title: An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

acronym: COBRA

summary: This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

location_country: Sweden France

location_facility:
Plastikkirurggruppen
Akademikliniken
Proforma Clinic
L'Institute du Sein
Sainte Anne


title: An Open Label, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.

summary: This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Paz-Ares LG, Gomez-Roca C, Delord JP, Cervantes A, Markman B, Corral J, Soria JC, Bergé Y, Roda D, Russell-Yarde F, Hollingsworth S, Baselga J, Umana P, Manenti L, Tabernero J. Phase I pharmacokinetic and pharmacodynamic dose-escalation study of RG7160 (GA201), the first glycoengineered monoclonal antibody against the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol. 2011 Oct 1;29(28):3783-90. doi: 10.1200/JCO.2011.34.8888. Epub 2011 Sep 6.

lead_sponsor: Hoffmann-La Roche

location_country: France Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women With Newly Diagnosed, Previously Untreated, Gynaecological Tumors

summary: This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

lead_sponsor: GlaxoSmithKline

location_country: Germany France


title: Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

summary: This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL).

ReferenceType: background

ReferenceCitation: Lindén O, Hindorf C, Cavallin-Ståhl E, Wegener WA, Goldenberg DM, Horne H, Ohlsson T, Stenberg L, Strand SE, Tennvall J. Dose-fractionated radioimmunotherapy in non-Hodgkin's lymphoma using DOTA-conjugated, 90Y-radiolabeled, humanized anti-CD22 monoclonal antibody, epratuzumab. Clin Cancer Res. 2005 Jul 15;11(14):5215-22.

ReferenceCitation: Lindén O, Tennvall J, Cavallin-Ståhl E, Darte L, Garkavij M, Lindner KJ, Ljungberg M, Ohlsson T, Sjögreen K, Wingårdh K, Strand SE. Radioimmunotherapy using 131I-labeled anti-CD22 monoclonal antibody (LL2) in patients with previously treated B-cell lymphomas. Clin Cancer Res. 1999 Oct;5(10 Suppl):3287s-3291s.

ReferenceCitation: Hindorf C, Lindén O, Stenberg L, Tennvall J, Strand SE. Change in tumor-absorbed dose due to decrease in mass during fractionated radioimmunotherapy in lymphoma patients. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):4003S-6S.

ReferenceCitation: Sharkey RM, Burton J, Goldenberg DM. Radioimmunotherapy of non-Hodgkin's lymphoma: a critical appraisal. Expert Rev Clin Immunol. 2005 May;1(1):47-62. doi: 10.1586/1744666X.1.1.47.

ReferenceCitation: Sharkey RM, Brenner A, Burton J, Hajjar G, Toder SP, Alavi A, Matthies A, Tsai DE, Schuster SJ, Stadtmauer EA, Czuczman MS, Lamonica D, Kraeber-Bodere F, Mahe B, Chatal JF, Rogatko A, Mardirrosian G, Goldenberg DM. Radioimmunotherapy of non-Hodgkin's lymphoma with 90Y-DOTA humanized anti-CD22 IgG (90Y-Epratuzumab): do tumor targeting and dosimetry predict therapeutic response? J Nucl Med. 2003 Dec;44(12):2000-18.

ReferenceCitation: Griffiths GL, Govindan SV, Sharkey RM, Fisher DR, Goldenberg DM. 90Y-DOTA-hLL2: an agent for radioimmunotherapy of non-Hodgkin's lymphoma. J Nucl Med. 2003 Jan;44(1):77-84.

ReferenceCitation: Lindén O, et al. Outcome and absorbed dose following 90-yttrium-epratuzumab in B-cell lymphoma, using a dose-fractionation schedule. (Abstract No. 1479) Blood 2003; 102/11:407a.

ReferenceCitation: Postema EJ, et al. Dosimetric analysis of radioimmunotherapy with 186Re-epratuzumab. (Abstract No. 102) J Nucl Med Suppl 2003; 44/5:32P-33P.

ReferenceCitation: Leonard JP, Siegel JA, Goldsmith SJ. Comparative physical and pharmacologic characteristics of iodine-131 and yttrium-90: implications for radioimmunotherapy for patients with non-Hodgkin's lymphoma. Cancer Invest. 2003 Apr;21(2):241-52. Review.

ReferenceCitation: Lindén O, et al. Radioimmunotherapy with Y-90-Epratuzumab in patients with previously treated B-cell lymphoma. A fractionated dose-escalation study. (Abstract 5.05 Hematology) Special Issue: World Congress of Nuclear Medicine, September 2002; 5/17.

ReferenceCitation: Liu, Huaitian, et al. Targeting the CD22 receptor with RNA damaging agents. Cancer Drug Discovery and Development: Tumor Targeting in Cancer Therapy. Edited by: M Pagé, Humana Press Inc., Totowa, NJ: 109-118

ReferenceCitation: Lindén O, et al. Durable response to 90-yttrium-epratuzumab (hLL2) in B-cell lymphoma failing chemotherapy by using dose-fractionation schedule. (Abstract presented at the American Society of Hematology 43rd Annual Meeting) Blood 2001; 98/11: 602a

ReferenceCitation: Hajjar G. et al. Phase I/II radioimmunotherapy trial with 90Y-labeled epratuzumab (LymphoCide; anti-CD22 monoclonal antibody) in relapsed/refractory non-Hodgkin's lymphoma (NHL). (Abstract #583) J Nucl Med Suppl, May 2001; 42/5: 156P.

ReferenceCitation: Goldenberg DM. The role of radiolabeled antibodies in the treatment of non-Hodgkin's lymphoma: the coming of age of radioimmunotherapy. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):195-201. Review.

ReferenceCitation: Juweid M, Schuster SL, et al. Updated results of radioimmunotherapy of relapsed/refractory non-Hodgkin's lymphoma with conventional and stem cell supported doses of 90Y-labeled humanized LL2 anti-CD22 monoclonal antibody. (Abstract #40) Cancer Biother & Radiopharm 2000, 15/4: 408

ReferenceCitation: Lindén O, Tennvall J, et al. A Phase I/II trial with Y-90 hLL2 in recurrent B-cell lymphomas. Preliminary results. (Abstract #67) Cancer Biother & Radiopharm 2000, 15/4: 413

ReferenceType: result

ReferenceCitation: Bodet-Milin C, et al. FDG-PET predicts response to fractionated radioimmunotherapy with 90Y-epratuzumab anti-CD22 MAb in patients with NHL. (Abstract #4782) Blood 2995; 106/11:275b.

