title: A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

summary: The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

ReferenceCitation: Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Björck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

location_country: Romania Australia Netherlands Hungary France Belgium Norway Germany


type: EudraCT Number

title: An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge in Participants With Chronic Kidney Disease Treated for Hyperkalaemia

acronym: CONTINUITY

summary:
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining:

If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital.
If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

acronym: RESOLVE-MR

summary: To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Saudi Arabia
Italy
Austria
Netherlands
Spain
United Kingdom
Switzerland
France
Israel
Belgium
Norway
Germany
Czechia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Lancisi Cardiovascular Center - Politechnic University of Marcher

location_facility: University Hospital Basel, Clinic for Cardiac Surgery

intervention_type: Device


intervention_type: Biological

title: A Phase 3b, Prospective, Open-label, Multicenter, Single Treatment Arm, Continuation Study of the Safety and Efficacy of TAK-755 (rADAMTS13, Also Known as BAX 930/SHP655) in the Prophylactic and On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP; Upshaw-Schulman Syndrome, or Hereditary Thrombotic Thrombocytopenic Purpura)

lead_sponsor: Takeda

source: euctr

design_allocation: Non-Randomized

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:
Poland
Spain
Italy
Austria
United Kingdom
Switzerland
United States
France
Japan
Germany

location_facility: Medical Hospital,Tokyo Medical and Dental University

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Universitaetsklinikum Jena, Klinik fuerKinder-und Jugendmedizin

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

summary:
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can also occur. People who have TTP may bleed underneath the skin forming purple bruises, or purpura. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them, leading to fewer red blood cells than in normal.

TTP is caused by a lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in controlling clotting of the blood. The ADAMTS13 enzyme breaks up another blood protein called von Willebrand factor that forms blood clots by clumping together with platelets. Some people are born with this condition, while others develop the condition during their life. Many people who are born with TTP experience frequent flare-ups that need to be treated right away. TAK-755 is a medicine that replaces ADAMTS13 and may prevent or control TTP flare-ups, called acute TTP events.

The main aim of the study is to check for side effects of long-term treatment with TAK-755. Treatment will be given in 2 ways:

TAK-755 treatment given either every week or every other week to prevent acute TTP events from happening (the "prophylactic" cohort).
TAK-755 treatment given to control an acute TTP event when it happens (the "on-demand" cohort).

Participants in the prophylactic cohort will receive treatment in the clinic or at home for up to approximately 3 years. They will visit the clinic at least every 12 weeks. Participants in the on-demand cohort will receive daily treatment for the acute TTP event until the flare-up has gotten better. They will have a follow-up visit at the clinic 4 weeks later.


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.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital Tuebingen

location_country: Spain Finland France Belgium Germany

location_facility: Fundacio Hospital Universitari Vall D'Hebron

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


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

acronym: ANGEL

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).

status: Completed

lead_sponsor: Elevar Therapeutics

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

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

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

location_facility: Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Japan Community Health Care Organization Kyushu Hospital

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

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

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

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: Municipal Institution "Kyiv City Clinical Oncological Center"

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: Saint Constantin Hospital (TEO HEALTH SA)

location_facility: Chungbuk National University Medical Center

location_facility: Ospedale di Piacenza - Oncology and heamatology

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

location_facility: Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

location_facility: Institut Regional du Cancer Montpellier (ICM)

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

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

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

location_facility: Communal Institution "Transcarpathian Regional Clinical Oncological Center"

location_facility: Fondazione IRCCS-Istituto Nazionale Tumori

location_facility: Kyungpook National University Medical Center

location_facility: Chi Mei Medical Center - LiouYing Branch

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

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

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Saku Central Hospital Advanced Care Center

location_facility: Severence Hospital, Yonsei University Health System

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

location_facility: Seoul National University Bundang Hospital

location_facility: Chang Gung Memorial Hospital - Linko Branch

location_facility: Keimyung University Dongsan Medical Center

location_facility: Veterans Health Service (VHS) Medical Center

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

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

location_facility: Ospedali Riuniti di Ancona - SOD Clinica Oncologica

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

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

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

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

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Dnipropetrovsk Medical Academy, Department of Oncology

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

location_facility: Centre Hospitalier Franco-Britannique; Oncologie Médicale

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

location_country: Poland France Czechia

location_facility: Maison de santé protestante de Bordeaux Bagatelle

location_facility: Institute for Clinical and Experimental Medicine

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

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

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


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

lead_sponsor: CSL Behring

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

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 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:
Italy
Korea, Republic of
United States
France
Germany

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.

