title: Effect of Stress-dose Steroids on Post-resuscitation Infectious (Septic) Complications After In-hospital Cardiac Arrest. Individual Patient Data-based Re-analysis of Synthesized Prior Randomized Clinical Trial Data

summary: Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal insufficiency, and circulatory failure. Such severe pathology may be associated with increased susceptibility to infectious complications and increased risk of death due to postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 & NCT00729794), in order to determine the effect of stress-dose steroids on the severity of postresuscitation infectious complications, and more specifically, on the risk of septic shock-associated death.

time_perspective: Retrospective

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8.

ReferenceCitation: Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. Review.

ReferenceCitation: Pene F, Hyvernat H, Mallet V, Cariou A, Carli P, Spaulding C, Dugue MA, Mira JP. Prognostic value of relative adrenal insufficiency after out-of-hospital cardiac arrest. Intensive Care Med. 2005 May;31(5):627-33. Epub 2005 Apr 19.

ReferenceCitation: Kim JJ, Lim YS, Shin JH, Yang HJ, Kim JK, Hyun SY, Rhoo I, Hwang SY, Lee G. Relative adrenal insufficiency after cardiac arrest: impact on postresuscitation disease outcome. Am J Emerg Med. 2006 Oct;24(6):684-8.

ReferenceCitation: Hékimian G, Baugnon T, Thuong M, Monchi M, Dabbane H, Jaby D, Rhaoui A, Laurent I, Moret G, Fraisse F, Adrie C. Cortisol levels and adrenal reserve after successful cardiac arrest resuscitation. Shock. 2004 Aug;22(2):116-9.

ReferenceCitation: Tsai MS, Huang CH, Chang WT, Chen WJ, Hsu CY, Hsieh CC, Yang CW, Chiang WC, Ma MH, Chen SC. The effect of hydrocortisone on the outcome of out-of-hospital cardiac arrest patients: a pilot study. Am J Emerg Med. 2007 Mar;25(3):318-25.

ReferenceCitation: Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM. A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest. Crit Care Med. 1993 Sep;21(9):1339-47. Review.

ReferenceCitation: Nolan JP, Deakin CD, Soar J, Böttiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. Review.

ReferenceCitation: Keh D, Boehnke T, Weber-Cartens S, Schulz C, Ahlers O, Bercker S, Volk HD, Doecke WD, Falke KJ, Gerlach H. Immunologic and hemodynamic effects of "low-dose" hydrocortisone in septic shock: a double-blind, randomized, placebo-controlled, crossover study. Am J Respir Crit Care Med. 2003 Feb 15;167(4):512-20. Epub 2002 Nov 8.

ReferenceCitation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416.

ReferenceCitation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.

ReferenceCitation: Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63.

ReferenceCitation: Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

ReferenceCitation: ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

ReferenceCitation: A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest. Design, methods, and patient characteristics. The Brain Resuscitation Clinical Trial II Study Group. Control Clin Trials. 1991 Aug;12(4):525-45.

ReferenceCitation: Vollmar B, Menger MD. Intestinal ischemia/reperfusion: microcirculatory pathology and functional consequences. Langenbecks Arch Surg. 2011 Jan;396(1):13-29. doi: 10.1007/s00423-010-0727-x. Epub 2010 Nov 19. Review.

ReferenceCitation: Davies KJ, Walters JH, Kerslake IM, Greenwood R, Thomas MJ. Early antibiotics improve survival following out-of hospital cardiac arrest. Resuscitation. 2013 May;84(5):616-9. doi: 10.1016/j.resuscitation.2012.11.004. Epub 2012 Nov 12.

ReferenceCitation: Chalkias A, Scheetz MH, Gulati A, Xanthos T. Periarrest intestinal bacterial translocation and resuscitation outcome. J Crit Care. 2016 Feb;31(1):217-20. doi: 10.1016/j.jcrc.2015.09.015. Epub 2015 Sep 25.

ReferenceCitation: Haller B, Schmidt G, Ulm K. Applying competing risks regression models: an overview. Lifetime Data Anal. 2013 Jan;19(1):33-58. doi: 10.1007/s10985-012-9230-8. Epub 2012 Sep 26. Review.

ReferenceCitation: Trzeciak S, Jones AE, Kilgannon JH, Milcarek B, Hunter K, Shapiro NI, Hollenberg SM, Dellinger P, Parrillo JE. Significance of arterial hypotension after resuscitation from cardiac arrest. Crit Care Med. 2009 Nov;37(11):2895-903; quiz 2904.

ReferenceCitation: Tsai MS, Chuang PY, Yu PH, Huang CH, Tang CH, Chang WT, Chen WJ. Glucocorticoid use during cardiopulmonary resuscitation may be beneficial for cardiac arrest. Int J Cardiol. 2016 Nov 1;222:629-635. doi: 10.1016/j.ijcard.2016.08.017. Epub 2016 Aug 4.

ReferenceCitation: Callaway CW, Soar J, Aibiki M, Böttiger BW, Brooks SC, Deakin CD, Donnino MW, Drajer S, Kloeck W, Morley PT, Morrison LJ, Neumar RW, Nicholson TC, Nolan JP, Okada K, O'Neil BJ, Paiva EF, Parr MJ, Wang TL, Witt J; Advanced Life Support Chapter Collaborators. Part 4: Advanced Life Support: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S84-145. doi: 10.1161/CIR.0000000000000273. Review.

ReferenceCitation: Mentzelopoulos SD, Zakynthinos SG, Tzoufi M, Katsios N, Papastylianou A, Gkisioti S, Stathopoulos A, Kollintza A, Stamataki E, Roussos C. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009 Jan 12;169(1):15-24. doi: 10.1001/archinternmed.2008.509.