ReferenceCitation: Bodet-Milin C, et al. Positron emission tomography with F-18-fluorodeoxyglucose (PET-FDG) predicts response to fractionated radioimmunotherapy (RIT) using 90Y-epratuzumab in non-Hodgkin's lymphoma (NHL). (Abstract #1234) J Nucl Med Abstract Bk Suppl 2 2005; 46/5:379P.

ReferenceCitation: Chatal J-F, et al. Fractionated radioimmunotherapy in NHL with DOTA-conjugated humanized anti-CD22 epratuzumab at high cumulative 90Y doses. (Abstract #447) J Nucl Med Abstract Bk Suppl 2 2005; 46/5:155P.

ReferenceCitation: Chatal J-F, et al. Radioimmunotherapy in non-Hodgkin's lymphoma (NHL) using a fractionated schedule of DOTA-conjugated, 90Y-radiolabeled, humanized anti-CD22 monoclonal antibody, epratuzumab. (Abstract #2545) Proceedings of ASCO 2004; 23:174.

ReferenceCitation: Chatal J-F, et al. Fractionated-dose radioimmunotherapy in non-Hodgkin's lymphoma (NHL) using DOTA-conjugated, 90Y-radiolabeled, humanized anti-CD22 monoclonal antibody (epratuzumab). Interim results. (Abstract No. 1482) Blood 2003; 102/11:408a.

lead_sponsor: Gilead Sciences

location_facility: Universitatsklinikum University of Saarland

location_facility: Klinikum der Georg-August-Universitat Gottingen

intervention_type: Biological


title: An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients Aged 4 to 11 Years With Activated Phosphoinositide 3-Kinase Delta Syndrome Followed by an Open-label Long-term Extension

summary: This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 4 to 11 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Pharming Technologies B.V.

location_country:
Netherlands
United States
France

location_facility:
National Institutes of Health
Necker Hospital Paris
Sophia Childerns Hospital
University of California Los Angeles

status_simplified: Ongoing


title: A Prospective, Randomized, Double-Blind (Subject and Rater) Controlled Study to Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With Major Depressive Disorder (MDD)

summary: A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.

study_start_date_type: Actual

status: Recruiting

design_allocation: Randomized

primary_purpose: Supportive Care

ReferenceCitation: Taliaz D, Spinrad A, Barzilay R, Barnett-Itzhaki Z, Averbuch D, Teltsh O, Schurr R, Darki-Morag S, Lerer B. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry. 2021 Jul 8;11(1):381. doi: 10.1038/s41398-021-01488-3.

ReferenceCitation: Taliaz D, Souery D. A New Characterization of Mental Health Disorders Using Digital Behavioral Data: Evidence from Major Depressive Disorder. J Clin Med. 2021 Jul 14;10(14):3109. doi: 10.3390/jcm10143109.

lead_sponsor: Taliaz Ltd.

location_country: France Switzerland Belgium

location_facility:
Hôpitaux Universitaires de Genève
Psy Pluriel
Hospital Pitié Salpétrière

intervention_type: Device


type: EudraCT Number

title: Phase 1 Dose Finding Study Evaluating the Bispecific Antibody MCLA-158 in Metastatic Colorectal Cancer and Other Advanced Solid Tumors

summary: This is a Phase I, open-label, multi-center, multi-national, dose escalation, single agent study to determine the recommended Phase II dose (RP2D) of MCLA-158 in metastatic colorectal cancer (mCRC). The study will assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in mCRC and other advanced solid tumors.

status: Unknown status

ipd_sharing: Yes

ipd_sharing_description: Individual participant data are made available only to the individual patient upon specific request of that individual patient or its treating physician.

lead_sponsor: Merus N.V.

location_country:
United States
France
Spain
Belgium

location_facility:
Vall d'Hebron
Sarah Cannon Research Institute
Institut Jules Bordet
Institut Gustave Roussy

status_simplified: Unknown


title: Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

acronym: SiMPlyRehab

summary:
The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury.

This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.

ReferenceCitation: Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The Cardiac Autonomic Response Recovery to the Modified Tilt Test in Children Post Moderate-Severe Traumatic Brain Injury. Brain Inj. 2022 Jul 3;36(8):1033-1038. doi: 10.1080/02699052.2022.2110942. Epub 2022 Aug 15.

ReferenceCitation: Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.

lead_sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

location_country: Canada Israel France

location_facility: Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice

location_facility: Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine

location_facility: Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,

intervention_type: Other

lead_sponsor_type: academique


title: Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis

summary: Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.

ReferenceCitation: Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France

location_facility:
Universität Heidelberg
CHU de Hautepierre
Jackson Memorial Hospital
Ohio State University


title: Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old

lead_sponsor: Boehringer Ingelheim

source: euctr

location_country:
Russian Federation
Canada
France

location_facility: 1160.105.33001 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.10003 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.10002 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.70005 Boehringer Ingelheim Investigational Site

summary: The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

summary: Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.

ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

ReferenceCitation: Pignolo RJ, Baujat G, Hsiao EC, Keen R, Wilson A, Packman J, Strahs AL, Grogan DR, Kaplan FS. Palovarotene for Fibrodysplasia Ossificans Progressiva (FOP): Results of a Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial. J Bone Miner Res. 2022 Oct;37(10):1891-1902. doi: 10.1002/jbmr.4655. Epub 2022 Aug 17.

lead_sponsor: Clementia Pharmaceuticals Inc.

location_country:
United States
United Kingdom
France

location_facility: University of Pennsylvania, Center for Research in FOP & Related Disorders

location_facility: University of California San Francisco, Division of Endocrinology and Metabolism

location_facility: The Royal National Orthopaedic Hospital, Brockley Hill

location_facility: Hôpital Necker-Enfants Malades, Department of Genetics


title: Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence

acronym: CACTUS-D

summary: To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

ReferenceCitation: Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5.

ReferenceCitation: Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.

ReferenceCitation: Tannenbaum C, van den Heuvel E, Fritel X, Southall K, Jutai J, Rajabali S, Wagg A. Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial. Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.

lead_sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

location_country:
Canada
United Kingdom
France

location_facility: Institut universitaire de gériatrie de Montréal

intervention_type: Behavioral


type: Other Identifier

title: A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy

summary:
Primary Objectives:

To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in participants with metastatic Castrate-resistant prostate cancer (CRPC)
To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.

