The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)

acronym: ADHOC

summary: The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot ulcers

lead_sponsor: INRESA Pharma

sponsor_collaborators:
INRESA Pharma
RCTs

location_country: Czechia Poland France

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Maison de santé protestante de Bordeaux Bagatelle

location_facility: Podiatrie - Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

location_facility: Cardiologic and pediatric ambulance s.r.o.

location_facility: Faculty of Medicine MU a FH St. Ann Brno

intervention_type: Device


intervention_type: Biological

lead_sponsor: CSL Behring

summary: This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.

title: A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A

type: EudraCT Number

location_country:
Germany
Poland
Australia
Thailand
Turkey
France
Portugal
Switzerland
United States
Ukraine
Romania
Lebanon
Malaysia
Philippines
Italy
Netherlands
Austria
Spain
Georgia


title: A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

summary: This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
United States
Korea, Republic of
France

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Promedica Hematology & Oncology Assoicates


type: Other Identifier

title: A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)

summary:
Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy

Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Melisi D, Garcia-Carbonero R, Macarulla T, Pezet D, Deplanque G, Fuchs M, Trojan J, Kozloff M, Simionato F, Cleverly A, Smith C, Wang S, Man M, Driscoll KE, Estrem ST, Lahn MMF, Benhadji KA, Tabernero J. TGFbeta receptor inhibitor galunisertib is linked to inflammation- and remodeling-related proteins in patients with pancreatic cancer. Cancer Chemother Pharmacol. 2019 May;83(5):975-991. doi: 10.1007/s00280-019-03807-4. Epub 2019 Mar 18.

publisher_dissemination: Springer-Nature

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Belgium
United States
Spain
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.

location_facility: Florida Hospital Tampa HPG and Foregut Surgery


title: A Phase I-II, Open-label Study of RAD001 in Combination With Glivec®/Gleevec™ (Imatinib) in Patients With Glivec/Gleevec-refractory/Resistant Gastrointestinal Stromal Tumors.

summary: This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2-part design.

ipd_sharing: Yes

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 expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the triasl in line with applicable laws and regulations.

This trial data will be available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Germany
Belgium
France

location_facility: Dana Farber Cancer Institute Dept of Sarcoma Oncology

location_facility: College of Physicians and Surgeons of Columbia University


title: An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa

summary: MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrol. 2019 Mar 5;20(1):81. doi: 10.1186/s12882-019-1251-z.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: The University of Arizona - UA Campus Repository

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

repository_normalized: HAL

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

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

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

evidence: oa repository (via pmcid lookup)

license_normalized: no license

unpaywall_oa_status: gold

ReferenceCitation: Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.

ipd_sharing: Undecided

lead_sponsor: Sandoz

sponsor_collaborators:
Sandoz
Hexal AG

location_country:
Germany
Italy
Poland
Slovenia
United Kingdom
Romania
Switzerland
Austria
Spain
France


title: Multi-centre Randomised Trial to Evaluate the Effect of Early Hypothermia on Neurological Function in Patients With Severe Traumatic Brain Injury. Including Renal Sub Study

acronym: POLAR-RCT

summary:
Traumatic brain injury (TBI) is a leading cause of death and long term disability, particularly in young adults. Studies from Australia have shown that approximately half of those with severe traumatic brain injury will be severely disabled or dead 6 months post injury. Given the young age of many patients with severe TBI and the long term prevalence of major disability, the economic and more importantly the social cost to the community is very high.

Pre-hospital and hospital management of patients with severe brain injury focuses on prevention of additional injury due primarily to lack of oxygen and insufficient blood pressure. This includes optimising sedation and ventilation, maintaining the fluid balance and draining Cerebrospinal Fluid (CSF) and performing surgery where appropriate. In recent years there has been a research focus on specific pharmacologic interventions, however, to date, there has been no treatment that has been associated with improvement of neurological outcomes.

One treatment that shows promise is the application of hypothermia (cooling). This treatment is commonly used in Australia to decrease brain injury in patients with brain injury following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a number of mechanisms. There have been a number of animal studies that have looked at how cooling is protective and also some clinical research that suggests some benefit. However at the current time there is insufficient evidence to provide enough proof that cooling should be used routinely for patients with brain injury and like all treatments there can be some risks and side effects.

