acronym: COMMUTE-p

title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

location_country:
Poland
Brazil
Spain
Italy
Canada
United States
France
China
Israel
Belgium
Japan
South Africa

location_facility: University of Nebraska; Pediatric Nephrology

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia

location_facility: UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Nefrologia Pediatrica

location_facility: Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

location_facility: Santa Casa de Belo Horizonte; Centro de Hemodiálise

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: The children's hospital , Zhejiang university school of medicine

location_facility: Cincinnati Children's Hospital Medical Center; Investigational Drug Services

location_facility: Aichi Children's Health and Medical Center

location_facility: Red Cross War Memorial Children's Hospital; Pediatric Nephrology

location_facility: Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Rambam medical Center; Pediatric Nephrology

summary: This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.


type: EudraCT Number

type: Other Identifier

title: A Phase 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

summary: The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care. The study will last up to approximately 2 years.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Eli Lilly and Company

location_country:
Australia
Canada
Korea, Republic of
United States
France
Japan

location_facility: Vanderbilt Univeristy School of Medicine

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

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Chonnam National University Hwasun Hospital

location_facility: Indiana Univ Melvin & Bren Simon Cancer Center

location_facility: South Texas Accelerated Research Therapeutics (START)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

summary: This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

primary_purpose: Other

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Hong Kong
United Kingdom
Italy
Russian Federation
Argentina
Canada
Thailand
Korea, Republic of
France
South Africa
China
Romania
Japan
Singapore
Bulgaria


status: Completed

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

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

study_completion_date_type: Actual

lead_sponsor: Merck Sharp & Dohme LLC

source: euctr

design_allocation: Randomized

enrollment_type: Actual

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

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

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

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

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

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

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

location_facility: Hacettepe Universitesi-internal diseases ( Site 1602)

location_facility: Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (

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

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

location_facility: Christchurch Hospital-Gastroenterology Research ( Site 1002)

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

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

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

location_facility: Texas Clinical Research Institute ( Site 1910)

location_facility: centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)

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

location_facility: Floridian Clinical Research, LLC ( Site 1950)

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

location_facility: Korea University Guro Hospital ( Site 1300)

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

location_facility: Centro de Investigación y Gastroenterología ( Site 0902)

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

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

location_facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)

location_facility: National Taiwan University Hospital ( Site 1501)

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

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

location_facility: New Technologies of Medicine Clinic ( Site 1204)

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

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

location_facility: Azienda Ospedaliero Universitaria ( Site 0803)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 1107)

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

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)

location_facility: Ukrainian Research Institute of Therapy ( Site 1704)

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

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (

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

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

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

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

location_facility: Heritage Medical Research Clinic ( Site 0302)

location_facility: Adonis Plus-Outpatient department ( Site 1701)

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

location_facility: Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)

location_facility: Istanbul University Capa Campus-Gastroenterology ( Site 1604)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)

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

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1105)

location_facility: Gazi Universitesi-gastroenterology ( Site 1605)

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

location_facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)

location_facility: Catalina Research Institute, LLC ( Site 1939)

location_facility: CHUS - Hospital Clinico Universitario ( Site 1403)

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

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)

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

status_simplified: Completed


title: An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Denmark
Poland
Brazil
Portugal
Romania
Italy
Russian Federation
Lebanon
Spain
Argentina
Canada
Korea, Republic of
France
Singapore
Turkey
Mexico
Germany
Bulgaria
Czechia

summary: This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment


title: Lead EvaluAtion for Defibrillation and Reliability (LEADR)

summary: The study is designed to assess the safety and efficacy of the Next Generation ICD lead.

status: Active, not recruiting

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Hong Kong
Portugal
Serbia
Italy
Austria
Australia
Spain
Canada
United Kingdom
United States
France
China
Malaysia
Singapore
Japan
Germany

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Saint Luke's Mid America Heart Institute

location_facility: Washington University School of Medicine

location_facility: Virginia Commonwealth University Health System

location_facility: Institut Jantung Negara - National Heart Institute

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

location_facility: Klinicki Centar Srbije Pejsmejker centar

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Centre Hospitalier Universitaire de Grenoble - Site Nord

location_facility: National Cerebral and Cardiovascular Center

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Tokyo Women's Medical University Hospital

location_facility: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

location_facility: Texas Health Research & Education Institute

intervention_type: Device


title: A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients With EGFR Mutant Non-Small Cell Lung Cancer

summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib.