Secondary Objectives:

To characterize the safety profile of the combination
To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed combination and dosing schedule
To assess preliminary antitumor activity of the combination in terms of progression-free survival, PSA progression free survival and objective response rate, and overall survival

ReferenceCitation: Massard C, Mateo J, Loriot Y, Pezaro C, Albiges L, Mehra N, Varga A, Bianchini D, Ryan CJ, Petrylak DP, Attard G, Shen L, Fizazi K, de Bono J. Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone. Ann Oncol. 2017 Jan 1;28(1):90-95. doi: 10.1093/annonc/mdw441.

ReferenceCitation: Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35. Review.

lead_sponsor: Sanofi

location_facility:
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 250001
Investigational Site Number 826001


title: A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

summary: This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies. The purpose of the study is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing.

lead_sponsor: Amgen


title: Polymorphisms and Busulfan Pharmacokinetic Study in Pediatric Transplnatation

summary: Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in children receiving hematopoietic stem cell transplantation.

study_type: Observational

time_perspective: Other

ReferenceCitation: Ansari M, Lauzon-Joset JF, Vachon MF, Duval M, Théoret Y, Champagne MA, Krajinovic M. Influence of GST gene polymorphisms on busulfan pharmacokinetics in children. Bone Marrow Transplant. 2010 Feb;45(2):261-7. doi: 10.1038/bmt.2009.143. Epub 2009 Jul 6.

ReferenceCitation: Ansari M, Krajinovic M. Can the pharmacogenetics of GST gene polymorphisms predict the dose of busulfan in pediatric hematopoietic stem cell transplantation? Pharmacogenomics. 2009 Nov;10(11):1729-32. doi: 10.2217/pgs.09.135.

ReferenceCitation: Ansari M, Rezgui MA, Théoret Y, Uppugunduri CR, Mezziani S, Vachon MF, Desjean C, Rousseau J, Labuda M, Przybyla C, Duval M, Champagne M, Peters C, Bittencourt H, Krajinovic M; Pediatric Disease Working Parties of the European Blood and Marrow Transplant Group. Glutathione S-transferase gene variations influence BU pharmacokinetics and outcome of hematopoietic SCT in pediatric patients. Bone Marrow Transplant. 2013 Jul;48(7):939-46. doi: 10.1038/bmt.2012.265. Epub 2013 Jan 7.

ReferenceCitation: Ansari M, Théoret Y, Rezgui MA, Peters C, Mezziani S, Desjean C, Vachon MF, Champagne MA, Duval M, Krajinovic M, Bittencourt H; Pediatric Disease Working Parties of the European Blood and Marrow Transplant Group. Association between busulfan exposure and outcome in children receiving intravenous busulfan before hematopoietic stem cell transplantation. Ther Drug Monit. 2014 Feb;36(1):93-9. doi: 10.1097/FTD.0b013e3182a04fc7.

ReferenceCitation: Huezo-Diaz P, Uppugunduri CR, Tyagi AK, Krajinovic M, Ansari M. Pharmacogenetic aspects of drug metabolizing enzymes in busulfan based conditioning prior to allogenic hematopoietic stem cell transplantation in children. Curr Drug Metab. 2014 Mar;15(3):251-64. Review.

ReferenceCitation: Uppugunduri CR, Rezgui MA, Diaz PH, Tyagi AK, Rousseau J, Daali Y, Duval M, Bittencourt H, Krajinovic M, Ansari M. The association of cytochrome P450 genetic polymorphisms with sulfolane formation and the efficacy of a busulfan-based conditioning regimen in pediatric patients undergoing hematopoietic stem cell transplantation. Pharmacogenomics J. 2014 Jun;14(3):263-71. doi: 10.1038/tpj.2013.38. Epub 2013 Oct 29.

ReferenceCitation: Acosta-Martin AE, Antinori P, Uppugunduri CRS, Daali Y, Ansari M, Scherl A, Müller M, Lescuyer P. Detection of busulfan adducts on proteins. Rapid Commun Mass Spectrom. 2016 Dec 15;30(23):2517-2528. doi: 10.1002/rcm.7730.

ReferenceCitation: Bartelink IH, Lalmohamed A, van Reij EM, Dvorak CC, Savic RM, Zwaveling J, Bredius RG, Egberts AC, Bierings M, Kletzel M, Shaw PJ, Nath CE, Hempel G, Ansari M, Krajinovic M, Théorêt Y, Duval M, Keizer RJ, Bittencourt H, Hassan M, Güngör T, Wynn RF, Veys P, Cuvelier GD, Marktel S, Chiesa R, Cowan MJ, Slatter MA, Stricherz MK, Jennissen C, Long-Boyle JR, Boelens JJ. Association of busulfan exposure with survival and toxicity after haemopoietic cell transplantation in children and young adults: a multicentre, retrospective cohort analysis. Lancet Haematol. 2016 Nov;3(11):e526-e536. doi: 10.1016/S2352-3026(16)30114-4. Epub 2016 Oct 13.

ReferenceCitation: Huezo-Diaz Curtis P, Uppugunduri CRS, Muthukumaran J, Rezgui MA, Peters C, Bader P, Duval M, Bittencourt H, Krajinovic M, Ansari M. Association of CTH variant with sinusoidal obstruction syndrome in children receiving intravenous busulfan and cyclophosphamide before hematopoietic stem cell transplantation. Pharmacogenomics J. 2018 Jan;18(1):64-69. doi: 10.1038/tpj.2016.65. Epub 2016 Oct 25.

ReferenceCitation: Ansari M, Curtis PH, Uppugunduri CRS, Rezgui MA, Nava T, Mlakar V, Lesne L, Théoret Y, Chalandon Y, Dupuis LL, Schechter T, Bartelink IH, Boelens JJ, Bredius R, Dalle JH, Azarnoush S, Sedlacek P, Lewis V, Champagne M, Peters C, Bittencourt H, Krajinovic M. GSTA1 diplotypes affect busulfan clearance and toxicity in children undergoing allogeneic hematopoietic stem cell transplantation: a multicenter study. Oncotarget. 2017 Aug 27;8(53):90852-90867. doi: 10.18632/oncotarget.20310. eCollection 2017 Oct 31.