The POLAR trial has been developed to investigate whether early cooling of patients with severe traumatic brain injury is associated with better outcomes. It is a randomised controlled trial, which is a type of trial that provides the highest quality of evidence.

The null hypothesis is that there is no difference in the proportion of favourable neurological outcomes six months after severe traumatic brain injury in patients treated with early and sustained hypothermia, compared to standard normothermic management.

ReferenceType: background

ReferenceCitation: Nichol A, Gantner D, Presneill J, Murray L, Trapani T, Bernard S, Cameron P, Capellier G, Forbes A, McArthur C, Newby L, Rashford S, Rosenfeld JV, Smith T, Stephenson M, Varma D, Walker T, Webb S, Cooper DJ. Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury. Crit Care Resusc. 2015 Jun;17(2):92-100.

ReferenceCitation: Presneill J, Gantner D, Nichol A, McArthur C, Forbes A, Kasza J, Trapani T, Murray L, Bernard S, Cameron P, Capellier G, Huet O, Newby L, Rashford S, Rosenfeld JV, Smith T, Stephenson M, Varma D, Vallance S, Walker T, Webb S, James Cooper D; POLAR investigators and the ANZICS Clinical Trials Group. Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial. Trials. 2018 Apr 27;19(1):259. doi: 10.1186/s13063-018-2610-y.

ReferenceCitation: Ridley EJ, Davies AR, Bernard S, McArthur C, Murray L, Paul E, Trapani A, Cooper DJ; ANZICS Clinical Trials Group. Measured energy expenditure in mildly hypothermic critically ill patients with traumatic brain injury: A sub-study of a randomized controlled trial. Clin Nutr. 2021 Jun;40(6):3875-3882. doi: 10.1016/j.clnu.2021.05.012. Epub 2021 May 24.

publisher_dissemination: Elsevier

ReferenceCitation: Cooper DJ, Nichol AD, Bailey M, Bernard S, Cameron PA, Pili-Floury S, Forbes A, Gantner D, Higgins AM, Huet O, Kasza J, Murray L, Newby L, Presneill JJ, Rashford S, Rosenfeld JV, Stephenson M, Vallance S, Varma D, Webb SAR, Trapani T, McArthur C; POLAR Trial Investigators and the ANZICS Clinical Trials Group. Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury: The POLAR Randomized Clinical Trial. JAMA. 2018 Dec 4;320(21):2211-2220. doi: 10.1001/jama.2018.17075.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Moore EM, Nichol AD, Bernard SA, Bellomo R. Therapeutic hypothermia: benefits, mechanisms and potential clinical applications in neurological, cardiac and kidney injury. Injury. 2011 Sep;42(9):843-54. doi: 10.1016/j.injury.2011.03.027. Epub 2011 Apr 9.

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group

collaborators: National Health and Medical Research Council, Australia

collaborators: Délégation à la Recherche Clinique et à l'Innovation (DRCI) CHU Besançon

location_country:
New Zealand
Australia
Switzerland
Qatar
Saudi Arabia
France

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre

location_facility: Hôpital Gabriel Montpied + CHU Clermont-Ferrand

intervention_type: Other


acronym: SENSE

lead_sponsor: Janssen-Cilag International NV

summary: The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.

ReferenceType: result

ReferenceCitation: Nelson M, Stellbrink HJ, Podzamczer D, Banhegyi D, Gazzard B, Hill A, van Delft Y, Vingerhoets J, Stark T, Marks S. A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. AIDS. 2011 Jan 28;25(3):335-40. doi: 10.1097/QAD.0b013e3283416873.

ReferenceCitation: Gazzard B, Duvivier C, Zagler C, Castagna A, Hill A, van Delft Y, Marks S. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results. AIDS. 2011 Nov 28;25(18):2249-58. doi: 10.1097/QAD.0b013e32834c4c06.