ReferenceCitation: Mentzelopoulos SD, Malachias S, Chamos C, Konstantopoulos D, Ntaidou T, Papastylianou A, Kolliantzaki I, Theodoridi M, Ischaki H, Makris D, Zakynthinos E, Zintzaras E, Sourlas S, Aloizos S, Zakynthinos SG. Vasopressin, steroids, and epinephrine and neurologically favorable survival after in-hospital cardiac arrest: a randomized clinical trial. JAMA. 2013 Jul 17;310(3):270-9. doi: 10.1001/jama.2013.7832.

ReferenceCitation: Mentzelopoulos SD, Mongardon N, Xanthos T, Zakynthinos SG. Possible significance of hemodynamic and immunomodulatory effects of early stress-dose steroids in cardiac arrest. Crit Care. 2016 Jul 20;20(1):211. doi: 10.1186/s13054-016-1384-4.

lead_sponsor: University of Athens

location_country: France Greece

location_facility: President Hellenic Society of Cardiopulmonary Resuscitation

location_facility: Service d'anesthésie et des réanimations chirurgicales, ôHôpitaux Universitaires Henri Mondor, Assistance Publique des Hôpitaux de Paris, Université Paris Est, Faculté de Médecine

location_facility: Department of Intensive Care Medicine, Evaggelismos Hospital


title: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

summary: The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.

status: Completed

study_completion_date_type: Actual

study_type: Observational

enrollment_type: Actual

lead_sponsor: Integra LifeSciences Corporation

location_country:
Germany
France
Spain
United Kingdom

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: die Charité - Universitätsmedizin Berlin

lead_sponsor_type: industriel

status_simplified: Completed


title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

acronym: RANBI

summary: Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

lead_sponsor: Allergan

location_country:
Spain
United Kingdom
France
Israel
Germany

intervention_type: Device


title: New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe

acronym: NU-AGE

summary: NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving nutritionists, bio-gerontologists, immunologists and molecular biologists from the most prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and 1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13 European countries and the European Confederation the food and drink industry. NU-AGE aims are: 1. to counteract the physical/cognitive decline occurring in the elderly as a consequence of the progressive alteration of different organs/systems (immune and cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half control) from 5 different EU regions; 2. to assess the effect of the newly designed food pyramid specific for 65+ EU citizens on the different organs/systems using a large set of biomarkers related to nutrition and aging, with particular attention to the low grade, chronic, systemic inflammatory status named inflammageing, a major risk factor for common age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high throughput "omics" to identify cellular/molecular targets/mechanisms responsible for whole diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual variability on the response to diet; 5. to adopt an integrative comprehensive approach (systems biology) to analyze the whole set of data. The results of dietary intervention will be used to develop elderly-tailored prototypes of functional foods and to improve traditional foods. The research activity will be accompanied and followed by a strong activity of dissemination and industrial exploitation to support EU strategies on nutritional recommendations, thus contributing to the implementation of legislation related to nutritional and health claims for elderly in Europe.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Grootswagers P, Mensink M, Berendsen AAM, Deen CPJ, Kema IP, Bakker SJL, Santoro A, Franceschi C, Meunier N, Malpuech-Brugère C, Bialecka-Debek A, Rolf K, Fairweather-Tait S, Jennings A, Feskens EJM, de Groot LCPGM. Vitamin B-6 intake is related to physical performance in European older adults: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) study. Am J Clin Nutr. 2021 Apr 6;113(4):781-789. doi: 10.1093/ajcn/nqaa368.

ReferenceCitation: Jennings A, Tang J, Gillings R, Perfecto A, Dutton J, Speakman J, Fraser WD, Nicoletti C, Berendsen AAM, de Groot LCPGM, Pietruszka B, Jeruszka-Bielak M, Caumon E, Caille A, Ostan R, Franceschi C, Santoro A, Fairweather-Tait SJ. Changing from a Western to a Mediterranean-style diet does not affect iron or selenium status: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) 1-year randomized clinical trial in elderly Europeans. Am J Clin Nutr. 2020 Jan 1;111(1):98-109. doi: 10.1093/ajcn/nqz243.

ReferenceCitation: Giampieri E, Ostan R, Guidarelli G, Salvioli S, Berendsen AAM, Brzozowska A, Pietruszka B, Jennings A, Meunier N, Caumon E, Fairweather-Tait S, Sicinska E, Feskens EJM, de Groot LCPGM, Franceschi C, Santoro A. A Novel Approach to Improve the Estimation of a Diet Adherence Considering Seasonality and Short Term Variability - The NU-AGE Mediterranean Diet Experience. Front Physiol. 2019 Mar 5;10:149. doi: 10.3389/fphys.2019.00149. eCollection 2019.

ReferenceCitation: Pujos-Guillot E, Pétéra M, Jacquemin J, Centeno D, Lyan B, Montoliu I, Madej D, Pietruszka B, Fabbri C, Santoro A, Brzozowska A, Franceschi C, Comte B. Identification of Pre-frailty Sub-Phenotypes in Elderly Using Metabolomics. Front Physiol. 2019 Jan 24;9:1903. doi: 10.3389/fphys.2018.01903. eCollection 2018.

ReferenceCitation: Jennings A, Berendsen AM, de Groot LCPGM, Feskens EJM, Brzozowska A, Sicinska E, Pietruszka B, Meunier N, Caumon E, Malpuech-Brugère C, Santoro A, Ostan R, Franceschi C, Gillings R, O' Neill CM, Fairweather-Tait SJ, Minihane AM, Cassidy A. Mediterranean-Style Diet Improves Systolic Blood Pressure and Arterial Stiffness in Older Adults. Hypertension. 2019 Mar;73(3):578-586. doi: 10.1161/HYPERTENSIONAHA.118.12259.

