acronym: WINGS

title: A First in Human, Double-blind, Randomized, Intra-subject Placebo-controlled, Multiple Dose Study of QR-313 Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With DDEB or RDEB Due to Mutation(s) in Exon 73 of the COL7A1 Gene

lead_sponsor: Phoenicis Therapeutics

ReferenceCitation: Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. Review.

location_country:
United States
Spain
France

location_facility: Stanford University School of Medicine, LPCH

location_facility: Journey Clinic, Center for Pediatric Blood and Marrow Transplantation

summary: A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis with one or more pathogenic mutations in exon 73 in the COL7A1 gene.


ipd_sharing: No

status: Completed

primary_purpose: Treatment

acronym: GEMINI

intervention_type: Drug

title: An Open-Label Safety Study of Retinal Gene Therapy for Choroideremia With Bilateral, Sequential Administration of Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)

study_completion_date_type: Actual

lead_sponsor: NightstaRx Ltd, a Biogen Company

type: EudraCT Number

source: euctr

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5. Review.

enrollment_type: Actual

location_country:
Germany
United States
France

summary: The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).

lead_sponsor_type: industriel

status_simplified: Completed


title: ASPIRO: A Phase 1/2/3, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients

acronym: ASPIRO

summary: This is a multinational, open-label, ascending-dose, delayed-treatment concurrent control clinical study to evaluate the safety and efficacy of AT132 in subjects with X-Linked Myotubular Myopathy aged less than 5 years old. Subjects will receive a single dose of AT132 and will be followed for safety and efficacy for 10 years

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: Astellas Gene Therapies

location_country:
Germany
United States
Canada
France

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

location_facility: National Institute of Neurological Disorders and Stroke/NIH Porter

location_facility: Kinderklinik und Kinderpoliklinik im Dr. Von Haunerschen Kinderspital Klinikum der Universitat Munchen

intervention_type: Genetic

status_simplified: Ongoing


type: Other Identifier

title: A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer

summary: The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Eli Lilly and Company

location_country:
Australia
United States
Spain
France

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

location_facility: University of Texas MD Anderson Cancer Center

status_simplified: Unknown


ipd_sharing: Undecided

title: A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients With Iron Overload

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Italy
Oman
Lebanon
Russian Federation
Thailand
Tunisia
Hungary
United States
France
India
Panama
Belgium
Philippines
Malaysia
Turkey
Bulgaria
Egypt

location_facility: Medical University of South Carolina Medical Uni of South Carolina

location_facility: St. Jude Children's Research Hospital Memphis St Jude

location_facility: Childrens Hospital of Philadelphia Onc. Dept

location_facility: Childrens Healthcare of Atlanta Onc Dept

summary:
This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden.

Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.


title: A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors

summary:
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.

Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.

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

lead_sponsor: Pfizer

location_country:
Spain
Australia
Canada
United States
France

location_facility: University of Texas/MD Anderson Cancer Center MD Anderson PSC

location_facility: Massachusetts General Hospital Mass General 2


acronym: BET

intervention_type: Biological

title: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies

lead_sponsor: Bristol-Myers Squibb

location_facility: Institute for Translational Oncology Research-ITOR

summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers


title: Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.

location_country:
Netherlands
United States
Canada
France

location_facility: The University Of Texas Md Anderson Cancer Center


title: An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

summary: An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

ReferenceCitation: Barcenas CH, Hurvitz SA, Di Palma JA, Bose R, Chien AJ, Iannotti N, Marx G, Brufsky A, Litvak A, Ibrahim E, Alvarez RH, Ruiz-Borrego M, Chan N, Manalo Y, Kellum A, Trudeau M, Thirlwell M, Garcia Saenz J, Hunt D, Bryce R, McCulloch L, Rugo HS, Tripathy D, Chan A; CONTROL Study Investigators. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. 2020 Sep;31(9):1223-1230. doi: 10.1016/j.annonc.2020.05.012. Epub 2020 May 25.

ipd_sharing: Yes

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Spain
Austria
Australia
Canada
United States
France
Germany

location_facility: Univ. Klinik für Innere Medizin, Klin. Abt. Onkologie

location_facility: Charleston Hematology Oncology Associates

location_facility: Medical University of Vienna, Department of Oncology

location_facility: Washington University School of Medicine

location_facility: Great Plains Health (Callahan Cancer Center)

location_facility: Torrance Memorial Physician Network Cancer Care Associates

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: McGill University Health Centre, Cedars Cancer Centre

location_facility: Uniklinikum Salzburg, Landeskrankenhaus, Univ. Klinik fur Innere Medizin III der PMU

location_facility: Sana Klinikum Offenbach GmbH - Frauenklinik

location_facility: Medical University of Vienna,Department of Obstetrics and Gynecology

location_facility: Central Coast Medical Oncology Corporation

location_facility: North Mississippi Medical Center Hematology and Oncology Services

location_facility: Cancer Center of Santa Barbara with Sansum Clinic

location_facility: Universitaetsklinikum Schleswig-Holstein (UKSH), Klinik fuer Gynaekologie und Geburtshilfe, Studienzentrale Gynäkologische Onkologie (SGC) Kiel

location_facility: Medical University of Innsbruck-Department of Gynecology

location_facility: CHU Group Hospitalier Pitié-Salpêtrière, Service d'oncologie Médicale

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Decatur Memorial Hospital Cancer Care Specialists of Central Illinois

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: Saint Joseph / Candler SC Cancer Specialists

location_facility: Good Samaritan Hospital Samaritan Pastega Regional Cancer Center

location_facility: Hematology-Oncology Associates of the Treasure Coast


title: Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma

summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.

ReferenceType: result

ReferenceCitation: Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.

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

location_country: Croatia France Belgium Netherlands Egypt

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen


title: SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Merrimack Pharmaceuticals Inc.)

acronym: SHERLOC

summary: The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

ReferenceCitation: Sequist LV, Gray JE, Harb WA, Lopez-Chavez A, Doebele RC, Modiano MR, Jackman DM, Baggstrom MQ, Atmaca A, Felip E, Provencio M, Cobo M, Adiwijaya B, Kuesters G, Kamoun WS, Andreas K, Pipas JM, Santillana S, Cho BC, Park K, Shepherd FA. Randomized Phase II Trial of Seribantumab in Combination with Erlotinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer. Oncologist. 2019 Aug;24(8):1095-1102. doi: 10.1634/theoncologist.2018-0695. Epub 2019 Apr 11.

lead_sponsor: Elevation Oncology

location_country:
Spain
Canada
Hungary
United States
France
Germany

location_facility:
Centre Léon Bérard
CHI Creteil


title: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

summary: The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

ReferenceCitation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156.

lead_sponsor: Vascular Dynamics, Inc.

location_country:
United States
France

location_facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

intervention_type: Other


title: An Open-Label, Multicenter, Phase 1a/1b Study of Olaratumab (LY3012207) Plus Pembrolizumab (MK3475) in Patients With Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma (STS) Who Have Failed Standard Treatments

summary: The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.

location_country:
Denmark
United States
France
Belgium

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg


title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

summary: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation

lead_sponsor: Agios Pharmaceuticals, Inc.


title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Mease PJ, Gladman DD, Samad AS, Coates LC, Liu LXH, Aras GA, Collier DH, Chung JB. Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA). RMD Open. 2018 Feb 3;4(1):e000606. doi: 10.1136/rmdopen-2017-000606. eCollection 2018.

ReferenceCitation: Mease PJ, Gladman DD, Collier DH, Ritchlin CT, Helliwell PS, Liu L, Kricorian G, Chung JB. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol. 2019 Jul;71(7):1112-1124. doi: 10.1002/art.40851. Epub 2019 May 28.

ReferenceCitation: Strand V, Mease PJ, Maksabedian Hernandez EJ, Stolshek BS, Liu LXH, Collier DH, Kricorian G, Merola JF. Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination. RMD Open. 2021 Jan;7(1). pii: e001484. doi: 10.1136/rmdopen-2020-001484.

ReferenceCitation: Coates LC, Merola JF, Mease PJ, Ogdie A, Gladman DD, Strand V, van Mens LJJ, Liu L, Yen PK, Collier DH, Kricorian G, Chung JB, Helliwell PS. Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1137-1147. doi: 10.1093/rheumatology/keaa271.

ReferenceCitation: Helliwell PS, Mease PJ, Kavanaugh A, Coates LC, Ogdie A, Deodhar A, Strand V, Kricorian G, Liu LXH, Collier D, Gladman DD. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022 Jul;8(2):e002366. doi: 10.1136/rmdopen-2022-002366.

location_country:
Poland
Portugal
Spain
Greece
Latvia
Russian Federation
United Kingdom
Argentina
Canada
Hungary
Puerto Rico
United States
Chile
France
South Africa
Mexico
Bulgaria
Czechia

summary: The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.


title: A Phase Ib Multiple Ascending Dose Study to Evaluate the Safety of Brivanib in Combination With 5-Fluorouracil/Leucovorin (5FU/LV) and Brivanib in Combination With 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) in Subjects With Advanced or Metastatic Gastrointestinal Malignancies

summary: The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.

location_country:
United States
Canada
France

location_facility: Scott & White Memorial Hospital And Clinic


title: A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy

summary: This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: University of Colorado Health Sciences Center


title: A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath

acronym: ENLIVEN

summary:
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good.

The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS).

The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2.

Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.

ReferenceCitation: Healey JH, Tap WD, Gelhorn HL, Ye X, Speck RM, Palmerini E, Stacchiotti S, Desai J, Wagner AJ, Alcindor T, Ganjoo K, Martín-Broto J, Wang Q, Shuster D, Gelderblom H, van de Sande M. Pexidartinib Provides Modest Pain Relief in Patients With Tenosynovial Giant Cell Tumor: Results From ENLIVEN. Clin Orthop Relat Res. 2022 Aug 23. doi: 10.1097/CORR.0000000000002335. [Epub ahead of print]

ReferenceCitation: Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.

ReferenceCitation: Tap W. ENLIVEN study: Pexidartinib for tenosynovial giant cell tumor (TGCT). Future Oncol. 2020 Sep;16(25):1875-1878. doi: 10.2217/fon-2020-0307. Epub 2020 Aug 5.

ReferenceCitation: Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martín-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. doi: 10.1016/S0140-6736(19)30764-0. Epub 2019 Jun 19.

ReferenceCitation: Gelhorn HL, Tong S, McQuarrie K, Vernon C, Hanlon J, Maclaine G, Lenderking W, Ye X, Speck RM, Lackman RD, Bukata SV, Healey JH, Keedy VL, Anthony SP, Wagner AJ, Von Hoff DD, Singh AS, Becerra CR, Hsu HH, Lin PS, Tap WD. Patient-reported Symptoms of Tenosynovial Giant Cell Tumors. Clin Ther. 2016 Apr;38(4):778-93. doi: 10.1016/j.clinthera.2016.03.008. Epub 2016 Apr 1.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Hungary
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: Istituto Nazionale Tumori-Fondazione IRCCS

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


title: A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

acronym: OSA

summary: This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

ReferenceCitation: Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pépin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Finland
Sweden
United States
France
Germany

location_facility: Critical Care Pulmonary & Sleep Associates, LLC

location_facility: The Research Center of Southern California

location_facility: Center for Sleep & Circadian Neurobiology


status: Recruiting

title: Phase I / II, Open Label, Dose Escalation Part (Phase I) Followed by Noncomparative Expansion Part (Phase II), Multi-centre Study, Evaluating Safety, Pharmacokinetics and Efficacy of S65487, a Bcl2 Inhibitor Combined With Azacitidine in Adult Patients With Previously Untreated Acute Myeloid Leukemia Not Eligible for Intensive Treatment

lead_sponsor: Institut de Recherches Internationales Servier

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Korea, Republic of
France
Spain
United Kingdom

location_facility: Samsung Medical Center - Division of Hematology-Oncology

location_facility: University College London - Hospitals NHS Foundation Trust

location_facility: H. Universitario La Fe Servicio de Hematologia

location_facility: Seoul National University Hospital - Department of Hematology-Oncology

location_facility: Hospital 12 de Octubre Servicio de Hematología

location_facility: C. Universidad de Navarra Servicio de Hematologia

summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S65487 with azacitidine in patients with acute myeloid leukaemia.


title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes

summary:
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

location_country:
France
Spain
United Kingdom

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire de Reims

lead_sponsor_type: academique


title: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

acronym: BIO-GUARD-MI

summary: The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.

primary_purpose: Diagnostic

ReferenceCitation: Jons C, Sogaard P, Behrens S, Schrader J, Mrosk S, Bloch Thomsen PE. The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. Trials. 2019 Sep 11;20(1):563. doi: 10.1186/s13063-019-3644-5.

lead_sponsor: Biotronik SE & Co. KG

location_country:
Denmark
Poland
Spain
Latvia
Austria
Australia
Netherlands
Hungary
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: Hôpital Gabriel Montpied, Clermont Ferrand

location_facility: Charité Universitätsklinikum - Campus Benjamin Franklin

location_facility: Sjaellands Universitets Hospital, Roskilde

location_facility: East-Slovak Cardiology Institute (VUSCH)

location_facility: East Metropolitan Health Service Trading AS Royal Perth HOSPITAL

location_facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

location_facility: Herz- und Gefäß- Klinik GmbH Bad Neustadt

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Hungarian Defence Forces Military Hospital

location_facility: Klinika i Katedra Chorób Wewn. i Kardiologii

intervention_type: Device


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.

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

location_country:
Denmark
United Kingdom
Greece
Australia
United States
France

location_facility: Oregon Health Sciences University Hospital


title: The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study

acronym: EURORELAX

summary: Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) improves the surgical working conditions over a moderate NMB and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. Small prospective or retrospective studies shown an decrease of the incidence of intraoperative adverse events and postoperative complications after a deep NMB. There is a need to confirm these outcome data prospectively, in a large number of patients and clinics and during a variety of surgical procedures.

ReferenceCitation: Boon M, Martini C, Yang HK, Sen SS, Bevers R, Warlé M, Aarts L, Niesters M, Dahan A. Impact of high- versus low-dose neuromuscular blocking agent administration on unplanned 30-day readmission rates in retroperitoneal laparoscopic surgery. PLoS One. 2018 May 23;13(5):e0197036. doi: 10.1371/journal.pone.0197036. eCollection 2018.

ReferenceCitation: Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.

ReferenceCitation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

ReferenceCitation: Rosenthal R, Hoffmann H, Clavien PA, Bucher HC, Dell-Kuster S. Definition and Classification of Intraoperative Complications (CLASSIC): Delphi Study and Pilot Evaluation. World J Surg. 2015 Jul;39(7):1663-71. doi: 10.1007/s00268-015-3003-y.

ReferenceCitation: Madsen MV, Scheppan S, Mørk E, Kissmeyer P, Rosenberg J, Gätke MR. Influence of deep neuromuscular block on the surgeonś assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.

ReferenceCitation: Özdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warlé MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

ReferenceCitation: Honing M, Reijnders-Boerboom G, Dell-Kuster S, van Velzen M, Martini C, Valenza F, Proto P, Cambronero OD, Broens S, Panhuizen I, Roozekrans M, Fuchs-Buder T, Boon M, Dahan A, Warlé M. The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial - EURO-RELAX TRIAL. Trials. 2021 Oct 26;22(1):744. doi: 10.1186/s13063-021-05638-2.

ipd_sharing_description: Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.

lead_sponsor: Leiden University Medical Center

location_country: Netherlands France Spain Italy

location_facility: Hospital Universitari I Politecnic La Fe


title: AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)

acronym: DISCOVER

summary: AcQMap Registry is an observational study

time_perspective: Prospective

lead_sponsor: Acutus Medical

location_country:
Germany
France
Netherlands
United Kingdom

location_facility: Erasmus MC Cardiologie Elektrofysiologie

location_facility: Sheffield Teaching Hospital Northern General Hospital


title: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)

summary: This LIGHTSITE II study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

lead_sponsor: LumiThera, Inc.

location_country:
United Kingdom
Spain
Italy
France
Germany

location_facility: Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein

location_facility: Institut ophtalmologique de l'Ouest- Clinique jules VERNE

location_facility: Universitätsklinikum Freiburg- Klinik für Augenheilkunde


title: Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial

summary: The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF

status: Unknown status

ReferenceCitation: Marrache MK, Rockey DC. Statins for treatment of chronic liver disease. Curr Opin Gastroenterol. 2021 May 1;37(3):200-207. doi: 10.1097/MOG.0000000000000716. Review.

lead_sponsor: Judit Pich

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility:
Padova University Hospital
Academic Medical Centre
San Giovanni Battista Hospital
Bologna University Hospital
Hospital Universitari Vall d'Hebrón
Beajuon Hospital
Universitatsklinikum Frankurt
Hospital Clínic de Barcelona
Royal Free Hospital


title: Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)

acronym: ACROSS

summary: This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

primary_purpose: Other

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Canada
Switzerland
France
Germany


title: Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels

acronym: EXPAND

summary: The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment

lead_sponsor: W.L.Gore & Associates

location_country: Spain Italy Netherlands France Germany

location_facility: University Hospital of Santiago de Compostela

location_facility: Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Azienda Ospedaliero-Universitaria di Padova


acronym: FUTURE 4

title: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

ReferenceCitation: Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3). pii: e001845. doi: 10.1136/rmdopen-2021-001845.

ReferenceCitation: Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.

location_country:
Poland
United Kingdom
Italy
Russian Federation
Australia
Canada
Sweden
United States
France
Belgium
Germany
Bulgaria
Czechia

summary: The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy


summary: AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

ReferenceCitation: Parellada M, San José Cáceres A, Palmer M, Delorme R, Jones EJH, Parr JR, Anagnostou E, Murphy DGM, Loth E, Wang PP, Charman T, Strydom A, Arango C. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. Front Psychiatry. 2021 Aug 24;12:701729. doi: 10.3389/fpsyt.2021.701729. eCollection 2021.

lead_sponsor: Celso Arango, MD, PhD

location_facility: Servicio de Psiquiatría del Niño y del Adolescente, Hospital General Universitario Gregorio Marañón, SERMAS

location_facility: University of Salamanca & Complejo asistencial de Zamora


title: A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.

acronym: BISS

summary:
The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen.

Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.

Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.

In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.

As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.

Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.

ReferenceCitation: Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9.

ReferenceCitation: Tejedor J, Rodríguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7.

ReferenceCitation: Tejedor J, Rodríguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4.

ReferenceCitation: Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6.

ReferenceCitation: Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5.

ReferenceCitation: de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.

ReferenceCitation: McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8.

ReferenceCitation: Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.

ReferenceCitation: Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.

ReferenceCitation: Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.

ReferenceCitation: Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5.

ReferenceCitation: Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43.

ReferenceCitation: Kushner BJ, Morton GV. A randomized comparison of surgical procedures for infantile esotropia. Am J Ophthalmol. 1984 Jul 15;98(1):50-61.

ReferenceCitation: Helveston EM, Ellis FD, Schott J, Mitchelson J, Weber JC, Taube S, Miller K. Surgical treatment of congenital esotropia. Am J Ophthalmol. 1983 Aug;96(2):218-28.

ReferenceCitation: Scheiman M, Ciner E, Gallaway M. Surgical success rates in infantile esotropia. J Am Optom Assoc. 1989 Jan;60(1):22-31. Review.

ReferenceCitation: Hatt SR, Leske DA, Liebermann L, Holmes JM. Comparing outcome criteria performance in adult strabismus surgery. Ophthalmology. 2012 Sep;119(9):1930-6. doi: 10.1016/j.ophtha.2012.02.035. Epub 2012 Apr 26.

ReferenceCitation: Wan MJ, Mantagos IS, Shah AS, Kazlas M, Hunter DG. Comparison of Botulinum Toxin With Surgery for the Treatment of Acute-Onset Comitant Esotropia in Children. Am J Ophthalmol. 2017 Apr;176:33-39. doi: 10.1016/j.ajo.2016.12.024. Epub 2017 Jan 3.

ReferenceCitation: Dysli M, Keller F, Abegg M. Acute onset incomitant image disparity modifies saccadic and vergence eye movements. J Vis. 2015 Mar 18;15(3). pii: 12. doi: 10.1167/15.3.12.

ReferenceCitation: Dysli M, Abegg M. Gaze-dependent phoria and vergence adaptation. J Vis. 2016;16(3):2. doi: 10.1167/16.3.2.

ReferenceCitation: Mahan M, Engel JM. The resurgence of botulinum toxin injection for strabismus in children. Curr Opin Ophthalmol. 2017 Sep;28(5):460-464. doi: 10.1097/ICU.0000000000000408. Review.

ReferenceCitation: Pediatric Eye Disease Investigator Group, Christiansen SP, Chandler DL, Lee KA, Superstein R, de Alba Campomanes A, Bothun ED, Morin J, Wallace DK, Kraker RT. Tonic pupil after botulinum toxin-A injection for treatment of esotropia in children. J AAPOS. 2016 Feb;20(1):78-81. doi: 10.1016/j.jaapos.2015.09.011.

ReferenceCitation: Pehere N, Jalali S, Mathai A, Naik M, Ramesh K. Inadvertent intraocular injection of botulinum toxin A. J Pediatr Ophthalmol Strabismus. 2011 Jan 25;48 Online:e1-3. doi: 10.3928/01913913-20110118-06.

ReferenceCitation: Liu M, Lee HC, Hertle RW, Ho AC. Retinal detachment from inadvertent intraocular injection of botulinum toxin A. Am J Ophthalmol. 2004 Jan;137(1):201-2.

ReferenceCitation: Bradbury JA, Taylor RH. Severe complications of strabismus surgery. J AAPOS. 2013 Feb;17(1):59-63. doi: 10.1016/j.jaapos.2012.10.016. Epub 2013 Jan 23.

ReferenceCitation: Arès C, Superstein R. Retrobulbar hemorrhage following strabismus surgery. J AAPOS. 2006 Dec;10(6):594-5. Epub 2006 Oct 2.

ReferenceCitation: Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2017 Mar 2;3:CD006499. doi: 10.1002/14651858.CD006499.pub4. Review.

ReferenceCitation: Lyons CJ, Tiffin PA, Oystreck D. Acute acquired comitant esotropia: a prospective study. Eye (Lond). 1999 Oct;13 ( Pt 5):617-20.

ReferenceCitation: BURIAN HM, MILLER JE. Comitant convergent strabismus with acute onset. Am J Ophthalmol. 1958 Apr;45(4 Pt 2):55-64.

ipd_sharing_description: The de-identified study dataset will be made publicly available for secondary analyses by publishing the data on a data sharing platform such as Dryad or BORIS, the public online data repository from the University of Bern.

lead_sponsor: University Hospital Inselspital, Berne

location_country: France Switzerland

location_facility: Institut Ophtalmologique Sourdille Atlantique

intervention_type: Procedure


title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy

lead_sponsor: Bayer

location_country:
Denmark
Poland
Taiwan
Hong Kong
Spain
Ireland
Austria
Netherlands
United Kingdom
Canada
Finland
Switzerland
Korea, Republic of
United States
France
Israel
Singapore
Norway
Germany
Czechia

summary: The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy


title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6885247 Following 12 Weeks of Treatment in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH).

summary: This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA).

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Italy
Canada
Switzerland
Sweden
United States
France
Turkey
Netherlands

location_facility: Ch Pitie Salpetriere; Institut de Myologie

location_facility: Universitäts-Kinderspitalbeider Basel_Abteilung für Neuro- und Entwicklungspädiatrie

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: Drottning Silvias Barn- och ungdomssjukhus; Kliniken för barnmedicin

location_facility: UCL; GAP Unit, Institute of Child Health, UCL

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"; UO di Neurologia dello Sviluppo

location_facility: MRC Neuromuscular Centre - Institute of Genetic Medicine

location_facility: Hacettepe University, School of Medicine; Pediatrics Department; Pediatrics Child Neurology Unit


title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

acronym: VALUE

summary: This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

ReferenceCitation: Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ™ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.

lead_sponsor: Laminate Medical Technologies

location_country:
Germany
France
Spain
United Kingdom

location_facility: Klinikum Ernst von Bergmann gemeinnützige GmbH

location_facility: Harzklinikum Dorothea Christiane Erxleben


acronym: LIVERHOPE

title: Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.

ReferenceCitation: Pose E, Napoleone L, Amin A, Campion D, Jimenez C, Piano S, Roux O, Uschner FE, de Wit K, Zaccherini G, Alessandria C, Angeli P, Bernardi M, Beuers U, Caraceni P, Durand F, Mookerjee RP, Trebicka J, Vargas V, Andrade RJ, Carol M, Pich J, Ferrero J, Domenech G, Llopis M, Torres F, Kamath PS, Abraldes JG, Solà E, Ginès P. Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):31-41. doi: 10.1016/S2468-1253(19)30320-6. Epub 2019 Oct 10.

location_facility:
Padova University Hospital
Universitatsklinikum Bonn
Academic Medical Centre
San Giovanni Battista Hospital
Bologna University Hospital
Hospital Universitari Vall d'Hebrón
Beajuon Hospital
Hospital Clínic de Barcelona
Royal Free Hospital

summary:
The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis.

The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.


title: Current Treatment of HCV Infection After HSCT

summary:
The availability of novel therapies with DAAs might prompt clinicians caring for HSCT recipients with HCV infection to prescribe the treatment more frequently and possibly earlier after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most appropriate one is not straightforward. It depends not only on its efficacy, toxicity and rate of pharmacological interactions, but also on availability (both through healthcare system and in expanded access programs), and cost.

This observational prospective study will focus on treatment strategies in HSCT recipients with HCV infection. The main focus will be the therapeutic approach, the combination of drugs chosen, the length of treatment and the outcome. The main reasons for treating or not treating HSCT recipients with HCV infection will be also explored. Compared to previous cohorts, this study might provide additional data in the area of non-invasive assessment of fibrosis, HCV-RNA levels and genotyping.

In order to get as much data as possible on HCV treatment, patients with chronic HCV infection transplanted during the last 10 years will be included.

Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016 will be reported.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: France Spain Italy

location_facility:
Ospedale Civile
Ospedale Santa Maria della Misericordia
Policlinico G.B. Rossi
Ospedale San Raffaele s.r.l.
Hospital Santa Creu i Sant Pau
Centre Hospitalier de Meaux
Hospital de la Princesa


title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

acronym: TRI-REPAIR

summary: The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

ReferenceCitation: Nickenig G, Weber M, Schüler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schäfer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.

ReferenceCitation: Nickenig G, Weber M, Schueler R, Hausleiter J, Näbauer M, von Bardeleben RS, Sotiriou E, Schäfer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.

lead_sponsor: Edwards Lifesciences

location_country: Germany France Italy

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Bonn University - Universitätsklinikum Bonn

location_facility: Universitätsklinik Hamburg Eppendorf, Herzzentrum

location_facility: LMU Klinikum der Universität München, Medizinische Klinik I


title: An Open-label, Non-randomised, Phase I Study to Assess the Effect of Single and Multiple Oral Doses of Osimertinib (TAGRISSO™) on the Pharmacokinetics of a P-glycoprotein Probe Drug (Fexofenadine) in Patients With Advanced EGFRm NSCLC That Have Progressed on a Prior EGFR-TKI Regimen

summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.

Continuous Access will allow patients further access to osimertinib after the PK phase (Part A). All patients from Part A who completed treatment may continue to receive osimertinib 80 mg once daily until: they are no longer deriving clinical benefit; or any other reason

ReferenceCitation: Calvo E, Lee JS, Kim SW, Moreno V, deCastro Carpeno J, Weilert D, Laus G, Mann H, Vishwanathan K. Modulation of Fexofenadine Pharmacokinetics by Osimertinib in Patients With Advanced EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Pharmacol. 2019 Aug;59(8):1099-1109. doi: 10.1002/jcph.1403. Epub 2019 Mar 15.

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

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
France
Spain


title: A pRospective, Multicenter, Single-arm Study EvaLuating the Safety and feasIbility of Targeted Lung Denervation (TLD) for the trEatment oF Severe Asthma

summary: Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation (TLD) Therapy in subjects with severe asthma.

lead_sponsor: Nuvaira, Inc.

location_facility: Chelsea & Westminster Hospital NHS Foundation Trust

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust


title: Interventional, Randomised, Open Label, Multi-centre, Parallel-group, Controlled Study Investigating the Effects of Using the PReDicT Test to Guide the Antidepressant Treatment of Depressed Patients

summary:
Depression is a very common, serious and in some cases life-threatening condition, affecting around 350 million people globally. Approximately 11% of citizens in the European Union suffer from depression at some point in their lives. Depression is associated with significant socio-economic costs and has been predicted to become the greatest cause of disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion . Improvements in managing the treatment of depression are urgently needed to improve patient outcomes, contain rising healthcare costs, improve workplace productivity and help to address global economic and societal challenges.

While a range of effective antidepressant medications are available to treat depression, it takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working. However, surprisingly, more than 50% of patients fail to respond to the first antidepressant treatment they are prescribed. Therefore, it often takes several months to identify an effective antidepressant treatment for the majority of patients with depression. During this time a patient's ability to work and function socially is severely impaired. Individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and on healthcare resources.

ReferenceCitation: World Health Organization, The Global Burden of Disease: 2004 update. nDeneva, World Health Organization, 2008.

ReferenceCitation: Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jönsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018. Review.

ReferenceCitation: Rush AJ. STAR*D: what have we learned? Am J Psychiatry. 2007 Feb;164(2):201-4.

ReferenceCitation: Kingslake J, Dias R, Dawson GR, Simon J, Goodwin GM, Harmer CJ, Morriss R, Brown S, Guo B, Dourish CT, Ruhé HG, Lever AG, Veltman DJ, van Schaik A, Deckert J, Reif A, Stäblein M, Menke A, Gorwood P, Voegeli G, Pérez V, Browning M. The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial. Trials. 2017 Nov 23;18(1):558. doi: 10.1186/s13063-017-2247-2.

lead_sponsor: P1vital Products Limited

location_country:
Spain
United Kingdom
Netherlands
France
Germany

location_facility: University of Nottingham Health Service - Cripps Health Centre

location_facility: Dept of Psychiatry, Outpatient Clinic, University Hospital

location_facility: Rothwell and Desborough Healthcare Group


title: REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

acronym: REPAIR

summary:
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.

Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.

location_facility:
Bichat hospital
Koln, Universitätsklinikum
Bad Nauheim, Kerckhoff-Klinik
Universitatsmedizin Mainz
Hospital san raffaele
Universitätsklinikum Gießen und Marburg
University Hospital Halle (Saale)
Asklepios Klinik, St. Georg
Bonn University
Universitäres Herzzentrum Hamburg GmbH


title: A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

summary:
Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML) characterized by consistent clinical, morphologic, and genetic features. According to the FAB classification APL is designated as"M3 leukemia" and assigned to the WHO defined type of AML with recurrent cytogenetic abnormalities, "acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) and variants".

Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus anthracycline-based regimens, relapses still occur in approximately 20% of patients. Moreover, these regimens are associated with significant toxicities due to severe myelosuppression frequently associated with life-threatening infections and potentially serious late effects including development of secondary MDS/AML. In a recent randomized clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of arsenic trioxide (ATO) and ATRA has been shown to result into better survival with significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA) therapy. Inspired by the results of this trial the investigators intend to perform a randomized study in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard AIDA-based treatment with ATO/ATRA combination including low-doses idarubicin during induction. The investigators propose a modified ATO/ATRA protocol with the addition of two doses of IDA (50% compared to standard AIDA induction) for induction because of the anticipated need of adding anthracyclines to control hyperleukocytosis and to achieve long-term disease control in this high-risk APL population. This is followed by 4 cycles of ATO/ATRA consolidation therapy. As in the APL0406 study for low/intermediate-risk patients the investigators expect less severe hematologic toxicity and treatment-related mortality resulting in an improved outcome for patients in the experimental arm. Furthermore, from the start of consolidation, these patients (in contrast to the standard arm) can be treated on an outpatient basis, which is also considered to be associated with an improved quality of life. The study will be conducted as a European intergroup study.

lead_sponsor: Technische Universität Dresden

location_facility:
GIMEMA study group
OSHO study group
AML-SG study group
PETHEMA study group
AML-CG study group
HOVON study group
SAL study group
French-Belgian-Swiss APL study group


title: Multi-center, Prospective, Post-market Study

summary: The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).

lead_sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

location_country: Italy Ireland Switzerland France Germany

location_facility: AP Hospital Europeen G Pompidou and Hospital Necker


acronym: WE

title: Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

lead_sponsor: St. Olavs Hospital

ReferenceCitation: Brændvik SM, Roeleveld K, Andersen GL, Raftemo AE, Ramstad K, Majkic-Tajsic J, Lamvik T, Lund B, Follestad T, Vik T. The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):58. doi: 10.1186/s13063-016-1772-8.

location_country: Norway Poland France

location_facility: Department of Orthopaedic Surgery, St. Olavs University Hospital

location_facility: Mazowieckie Centrum Neuropsychiatrii, Zagorze

summary: In Norway, about 60% of all children with cerebral palsy (CP) are being treated with botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large variation in effect is seen by clinicians. The main objective of the present study is to investigate whether injections with BoNT-A in the calf muscles make walking easier in children with spastic CP within 6 months, reflected by reduced energy cost during walking.


title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section

summary: This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.

lead_sponsor: Polyganics BV

location_country: Netherlands France

location_facility:
MUMC
MC Groep
UMCG
Strasbourg University Hospitals
Martini Hospital Groningen
Haga Hospital
Albert Schweitzer Hospital


title: An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study

summary: This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.

location_country:
Serbia
Spain
Latvia
Russian Federation
Italy
France
South Africa
Japan

location_facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

location_facility: Clin Hospital Center - Kragujevac; Pulmonary Diseases

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

location_facility: University of the Witwatersrand Research

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

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

location_facility: National Hospital Organization Shikoku Cancer Center


title: Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety Study With PA101 in Patients With Indolent Systemic Mastocytosis

summary:
This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in adult patients with indolent systemic mastocytosis (ISM).

