title: An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

summary: An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Germany
Italy
United Kingdom
Austria
United States
Spain
Canada
France

location_facility: IRCCS San Raffaele Pisana - Clinical Trial Center

location_facility: Jefferson University Hospital Philadelphia

location_facility: Wilhelminenspital Department of Neurology

location_facility: Kings College, The Maurice Wohl Neuroscience Institute

location_facility: Park Nicolet Institute - Stuthers Parkinson's Center

location_facility: The Parkinson's and Movement Disorder Institute

location_facility: Duke University - Movement Disorders Clinic

location_facility: UC Irvine Health Gottschalk Medical Plaza

location_facility: Parkinson's Disease Treatment Center of Southwest Florida

location_facility: Houston Methodist Neurological Institute

location_facility: Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit

location_facility: SUNY Downstate Medical Center, Department of Neurology

location_facility: Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)

location_facility: Hospital Universitari General de Catalunya

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik

location_facility: The Ohio State University Wexner Medical Center

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center

location_facility: Medical University Innsbruck Neurology Department

location_facility: Centre d'Investigation Clinique, CIC 1436, CHU Purpan

location_facility: Muhammed Ali Parkinson and Movement Disorder Center/Barrow Neurological Institute

location_facility: Emory University Department of Neurology

location_facility: University of Miami, Miller School of Medicine

location_facility: Parkinsons Disease and Movement Disorders Center

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU

location_facility: USF Parkinson's Disease and Movement Disorder Center

location_facility: Kansas University Medical Center-Department of Neurology

location_facility: Columbia University Medical Center - Neurological Institute, Movement Disorders

location_facility: University of Colorado School of Medicine

location_facility: Michigan State University - Dept. of Neurology


type: EudraCT Number

title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

summary: Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Health Services Research

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Portugal
Hungary
United Kingdom
Denmark
Netherlands
Belgium
United States
Latvia
Spain
Bulgaria
Canada
Russian Federation
France

location_facility: AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia

location_facility: KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Universitätsklinikum Freiburg, Abteilung Pneumologie

location_facility: IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE

location_facility: FSBI "National Research Center - Institute of Immunology" of FMBA of Russia

location_facility: Debrecen Uni Medical School; Dept of Pulmonary Medicine

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Institut für Allergie- und Asthmaforschung Berlin, IAAB

location_facility: SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Hospital Universitario Reina Sofia; Servicio de Neumología

location_facility: Hvidovre Hospital, Lungemedicinsk Afdeling

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: Matrai Állami Gyógyintézet ; Bronchológia

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre

location_facility: Clinical Hospital Gailezers; Dept of Pulmonology

location_facility: Hospital de Galdakano; Servicio de Neumologia

location_facility: Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás

location_facility: Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia

location_facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Riga 1st hospital, outpatient clinic Bruninieks

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio

location_facility: Lungemedicinsk afd. L, Bispebjerg Hospital

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Hospital Clinic I provincial; Servicio de Neumologia

location_facility: Latvian University postgraduate institute

location_facility: Saratov State Medical University; Chair Of Clinical Allergology

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

location_facility: North Manchester Hospital; Respiratory Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neumologia

location_facility: Berks-Schuylkill Respiratory Specialists, Ltd

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Georgia Pollens Clinical Research Centers

location_facility: Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )

location_facility: A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B

location_facility: Jewish General Hospital; Endoscopy Department

location_facility: SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

summary:
Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844.

This study is to find out how safe and effective VTS-270 is for patients with Niemann-Pick Type C1 (NPC1) disease who have neurologic symptoms (listed under Keywords).

In Parts A/B, two out of every three patients will receive the study drug. The third patient will receive 1 to 2 small needle pricks at the location where the LP and IT injection is normally made (sham control).

In Part C, all participants will receive study drug, as described in the Part C registration record.

Start date for this record is the first day a participant was enrolled in Parts A/B. The trial is actually continuing until the last primary outcome measure of safety data are collected from Part C participants. The last primary outcome measure of safety, along with final adverse events results will be posted in the separate Part C registration record.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

ipd_sharing_description: Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02534844) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Mandos LLC

location_country:
Germany
New Zealand
United Kingdom
Singapore
Australia
United States
Spain
Turkey
France

location_facility: Multicare Institute for Research and Innovation

location_facility: National University Hospital (Singapore) Pte, Ltd

location_facility: Eunice Kennedy Shriver National Institute of Child Health and Human Development

location_facility: CHU Paris Est - Hospital d'Enfants Armand-Trousseau

location_facility: Birmingham Women's and Children's NHS Trust

location_facility: Dell Children's Medical Center of Central Texas


title: A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

summary: The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

lead_sponsor: Gilead Sciences

location_country:
Germany
United Kingdom
Australia
Netherlands
Belgium
United States
Canada
France


title: A Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Subjects With Selected Advanced Solid Tumors

summary:
This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies.

The study will be conducted in 2 parts, each part consisting of starting with a dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab.

The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2 years or 35 cycles, whichever comes first. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period will include disease assessments every 12 weeks until documented progressive disease (PD). Approximately 141 participants with selected advanced or recurrent solid tumors will be enrolled.

design_allocation: Non-Randomized

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Merck Sharp & Dohme LLC

location_country:
United States
Canada
Netherlands
France


type: Other Identifier

title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

acronym: TANGO

summary: This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

ReferenceType: derived

ReferenceCitation: Markman JD, Schnitzer TJ, Perrot S, Beydoun SR, Ohtori S, Viktrup L, Yang R, Bramson C, West CR, Verburg KM. Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial. Pain Ther. 2022 Dec;11(4):1267-1285. doi: 10.1007/s40122-022-00424-7. Epub 2022 Aug 13.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

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

sponsor_collaborators:
Pfizer
Eli Lilly and Company

location_country:
Hungary
Denmark
Japan
Sweden
United States
Korea, Republic of
Spain
Canada
France

location_facility: National Hospital Organization Beppu Medical Center

location_facility: National Clinical Research - Richmond, Inc.

location_facility: Centex Studies, Inc./Clear Lake Family Physicians

location_facility: Hospital Regional Universitario del Malaga

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: London Road Diagnostic Clinic & Medical Centre

location_facility: Lowcountry Orthopaedics & Sports Medicine

location_facility: CRU Hungary Ltd., MISEK-Radiology Department

location_facility: Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Clinical Trial Pharmacy, Samsung Medical Center

location_facility: Northwestern University, Feinberg School of Medicine, Lavin Pavilion

location_facility: Georgia Institute for Clinical Research, LLC

location_facility: Fukushima Medical University Aizu Medical Center

location_facility: Valley Medical Research/Valley Medical Primary Care

location_facility: Center for Advanced Research & Education

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: Willis-Knighton Physician Network/ Spine and Pain Specialist

location_facility: Hospital Universitario Quiron-Dexeus. Servicio de Farmacia

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Willis-Knighton Physician Network/WKB Family Medicine Associates

location_facility: KLR Business Group dba Arkansas Clinical Research

location_facility: CTC Pharmacy, Seoul National University Hospital

location_facility: Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center

location_facility: Tokyo Medical and Dental University Medical Hospital

location_facility: The Center for Rheumatology and Bone Research

location_facility: Professional Research Network of Kansas, LLC

location_facility: Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia

location_facility: Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: Chicago Clinical Research Institute, Inc.

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

location_facility: Collaborative Neuroscience Network, LLC.

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Medical corporate corporation hoshikai Onishi medical clinic

location_facility: Lafayette Regional Vein and Laser Center

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: CTC (Clinical Trial Center) Sahlgrenska University Hospital

intervention_type: Biological


title: A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

status: Terminated

location_country:
Ireland
Poland
New Zealand
Australia
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
South Africa
Taiwan
Bulgaria
Russian Federation

status_simplified: Unknown


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.

title: A Randomized, Sponsor Open, Site and Subject Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of LHW090 After 4 Weeks Treatment in Patients With Resistant Hypertension

source: euctr

location_country:
Germany
Denmark
Netherlands
Switzerland
United States
France


acronym: SEPSIS-ACT

lead_sponsor: Ferring Pharmaceuticals

summary: This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.

ReferenceCitation: Laterre PF, Berry SM, Blemings A, Carlsen JE, Francois B, Graves T, Jacobsen K, Lewis RJ, Opal SM, Perner A, Pickkers P, Russell JA, Windelov NA, Yealy DM, Asfar P, Bestle MH, Muller G, Bruel C, Brule N, Decruyenaere J, Dive AM, Dugernier T, Krell K, Lefrant JY, Megarbane B, Mercier E, Mira JP, Quenot JP, Rasmussen BS, Thorsen-Meyer HC, Vander Laenen M, Vang ML, Vignon P, Vinatier I, Wichmann S, Wittebole X, Kjolbye AL, Angus DC; SEPSIS-ACT Investigators. Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1476-1485. doi: 10.1001/jama.2019.14607. Erratum In: JAMA. 2019 Nov 12;322(18):1830.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Lewis RJ, Angus DC, Laterre PF, Kjolbye AL, van der Meulen E, Blemings A, Graves T, Russell JA, Carlsen JE, Jacobsen K, Yealy DM, Opal SM, Windelov NA, Francois B, Perner A, Pickkers P, Berry SM. Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. Ann Am Thorac Soc. 2018 Feb;15(2):250-257. doi: 10.1513/AnnalsATS.201708-669SD.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Thoracic Society

location_facility: Radboud University Nijmegen Medical Centre (there may be other sites in this country)

location_facility: Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)

location_facility: Cliniques Universitaires Saint-Luc (there may be other sites in this country)

location_facility: Aalborg Universitetshospital (there may be other sites in this country)

location_facility: University of Oklahoma Health Sciences Center

location_facility: Northshore University Healthsystem Research Institute

location_facility: Wake Forest University School of Medicine

title: A Double-blind, Randomised, Placebo-Controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients With Vasopressor-dependent Septic Shock

location_country:
Denmark
Netherlands
Belgium
United States
France


title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

summary:
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

ReferenceCitation: Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.

publisher_dissemination: Informa

ReferenceCitation: Ferrarotto R, Anderson I, Medgyasszay B, Garcia-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csoszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Wiley

ReferenceCitation: Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

evidence: open (via crossref license)

ReferenceCitation: Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2):e000847. doi: 10.1136/jitc-2020-000847.

publisher_dissemination: British Medical Journal

ReferenceCitation: Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.

publisher_dissemination: Elsevier

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Poland
Hungary
United States
Spain
Moldova, Republic of
Georgia
France

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, XI. Tudobelosztaly

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: University of Colorado Health, Oncology Clinical Research Northern Region

location_facility: Boca Raton Regional Hospital - Lynn Cancer Institute

location_facility: Hospital Regional Universitario HRU Carlos Haya Malaga

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera

location_facility: ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology

location_facility: UNC - Lineberger Comprehensive Cancer Center

location_facility: Memorial Hospital - Univ. of Colorado Health

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Samodzielny Publiczny ZespAA GruAicy i ChorAb PA¿uc

location_facility: Oklahoma University - Peggy and Charles Stephenson Cancer Center

location_facility: Hanna Cancer Associates - University of Tennessee


title: An Observational Study to Evaluate the Effectiveness and Safety of Ipilimumab, Administered During the European Expanded Access Programme in Pretreated Patients With Advanced (Unresectable or Metastatic) Melanoma

summary: Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Italy
Hungary
Norway
Denmark
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Russian Federation
France

location_facility:
Outcome Sciences Inc Dba Outcome
Local Institution
Elbe Klinikum Buxtehude


title: Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

summary: The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Zimmer Biomet

location_country:
Germany
Finland
Italy
United Kingdom
Australia
Netherlands
United States
France

location_facility: Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)

intervention_type: Device

status_simplified: Ongoing


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

acronym: focuSSced

summary: This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Wagner B, Zucchetto M, Raghu G, Martinez FJ, Goldin J, Siegel J, Denton CP. Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open-Label Extension of a Phase 3 Randomized Controlled Trial. Am J Respir Crit Care Med. 2022 Mar 15;205(6):674-684. doi: 10.1164/rccm.202103-0714OC.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ReferenceCitation: Roofeh D, Lin CJF, Goldin J, Kim GH, Furst DE, Denton CP, Huang S, Khanna D; focuSSced Investigators. Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2021 Jul;73(7):1301-1310. doi: 10.1002/art.41668. Epub 2021 May 25.

oa_host_type: repository

repository_institution: University of Michigan - Deep Blue

version: acceptedVersion

version: submittedVersion

repository_institution: California Digital Library - eScholarship

unpaywall_oa_status: green

ReferenceCitation: Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17.

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Goldin J, Kim G, Kuwana M, Allanore Y, Matucci-Cerinic M, Distler O, Shima Y, van Laar JM, Spotswood H, Wagner B, Siegel J, Jahreis A, Denton CP; focuSSced investigators. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020 Oct;8(10):963-974. doi: 10.1016/S2213-2600(20)30318-0. Epub 2020 Aug 28. Erratum In: Lancet Respir Med. 2020 Oct;8(10):e75. Lancet Respir Med. 2021 Mar;9(3):e29.

location_country:
Germany
Poland
Argentina
Japan
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
Bulgaria

location_facility: MHAT Sv.Ivan Rilski; Clinic of Rheumatology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia

location_facility: Uni Hospital Aintree; Academic Rheumatology Unit

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: University Hospital of Patras; Rheumatology

location_facility: Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica

location_facility: Spitalul Judetean Cluj; Sectia de Reumatologie

location_facility: National Institute of Rheumatology and Physiology

location_facility: Arthritis Associates of Southern California

location_facility: Royal Free Hospital; Department of Rheumatology

location_facility: Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens

location_facility: Thomas Jefferson Uni ; Division of Rheumatology

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Hospital Garcia de Orta; Servico de Reumatologia

location_facility: Klaipeda University Hospital; Department of Rheumatology

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Rheumatology Assoc. of S. Florida - Clinical Research Center

location_facility: Academisch Ziekenhuis Leiden; Dept of Rheumatology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Bispebjerg Hospital, Dermatologisk afdeling

location_facility: Queen Elizabeth Hospital; Rheumatology Dept.

location_facility: Universitätsspital Basel; Rheumatologische Poliklinik

location_facility: Arthritis and Rheumatology; Center of Oklahoma PLLC

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi

location_facility: Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica

location_facility: MHAT St.Ivan Rilski; Rheumtology Department

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki

location_facility: Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.

location_facility: Univ of Calif., Los Angeles; Rheumatology

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Policlinico Universitario-II Università di Napoli; Reumatologia

location_facility: Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Cantacuzino Hospital; Department of Internal Medicine and Rheumatology

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

location_facility: Universitätsspital Zürich; Klinik für Rheumatologie

location_facility: Puerto Rico Clinical & Translational Research Consortium

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III

location_facility: Hospital Prof. Dr. Fernando Fonseca; Medicina IV


title: A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

acronym: JULIET

summary: This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

ReferenceCitation: Cartron G, Fox CP, Liu FF, Kostic A, Hasskarl J, Li D, Bonner A, Zhang Y, Maloney DG, Kuruvilla J. Matching-adjusted indirect treatment comparison of chimeric antigen receptor T-cell therapies for third-line or later treatment of relapsed or refractory large B-cell lymphoma: lisocabtagene maraleucel versus tisagenlecleucel. Exp Hematol Oncol. 2022 Mar 25;11(1):17. doi: 10.1186/s40164-022-00268-z.

ReferenceCitation: Frigault MJ, Dietrich J, Gallagher K, Roschewski M, Jordan JT, Forst D, Plotkin SR, Cook D, Casey KS, Lindell KA, Depinho GD, Katsis K, Elder EL, Leick MB, Choi B, Horick N, Preffer F, Saylor M, McAfee S, O'Donnell PV, Spitzer TR, Dey B, DeFilipp Z, El-Jawahri A, Batchelor TT, Maus MV, Chen YB. Safety and efficacy of tisagenlecleucel in primary CNS lymphoma: a phase 1/2 clinical trial. Blood. 2022 Apr 14;139(15):2306-2315. doi: 10.1182/blood.2021014738.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. doi: 10.1016/S1470-2045(21)00375-2. Epub 2021 Sep 10.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

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

repositories_concat: PubMed Central;ora.ox.ac.uk

ReferenceCitation: Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021 Oct 1;96(10):1295-1312. doi: 10.1002/ajh.26301. Epub 2021 Aug 13.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Schuster SJ, Maziarz RT, Rusch ES, Li J, Signorovitch JE, Romanov VV, Locke FL, Maloney DG. Grading and management of cytokine release syndrome in patients treated with tisagenlecleucel in the JULIET trial. Blood Adv. 2020 Apr 14;4(7):1432-1439. doi: 10.1182/bloodadvances.2019001304.

evidence: oa journal (via observed oa rate)

ReferenceCitation: Maziarz RT, Schuster SJ, Romanov VV, Rusch ES, Li J, Signorovitch JE, Maloney DG, Locke FL. Grading of neurological toxicity in patients treated with tisagenlecleucel in the JULIET trial. Blood Adv. 2020 Apr 14;4(7):1440-1447. doi: 10.1182/bloodadvances.2019001305.

evidence: open (via free article)

ReferenceCitation: Maziarz RT, Waller EK, Jaeger U, Fleury I, McGuirk J, Holte H, Jaglowski S, Schuster SJ, Bishop MR, Westin JR, Mielke S, Teshima T, Bachanova V, Foley SR, Borchmann P, Salles GA, Zhang J, Tiwari R, Pacaud LB, Ma Q, Tam CS. Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Feb 25;4(4):629-637. doi: 10.1182/bloodadvances.2019001026.

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Awasthi R, Pacaud L, Waldron E, Tam CS, Jager U, Borchmann P, Jaglowski S, Foley SR, van Besien K, Wagner-Johnston ND, Kersten MJ, Schuster SJ, Salles G, Maziarz RT, Anak O, Del Corral C, Chu J, Gershgorin I, Pruteanu-Malinici I, Chakraborty A, Mueller KT, Waller EK. Tisagenlecleucel cellular kinetics, dose, and immunogenicity in relation to clinical factors in relapsed/refractory DLBCL. Blood Adv. 2020 Feb 11;4(3):560-572. doi: 10.1182/bloodadvances.2019000525.

ReferenceCitation: Bishop MR, Maziarz RT, Waller EK, Jager U, Westin JR, McGuirk JP, Fleury I, Holte H, Borchmann P, Del Corral C, Tiwari R, Anak O, Awasthi R, Pacaud L, Romanov VV, Schuster SJ. Tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion. Blood Adv. 2019 Jul 23;3(14):2230-2236. doi: 10.1182/bloodadvances.2019000151.

ReferenceCitation: Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jager U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak O, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.

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

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

location_country:
Germany
Italy
Norway
Australia
Japan
Netherlands
Austria
United States
Canada
France

location_facility: University of Chicago Medical Center Hematology and Oncology SC - CTL019B2207J

location_facility: University of Pennsylvania Perelman School of Medicine

location_facility: Emory University School of Medicine SC CTL019

location_facility: Sidney Kimmel Comprehensive Cancer Center SC-2

location_facility: University of Kansas Cancer Center SC - CTL019C2201

location_facility: Oregon Health and Science Univ Oregon Health & Sci Uni

location_facility: The Ohio State University James Cancer Hospital &


title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

status: Active, not recruiting

ReferenceCitation: Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Bohm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.

ReferenceCitation: Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Kario K, Weber MA, Bohm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.

ReferenceCitation: Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7. Erratum In: Clin Res Cardiol. 2020 May;109(5):653.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

repository_institution: Saarland University and State Library - SciDok

ReferenceCitation: Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.

lead_sponsor: Medtronic Vascular

location_country:
Germany
Ireland
United Kingdom
Australia
Japan
Austria
United States
Greece
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: University General Hospital of Thessaloniki (AHEPA)

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales

location_facility: Hospital of the University of Pennsylvania

location_facility: Weill Cornell Medical College/The New York Presbyterian Hospital

location_facility: Oregon Health & Science University Hospital

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH


title: A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

summary: This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.

ReferenceCitation: McKone EF, DiMango EA, Sutharsan S, Barto TL, Campbell D, Ahluwalia N, Higgins M, Owen CA, Tullis E. A phase 3, randomized, double-blind, parallel-group study to evaluate tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for F508del-CFTR and a gating mutation. J Cyst Fibros. 2021 Mar;20(2):234-242. doi: 10.1016/j.jcf.2020.11.003. Epub 2020 Dec 16.

oa_host_type: publisher

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Austria
Belgium
United States
Canada
France


title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

lead_sponsor: Genentech, Inc.

location_country:
Australia
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology


summary: This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

title: Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

location_country:
Germany
Poland
Australia
Japan
Thailand
Turkey
Chile
France
Portugal
Slovakia
Hungary
Denmark
India
Lebanon
Belgium
China
Italy
Sweden
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


title: Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis: a Prospective Outcome Study

acronym: ADJUST-DVT

summary: Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis (DVT)

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Geneva

sponsor_collaborators:
University Hospital, Geneva
The Ottawa Hospital
University Medical Center Groningen

location_country: Canada Switzerland France

location_facility: Thunder Bay regional Health Sciences center

intervention_type: Other

lead_sponsor_type: academique


title: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

summary: The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

ReferenceType: result

ReferenceCitation: Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

ReferenceCitation: Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections,Boston. March 4-7, 2018, Abstract 504.

ReferenceCitation: Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation atthe 16th European AIDS Conference, 2017 25-27 October Milan, Italy.

ReferenceCitation: Porter DP, Kulkarni R, Cao H, SenGupta D, White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster1381]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.

ReferenceCitation: Wohl D, Kulkarni R, Garner W, White KL, Porter DL. Viral Blips Were Infrequent in HIV1-Infected Virologically-Suppressed Adults Treated with Tenofovir Alafenamide or Tenofovir DF Rilpivirine-Containing Regimens [Poster1384]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.

ReferenceCitation: DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Molina J-M, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshopon HIV and Aging 2017 2-3 October, New York, New York.

ReferenceCitation: Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, Thalme A, et al. Efficacy and Odefsey® StudyGS-US-366-1216Final Synoptic Clinical Study Report Final CONFIDENTIAL Page4 30July2019 Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.

ReferenceCitation: Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science;2017 23-26July Paris, France.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.

ReferenceCitation: Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, WA.

ReferenceCitation: Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching toRPV/FTC/TAF in Women [Abstract12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study1160) or RPV/FTC/TDF (Study1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: North Texas Infectious Diseases Consultants

location_facility: Long Beach Education and Research Consultants

location_facility: Center for HIV and Hepatogastroenterology

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: The Hathersage Integrated Contraception, Sexual Health and HIV Service

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Desert Medical Group Inc., dba Desert Oasis Healthcare Medical Group

location_facility: University of North Carolina at Chapel Hill

location_facility: Infectious Disease Research Institute Inc.

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Carolinas Medical Center--Myers Park Infectious Disease Clinic

location_facility: Midway Immunology & Research Center, LLC

location_facility: Hospital Clínico Universitario San Carlos

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: World Health Clinicians' CIRCLE CARE Center

location_facility: Hospital General Universitario de Alicante

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: La Playa Medical Group and Clinical Research

location_facility: Infectious Diseases Associates of NW Florida, P.A.

location_facility: The University of Alabama at Birmingham (UAB)

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales


lead_sponsor: Amgen

summary: The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.

ReferenceType: background

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.

title: A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis

location_country:
Germany
Italy
Poland
Hungary
Belgium
United States
Greece
Czechia
Ukraine
Russian Federation
France


title: A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)

summary: This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

location_country:
Germany
Italy
Slovakia
Hungary
Japan
Netherlands
Belgium
United States
Canada
France


title: European Registry on the Management of Helicobacter Pylori Infection

summary:
The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency.

Primary aim

To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims

To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries.
To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.
To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection.
To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee

Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.

time_perspective: Prospective

ReferenceCitation: Arkkila PE, Seppala K, Kosunen TU, Sipponen P, Makinen J, Rautelin H, Farkkila M. Helicobacter pylori eradication as the sole treatment for gastric and duodenal ulcers. Eur J Gastroenterol Hepatol. 2005 Jan;17(1):93-101. doi: 10.1097/00042737-200501000-00018.

ReferenceCitation: Azevedo NF, Huntington J, Goodman KJ. The epidemiology of Helicobacter pylori and public health implications. Helicobacter. 2009 Sep;14 Suppl 1:1-7. doi: 10.1111/j.1523-5378.2009.00703.x. Erratum In: Helicobacter. 2010 Feb;15(1):78.

ReferenceCitation: Broutet N, Tchamgoue S, Pereira E, Lamouliatte H, Salamon R, Megraud F. Risk factors for failure of Helicobacter pylori therapy--results of an individual data analysis of 2751 patients. Aliment Pharmacol Ther. 2003 Jan;17(1):99-109. doi: 10.1046/j.1365-2036.2003.01396.x.

ReferenceCitation: de Vries AC, van Grieken NC, Looman CW, Casparie MK, de Vries E, Meijer GA, Kuipers EJ. Gastric cancer risk in patients with premalignant gastric lesions: a nationwide cohort study in the Netherlands. Gastroenterology. 2008 Apr;134(4):945-52. doi: 10.1053/j.gastro.2008.01.071. Epub 2008 Jan 30.

ReferenceCitation: Ford A, Moayyedi P. How can the current strategies for Helicobacter pylori eradication therapy be improved? Can J Gastroenterol. 2003 Jun;17 Suppl B:36B-40B. doi: 10.1155/2003/714124.

ReferenceCitation: Ford AC, Axon AT. Epidemiology of Helicobacter pylori infection and public health implications. Helicobacter. 2010 Sep;15 Suppl 1:1-6. doi: 10.1111/j.1523-5378.2010.00779.x.

ReferenceCitation: Gisbert JP, Calvet X. Review article: the effectiveness of standard triple therapy for Helicobacter pylori has not changed over the last decade, but it is not good enough. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1255-68. doi: 10.1111/j.1365-2036.2011.04887.x. Epub 2011 Oct 21.

ReferenceCitation: Gisbert JP, Calvet X, O'Connor A, Megraud F, O'Morain CA. Sequential therapy for Helicobacter pylori eradication: a critical review. J Clin Gastroenterol. 2010 May-Jun;44(5):313-25. doi: 10.1097/MCG.0b013e3181c8a1a3.

ReferenceCitation: Gisbert JP, Calvet X. Review article: non-bismuth quadruple (concomitant) therapy for eradication of Helicobater pylori. Aliment Pharmacol Ther. 2011 Sep;34(6):604-17. doi: 10.1111/j.1365-2036.2011.04770.x. Epub 2011 Jul 11.

ReferenceCitation: Gisbert JP, Khorrami S, Carballo F, Calvet X, Gene E, Dominguez-Munoz JE. H. pylori eradication therapy vs. antisecretory non-eradication therapy (with or without long-term maintenance antisecretory therapy) for the prevention of recurrent bleeding from peptic ulcer. Cochrane Database Syst Rev. 2004;(2):CD004062. doi: 10.1002/14651858.CD004062.pub2.

ReferenceCitation: Graham DY, Rimbara E. Understanding and appreciating sequential therapy for Helicobacter pylori eradication. J Clin Gastroenterol. 2011 Apr;45(4):309-13. doi: 10.1097/MCG.0b013e31820ac05e.

ReferenceCitation: Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.

ReferenceCitation: Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.

ReferenceCitation: Hsu PI, Wu DC, Wu JY, Graham DY. Is there a benefit to extending the duration of Helicobacter pylori sequential therapy to 14 days? Helicobacter. 2011 Apr;16(2):146-52. doi: 10.1111/j.1523-5378.2011.00829.x.

ReferenceCitation: Ikenberry SO, Harrison ME, Lichtenstein D, Dominitz JA, Anderson MA, Jagannath SB, Banerjee S, Cash BD, Fanelli RD, Gan SI, Shen B, Van Guilder T, Lee KK, Baron TH; ASGE STANDARDS OF PRACTICE COMMITTEE. The role of endoscopy in dyspepsia. Gastrointest Endosc. 2007 Dec;66(6):1071-5. doi: 10.1016/j.gie.2007.07.007. Epub 2007 Oct 29. No abstract available.

ReferenceCitation: Maconi G, Sainaghi M, Molteni M, Bosani M, Gallus S, Ricci G, Alvisi V, Porro GB. Predictors of long-term outcome of functional dyspepsia and duodenal ulcer after successful Helicobacter pylori eradication--a 7-year follow-up study. Eur J Gastroenterol Hepatol. 2009 Apr;21(4):387-93. doi: 10.1097/MEG.0b013e3283069db0.

ReferenceCitation: Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

ReferenceCitation: McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.

ReferenceCitation: McNicholl AG, Linares PM, Nyssen OP, Calvet X, Gisbert JP. Meta-analysis: esomeprazole or rabeprazole vs. first-generation pump inhibitors in the treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 2012 Sep;36(5):414-25. doi: 10.1111/j.1365-2036.2012.05211.x. Epub 2012 Jul 15.

ReferenceCitation: Moayyedi P. The health economics of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):347-61. doi: 10.1016/j.bpg.2006.11.004.

ReferenceCitation: Moayyedi P, Deeks J, Talley NJ, Delaney B, Forman D. An update of the Cochrane systematic review of Helicobacter pylori eradication therapy in nonulcer dyspepsia: resolving the discrepancy between systematic reviews. Am J Gastroenterol. 2003 Dec;98(12):2621-6. doi: 10.1111/j.1572-0241.2003.08724.x.

ReferenceCitation: Niv Y, Hazazi R. Helicobacter pylori recurrence in developed and developing countries: meta-analysis of 13C-urea breath test follow-up after eradication. Helicobacter. 2008 Feb;13(1):56-61. doi: 10.1111/j.1523-5378.2008.00571.x.

ReferenceCitation: Oderda G, Shcherbakov P, Bontems P, Urruzuno P, Romano C, Gottrand F, Gomez MJ, Ravelli A, Gandullia P, Roma E, Cadranel S, De Giacomo C, Canani RB, Rutigliano V, Pehlivanoglu E, Kalach N, Roggero P, Celinska-Cedro D, Drumm B, Casswall T, Ashorn M, Arvanitakis SN; European Pediatric Task Force on Helicobacter pylori. Results from the pediatric European register for treatment of Helicobacter pylori (PERTH). Helicobacter. 2007 Apr;12(2):150-6. doi: 10.1111/j.1523-5378.2007.00485.x.

ReferenceCitation: Rokkas T, Sechopoulos P, Robotis I, Margantinis G, Pistiolas D. Cumulative H. pylori eradication rates in clinical practice by adopting first and second-line regimens proposed by the Maastricht III consensus and a third-line empirical regimen. Am J Gastroenterol. 2009 Jan;104(1):21-5. doi: 10.1038/ajg.2008.87.

ReferenceCitation: Nyssen OP, Vaira D, Perez Aisa A, Rodrigo L, Castro-Fernandez M, Jonaitis L, Tepes B, Vologzhanina L, Caldas M, Lanas A, Lucendo AJ, Bujanda L, Ortuno J, Barrio J, Huguet JM, Voynovan I, Lasala JP, Sarsenbaeva AS, Fernandez-Salazar L, Molina-Infante J, Jurecic NB, Areia M, Gasbarrini A, Kupcinskas J, Bordin D, Marcos-Pinto R, Lerang F, Leja M, Buzas GM, Niv Y, Rokkas T, Phull P, Smith S, Shvets O, Venerito M, Milivojevic V, Simsek I, Lamy V, Bytzer P, Boyanova L, Kunovsky L, Beglinger C, Doulberis M, Marlicz W, Goldis A, Tonkic A, Capelle L, Puig I, Megraud F, Morain CO, Gisbert JP; European Registry on Helicobacter pylori Management Hp-EuReg Investigators. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clin Gastroenterol Hepatol. 2022 Oct;20(10):2243-2257. doi: 10.1016/j.cgh.2021.12.025. Epub 2021 Dec 23.

ReferenceCitation: Nyssen OP, Perez-Aisa A, Tepes B, Castro-Fernandez M, Kupcinskas J, Jonaitis L, Bujanda L, Lucendo A, Jurecic NB, Perez-Lasala J, Shvets O, Fadeenko G, Huguet JM, Kikec Z, Bordin D, Voynovan I, Leja M, Machado JC, Areia M, Fernandez-Salazar L, Rodrigo L, Alekseenko S, Barrio J, Ortuno J, Perona M, Vologzhanina L, Romero PM, Zaytsev O, Rokkas T, Georgopoulos S, Pellicano R, Buzas GM, Modolell I, Gomez Rodriguez BJ, Simsek I, Simsek C, Lafuente MR, Ilchishina T, Camarero JG, Dominguez-Cajal M, Ntouli V, Dekhnich NN, Phull P, Nunez O, Lerang F, Venerito M, Heluwaert F, Tonkic A, Caldas M, Puig I, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg Investigators. Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg). Am J Gastroenterol. 2021 Jun 1;116(6):1220-1229. doi: 10.14309/ajg.0000000000001246.

ReferenceCitation: Nyssen OP, Perez-Aisa A, Castro-Fernandez M, Pellicano R, Huguet JM, Rodrigo L, Ortun J, O, Gomez-Rodriguez BJ, Pinto RM, Areia M, Perona M, Nunez O, Romano M, Gravina AG, Pozzati L, Fernandez-Bermejo M, Venerito M, Malfertheiner P, Fernanadez-Salazar L, Gasbarrini A, Vaira D, Puig I, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg investigators. European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice. United European Gastroenterol J. 2021 Feb;9(1):38-46. doi: 10.1177/2050640620972615. Epub 2021 Feb 11.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: McNicholl AG, Bordin DS, Lucendo A, Fadeenko G, Fernandez MC, Voynovan I, Zakharova NV, Sarsenbaeva AS, Bujanda L, Perez-Aisa A, Vologzhanina L, Zaytsev O, Ilchishina T, Coba C, Lasala JP, Alekseenko S, Modolell I, Molina-Infante J, Ruiz-Zorrilla Lopez R, Alonso-Galan H, Moreno NF, Hinojosa J, Santaella I, Varela P, Gonzalez-Cordero PL, Barrio J, Dominguez-Jimenez JL, Nunez O, Alcedo J, Nyssen OP, Caldas M, Donday MG, Shvetz O, Megraud F, O'Morain C, Gisbert JP. Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infection in More than 90% of Patients. Clin Gastroenterol Hepatol. 2020 Jan;18(1):89-98. doi: 10.1016/j.cgh.2019.03.048. Epub 2019 Apr 10.

ipd_sharing: Undecided

lead_sponsor: Javier P. Gisbert

location_country:
Finland
Germany
Ireland
Poland
Turkey
Croatia
Czechia
Serbia
France
Slovenia
Lithuania
Portugal
Hungary
Denmark
Switzerland
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Russian Federation
Sweden

location_facility: Ferencváros Health Centre, Gaastroenterology

location_facility: Departament of Gastroenterology, Medical Centre for Postgraduate Education

location_facility: Ikazia Ziekenhuis/ Erasmus Medisch Centrum

location_facility: Central Scientific Research Institute of Gastroenterology

location_facility: Gastroenterology Clinic, Henry Dunant Hospital

location_facility: Lithuanian university of Health Sciences Hospital

location_facility: Dokuz Eylul University School of Medicine


title: An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688, A Novel T-cell Bispecific Antibody That Targets the Human Carcinoembryonic Antigen (CEA) on Tumor Cells and CD3 on T Cells, Administered Intravenously in Patients With Locally Advanced and/or Metastatic CEA(+) Solid Tumors

summary: Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical study of single-agent RO6958688 in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two parts. Part I of the study will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.

ReferenceCitation: Martinez-Sabadell A, Morancho B, Rius Ruiz I, Roman Alonso M, Ovejero Romero P, Escorihuela M, Chicote I, Palmer HG, Nonell L, Alemany-Chavarria M, Klein C, Bacac M, Arribas J, Arenas EJ. The target antigen determines the mechanism of acquired resistance to T cell-based therapies. Cell Rep. 2022 Oct 18;41(3):111430. doi: 10.1016/j.celrep.2022.111430.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

location_country:
Italy
Denmark
Netherlands
United States
Spain
Canada
France

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

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

location_facility: IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz


title: An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

summary:
PILOT:

The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients.

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

ReferenceCitation: Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, Kirshner M, Bajwa T, Weiss E, Kodali S, George I, Heiser J, Merhi WM, Thaden JJ, Zhang A, Lim DS, Reardon MJ, Adams DH, Mack MJ, Leon MB. 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.

lead_sponsor: Medtronic Cardiovascular

sponsor_collaborators:
Medtronic Cardiovascular
Medtronic

location_country:
United Kingdom
Denmark
Australia
United States
France

location_facility: Oregon Health Sciences University Hospital


title: Clinical Study of the BreathID® System to Train the Algorithm for the ¹³C-Octanoate Breath Test With or Without the ¹³C-Methacetin Breath Test (OBT and MBT Respectively) for Correlation With Histological Findings Associated With Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases

summary: This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases using the BreathID® System

lead_sponsor: Meridian Bioscience, Inc.

location_country:
United States
United Kingdom
Belgium
France

location_facility: Northwestern University, Feinberg School of Medicine


title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors

acronym: RIFTOS MKI

summary: The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.

ReferenceCitation: Brose MS, Smit JWA, Lin CC, Tori M, Bowles DW, Worden F, Shen DH, Huang SM, Tsai HJ, Alevizaki M, Peeters RP, Takahashi S, Rumyantsev P, Guan R, Babajanyan S, Ozgurdal K, Sugitani I, Pitoia F, Lamartina L. Multikinase Inhibitors for the Treatment of Asymptomatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Global Noninterventional Study (RIFTOS MKI). Thyroid. 2022 Sep;32(9):1059-1068. doi: 10.1089/thy.2022.0061.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Porcelli T, Luongo C, Sessa F, Klain M, Masone S, Troncone G, Bellevicine C, Schlumberger M, Salvatore D. Long-term management of lenvatinib-treated thyroid cancer patients: a real-life experience at a single institution. Endocrine. 2021 Aug;73(2):358-366. doi: 10.1007/s12020-021-02634-z. Epub 2021 Feb 3.

ReferenceCitation: Brose MS, Smit J, Lin CC, Pitoia F, Fellous M, DeSanctis Y, Schlumberger M, Tori M, Sugitani I. Timing of multikinase inhibitor initiation in differentiated thyroid cancer. Endocr Relat Cancer. 2017 May;24(5):237-242. doi: 10.1530/ERC-17-0016. Epub 2017 Mar 7.

repository_institution: Radboud University - Radboud Repository

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

repositories_concat: PubMed Central;repository.ubn.ru.nl

publisher_dissemination: Bioscientifica

lead_sponsor: Bayer

location_country:
Germany
Argentina
Algeria
Japan
Brazil
Turkey
France
United States
India
Lebanon
Philippines
Egypt
Netherlands
Mexico
Saudi Arabia
Spain
Greece
Taiwan
Russian Federation


title: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

acronym: LUMINIST

summary: The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Quintiles, Inc.

location_country:
Germany
Poland
Australia
Turkey
Chile
Canada
France
Portugal
Hungary
Ukraine
Romania
Belgium
Peru
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation
Israel


acronym: CHERISH

lead_sponsor: Biogen

summary: The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA). The secondary objective is to examine the safety and tolerability of nusinersen administered intrathecally to participants with later-onset SMA.

ReferenceCitation: Darras BT, Farrar MA, Mercuri E, Finkel RS, Foster R, Hughes SG, Bhan I, Farwell W, Gheuens S. An Integrated Safety Analysis of Infants and Children with Symptomatic Spinal Muscular Atrophy (SMA) Treated with Nusinersen in Seven Clinical Trials. CNS Drugs. 2019 Sep;33(9):919-932. doi: 10.1007/s40263-019-00656-w.

ReferenceCitation: Mercuri E, Darras BT, Chiriboga CA, Day JW, Campbell C, Connolly AM, Iannaccone ST, Kirschner J, Kuntz NL, Saito K, Shieh PB, Tulinius M, Mazzone ES, Montes J, Bishop KM, Yang Q, Foster R, Gheuens S, Bennett CF, Farwell W, Schneider E, De Vivo DC, Finkel RS; CHERISH Study Group. Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy. N Engl J Med. 2018 Feb 15;378(7):625-635. doi: 10.1056/NEJMoa1710504.

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

publisher_dissemination: Massachusetts Medical Society

location_facility: AOU Policlinico G. Martino Dipartimento di Neuroscienze e Centro Clinico Nemo Sud

location_facility: McGill University Health Centre-Glen Site-CIM

location_facility: UCLA Clinical and Translational Research Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Universita Cattolica de Sacro Cuore-UOC Neuropsichiatre Infantile

location_facility: Children's Hospital - London Health Sciences Centre

location_facility: Children's Hospital of Philadelphia - Neurology

location_facility: Lucile Packard Children's Hospital at Stanford

location_facility: Seoul National University Children's Hospital

location_facility: Washington University School of Medicine

location_facility: Armand Trousseau Hospital, I-Motion, Clinical Trials Platform

location_facility: University Hospital Freiberg, Center for Paediatrics and Adolescent Medicine, Department of Neuropaediatrics and Muscular Disease

location_facility: The University of Hong Kong, Queen Mary Hospital, Department of Paediatrics and Adolescent Medicine

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

location_facility: University of Gothenburg, The Queen Silvia Children's Hospital

title: A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

location_country:
Germany
Italy
Hong Kong
Japan
Sweden
United States
Korea, Republic of
Spain
Canada
France


title: Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

acronym: LIBERTY-HCM

summary: The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).

ReferenceCitation: Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764.

lead_sponsor: Gilead Sciences

location_country:
Germany
France
Italy
United Kingdom
Australia
Netherlands
United States
Israel

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Azienda Ospedaliero Universitaria Di Bologna

location_facility: University of Iowa Hospitals and Clinics

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera San Camillo Forlanini


title: A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program

acronym: SPRING

summary: The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.

lead_sponsor: Santen Inc.

location_country:
Italy
India
Austria
United States
Turkey
France


title: A Natural History Study of Acute Hepatic Porphyria (AHP) Patients With Recurrent Attacks

summary: The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Finland
Germany
Poland
Australia
Czechia
France
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel


title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.

summary: The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).