ReferenceCitation: Ostan R, Guidarelli G, Giampieri E, Lanzarini C, Berendsen AAM, Januszko O, Jennings A, Lyon N, Caumon E, Gillings R, Sicinska E, Meunier N, Feskens EJM, Pietruszka B, de Groot LCPGM, Fairweather-Tait S, Capri M, Franceschi C, Santoro A. Cross-Sectional Analysis of the Correlation Between Daily Nutrient Intake Assessed by 7-Day Food Records and Biomarkers of Dietary Intake Among Participants of the NU-AGE Study. Front Physiol. 2018 Oct 1;9:1359. doi: 10.3389/fphys.2018.01359. eCollection 2018.

ReferenceCitation: Maijo M, Ivory K, Clements SJ, Dainty JR, Jennings A, Gillings R, Fairweather-Tait S, Gulisano M, Santoro A, Franceschi C, Carding SR, Nicoletti C. One-Year Consumption of a Mediterranean-Like Dietary Pattern With Vitamin D3 Supplements Induced Small Scale but Extensive Changes of Immune Cell Phenotype, Co-receptor Expression and Innate Immune Responses in Healthy Elderly Subjects: Results From the United Kingdom Arm of the NU-AGE Trial. Front Physiol. 2018 Jul 26;9:997. doi: 10.3389/fphys.2018.00997. eCollection 2018.

ReferenceCitation: Jennings A, Cashman KD, Gillings R, Cassidy A, Tang J, Fraser W, Dowling KG, Hull GLJ, Berendsen AAM, de Groot LCPGM, Pietruszka B, Wierzbicka E, Ostan R, Bazzocchi A, Battista G, Caumon E, Meunier N, Malpuech-Brugère C, Franceschi C, Santoro A, Fairweather-Tait SJ. A Mediterranean-like dietary pattern with vitamin D3 (10 µg/d) supplements reduced the rate of bone loss in older Europeans with osteoporosis at baseline: results of a 1-y randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):633-640. doi: 10.1093/ajcn/nqy122.

ReferenceCitation: Marseglia A, Xu W, Fratiglioni L, Fabbri C, Berendsen AAM, Bialecka-Debek A, Jennings A, Gillings R, Meunier N, Caumon E, Fairweather-Tait S, Pietruszka B, De Groot LCPGM, Santoro A, Franceschi C. Effect of the NU-AGE Diet on Cognitive Functioning in Older Adults: A Randomized Controlled Trial. Front Physiol. 2018 Apr 4;9:349. doi: 10.3389/fphys.2018.00349. eCollection 2018.

ReferenceCitation: Fairweather-Tait SJ, Jennings A, Harvey LJ, Berry R, Walton J, Dainty JR. Modeling tool for calculating dietary iron bioavailability in iron-sufficient adults. Am J Clin Nutr. 2017 Jun;105(6):1408-1414. doi: 10.3945/ajcn.116.147389. Epub 2017 Apr 5.

ReferenceCitation: Hooper L, Bunn DK, Abdelhamid A, Gillings R, Jennings A, Maas K, Millar S, Twomlow E, Hunter PR, Shepstone L, Potter JF, Fairweather-Tait SJ. Water-loss (intracellular) dehydration assessed using urinary tests: how well do they work? Diagnostic accuracy in older people. Am J Clin Nutr. 2016 Jul;104(1):121-31. doi: 10.3945/ajcn.115.119925. Epub 2016 May 25.

ReferenceCitation: Hooper L, Abdelhamid A, Ali A, Bunn DK, Jennings A, John WG, Kerry S, Lindner G, Pfortmueller CA, Sjöstrand F, Walsh NP, Fairweather-Tait SJ, Potter JF, Hunter PR, Shepstone L. Diagnostic accuracy of calculated serum osmolarity to predict dehydration in older people: adding value to pathology laboratory reports. BMJ Open. 2015 Oct 21;5(10):e008846. doi: 10.1136/bmjopen-2015-008846.

ReferenceCitation: Berendsen A, Santoro A, Pini E, Cevenini E, Ostan R, Pietruszka B, Rolf K, Cano N, Caille A, Lyon-Belgy N, Fairweather-Tait S, Feskens E, Franceschi C, de Groot CP. Reprint of: A parallel randomized trial on the effect of a healthful diet on inflammageing and its consequences in European elderly people: design of the NU-AGE dietary intervention study. Mech Ageing Dev. 2014 Mar-Apr;136-137:14-21. doi: 10.1016/j.mad.2014.03.001. Epub 2014 Mar 20.

ReferenceCitation: Hooper L, Bunn D, Jimoh FO, Fairweather-Tait SJ. Water-loss dehydration and aging. Mech Ageing Dev. 2014 Mar-Apr;136-137:50-8. doi: 10.1016/j.mad.2013.11.009. Epub 2013 Dec 9. Review.

ReferenceCitation: Fairweather-Tait SJ, Wawer AA, Gillings R, Jennings A, Myint PK. Iron status in the elderly. Mech Ageing Dev. 2014 Mar-Apr;136-137:22-8. doi: 10.1016/j.mad.2013.11.005. Epub 2013 Nov 22. Review.

lead_sponsor: University of Bologna

location_country:
Poland
United Kingdom
Italy
France
Netherlands

location_facility: Auvergne Research Center on Human Nutrition

location_facility: Department of Nurition-University of East Anglia

location_facility: University of Wageningen-Division of Human Nutrition

location_facility: University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

location_facility: Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition

intervention_type: Dietary Supplement

lead_sponsor_type: academique


title: A Multi-center, Randomized, Double Blind, Dose Escalation Safety Study of MP4CO in Clinically Stable Adult Sickle Cell Patients

summary:
Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this occurs, the red blood cells can become sticky and elongated. These sickled red blood cells are less flexible and will obstruct small blood vessels and block normal red blood cells from traveling through the circulatory system, which limits oxygen delivery to tissues and organs. This is known as a "sickle crisis".