ReferenceCitation: Jurkovic Mlakar S, Uppugunduri SCR, Nava T, Mlakar V, Golay H, Robin S, Waespe N, Rezgui MA, Chalandon Y, Boelens JJ, Bredius RGM, Dalle JH, Peters C, Corbacioglu S, Bittencourt H, Krajinovic M, Ansari M; paediatric diseases working party of the European society for blood and marrow transplantation. GSTM1 and GSTT1 double null genotypes determining cell fate and proliferation as potential risk factors of relapse in children with hematological malignancies after hematopoietic stem cell transplantation. J Cancer Res Clin Oncol. 2022 Jan;148(1):71-86. doi: 10.1007/s00432-021-03769-2. Epub 2021 Sep 9. Erratum in: J Cancer Res Clin Oncol. 2021 Oct 30;:.

ReferenceCitation: Uppugunduri CRS, Storelli F, Mlakar V, Huezo-Diaz Curtis P, Rezgui A, Théorêt Y, Marino D, Doffey-Lazeyras F, Chalandon Y, Bader P, Daali Y, Bittencourt H, Krajinovic M, Ansari M. The Association of Combined GSTM1 and CYP2C9 Genotype Status with the Occurrence of Hemorrhagic Cystitis in Pediatric Patients Receiving Myeloablative Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation. Front Pharmacol. 2017 Jul 11;8:451. doi: 10.3389/fphar.2017.00451. eCollection 2017.

lead_sponsor: University Hospital, Geneva

location_country: Canada Switzerland France

location_facility:
Hopital Rebert Debré
Chu St Justine
Alberta children's hospital
Hopital Cantonal de Genève


summary: This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.

lead_sponsor: Allergan

location_country:
Germany
United States
Canada
France


title: Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

summary:
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.

Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.

After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

status: Terminated

lead_sponsor: Nestlé

location_country:
United States
France
United Kingdom
Belgium

location_facility: Service Universitaire de Néonatologie CHR de la Citadelle

location_facility: Department of Pediatrics St Louis University

location_facility: Department of Child Health Royal Victoria Infirmary

location_facility: Service de néonatologie Hôpital de la Croix Rousse


summary: This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

ReferenceCitation: Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.


title: An Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: McCormack FX, Inoue Y, Moss J, Singer LG, Strange C, Nakata K, Barker AF, Chapman JT, Brantly ML, Stocks JM, Brown KK, Lynch JP 3rd, Goldberg HJ, Young LR, Kinder BW, Downey GP, Sullivan EJ, Colby TV, McKay RT, Cohen MM, Korbee L, Taveira-DaSilva AM, Lee HS, Krischer JP, Trapnell BC; National Institutes of Health Rare Lung Diseases Consortium; MILES Trial Group. Efficacy and safety of sirolimus in lymphangioleiomyomatosis. N Engl J Med. 2011 Apr 28;364(17):1595-606. doi: 10.1056/NEJMoa1100391. Epub 2011 Mar 16.

ReferenceCitation: Goldberg HJ, Harari S, Cottin V, Rosas IO, Peters E, Biswal S, Cheng Y, Khindri S, Kovarik JM, Ma S, McCormack FX, Henske EP. Everolimus for the treatment of lymphangioleiomyomatosis: a phase II study. Eur Respir J. 2015 Sep;46(3):783-94. doi: 10.1183/09031936.00210714. Epub 2015 Jun 25.

location_country:
United States
Italy
France

location_facility: Center for LAM Research and Clinical Care

location_facility: University of Cincinnati, Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine,

summary: This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis


title: Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin

acronym: PROSE

summary: The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals for Thelin. The registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (INR) measurements), concomitant medications, information on AEs and Thelin drug discontinuation. Regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each Periodic Safety Update Report (PSUR).

time_perspective: Prospective

lead_sponsor: Pfizer

location_country: Germany France Belgium


title: An Observational Study to Assess the Natural History Including Growth and Hearing in Patients With Cockayne Syndrome

summary:
This is an Observational Study of children under the age of 11 diagnosed with Cockayne Syndrome to assess the natural progression of Cockayne Syndrome disease, with special attention to hearing and physical changes in length or height, weight, head circumference, and arm span during standard treatment.

The primary analytical objective is to determine the rate of linear growth over a 6-month period in children < 2 years of age and over a 12-month period in children ≥ 2 years of age.

lead_sponsor: DNage B.V.

location_facility: Hopitaux Universitaires de Strasbourg, Service de Pédiatrie 1

location_facility: St. Mary's Hospital, Genetic Medicine, 6th Floor, Oxford Road

location_facility: Harvard medical School, Children's Hospital Boston, Division of Genetics & Metabolism


title: An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

summary: To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST

location_facility:
Dana Farber Cancer Institute
Novartis Investigative Site
Fox Chase Cancer Center


title: A Randomized, Double-blind, Two Arm, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors

summary:
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.

Primary objectives:

To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).

Secondary objectives:

To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
To assess effect of Rimonabant on body composition
To assess safety of Rimonabant

ReferenceCitation: Vergès B, Adiels M, Boren J, Barrett PH, Watts GF, Chan D, Duvillard L, Söderlund S, Matikainen N, Kahri J, Robin I, Taskinen MR. Interrelationships between the kinetics of VLDL subspecies and HDL catabolism in abdominal obesity: a multicenter tracer kinetic study. J Clin Endocrinol Metab. 2014 Nov;99(11):4281-90. doi: 10.1210/jc.2014-2365. Epub 2014 Jul 31.

location_country:
Australia
Finland
United Kingdom
France


primary_purpose: Prevention

title: A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With Maroteaux-Lamy Syndrome (MPS VI)

lead_sponsor: BioMarin Pharmaceutical

ReferenceCitation: Garcia P, Phillips D, Johnson J, Martin K, Randolph LM, Rosenfeld H, Harmatz P. Long-term outcomes of patients with mucopolysaccharidosis VI treated with galsulfase enzyme replacement therapy since infancy. Mol Genet Metab. 2021 May;133(1):100-108. doi: 10.1016/j.ymgme.2021.03.006. Epub 2021 Mar 14.

