title: PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation

summary: PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.

ReferenceCitation: Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

family: Reddy

full_name: Vivek Y. Reddy

given: Vivek Y.

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Koruth

full_name: Jacob S. Koruth

given: Jacob S.

family: Petru

full_name: Jan Petru

given: Jan

family: Funosako

full_name: Moritoshi Funosako

given: Moritoshi

family: Cochet

full_name: Hubert Cochet

given: Hubert

family: Sediva

full_name: Lucie Sediva

given: Lucie

family: Chovanec

full_name: Milan Chovanec

given: Milan

family: Dukkipati

full_name: Srinivas R. Dukkipati

given: Srinivas R.

family: Jais

full_name: Pierre Jais

given: Pierre

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Farapulse, Inc.

location_country: France Czechia

location_facility:
CHU Bordeaux
Nemocnice Na Homolce


title: The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation

summary: IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

sequence: first

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

host_type: publisher

version: publishedVersion

title: Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation

ipd_sharing: No

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: Crohn's Disease Endoscopic REmission Definition in an Objective Way

summary:
The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is thought to be predictive of a favourable evolution of the disease. However, up to now there is no measure of endoscopic remission, objectively constructed and validated, not even a consensus for its definition. An objective measure of endoscopic remission is necessary, notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and EMA), but also in clinical practice if one wishes to adapt the treatment of patient according to the level of endoscopic remission.

The aim of the study is to construct a measure of endoscopic remission based on an objective assessment (depth or grade) of remission, that must be reproducible, little or not dependent on the reader interpreting the endoscopy.

The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of the endoscopic remission of CD through an index measuring its depth or a score measuring its grade and to evaluate its reproducibility.

This study is composed of four main parts:

Training and selection of readers:

Selection and definition of all lesions to be studied at consensus meetings, first between the central readers, then with the participation of local investigators.
Specific training of local investigators in the recognition of endoscopic lesions
Checking the performance of the central readers

Recruitment of patients by investigators - local readers:

Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for at least 3 months, with a Crohn's disease activity index < 150 at the time of endoscopy.
Each local investigator will have to record 15 videos divided according to his/her overall judgment into 3 status of remission: Complete Remission; Remission almost complete; Remission neither complete nor nearly complete.
The colon will be divided into 7 segments: ileum, ileocecal valve, right colon, transverse colon, descending colon, sigmoid colon and rectum. Each segment will be identified by landmarks.
Videos will be anonymized and then centralized at a healthcare provider (OVH - SAS).
16 French and Belgian centers will participate in the study leading to a total of 240 films.

Analysis of videos by central readers:

12 central readers will independently read 80 out of the 240 videos
Videos allocation to central readers will be performed through balanced incomplete block method to ensure that each central reader, as well as each central reader pair, has the same weight in achieving the results.
A quantitative evaluation of the depth of endoscopic remission on a visual analogue scale and a qualitative evaluation of the grade of remission on a 5-level ordinal scale will be provided by each central reader, segment by segment and globally, in addition to the description of all lesions identified by segment.

Analysis of the data recorded by the central readers:

An index (depth of remission) or score (grade of remission) will be constructed from linear or multiple logistic regression models, considering the reader and endoscopy as random factors, to take into account the dependence between the readings performed on different endoscopies by the same central reader or on the same endoscopy by different readers.
Variations in readings between central readers will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.

In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested whether the index or score thus constructed is able to predict prolonged clinical remission for 2 years in patients in clinical remission at baseline. If this test is successful, we will have a primary objective and reproducible criterion for evaluating treatments in CD and a useful tool for the management of these patients in clinical practice.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

ipd_sharing_description: ND

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Belgium France

location_facility:
Leuven University Hospital
APHP- Hopital BEAUJON

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System

summary: This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.

study_type: Observational

time_perspective: Other

lead_sponsor: Zimmer Biomet

location_facility:
Orthokliniek Waasland
Institut Calot


title: Characteristics and Care of Solid Tumor Patients Treated With Immunotherapy Admitted in Intensive Care Unit.

acronym: IMMUNO-REA

summary: This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

time_perspective: Prospective

lead_sponsor: University Hospital, Grenoble

location_facility:
Institut Jules Bordet
UniversityHospitalGrenoble

lead_sponsor_type: academique


title: A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction

summary: The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee, Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29. Review.

family: Abu Dayyeh

full_name: Barham K. Abu Dayyeh

given: Barham K.

family: Kumar

full_name: Nitin Kumar

given: Nitin

family: Edmundowicz

full_name: Steven A. Edmundowicz

given: Steven A.

family: Jonnalagadda

full_name: Sreenivasa Jonnalagadda

given: Sreenivasa

family: Larsen

full_name: Michael Larsen

given: Michael

family: Sullivan

full_name: Shelby Sullivan

given: Shelby

family: Thompson

full_name: Christopher C. Thompson

given: Christopher C.

family: Banerjee

full_name: Subhas Banerjee

given: Subhas

journal_name: Gastrointestinal Endoscopy

ReferenceCitation: Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.

family: Magro

full_name: Daniéla Oliveira Magro

given: Daniéla Oliveira

family: Geloneze

full_name: Bruno Geloneze

given: Bruno

family: Delfini

full_name: Regis Delfini

given: Regis

family: Pareja

full_name: Bruna Contini Pareja

given: Bruna Contini

family: Callejas

full_name: Francisco Callejas

given: Francisco

full_name: José Carlos Pareja

given: José Carlos

journal_name: Obesity Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Long-term Weight Regain after Gastric Bypass: A 5-year Prospective Study

ReferenceCitation: Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.

family: Menchaca

full_name: Hector J. Menchaca

given: Hector J.

family: Harris

full_name: Jason L. Harris

given: Jason L.

full_name: Suzanne E. Thompson

given: Suzanne E.

family: Mootoo

full_name: Mary Mootoo

given: Mary

journal_name: Surgery for Obesity and Related Diseases

ReferenceCitation: Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.