Patients suffering from a sickle crisis experience severe pain and are at risk of stroke, heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could mean less time in the hospital and an improved quality of life for patients with sickle cell anemia.

lead_sponsor: Sangart

location_country:
Lebanon
France
Jamaica
United Kingdom

location_facility: Sickle Cell Unit, University of West Indies

intervention_type: Drug


title: International, Multicenter, Randomized, Non-comparative Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression

summary: Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Murphy RL, Autran B, Katlama C, Brucker G, Debre P, Calvez V, Clotet B, Clumeck N, Costagliola D, Deeks SG, Dorrell L, Gatell J, Haase A, Klein M, Lazzarin A, McMichael AJ, Papagno L, Schacker TW, Wain-Hobson S, Walker BD, Youle M. A step ahead on the HIV collaboratory. Science. 2009 Jun 5;324(5932):1264-5. doi: 10.1126/science.324_1264b.

ReferenceCitation: Lewin SR, Rouzioux C. HIV cure and eradication: how will we get from the laboratory to effective clinical trials? AIDS. 2011 Apr 24;25(7):885-97. doi: 10.1097/QAD.0b013e3283467041. Review.

ReferenceCitation: Lafeuillade A. Eliminating the HIV reservoir. Curr HIV/AIDS Rep. 2012 Jun;9(2):121-31. doi: 10.1007/s11904-012-0115-y. Review.

ReferenceCitation: Cohen J. The emerging race to cure HIV infections. Science. 2011 May 13;332(6031):784-5, 787-9. doi: 10.1126/science.332.6031.784.

ReferenceCitation: Lewin SR, Evans VA, Elliott JH, Spire B, Chomont N. Finding a cure for HIV: will it ever be achievable? J Int AIDS Soc. 2011 Jan 24;14:4. doi: 10.1186/1758-2652-14-4.

ReferenceCitation: Katlama C, Lambert-Niclot S, Assoumou L, Papagno L, Lecardonnel F, Zoorob R, Tambussi G, Clotet B, Youle M, Achenbach CJ, Murphy RL, Calvez V, Costagliola D, Autran B; EraMune-01 study team. Treatment intensification followed by interleukin-7 reactivates HIV without reducing total HIV DNA: a randomized trial. AIDS. 2016 Jan;30(2):221-30. doi: 10.1097/QAD.0000000000000894.

lead_sponsor: Objectif Recherche Vaccins SIDA

location_country:
United Kingdom
France
Spain
Italy

location_facility:
University Hospital Clinic of Barcelona
San Raffaele Scientific Institute
Groupe Hospitalier Pitié-Salpêtrière
Royal Free Hospital
Fundacio Irsicaixa

intervention_type: Biological


status: Terminated

acronym: EORTC protocol 26083

title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

lead_sponsor: Bristol-Myers Squibb

type: Other Identifier

type: EudraCT Number

source: euctr

location_country: Netherlands France Switzerland Italy

summary: To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

status_simplified: Unknown


title: A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of a Single Dose (50IU/kg) of KW-3357 in Subjects With Congenital Antithrombin Deficiency.

summary: The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Kyowa Hakko Kirin UK, Ltd.

location_country:
United Kingdom
Italy
Sweden
France
Germany


title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients

acronym: FRI

summary:
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.

However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.

A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.

The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.

The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.

status: Unknown status

time_perspective: Prospective

lead_sponsor: Bicetre Hospital

location_country: Germany France Israel Spain

location_facility: Department of Anesthesiology and Intensive Care Sheba Medical Centre

location_facility: Unidad de cuidados intensivos, Fundacion Jimenez Diaz


title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

summary: The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

lead_sponsor: Photocure

location_country: Norway Germany France

location_facility: Department of Obstetrics and Gynaecology, Ullevål University Hospital

location_facility: Department of Obstetrics and Gyneacology, Lille University Hospital


title: Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer

summary:
RATIONALE: Collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying the European Organization of Research for the Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.

ReferenceType: result

ReferenceCitation: Arraras JI, Suárez J, Arias de la Vega F, Vera R, Asín G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.

ReferenceCitation: Nowak W, Tobiasz-Adamczyk B, Brzyski P, Sałówka J, Kuliś D, Richter P. Adaptation of quality of life module EORTC QLQ-CR29 for Polish patients with rectal cancer: initial assessment of validity and reliability. Pol Przegl Chir. 2011 Sep;83(9):502-10. doi: 10.2478/v10035-011-0078-5.

ReferenceCitation: Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Germany
France
United Kingdom

location_facility: Basingstoke and North Hampshire NHS Foundation Trust

location_facility: Charite University Medical Center of Berlin

intervention_type: Procedure


title: Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

summary: To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.

lead_sponsor: Zeneus Pharma

location_country:
United Kingdom
Spain
Italy
France
Germany

location_facility: Universita Degli Studi Di Modena AZ Ospedaliere Policlinico


title: Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

acronym: COATING

summary: To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspötter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2022 May 24. pii: neurintsurg-2022-018969. doi: 10.1136/neurintsurg-2022-018969. [Epub ahead of print]

lead_sponsor: Phenox GmbH

location_country:
Germany
France
Switzerland
United Kingdom

location_facility:
CHU Reims - Hôpital Maison Blanche
Hôpital Bicêtre
CHU de Lyon
Western General Hospital
Universitätsklinikum Augsburg
CHU Bordeaux
Queen Elisabeth Hospital Birmingham
CHU Toulouse
Klinikum Nürnberg Süd
Universitätsspital Basel
Helios Klinikum Erfurt
CHU de Montpellier
Klinikum Stuttgart

status_simplified: Ongoing


title: Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease

acronym: META-DEM

summary: This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility:
CHU Vaudois
Hôpital Neurologique de Lyon
CHU Angers
CHU Bordeaux
Chu Grenoble Alpes
CHU Rennes
Hôpitaux Civils Colmar

intervention_type: Other


title: A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer

summary:
-Interventional trials aim at preventing severe RIF occurrence in BC patients selected by individual radiosensitivity:

PRAVAPREV-01 will be the first interventional double blind trial that will offer a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery:

By assessing individual risk of severe RIF development
By offering a statin targeted therapy to the high-risk patients identified.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_country: France Monaco

location_facility: Centre Hospitalier Universitaire Lyon Sud

intervention_type: Radiation


title: ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes

acronym: ADAPT

summary: The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.

status: Active, not recruiting

ReferenceCitation: Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Ré R, de Portu S, Vorrink L, Shin J, Habteab A, Castañeda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1.