ReferenceCitation: Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_concat: UCL Discovery;pure.ed.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Privitera M, Bhathal H, Wong M, Cross JH, Wirrell E, Marsh ED, Mazurkiewicz-Beldzinska M, Villanueva V, Checketts D, Knappertz V, VanLandingham K. Time to onset of cannabidiol (CBD) treatment effect in Lennox-Gastaut syndrome: Analysis from two randomized controlled trials. Epilepsia. 2021 May;62(5):1130-1140. doi: 10.1111/epi.16878. Epub 2021 Apr 2.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Perry MS. Don't Fear the Reefer-Evidence Mounts for Plant-Based Cannabidiol as Treatment for Epilepsy. Epilepsy Curr. 2019 Mar-Apr;19(2):93-95. doi: 10.1177/1535759719835671.

publisher_dissemination: SAGE Publications

lead_sponsor: Jazz Pharmaceuticals

location_country:
United States
Spain
United Kingdom
France


summary: The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

ReferenceCitation: Lecendreux M, Plazzi G, Dauvilliers Y, Rosen CL, Ruoff C, Black J, Parvataneni R, Guinta D, Wang YG, Mignot E. Long-term safety and maintenance of efficacy of sodium oxybate in the treatment of narcolepsy with cataplexy in pediatric patients. J Clin Sleep Med. 2022 Sep 1;18(9):2217-2227. doi: 10.5664/jcsm.10090.

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Wang YG, Menno D, Chen A, Steininger TL, Morris S, Black J, Profant J, Johns MW. Validation of the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) questionnaire in pediatric patients with narcolepsy with cataplexy aged 7-16 years. Sleep Med. 2022 Jan;89:78-84. doi: 10.1016/j.sleep.2021.11.003. Epub 2021 Nov 11.

ReferenceCitation: Plazzi G, Ruoff C, Lecendreux M, Dauvilliers Y, Rosen CL, Black J, Parvataneni R, Guinta D, Wang YG, Mignot E. Treatment of paediatric narcolepsy with sodium oxybate: a double-blind, placebo-controlled, randomised-withdrawal multicentre study and open-label investigation. Lancet Child Adolesc Health. 2018 Jul;2(7):483-494. doi: 10.1016/S2352-4642(18)30133-0. Epub 2018 May 21.

location_facility: University Hospitals Cleveland Medical Center

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital of The King's Daughters

location_facility: Dipartimento di Scienze Biomediche e Biomotorie

title:
A Double-Blind, Placebo-Controlled, Randomized-Withdrawal,
 Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

location_country:
United States
Italy
Netherlands
France


title: A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty

summary: The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

lead_sponsor: Smith & Nephew, Inc.

location_facility: Hospital of the University of Pennsylvania


lead_sponsor: Boehringer Ingelheim

summary: This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.

ReferenceCitation: Brandao LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.

ReferenceCitation: Brandao LR, Albisetti M, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Svirin P, Kuhn T, Zapletal O, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Brueckmann M, Luciani M; DIVERSITY Study Investigators. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. 2020 Feb 13;135(7):491-504. doi: 10.1182/blood.2019000998. Erratum In: Blood. 2020 May 7;135(19):1720.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_facility: Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius

location_facility: Cukurova Universitesi Tip Fakultesi Cocuk Sagligi

location_facility: Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol

location_facility: Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

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

location_facility: Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow

location_facility: Faculdade de Ciencias Medicas da UNICAMP

location_facility: Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: State Budget Healthcare Institution "Republican children's clinical hospital"

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali

location_facility: St.Petersburg State Pediatric Univ.Ministry of Healthcare RF

location_facility: Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery

location_facility: Western Ukrainian Spec.Children Med.Center,Lviv

location_facility: Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH

title: Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years

primary_purpose: Prevention

location_country:
Germany
Brazil
Thailand
Turkey
Czechia
Canada
France
Lithuania
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
Sweden
Austria
Mexico
Taiwan
Russian Federation
Israel


title: A Phase 3, Randomized, Double-Blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy

acronym: ENDEAR

summary: The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.

ReferenceCitation: Dabbous O, Maru B, Jansen JP, Lorenzi M, Cloutier M, Guerin A, Pivneva I, Wu EQ, Arjunji R, Feltner D, Sproule DM. Survival, Motor Function, and Motor Milestones: Comparison of AVXS-101 Relative to Nusinersen for the Treatment of Infants with Spinal Muscular Atrophy Type 1. Adv Ther. 2019 May;36(5):1164-1176. doi: 10.1007/s12325-019-00923-8. Epub 2019 Mar 16.

ReferenceCitation: Finkel RS, Mercuri E, Darras BT, Connolly AM, Kuntz NL, Kirschner J, Chiriboga CA, Saito K, Servais L, Tizzano E, Topaloglu H, Tulinius M, Montes J, Glanzman AM, Bishop K, Zhong ZJ, Gheuens S, Bennett CF, Schneider E, Farwell W, De Vivo DC; ENDEAR Study Group. Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. N Engl J Med. 2017 Nov 2;377(18):1723-1732. doi: 10.1056/NEJMoa1702752.

repository_institution: University College London - UCL Discovery

repositories_concat: UCL Discovery;ora.ox.ac.uk

ReferenceCitation: Finkel RS, Chiriboga CA, Vajsar J, Day JW, Montes J, De Vivo DC, Yamashita M, Rigo F, Hung G, Schneider E, Norris DA, Xia S, Bennett CF, Bishop KM. Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study. Lancet. 2016 Dec 17;388(10063):3017-3026. doi: 10.1016/S0140-6736(16)31408-8. Epub 2016 Dec 7.

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Sweden
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
France

location_facility: British Columbia Children's Hospital/UBC

location_facility: Hôpital Universitaire des Enfants Reine FABIOLA (HUDERF)

location_facility: Children's Hospital of Philadelphia - Neurology

location_facility: Washington University School of Medicine

location_facility: Istituto Giannina Gaslini, Centro Traslazionale di Miologia e Patologie Neurodegenerative

location_facility: Primary Children's Medical Center (University of Utah)

location_facility: UT Southwestern Medical Center/Children's Medical Center Dallas

location_facility: MRC Centre for Neuromuscular Diseases at Newcastle, Institute of Genetic Medicine Newcastle University

location_facility: UCL Institute of Child Health/Great Ormond Street

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

location_facility: Pediatric Neurology Unit, Catholic University

location_facility: University of Gothenburg, The Queen Silvia Children's Hospital

location_facility: Hospital Universitario La Paz, Pediatric Neurology Department

location_facility: Universtatsklinikum Freiburg, Zentrum fur Kinder-und Jugendmedizin , Abteilung Neuropadiatrie und Muskelerkrankungen

location_facility: Royal Children's Hospital, Children's Neuroscience Centre