ReferenceCitation: Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. Review.

ReferenceCitation: Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Devière J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.

ReferenceCitation: ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee, Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. Review.

title: Endoscopic bariatric therapies

ReferenceCitation: ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy, Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053.

ReferenceCitation: Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728.

ReferenceCitation: Huberty V, Boskoski I, Bove V, Van Ouytsel P, Costamagna G, Barthet MA, Devière J. Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial. Gut. 2020 Oct 28. pii: gutjnl-2020-322026. doi: 10.1136/gutjnl-2020-322026. [Epub ahead of print]

location_facility: Gastroenterology Department Erasme Hospital

location_facility: APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive


type: Other Identifier

title: Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.

summary:
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the adult population. This prevalence is expected to increase over the coming decades due to the aging of the population and the continued exposure to risk factors for the disease. The evolution of COPD is marked by the occurrence of exacerbations of varying severity and patients are frequently admitted to the emergency department for evaluation, treatment and / or hospitalization. Admission in emergency department for COPD exacerbation represents approximately 1% of emergency admission.

Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbations. This study is aimed to compare pain intensity during exacerbation and stable phase of patients with chronic obstructive pulmonary disease (COPD).

location_country: Canada France

location_facility: Emergency department of Hôpital du Sacré Coeur de Montréal

location_facility: Emergency Department of university hospital


title: Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis

summary: The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.

ReferenceType: background

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

name: Bloomsbury Institute of Intensive Care Medicine, University College London, London, United Kingdom

family: Singer

full_name: Mervyn Singer

given: Mervyn

name: Hofstra–Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York

family: Deutschman

full_name: Clifford S. Deutschman

given: Clifford S.

name: Department of Critical Care and Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

family: Seymour

full_name: Christopher Warren Seymour

given: Christopher Warren

name: Department of Critical Care Medicine, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom

family: Shankar-Hari

full_name: Manu Shankar-Hari

given: Manu

name: Department of Critical Care Medicine, University of Versailles, France

family: Annane

full_name: Djillali Annane

given: Djillali

name: Center for Sepsis Control and Care, University Hospital, Jena, Germany

family: Bauer

full_name: Michael Bauer

name: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Austin Hospital, Melbourne, Victoria, Australia

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

name: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, Tennessee

family: Bernard

full_name: Gordon R. Bernard

given: Gordon R.

name: Réanimation Médicale-Hôpital Cochin, Descartes University, Cochin Institute, Paris, France

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

name: Critical Care Center, Emory University School of Medicine, Atlanta, Georgia

family: Coopersmith

full_name: Craig M. Coopersmith

given: Craig M.

name: Washington University School of Medicine, St Louis, Missouri

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

name: Infectious Disease Section, Division of Pulmonary and Critical Care Medicine, Brown University School of Medicine, Providence, Rhode Island

family: Levy

full_name: Mitchell M. Levy

given: Mitchell M.

name: Department of Surgery, University of Toronto, Toronto, Ontario, Canada

family: Marshall

full_name: John C. Marshall

given: John C.

name: Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia

family: Martin

full_name: Greg S. Martin

given: Greg S.

family: Opal

full_name: Steven M. Opal

given: Steven M.

name: Trauma, Emergency & Critical Care Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada16Interdepartmental Division of Critical Care, University of Toronto

family: Rubenfeld

full_name: Gordon D. Rubenfeld

given: Gordon D.

name: Department of Infectious Diseases, Academisch Medisch Centrum, Amsterdam, the Netherlands

family: van der Poll

full_name: Tom van der Poll

given: Tom

name: Department of Intensive Care, Erasme University Hospital, Brussels, Belgium

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

name: Department of Critical Care Medicine, University of Pittsburgh and UPMC Health System, Pittsburgh, Pennsylvania20Associate Editor, JAMA

family: Angus

full_name: Derek C. Angus

given: Derek C.

journal_name: JAMA

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

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

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Randomized Double Blind Clinical Trial on the Effect of Levobupivacaine Infiltration Versus Placebo on the Post Partum Perineal Pain in Episiotomy in Primiparous Women After Instrumental Delivery

summary:
An episiotomy is an incision of the perineum to facilitate childbirth by natural means. Perineal pain are more frequent and intense if the incision of the perineum is important. In particular, simple vaginal or perineal tears are less painful than episiotomies in the first seven days postpartum, whereas at six weeks postpartum, there is no significant difference anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often undervalued and may interfere with the mother-child bond in the absence of an effective treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal anti-inflammatory drugs given orally or rectally and paracetamol.

The scar infiltration is one of the components of a multimodal postoperative analgesia strategy. It consists in the simultaneous use of several drugs or analgesic techniques, acting on different pain components in order to improve the overall efficiency.The most used local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the injection point and a blood resorption that is more spread. The systemic toxicity threshold is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects, and an intermediate systemic toxicity threshold intermediate between bupivacaine and ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement infiltrations when a rapid onset of action is desired.

So far, there is no data in the literature regarding the effect of levobupivacaine in episiotomies associated pain. The objective of this study is to evaluate the effect of local injections of levobupivacaine on episiotomies associated pain.

status: Withdrawn

ReferenceCitation: Vendittelli F, Gallot D. [What are the epidemiologic data in regard to episiotomy?]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S12-1S23. Review. French.

ReferenceCitation: de Tayrac R, Panel L, Masson G, Mares P. [Episiotomy and prevention of perineal and pelvic floor injuries]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S24-1S31. Review. French.

ReferenceCitation: College National de Gynecolegues et Obstetriciens Francais. [Text of the guideline for episiotomy]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S77-1S80. French.