ReferenceCitation: de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.

ipd_sharing: No

lead_sponsor: Medtronic Diabetes

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

location_facility: Medical Center am Clemenshospital Dr. Winfried Keuthage

location_facility: Harrogate and District Hospital - NHS Foundation Trust

location_facility: University Hospitals of Leicester NHS Trust Leicester General Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis

location_facility: Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa


title: Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

acronym: PROTECT

summary: This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated >6 months therapy with NCG are collected at baseline, 12 months, and 18 months. Qualitative interviews with adult patients and caregivers are conducted >6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.

lead_sponsor: Recordati Rare Diseases

location_country:
United Kingdom
Spain
Italy
France
Norway

location_facility: San Paola Hospital, ASST Santi Paolo e Carlo

location_facility: Hopital Des Enfants, CHU de Bordeaux-GH Pellegrin

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Sheffield Children's Hospital NHS Foundation Trust

location_facility: Hospital Universitario Virgen de la Arrixaca

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

location_facility: Hospital Infantil Universitario Nino Jesus


title: SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

summary: This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

ReferenceCitation: Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704. Review.

ipd_sharing: Undecided

lead_sponsor: AstraZeneca

location_country:
Germany
France
United Kingdom
Italy


title: Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease

summary: This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

lead_sponsor: Sahajanand Medical Technologies Pvt. Ltd.

location_country: Germany France Switzerland

location_facility: Heart and Diabetes Center Nordrhine Westfalia

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus

location_facility: Herzzentrum Dresden - Universitätklinikum an der TU Dresden


title: An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients

summary:
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7.

The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.

lead_sponsor: Hansa Biopharma AB

location_country:
Netherlands
France
United Kingdom

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: CHU Le Kremlin-Bicêtre. Service Neurologie

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: CHU Bordeaux - Hôpital Pellegrin Tripode

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

location_facility: Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA


title: A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta

lead_sponsor: Gilead Sciences

location_country:
Russian Federation
France
Moldova, Republic of
Romania

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 4 / Medical University Department of Infectious Diseases

location_facility: "Matei Bals" National Institute of Infectious Diseases, Hospital department

location_facility: CH Pitié-Salpétrière - Hépato-Gastroentérologie

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Hôpital Saint Joseph Hépato-Gastroentérologie

location_facility: "Victor Babes" Centre of Diagnostic and Treatment

location_facility: Specialized clinical Infectious diseases Hospital

location_facility: Hôpital Beaujon-Pavillon Abrami -Sce Hépatologie

location_facility: Hôpital Cochin - Unité d'Hépatologie Pavillon Achard

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 5 / Medical University Department of Infectious Diseases

location_facility: State Budgetary Educational Institution of Higher Professional Education "South Ural State Medical University" of the Ministry of Healthcare of the Russian Federation

location_facility: Dr. V. Babes Clinical Hospital of Infectious and Tropical Diseases

location_facility: Federal State Budgetary Institution National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation

location_facility: Federal Budget Institute of Science "Central Research Institute for Epidemiology" of Federal Service on Consumers Rights Protection and Human Well-Being Surveillance

location_facility: N.V.Sklifosovsky Scientific Research Institute of Emergency care of the Moscow Healthcare Department

location_facility: Moscow Regional Scientific and Research Clinical Institute

location_facility: "Matei Bals" National Institute of Infectious Diseases,Clinical Trials department

summary: The primary objective of this study is to evaluate the efficacy of bulevirtide combination with pegylated interferon in participants with chronic hepatitis delta (CHD).


type: Registry Identifier

title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First Line, Extensive Stage Subjects With Small Cell Lung Cancer

summary:
CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

ReferenceCitation: Kanouni T, Severin C, Cho RW, Yuen NY, Xu J, Shi L, Lai C, Del Rosario JR, Stansfield RK, Lawton LN, Hosfield D, O'Connell S, Kreilein MM, Tavares-Greco P, Nie Z, Kaldor SW, Veal JM, Stafford JA, Chen YK. Discovery of CC-90011: A Potent and Selective Reversible Inhibitor of Lysine Specific Demethylase 1 (LSD1). J Med Chem. 2020 Dec 10;63(23):14522-14529. doi: 10.1021/acs.jmedchem.0c00978. Epub 2020 Oct 9.

ipd_sharing: Yes

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country: France Spain Italy

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Hospital Universitario Virgen de la Victoria


title: HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

summary: Multicenter feasibility study of the HighLife™ TMVR system.

ReferenceCitation: Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. Review.

ReferenceCitation: Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.

ReferenceCitation: Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.

lead_sponsor: HighLife SAS

location_country: Germany France

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)

location_facility: Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie


title: Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.

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

ipd_sharing_description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

location_country:
Poland
Spain
United Kingdom
Netherlands
France
Germany

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

summary:
Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma.