lead_sponsor: Blueprint Medicines Corporation

location_country:
Taiwan
Spain
United Kingdom
Canada
Korea, Republic of
United States
France
China
Singapore
Japan
Netherlands

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

location_facility: Seoul National University, Department of Internal Medicine

location_facility: Asan Medical Center, Department of Oncology

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

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

location_facility: NYU Langone Health, Laura and Isaac Perlmutter Cancer Center

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Institut Claudius Regaud (IUCT-O) - Cancer Comprehensive Center

location_facility: Vall d'Hebron University Hospital, Oncology Department

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: UC Irvine Health, Chao Family Comprehensive Cancer Center

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Yonsei Cancer Center, Severance Hospital, Yonsei University

location_facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek


title: A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

summary: A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

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:
Denmark
Poland
Spain
Australia
Canada
Thailand
United States
France
China
India
Belgium
Japan
Sweden


title: A Phase IIIb, Open-label, Single-arm, Single-dose, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Gene Replacement Therapy With Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)

acronym: SMART

summary: To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.

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

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

location_country:
Taiwan
Portugal
United Kingdom
Italy
Australia
Canada
Switzerland
United States
France
Belgium

intervention_type: Genetic


title: A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA

lead_sponsor: Pfizer

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
Hungary
France
Mexico
Japan
Czechia

location_facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

location_facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

location_facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

summary: An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.


title: A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)

summary: A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

lead_sponsor: Crinetics Pharmaceuticals Inc.

location_country:
Poland
Brazil
Serbia
United Kingdom
Italy
Russian Federation
Argentina
Hungary
United States
France
Israel
Peru
Belgium
Bulgaria


title: European Registry of Type A Aortic Dissection

acronym: ERTAAD

summary: Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum in: J Cardiothorac Surg. 2021 Aug 9;16(1):225.

lead_sponsor: Helsinki University Central Hospital

location_country:
Spain
Italy
United Kingdom
Finland
France
Belgium
Germany
Czechia

location_facility: Institute of Clinical and Experimental Medicine

location_facility: University Heart & Vascular Centre Hamburg

intervention_type: Procedure

lead_sponsor_type: academique


title: A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

summary: The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

time_perspective: Prospective

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

lead_sponsor: Ethicon, Inc.

location_country:
Denmark
Poland
Sweden
United States
France
Germany
Czechia

location_facility:
UPMC
General University Hospital
Hopital Jeanne de Flandres
University of Pennsylvania
CHU de Clermont-Ferrand
Universitatsklinikum Tubingen
Karolinska Institute
Duke University
Herlev Hospital
Yale University
Żelazna Medical Center


status: Terminated

acronym: TAK-994 Extension and Randomized Withdrawal Study in Adult Subjects With Narcolepsy Type 1

title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)

lead_sponsor: Takeda

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https:// clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Spain
Italy
Finland
Canada
Hungary
Korea, Republic of
United States
France
Japan
Czechia

location_facility: Sleep Medicine Specialists of South Florida

location_facility: Hopital Roger Salengro - CHU Lille service de neurologie D

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia

location_facility: Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica

location_facility: Florida Pulmonary Research Institute, LLC 300127039

location_facility: Hospital Universitario Araba Sede Santiago Sleep Unit

location_facility: University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital

location_facility: Shunkaikai Inoue Hospital Dept of Respiratory Medicine

location_facility: Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika

location_facility: SOUSEIKAI PS Clinic Dept of Internal Medicine

location_facility: Ohio Sleep Medicine and Neuroscience Institute 186

location_facility: Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine

location_facility: Nihon University Itabashi Hospital Dept of Neuropsychiatry

location_facility: Sleep & Stress Clinic Dept of Psychiatry

location_facility: Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry

location_facility: Hospital General de Castellon Servicio de Neurofisiologia

location_facility: You Ariyoshi Sleep Clinic Dept of Psychiatry

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine

location_facility: Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno

location_facility: Koishikawa Tokyo Hospital Dept of Psychiatry

location_facility: Delta Waves Sleep Disorders and Research Center 300148510

location_facility: Hopital Gui de Chauliac Service de Neurologie

location_facility: Kurume University Hospital Dept of Neuropsychiatry

location_facility: Yoyogi Sleep Disorder Center Dept of Psychiatry

location_facility: Kyowakai Hannan Hospital Dept of Psychiatry

location_facility: Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd

location_facility: Terveystalo Helsinki Uniklinikka 300186257

location_facility: Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420

location_facility: Hospital Clinic de Barcelona Servicio de Neurologia

location_facility: Fort Wayne Neurological Center 150711262

location_facility: The Catholic University of Korea, St. Vincent's Hospital 300187879