ReferenceCitation: Harmatz PR, Garcia P, Guffon N, Randolph LM, Shediac R, Braunlin E, Lachman RS, Decker C. Galsulfase (Naglazyme®) therapy in infants with mucopolysaccharidosis VI. J Inherit Metab Dis. 2014 Mar;37(2):277-87. doi: 10.1007/s10545-013-9654-7. Epub 2013 Oct 10.

location_country:
United States
Portugal
France

location_facility:
Children's Hospital Oakland
Children's Hospital Los Angeles
Hospital Femme Mere Enfant Centre
Hospital PediAtrico de Coimbra

summary: The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.


title: An Open-label, Single Arm Phase II Study of DFV890 to Assess the Safety, Tolerability and Efficacy in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)

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

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

location_country:
Germany
United States
Italy
France

summary:
This is an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS.

The study includes a screening period, a treatment period and a follow-up period. At most, the study will last up to 7 months (and up to 13 months for participants with a historical screening cold challenge prior to protocol amendment 04).


title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

summary: Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

lead_sponsor: Enterome

location_country: Austria Germany France Italy

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel


title: A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

summary: This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

ReferenceCitation: Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).

ReferenceCitation: Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourlière M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

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

lead_sponsor: Gilead Sciences


title: Pilot Evaluation Of CORACTO® (Rapamycin-Eluting Coronary Stent Delivery System) in The Treatment Of Patients With Coronary Artery Disease

acronym: PILOT-SECRET

summary: The purpose of this study is to evaluate the safety and effectiveness of the CORACTO® (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from 2.5 to 4.0 mm in diameter < than 15 mm suitable for treatment with a single CORACTO® stent in a population of 100 patients.

lead_sponsor: Alvimedica

location_country: Turkey France Spain Belgium

location_facility: Groupe Hospitalier Mutualiste de Grenoble


title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

summary: The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

lead_sponsor: AB Science

location_country:
Netherlands
United States
Italy
France

location_facility: Washington University School of Medicine

location_facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)

location_facility: Hôpital l'Archet 2- Service de Cancérologie Digestive


title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study)

summary:
The outcome of patients with resected pancreatic cancer has significantly been improved by adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be safe and effective and can be applied to all patients. This study should test neoadjuvant chemotherapy in a randomized manner.

Patients with resectable cytologically proven adenocarinoma of the pancreatic head are randomized to arm A or B.

Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant gemcitabine for six months.

Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A.

The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined by computed tomography in a defined protocol.

Trial with medicinal product

ReferenceCitation: Heinrich S, Pestalozzi B, Lesurtel M, Berrevoet F, Laurent S, Delpero JR, Raoul JL, Bachellier P, Dufour P, Moehler M, Weber A, Lang H, Rogiers X, Clavien PA. Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). BMC Cancer. 2011 Aug 10;11:346. doi: 10.1186/1471-2407-11-346.

lead_sponsor: University of Zurich

location_country: Germany France Switzerland Belgium

location_facility:
University Hospital Mainz
University Hospital of Gent
University Hospital of Marseille
University Hospital of Strasbourg
University Hospital of Zurich


title: A Multicenter Open Label Phase II Study of to Assess the Efficacy and Safety of APO866 in the Treatment of Patients With Refractory or Relapsed Cutaneous T-cell Lymphoma

summary: This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has shown to induce growth inhibition in cultures of human CTCL cells as well as in animal models with subcutaneously implanted human CTCL tumors. APO866 was considered to be safe and well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is administered by intravenous infusion continuously for 96 hours and that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. patients will be followed up for 12 months

lead_sponsor: Onxeo

location_country: Austria Germany France Switzerland

location_facility: Department of Dermatology, University Hospital of Zürich

location_facility: University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University

location_facility: Department of Dermatology, Medical University Graz


title: An Open-label, Multicenter, Phase I/II Dose Escalation Study of Oral GW572016 in Combination With Docetaxel (Taxotere) Plus Trastuzumab (Herceptin) in Subjects Previously Untreated for ErbB2-overexpressing Metastatic Breast Cancer

summary: This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

ReferenceCitation: Crown J, Kennedy MJ, Tresca P, Marty M, Espie M, Burris HA, DeSilvio M, Lau MR, Kothari D, Koch KM, Diéras V. Optimally tolerated dose of lapatinib in combination with docetaxel plus trastuzumab in first-line treatment of HER2-positive metastatic breast cancer. Ann Oncol. 2013 Aug;24(8):2005-11. doi: 10.1093/annonc/mdt222.

location_country:
Ireland
United States
France


type: Registry Identifier

title: A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

summary:
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery.

Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.

ReferenceCitation: Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-7.

ReferenceCitation: Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country: Bahamas France Spain Italy

location_facility:
Hopital Hotel Dieu de Lyon
Hosp Doce De Octubre
CHRU de Nantes
Princess Margaret Hosp
Universita Frederico II


title: Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma

summary: This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).

lead_sponsor: iTeos Belgium SA

location_country:
United States
France
Belgium

location_facility: Centre Hospitalier Universitaire de Nantes


title: A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

summary: This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

location_facility:
Institut de Cancérologie de l'Ouest
Cliniques universitaires St Luc-UCL
Hackensack University Medical Center
GZA Ziekenhuizen campus Sint-Augustinus


title: Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)

acronym: PVISION

summary: A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.

lead_sponsor: CathVision ApS

location_country: France Belgium

location_facility:
Universitair Ziekenhuis Brussel
AZ Sint-Jan Hospital
Clinique Pasteur Toulouse,
Ghent University Hospital


title: Safety and Pharmacokinetics of ODM-209 in Patients With Metastatic Castration-resistant Prostate Cancer or Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer

acronym: STESIDES

summary: The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.

status: Active, not recruiting

lead_sponsor: Orion Corporation, Orion Pharma

location_country: Denmark Finland France

location_facility: Rigshospitalet, University Hospital of Copenhagen


title: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)

acronym: CARIOCA

summary: Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Universitair Ziekenhuis Antwerpen
Hopital Louis Pradel
CHU de Charleroi
Algemeen Ziekenhuis Sint Jan


title: Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer

summary:
Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035.

The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management.

The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity.

The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.

status: Withdrawn

primary_purpose: Diagnostic

lead_sponsor: Brugmann University Hospital

location_facility:
Hôpitaux Iris Sud - Site Ixelles
CHR Citadelle
CHU Brugmann
Hôpital Bicêtre

intervention_type: Procedure


title: Multicenter, Open-label, Phase 1, Dose-escalation, Cohort-expansion, First-in-Human Study of KHK2455 Administered as Monotherapy and in Combination With Mogamulizumab in Adult Subjects With Locally Advanced or Metastatic Solid Tumors

summary: The purpose of this study is to characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to subjects with locally advanced or metastatic solid tumors.

lead_sponsor: Kyowa Kirin, Inc.

location_country:
United States
France


title: Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation

acronym: TRAC-AF

summary: The primary objective of this study is to establish the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).