ReferenceCitation: Fatkenheuer G, Duvivier C, Rieger A, Durant J, Rey D, Schmidt W, Hill A, van Delft Y, Marks S; SENSE Study Team. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. J Antimicrob Chemother. 2012 Mar;67(3):685-90. doi: 10.1093/jac/dkr533. Epub 2011 Dec 29.

title: A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects

location_country:
Germany
Hungary
Israel
Denmark
Romania
United Kingdom
Switzerland
Austria
Spain
Russian Federation
France


title: A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men With Prostate Cancer and Biochemical Failure (PSA Increase) After Radical Therapy With Curative Intent

acronym: ARTS

summary: ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

ReferenceCitation: Schroder F, Bangma C, Angulo JC, Alcaraz A, Colombel M, McNicholas T, Tammela TL, Nandy I, Castro R. Dutasteride treatment over 2 years delays prostate-specific antigen progression in patients with biochemical failure after radical therapy for prostate cancer: results from the randomised, placebo-controlled Avodart After Radical Therapy for Prostate Cancer Study (ARTS). Eur Urol. 2013 May;63(5):779-87. doi: 10.1016/j.eururo.2012.11.006. Epub 2012 Nov 12.

oa_host_type: repository

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Erasmus University, Rotterdam - RePub

unpaywall_oa_status: green

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
United Kingdom
Sweden
Netherlands
Spain
Estonia
Russian Federation
France


title: Observational Study to Determine the Incidence of New-Onset Valvulopathy in Patients Treated With Pergolide as Second-Line Therapy for Parkinson's Disease

summary:
The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line therapy.

The secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have Parkinson's Disease and are being considered for pergolide as second-line therapy.

time_perspective: Other

enrollment_type: Anticipated

location_country: Germany Italy Belgium France


title: A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma

summary: The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.

ReferenceCitation: Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.

location_country: Germany Australia Netherlands France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.

ReferenceCitation: Matzinger O, Poortmans P, Giraud JY, Maingon P, Budiharto T, van den Bergh AC, Davis JB, Musat E, Ataman F, Huyskens DP, Gulyban A, Bolla M; EORTC Radiation Oncology Group. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27.

ReferenceCitation: Matzinger O, Duclos F, van den Bergh A, Carrie C, Villa S, Kitsios P, Poortmans P, Sundar S, van der Steen-Banasik EM, Gulyban A, Collette L, Bolla M; EORTC Radiation Oncology Group. Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.

ReferenceCitation: Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. doi: 10.1200/JCO.21.00855. Epub 2021 Jul 26.

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

repository_institution: Université de Lausanne - SERVAL

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. doi: 10.1200/JCO.2015.64.8055. Epub 2016 Mar 14.

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

location_country:
Ireland
Italy
Cyprus
Poland
United Kingdom
Netherlands
Belgium
Spain
Luxembourg
Czech Republic
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Belfast City Hospital Trust Incorporating Belvoir Park Hospital


title: A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.

status: Terminated

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

location_country: Denmark Netherlands Belgium Croatia Egypt France

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

intervention_type: Radiation

status_simplified: Unknown


title: SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

summary: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
United States
India
Romania
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: Wannan Medical College Yijishan Hospital

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: The Catholic University of Korea, Yeouido St. Mary's Hospital

location_facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Xiangya Hospital Central South University

location_facility: Clinica Integral Internacional de Oncología

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region

location_facility: The University of Vermont Medical Center Inc.

location_facility: The Third People's Hospital of Chengdu (CDTPH)

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Centro Hospitalar E Universitário De Coimbra

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Affiliated Hospital of Guangdong Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: CIO - Centro de Inmuno-Oncología de Occidente

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala

location_facility: National Taiwan University Cancer Center (NTUCC)

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Tata Memorial Centre - Homi Bhabha Cancer Hospital

location_facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island

location_facility: Saitama Medical University International Medical Center

location_facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Instituto de Assist├ncia M├dica ao Servidor P

location_facility: The First Affiliated Hospital of the Third Military Medical University

location_facility: Health Pharma Professional Research S.A. de C.V:

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Cancer Hospital Chinese Academy of Medical Science

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Harbin Medical University Cancer Hospital

location_facility: Krishna Institute of Medical Sciences - Karad

location_facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hämato-Onkologie Hamburg, Prof. Laack und Partner

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Capital Health Medical Center - Hopewell

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Laura and Isaac Perlmutter Cancer Center

location_facility: University General Hospital of Heraklion

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: West China Hospital of Sichuan University

location_facility: Winship Cancer Institute, Emory University

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: PanAmerican Clinical Research - Guadalajara

location_facility: Chang Gung Medical Foundation-Linkou Branch

status_simplified: Ongoing


title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)

acronym: MIRANDA

summary: The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

status: Recruiting

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
Ireland
Poland
Argentina
Japan
Brazil
Thailand
Canada
France
Hungary
United States
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Spain
Greece


title: A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve Adults

acronym: CINNAMON

summary: The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: ViiV Healthcare

location_country:
Germany
Italy
United Kingdom
Argentina
Mexico
United States
Spain
Canada
France


title: Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors

summary: The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

location_country:
Italy
Israel
Argentina
Australia
Belgium
United States
Spain
France

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Atlantic Health System Morristown Medical Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)

acronym: HORIZON

summary: To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

sponsor_collaborators: AstraZeneca Amgen

location_country:
Poland
Colombia
Hungary
Argentina
Japan
Brazil
Netherlands
Mexico
United States
China
Korea, Republic of
Spain
Canada
Philippines
France


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of Leramistat in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary: To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

lead_sponsor: Modern Biosciences Ltd

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
United States
Spain
Greece
France

location_facility: Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Hudson County Clinical Trials Research Center

location_facility: General Hospital of Diseases Thoracos of Athens "Sotiria"

location_facility: Medical University of South Carolina - PPDS

location_facility: Benchmark Research - Covington - HyperCore - PPDS

location_facility: Howard County Center for Lung and Sleep Medicine, LLC

location_facility: Fondazione Policlinico Universitario A Gemelli-Rome

location_facility: North Manchester General Hospital - PPDS

location_facility: IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis

summary:
The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses.

The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks.

The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin.

At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.

lead_sponsor: LEO Pharma

location_country:
Germany
Poland
United Kingdom
Japan
United States
Canada
France

location_facility:
LEO investigational Site
LEO Investigational Site
LEO Investigationa Site
LEO investigational site


title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)

acronym: BLISSc-ILD

summary: This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Canada
France
Denmark
United States
Belgium
China
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Israel


type: Registry Identifier

title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

summary: The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Japan
Chile
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Belgium
China
Puerto Rico
Italy
Singapore
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Velocity Clinical Research, Salt Lake City ( Site 3223)

location_facility: Taichung Veterans General Hospital ( Site 2703)

location_facility: Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)

location_facility: Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)

location_facility: Kagawa Prefectural Central Hospital ( Site 1514)

location_facility: Osaka Saiseikai Suita Hospital ( Site 1503)

location_facility: California Liver Research Institute ( Site 3232)

location_facility: Fondazione Epatocentro Ticino ( Site 2602)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2702)

location_facility: Yokohama City University Hospital ( Site 1505)

location_facility: Heritage Medical Research Clinic ( Site 0403)

location_facility: Latin Clinical Trial Center ( Site 2004)

location_facility: Fukuiken Saiseikai Hospital ( Site 1507)

location_facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)

location_facility: Vancouver General Hospital-Gastroenterology ( Site 0408)

location_facility: National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi

location_facility: A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)

location_facility: Del Sol Research Management, LLC ( Site 3211)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)

location_facility: Velocity Clinical Research, Providence ( Site 3222)

location_facility: CHUS - Hospital Clinico Universitario ( Site 2503)

location_facility: Nara Medical University Hospital ( Site 1513)

location_facility: Floridian Clinical Research, LLC ( Site 3203)

location_facility: Velocity Clinical Research, Hallandale Beach ( Site 3241)

location_facility: Kawasaki Medical School General Medical Center ( Site 1508)

location_facility: Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)

location_facility: Pan American Center for Oncology Trials ( Site 2000)

location_facility: ULSAM - Hospital de Santa Luzia ( Site 1907)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1904)

location_facility: Southeast Clinical Research Center ( Site 3288)

location_facility: Covenant Metabolic Specialists, LLC ( Site 3231)

location_facility: Hôpital Beaujon-Hépatologie ( Site 0908)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas

location_facility: Southern Medical University Nanfang Hospital ( Site 0601)

location_facility: Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira-Internal Medicine ( Site 1905)

location_facility: West China Hospital, Sichuan University ( Site 0611)

location_facility: Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)

location_facility: Velocity Clinical Research, Panorama City ( Site 3214)

location_facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)

location_facility: Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)

location_facility: Velocity Clinical Research, Dallas ( Site 3220)

location_facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)

location_facility: CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)

location_facility: Velocity Clinical Research, Huntington Park ( Site 3217)

location_facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)

location_facility: American Research Corporation ( Site 3202)

location_facility: Velocity Clinical Research, Gardena ( Site 3225)

location_facility: Indago Research & Health Center, Inc ( Site 3207)

location_facility: National Taiwan University Hospital-Internal Medicine ( Site 2700)

location_facility: CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)

location_facility: Velocity Clinical Research, Syracuse ( Site 3227)

location_facility: The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3

location_facility: St. Marianna University Hospital ( Site 1516)

location_facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)

location_facility: Velocity Clinical Research, Westlake ( Site 3216)

location_facility: Boramae Medical Center-Internal Medicine ( Site 2403)

location_facility: Shinyurigaoka General Hospital ( Site 1518)

location_facility: Shaare Zedek Medical Center-Liver Unit ( Site 1302)

location_facility: Toranomon Hospital Kajigaya ( Site 1502)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)

location_facility: Japanese Red Cross Musashino Hospital ( Site 1517)

location_facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)

location_facility: Humanitas-Medicina interna ed Epatologia ( Site 1400)

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol

location_facility: Sweet Hope Research Specialty, Inc-Research ( Site 3200)

location_facility: Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (

location_facility: SYNEXUS Magyarország Kft. Eü. ( Site 1110)

location_facility: Hospital Universitario Ramón y Cajal ( Site 2508)

location_facility: Klinical Investigations Group-Clinical Research ( Site 2001)

location_facility: Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)

location_facility: Velocity Clinical Research, Cincinnati ( Site 3237)

location_facility: Severance Hospital, Yonsei University Health System ( Site 2401)

location_facility: Sapporo Kosei General Hospital ( Site 1521)

location_facility: Osaka Metropolitan University Hospital ( Site 1520)

location_facility: centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)

location_facility: New York Gastroenterology Associates ( Site 3252)

location_facility: Beijing Tsinghua Changgung Hospital ( Site 0606)

location_facility: Velocity Clinical Research, San Diego ( Site 3226)

location_facility: Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)

location_facility: ISIS CLINICAL RESEARCH CENTER ( Site 2006)

location_facility: Maccabi Health Services - Ramat Hasharon ( Site 1303)

location_facility: Shinshu University Hospital ( Site 1512)


title: A Phase 3 Randomized, Placebo-controlled, Double-blind, Parallel-group Program to Evaluate Efficacy and Safety of Filgotinib in Adult Subjects With Active Axial Spondyloarthritis

acronym: OLINGUITO

summary: This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.

lead_sponsor: Galapagos NV

location_country:
Germany
Poland
Croatia
Czechia
France
Lithuania
Hungary
Romania
Belgium
Estonia
Philippines
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria

location_facility: Royal United Hospital Bath NHS Foundation Trust

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Ilocos Training and Regional Medical Center

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Instytut Reumatologii im. Eleonory Reicher

location_facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation

location_facility: Klaipeda University Hospital, Public Institution

location_facility: Fakultni nemocnice u sv Anny, Interni klinika


title: A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of Tobemstomig Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.

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

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Australia
Brazil
Mexico
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
France

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Henry Ford Health System; Hematology/Oncology

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Virginia Commonwealth University Medical Center Main Hospital

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Cooper Health System; MD Anderson Cancer Center


title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

summary: The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
Argentina
Brazil
Netherlands
Belgium
United States
Spain
Chile
Canada
France

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore

location_facility: Universitaetsklinikum Carl Gustav Carus Tu Dresden

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Cedic Centro de Investigaciones Clinicas

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Hospital General Unviersitario de Alicante

location_facility: International Clinical Research Tennessee Llc

location_facility: Austin Institute For Clinical Research Aicr Pflugerville

location_facility: Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz

location_facility: Instituto de Especialidades de La Salud Rosario

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Luxderm Specjalistyczny Gabinet Dermatologiczny

location_facility: Hautarztpraxis Dr. Med. Matthias Hoffmann

location_facility: Ciec - Centro Internacional de Estudios Cli-Nicos

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: North Texas Center For Clinical Research Ntccr

location_facility: Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Dorota Bystrzanowska 'High-Med'. Przychodnia Specjalistyczna