This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke

summary: This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.

lead_sponsor: Hoffmann-La Roche

location_country: France Spain

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Hospital Clnico Universitario de Zaragoza

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Hôpital Pellegrin Tripode - CHU de Bordeaux

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie


title: A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

summary: Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

ReferenceCitation: Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sánchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Phase I Study of Lysine-Specific Demethylase 1 Inhibitor, CC-90011, in Patients with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jan 15;27(2):438-446. doi: 10.1158/1078-0432.CCR-20-2380. Epub 2020 Oct 12.

ReferenceCitation: Hollebecque A, Salvagni S, Plummer R, Niccoli P, Capdevila J, Curigliano G, Moreno V, de Braud F, de Villambrosia SG, Martin-Romano P, Baudin E, Arias M, de Alvaro J, Parra-Palau JL, Sánchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Clinical activity of CC-90011, an oral, potent, and reversible LSD1 inhibitor, in advanced malignancies. Cancer. 2022 Sep 1;128(17):3185-3195. doi: 10.1002/cncr.34366. Epub 2022 Jun 23.

location_country:
United Kingdom
Spain
Italy
France
Japan

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

location_facility: Hospital Universitario Vall D hebron - PPDS

location_facility: Hospital Universitario Marques de Valdecilla


title: Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

acronym: ATLAS EU PMCF

summary: The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

ReferenceCitation: Lefevre PH, Schramm P, Kemmling A, Barreau X, Marnat G, Piotin M, Berlis A, Wanke I, Bonafe A, Houdart E; ATLAS EU PMCF Investigators. Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results. J Neurointerv Surg. 2022 Jul;14(7):694-698. doi: 10.1136/neurintsurg-2021-017849. Epub 2021 Sep 2.

lead_sponsor: Stryker Neurovascular

location_country: Germany France Slovakia


title: Phase III, Randomised, Double Blind, Placebo Controlled and Open Label Phase Multicentre Study to Investigate the Efficacy and Safety of BTX-A-HAC NG in the Treatment of Moderate to Severe Glabellar Lines, and Assess the Long Term Efficacy and Safety of BTX-A-HAC NG Following Repeated Treatments in This Indication

summary: The purpose of the protocol is to demonstrate the safety and the efficacy of a single injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after repeated injections.

ReferenceCitation: Hilton S, Kestemont P, Sattler G, Volteau M, Thompson C, Andriopoulos B, Prygova I, Berg AK, Ascher B. Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. Dermatol Surg. 2022 Sep 29. doi: 10.1097/DSS.0000000000003594. [Epub ahead of print]

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

.

lead_sponsor: Ipsen

location_facility: Privatpraxis für Dermatologie und Ästhetik

location_facility: Universitäts-Hautklinik der Gutenberg Universität Mainz

location_facility: Privatpraxis für Dermatologie und ästhetische Medizin

location_facility: Abteilung Biochemie und Molekularbiologie Fachrichtung Kosmetikwissenschaft

location_facility: MEDITI/ Clinique Science et Beauté, Villa Sylvana


title: A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma

summary: CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.

ReferenceCitation: Michot JM, Bouabdallah R, Vitolo U, Doorduijn JK, Salles G, Chiappella A, Zinzani PL, Bijou F, Kersten MJ, Sarmiento R, Mosulen S, Mendez C, Uttamsingh S, Pourdehnad M, Hege K, Chen T, Klein C, Hagner PR, Nikolova Z, Ribrag V. Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study. Lancet Haematol. 2020 Sep;7(9):e649-e659. doi: 10.1016/S2352-3026(20)30208-8. Epub 2020 Aug 3.

location_country: Netherlands France Italy

location_facility: Institute of Hematology and Medical Oncology L. and A. Seragnoli

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino


title: International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"

summary:
Primary objective:

To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302).

Secondary objective:

To assess the safety of I10E in this patient population.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Spain
Italy
United Kingdom
Tunisia
Turkey
France

location_facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi

location_facility: Hacettepe University medical School Neurology

location_facility: Ankara university medical school Neurology

location_facility: Azienda Ospedaliera Universitaria san Giovanni

location_facility: istanbul University Cerrahpasa Medical School Neurology

location_facility: IRRCS Istutito Nazionale Neurologico Besta

location_facility: Uludag University Medical School Neurology

location_facility: University Hospital of North Straffordshire

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Hospital Universitario i Politècnico La Fe

location_facility: Hospital Clinico Universitario de Santiago


title: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

acronym: EASY

summary: This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

lead_sponsor: Coloplast A/S

location_country: Spain Italy Netherlands France Germany

location_facility: Chirurgische Klinik München - Bogenhausen GmbH

location_facility: Centre Hospitalier Universitaire Carémeau - Gyneacology

location_facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle


title: An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years

summary:
Primary objective:

To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
To describe the immune responses to REPEVAX in these subjects
To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

lead_sponsor: Sanofi Pasteur, a Sanofi Company


acronym: SOLTI NEOPARP

title: Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)

lead_sponsor: Sanofi

ReferenceCitation: Llombart-Cussac A, Bermejo B, Villanueva C, Delaloge S, Morales S, Balmaña J, Amillano K, Bonnefoi H, Casas A, Manso L, Roché H, Gonzalez-Santiago S, Gavilá J, Sánchez-Rovira P, Di Cosimo S, Harbeck N, Charpentier E, Garcia-Ribas I, Radosevic-Robin N, Aura C, Baselga J. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):351-7. doi: 10.1007/s10549-015-3616-8. Epub 2015 Nov 4.

location_country: Germany France Spain

location_facility:
Investigational Site Number 250003
Investigational Site Number 724013
Investigational Site Number 724015
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Investigational Site Number 724018
Investigational Site Number 276003
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Investigational Site Number 724017

summary:
Primary Objective:

- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.