The purpose of the study is to determine the efficacy and safety profile of PA101 delivered via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using standard treatments.

lead_sponsor: Patara Pharma

location_facility:
Technical University München
Charité - Universitätsmedizin Berlin
University of Salerno
Hospital Universitario de Fuenlabrada
University Medical Center of Groningen
Hopital Necker - Enfants Malades
Klinikum Darmstadt
University Medical Center Mainz


title: Care for Late Stage Parkinsonism

acronym: CLaSP

summary: The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

ReferenceCitation: Kruse C, Kretschmer S, Lipinski A, Verheyen M, Mengel D, Balzer-Geldsetzer M, Lorenzl S, Richinger C, Schmotz C, Tönges L, Woitalla D, Klebe S, Schrag A, Dodel R. Resource Utilization of Patients with Parkinson's Disease in the Late Stages of the Disease in Germany: Data from the CLaSP Study. Pharmacoeconomics. 2021 May;39(5):601-615. doi: 10.1007/s40273-021-01011-y. Epub 2021 Mar 19.

ReferenceCitation: Balzer-Geldsetzer M, Ferreira J, Odin P, Bloem BR, Meissner WG, Lorenzl S, Wittenberg M, Dodel R, Schrag A. Study protocol: Care of Late-Stage Parkinsonism (CLaSP): a longitudinal cohort study. BMC Neurol. 2018 Nov 5;18(1):185. doi: 10.1186/s12883-018-1184-3.

lead_sponsor: University College, London

location_country:
Portugal
United Kingdom
Netherlands
Sweden
France
Germany

location_facility:
University College London
University of Bordeaux
Instituto de Medicina Molecular
University of Munich
Radboud university medical center
Lund University
University of Marburg


title: Phase I/Prospective Randomized Phase II Trial Of the Safety and Efficacy of Tamoxifen in Combination With GDC-0032 Compared With Tamoxifen alONe.

acronym: Poseidon

summary:
This study is designed as a phase 1 dose escalation study followed by a randomised phase II study. The study will be performed in three different centres: Addenbrooke & Cambridge university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron Hospital (Barcelona, Spain).

Three to six patients will be followed for one completed cycle of therapy (28 days) and subsequent enrolment of new cohorts will be based on the safety assessment in that first cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alone.

lead_sponsor: The Netherlands Cancer Institute

location_country:
Netherlands
France
Spain
United Kingdom

location_facility:
MUMC
Antoni van Leeuwenhoek
Haaglanden Medisch Centrum
Deventer Ziekenhuis
Hospital ICO-Hospitalet (Bellvitge)
Ziekenhuis Groep Twente
Hospital Arnau de Vilanova
Vall d'Hebron University Hospital/VHIO
Hospital Universitari Sant Joan de Reus
Reinier de Graaf Gasthuis
University of Cambridge
Hospital Clínic de Barcelona
Hospital Germans Trias i Pujol
Gustave Roussy


title: The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

acronym: EUROCRIPS

summary: The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

ReferenceCitation: D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.

ReferenceCitation: Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefèvre T, Gasparetto V, Garbo R, Omedè P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.

lead_sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier

location_facility: Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto


title: Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)

summary: The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib.

time_perspective: Cross-Sectional

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country: Germany France Spain Italy

location_facility: U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

location_facility: Divisione di Ematologia con trapianto di midollo - A.O.U. Policlinico "Paolo Giaccone"

location_facility: Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"

location_facility: U.O. Ematologia - Azienda USLL12 Veneziana - Ospedale dell'Angelo e Ospedale civile S. Giovanni e Paolo

location_facility: Divisione di Ematologia - Policlinico Careggi

location_facility: U.O. di Ematologia - Casa Sollievo della Sofferenza

location_facility: Clinica Ematologica ed Unità di Terapie Cellulari Carlo Melzi - A.O. Universitaria

location_facility: Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines

location_facility: Divisione di Ematologia - A.O. Ospedali Riuniti di Reggio Calabria "Bianchi-Melacrino-Morelli"

location_facility: U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Dipartimento di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

location_facility: Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"

location_facility: U.O.C. Ematologia e Trapianto cellule staminali - Pad Cesalpino- A.O. San Camillo Forlanini

location_facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

location_facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

location_facility: Universität Heidelberg - III. Medizinische Klinik - Universitätsmedizin Mannheim

location_facility: Azienda Ospedaliera - Arcispedale S. Anna Sezione di Ematologia e Fisiopatologia delle Emostasi

location_facility: Divisione di Ematologia - Ospedale S.Eugenio

location_facility: S.C. di Oncoematologia - A.O. "S. Maria"

location_facility: Ematologia e CTMO - A.O.U. Università degli Studi di Parma

location_facility: S. C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

location_facility: Department of Onco-Hematology - IRCCS; Centro di Riferimento Oncologico della Basilicata

location_facility: USD - Centro Trapianti Midollo Osseo Adulti - Cattedra di Ematologia - Azienda Spedali Civili - Brescia

location_facility: Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST

location_facility: S.C.D.O. Ematologia II - A.O.U.S. San Giovanni Battista di Torino (Molinette)

location_facility: U.O.C. Ematologia - A.O. SS Annunziata - P.O.S.G. Moscati

location_facility: Onco-Ematologia - Ospedale S. Andrea- Vercelli

location_facility: Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

location_facility: U.O.C. Ematologia - A.O. Ospedali Riuniti "Villa Sofia-Cervello"

location_facility: U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano

location_facility: U.O. Ematologia Brindisi- Ospedale A. Perrino ASL BR

location_facility: Dipartimento di Med. Clinica e Sperimentale- Area di Ematologia - Facoltà di Medicina e Chirurgia - Università degli Studi di Napoli "Federico II" -

location_facility: XIX Divisione di Ematologia con trapianto - A.O.R.N. "A. Cardarelli"

location_facility: U.O. di Ematologia - Ente Ospedaliero San Giovanni Addolorata

location_facility: Clinica di Ematologia - Azienda Ospedaliera Regionale di Torrette

location_facility: Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"

location_facility: Divisione Ematologia - Dipartimento di Medicina Interna -Policlinico Universitario di Messina

location_facility: Ematologia ed Immunologia Clinica - Università degli studi di Padova

location_facility: Istituto di Ematologia "L. e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

location_facility: Department of Hematology, Hospital Universitario de la Princesa


title: Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria

summary: The aim of the present study is to investigate the efficacy, safety and tolerability of a therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P. vivax in endemic countries.

ReferenceCitation: Hasugian AR, Purba HL, Kenangalem E, Wuwung RM, Ebsworth EP, Maristela R, Penttinen PM, Laihad F, Anstey NM, Tjitra E, Price RN. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and posttreatment prophylaxis against multidrug-resistant Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis. 2007 Apr 15;44(8):1067-74. Epub 2007 Mar 5.

ReferenceCitation: Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.

ReferenceCitation: Sinclair D, Gogtay N, Brand F, Olliaro P. Artemisinin-based combination therapy for treating uncomplicated Plasmodium vivax malaria. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD008492. doi: 10.1002/14651858.CD008492.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD008492.

lead_sponsor: Alfasigma S.p.A.

location_country: Spain Italy Switzerland France Israel Netherlands Germany

location_facility: Clinica di Malattie Infettive e Tropicali, Universitá di Brescia

location_facility: Medizinische Klinik mit Schwerpunkt Infektiologie, Charite/Campus Virchow-Klinikum

location_facility: Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute

location_facility: Hôpital St André-CHU, Médecine interne et Maladies tropicales

location_facility: Centro di Malattie Tropicali - INMI Spallanzani

location_facility: Azienda Ospedaliera Arcispedale S. Maria Nuova IRCCS - Dip. Medicina Interna e Spec. Mediche

location_facility: 15. The Center for Geographic Medicine and Tropical Diseases, Department of Medicine C - The Chaim Sheba Medical Center

location_facility: Department of Infectious Diseases & Tropical Medicine, University of Munich

location_facility: Dep. Infectious Disease, Section Travel Medicine, Leiden University Medical Centre


title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

summary: Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.

lead_sponsor: PharmaMar

location_country: France Spain

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Hospital Universitari i Politècnic la Fe


title: A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Taher AT, Origa R, Perrotta S, Kouraklis A, Ruffo GB, Kattamis A, Goh AS, Huang V, Zia A, Herranz RM, Porter JB. Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias. Health Qual Life Outcomes. 2018 Nov 19;16(1):216. doi: 10.1186/s12955-018-1041-5.

location_country:
Saudi Arabia
Greece
Austria
Italy
Lebanon
Argentina
Russian Federation
Spain
Thailand
United Kingdom
United States
France
Malaysia
Mexico
Germany
United Arab Emirates

location_facility: Children's Hospital of Orange County Onc Dept

location_facility: Weill Cornell Medical College-Cornell University Onc Dept

location_facility: Children's Hospital of Philadelphia Onc. Dept

location_facility: Lurie Children's Hospital of Chicago Onc Dept

location_facility: Children's Hospital Boston Department of Hematology

summary: Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance


title: Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis

summary:
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.

This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational try is to identify:

The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression
The potential predictors and confounders for response to therapy

lead_sponsor: Gabriela Riemekasten

location_country:
United Kingdom
Italy
Switzerland
Hungary
France
Germany

location_facility: University of Zurich, Department of Rheumatology

location_facility: Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

location_facility: University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

location_facility: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

location_facility: Royal Free Hospital, University College London

location_facility: The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

location_facility: Centre for Pediatric Rheumatology, Klinikum Eilbek

location_facility: Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: Pecsi Tudomanyegyetem - University of Pecs

location_facility: Felix-Platter Spital, University of Basel


title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

ReferenceCitation: Bouffet E, Geoerger B, Moertel C, Whitlock JA, Aerts I, Hargrave D, Osterloh L, Tan E, Choi J, Russo M, Fox E. Efficacy and Safety of Trametinib Monotherapy or in Combination With Dabrafenib in Pediatric BRAF V600-Mutant Low-Grade Glioma. J Clin Oncol. 2022 Nov 14:JCO2201000. doi: 10.1200/JCO.22.01000. [Epub ahead of print]

ReferenceCitation: Shahid S, Kushner BH, Modak S, Basu EM, Rubin EM, Gundem G, Papaemmanuil E, Roberts SS. Association of BRAF V600E mutations with vasoactive intestinal peptide syndrome in MYCN-amplified neuroblastoma. Pediatr Blood Cancer. 2021 Oct;68(10):e29265. doi: 10.1002/pbc.29265. Epub 2021 Jul 31.

location_country:
United Kingdom
Australia
Canada
United States
France

summary:
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.

Part A was a repeat dose, dose escalation and expansion phase that identified the recommended phase II dose (RP2D) of trametinib monotherapy. Part B evaluated the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects. Part C was aimed to determine the safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a limited dose escalation of dabrafenib. Part D evaluated the preliminary activity of trametinib in combination with dabrafenib in 2 disease-specific cohorts of subjects.

The overall goal of this trial was to efficiently establish safe, pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with dabrafenib in infants, children and adolescents and determine preliminary activity of trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent, refractory or unresectable childhood tumors.


title: Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

summary: This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.

lead_sponsor: Sierra Oncology, Inc.

location_country:
Australia
Canada
United States
France
Germany


title: VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment

acronym: VIRTUS

summary: This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

ReferenceCitation: Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. Circ Cardiovasc Interv. 2019 Dec;12(12):e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268. Epub 2019 Dec 13.

ReferenceCitation: Razavi M, Marston W, Black S, Bentley D, Neglén P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Ireland
United Kingdom
Netherlands
United States
France
Germany

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

location_facility: The University of North Carolina at Chapel Hill

location_facility: New York Presbyterian Hospital/Cornell University