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)


title: A Phase 2, Open-label, Multicenter Study Investigating Oncolytic Immunotherapy in Combination With Other Therapy in Patients With Locoregionally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

summary: This is a Phase 2, multicenter, open-label, 2-cohort (Locoregionally Advanced Cohort or Recurrent/Metastatic Cohort) study evaluating RP3 in combination with concurrent chemoradiation therapy (CCRT) followed by nivolumab (for the LA Cohort) or combined with chemotherapy and nivolumab (for the R/M Cohort) in patients with advanced, inoperable squamous cell carcinomas of the head and neck (SCCHN), including of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.

status: Withdrawn

lead_sponsor: Replimune Inc.

sponsor_collaborators:
Replimune Inc.
Bristol-Myers Squibb

location_country:
Germany
Poland
United Kingdom
United States
Spain
Greece
Czechia
France

location_facility: University of Washington / Fred Hutchinson Cancer Center

location_facility: UCLA Medicine Division of Hematology-Oncology

location_facility: University of Pittsburgh Medical Center, UPMC

location_facility: Charite University Hospital of Berlin, Comprehensive Cancer Center

location_facility: La Paz Univeristy Hospital, Universidad Autonoma de Madrid

location_facility: Assistance Publique Hopitaux De Marseille

location_facility: University of Iowa Hospitals and Clinics

location_facility: Jefferson Health Abington Asplunhd Cancer Pavillion

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: University of California San Diego, UCSD

location_facility: Thomas Jefferson University City Center and Abington

location_facility: LMU Klinikum, Medizinische Klinik und Poliklinikum III

location_facility: Vall d'Hebron University Hospital, Vall d' Hebron Institute of Oncology (VHIO)

location_facility: Centre Georges Francois Leclerc, Department of Oncology

location_facility: Universitatsklinik Jena Klinik und Poliklinik fur Hals-, Nasen - und Ohrenheilkunde

location_facility: Szpital Specjalistyczny im Ludwika Rydygiera w Krakowie sp z oo, Department of Clinical Oncology

location_facility: CHU Nimes, Instiut de Cancerologie du Gard, Medical Oncology

location_facility: University Hospital Leipzig Clinic and Polyclinic for otorhinolaryngology


title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab (MEDI3506) in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations.

acronym: PROSPERO

summary: Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
United States
India
Romania
Belgium
China
Peru
Philippines
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

intervention_type: Combination Product


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

summary: The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trialsand research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
United Kingdom
Australia
Japan
United States
Spain
Czechia
Canada
France

location_facility: Center For Dermatology Clinical Research, Inc.

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: Center for Clinical Studies (CCS) - Webster/Clear Lake Location

location_facility: NorthShore Medical Group - Dermatology - Skokie

location_facility: Dermatology Treatment and Research Center

location_facility: Dermatology Research Associates - Howard Sofen, MD

location_facility: Palmetto Clinical Trial Services, LLC - Greenville

location_facility: Dermatology Specialists Research - Indiana


title: A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

summary: The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
United States
Korea, Republic of
Spain
Canada
France


title: A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

summary: The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

lead_sponsor: Enliven Therapeutics

location_country:
Italy
Australia
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: lnstitut Catala d'Oncologia (ICO) L'Hospitalet, Servicio de Oncologia Medica

location_facility: University of Colorado - Anschutz Medical Campus - PPDS

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Hospital Universitari i Politècnic La Fe


title: A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

lead_sponsor: TeneoOne Inc.

location_country:
France
United Kingdom
Denmark
United States
Spain
Canada
Israel

location_facility: The Chaim Sheba Medical Center /ID# 251329

location_facility: Ottawa Hospital Research Institute /ID# 252151

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 251196

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167

location_facility: Tel Aviv Sourasky Medical Center /ID# 251573

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 251545

location_facility: University of North Carolina /ID# 251203

location_facility: Hospital Universitario de Salamanca /ID# 251529

location_facility: University College London Hospitals NHS Foundation Trust /ID# 251357

location_facility: Hospital Universitario Marques de Valdecilla /ID# 251528

location_facility: AP-HP - Hopital Saint-Antoine /ID# 252326

location_facility: Odense Universitets Hospital /ID# 251261

location_facility: Hadassah Medical Center-Hebrew University /ID# 252079

location_facility: Vanderbilt Ingram Cancer Center /ID# 252470


title: An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Adaptive Study of the Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

acronym: FALCON

summary: The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.

status: Active, not recruiting

lead_sponsor: Abliva AB

location_country:
United Kingdom
Denmark
Belgium
United States
Spain
France

location_facility: Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario de Catalunya

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: The University of Texas Health Science Center at Houston

location_facility: Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2

location_facility: Copenhagen Neuromuscular Center, Rigshospitalet

location_facility: Universitair Ziekenhuis Leuven Gasthuisberg Campus

location_facility: CIBERER- IDIBAPS, Faculty of Medicine, University of Barcelona

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: Department of Clinical Neurosciences, Addenbrooke's Hospital


title: A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Brazil
Mexico
United States
China
Korea, Republic of
Spain
Greece
Turkey
France

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

location_facility: Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Seoul National University Bundang Hospital; Internal Medicine

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: West China Hospital - Sichuan University

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

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

location_facility: Hospital Universitario Evangelico De Curitiba

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: Western General Hospital; Clinical Oncology


title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects With Severe Alcohol Associated Hepatitis

acronym: FRESH

summary: The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).

lead_sponsor: Intercept Pharmaceuticals

location_country:
United States
United Kingdom
France

location_facility: VCU Health Clinical Research Services Unit

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Northwell Health Center for Liver Disease and Transplantation


title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia

summary: The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Italy
Poland
Portugal
Slovakia
Hungary
Norway
Denmark
Netherlands
United States
Spain
Czechia
Bulgaria
Canada
France

location_facility: Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

location_facility: Centricity Research - Etobicoke Endocrinology

location_facility: Centricity Research - Toronto LMC Multispecialty

location_facility: Institute de Recherches Cliniques de Montreal

location_facility: MUDr. Nina Zemkova s.r.o. Interni Ambulance

location_facility: Suncoast Clinical Research, Inc. - New Port Richey

location_facility: Centricity Research - Brampton Endocrinology

location_facility: CHU Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: Montreal Heart Institute - Institut de Cardiologie de Montreal

location_facility: The Lipid Clinic (Oslo University Hospital)

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

location_facility: Interna SK, s.r.o., Kardiologicka a interna ambulancia

location_facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

location_facility: Advanced Medical Research Institute (AMRI)

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Specialized Hospital for Active Treatment of Cardiology

location_facility: Alabama Clinical Therapeutics, LLC Alabaster

location_facility: Charleston Area Medical Center (CAMC) Clinical Trials Center

location_facility: ASST NORD MILANO-Ospedale Edoardo Bassini

location_facility: Centricity Research - Vaughan Endocrinology

location_facility: Clinical Best Solutions Sp. z.o.o Spolka Komandytowa

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod

location_facility: Medical University of South Carolina (MUSC)

location_facility: Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.o

location_facility: FutureMeds - Centrum Medyczne AMED Warszawa Targowek

location_facility: INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych

location_facility: Cardiovascular Research Foundation of Southern California

location_facility: Diabetes/Lipid Management & Research Center

location_facility: Jagiellonskie Centrum Innowacji Sp. z o.o.

location_facility: Diagnostic Consultative Center Equita (DCC Equita)

location_facility: Centricity Research - Barrie Endocrinology

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: University of California, San Diego (UCSD)

location_facility: Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: Centricity Research - Oshawa Multispecialty

location_facility: Albert Schweitzer Ziekenhuis - Location Dordrecht

location_facility: Aultman Hospital Cardiology Clinical Trials

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Academic Medical Center - Department of Vascular Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o

location_facility: Groupement de Cooperation Sanitaire (GCS) ELSAN - Polyclinique Vauban

location_facility: Medico Dental Center ISUL Tsaritsa Yoanna EOOD

location_facility: Suncoast Clinical Research, Inc. - Palm Harbor

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Westside Medical Associates of Los Angeles

location_facility: UNIVMED s.r.o. - Kardiologicka Ambulance

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: Louisville Metabolic and Atherosclerosis Research Center

location_facility: Evanston Premier Healthcare Research LLC

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: University Multiprofile Hospital for Active Treatment Pulmed OOD