location_facility: Keimyung University Dongsan Hospital 300144594

location_facility: Beth Israel Deaconess Medical Center CardioVascular Institute

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

location_facility: Howakai Kuwamizu Hospital Dept of Internal Medicine

location_facility: Sleep Therapy & Research Center 300151246

location_facility: Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze

location_facility: Medical University of South Carolina (MUSC) PARENT

summary:
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

status_simplified: Unknown


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

lead_sponsor: Concert Pharmaceuticals

location_country:
Poland
Spain
Canada
Hungary
United States
France
Germany

location_facility: Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika

location_facility: North Texas Center for Clinical Research

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie

location_facility: Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas

location_facility: Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

location_facility: The Rector and Visitors of the University of Virginia

location_facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Archet 2

location_facility: Klinikum Rechts Der Isar, Technische Universität München

location_facility: Wromedica I. Bielicka, A. Strzalkowska S.C.

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitan

location_facility: Columbia University Medical Center - Department of Dermatology

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika

location_facility: Velocity Clinical Research/Swinyer-Woseth Dermatology

location_facility: Fachklinik Bad Bentheim - Dermatologische Studienambulanz

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika


title: A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

acronym: HI-PEITHO

summary:
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.

Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

ReferenceType: background

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ReferenceCitation: Becattini C, Agnelli G, Lankeit M, Masotti L, Pruszczyk P, Casazza F, Vanni S, Nitti C, Kamphuisen P, Vedovati MC, De Natale MG, Konstantinides S. Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model. Eur Respir J. 2016 Sep;48(3):780-6. doi: 10.1183/13993003.00024-2016. Epub 2016 May 12.

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galiè N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

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ReferenceCitation: Kucher N, Boekstegers P, Müller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Müller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Härtel D, Grünwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

ReferenceCitation: Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

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ReferenceCitation: Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

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lead_sponsor: Boston Scientific Corporation

location_country:
Poland
United Kingdom
Ireland
Austria
Netherlands
Switzerland
United States
France
Germany

location_facility: University of Maryland School of Medicine

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University of Oklahoma Health Science Center

location_facility: Guys and St. Thomas NHS Foundation Trust


title: VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

acronym: VANTAGE

summary: Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Netherlands
France
Germany

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Universitätsmedizin Berlin - Charité Campus Mitte (CCM)


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)

acronym: ENERGIZE

summary: The primary purpose of this study is to compare the effect of mitapivat versus placebo on anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Denmark
Taiwan
Brazil
Saudi Arabia
Greece
Italy
Lebanon
Netherlands
Canada
Spain
Thailand
United Arab Emirates
United Kingdom
United States
France
Malaysia
Turkey
Germany
Bulgaria
Egypt

location_facility: Amsterdam Universitair Medisch Centrum, Locatie AMC

location_facility: Toronto General Hospital, University Health Network

location_facility: Abul Reesh Children's Hospital, Cairo University

location_facility: Manchester Royal Infirmary, Manchester University NHS Foundation Trust

location_facility: Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School

location_facility: King Abdullah International Medical Research Center

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo

location_facility: Research Institute for Languages and Cultures of Asia, Mahidol University

location_facility: HEMORIO Instituto Nacional de Hematologia

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Clinical Research Center, Cairo University

location_facility: Penn Medicine - University of Pennsylvania Health System

location_facility: Centro Microcitemia-Ospedale SS. Annunziata

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: BALATON

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Brazil
Hungary
China
Germany
Taiwan
Korea, Republic of
France

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Centro Hospitalar Universitário do Porto - Hospital de Santo António; Servico de Oftalmologia

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: University Retina and Macula Associates, PC

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: California Eye Specialists Medical group Inc.