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.

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. TGFβ 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.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United States
France
Belgium
Germany

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_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:
Germany
United States
France
Belgium

location_facility: College of Physicians and Surgeons of Columbia University

location_facility: Dana Farber Cancer Institute Dept of Sarcoma Oncology


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.

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.

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

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


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.

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.

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. Review.

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

location_country:
Saudi Arabia
New Zealand
Australia
Qatar
Switzerland
France

location_facility: Hôpital Gabriel Montpied + CHU Clermont-Ferrand

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre


acronym: SENSE

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

lead_sponsor: Janssen-Cilag International NV

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: Fätkenheuer 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.

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

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.


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: Schröder 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.

lead_sponsor: GlaxoSmithKline

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


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

location_country: Germany France Italy Belgium


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.

location_country: Australia France Germany Netherlands

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, Villà 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.

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

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro

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

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation


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.

location_country: Denmark Croatia France Belgium Netherlands Egypt

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center


title: A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) for the Treatment of Advanced, Refractory Microsatellite Stable Colorectal Cancer Without Liver Metastases

summary: This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced refractory microsatellite stable colorectal cancer without liver metastases.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Agenus Inc.

location_country:
Spain
Italy
United States
France
Belgium

location_facility: CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)

location_facility: Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island)

location_facility: Service d'Oncologie Medicale - CHRU Besancon

location_facility: Virginia Cancer Specialists/ NEXT Virginia

location_facility: Tennessee Oncology Nashville (Sarah Cannon)

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Florida Cancer Specialists and Research Institute - Lake Mary

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

location_facility: Keck School of Medicine of the University of Southern California

location_facility: Hôpital Saint Antoine/AP-HP Hopital Saint Antoine (Pierre and Marie Curie University)

location_facility: Unversite Paris-Saclay Gustave Roussy Cancer Center Campus Paris

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Fondazione IRCCS Instituto Nazionale dei Tumori

location_facility: Oregon Health & Science University (OHSU)

location_facility: Atlantic Health System - Morristown Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara

location_facility: Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute

location_facility: Clínica Universidad de Navarra - Sede Madrid

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Vanderbilt University School of Medicine


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

location_facility: University Hospital Centre "Mother Theresa" Tirana

location_facility: Emergency Center Belgrade, Clinical Centre Belgade

location_facility: AHEPA Univesrity General Hospital of Thessaloniki

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: University Hospital Coventry & Warwickshire

location_facility: Cluj Napoca County Emergency Clinical Hospital

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

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

location_facility: Regional Hospital Centre "Xh. Kongoli" Elbasan

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

location_facility: Semmelweis University Department of Emergency Medicine

location_facility: Necmettin Erbakan University Medical Faculty Department of Emergency Medicine

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

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

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

location_facility: Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken

location_facility: Gazi University Medical Faculty Department of Emergency Medicine

location_facility: Emergency Department Zaječar, Health Center Zaječar


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

summary: The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

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.

location_country:
Poland
Taiwan
Spain
Australia
Argentina
Canada
United States
France
Mexico
Japan
Germany
Czechia

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Respiratory Medicine Research Institute of Michigan, PLC

location_facility: The University of Texas Health Science Center at Houston

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: PanAmerican Clinical Research - Cuernavaca

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Studienzentrum an der Hase Dr. Weyergraf/Dr. Frick/T. Heiber GbR

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: National Taiwan University Hospital - Hsinchu branch

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu


type: U.S. NIH Grant/Contract

title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-part Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary: The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Part 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6. Review.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13. Review.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

location_country:
Spain
Ireland
Italy
Australia
Mexico
Argentina
Canada
Netherlands
United Kingdom
Puerto Rico
United States
France
Colombia
Germany

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: University of California San Diego Medical Center

location_facility: University of Puerto Rico, School of Medicine

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI


title: An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)

acronym: VENTURA-LT

summary: The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Serbia
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Japan
Czechia
Poland
Portugal
Australia
Argentina
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
Bulgaria
Taiwan
Korea, Republic of
France

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: Univerzitna nemocnica L. Pasteura Kosice

location_facility: Psychiatricka ambulance Saint Anne s.r.o.