Secondary objectives are:

pCR rate in the breast and axilla,
Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
Safety profiles of study combinations and of the single agent reference treatment,
Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

summary: Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.

lead_sponsor: Eli Lilly and Company

location_country: Hungary Germany 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: Plerixafor and G-CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) - Safety Study in a General Autologous Transplant Population

acronym: PREDICT

summary: This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Germany

location_facility: L. & A. Seragnoli, University of Bologna


acronym: BVT. BSSL - 021

title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

lead_sponsor: Swedish Orphan Biovitrum

ReferenceCitation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vågerö M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.

location_country: France Italy

location_facility: Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria

location_facility: Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"

location_facility: CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville

summary: The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.


title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility: University Hospital, Department of Surgery

location_facility: University Hospital, Department of Endocrinology


title: A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

lead_sponsor: Bayer

location_country:
Poland
United Kingdom
Italy
France
Germany

summary:
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.


title: A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.

ReferenceCitation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4. Review.

ReferenceCitation: Liebl A, Davidson J, Mersebach H, Dykiel P, Tack CJ, Heise T. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1328-36.

location_country: Spain France Romania Norway Germany

summary: This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years

lead_sponsor: GlaxoSmithKline

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

summary: In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.


title: Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.

summary: Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

ReferenceCitation: GEMZELL CA, DICZFALUSY E, TILLINGER G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958 Dec;18(12):1333-48.

ReferenceCitation: Thompson CR, Hansen LM. Pergonal (menotropins): a summary of clinical experience in the induction of ovulation and pregnancy. Fertil Steril. 1970 Dec;21(12):844-53.

ReferenceCitation: Oelsner G, Serr DM, Mashiach S, Blankstein J, Snyder M, Lunenfeld B. The study of induction of ovulation with menotropins: analysis of results of 1897 treatment cycles. Fertil Steril. 1978 Nov;30(5):538-44.

ReferenceCitation: Schwartz M, Jewelewicz R, Dyrenfurth I, Tropper P, Vande Wiele RL. The use of human menopausal and chorionic gonadotropins for induction of ovulation. Sixteen years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol. 1980 Dec 1;138(7 Pt 1):801-7.

ReferenceCitation: Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.

ReferenceCitation: Doré PC, Rice C, Killick S. Human gonadotrophin preparations. May cause allergic reaction. BMJ. 1994 Jun 4;308(6942):1509.

ReferenceCitation: Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod. 1994 Mar;9(3):424-30.

ReferenceCitation: Wikland M, Borg J, Hamberger L, Svalander P. Simplification of IVF: minimal monitoring and the use of subcutaneous highly purified FSH administration for ovulation induction. Hum Reprod. 1994 Aug;9(8):1430-6.

ReferenceCitation: Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod. 1999 Sep;14(9):2207-15.

ReferenceCitation: Remorgida V, Venturini PL, Anserini P, Lanera P, De Cecco L. Administration of pure follicle-stimulating hormone during gonadotropin-releasing hormone agonist therapy in patients with clomiphene-resistant polycystic ovarian disease: hormonal evaluations and clinical perspectives. Am J Obstet Gynecol. 1989 Jan;160(1):108-13.

ReferenceCitation: Hackelöer BJ, Fleming R, Robinson HP, Adam AH, Coutts JR. Correlation of ultrasonic and endocrinologic assessment of human follicular development. Am J Obstet Gynecol. 1979 Sep 1;135(1):122-8.

ReferenceCitation: Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11.

ReferenceCitation: Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4.

ReferenceCitation: Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review.

ReferenceCitation: Wang CF, Gemzell C. The use of human gonadotropins for the induction of ovulation in women with polycystic ovarian disease. Fertil Steril. 1980 May;33(5):479-86.

lead_sponsor: IBSA Institut Biochimique SA

location_country: Hungary France

location_facility:
Semmelweis Medical School
Hôpital Jeanne de Flandre
Private Consulting
Hôpital Edouard Herriot
Hôpital Tenon
Institut de Médecine de la Reproduction
Hôpital Américain


title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

summary: A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

ReferenceCitation: Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

ReferenceCitation: Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.

ReferenceCitation: Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

lead_sponsor: UCB Pharma


title: A Confirmatory, Multi-centre, Randomised, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.

summary: A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject will be approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, catheterisations will be performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

primary_purpose: Other

location_country:
Denmark
France
Germany
United Kingdom

location_facility:
Hopital Claude Huriez
Rigshospitalet
Artimed
Illingworth Research Group
Hôpital Tenon
Sanos Clinic


title: A Randomized, Open Label, Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFG316 in Patients With Transplant Associated Microangiopathy After Hematopoietic Precursor Cell Transplantation

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Germany
United States
France

summary:
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) .

Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed


title: Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

summary: This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country:
Netherlands
United States
France


title: EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea

summary: This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.

location_country:
United Kingdom
France
Spain
Czechia


title: Phase IIb, Randomized, Double-blind, Placebo-controlled Study in Parallel Groups Assessing the Efficacy and Safety of Two Doses of SOM3355 in Patients Suffering From Huntington's Disease With Choreic Movements

summary: Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.

lead_sponsor: SOM Innovation Biotech SA

location_country:
Poland
Spain
Italy
United Kingdom
Switzerland
France
Germany

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Indywidualna Praktyka Lekarska Daniel Zielonka

location_facility: NIHR Wellcome Trust Manchester Clinical Research Facility

location_facility: Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna


title: A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

summary: The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.

lead_sponsor: Almirall, S.A.