ReferenceCitation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204.

ReferenceCitation: Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999 Mar;26(1):11-7.

ReferenceCitation: Peter EA, Janssen PA, Grange CS, Douglas MJ. Ibuprofen versus acetaminophen with codeine for the relief of perineal pain after childbirth: a randomized controlled trial. CMAJ. 2001 Oct 30;165(9):1203-9.

ReferenceCitation: Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. Review.

ReferenceCitation: White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7. Review.

ReferenceCitation: Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60.

ReferenceCitation: Brennan TJ, Zahn PK, Pogatzki-Zahn EM. Mechanisms of incisional pain. Anesthesiol Clin North Am. 2005 Mar;23(1):1-20. Review.

ReferenceCitation: Kawamata M, Watanabe H, Nishikawa K, Takahashi T, Kozuka Y, Kawamata T, Omote K, Namiki A. Different mechanisms of development and maintenance of experimental incision-induced hyperalgesia in human skin. Anesthesiology. 2002 Sep;97(3):550-9.

ReferenceCitation: Sanford M, Keating GM. Levobupivacaine: a review of its use in regional anaesthesia and pain management. Drugs. 2010 Apr 16;70(6):761-91. doi: 10.2165/11203250-000000000-00000. Review.

ReferenceCitation: Ausems ME, Hulsewé KW, Hooymans PM, Hoofwijk AG. Postoperative analgesia requirements at home after inguinal hernia repair: effects of wound infiltration on postoperative pain. Anaesthesia. 2007 Apr;62(4):325-31.

ReferenceCitation: Franchi M, Cromi A, Scarperi S, Gaudino F, Siesto G, Ghezzi F. Comparison between lidocaine-prilocaine cream (EMLA) and mepivacaine infiltration for pain relief during perineal repair after childbirth: a randomized trial. Am J Obstet Gynecol. 2009 Aug;201(2):186.e1-5. doi: 10.1016/j.ajog.2009.04.023. Epub 2009 Jun 26.

ReferenceCitation: Minassian VA, Jazayeri A, Prien SD, Timmons RL, Stumbo K. Randomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain. Obstet Gynecol. 2002 Dec;100(6):1239-43.

ReferenceCitation: Kafali H, Iltemur Duvan C, Gözdemir E, Simavli S, Oztürk Turhan N. Placement of bupivacaine-soaked Spongostan in episiotomy bed is effective treatment modality for episiotomy-associated pain. J Minim Invasive Gynecol. 2008 Nov-Dec;15(6):719-22. doi: 10.1016/j.jmig.2008.08.006.

ReferenceCitation: Sillou S, Carbonnel M, N'Doko S, Dhonneur G, Uzan M, Poncelet C. [Postpartum perineal pain: effectiveness of local ropivacaine infiltration]. J Gynecol Obstet Biol Reprod (Paris). 2009 Oct;38(6):510-5. doi: 10.1016/j.jgyn.2009.03.008. Epub 2009 Jun 2. French.

lead_sponsor: Brugmann University Hospital

location_facility:
CHU Montpellier
CHU Brugmann

intervention_type: Other

status_simplified: Unknown


title: Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study

summary: This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].

status: Active, not recruiting

lead_sponsor: Mardil Medical

location_facility:
Na Homolce Hospital
Bordeaux Heart University Hospital


title: MONOBISY: Randomized Controlled Trial Comparing Intra Uterine Synechiae Occurence Using Bipolar Energy Compared With Monopolar Energy in Myoma Resection on Women Having Menorraghia and/or Infertility

summary:
Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current.

It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

ReferenceCitation: Neuwirth RS, Amin HK. Excision of submucus fibroids with hysteroscopic control. Am J Obstet Gynecol. 1976 Sep 1;126(1):95-9.

ReferenceCitation: Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70.

ReferenceCitation: Jewelewicz R, Khalaf S, Neuwirth RS, Vande Wiele RL. Obstetric complications after treatment of intrauterine synechiae (Asherman's syndrome). Obstet Gynecol. 1976 Jun;47(6):701-5.

ReferenceCitation: Taskin O, Sadik S, Onoglu A, Gokdeniz R, Erturan E, Burak F, Wheeler JM. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. J Am Assoc Gynecol Laparosc. 2000 Aug;7(3):351-4.

ReferenceCitation: Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21.

ReferenceCitation: Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. Epub 2004 Apr 22.

ReferenceCitation: Vilos GA, Abu-Rafea B. New developments in ambulatory hysteroscopic surgery. Best Pract Res Clin Obstet Gynaecol. 2005 Aug;19(5):727-42. Epub 2005 Aug 26. Review.

ReferenceCitation: Touboul C, Fernandez H, Deffieux X, Berry R, Frydman R, Gervaise A. Uterine synechiae after bipolar hysteroscopic resection of submucosal myomas in patients with infertility. Fertil Steril. 2009 Nov;92(5):1690-3. doi: 10.1016/j.fertnstert.2008.08.108. Epub 2008 Oct 19.

location_facility:
CHU Bicêtre, Kremlin Bicêtre
CHU Brugmann

intervention_type: Procedure


title: Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)

summary: The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

primary_purpose: Supportive Care

lead_sponsor: Nestlé

location_facility:
Grand hopital de Charleroi
Centre Hospitalier Charles Nicolle


title: Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter: a Multicenter, Randomized, Double-blind, Sham-controlled Parallel-group Trial Evaluating Short Term Efficacy of EndoStim Device on GERD

acronym: EST-SHAM-EUR

summary:
The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System.

The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD).

The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily PPI use.

status: Terminated

lead_sponsor: Erasme University Hospital

location_facility: Gastroenterology Department, Erasme University Hospital

location_facility: Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval


title: Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

summary: Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Austria France

location_facility:
Allgemeines Krankenhaus der Stadt Linz
Hôpital Cardiologique du Haut-Lévêque


title: Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU

summary:
Pain in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales.

When a patient is unable to communicate, a method that would allow the caregiver to continuously monitor patients' pain and alert the provider that the patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing changes in skin conductance that can be used in patients who are unable to provide a subjective pain score. This study will compare the relationship between the measurements taken by the PainMonitor and pain scores given by communicative patients to evaluate the safety and efficacy of this monitor during planned, routine procedures.

lead_sponsor: Milton S. Hershey Medical Center

location_country:
United States
France

location_facility:
Hopital Foch
Hershey Medical Center


title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of ASP8477 in Healthy Postmenopausal Females and Healthy Young Vasectomized Males, Including a Food Effect Part and a Part to Investigate the Interaction Between ASP8477 and Omeprazole

summary:
This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is similar to part I except that the study is conducted in young, vasectomized males.

Part III assesses the effect of food (fed or fasted conditions) on ASP8477 in postmenopausal subjects.

Part IV assesses the drug-drug interaction between ASP8477 and omeprazole in postmenopausal subjects.

primary_purpose: Basic Science

lead_sponsor: Astellas Pharma Europe B.V.

location_facility:
SGS Belgium N.V.
SGS Aster

intervention_type: Drug


title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

summary: Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

primary_purpose: Diagnostic

lead_sponsor: Bracco Diagnostics, Inc

location_facility: Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte


title: Long-term Outcome After Vemurafenib / BRAF Inhibitors Interruption in Erdheim-chester Disease

acronym: LOVE

summary:
Erdheim-Chester disease (ECD) is a rare non-Langerhans cell histiocytosis. Diagnosis of ECD is based on clinical symptoms, imaging and histology with infiltration of tissues by foamy CD68 positive CD1a negative histiocytes.

Because half of the ECD patients carry a BRAFV600E mutation, we recently proposed vemurafenib, an inhibitor of mutant BRAF, as a possible targeted therapy. We have treated more than10 patients with refractory ECD with life-threatening manifestations associated with the BRAFV600E mutation and observed a short and long term efficacy.

However, vemurafenib may have several side effects and long term administration of this drug has not been evaluated. In other diseases such as melanoma, duration of administration is usually shorter, due to bad prognosis of the disease and progression despite treatment.

As in long-term follow-up, ECD patients with vemurafenib seem to have a stable disease, we want to evaluate the possibility of treatment interruption as this is what we do in our current practice. Other BRAF inhibitors, such as dabrafenib, have recently been proposed for treating BRAF mutated histiocytoses. Other BRAF inhibitor interruption treatment should also be prospectively evaluated.

status: Unknown status

ReferenceCitation: Haroche J, Arnaud L, Cohen-Aubart F, Hervier B, Charlotte F, Emile JF, Amoura Z. Erdheim-Chester disease. Curr Rheumatol Rep. 2014 Apr;16(4):412. doi: 10.1007/s11926-014-0412-0. Review.

ReferenceCitation: Haroche J, Cohen-Aubart F, Emile JF, Arnaud L, Maksud P, Charlotte F, Cluzel P, Drier A, Hervier B, Benameur N, Besnard S, Donadieu J, Amoura Z. Dramatic efficacy of vemurafenib in both multisystemic and refractory Erdheim-Chester disease and Langerhans cell histiocytosis harboring the BRAF V600E mutation. Blood. 2013 Feb 28;121(9):1495-500. doi: 10.1182/blood-2012-07-446286. Epub 2012 Dec 20.

ReferenceCitation: Haroche J, Charlotte F, Arnaud L, von Deimling A, Hélias-Rodzewicz Z, Hervier B, Cohen-Aubart F, Launay D, Lesot A, Mokhtari K, Canioni D, Galmiche L, Rose C, Schmalzing M, Croockewit S, Kambouchner M, Copin MC, Fraitag S, Sahm F, Brousse N, Amoura Z, Donadieu J, Emile JF. High prevalence of BRAF V600E mutations in Erdheim-Chester disease but not in other non-Langerhans cell histiocytoses. Blood. 2012 Sep 27;120(13):2700-3. Epub 2012 Aug 9.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Groupe Hospitalier Pitié-Salpêtrière


title: Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

acronym: PRODIGE

summary: The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.

lead_sponsor: Artialis

location_facility:
University Hospital of Liege-CHU
University Hospital of Nancy


title: An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

summary:
Primary Objective:

To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B

Secondary Objective:

To assess long-term safety and biological activity of SAR421869

ipd_sharing: Yes

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, blank 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 trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_facility:
Investigational Site Number 840001
Investigational Site Number 250001


title: Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial

acronym: Neurophenol

summary:
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals.

Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults.

Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities.

Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.

primary_purpose: Prevention

ReferenceCitation: Krikorian R, Boespflug EL, Fleck DE, Stein AL, Wightman JD, Shidler MD, Sadat-Hossieny S. Concord grape juice supplementation and neurocognitive function in human aging. J Agric Food Chem. 2012 Jun 13;60(23):5736-42. doi: 10.1021/jf300277g. Epub 2012 Apr 9.

ReferenceCitation: Kesse-Guyot E, Fezeu L, Andreeva VA, Touvier M, Scalbert A, Hercberg S, Galan P. Total and specific polyphenol intakes in midlife are associated with cognitive function measured 13 years later. J Nutr. 2012 Jan;142(1):76-83. doi: 10.3945/jn.111.144428. Epub 2011 Nov 16.

ReferenceCitation: Rossi L, Mazzitelli S, Arciello M, Capo CR, Rotilio G. Benefits from dietary polyphenols for brain aging and Alzheimer's disease. Neurochem Res. 2008 Dec;33(12):2390-400. doi: 10.1007/s11064-008-9696-7. Epub 2008 Apr 16. Review.

ReferenceCitation: Spencer JP, Vauzour D, Rendeiro C. Flavonoids and cognition: the molecular mechanisms underlying their behavioural effects. Arch Biochem Biophys. 2009 Dec;492(1-2):1-9. doi: 10.1016/j.abb.2009.10.003. Epub 2009 Oct 12. Review.

ReferenceCitation: Vauzour D, Vafeiadou K, Rodriguez-Mateos A, Rendeiro C, Spencer JP. The neuroprotective potential of flavonoids: a multiplicity of effects. Genes Nutr. 2008 Dec;3(3-4):115-26. doi: 10.1007/s12263-008-0091-4.

lead_sponsor: Neurophenols Consortium

location_facility: INAF (Institute of nutrition and functionnal foods)

intervention_type: Dietary Supplement


title: A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device

summary:
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.

We hypothesize that intubation is obtained equally effective with both types of flexible scopes

lead_sponsor: Rigshospitalet, Denmark

location_country: Denmark France

location_facility: Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre


title: A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome

summary: The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.

ReferenceCitation: Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clément K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9.

family: Bel Lassen

full_name: Pierre Bel Lassen

given: Pierre

family: Belda

full_name: Eugeni Belda

given: Eugeni

family: Prifti

full_name: Edi Prifti

given: Edi

family: Dao

full_name: Maria Carlota Dao

given: Maria Carlota

family: Specque

full_name: Florian Specque

given: Florian

family: Henegar

full_name: Corneliu Henegar

given: Corneliu

family: Rinaldi

full_name: Laure Rinaldi

given: Laure

family: Wang

full_name: Xuedan Wang

given: Xuedan

family: Kennedy

full_name: Sean P. Kennedy

given: Sean P.

family: Zucker

full_name: Jean-Daniel Zucker

family: Calame

full_name: Wim Calame

given: Wim

family: Lamarche

full_name: Benoît Lamarche

given: Benoît

family: Claus

full_name: Sandrine P. Claus

given: Sandrine P.

family: Clément

full_name: Karine Clément

given: Karine

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Scientific Reports

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Laboratoires Nutrition et Cardiometabolisme

location_facility: Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

location_facility: Institut CardioMetabolisme et Nutrition (ICAN)


title: An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration

summary:
Primary Objective:

To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.

Secondary Objective:

To assess:

Safety
Biological activity

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, blank 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 trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at:

https://www.clinicalstudydatarequest.com


title: Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss

summary: The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2

lead_sponsor: Obalon Therapeutics, Inc.

location_facility: Department of Gastroenterology, Erasme Hospital

location_facility: Service D'exploration Functionelle Digestive, Hospital Edouard Harriot


ReferenceCitation: Cros J, Sengès P, Kaprelian S, Desroches J, Gagnon C, Labrunie A, Marin B, Crépin S, Nathan N, Beaulieu P. Pectoral I Block Does Not Improve Postoperative Analgesia After Breast Cancer Surgery: A Randomized, Double-Blind, Dual-Centered Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):596-604. doi: 10.1097/AAP.0000000000000779.

family: Cros

full_name: Jérôme Cros

given: Jérôme

family: Sengès

full_name: Patrick Sengès

given: Patrick

family: Kaprelian

full_name: Suzan Kaprelian

given: Suzan

family: Desroches

full_name: Julie Desroches

given: Julie

family: Gagnon

full_name: Caroline Gagnon

given: Caroline

family: Labrunie

full_name: Anaïs Labrunie

given: Anaïs

family: Marin

full_name: Benoît Marin

family: Crépin

full_name: Sabrina Crépin

given: Sabrina

family: Nathan

full_name: Nathalie Nathan

given: Nathalie

family: Beaulieu

full_name: Pierre Beaulieu

journal_name: Regional Anesthesia and Pain Medicine

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

acronym: PECBLOC

location_facility:
CHUM
University Hospital, Limoges

source: euctr

title: The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.

summary: Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.


title: The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation

summary: The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.

lead_sponsor: Medicrea International

location_facility:
UC Denver
Santy orthopedic center


title: A Multiple-center, Multiple-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Parallel Group Study to Investigate the Effect of RO4917838 on the QTc Interval in Healthy Subjects.

summary: This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.

ReferenceCitation: Hofmann C, Banken L, Hahn M, Swearingen D, Nagel S, Martin-Facklam M. Evaluation of the effects of bitopertin (RG1678) on cardiac repolarization: a thorough corrected QT study in healthy male volunteers. Clin Ther. 2012 Oct;34(10):2061-71. doi: 10.1016/j.clinthera.2012.08.010. Epub 2012 Sep 12.

family: Hofmann

full_name: Carsten Hofmann

given: Carsten

family: Banken

full_name: Ludger Banken

given: Ludger

family: Hahn

full_name: Michael Hahn

given: Michael

family: Swearingen

full_name: Dennis Swearingen

given: Dennis

family: Nagel

full_name: Sandra Nagel

given: Sandra

family: Martin-Facklam

full_name: Meret Martin-Facklam

given: Meret

bso_classification: Chemistry

journal_name: Clinical Therapeutics

title: Evaluation of the Effects of Bitopertin (RG1678) on Cardiac Repolarization: A Thorough Corrected QT Study in Healthy Male Volunteers

lead_sponsor: Hoffmann-La Roche


title: Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis

summary: The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.

lead_sponsor: ProTiP Medical

location_facility:
CHU Mont-Godinne
Hopital Avicenne


title: A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Venous Stasis Ulcers

summary: The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.

lead_sponsor: Erchonia Corporation

location_facility:
Jeffrey Kenkel, MD
Luc Teot, MD


summary:
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.

Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.

ReferenceCitation: Devillier P, Garrigue E, D'Auzers G, Monjotin N, Similowski T, Clerc T. V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results. Respir Res. 2015 Jun 8;16:68. doi: 10.1186/s12931-015-0227-1.

family: Devillier

full_name: Philippe Devillier

given: Philippe

family: Garrigue

full_name: Eric Garrigue

given: Eric

family: D’Auzers

full_name: Guillaume D’Auzers

given: Guillaume

family: Monjotin

full_name: Nicolas Monjotin

given: Nicolas

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Clerc

full_name: Thierry Clerc

given: Thierry

currency_apc_doaj: GBP

journal_name: Respiratory Research

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: Pierre Fabre Medicament

location_facility:
SGS Aster SAS
SGS


type: Other Grant/Funding Number

title: Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants

summary:
Breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. The investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images.

Hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.

time_perspective: Retrospective

lead_sponsor: University of Minnesota

location_facility:
University of Minnesota
Clinique SPONTINI


title: A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male Subjects

summary:
Primary objective:

Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

ReferenceCitation: Hurbin F, Boulenc X, Daskalakis N, Farenc C, Taylor T, Bonneau D, Lacreta F, Cheng S, Sultan E. Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men. J Clin Pharmacol. 2012 Oct;52(10):1506-15. Epub 2011 Nov 29.


title: A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Subcutaneous Injections of GSK2402968 in Non-ambulant Subjects With Duchenne Muscular Dystrophy

acronym: DEMAND I

summary: The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy

lead_sponsor: GlaxoSmithKline


title: An International, Multi-centre, Prospective, Randomised, Double-blind, 4-arm, Placebo Controlled, Parallel Group Study With 12 Weeks Once Daily Oral Treatment in Subjects With Psoriasis Vulgaris

summary: An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.

lead_sponsor: LEO Pharma

location_facility: Hôpital Saint-Louis, Service de Dermatologie

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain


title: Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus

summary: This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.

design_allocation: Non-Randomized

lead_sponsor: NeuroSystec Corporation

location_facility:
Cliniques Universitaries U.C.L.
Hôpital Avicenne


title: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas

summary: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in Combination with Sorafenib or Gemcitabine in Patients with Advanced Solid Tumors or Lymphomas to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of plitidepsin in combination with sorafenib or gemcitabine in patients with advanced solid tumors or lymphomas.

lead_sponsor: PharmaMar

location_facility: The Cancer Institute of New Jersey (CINJ)


title: A Multicentre, Randomised, Open Label, Comparative Phase 4 Trial to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism in a General Neurologist Setting.

summary: Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.

ReferenceCitation: Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.

family: Kupsch

full_name: Andreas R Kupsch

given: Andreas R

family: Bajaj

full_name: Nin Bajaj

given: Nin

family: Weiland

full_name: Frederick Weiland

given: Frederick

family: Tartaglione

full_name: Antonio Tartaglione

given: Antonio

family: Klutmann

full_name: Susanne Klutmann

given: Susanne

family: Buitendyk

full_name: Melanie Buitendyk

given: Melanie

family: Sherwin

full_name: Paul Sherwin

given: Paul

family: Tate

full_name: Ann Tate

given: Ann

family: Grachev

full_name: Igor D Grachev

given: Igor D

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

lead_sponsor: GE Healthcare


title: A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

summary: This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.

lead_sponsor: Guerbet

location_facility:
CHU Charles Nicolle
AKH


title: A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy

summary: The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.

lead_sponsor: Sanofi


title: Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

summary:
Primary objective:

To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.

Secondary objective:

To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.


title: Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery

acronym: ARCH

summary:
The ARCH is a controlled trial with a sequential design and with a prospective, randomized, open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy and tolerance (net benefit) of two antithrombotic strategies in patients with atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral embolic event.

Hypothesis:

The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.

ReferenceCitation: Amarenco P, Davis S, Jones EF, Cohen AA, Heiss WD, Kaste M, Laouénan C, Young D, Macleod M, Donnan GA; Aortic Arch Related Cerebral Hazard Trial Investigators. Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques. Stroke. 2014 May;45(5):1248-57. doi: 10.1161/STROKEAHA.113.004251. Epub 2014 Apr 3.

name: From the Department of Neurology, Stroke Centre, DHU FIRE, INSERM U 1148, Paris Diderot–Sorbonne University, Hôpital Bichat (P.A.), Department of Cardiology, Saint-Antoine Hospital and Medical School, Univeristé Pierre et Marie Curie (A.A.C.), and Department of Biostatistics, Paris-Diderot–Sorbonne University, Hôpital Bichat (C.L.), Assistance Publique-Hôpitaux de Paris, Paris, France; Department of Neurology, Royal Melbourne Hospital (S.D.) and Florey Institute of Neuroscience and Mental Health (D...

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

family: Davis

full_name: Stephen Davis

given: Stephen

family: Jones

full_name: Elizabeth F. Jones

given: Elizabeth F.

family: Cohen

full_name: Ariel A. Cohen

given: Ariel A.

family: Heiss

full_name: Wolf-Dieter Heiss

given: Wolf-Dieter

family: Kaste

full_name: Markku Kaste

given: Markku

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

family: Young

full_name: Dennis Young

given: Dennis

family: Macleod

full_name: Malcolm Macleod

given: Malcolm

family: Donnan

full_name: Geoffrey A. Donnan

given: Geoffrey A.

family: Bladin

full_name: Christopher F. Bladin

given: Christopher F.

family: Chambers

full_name: Brian R. Chambers

given: Brian R.

family: Frayne

full_name: Judith Frayne

given: Judith

family: Hankey

full_name: Graeme J. Hankey

given: Graeme J.

family: Levi

full_name: Christopher R. Levi

given: Christopher R.

family: Read

full_name: Stephen J. Read

given: Stephen J.

family: Ravaud

full_name: Philippe Ravaud

family: Tatlisumak

full_name: Turgut Tatlisumak

given: Turgut

family: Soinne

full_name: Lauri Soinne

given: Lauri

family: Laine

full_name: Mika Laine

given: Mika

family: Syvänne

full_name: Mikko Syvänne

given: Mikko

family: Vikatmaa

full_name: Pirkka Vikatmaa

given: Pirkka

family: Lepäntalo

full_name: Mauri Lepäntalo

given: Mauri

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques

location_facility: Bichat Hospital Head of Neurology Department

location_facility: National Stroke Research Institute-Austin Health


title: A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)

summary: The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.

lead_sponsor: Eli Lilly and Company

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: Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media

summary: The clinical activity of telithromycin vs. cefuroxime in children with acute infections of the middle ear, ages 6 months to 59 months old will be studied.

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


title: An EORTC-IDBBC/ECSG Phase II Study Evaluating The Role Of The Multi-Drug Resistance (MDR) Reversor, R101933, In Patients With Taxane Refractory Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor cells to be killed.

PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy.

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

location_facility:
CRLCC Nantes - Atlantique
Institut Jules Bordet


title: Facilitated Immunoglobulin Administration Registry and Outcomes Study

acronym: FIGARO

summary: Long-term observational study on the utilisation and outcomes of HyQvia (a product consisting of recombinant human hyaluronidase and a human normal immunoglobulin 10% solution) under everyday clinical practice conditions.

lead_sponsor: GWT-TUD GmbH

location_country: Italy Germany France

location_facility: Hospital for Children and Adolescents, St. Georg Hospital, Academic Teaching Hospital

intervention_type: Biological


title: A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

acronym: PROPEL

summary:
This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.

ReferenceCitation: Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. Epub 2012 Mar 15.

ReferenceCitation: Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10.

name: Division of Urogynecology, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, 825 Fairfax Avenue, Suite 310, Norfolk, VA 23507, USA

family: Lukban

full_name: James C. Lukban

given: James C.

name: Women's Health Care Specialists, PC, 7110 Stadium Drive, Kalamazoo, MI 49009, USA

family: Beyer

full_name: Roger D. Beyer

given: Roger D.

name: Atlanta Urogynecology Associates, 3400 Old Milton Parkway, Building C, Suite 330, Alpharetta, GA 30005, USA

family: Moore

full_name: Robert D. Moore

given: Robert D.

journal_name: Obstetrics and Gynecology International

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

title: Incidence of Extrusion Following Type I Polypropylene Mesh “Kit” Repairs in the Correction of Pelvic Organ Prolapse

ReferenceCitation: Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. Epub 2012 May 10.

lead_sponsor: ASTORA Women's Health

location_country:
United States
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: Kaiser Permanente - Dept. of Obstetrics & Gynecology

location_facility: Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest

location_facility: University Hospital of Leicester NHS Trust

location_facility: Female Pelvic Medicine and Urogynecology Inst. of Michigan

location_facility: CHU de Rouen - Pavillon Derocque - Rez de Chaussée

location_facility: Texas Tech University Health Science Center - OB/GYN Department

location_facility: Service urologie de Paris l'Hôpital Tenon

location_facility: University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics

location_facility: University of Tennessee - Dept of Obstetrics & Gynecology


title: Identification of Thoracic CT Scan Biomarkers by Deep Learning for Evaluating the Prognosis of Patients With COVID-19 Disease

acronym: COVID 19-IA

summary:
The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificial intelligence by deep learning would generate imaging biomarkers linked to the patient's short- and medium-term prognosis.

The purpose of this study is to rapidly make available an early decision-making tool (from the first hospital consultation of the patient with symptoms related to SARS-CoV-2) based on the integration of several biomarkers (clinical, biological, imaging by thoracic scanner) allowing both personalized medicine and better anticipation of the patient's evolution in terms of care organization.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: Martinique France

location_facility:
CHU Strasbourg
CHU Poitiers
CHU de Nimes
CHU Montpellier
CHU la Timone
CHU Martinique


title: A Prospective, Multi-center, Randomized, Controlled, Single-blind Study of the Safety and Effectiveness of Algeness® DF 3.5% Deep Volumizing Filler to Correct Age-related Volume Deficit in the Mid-face

summary: A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.

ipd_sharing_description: All summary results will be posted to this website. Safety results will be shared with medical monitor and study physicians.

lead_sponsor: Advanced Aesthetic Technologies, Inc

location_facility:
THINKIN
J. Vandeputte, Plastische Chirurgie
MEDITI


lead_sponsor: Hansa Biopharma AB

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW

location_facility: CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

location_facility: Hôpital Saint-Louis. Service de Néphrologie et Transplantation

title: A Prospective, Observational Long-term Follow-up Trial of Kidney Transplant Patients Treated With Imlifidase or Plasma Exchange After an Active/Chronic Active Antibody-Mediated Rejection Episode

summary: The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.


title: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With 5T4-expressing Locally Advanced or Metastatic Solid Tumours

summary: This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

lead_sponsor: Byondis B.V.

location_facility:
Institut Bergonié
Institut Jules Bordet
Centre Oscar Lambret


title: SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.

summary:
The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described.

These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression.

It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French.

The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model.

The development of such a tool will be of major interest for clinical practice and future clinical research.

lead_sponsor: Eric Durand

location_facility:
Brugmann University Hospital
Hôpitaux Saint Maurice
Hôpital Universitaire Pitié-Salpêtrière


title: Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

acronym: NeoFIND

summary: This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).

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

lead_sponsor: Advanced Accelerator Applications

location_facility: Medical University Innsbruck Department of Nuclear Medicine

location_facility: University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan

location_facility: University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire


title: An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.

summary:
An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy.