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: CENydET - Centro Neurobiologico y de Stress Traumatico

location_facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

location_facility: INSA Instituto de Neurociencias San Agustín

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

location_facility: Medical Research Group of Central Florida

location_facility: Ambulatory Group practice for specialized help in psychiary Philipopolis ODD

location_facility: C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

location_facility: Instituto de Informacion e Investigacion en Salud Mental A.C.

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

location_facility: Hospital Aranda de la Parra S.A. de C.V.

location_facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais

location_facility: Psychiatric Care and Research Center (PCRC)

location_facility: Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Alabama at Birmingham - The Kirklin Clinic

location_facility: USF, Department of Psychiatry and Behavioral Neurosciences

location_facility: The Catholic University Of Korea St Mary'S Hospital

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

location_facility: SP Research, PLLC (dba Rivus Wellness & Research Institute)

location_facility: CEN-Consultorios Especializados en Neurociencias

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: University of Ottawa Institute of Mental Health Research

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: Psychiatricka Ambulancia Psycholine S.R.O.

location_facility: Mental Health Center - Veliko Tarnovo EOOD

location_facility: Innovative Research of West Florida, Incorporated

location_facility: Hospital De Clínicas Da Universidade Federal Do Paraná

location_facility: Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard

location_facility: Specjalistyczna Indywidualna Praktyka Lekarska

location_facility: SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi

location_facility: True North Clinical Research Halifax - D.B.A Centricity Research Halifax

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

location_facility: Ruschel Medicina e Pesquisa Clínica Ltda

location_facility: Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

location_facility: Crisis Resolution and Home Treatment Team

location_facility: University of Kansas Medical Center Research Institute

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

location_facility: CHRU de Tours Clinique Psychiatrique Universitaire

location_facility: Premier Psychiatric Research Institute, LLC

location_facility: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

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

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

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. 'SINACOR'

location_facility: Hospital Universitário Walter Cantídio - UFCE

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Hospital de Base da Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

location_facility: Instituto Medico de La Fundacion Estudios Clinicos


title: TALISMAN - Tracking Longitudinal Changes in MSA - International Natural History Study

acronym: TALISMAN

summary:
Talisman is global clinical study (20058N) in Multiple System Atrophy (MSA) patients. It will be conducted in two regions (China and the European Union [EU]). There will be common study objectives between China and EU regions (including prospective assessments for MSA disease progression during routine clinical visits for MSA), and this will allow for data (on common objectives) to be presented overall and stratified by region. There will also be study objectives specific to each region: 1) the clinical assessment for MSA (Unified MSA Rating Scale [UMSARS]) has not been validated using standardised methods in China, and so the psychometric properties of the Chinese version of the UMSARS will be examined in Chinese patients in this study; 2) there will be retrospective assessments and prospective protocol-mandated assessments (of Magnetic Resonance Imaging [MRI] and bloods biomarkers) and study visits for EU patients.

Because some study objectives are the same for China and the EU (i.e., prospective assessments during routine clinical visits for MSA), and other objectives are specific to each region, there will be one regional protocol for China and one regional protocol for the EU; each describing the study assessments relevant to each region.

lead_sponsor: H. Lundbeck A/S

location_country: Germany France China Italy

location_facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

location_facility: Xiangya Hospital of Central South University

location_facility: West China Hospital of Sichuan University

location_facility: IRCCS IStituto delle Scienze Neurologiche di Bologna

location_facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Beijing Xuanwu Hospital, Capital Medical University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore

intervention_type: Diagnostic Test


title: A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

summary: The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

location_country:
Denmark
Poland
Australia
United States
France
Israel

location_facility: Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole


title: A Randomized, Double-blind, Placebo-controlled, Two Parallel Groups, International Multicenter Trial to Evaluate the Effect of Plerixafor in Acute Respiratory Failure Related to COVID-19.

acronym: LEONARDO

summary:
This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age,

with acute respiratory failure related to COVID-19 and
Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure
without invasive mechanical ventilation and
requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation > 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...).

Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

status: Active, not recruiting

lead_sponsor: 4Living Biotech

location_country: Bulgaria France

location_facility: Multiprofile Hospital For Active Treatment Pazardzhik AD

location_facility: Multiprofile Hospital for Active Treatment AD Haskovo

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Multiprofile Hospital for Active Treatment Dr Ivan SeliminskiSliven AD

location_facility: University Multiprofile Hospital for Active Treatment Prof Dr Stoyan Kirkovich AD

location_facility: University Hospital for Active Treatment and Emergency Medicine NI Pirogov EAD

location_facility: University First Multiprofile Hospital for Active Treatment Sofia St John the Baptist

location_facility: Centre Hospitalier Départemental de Vendée - Les Oudairies

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment Sofia


type: Other Grant/Funding Number

type: Registry Identifier

title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

summary: To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.

ReferenceCitation: Jack CR Jr, Knopman DS, Jagust WJ, Petersen RC, Weiner MW, Aisen PS, Shaw LM, Vemuri P, Wiste HJ, Weigand SD, Lesnick TG, Pankratz VS, Donohue MC, Trojanowski JQ. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013 Feb;12(2):207-16. doi: 10.1016/S1474-4422(12)70291-0.

ReferenceCitation: Fitzpatrick AWP, Falcon B, He S, Murzin AG, Murshudov G, Garringer HJ, Crowther RA, Ghetti B, Goedert M, Scheres SHW. Cryo-EM structures of tau filaments from Alzheimer's disease. Nature. 2017 Jul 13;547(7662):185-190. doi: 10.1038/nature23002. Epub 2017 Jul 5.

ReferenceCitation: Falcon B, Zhang W, Murzin AG, Murshudov G, Garringer HJ, Vidal R, Crowther RA, Ghetti B, Scheres SHW, Goedert M. Structures of filaments from Pick's disease reveal a novel tau protein fold. Nature. 2018 Sep;561(7721):137-140. doi: 10.1038/s41586-018-0454-y. Epub 2018 Aug 29.

ReferenceCitation: Kopeikina KJ, Hyman BT, Spires-Jones TL. Soluble forms of tau are toxic in Alzheimer's disease. Transl Neurosci. 2012 Sep;3(3):223-233.

ReferenceCitation: Braak H, Braak E. Neuropathological stageing of Alzheimer-related changes. Acta Neuropathol. 1991;82(4):239-59. Review.

ReferenceCitation: Goedert M, Spillantini MG. Propagation of Tau aggregates. Mol Brain. 2017 May 30;10(1):18. doi: 10.1186/s13041-017-0298-7. Review.

ReferenceCitation: Falcon B, Cavallini A, Angers R, Glover S, Murray TK, Barnham L, Jackson S, O'Neill MJ, Isaacs AM, Hutton ML, Szekeres PG, Goedert M, Bose S. Conformation determines the seeding potencies of native and recombinant Tau aggregates. J Biol Chem. 2015 Jan 9;290(2):1049-65. doi: 10.1074/jbc.M114.589309. Epub 2014 Nov 18.

ReferenceCitation: Barghorn S, Zheng-Fischhöfer Q, Ackmann M, Biernat J, von Bergen M, Mandelkow EM, Mandelkow E. Structure, microtubule interactions, and paired helical filament aggregation by tau mutants of frontotemporal dementias. Biochemistry. 2000 Sep 26;39(38):11714-21.

ReferenceCitation: von Bergen M, Friedhoff P, Biernat J, Heberle J, Mandelkow EM, Mandelkow E. Assembly of tau protein into Alzheimer paired helical filaments depends on a local sequence motif ((306)VQIVYK(311)) forming beta structure. Proc Natl Acad Sci U S A. 2000 May 9;97(10):5129-34.

ReferenceCitation: von Bergen M, Barghorn S, Li L, Marx A, Biernat J, Mandelkow EM, Mandelkow E. Mutations of tau protein in frontotemporal dementia promote aggregation of paired helical filaments by enhancing local beta-structure. J Biol Chem. 2001 Dec 21;276(51):48165-74. Epub 2001 Oct 17.