location_country:
Poland
Spain
Italy
United Kingdom
France
Germany

location_facility:
Almirall Investigational Site 106
Almirall Investigational Site 26
Almirall Investigational Site 402
Almirall Investigational Site 704
Almirall Investigational Site 706
Almirall Investigational Site 309
Almirall Investigational Site 205
Almirall Investigational Site 305
Almirall Investigational Site 307
Almirall Investigational Site 306
Almirall Investigation Site 102
Almirall Investigational Site 503
Almirall Investigational Site 408
Almirall Investigational Site 501
Almirall Investigational Site 506
Almirall Investigational Site 709
Almirall Investigation Site 104
Almirall Investigational Site 708
Almirall Investigational Site 505
Almirall Investigational Site 509
Almirall Investigational Site 206
Almirall Investigational Site 302
Almirall Investigation Site 202
Almirall Investigation Site 201
Almirall Investigational Site 508
Almirall Investigational Site 208
Almirall Investigational Site 502
Almirall Investigational Site 407
Almirall Investigational Site 204
Almirall Investigational Site 210
Almirall Investigational Site 101
Almirall Investigational Site 310
Almirall Investigation Site 103
Almirall Investigational Site 303
Almirall Investigational Site 401
Almirall Investigational Site 701
Almirall Investigational Site 209
Almirall Investigational Site 27
Almirall Investigational Site 301
Almirall Investigational Site 507
Almirall Investigational Site 304
Almirall Investigational Site 308
Almirall Investigational Site 403
Almirall Investigational Site 703
Almirall Investigational Site 207
Almirall Investigational Site 504


title: A Randomised, Placebo-controlled, Multicentre Phase IIb Study Evaluating the Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease

summary: This is a Phase 2b study investigating the efficacy and safety of pirepemat as adjunct therapy on falls frequency in patients with Parkinson disease. Pirepemat is taken for 84 days.

lead_sponsor: Integrative Research Laboratories AB

location_country: Poland Spain Sweden France Germany

location_facility: Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Neurologie

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm Klinik für Neurologie

location_facility: Karolinska Universitetssjukhuset - Neurologiska kliniken

location_facility: Charite Universitatsmedizin Berlin - Klinik fuer neurologie mit experimenteller neurologie

location_facility: Skane University Hospital - Division of Neurology

location_facility: Institute of Neuroscience and Physiology

location_facility: Hôpital Laennec - Centre d'investigation clinique de Neurologie

location_facility: Praxis Dr.med. Christian Oehlwein Facharzt für Neurologie und Psychiatrie


title: How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA

acronym: ASSIST

summary:
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.

This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.

This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

time_perspective: Cross-Sectional

ipd_sharing_description: Available on reasonable request

lead_sponsor: University of Oxford

location_country:
United Kingdom
Spain
Italy
France
Germany

location_facility: Manchester University NHS Foundation Trust

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: MVZ für Rheumatologie Dr. Martin Welcker GmbH

location_facility: Midlands Partnership NHS Foundation Trust

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Oxford University Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse


primary_purpose: Supportive Care

acronym: TOLAK

title: Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

lead_sponsor: Pierre Fabre Medicament

location_country: Germany France Spain Italy

location_facility: Catholic University Fondazione Policlinico Universitario A. Gemelli

location_facility: Sapienza University of Rome - Polo Pontino

location_facility: NAPLES VANVITELLI UNIVERSITI (Federico II Hospital)

location_facility: Kath. Klinikum Bochum St. Josef-Hospital

summary:
Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.

The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.


title: Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

acronym: IVUS-CHIP

summary:
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI .

The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI.

The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.

primary_purpose: Diagnostic

lead_sponsor: ECRI bv

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility: Centre Cardiologique du Nord Saint-Denis

location_facility: Marques de Valdecilla University Hospital

location_facility: University Clinical Hospital of Valladolid

location_facility: Cardiovascular Institute of Grenoble, GHM


title: Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

acronym: GuideView

summary:
The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.

Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.

location_country: France Switzerland Spain Italy


acronym: GuidePath

title: Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

location_country: France Switzerland Spain

summary:
The current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.

Approximately 190 participants will be enrolled to ensure at least 152 participants are evaluable (i.e. have both an evaluable [18F]CTT1057 PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures), which will be required for the calculation of the co-primary endpoints.


title: TEMOkids Study: A Population Pharmacokinetic, Acceptability and Safety Study for KIMOZO, a Paediatric Oral Suspension of Temozolomide

summary: Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

lead_sponsor: Orphelia Pharma

location_country:
Spain
United Kingdom
Netherlands
France
Germany

location_facility: Great Ormond Street Hospital for Children

location_facility: Hopp Children's Cancer Center Heidelberg

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Princess Maxima Center for Pediatric Oncology


title: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

lead_sponsor: University Hospital, Rouen

location_country: France Spain

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Universitari Germans Trias i Pujol


acronym: JUVE-BRIGHT

title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5.

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_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Hamburger Zentrum für Kinder und Jugendrheumatologie

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.


title: Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

acronym: DREPSUFINDOL

summary: The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).

lead_sponsor: University Hospital, Bordeaux

location_country:
French Guiana
France
Guadeloupe

location_facility:
CH de Cayenne
Hôpital Edouard Herriot
Hôpital Charles Nicolle
Hopital Pellegrin
CHU Pointe à Pitre
Hôpital Louis Mourier
Hôpital Rangueil


title: European HIV&STI Prevention Network Study

summary:
The University Hospital Essen is sponsoring the Multicenter human immunodeficiency virus (HIV) and sexually transmitted infections Prevention Network Study (STIPnet) which is funded by Janssen, Pharmaceutical Companies of Johnson & Johnson.

STIPnet study is a prospective observational cohort study aiming to determine the incidence and point prevalence of HIV infection and the most common sexually transmitted infections (STIs) in individuals with sexual risk behavior. In addition, the University Hospital Essen will examine whether individuals at risk for HIV and STI infections would retain in such a study (retention rate) and would be willing to participate in potential HIV and STI prevention trials (willingness to participate).

ipd_sharing_description: The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analysed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study.Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.

lead_sponsor: Hendrik Streeck

location_country: Poland Spain Italy Hungary France

location_facility: Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: National Institute for Infectious Diseases L. Spallanzani

intervention_type: Behavioral