location_facility: Green and Seidner Family Practice Associates

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: Cardiovascular Research of Northwest Indiana, LLC


title: A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC OLE)

summary: This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001

status: Enrolling by invitation

lead_sponsor: Marinus Pharmaceuticals

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

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: McGovern Medical School at the University of Texas Health Science Center

location_facility: University of Utah Health Care-Pediatric Neurology

location_facility: University of Texas Southwestern Medical Center

location_facility: NHS acute tertiary referral centre, John Radcliffe Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Royal Aberdeen Children's Hospital, NHS Grampian

location_facility: Pediatric Neurology and Muscular Diseases Unit - University of Genoa

location_facility: Nemours Children's Hospital - Delaware Valley

location_facility: UCLA Mattel Children's Hospital, TSC Center

location_facility: ZNN - Epilepsiezentrum Frankfurt am Main

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Institute of Neurology and Neurosurgery at Saint Barnabas

location_facility: Hospital Regional Universitario de Málaga

location_facility: Children's Hospital of Michigan Central Michigan University

location_facility: Barrow Neurological Institute at Phoenix Children's Hospital

location_facility: Child Neurology Consultants of Austin (CNCA)

location_facility: Boston Children's Hospital, Harvard Medical School

location_facility: TSC Clinic at Northeast Regional Epilepsy Group

location_facility: Epilepsie-Zentrum Bethel - Krankenhaus Mara

location_facility: Virginia Commonwealth University (VCU) Health System

location_facility: Atrium Health/Levine Children's Hospital

location_facility: Department of Neurology and Sense Organs, AOU Policlinico di Bari


title: A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers

summary: This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.

lead_sponsor: Adaptimmune

sponsor_collaborators:
Adaptimmune
GOG Foundation

location_country:
United Kingdom
United States
Spain
Canada
France

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Hospotal Clinico Universitario de Valencia

location_facility: University Health Network (Princess Margaret Cancer Center)

location_facility: Institut de Cancerologie des Hospices Civils de Lyon

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Texas Southwestern Medical Center

intervention_type: Genetic


title: 17 β-Hydroxysteroid Dehydrogenase Type 13 Minimization for the Treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Pre-Cirrhotic Nonalcoholic Steatohepatitis

summary: The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced (F3) fibrosis. The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
India
United Kingdom
Argentina
Japan
Mexico
Belgium
United States
Korea, Republic of
Spain
Greece
Turkey
Canada
Puerto Rico
France


title: A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

summary: The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

sponsor_collaborators:
Bristol-Myers Squibb
Eisai Inc.

location_country:
Australia
Belgium
United States
Spain
Chile
France

location_facility: Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Rocky Mountain Cancer Centers - Lone Tree


title: The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study

acronym: SEED

summary: Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

lead_sponsor: NHS Lothian

location_country:
Finland
Italy
Poland
Albania
Hungary
Norway
Denmark
Romania
United Kingdom
Malta
Austria
Belgium
Spain
Greece
Turkey
Czechia
Serbia
France

location_facility: AHEPA Univesrity General Hospital of Thessaloniki

location_facility: Regional Hospital Centre "Xh. Kongoli" Elbasan

location_facility: Emergency Center Belgrade, Clinical Centre Belgade

location_facility: Gazi University Medical Faculty Department of Emergency Medicine

location_facility: Cluj Napoca County Emergency Clinical Hospital

location_facility: Semmelweis University Department of Emergency Medicine

location_facility: ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)

location_facility: University Hospital Coventry & Warwickshire

location_facility: Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine

location_facility: ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)

location_facility: Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine

location_facility: ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)

location_facility: Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken

location_facility: Necmettin Erbakan University Medical Faculty Department of Emergency Medicine

location_facility: ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)

location_facility: University Hospital Centre "Mother Theresa" Tirana

location_facility: Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)

location_facility: Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine

location_facility: Emergency Department Zaječar, Health Center Zaječar


title: Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

acronym: REDEFINE 1

summary:
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Turkey
Canada
Serbia
France
Denmark
United States
India
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria


title: A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

summary: This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

sponsor_collaborators:
GlaxoSmithKline
iTeos Therapeutics

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Thailand
France
Portugal
Hungary
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
South Africa