ReferenceCitation: Salloway S, Farlow M, McDade E, Clifford DB, Wang G, Llibre-Guerra JJ, Hitchcock JM, Mills SL, Santacruz AM, Aschenbrenner AJ, Hassenstab J, Benzinger TLS, Gordon BA, Fagan AM, Coalier KA, Cruchaga C, Goate AA, Perrin RJ, Xiong C, Li Y, Morris JC, Snider BJ, Mummery C, Surti GM, Hannequin D, Wallon D, Berman SB, Lah JJ, Jimenez-Velazquez IZ, Roberson ED, van Dyck CH, Honig LS, Sánchez-Valle R, Brooks WS, Gauthier S, Galasko DR, Masters CL, Brosch JR, Hsiung GR, Jayadev S, Formaglio M, Masellis M, Clarnette R, Pariente J, Dubois B, Pasquier F, Jack CR Jr, Koeppe R, Snyder PJ, Aisen PS, Thomas RG, Berry SM, Wendelberger BA, Andersen SW, Holdridge KC, Mintun MA, Yaari R, Sims JR, Baudler M, Delmar P, Doody RS, Fontoura P, Giacobino C, Kerchner GA, Bateman RJ; Dominantly Inherited Alzheimer Network-Trials Unit. A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer's disease. Nat Med. 2021 Jul;27(7):1187-1196. doi: 10.1038/s41591-021-01369-8. Epub 2021 Jun 21.

ReferenceCitation: Sandusky-Beltran LA, Sigurdsson EM. Tau immunotherapies: Lessons learned, current status and future considerations. Neuropharmacology. 2020 Sep 15;175:108104. doi: 10.1016/j.neuropharm.2020.108104. Epub 2020 Apr 28. Review.

location_country:
Brazil
Spain
Ireland
Italy
Australia
Mexico
Argentina
Canada
Netherlands
United Kingdom
Puerto Rico
United States
France
Colombia
Japan
Germany

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Niigata University Medical & Dental Hospital

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: University of California San Diego Medical Center

location_facility: University of Puerto Rico, School of Medicine

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: Osaka City University Hospital Clinical Research Center of Dementia


title: A Phase 2, Randomised, Double-Blind, Placebo and Active Comparator-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD5718 Given Orally Once Daily for Twelve Weeks in Adults With Moderate-to-Severe Uncontrolled Asthma

acronym: FLASH

summary: This is a randomised, placebo-controlled, double-blind study with an active comparator (montelukast) arm to assess the efficacy and safety of AZD5718 administered at multiple dose levels over a 12-week treatment period to adult participants with moderate-to-severe uncontrolled asthma.

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:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
South Africa
Japan
Poland
Slovenia
Australia
Turkey
Mexico
Slovakia
Hungary
Germany
Bulgaria
Korea, Republic of
France
Netherlands


title: A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 4 tumor-specific cohorts at the RDE(s) defined in Part 1A.

lead_sponsor: Incyte Corporation

location_country:
United Kingdom
Italy
Switzerland
United States
France
Japan
Netherlands

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Oncological Institute of Southern Switzerland

location_facility: Saitama Medical University International Medical Center

location_facility: Texas Oncology - Fort Worth South Henderson

location_facility: Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Rocky Mountain Cancer Centers- Sky Ridge

location_facility: City of Hope - Lennar Foundation Cancer Center

location_facility: Inselspital Universitatsklinik Fur Medizinische Onkologie

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Centre Hospitalier Universitaire Vaudois (Chuv)

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore 2

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole


title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)

summary:
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.

Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

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 http://trials.boehringeringelheim.com/ 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.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Australia
Israel
Mexico
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Korea, Republic of
France
Netherlands

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Dr. Piotr Napora, Center of Clinical Research

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: University of Florida College of Medicine

location_facility: University of Texas Health Science Center at Tyler

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: New York University Langone Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Institute for Translational Oncology Research

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

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

location_facility: Respiratory Medicine Centre, private prac., Bialystok


title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

acronym: SEAMARK

summary:
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that:

is metastatic (spread to other parts of the body);
has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR)
has a certain type of abnormal gene called "BRAF" and;
has not received prior treatment.

All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic.

In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic.