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Seoul National University Bundang Hospital

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Retina Consultants of Southern Colorado PC

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Queen Mary Hospital; Department of Ophthalmology


acronym: RISE

title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
Poland
Brazil
Belgium
United Kingdom
France
United States
Mexico

location_facility: Consultorio de Joshue David Covarrubias Esquer

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio-Libanês

location_facility: University of California - San Francisco

summary: This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].


title: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

summary: The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

primary_purpose: Diagnostic

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Brazil
Spain
Netherlands
Argentina
United States
France
Turkey
Germany

location_facility: Grady Memorial Hospital/Emory University

location_facility: İstanbul Aydin University medical park florya hospital


intervention_type: Biological

title: A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

ReferenceCitation: Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRAS(G12C) for the Treatment of Solid Tumors. J Med Chem. 2022 Nov 18. doi: 10.1021/acs.jmedchem.2c01438. [Epub ahead of print]

location_country:
Denmark
Taiwan
Hong Kong
Spain
Italy
Australia
Netherlands
Canada
Korea, Republic of
United States
France
China
Singapore
Belgium
Japan
Germany

location_facility: Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center

location_facility: Washington University School of Medicine

location_facility: University of Texas MD Anderson Cancer Center Dept of MD Anderson CancerCent

location_facility: Massachusetts General Hospital Cancer Center

summary: This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose.


title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

acronym: ADVANCE SC

summary: This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Japan
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
Tunisia
Israel
Turkey
Mexico
Norway
China
Germany
Bulgaria
Denmark
Taiwan
Jordan
Greece
Georgia
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile

location_facility:
Investigator Site 0860013
Investigator Site 9720009
Investigator Site 3510003
Investigator Site 0010079
Investigator Site 9950019
Investigator Site 0860008
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Investigator Site 9950009
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Investigator Site 0540001
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Investigator Site 0860003
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Investigator Site 9950006
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Investigator Site 0610011
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Investigator Site 0860001
Investigator Site 0810053
Investigator Site 0860014
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Investigator Site 9720007
Investigator Site 0810052
Investigator Site 0400012
Investigator Site 0390015
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Investigator Site 0330018
Investigator Site 0070040
Investigator Site 0340006
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Investigator Site 0340036
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Investigator Site 0610005
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Investigator Site 0390035
Investigator Site 0010102
Investigator Site 0560002
Investigator Site 0900009
Investigator Site 0810044
Investigator Site 0860010
Investigator Site 0810057
Investigator Site 3590017
Investigator Site 3510005
Investigator Site 0440005
Investigator Site 0610012
Investigator Site 0390037
Investigator Site 0520004
Investigator Site 0390046
Investigator Site 0660008
Investigator Site 0470003
Investigator Site 0540004
Investigator Site 0610009
Investigator Site 0300009
Investigator Site 0440008
Investigator Site 0070024
Investigator Site 0270005
Investigator Site 3510004
Investigator Site 0610001
Investigator Site 0810048
Investigator Site 3510006
Investigator Site 0400007
Investigator Site 0070026
Investigator Site 9720013
Investigator Site 0610003
Investigator Site 3810006
Investigator Site 3530002
Investigator Site 0660001
Investigator Site 0070012
Investigator Site 3590015
Investigator Site 0340004
Investigator Site 0340024
Investigator Site 0340037
Investigator Site 0400006
Investigator Site 0860006
Investigator Site 0810056
Investigator Site 0820004
Investigator Site 0270001
Investigator Site 0390011
Investigator Site 3510001
Investigator Site 0900018
Investigator Site 9720008
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Investigator Site 3510002
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Investigator Site 0900016
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Investigator Site 0560003
Investigator Site 0480033
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Investigator Site 0400005
Investigator Site 0860055
Investigator Site 0450005
Investigator Site 0810051
Investigator Site 2160006
Investigator Site 0490012
Investigator Site 9720012
Investigator Site 0070015
Investigator Site 0810018
Investigator Site 0070025
Investigator Site 9950008
Investigator Site 0660003


title: An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

acronym: INSTRUCT-UC

summary: The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study will last about 52 weeks.