ReferenceCitation: Starek Z, Lehar F, Jez J, Pesl M, Neuzil P, Sediva L, Petru J, Dujka L, Funasako M, Kautzner J, Peichl P, Aldhoon B, Albenque JP, Combes S, Boveda S, Dukkipati SR, Reddy VY. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. J Interv Card Electrophysiol. 2022 Aug;64(2):375-381. doi: 10.1007/s10840-021-00986-0. Epub 2021 Jun 5.

ReferenceCitation: Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

ipd_sharing: Undecided

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: France Czechia

location_facility: Institut Klinické a Experimentální Medicíny (IKEM)


title: An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.

primary_purpose: Other

lead_sponsor: Genentech, Inc.

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale


title: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

summary: This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.

lead_sponsor: Merrimack Pharmaceuticals


title: An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

summary: The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).

lead_sponsor: Torax Medical Incorporated

location_country:
Denmark
United States
France

location_facility:
University of Medicine
Arhus Universitetshospital
Colon and Rectal Surgery Associates
Providence Medical Research Center


title: Cryoablation for the Palliation of Painful Bone Metastases

summary: This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.

ReferenceCitation: Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80.

ReferenceCitation: Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. Review.

ReferenceCitation: Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Grönemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6.

ReferenceCitation: Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97.

ReferenceCitation: Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. Epub 2006 Apr 5. Review.

ReferenceCitation: Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. Review.

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Canada
France

location_facility: University of Texas M.D. Anderson Cancer Center


title: Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

acronym: ECLIPSE

summary: ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.

ReferenceCitation: Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8:116-7. doi: 10.1102/1470-7330.2008.0015.

ReferenceCitation: Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6.

ReferenceCitation: Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14.

ReferenceCitation: Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13.

ReferenceCitation: Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98.

ReferenceCitation: Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006 Jul 1;24(19):3178-86. Review.

ReferenceCitation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33.

location_facility:
Karmanos Cancer Institute
Mayo Clinic Rochester
Ronald Regan UCLA Medical Center
Institut Gustave Roussy


title: A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®) Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects With Choroidal Neovascularization (CNV) Associated With Age-Related Macular Degeneration (AMD)

summary:
The objectives of this study are to evaluate the safety(first objective) and efficacy(second objective)of an experimental drug product,Stakel®, in the treatment of neovascular Age related Macular Degeneration (AMD). The drug product is activated in patients by exposure to light at a specific wavelength ("Vascular Targeted Photodynamic therapy", "VTP"). The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti Vascular Endothelium Growth Factor (anti VEGF) intravitreal therapy in the first 12 weeks after VTP.

All subjects will have a 52 weeks safety follow up telephone call (Not for Adverse Events (AEs) collection).

ipd_sharing_description: The data are available in case report form for each patient

lead_sponsor: Steba Biotech S.A.

location_facility:
Johns Hopkins,Wilmer Eye Institute
Hotel Dieu de Paris Hospital
Palmetto Retina Center
Valley Retina Institute


title: A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors

summary: The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_facility:
Karmanos Cancer Institute
Local Institution
Dana-Farber Cancer Institute


title: Long-Term Outcome in Offspring and Mothers of Dexamethasone-Treated Pregnancies at Risk for Classical Congenital Adrenal Hyperplasia Owing to 21-Hydroxylase Deficiency

summary: Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency (21OHD), which leads to cortisol deficiency and causes the development of mature masculine characteristics in newborn, prepubescent, and grown females, and prepubescent males. Prenatal treatment with dexamethasone, a corticosteroid, has been shown to reduce the masculinization of genitalia. However, the long-term effects of dexamethasone on the children who received it as fetuses and on mothers who were exposed to it while they were pregnant have not been determined. This study will investigate potential long-term adverse side effects of prenatal dexamethasone treatment in children and young adults who received dexamethasone as fetuses and their mothers who were exposed to it during pregnancy.

lead_sponsor: Office of Rare Diseases (ORD)

location_country:
United States
Brazil
France

location_facility: University of Texas Southwestern Medical Center


type: U.S. NIH Grant/Contract

title: Apparent Mineralocorticoid Excess Syndrome Natural History Clinical Protocol

summary: Apparent mineralocorticoid excess (AME) is a rare inherited disease that can cause severe high blood pressure and low blood potassium in children and adults. It is caused by abnormal hormone metabolism and can be fatal. This study will focus on the genetic basis, natural history, disease progression, and survival of people with AME.

ReferenceCitation: New MI, Geller DS, Fallo F, Wilson RC. Monogenic low renin hypertension. Trends Endocrinol Metab. 2005 Apr;16(3):92-7. Review.

ReferenceCitation: Palermo M, Quinkler M, Stewart PM. Apparent mineralocorticoid excess syndrome: an overview. Arq Bras Endocrinol Metabol. 2004 Oct;48(5):687-96. Epub 2005 Mar 7. Review.

ReferenceCitation: Quinkler M, Bappal B, Draper N, Atterbury AJ, Lavery GG, Walker EA, DeSilva V, Taylor NF, Hala S, Rajendra N, Stewart PM. Molecular basis for the apparent mineralocorticoid excess syndrome in the Oman population. Mol Cell Endocrinol. 2004 Mar 31;217(1-2):143-9.

lead_sponsor: Icahn School of Medicine at Mount Sinai


title: A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003

summary: This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.

lead_sponsor: Novartis

location_country:
United States
China
Canada
France


title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

summary: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure, and who are at risk for TAVR-induced coronary artery ostium obstruction.

lead_sponsor: Pi-cardia

location_country:
United States
Israel
France

location_facility: CHU de Bordeaux (Bordeaux University Hospital)


title: HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem

acronym: PROLONGSTEM

summary: All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences

status: Enrolling by invitation

lead_sponsor: Promethera Therapeutics

location_country: France Spain Belgium

location_facility:
UCL
CHU Lille
UZ Leuven
CHU Toulouse
Hospital de Badajoz


title: BIOTRONIK 4French for AMBulatory Peripheral Intervention. A Multicenter, Controlled Trial Comparing 4French Versus 6French Femoral Access for Endovascular Treatment of Lower-extremity Peripheral Artery Disease in an Ambulatory Setting: BIO4AMB

summary: BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory setting: BIO4AMB

lead_sponsor: Biotronik AG

location_country: Austria France Switzerland Belgium

location_facility:
Osepedale Regionale di Lugano
CHU du Bocage
Medizinische Universitaet Graz
Clinique Saint Joseph
A.Z.Sint-Blasius


title: Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure

acronym: ADVANCEHF

summary:
The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support.

Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

The results of the study will be used to support a CE mark application.

status: Suspended

ReferenceCitation: Netuka I, Pya Y, Bekbossynova M, Ivak P, Konarik M, Gustafsson F, Smadja DM, Jansen P, Latrémouille C. Initial bridge to transplant experience with a bioprosthetic autoregulated artificial heart. J Heart Lung Transplant. 2020 Dec;39(12):1491-1493. doi: 10.1016/j.healun.2020.07.004. Epub 2020 Jul 14.

ReferenceCitation: Bizouarn P, Roussel JC, Trochu JN, Perlès JC, Latrémouille C. Effects of pre-load variations on hemodynamic parameters with a pulsatile autoregulated artificial heart during the early post-operative period. J Heart Lung Transplant. 2018 Jan;37(1):161-163. doi: 10.1016/j.healun.2017.06.018. Epub 2017 Jul 8.

lead_sponsor: Carmat SA

location_country: Kazakhstan Denmark France Czechia

location_facility: CHU Pontchaillou Centre Cardio-Pneumologie

location_facility: "National Research Cardiac Surgery Center"

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Service de Chirurgie Cardiaque - Institut Cœur Poumon


title: An Open-Label, Phase 1a/1b Study of Ramucirumab in Combination With Other Targeted Agents in Advanced Cancers

summary: The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.

ReferenceCitation: Saleh M, Cassier PA, Eberst L, Naik G, Morris VK, Pant S, Terret C, Gao L, Long A, Mao H, McNeely S, Wagner EK, Carlesi RM, Fu S. Phase I Study of Ramucirumab Plus Merestinib in Previously Treated Metastatic Colorectal Cancer: Safety, Preliminary Efficacy, and Pharmacokinetic Findings. Oncologist. 2020 Nov;25(11):e1628-e1639. doi: 10.1634/theoncologist.2020-0520. Epub 2020 Jul 17.

lead_sponsor: Eli Lilly and Company

location_country:
United States
United Kingdom
France

location_facility: University of Texas MD Anderson Cancer Center

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.


title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD

summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

ReferenceCitation: Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Poland
Italy
Australia
Switzerland
United States
France
Belgium
Germany


title: Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma

acronym: RESILSTIGMA

summary: This study is perform to study the effect of psychological and psychosocial factors associated with resilience to the self-stigmatization of people living with HIV

lead_sponsor: University Hospital, Clermont-Ferrand

location_country: France Guadeloupe Réunion

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Hôpital Nord Ouest villefranche sur Saone

location_facility: Groupe Hospitalier de La rochelle-Ré-Aunis


title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

summary: This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

lead_sponsor: Adlai Nortye Biopharma Co., Ltd.

location_facility: University of Utah School of Medicine Huntsman Cancer Institute


title: Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer

acronym: RHEA

summary: This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy.

lead_sponsor: Jules Bordet Institute

location_facility:
Institut de Cancérologie Gustave Roussy
Grand Hopital de Charleroi
CMSE
Institut Jules Bordet
Institut Curie


title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

summary:
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market.

The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP.

The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication).

Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve.

This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers.

Up to 70 people will participate in this study from study sites across Europe.

ReferenceCitation: Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015 Jul 2;373(1):48-59. doi: 10.1056/NEJMoa1411481.

lead_sponsor: Clinuvel Pharmaceuticals Limited

location_country:
United Kingdom
Ireland
Netherlands
Finland
France
Germany

location_facility: HUS:n Iho-ja allergiasairaala (Skin and Allergy Hospital)

location_facility: Centre Français des Porphyries, Hôpital Louis Mourier

location_facility: Photobiology Unit - Hope Hospital, University of Manchester

location_facility: Beaumont Hospital, Department of Dermatology

location_facility: Department of Dermatology , Heinrich-Heine-University Duesseldorf


title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

acronym: SENTICOLIII

summary:
SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).

There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".

ReferenceCitation: Lecuru FR, McCormack M, Hillemanns P, Anota A, Leitao M, Mathevet P, Zweemer R, Fujiwara K, Zanagnolo V, Zahl Eriksson AG, Hudson E, Ferron G, Plante M. SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer. 2019 May;29(4):829-834. doi: 10.1136/ijgc-2019-000332. Epub 2019 Mar 20.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_country: Japan France China Italy

location_facility: Centre Hospitalier Bichat - Claude Bernard

location_facility: Centre de Lutte Contre le Cancer Antoine Lacassagne

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre de Lutte Contre le Cancer Gustave Roussy

location_facility: Centre de Lutte Contre le Cancer Jean Perrin

location_facility: Center de Lutte Contre le Cancer François Baclesse

location_facility: Saitama Medical University International Medical Center

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Groupement Hospitalier Est - Hôpital Femme Mère Enfant

location_facility: Institut de Cancérologie de Montpellier Val d'Aurelle

location_facility: Institut Universitaire du Cancer de Toulouse

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Cancer Hospital of University of Chinese Academy of Science

location_facility: CHU de Clermont-Ferrand - Hôpital d'Estaing

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre


title: European Surgical Outcomes Study: A Multi-centre, International Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Non-cardiac Surgery

acronym: EuSOS

summary:
The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.

Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

ReferenceCitation: Ahmad T, Beilstein CM, Aldecoa C, Moreno RP, Molnár Z, Novak-Jankovic V, Hofer CK, Sander M, Rhodes A, Pearse RM. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med (Lond). 2015 Sep 23;4:8. doi: 10.1186/s13741-015-0018-8. eCollection 2015.

ReferenceCitation: van Zaane B, van Klei WA, Buhre WF, Bauer P, Boerma EC, Hoeft A, Metnitz P, Moreno RP, Pearse R, Pelosi P, Sander M, Vallet B, Pettilä V, Vincent JL, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Nonelective surgery at night and in-hospital mortality: Prospective observational data from the European Surgical Outcomes Study. Eur J Anaesthesiol. 2015 Jul;32(7):477-85. doi: 10.1097/EJA.0000000000000256.