The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

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:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Belgium
Norway
Germany
Slovakia
Czechia

location_facility: Guy's & St Thomas's NHS Foundation Trust

location_facility: Mayo Clinic Cancer Center Outpatient Pharmacy

location_facility: Hospital General Universitario de Valencia

location_facility: Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie

location_facility: Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

location_facility: Institut für Klinisch Onkologische Forschung

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The West Clinic, PLLC dba West Cancer Center

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: ASST Grande Ospedale Metropolitano Niguarda


title: A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

summary: A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

lead_sponsor: Crinetics Pharmaceuticals Inc.

location_country:
Poland
Spain
Italy
Argentina
Hungary
United States
France
Germany


title: An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

summary: The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.

lead_sponsor: Gilead Sciences

location_country:
Taiwan
Hong Kong
Spain
Australia
Korea, Republic of
United States
France
Germany

location_facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: University of California Los Angeles (UCLA)

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

location_facility: Northside Hospital Central Research Department

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Regional Universitario de Malaga-Hospital Civil

location_facility: Sunshine Coast University Private Hospital


title: Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®

acronym: RANS

summary: The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

time_perspective: Retrospective

location_country:
Spain
Italy
United States
France
Japan
Germany


title: A Multicenter, Open-label, Phase 1 Study Evaluating the Safety and Tolerability of HMPL-760 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Other Non-Hodgkin Lymphoma (NHL)

summary: An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL

lead_sponsor: Hutchmed

location_country:
Poland
Spain
Italy
Australia
United States
Israel
France

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: New York University Langone Med Center. Lab

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals


title: A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Norway
Sweden

location_facility: UT Southwestern-Harold C. Simmons Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology

location_facility: The University Of Texas MD Anderson Cancer Center

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


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects With Focal Onset Seizures (FOS)

summary: This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures

lead_sponsor: Neurocrine Biosciences

location_country: Spain Italy Australia Hungary France Belgium Czechia


title: A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma

summary: This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.

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 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 shared.

location_country:
Taiwan
Hong Kong
United Kingdom
Italy
Australia
Sweden
Korea, Republic of
United States
France
Singapore


title: A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms

lead_sponsor: Amzell

location_country:
Poland
United States
Spain
France

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

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Provincial Specialist Children's Hospital st. Ludwika

location_facility: Staten Island University Hospital, North

summary: The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).


title: A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

summary: The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

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-trials-and-research/disclosurecommitment.html

location_country:
Poland
Spain
United Kingdom
Russian Federation
United States
France
Israel
Belgium
Japan

location_facility:
Washington University
Cedars-Sinai Medical Center
Local Institution - 0071
Local Institution - 0058
Texas Children's Hospital
Local Institution - 0073
Local Institution - 0068
Local Institution - 0066
Local Institution - 0056
Local Institution - 0030
Local Institution - 0061
Local Institution - 0044
Measurable Outcomes Research
AdventHealth Orlando
Valley View Wellness Medical Center
Local Institution - 0059
Local Institution - 0069
Local Institution - 0017
Local Institution
Mayo Clinic in Rochester, Minnesota


title: Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

lead_sponsor: Novo Nordisk A/S

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

location_country:
Denmark
Saudi Arabia
Spain
Russian Federation
Canada
United States
France
South Africa
Colombia
Norway
Sweden

summary:
This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


title: A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)

acronym: DREAMM 14

summary: This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Ireland
Australia
Italy
Argentina
Canada
Thailand
United Kingdom
Korea, Republic of
United States
France
India
Mexico
Germany


title: A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

summary:
The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).

The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Japan
Czechia
Russian Federation
Australia
Turkey
Israel
Norway
Malaysia
Canada
China
Germany
Taiwan
Korea, Republic of
France
Chile

location_facility: Masarykuv onkologicky ustav ( Site 1203)

location_facility: St John of God Subiaco Hospital ( Site 0051)

location_facility: China Medical University Hospital ( Site 0953)

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0956)

location_facility: Fakultni Thomayerova nemocnice ( Site 1205)

location_facility: Southern Medical University Nanfang Hospital ( Site 1154)

location_facility: LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)

location_facility: Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)

location_facility: Wuhan Union Hospital Cancer Center ( Site 1162)

location_facility: The Third Xiangya Hospital of Central South University ( Site 1175)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1257)

location_facility: Institut du Cancer Avignon-Provence ( Site 0306)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)

location_facility: Hospital Universitari Vall d Hebron ( Site 0900)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1703)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

location_facility: Japanese Foundation for Cancer Research ( Site 0602)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)

location_facility: Intermountain Medical Center ( Site 1707)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0860)

location_facility: Universitetssykehuset i Nord Norge. ( Site 1355)

location_facility: Shanghai Tenth People's Hospital ( Site 1170)