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.

lead_sponsor: Eli Lilly and Company

location_country:
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
India
Israel
Slovakia
Brazil
Canada
Hungary
China
Latvia
Georgia
Korea, Republic of
France

location_facility: Medical Center of LLC Medical Center Clinic of Family Medicine

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: International Institute of Clinical Trials LLC

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

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

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: CHU De Grenoble Hopital Albert Michallon

location_facility: Vinnytsia War Veterans Regional Clinical Hospital

location_facility: Gastroenterology Research, Nova Scotia Health Authority

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Acad. F. Todua Medical Center - Research Institute of Clinical Medicine

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Gastroenterology and internal medicine research institute

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: A. Novak Transcarpathian Regional Clinical Hospital


title: An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD 1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

summary: The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

lead_sponsor: Symphogen A/S

location_country:
United States
Spain
Canada
France

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Centre Georges-François Leclerc, Department of Medical Oncology


title: An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

summary: This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Spain
Italy
Austria
Canada
United States
France
Israel


title: International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study

acronym: ICAVS

summary: This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

lead_sponsor: University of Milano Bicocca

location_country:
Kenya
Denmark
Brazil
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
Bangladesh
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division

location_facility: Medical Oncoloy Unit - University of Nairobi

location_facility: University of Basel - Department of Sport, Exercise and Health

location_facility: Dept. of Neurology, Medical University of Vienna

location_facility: University of Michigan School of Nursing

location_facility: Dong-A University - Internal Medicine Dept.

location_facility: International Centre for Diarrhoeal Disease Research

location_facility: Hospital Universitari de Bellvitge-ICO L'Hospitalet

location_facility: Columbia University Irving Medical Center

location_facility: Birmingham School of Nursing, University of Alabama

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho

intervention_type: Other


title: A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Haematological Malignancies

summary: This is a modular, multicentre, open-label, non-randomised, Phase I/II, dose-setting and expansion study including an intra-participants dose ramp up. AZD4573 will be administered intravenously, in novel combinations with anti-cancer agents, to participants with relapsed/refractory (r/r) haematological malignancies.

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:
Poland
Spain
Ireland
Italy
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Germany


title: OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

summary:
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled.

All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met.

The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

ReferenceType: result

ReferenceCitation: Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.

ReferenceCitation: Kelsen JR, Sullivan KE, Rabizadeh S, Singh N, Snapper S, Elkadri A, Grossman AB. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the Evaluation and Management for Patients With Very Early-onset Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):389-403. doi: 10.1097/MPG.0000000000002567.

ReferenceCitation: Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. Epub 2007 May 21.

ReferenceCitation: Otley A, Smith C, Nicholas D, Munk M, Avolio J, Sherman PM, Griffiths AM. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):557-63.

ReferenceCitation: Marcovitch L, Nissan A, Mack D, Otley A, Hussey S, Mclean B, Lewis M, Croft N, Barakat FM, Griffiths AM, Turner D. Item Generation and Reduction Toward Developing a Patient-reported Outcome for Pediatric Ulcerative Colitis (TUMMY-UC). J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):373-377. doi: 10.1097/MPG.0000000000001259.

ReferenceCitation: Taylor SJ, Whincup PH, Hindmarsh PC, Lampe F, Odoki K, Cook DG. Performance of a new pubertal self-assessment questionnaire: a preliminary study. Paediatr Perinat Epidemiol. 2001 Jan;15(1):88-94.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Finland
Canada
Sweden
Hungary
United States
France
Israel
Belgium
Japan
Germany
Slovakia

location_facility: Hospital Materno-Infantil de Málaga (Hospital Regional Universitario de Málaga)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Sahlgrenska Sjukhuset, Drottning Silvias Barn- och Ungdomssjukhus

location_facility: Outpatient Pediatric Research Center Children's Healthcare of Atlanta

location_facility: London Health Sciences Centre - Children's Hospital

location_facility: University of California, San Francisco Pediatric Clinical Research Center (PCRC)

location_facility: Schneider Children's Medical Center of Israel

location_facility: Buerger Center for Advanced Pediatric Care

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: University of California, San Francisco (Admin Only)

location_facility: Erasmus Medical Center - Sophia Children's Hospital

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Azienda USL di Bologna - IRCCS ISNB - Programma Gastroenterologia Pediatrica

location_facility: Texas Children's Hospital - Clinical Research Center

location_facility: Borsod- Abauj- Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Connecticut Children's Ambulatory Surgical Center

location_facility: Sachsska Children's and Youth Hospital/South General Hospital

location_facility: Texas Children's Hospital - RRO Regulatory (Administrative Offices - Regulatory Location)

location_facility: Northwell Health - Cohen Children's Medical Center

location_facility: Texas Children's Hospital - Wallace Tower

location_facility: Karolinska Universitetssjukhuset Barngastroenterologi, hepatologi och nutrition

location_facility: Weill Cornell Medicine - New York Presbyterian Hospital

location_facility: The Hospital for Sick Children - Division of Gastroenterology, Hepatology and Nutrition

location_facility: Atlantic Health System- Morristown Medical Center (Pharmacy)

location_facility: University of California, San Francisco Benioff Children's Hospital

location_facility: Aichi Children's Health and Medical Center

location_facility: Women's and Children's Hospital, Women's and Children's Health Network Inc.

location_facility: Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai

location_facility: Atlantic Children's Health-Pediatric Gastroenterology & Nutrition

location_facility: Texas Children's Hospital - Feigin Tower (Administrative Offices - Research Administrative Offices)

location_facility: Morgan Stanley Children's Hospital, CUIMC

location_facility: CUIMC Research Pharmacy - Milstein Hospital (Pharmacy Only)

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Stollery Children's Hospital University of Alberta

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy

location_facility: King's College Hospital NHS Foundation Trust

location_facility: National Center for Child Health and Development

location_facility: Mount Sinai Hospital (Investigational Drug Pharmacy)

location_facility: Mount Sinai Hospital Endoscopy Center (Endoscopy Only)

location_facility: Goryeb Children's Hospital (Endoscopy only)


title: RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

summary: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

lead_sponsor: CymaBay Therapeutics, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Canada
Switzerland
Hungary
Germany
Denmark
Greece
New Zealand
Korea, Republic of
France
Chile

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Southern Therapy and Advanced Research, LLC (STAR)

location_facility: Ankara Gazi University Faculty of Medicine Hospital

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases

location_facility: Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: The Institute for Liver Health DBA Arizona Liver Health

location_facility: University of Minnesota Medical Center, Fairview

location_facility: University of California, Davis Medical Center

location_facility: CINME (Centro de Investigaciones Metabolicas)

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme

location_facility: Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie

location_facility: Bon Secours Richmond Community Hospital LLC

location_facility: Hospital Universitario Dr. Jose Eleuterio González

location_facility: Clinic of High Medical Technologies n.a. N.I. Pirogov

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Hospital Universitario German Trias i Pujol

location_facility: Domaine Universitaire du Sart Tilman Batiment B 35

location_facility: Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie

location_facility: Gastroenterology Research Unit Dunedin Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Institute for Digestive Tract & Liver Disease

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Hospital Universitario Margues de Valdecilla

location_facility: University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)

location_facility: Universitatsklinik Tubingen, Medizinische Klinik, lnnere Medizin I

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: University of Colorado Denver and Hospital

location_facility: State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology

location_facility: Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Liver Disease Center, Sheba Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Tulane University Health Sciences Center

location_facility: University of Zurich, Gastroenterology and Hepatology

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie

location_facility: Universitatsklinikum Frankfurt. Medizinische Klinik I

location_facility: University of Texas Southwestern Medical Center

location_facility: Gastroenterologisch Hepatologisches Zentrum Kiel


title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease

lead_sponsor: Wave Life Sciences Ltd.

location_country:
Denmark
Poland
United Kingdom
Australia
Canada
France
Germany

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Odense University Hospital and University of Southern Denmark

summary: WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.


title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's Disease

summary: WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.


title: A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study With a 36-Week Extension to Investigate the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis Despite Treatment With Topical Medications (The HILLIER Study)

summary: The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

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:
Poland
Spain
Australia
Korea, Republic of
United States
France
Bulgaria
Czechia


title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect

acronym: ASCENT ASD

summary: Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

lead_sponsor: atHeart Medical

location_country:
United States
France

location_facility: Joe DiMaggio Children's Hospital/Memorial Healthcare System

location_facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)


title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia

summary: This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

ReferenceCitation: Augsberger C, Hänel G, Xu W, Pulko V, Hanisch LJ, Augustin A, Challier J, Hunt K, Vick B, Rovatti PE, Krupka C, Rothe M, Schönle A, Sam J, Lezan E, Ducret A, Ortiz-Franyuti D, Walz AC, Benz J, Bujotzek A, Lichtenegger FS, Gassner C, Carpy A, Lyamichev V, Patel J, Konstandin N, Tunger A, Schmitz M, von Bergwelt-Baildon M, Spiekermann K, Vago L, Jeremias I, Marrer-Berger E, Umaña P, Klein C, Subklewe M. Targeting intracellular WT1 in AML with a novel RMF-peptide-MHC-specific T-cell bispecific antibody. Blood. 2021 Dec 23;138(25):2655-2669. doi: 10.1182/blood.2020010477. Erratum in: Blood. 2022 Mar 31;139(13):2086-2087.

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

location_country:
Denmark
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Germany

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Institut Paoli Calmettes; Departement D' Onco-Hematologie

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

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

location_facility: Washington University; Wash Uni. Sch. Of Med


title: Abbott Vascular Medical Device Registry

acronym: AV-MDR

summary: The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

location_country:
Taiwan
Spain
Italy
Austria
Australia
Netherlands
Switzerland
Hungary
United States
France
China
Belgium
Germany
United Arab Emirates

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Cardioangiologisches Centrum am Bethanien Krankenhaus

location_facility: Hospital General Universitario de Alicante

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

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

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Inselspital - University Hospital of Bern


title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Stoffers-Winterling JM, Storebø OJ, Pereira Ribeiro J, Kongerslev MT, Völlm BA, Mattivi JT, Faltinsen E, Todorovac A, Jørgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11:CD012956. doi: 10.1002/14651858.CD012956.pub2. Review.

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Denmark
Poland
Spain
Italy
Australia
Mexico
Argentina
Sweden
United States
France
Belgium
Japan
Germany
Bulgaria
Czechia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Hospital Provincial. Complejo Asistencial de Zamora

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Region Zealand, Psychiatric Research Unit

location_facility: University at Buffalo, The State University of New York

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Centro de Estudios Clinicos de Queretaro S.C

location_facility: Peninsula Therapeutic and Research Group

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: IRCCS San Giovanni Di Dio Fatebenefratelli

location_facility: Pacific Clinical Research Management Group LLC

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

summary:
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study.

Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.

Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.


acronym: PAGANINI

title: Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

lead_sponsor: Bayer

ReferenceCitation: Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Hungary
United States
France
Turkey
Belgium
Japan
Germany
Slovakia
Czechia

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

location_facility: Zentrum f. ambulante pneumologische Forschung Marburg GbR

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Japan community health care organization Kanazawa Hospital

location_facility: Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

location_facility: City Clinical Hospital n.a. D.D. Pletnev

location_facility: Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna

location_facility: Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.

location_facility: Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.

location_facility: California Allergy & Asthma Medical Group & Research Center

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Burlington Lung Clinic (BLC) Clinical Research

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Investigación en Alergias y Enfermedades Respiratorias-INAER

location_facility: Praxis f. Lungen- und Bronchialheilkunde,

location_facility: City Consultative and Diagnostic Center #1

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Ordinace pro TBC a respiracni nemoci, s.r.o.

location_facility: Centro Médico Dra. De Salvo - Clinical Research Center

location_facility: Investigaciones en Patologías Respiratorias

location_facility: Bellingham Asthma, Allergy & Immunology Clinic

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: King's College Hospital - NHS Foundation Trust

location_facility: EKBC, Uj Szent Janos Korhaz es Szakrendelo

location_facility: University of Occupational and Environmental Health

summary:
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.

Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


title: ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

acronym: ConTTRibute

summary:
The purpose of this study is to:

Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
Characterize the safety and effectiveness of patisiran as part of routine clinical practice in the real-world clinical setting
Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) mutation

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Denmark
Portugal
Spain
Italy
Netherlands
United States
Israel
France
Germany


title: A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

summary: 160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 48 weeks.

lead_sponsor: Savara Inc.

location_country:
Poland
Portugal
Romania
Spain
Greece
Ireland
Australia
Italy
Canada
Netherlands
United Kingdom
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany

location_facility: Tohoku University Hospital - Respiratory Tract Medicine

location_facility: Yedikule Chest Disease and Surgery Training and Research Hospital

location_facility: University Of Arkansas For Medical Services

location_facility: Ege University Hospital - Department of Pulmonology

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: St Joseph's Healthcare Hamilton Research

location_facility: Chiba University Hospital - Respiratory Medicine

location_facility: UZ Leuven - Campus Gasthuisberg - Pneumologie

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: National Hospital Organization Kinki-Chuo Chest medical Center

location_facility: Health Sciences University Gulhane Training and Research Hospital

location_facility: Institutul de Pneumoftiziologie "Marius Nasta"

location_facility: University of Pennsylvania Perelman School of Medicine - Pulmonology

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Severance Hospital - Yonsei University Health System - Pulmonary

location_facility: Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: University Institute of Cardiology and Respirology of Quebec