ReferenceCitation: Jammer I, Ahmad T, Aldecoa C, Koulenti D, Goranović T, Grigoras I, Mazul-Sunko B, Matos R, Moreno R, Sigurdsson GH, Toft P, Walder B, Rhodes A, Pearse RM; European Surgical Outcomes Study (EuSOS) group. Point prevalence of surgical checklist use in Europe: relationship with hospital mortality. Br J Anaesth. 2015 May;114(5):801-7. doi: 10.1093/bja/aeu460. Epub 2015 Jan 13.

ReferenceCitation: Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14.

lead_sponsor: Queen Mary University of London

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Romania
Belgium
Iceland
Poland
Portugal
Slovenia
Norway
Sweden
Slovakia
Cyprus
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Estonia
Latvia
Finland
Czech Republic
France
Netherlands


title: Myocardial Ischemia and Transfusion

acronym: MINT

summary: The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

ReferenceCitation: Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

ReferenceCitation: Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

ReferenceCitation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.

ipd_sharing_description: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.

lead_sponsor: Rutgers, The State University of New Jersey

location_country:
Brazil
Australia
New Zealand
Canada
United States
France

location_facility: Minneapolis Heart Institute (Foundation)

location_facility: University of Arkansas Medical Sciences (UAMS) Hospital

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: University of Minnesota Medical Center Fairview

location_facility: The University of North Carolina at Chapel Hill

location_facility: Hospital Maternidade e Pronto Socorro Santa Lúcia

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

location_facility: Hospital Universitário Professor Edgard Santos

location_facility: NYU Langone Medical Center, Bellevue Hospital

location_facility: Hôpital Universitaire Carémeau (CHU Carémeau)

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil


title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

acronym: CERPASS

summary: To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

lead_sponsor: Replimune Inc.

location_country:
Poland
Spain
Greece
Italy
Australia
Canada
United States
France
Germany
Bulgaria

location_facility: Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku

location_facility: Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie

location_facility: University Of North Carolina at Chapel Hill

location_facility: Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori di Meldola

location_facility: "Multiprofile Hospital for Active Treatment "Heart and Brain"" EAD Clinic of Medical Oncology"

location_facility: Hospital General Universitario De Valencia

location_facility: "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "

location_facility: John Theurer Cancer Center at Hackensack Univeristy Medical Center

location_facility: Universitatsklinikum Leipzig Klinik u. Poliklinik f. Dermatologie, Venerologie u. Allergologie

location_facility: Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)

location_facility: Istituto Tumori "Giovanni Paolo II" IRCCS

location_facility: General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School

location_facility: CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC

location_facility: Multiprofile Hospital for Active Treatment "Dr. Tota Venkova"" AD Department of Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Universitatsklinikum Mainz Hautklinik und Poliklinik

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie

location_facility: Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu

location_facility: Winship Cancer Institute of Emory University


title: A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

summary:
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

lead_sponsor: Seagen Inc.

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Australia
Canada
Switzerland
Korea, Republic of
United States
France
China
Belgium
Japan
Germany

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: The first Affiliated Hospital of Hainan Medical University

location_facility: Przychodnia Lekarska KOKMED Roman Karaszewski

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: UCLA Medical Center / David Geffen School of Medicine

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: The Royal Marsden NHS Foundation Trust (RM)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cleveland Clinic Lerner College of Medicine

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Medical College of Wisconsin (Milwaukee)

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Fundação NAtonio Prudente (AC Camargo Cancer Center)

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: University of Alberta / Cross Cancer Institute

location_facility: University College London Hospitals NHS Foundation Trust


acronym: Neptuno

title: A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection

lead_sponsor: PharmaMar

location_country:
Brazil
Portugal
Romania
Greece
Spain
Mexico
Argentina
France
Peru
South Africa
Turkey
Colombia
Bulgaria

location_facility: CliniSalud del Sur S.A.S - Centro de Investigación

location_facility: "Specialised Hospital for Active Treatment for Pneumophthisiatric Diseases Dr. Dimitar Gramatikov - Ruse" Ltd Department of Pneumology and Phthisiatry

location_facility: Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) - Hopital Bretonneau

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes - Bucharest

location_facility: Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM CITY CLINIC TOKUDA HOSPIAL

location_facility: Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi - Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: Sotiria Hospital General Hospital of Chest Diseases of Athens "Sotiria" 3rd Department of Internal Medicine of University of Athens

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: Instituto de Investigación Sanitaria Valdecilla (IDIVAL)

location_facility: University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava, Sectia de Boli Infectioase

location_facility: Democritus University Hospital University General Hospital of Alexandroupolis

location_facility: Spitalul Clinic de Boli Infectioase Constanta

location_facility: "Hospital of Infectious Diseases and Pneumology ""Victor Babes'' Timisoara "

location_facility: Evangelismos Hospital General Hospital of Athens Evangelismos, Intensive Care Unit

location_facility: Hacettepe University, School of Medicine

location_facility: CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

location_facility: Spitalul Clinic De Boli Infectioase Cluj-Napoca, Sectia HIV/SIDA

location_facility: Ege University Medical School, Department of Infectious Diseases and Clinical Microbiology

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: University First MHAT "St.Yoan Krastitel"-Sofia EAD

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: General Hospital of Athens "Laiko", University of Athens Agiou

location_facility: Hospital General Universitario de Alicante

location_facility: T.C. Saglik Bakanligi Tepecik Egitim ve Arastirma Hastanesi - Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Klinigi

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universidad de Cadiz (UCA) - Hospital Universitario Puerta del Mar (HUPM)

location_facility: Hospital Nacional Hipolito Unanue (HNHU)

location_facility: Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Tzaneio Hospital General Hospital of Piraeus Tzaneio

location_facility: Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

location_facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo

location_facility: Centre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Universidad Peruana Cayetano Heredia (UPCH) - Hospital Cayetano Heredia (HCH)

location_facility: Centro de Investigación Clínica Chapultepec

location_facility: Nouvel Hôpital Civil Service des maladies infectieuses

location_facility: Hospital de Emergencias Enfermera Isabel Zendal

location_facility: Spitalul Clinic De Boli Infectioase "Sfanta Parascheva" IASI, Sectia Boli Infectioase III

summary: Treatment of patients hospitalised for management of moderate COVID-19 infection