location_facility: Western Health-Sunshine & Footscray Hospitals ( Site 0052)

location_facility: National Cancer Center Hospital ( Site 0601)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0208)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)

location_facility: Seattle Cancer Care Alliance ( Site 1107)

location_facility: The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

location_facility: National Cancer Center Hospital East ( Site 0600)

location_facility: Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)

location_facility: Ukrainian Center of Tomotherapy ( Site 1658)

location_facility: MUSC Hollings Cancer Center ( Site 1715)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1056)

location_facility: Royal Brisbane and Women s Hospital ( Site 0058)

location_facility: Seoul National University Hospital ( Site 0653)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0609)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 1208)

location_facility: Fakultni nemocnice Na Bulovce ( Site 1202)

location_facility: University Hospital Coventry & Warwickshire ( Site 1062)

location_facility: Cancercare Rondebosch Oncology ( Site 1509)

location_facility: Istituto Clinico Humanitas - Cancer Center ( Site 0555)

location_facility: UT Southwestern Medical Center ( Site 1709)

location_facility: Hadassa Ein Karem Medical Center ( Site 0504)

location_facility: Taipei Veterans General Hospital ( Site 0951)

location_facility: Hospital Universitario Virgen Macarena ( Site 0906)

location_facility: Centro Investigacion Cancer James Lind ( Site 0204)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1064)

location_facility: Philipps-Universitaet Marburg. ( Site 1252)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 1351)

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1050)

location_facility: London Regional Cancer Program - London HSC ( Site 0154)

location_facility: IRCCS Casa Sollievo della Sofferenza ( Site 0554)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0952)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)

location_facility: Hospital Universitario 12 de Octubre ( Site 0901)

location_facility: Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)

location_facility: Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)

location_facility: Policlinico Gemelli di Roma ( Site 0552)

location_facility: SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)

location_facility: Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)

location_facility: Akershus universitetssykehus ( Site 1352)

location_facility: Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

location_facility: Fujian Province Cancer Hospital ( Site 1178)

location_facility: FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)

location_facility: Pantai Hospital Kuala Lumpur ( Site 1303)

location_facility: A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)

location_facility: Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)

location_facility: West China Hospital Sichuan University ( Site 1172)

location_facility: National Taiwan University Hospital ( Site 0950)

location_facility: Odessa Regional Clinical Hospital ( Site 1664)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 1149)

location_facility: Hopital Europeen Georges Pompidou ( Site 0300)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1105)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0206)

location_facility: Antalya Egitim ve Arastirma Hastanesi ( Site 1010)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0500)

location_facility: Inova Schar Cancer Institute ( Site 1130)

location_facility: National Cheng Kung University Hospital ( Site 0955)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1654)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1506)

location_facility: Xiangya Hospital Central South University ( Site 1171)

location_facility: VCU Health Adult Outpatient Pavillion ( Site 1712)

location_facility: Hospital Sant Pau i la Santa Creu ( Site 0905)

location_facility: Johanniter Krankenhaus Bonn ( Site 1254)

location_facility: Fakultni nemocnice v Motole ( Site 1201)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1501)

location_facility: Georgetown University Hospital ( Site 1148)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 1003)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)

location_facility: Hospital Clinico San Carlos ( Site 0902)

location_facility: University Malaya Medical Centre ( Site 1301)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 1207)

location_facility: Saitama Prefectural Cancer Center ( Site 0603)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 1302)

location_facility: Sun Yat-Sen University Cancer Center ( Site 1150)

location_facility: Fudan University Shanghai Cancer Center ( Site 1176)

location_facility: Oregon Health & Science University ( Site 1141)

location_facility: SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (


title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

summary: The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
United Kingdom
Australia
United States
France
Belgium
Netherlands

location_facility: Washington University School of Medicine

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole


title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

acronym: OASIS 1

summary:
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

healthy food choices
how to be more physically active
what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

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

location_country:
Denmark
Poland
Russian Federation
Finland
Canada
United States
France
Japan
Germany


acronym: PEARL-PROVOKE

title: A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

lead_sponsor: Novartis Pharmaceuticals

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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:
Taiwan
Slovenia
Greece
Italy
Australia
Lebanon
Russian Federation
Spain
Hungary
United States
France
Singapore
Turkey
Netherlands
Slovakia

summary: This is a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines