title: An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease

summary: The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

ReferenceCitation: Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med. 2009 Nov 5;361(19):1848-55. doi: 10.1056/NEJMoa074037.

family: Macdougall

full_name: Iain C. Macdougall

given: Iain C.

family: Rossert

full_name: Jerome Rossert

given: Jerome

family: Casadevall

full_name: Nicole Casadevall

given: Nicole

family: Stead

full_name: Richard B. Stead

given: Richard B.

family: Duliege

full_name: Anne-Marie Duliege

given: Anne-Marie

family: Froissart

full_name: Marc Froissart

given: Marc

family: Eckardt

full_name: Kai-Uwe Eckardt

given: Kai-Uwe

title: A Peptide-Based Erythropoietin-Receptor Agonist for Pure Red-Cell Aplasia

lead_sponsor: Takeda

location_country:
Germany
United Kingdom
France


title: A Phase II Open-Label Clinical Trial of Recombinant Human Alpha-L-iduronidase (Aldurazyme®) to Evaluate the Safety and Pharmacokinetics in Mucopolysaccharidosis I (MPS I) Patients Less Than 5 Years Old

summary: The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of enzyme replacement therapy with recombinant human alpha-L-iduronidase [Aldurazyme® (laronidase)] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy measurements will also be evaluated in this study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
United Kingdom
France
Netherlands

location_facility: Willink Biochemical Genetics Unit Royal Hospital for Children

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: Nephroblastoma (Wilms Tumour) Clinical Trial And Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery. Giving more chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilm's tumor.

PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilm's tumor.

status: Unknown status

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Warmann SW, Nourkami N, Frühwald M, Leuschner I, Schenk JP, Fuchs J, Graf N. Primary lung metastases in pediatric malignant non-Wilms renal tumors: data from SIOP 93-01/GPOH and SIOP 2001/GPOH. Klin Padiatr. 2012 Apr;224(3):148-52. doi: 10.1055/s-0032-1304600. Epub 2012 Apr 18.

ReferenceCitation: Furtwängler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rübe C, Siemer S, Leuschner I, Graf N. Update on relapses in unilateral nephroblastoma registered in 3 consecutive SIOP/GPOH studies - a report from the GPOH-nephroblastoma study group. Klin Padiatr. 2011 May;223(3):113-9. doi: 10.1055/s-0031-1275293. Epub 2011 Apr 20.

ReferenceCitation: van den Heuvel-Eibrink MM, van Tinteren H, Rehorst H, Coulombe A, Patte C, de Camargo B, de Kraker J, Leuschner I, Lugtenberg R, Pritchard-Jones K, Sandstedt B, Spreafico F, Graf N, Vujanic GM. Malignant rhabdoid tumours of the kidney (MRTKs), registered on recent SIOP protocols from 1993 to 2005: a report of the SIOP renal tumour study group. Pediatr Blood Cancer. 2011 May;56(5):733-7. doi: 10.1002/pbc.22922. Epub 2010 Dec 22.

ReferenceCitation: Warmann SW, Furtwängler R, Blumenstock G, Armeanu S, Nourkami N, Leuschner I, Schenk JP, Graf N, Fuchs J. Tumor biology influences the prognosis of nephroblastoma patients with primary pulmonary metastases: results from SIOP 93-01/GPOH and SIOP 2001/GPOH. Ann Surg. 2011 Jul;254(1):155-62. doi: 10.1097/SLA.0b013e318222015e.

ReferenceCitation: Szavay P, Luithle T, Graf N, Furtwängler R, Fuchs J. Primary hepatic metastases in nephroblastoma--a report of the SIOP/GPOH Study. J Pediatr Surg. 2006 Jan;41(1):168-72; discussion 168-72.

ReferenceType: result

ReferenceCitation: Smets AM, van Tinteren H, Bergeron C, De Camargo B, Graf N, Pritchard-Jones K, de Kraker J. The contribution of chest CT-scan at diagnosis in children with unilateral Wilms' tumour. Results of the SIOP 2001 study. Eur J Cancer. 2012 May;48(7):1060-5. doi: 10.1016/j.ejca.2011.05.025. Epub 2011 Jun 22.

family: Smets

full_name: Anne M.J.B. Smets

given: Anne M.J.B.

sequence: first

family: Tinteren

full_name: Harm van Tinteren

given: Harm van

sequence: additional

family: Bergeron

full_name: Christophe Bergeron

given: Christophe

family: Camargo

full_name: Beatriz De Camargo

given: Beatriz De

family: Graf

full_name: Norbert Graf

given: Norbert

family: Pritchard-Jones

full_name: Kathy Pritchard-Jones

given: Kathy

family: Kraker

full_name: Jan de Kraker

given: Jan de

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The contribution of chest CT-scan at diagnosis in children with unilateral Wilms’ tumour. Results of the SIOP 2001 study

ReferenceCitation: Williams RD, Al-Saadi R, Chagtai T, Popov S, Messahel B, Sebire N, Gessler M, Wegert J, Graf N, Leuschner I, Hubank M, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group; SIOP Wilms' Tumour Biology Group. Subtype-specific FBXW7 mutation and MYCN copy number gain in Wilms' tumor. Clin Cancer Res. 2010 Apr 1;16(7):2036-45. doi: 10.1158/1078-0432.CCR-09-2890. Epub 2010 Mar 23.

family: Williams

full_name: Richard D. Williams

given: Richard D.

family: Al-Saadi

full_name: Reem Al-Saadi

given: Reem

family: Chagtai

full_name: Tasnim Chagtai

given: Tasnim

family: Popov

full_name: Sergey Popov

given: Sergey

family: Messahel

full_name: Boo Messahel

given: Boo

family: Sebire

full_name: Neil Sebire

given: Neil

family: Gessler

full_name: Manfred Gessler

given: Manfred

family: Wegert

full_name: Jenny Wegert

given: Jenny

family: Leuschner

full_name: Ivo Leuschner

given: Ivo

family: Hubank

full_name: Mike Hubank

given: Mike

family: Jones

full_name: Chris Jones

given: Chris

family: Vujanic

full_name: Gordan Vujanic

given: Gordan

publisher: American Association for Cancer Research (AACR)

title: Subtype-Specific FBXW7 Mutation and MYCN Copy Number Gain in Wilms' Tumor

ReferenceCitation: Messahel B, Williams R, Ridolfi A, A'hern R, Warren W, Tinworth L, Hobson R, Al-Saadi R, Whyman G, Brundler MA, Kelsey A, Sebire N, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group (CCLG). Allele loss at 16q defines poorer prognosis Wilms tumour irrespective of treatment approach in the UKW1-3 clinical trials: a Children's Cancer and Leukaemia Group (CCLG) Study. Eur J Cancer. 2009 Mar;45(5):819-26. doi: 10.1016/j.ejca.2009.01.005. Epub 2009 Feb 21.

title: Allele loss at 16q defines poorer prognosis Wilms tumour irrespective of treatment approach in the UKW1–3 clinical trials: A Children’s Cancer and Leukaemia Group (CCLG) study

location_facility: Academisch Medisch Centrum at University of Amsterdam


title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

acronym: CheckMate 7FL

summary: A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery)chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Netherlands
Switzerland
Singapore
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Ft. Worth Center For Cancer Blood Disorders

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc

location_facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Centre Hospitalier de l'Université de Montréal-Breast Cancer

location_facility: Fondazione Irccs - Policlinico San Matteo

location_facility: Radioterapeuticka a onkologicka klinika FNKV

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: Northside Hospital,Inc.- Central Research Department

location_facility: American Oncology Partners of Maryland, PA

location_facility: Hospital Clinico Pontificia Universidad Catolica De Chile

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

location_facility: Centro de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Universitaetsklinik F. Frauenheilkunde / Geburtshilfe

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III

location_facility: Oncocentro Servico Medicos e Hospitalares Ltda

location_facility: University of South Alabama Mitchell Cancer Institute

intervention_type: Other

status_simplified: Ongoing


title: Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

summary:
This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.

Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging

primary_purpose: Diagnostic

lead_sponsor: Lightpoint Medical Limited

location_country: Germany Belgium France Spain

location_facility:
UZ Leuven
University Hospital Essen
Institute Paoli-Calmettes
Hospital del Mar

intervention_type: Device


title: JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study

summary: This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).

ipd_sharing: No

lead_sponsor: Zimmer Biomet

location_country:
Germany
United States
France
Japan

location_facility: Tokyo Medical and Dental University Hospital of Medicine

location_facility: Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy

location_facility: Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg


type: Other Identifier

title: Hypophosphatemia in the ICU - A One-day Point Prevalence Survey

acronym: HYPO-P-ICU

summary: The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value < 0.8 mmol/l) in international critical care settings

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Berger MM, Appelberg O, Reintam-Blaser A, Ichai C, Joannes-Boyau O, Casaer M, Schaller SJ, Gunst J, Starkopf J; ESICM-MEN section. Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey. Clin Nutr. 2021 May;40(5):3615-3621. doi: 10.1016/j.clnu.2020.12.017. Epub 2020 Dec 29.

family: Berger

full_name: M.M. Berger

family: Appelberg

full_name: O. Appelberg

given: O.

family: Reintam-Blaser

full_name: A. Reintam-Blaser

given: A.

family: Ichai

full_name: C. Ichai

given: C.

family: Joannes-Boyau

full_name: O. Joannes-Boyau

family: Casaer

full_name: M. Casaer

given: M.

family: Schaller

full_name: S.J. Schaller

family: Gunst

full_name: J. Gunst

given: J.

family: Starkopf

full_name: J. Starkopf

family: Abel

full_name: Arroyo Abel

given: Arroyo

family: Erna

full_name: Alberts Erna

given: Alberts

family: Berger Mette

full_name: M. Berger Mette

family: Guillaume

full_name: Besch Guillaume

given: Besch

family: Costel

full_name: Besançon Bodolea Costel

given: Besançon Bodolea

family: Michael

full_name: Casaer Michael

given: Casaer

family: Pérez

full_name: Cheng Meisy Pérez

given: Cheng Meisy

family: Jean-Michel

full_name: Constantin Jean-Michel

given: Constantin

family: Swarna

full_name: Deepak Swarna

given: Deepak

family: de Man Angelique

full_name: M.E. de Man Angelique

family: Frantisek

full_name: Duska Frantisek

given: Duska

family: Patricia

full_name: Fodor Patricia

given: Fodor

family: Kristina

full_name: Fuest Kristina

given: Fuest

family: Thierry

full_name: Fumeaux Thierry

given: Fumeaux

family: Hubert

full_name: Grand Hubert

title: Prevalence of hypophosphatemia in the ICU – Results of an international one-day point prevalence survey

ipd_sharing_description: Data will be collected in central REDCap database. No individual patient data will be made available

lead_sponsor: Centre Hospitalier Universitaire Vaudois

location_facility:
Lausanne University Hospital
Hôpital Pasteur 2
Hôpital de Nyon
Tartu University Hospital


intervention_type: Drug

status: Enrolling by invitation

lead_sponsor: Sarepta Therapeutics, Inc.

location_country:
Italy
United Kingdom
Belgium
France

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre

location_facility: Fondazione Policlinico Universitario Agostino Gemelli, UOC Neuropsichiatria Infantile

type: EudraCT Number

source: euctr

title: An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients With Duchenne Muscular Dystrophy Who Have Completed Study 4658-102

summary: The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male DMD patients who have successfully completed the 96-week eteplirsen study: Study 4658-102 (NCT03218995)

status_simplified: Unknown


title: Phase I/II Gene Transfer Clinical Trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB

acronym: MPSIIIB

summary: Open-label, dose-escalation clinical trial of rAAV9.CMV.hNAGLU injected intravenously through a peripheral limb vein

status: Active, not recruiting

ReferenceCitation: Fu H, Dirosario J, Killedar S, Zaraspe K, McCarty DM. Correction of neurological disease of mucopolysaccharidosis IIIB in adult mice by rAAV9 trans-blood-brain barrier gene delivery. Mol Ther. 2011 Jun;19(6):1025-33. doi: 10.1038/mt.2011.34. Epub 2011 Mar 8.

ReferenceCitation: Truxal KV, Fu H, McCarty DM, McNally KA, Kunkler KL, Zumberge NA, Martin L, Aylward SC, Alfano LN, Berry KM, Lowes LP, Corridore M, McKee C, McBride KL, Flanigan KM. A prospective one-year natural history study of mucopolysaccharidosis types IIIA and IIIB: Implications for clinical trial design. Mol Genet Metab. 2016 Nov;119(3):239-248. doi: 10.1016/j.ymgme.2016.08.002. Epub 2016 Aug 18.

ReferenceCitation: Neufeld EF, Cantz MJ. Corrective factors for inborn errors of mucopolysaccharide metabolism. Ann N Y Acad Sci. 1971 Jul 6;179:580-7.

ReferenceCitation: Weber B, Guo XH, Kleijer WJ, van de Kamp JJ, Poorthuis BJ, Hopwood JJ. Sanfilippo type B syndrome (mucopolysaccharidosis III B): allelic heterogeneity corresponds to the wide spectrum of clinical phenotypes. Eur J Hum Genet. 1999 Jan;7(1):34-44.

ReferenceCitation: Wijburg FA, Węgrzyn G, Burton BK, Tylki-Szymańska A. Mucopolysaccharidosis type III (Sanfilippo syndrome) and misdiagnosis of idiopathic developmental delay, attention deficit/hyperactivity disorder or autism spectrum disorder. Acta Paediatr. 2013 May;102(5):462-70. doi: 10.1111/apa.12169. Epub 2013 Feb 6. Review.

ReferenceCitation: de Ruijter J, Valstar MJ, Wijburg FA. Mucopolysaccharidosis type III (Sanfilippo Syndrome): emerging treatment strategies. Curr Pharm Biotechnol. 2011 Jun;12(6):923-30. doi: 1389-2010/11 $58.00+.00. Review.

ReferenceCitation: Murrey DA, Naughton BJ, Duncan FJ, Meadows AS, Ware TA, Campbell KJ, Bremer WG, Walker CM, Goodchild L, Bolon B, La Perle K, Flanigan KM, McBride KL, McCarty DM, Fu H. Feasibility and safety of systemic rAAV9-hNAGLU delivery for treating mucopolysaccharidosis IIIB: toxicology, biodistribution, and immunological assessments in primates. Hum Gene Ther Clin Dev. 2014 Jun;25(2):72-84. doi: 10.1089/humc.2013.208. Epub 2014 Apr 10.

ReferenceCitation: Ribera A, Haurigot V, Garcia M, Marcó S, Motas S, Villacampa P, Maggioni L, León X, Molas M, Sánchez V, Muñoz S, Leborgne C, Moll X, Pumarola M, Mingozzi F, Ruberte J, Añor S, Bosch F. Biochemical, histological and functional correction of mucopolysaccharidosis type IIIB by intra-cerebrospinal fluid gene therapy. Hum Mol Genet. 2015 Apr 1;24(7):2078-95. doi: 10.1093/hmg/ddu727. Epub 2014 Dec 18.

ReferenceCitation: Hamano K, Hayashi M, Shioda K, Fukatsu R, Mizutani S. Mechanisms of neurodegeneration in mucopolysaccharidoses II and IIIB: analysis of human brain tissue. Acta Neuropathol. 2008 May;115(5):547-59. Epub 2007 Dec 4.

ReferenceCitation: Tamagawa K, Morimatsu Y, Fujisawa K, Hara A, Taketomi T. Neuropathological study and chemico-pathological correlation in sibling cases of Sanfilippo syndrome type B. Brain Dev. 1985;7(6):599-609.

ReferenceCitation: Mingozzi F, High KA. Immune responses to AAV in clinical trials. Curr Gene Ther. 2011 Aug;11(4):321-30. Review.

ReferenceCitation: Saeki I, Tokunaga S, Matsuura T, Hayashida M, Yanagi Y, Taguchi T. A formula for determining the standard liver volume in children: a special reference for neonates and infants. Pediatr Transplant. 2012 May;16(3):244-9. doi: 10.1111/j.1399-3046.2011.01624.x. Epub 2011 Dec 12.

ReferenceCitation: Schlesinger AE, Edgar KA, Boxer LA. Volume of the spleen in children as measured on CT scans: normal standards as a function of body weight. AJR Am J Roentgenol. 1993 May;160(5):1107-9.

ReferenceCitation: Malm G, Månsson JE. Mucopolysaccharidosis type III (Sanfilippo disease) in Sweden: clinical presentation of 22 children diagnosed during a 30-year period. Acta Paediatr. 2010 Aug;99(8):1253-7. doi: 10.1111/j.1651-2227.2010.01800.x. Epub 2010 Mar 14.

ReferenceCitation: Dale DC, Fauci AS, Guerry D IV, Wolff SM. Comparison of agents producing a neutrophilic leukocytosis in man. Hydrocortisone, prednisone, endotoxin, and etiocholanolone. J Clin Invest. 1975 Oct;56(4):808-13.

ReferenceCitation: Summers C, Rankin SM, Condliffe AM, Singh N, Peters AM, Chilvers ER. Neutrophil kinetics in health and disease. Trends Immunol. 2010 Aug;31(8):318-24. doi: 10.1016/j.it.2010.05.006. Review.

ReferenceCitation: McCurdy VJ, Johnson AK, Gray-Edwards HL, Randle AN, Bradbury AM, Morrison NE, Hwang M, Baker HJ, Cox NR, Sena-Esteves M, Martin DR. Therapeutic benefit after intracranial gene therapy delivered during the symptomatic stage in a feline model of Sandhoff disease. Gene Ther. 2021 Apr;28(3-4):142-154. doi: 10.1038/s41434-020-00190-1. Epub 2020 Sep 3.

family: McCurdy

full_name: Victoria J. McCurdy

given: Victoria J.

family: Johnson

full_name: Aime K. Johnson

given: Aime K.

family: Gray-Edwards

full_name: Heather L. Gray-Edwards

given: Heather L.

family: Randle

full_name: Ashley N. Randle

given: Ashley N.

family: Bradbury

full_name: Allison M. Bradbury

given: Allison M.

family: Morrison

full_name: Nancy E. Morrison

given: Nancy E.

family: Hwang

full_name: Misako Hwang

given: Misako

family: Baker

full_name: Henry J. Baker

given: Henry J.

family: Cox

full_name: Nancy R. Cox

given: Nancy R.

family: Sena-Esteves

full_name: Miguel Sena-Esteves

given: Miguel

family: Martin

full_name: Douglas R. Martin

given: Douglas R.

journal_name: Gene Therapy

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: There is no plan to share data

lead_sponsor: Abeona Therapeutics, Inc

location_country:
Germany
United States
France
Spain

location_facility: Hospital Clinico Universitario de Santiago


intervention_type: Procedure

status: Terminated

ipd_sharing_description: IPD sharing is not foreseen

lead_sponsor: International CTEPH Association

location_country:
Germany
United States
United Kingdom
France

acronym: Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy

location_facility:
Kerckhoff-Klinik GmbH
Hopital de Bicêtre
UC San Diego
Papworth Hospital

title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance

summary: This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.


location_facility: Site Fondazione Policlinico Universitario Agostino Gemelli

location_facility: UCL Great Ormond Street Institute of Child Health

title: An Open-label Safety, Tolerability, and Pharmacokinetics Study of Eteplirsen in Young Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

summary: This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, and efficacy of once-weekly IV infusions of eteplirsen in approximately 12 male patients, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD with a deletion mutation amenable to exon 51 skipping.


title: Phase 1 Study of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis Phase 1 Study of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin And In Combination With Nivolumab In Patients With Peritoneal Carcinomatosis

acronym: PIPAC

summary:
PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using an innovative concept that enhances the efficacy by taking advantage of the physical properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form. This results in a superior distribution and depth of penetration of the drug.

This research study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It may offer a novel and effective option of treatment for patients with peritoneal carcinomatosis, who, at present have limited options involving the use of systemic chemotherapy and who suffer from poor life expectancy and poor quality of life.

To date, most trials have used PIPAC cisplatin with doxorubicin, or oxaliplatin alone, and more studies are on-going globally.

Intravenous (IV) nivolumab has been approved for the treatment of progressive gastric cancer after conventional chemotherapy. PIPAC in combination with nivolumab may have the potential to improve immune activation and response to immune checkpoint inhibition for patients with peritoneal disease.

Hence we propose an amendment to our trial protocol for the addition of a second cohort (Cohort 2) to investigate the safety and tolerability of the combination of PIPAC oxaliplatin and IV nivolumab.

ReferenceCitation: Ishigami H, Kitayama J, Kaisaki S, Hidemura A, Kato M, Otani K, Kamei T, Soma D, Miyato H, Yamashita H, Nagawa H. Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis. Ann Oncol. 2010 Jan;21(1):67-70. doi: 10.1093/annonc/mdp260. Epub 2009 Jul 15.

ReferenceCitation: Solaß W, Hetzel A, Nadiradze G, Sagynaliev E, Reymond MA. Description of a novel approach for intraperitoneal drug delivery and the related device. Surg Endosc. 2012 Jul;26(7):1849-55. doi: 10.1007/s00464-012-2148-0. Epub 2012 May 12.

ReferenceCitation: Solass W, Herbette A, Schwarz T, Hetzel A, Sun JS, Dutreix M, Reymond MA. Therapeutic approach of human peritoneal carcinomatosis with Dbait in combination with capnoperitoneum: proof of concept. Surg Endosc. 2012 Mar;26(3):847-52. doi: 10.1007/s00464-011-1964-y. Epub 2011 Nov 1.

ReferenceCitation: Robella M, Vaira M, De Simone M. Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis. World J Surg Oncol. 2016 Apr 29;14:128. doi: 10.1186/s12957-016-0892-7.

ReferenceCitation: Solass W, Kerb R, Mürdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

ReferenceCitation: Demtröder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

ReferenceCitation: Kim G, Tan HL, Chen E, Teo SC, Jang CJM, Ho J, Ang Y, Ngoi NYL, Chee CE, Lieske B, Shabbir A, Wang LZ, So JBY, Yong WP. Study protocol: phase 1 dose escalating study of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin in peritoneal metastasis. Pleura Peritoneum. 2018 Aug 29;3(3):20180118. doi: 10.1515/pp-2018-0118. eCollection 2018 Sep 1.

apc_source: doaj

name: University Surgical Cluster, National University Health System, Singapore, Singapore

family: Kim

full_name: Guowei Kim

given: Guowei

name: Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore

family: Tan

full_name: Hon Lyn Tan

given: Hon Lyn

name: Department of Surgery, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, Singapore

family: Chen

full_name: Elya Chen

given: Elya

family: Teo

full_name: Siok Chin Teo

given: Siok Chin

family: Jang

full_name: Clarisse Jia Min Jang

given: Clarisse Jia Min

family: Ho

full_name: Jingshan Ho

given: Jingshan

family: Ang

full_name: Yvonne Ang

given: Yvonne

family: Ngoi

full_name: Natalie Yan Li Ngoi

given: Natalie Yan Li

family: Chee

full_name: Cheng Ean Chee

given: Cheng Ean

family: Lieske

full_name: Bettina Lieske

given: Bettina

family: Shabbir

full_name: Asim Shabbir

given: Asim

name: Cancer Science Institute of Singapore, Singapore, Singapore

family: Wang

full_name: Ling-Zhi Wang

given: Ling-Zhi

family: So

full_name: Jimmy Bok Yan So

given: Jimmy Bok Yan

family: Yong

full_name: Wei Peng Yong

given: Wei Peng

currency_apc_doaj: EUR

journal_name: Pleura and Peritoneum

oa_colors: green diamond

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher: Walter de Gruyter GmbH

publisher_dissemination: De Gruyter

publisher_group: De Gruyter

publisher_normalized: De Gruyter

location_facility:
National University Hospital
Ghent University Hospital
Hospices Civils de Lyon
National Cancer Centre Singapore


title: A Clinical Trial to Investigate Biomarker Effects of Pre-Surgical Treatment With DDR Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Who Are Planned to Undergo Surgery That is Likely to be Followed by Radiotherapy and/or Chemotherapy.

summary: This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).

ipd_sharing: Yes

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

lead_sponsor: AstraZeneca

location_country:
United States
France
Taiwan


summary: The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

primary_purpose: Other

lead_sponsor: Laboratoires Thea

location_country: Turkey France Bulgaria Spain

location_facility:
Hospital
CHU
Erciyes Üniversitesi Tıp Fakültesi


title: Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve

acronym: DOCK 1

summary: This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

lead_sponsor: MValve Technologies Ltd

location_country: Brazil Germany France Poland

location_facility: University of Bonn - Medizinische Klinik und Poliklinik II


title: An Open-Label, Multicenter, Dose-Escalation Phase I Study of RO6874813, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
France
Spain

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

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale


title: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion

acronym: DUALIDES

summary: The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
United Kingdom
France
Latvia

location_facility: P. Stradins Clinical University Hospital


title: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

summary:
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.

This is an investigational study.

Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.

lead_sponsor: M.D. Anderson Cancer Center

location_country:
Israel
United States
France
Spain

location_facility: Chaim Sheba Medical Center at Tel Hasomer

location_facility: University of Texas MD Anderson Cancer Center


title: A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone

acronym: OAK

summary: This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.

location_country:
Germany
United Kingdom
Belgium
France

location_facility:
Dr. Felix Hanssler
Dr. Tommie VanDeVelde
Dr. Dominique Caspar
Dr. Nicholas Lewis


title: Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

summary: The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United States
France

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


title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

summary: The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.

lead_sponsor: Novartis Pharmaceuticals

location_country: Austria Germany France


title: An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer

summary: To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

lead_sponsor: Dendreon

location_country:
Austria
United Kingdom
France
Netherlands

location_facility: Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London

location_facility: Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine

location_facility: Ludwig Boltzmann-Institute for Applied Cancer Research

location_facility: Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie


title: Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment)

summary: Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

ReferenceCitation: Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Dührsen U, Reinke P, Verhoef G, Subklewe M, Hüttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.

name: Ralf U. Trappe and Heiner Zimmermann, DIAKO Evangelisches Diakonie-Krankenhaus Bremen, Bremen; University Medical Centre Schleswig-Holstein, Kiel; Ralf U. Trappe, Petra Reinke, Ioannis Anagnostopoulos, and Hanno Riess, Charité-Universitätsmedizin Berlin, Berlin; Martin H. Dreyling and Marion Subklewe, University of Munich, Munich; Ulrich Dührsen and Andreas Hüttmann, University of Duisburg-Essen, Essen; Volker Kliem, Nephrological Centre Lower Saxony, Hann. Münden; Ingeborg A. Hauser, J.W. Goethe...

family: Trappe

full_name: Ralf U. Trappe

given: Ralf U.

family: Dierickx

full_name: Daan Dierickx

given: Daan

family: Zimmermann

full_name: Heiner Zimmermann

given: Heiner

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Mollee

full_name: Peter Mollee

given: Peter

family: Zaucha

full_name: Jan M. Zaucha

given: Jan M.

family: Dreyling

full_name: Martin H. Dreyling

given: Martin H.

family: Dührsen

full_name: Ulrich Dührsen

given: Ulrich

family: Reinke

full_name: Petra Reinke

given: Petra

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Subklewe

full_name: Marion Subklewe

given: Marion

family: Hüttmann

full_name: Andreas Hüttmann

given: Andreas

family: Tousseyn

full_name: Thomas Tousseyn

given: Thomas

family: Salles

full_name: Gilles Salles

given: Gilles

family: Kliem

full_name: Volker Kliem

given: Volker

family: Hauser

full_name: Ingeborg A. Hauser

given: Ingeborg A.

family: Tarella

full_name: Corrado Tarella

given: Corrado

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Gheysens

full_name: Olivier Gheysens

given: Olivier

family: Anagnostopoulos

full_name: Ioannis Anagnostopoulos

given: Ioannis

family: Leblond

full_name: Veronique Leblond

given: Veronique

family: Riess

full_name: Hanno Riess

given: Hanno

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

repository_institution: The University of Queensland - Queensland's institutional digital repository

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Trappe R, Oertel S, Leblond V, Mollee P, Sender M, Reinke P, Neuhaus R, Lehmkuhl H, Horst HA, Salles G, Morschhauser F, Jaccard A, Lamy T, Leithäuser M, Zimmermann H, Anagnostopoulos I, Raphael M, Riess H, Choquet S; German PTLD Study Group; European PTLD Network. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial. Lancet Oncol. 2012 Feb;13(2):196-206. doi: 10.1016/S1470-2045(11)70300-X. Epub 2011 Dec 13.

location_facility: Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1

location_facility: Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102

location_facility: Sahlgrens hospital, Department of Hematology


title: Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer

summary: The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.

ReferenceCitation: Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Jones

full_name: Robert J. Jones

given: Robert J.

family: Van den Brande

full_name: Jan Van den Brande

given: Jan

family: Molife

full_name: Rhoda L. Molife

given: Rhoda L.

family: Omlin

full_name: Aurelius Omlin

given: Aurelius

family: James

full_name: Nicholas D. James

given: Nicholas D.

family: Baskin-Bey

full_name: Edwina Baskin-Bey

given: Edwina

family: Heeringa

full_name: Marten Heeringa

given: Marten

family: Baron

full_name: Benoit Baron

given: Benoit

family: Holtkamp

full_name: Gertjan M. Holtkamp

given: Gertjan M.

family: Ouatas

full_name: Taoufik Ouatas

given: Taoufik

family: De Bono

full_name: Johann S. De Bono

given: Johann S.

journal_name: Investigational New Drugs

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Astellas Pharma Inc

location_country:
United Kingdom
Belgium
France

location_facility:
Site: 121
Site 131
Site:109
Site: 101


title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

summary: To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

lead_sponsor: Abbott Medical Optics

location_facility: Paracelsus Medizinische Privat-Universitat, PMU


title: Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma

summary: This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.

location_country:
Denmark
United Kingdom
France
Switzerland


title: A Double-blind Placebo-controlled Study of the Application of the SCIO Universal Electrophysiological Biofeedback System for Statistical Evaluation of the SCIO's Ability to Increase Body Wellness After One 45-minute Session

summary: The objective of the study is to determine if one 45-minute treatment with the SCIO (Scientific Consciousness Interface Operations System) biofeedback device would show a change, and hopefully an improvement, on a person's Body Wellness indicators (Quality of Life Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory, pH, and VARHOPE scores (V=voltage, A=amperage, R=resistance, H=hydration, O=oxygenation, P=proton pressure and E=electron pressure), electrical measures within the device. For subjects in the control group, it is expected that there will likely be an improvement of approximately 5% in measured variables. That is, subjects in the control group will likely report some of the positive changes listed above for test group subjects. However, on average, any positive change in post-treatment measures for control subjects is expected to occur to a significantly lesser degree than for subjects in the test group.

lead_sponsor: Maitreya Kft.

location_country:
Germany
United States
France
Romania

location_facility:
Annex of Quantum Northwest Presents
Annex of Hexagram SARL
CFI Centrum für Integrative Medizin
Centrul de Biorezonanţă Dr. Băcean


title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study

summary: The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

ReferenceCitation: Håkansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.

name: Department of Surgery; Ersta Hospital; Karolinska Institutet; Danderyds Hospital; Stockholm Sweden

family: Håkansson

full_name: B. Håkansson

given: B.

family: Montgomery

full_name: M. Montgomery

given: M.

name: Department of Surgery and Gastroenterology; Park Leopold Clinic; CHIREC; Brussels Belgium

family: Cadiere

full_name: G. B. Cadiere

given: G. B.

family: Rajan

full_name: A. Rajan

given: A.

name: CHU Hotel Dieu Institut des Maladies de l' Appareil Digestif; Nantes France

family: Bruley des Varannes

full_name: S. Bruley des Varannes

given: S.

family: Lerhun

full_name: M. Lerhun

family: Coron

full_name: E. Coron

given: E.

name: Department of Gastroenterology; University Hospitals Leuven; Leuven Belgium

family: Tack

full_name: J. Tack

given: J.

family: Bischops

full_name: R. Bischops

given: R.

family: Thorell

full_name: A. Thorell

name: Department of Surgery; Centre for Digestive Diseases; Karolinska University Huddinge Hospital; Karolinska Institutet; Stockholm Sweden

family: Arnelo

full_name: U. Arnelo

given: U.

family: Lundell

full_name: L. Lundell

given: L.

journal_name: Alimentary Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: EndoGastric Solutions

location_country: Sweden Belgium France

location_facility: Karolinska University, Huddinge Hospital


title: A Phase I Study to Evaluate the Safety and Tolerability of the Histone Deacetylase Inhibitor, CHR-2845, in Patients With Advanced or Treatment Refractory Haematological Diseases or Lymphoid Malignancies

summary: The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845 is tolerated in patients with haematological diseases and lymphoid malignancies.

ReferenceCitation: Ossenkoppele GJ, Lowenberg B, Zachee P, Vey N, Breems D, Van de Loosdrecht AA, Davidson AH, Wells G, Needham L, Bawden L, Toal M, Hooftman L, Debnam PM. A phase I first-in-human study with tefinostat - a monocyte/macrophage targeted histone deacetylase inhibitor - in patients with advanced haematological malignancies. Br J Haematol. 2013 Jul;162(2):191-201. doi: 10.1111/bjh.12359. Epub 2013 May 7.

name: Department of Haematology; VU University Medical Centre; Amsterdam The Netherlands

family: Ossenkoppele

full_name: Gert J. Ossenkoppele

given: Gert J.

name: Erasmus University Medical Centre; Department of Haematology; Rotterdam The Netherlands

family: Lowenberg

full_name: Bob Lowenberg

given: Bob

name: Department of Haematology; ZNA Stuivenberg; Antwerp Belgium

family: Zachee

full_name: Pierre Zachee

given: Pierre

name: Hématologie III; Institut Paoli-Calmettes; Marseille France

family: Vey

full_name: Norbert Vey

given: Norbert

family: Breems

full_name: Dimitri Breems

given: Dimitri

family: Van de Loosdrecht

full_name: Arjan A. Van de Loosdrecht

given: Arjan A.

family: Davidson

full_name: Alan H. Davidson

given: Alan H.

family: Wells

full_name: Graham Wells

given: Graham

family: Needham

full_name: Lindsey Needham

given: Lindsey

family: Bawden

full_name: Lindsay Bawden

given: Lindsay

family: Toal

full_name: Martin Toal

given: Martin

family: Hooftman

full_name: Leon Hooftman

given: Leon

family: Debnam

full_name: Phillip M. Debnam

given: Phillip M.

journal_name: British Journal of Haematology

lead_sponsor: Chroma Therapeutics

location_country: Belgium France Netherlands

location_facility:
Institut Paoli-Calmettes
Erasmus University Medical Center
ZNA Stuivenberg
VU University Medical Center


title: EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS

summary: This clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. This study will be performed in a healthy adult population of shift workers.

primary_purpose: Prevention

lead_sponsor: Danone Research

location_country:
United Kingdom
Belgium
France
Spain

location_facility:
Therapharm
VEEDA
SGS
Hospital de la Santa Creu


ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country: Italy Austria France Poland

title: Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

summary: This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.


title: Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease

summary:
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.

The secondary objectives were to :

evaluate the efficacy of rasburicase in terms of renal protection,
evaluate the safety of rasburicase in the two cohorts of patients,
correlate efficacy and safety results with antibodies generation/level.

lead_sponsor: Sanofi

location_country: Italy Germany Belgium France

location_facility:
Sanofi- Aventis Administrative Office
Sanofi-Aventis Administrative Office


summary: This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

lead_sponsor: Allergan

location_country:
Germany
United States
France
Portugal


title: A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer

summary: The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.

ReferenceCitation: Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.

family: Berghmans

full_name: Thierry Berghmans

given: Thierry

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Meert

full_name: Anne-Pascale Meert

given: Anne-Pascale

family: Giner

full_name: Vicente Giner

given: Vicente

family: Lecomte

full_name: Jacques Lecomte

given: Jacques

family: Lafitte

full_name: Jean-Jacques Lafitte

given: Jean-Jacques

family: Leclercq

full_name: Nathalie Leclercq

given: Nathalie

family: Paesmans

full_name: Marianne Paesmans

given: Marianne

family: Sculier

full_name: Jean-Paul Sculier

given: Jean-Paul

name: for the European Lung Cancer Working Party (ELCWP)

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

oa_colors: green gold

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: European Lung Cancer Working Party

location_country: Spain Belgium France Greece

location_facility: Hellenic Cancer Institute - St Savas Oncology Hospital

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet


title: The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients With Non-V30M Transthyretin Amyloidosis

summary:
This is an open-label, multicenter, international study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with non-V30M TTR amyloidosis.

Strong pre-clinical and clinical evidence support a daily dose of 20 mg of Fx-1006A to be the optimum dose to achieve stabilization of tetrameric TTR in ATTR-PN patients. Since disease presentation is similar between V30M and non-V30M TTR mutations associated with ATTR-PN and Fx-1006A has been shown to stabilize wild-type and V30M TTR in vitro and ex vivo, the present study is being conducted to determine the effects of Fx-1006A on TTR stabilization in ATTR-PN patients with TTR mutations other than V30M. Safety and exploratory efficacy of Fx-1006A administered once daily for 12 months will also be evaluated in this patient population.

This is an open-label, multicenter, international study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with non-V30M TTR amyloidosis. The study will be conducted in two parts. Part 1 will include a six-week dosing period during which all enrolled patients will receive oral Fx-1006A 20 mg soft gelatin capsules once daily for six weeks. At Week 6, blood samples will be collected from each patient to determine TTR stabilization. Patients who complete the Week 6 visit will continue receiving daily oral Fx-1006A 20 mg for up to a total of 12 months during Part 2 of this study. If it is determined that a patient is not stabilized at Week 6, the patient will be discontinued from the study.

During Part 2, clinical outcomes will be measured at Months 6 and 12, based on NIS, Norfolk QOL-DN, mBMI, NCS, HRDB, SF-36, Karnofsky score, and echocardiography; NT-pro-BNP and troponin I levels will be measured at Baseline, Weeks 2 and 6, and Months 3, 6, and 12.

Pharmacokinetic measurements will be made using samples collected at Baseline, Week 6, and Months 6 and 12.

Safety and tolerability will be assessed throughout the study based on vital signs, physical examinations, ECG, echocardiography, 24-hour Holter monitoring, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and monitoring adverse events and concomitant medication use.

Day 1 will be defined as administration of the first dose of study drug. Clinic Visits will be conducted during Screening (Days -30 to -1) and at Baseline (Day 0), and Week 2, and Week 6, and Months 3, 6, and 12 (± 2 weeks of the scheduled date for post-Baseline visits). Monthly telephone contacts (+ 1 week of the scheduled date) will be made during months in which no investigative site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for assessment of adverse events and concomitant medications. A final telephone contact to assess adverse events and concomitant medication usage will be made 30 days after the last dose of study drug.

Patients who discontinue from the study at any time following enrollment will have a final visit performed, including all safety assessments, at the time of discontinuation. Any patient discontinuing after the Month 6 visit will also have all exploratory assessments performed.

ReferenceCitation: Merlini G, Coelho T, Waddington Cruz M, Li H, Stewart M, Ebede B. Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years. Neurol Ther. 2020 Jun;9(1):105-115. doi: 10.1007/s40120-020-00180-w. Epub 2020 Feb 27.

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

family: Coelho

full_name: Teresa Coelho

given: Teresa

family: Waddington Cruz

full_name: Márcia Waddington Cruz

given: Márcia

family: Li

full_name: Huihua Li

given: Huihua

family: Stewart

full_name: Michelle Stewart

given: Michelle

family: Ebede

full_name: Ben Ebede

given: Ben

journal_name: Neurology and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

family: Huber

full_name: Peter Huber

given: Peter

family: Flynn

full_name: Alison Flynn

given: Alison

family: Sultan

full_name: Marla B. Sultan

given: Marla B.

family: Rill

full_name: Denise Rill

given: Denise

family: Gundapaneni

full_name: Balarama Gundapaneni

given: Balarama

family: Schwartz

full_name: Jeffrey H. Schwartz

given: Jeffrey H.

journal_name: Amyloid

oa_host_type: publisher

evidence: open (via crossref license)

ReferenceCitation: Gundapaneni BK, Sultan MB, Keohane DJ, Schwartz JH. Tafamidis delays neurological progression comparably across Val30Met and non-Val30Met genotypes in transthyretin familial amyloid polyneuropathy. Eur J Neurol. 2018 Mar;25(3):464-468. doi: 10.1111/ene.13510. Epub 2017 Dec 26.

title: Tafamidis delays neurological progression comparably across Val30Met and non‐Val30Met genotypes in transthyretin familial amyloid polyneuropathy

ReferenceCitation: Merlini G, Planté-Bordeneuve V, Judge DP, Schmidt H, Obici L, Perlini S, Packman J, Tripp T, Grogan DR. Effects of tafamidis on transthyretin stabilization and clinical outcomes in patients with non-Val30Met transthyretin amyloidosis. J Cardiovasc Transl Res. 2013 Dec;6(6):1011-20. doi: 10.1007/s12265-013-9512-x. Epub 2013 Oct 8.

journal_name: Journal of Cardiovascular Translational Research

title: Effects of Tafamidis on Transthyretin Stabilization and Clinical Outcomes in Patients with Non-Val30Met Transthyretin Amyloidosis

location_facility: Universitatsklinikum Munster, Transplant Hepatology

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche


title: A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC


title: A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events

summary: This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.

lead_sponsor: Novartis

location_country: Germany Belgium France Switzerland

location_facility:
Novartis Investigative site
Novartis Investigative Site


summary:
Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population.

Primary Objective:

To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination.

Secondary Objectives:

Immunogenicity:

To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects.

To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects.

Safety:

To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions.

To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.

ReferenceCitation: Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.

family: Chevat

full_name: Catherine Chevat

given: Catherine

family: Viala-Danten

full_name: Muriel Viala-Danten

given: Muriel

family: Dias-Barbosa

full_name: Carla Dias-Barbosa

given: Carla

family: Nguyen

full_name: Van Hung Nguyen

given: Van Hung

currency_apc_doaj: GBP

journal_name: Health and Quality of Life Outcomes

title: Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaire

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Italy Belgium France Lithuania

lead_sponsor_type: academique


title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C

summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

ReferenceCitation: Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourlière M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. doi: 10.1056/NEJMoa0807650.

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Forestier

full_name: Nicole Forestier

given: Nicole

family: Dusheiko

full_name: Geoffrey Dusheiko

given: Geoffrey

family: Ferenci

full_name: Peter Ferenci

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Goeser

full_name: Tobias Goeser

given: Tobias

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Gharakhanian

full_name: Shahin Gharakhanian

given: Shahin

family: Bengtsson

full_name: Leif Bengtsson

given: Leif

family: McNair

full_name: Lindsay McNair

given: Lindsay

family: George

full_name: Shelley George

given: Shelley

family: Kieffer

full_name: Tara Kieffer

given: Tara

family: Kwong

full_name: Ann Kwong

given: Ann

family: Kauffman

full_name: Robert S. Kauffman

given: Robert S.

family: Alam

full_name: John Alam

given: John

family: Pawlotsky

full_name: Jean-Michel Pawlotsky

given: Jean-Michel

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

journal_name: New England Journal of Medicine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Telaprevir and Peginterferon with or without Ribavirin for Chronic HCV Infection

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_facility:
Call For Information
Call for Information


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.

summary:
The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

location_country: Germany Hungary Belgium France


title: An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer

summary:
RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment.

PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.

ReferenceCitation: Chie WC, Tsai CJ, Chiang C, Lee YC. Quality of life of patients with oesophageal cancer in Taiwan: validation and application of the Taiwan Chinese (Mandarin) version of the EORTC QLQ-OES18: a brief communication. Qual Life Res. 2010 Oct;19(8):1127-31. doi: 10.1007/s11136-010-9675-8. Epub 2010 May 22.

family: Chie

full_name: Wei-Chu Chie

given: Wei-Chu

family: Tsai

full_name: Chia-Jih Tsai

given: Chia-Jih

family: Chiang

full_name: Chieh Chiang

given: Chieh

family: Lee

full_name: Yung-Chie Lee

given: Yung-Chie

journal_name: Quality of Life Research

ReferenceCitation: Cull A, Howat S, Greimel E, Waldenstrom AC, Arraras J, Kudelka A, Chauvenet L, Gould A; EORTC Quality of Life Group [European Organization for Research and Treatment of Cancer]; Scottish Gynaecological Cancer Trials Group. Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report. Eur J Cancer. 2001 Jan;37(1):47-53.

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

location_country:
Austria
United Kingdom
France
Spain


title: InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

acronym: GRAMMY

summary: Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

time_perspective: Other

lead_sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

location_country: Italy France Greece

location_facility: 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)

location_facility: Centre Hospitalier Regional et Universitaire (CHRU)


title: Wright™ Elbow Outcomes Clinical Study (WELBOW)

acronym: WELBOW

summary: WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF). Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR) and Clinical Evaluation Report (CER) on Wright Medical Elbow system devices and support peer-reviewed publications on long-term product performance and safety.

lead_sponsor: Tornier, Inc.

location_country:
Sweden
United Kingdom
France

location_facility:
Linköping University
Rouen University Hospital
CHU Tours
Sjukhuset i Varberg Hospital
Wrightington Hospital


lead_sponsor: European Myeloma Network

location_country: Italy France Netherlands Greece

location_facility: National and Kapodistrian University of Athens, School of Medicine

title: Phase 2 Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis

summary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed stage 3B light chain (AL) amyloidosis.


title: Lumenate Observational Vasospasm Interventional Trial (LOVIT)

acronym: LOVIT

summary: The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm.

lead_sponsor: Neurvana Medical

location_country: Germany Hungary Sweden France

location_facility:
National Institute of Neurosciences
Hospital Purpan
Uniklinik RWTH Aachen
Karolinska Universitetssjukhuset
Foundation Adolphe de Rothschild


title: Prospective Validation of the ROX Index Utility in Predicting Failure of HFNC Treatment in Patients With Acute Respiratory Failure

summary: We recently described the ROX index, defined as the ratio of SpO2/FIO2 to respiratory rate that outperformed the diagnostic accuracy of the two variables separately. Patients who had a ROX index ≥4.88 after 12 hours of HFNC therapy were less likely to be intubated, even after adjusting for potential covariates. Like any other scoring system, an independent validation of the score in a different population is necessary. We therefore undertook a multicenter, prospective study to validate the ROX index's diagnostic accuracy for determining which patients will fail on HFNC and will need to be intubated.

ReferenceCitation: Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

ReferenceCitation: Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

family: Frat

full_name: Jean-Pierre Frat

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Mercat

full_name: Alain Mercat

given: Alain

family: Girault

full_name: Christophe Girault

given: Christophe

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Prat

full_name: Gwénael Prat

given: Gwénael

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Nseir

full_name: Saad Nseir

given: Saad

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Chevalier

full_name: Stéphanie Chevalier

family: Herbland

full_name: Alexandre Herbland

given: Alexandre

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Constantin

full_name: Jean-Michel Constantin

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

title: High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure

ReferenceCitation: Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

name: Critical Care Department, Vall d’Hebron University Hospital, Vall d’Hebron Research Institute and

name: Ciber Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain

name: Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain

name: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique–Hôpitaux de Paris (AP-HP), Colombes, France

name: INSERM, Infection Antimicrobials Modelling Evolution (IAME), Unité Mixte de Recherche (UMR) 1137, Paris, France

name: Université Paris Diderot, IAME, UMR 1137, Sorbonne Paris Cité, Paris, France

name: Critical Care Department, Hospital del Mar, Mar Research Institute, Barcelona, Spain

name: Service de Réanimation Polyvalente et Surveillance Continue, Hôpital Antoine Béclère, AP-HP, Clamart, France

name: INSERM U999: Pulmonary Hypertension, Physiopathologie et Innovation Thérapeutique, Hôpital Marie Lannelongue, Le Plessis Robinson, France

name: Critical Care Department, Virgen de la Salud University Hospital, Toledo, Spain

name: Réanimation Médicale, Centre Hospitalier Universitaire de Poitiers, Poitiers, France

name: Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France; and

name: INSERM, Centre d’Investigation Clinique-1402, Equipe 5 Acute Lung Injury and Ventilatory Support, Poitiers, France

journal_name: American Journal of Respiratory and Critical Care Medicine

lead_sponsor: Hospital Universitari Vall d'Hebron Research Institute

location_facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

location_facility: Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale

location_facility: Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue


title: Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy

summary: This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

lead_sponsor: Laboratorios Ordesa

location_country: France Spain

location_facility: Hospital Universitari i Politècnic La Fe


title: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

acronym: FIRST

summary:
The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.

lead_sponsor: Galderma R&D

location_country:
United Kingdom
France
Spain


title: A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation

summary: To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD, single or recurrent episode on mood as measured by the MADRS.

lead_sponsor: Abbott Medical Devices

location_country:
Israel
United Kingdom
France

location_facility: National Hospital for Neurology and Neurosurgery - UCL

location_facility: Hadassah-Hebrew University Medical Center


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.

lead_sponsor: Q-Med AB

location_country: Sweden France

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


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.

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.

name: Luis G. Paz-Ares and Jesus Corral, Instituto de Biomedicina de Sevilla and Hospital Universitario Virgen del Rocio, Seville; Andres Cervantes and Desamparados Roda, Fundación Investigación Hospital Clínico Valencia, University of Valencia, Valencia; Ben Markman, José Baselga, and Josep Tabernero, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain; Carlos Gomez-Roca and Jean-Charles Soria, Institut Gustave Roussy, Villejuif; Jean-Pierre Delord and Yann Bergé, Institut...

family: Paz-Ares

full_name: Luis G. Paz-Ares

given: Luis G.

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Cervantes

full_name: Andres Cervantes

given: Andres

family: Markman

full_name: Ben Markman

given: Ben

family: Corral

full_name: Jesus Corral

given: Jesus

family: Soria

full_name: Jean-Charles Soria

family: Bergé

full_name: Yann Bergé

given: Yann

family: Roda

full_name: Desamparados Roda

given: Desamparados

family: Russell-Yarde

full_name: Fiona Russell-Yarde

given: Fiona

family: Hollingsworth

full_name: Simon Hollingsworth

given: Simon

family: Baselga

full_name: José Baselga

given: José

family: Umana

full_name: Pablo Umana

given: Pablo

family: Manenti

full_name: Luigi Manenti

given: Luigi

family: Tabernero

full_name: Josep Tabernero

given: Josep

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: 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

lead_sponsor: Hoffmann-La Roche


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).

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

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: Klinikum der Georg-August-Universitat Gottingen

location_facility: Universitatsklinikum University of Saarland


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.

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.

family: Taliaz

full_name: Dekel Taliaz

given: Dekel

family: Spinrad

full_name: Amit Spinrad

given: Amit

family: Barzilay

full_name: Ran Barzilay

given: Ran

family: Barnett-Itzhaki

full_name: Zohar Barnett-Itzhaki

given: Zohar

family: Averbuch

full_name: Dana Averbuch

given: Dana

family: Teltsh

full_name: Omri Teltsh

given: Omri

family: Schurr

full_name: Roy Schurr

given: Roy

family: Darki-Morag

full_name: Sne Darki-Morag

given: Sne

family: Lerer

full_name: Bernard Lerer

given: Bernard

journal_name: Translational Psychiatry

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). pii: 3109. doi: 10.3390/jcm10143109.

family: Souery

full_name: Daniel Souery

given: Daniel

currency_apc_doaj: CHF

journal_name: Journal of Clinical Medicine

repositories_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

publisher: MDPI AG

publisher_dissemination: MDPI

location_facility:
Hospital Pitié Salpétrière
Hôpitaux Universitaires de Genève
Psy Pluriel


study_start_date_type: Anticipated

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
France
Poland

acronym: UNITED

location_facility: Children's Center For Digestive Healthcare, Llc

title: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

summary: The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab


title: A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

summary: A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

lead_sponsor: SOTIO a.s.

location_country:
United States
France
Spain

location_facility:
Institut Gustave Roussy
Vall d'Hebron Institute of Oncology
MD Anderson Cancer Center
Yale Cancer Center


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.

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
Belgium
France
Spain

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