The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. A visualization of glucose CGM curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low Blood Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
Necker Enfants Malades Hospital
Toulouse University Hospital Center
University Hospitals Leuven


title: Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem

summary: The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.

lead_sponsor: Zimmer Biomet

location_facility: Hôpital Gabriel Montpied - Service de chirurgie Orthopédique


title: Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study

summary: The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).

primary_purpose: Device Feasibility

lead_sponsor: Safeheal

location_facility:
Hopital Saint-Antoine
UZA Antwerp
Ihu Strasbourg


title: Developmental Language Difficulties: Behavioural and Electrophysiological Studies of the Connections Between Spoken and Written Language and Specificity of These Disorders

acronym: LANGAGE

summary: This study will help to better characterize oral and written language disorders and determine if these disorders are continuous or not. The participants ( dyslexic and dysphasic patients and control adults) will carry out an auditory lexical decision task during which an electroencephalogram (EEG) will be recorded.

lead_sponsor: Lille Catholic University

location_facility: Université de Lille 3 Charles de Gaulle (URECA)


lead_sponsor: BioCryst Pharmaceuticals

title: OPuS-4: An Open-label Study to Evaluate the Long-term Safety of Avoralstat in Subjects With Hereditary Angioedema

summary: This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.


title: Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root

acronym: CAVIAAR

summary:
The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45% increase of 3 years-survival rate without increased mortality or serious increased morbidity events when compared to mechanical valve replacement.

The main hypothesis of this study is that a standardized procedure of valve sparing based on external aortic annuloplasty in patients with dystrophic aortic insufficiency and/or aortic root aneurysm increases survival rate without increased mortality or serious increased morbidity events when compared with patients undergoing mechanical aortic valve replacement.

ReferenceCitation: Lansac E, Di Centa I, Bonnet N, Leprince P, Rama A, Acar C, Pavie A, Gandjbakhch I. Aortic prosthetic ring annuloplasty: a useful adjunct to a standardized aortic valve-sparing procedure? Eur J Cardiothorac Surg. 2006 Apr;29(4):537-44. Epub 2006 Feb 24.

ReferenceCitation: Lansac E, Bouchot O, Arnaud Crozat E, Hacini R, Doguet F, Demaria R, Leguerrier A, Jouan J, Chatel D, Lopez S, Folliguet T, Acar C, Leprince P, Langanay T, Jegaden O, Bessou JP, Albat B, Latremouille C, Fabiani JN, Fayad G, Fleury JP, Pasquet B, Debauchez M, Di Centa I, Tubach F. Standardized approach to valve repair using an expansible aortic ring versus mechanical Bentall: early outcomes of the CAVIAAR multicentric prospective cohort study. J Thorac Cardiovasc Surg. 2015 Feb;149(2 Suppl):S37-45. doi: 10.1016/j.jtcvs.2014.07.105. Epub 2014 Aug 12.

family: Lansac

full_name: Emmanuel Lansac

given: Emmanuel

family: Bouchot

full_name: Olivier Bouchot

given: Olivier

family: Arnaud Crozat

full_name: Eric Arnaud Crozat

given: Eric

family: Hacini

full_name: Rachid Hacini

given: Rachid

family: Doguet

full_name: Fabien Doguet

given: Fabien

family: Demaria

full_name: Roland Demaria

given: Roland

family: Leguerrier

full_name: Alain Leguerrier

given: Alain

family: Jouan

full_name: Jerome Jouan

given: Jerome

family: Chatel

full_name: Didier Chatel

given: Didier

family: Lopez

full_name: Stephane Lopez

given: Stephane

family: Folliguet

full_name: Thierry Folliguet

given: Thierry

family: Acar

full_name: Christophe Acar

given: Christophe

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Langanay

full_name: Thierry Langanay

family: Jegaden

full_name: Oliver Jegaden

given: Oliver

family: Bessou

full_name: Jean Paul Bessou

given: Jean Paul

family: Albat

full_name: Bernard Albat

given: Bernard

family: Latremouille

full_name: Christian Latremouille

given: Christian

family: Fabiani

full_name: Jean-Noel Fabiani

given: Jean-Noel

family: Fayad

full_name: Georges Fayad

given: Georges

family: Fleury

full_name: Jean Pierre Fleury

given: Jean Pierre

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

family: Debauchez

full_name: Mathieu Debauchez

journal_name: The Journal of Thoracic and Cardiovascular Surgery

title: Standardized approach to valve repair using an expansible aortic ring versus mechanical Bentall: Early outcomes of the CAVIAAR multicentric prospective cohort study


title: A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

acronym: MAESTRO-NASH

summary: A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

ReferenceCitation: Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.

name: Radcliffe Department of Medicine University of Oxford Oxford United Kingdom

name: Department of Medicine Pinnacle Clinical Research San Antonio TX USA

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

name: Department of Radiology Center for Advanced Magnetic Resonance Duke University Medical Center Durham NC USA

family: Bashir

full_name: Mustafa Bashir

given: Mustafa

name: Department of Medicine University of Arizona for Medical Sciences Tuscon AZ USA

family: Moussa

full_name: Sam E. Moussa

given: Sam E.

family: McCarty

full_name: Kevin McCarty

given: Kevin

name: Department of Medicine University of California San Diego CA USA

family: Pablo Frias

full_name: Juan Pablo Frias

given: Juan

name: Madrigal Pharmaceuticals West Conshohocken PA USA

family: Taub

full_name: Rebecca Taub

given: Rebecca

family: Alkhouri

full_name: Naim Alkhouri

given: Naim

journal_name: Hepatology Communications

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effects of Resmetirom on Noninvasive Endpoints in a 36‐Week Phase 2 Active Treatment Extension Study in Patients With NASH

lead_sponsor: Madrigal Pharmaceuticals, Inc.

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Poland
Israel
Hungary
Australia
Belgium
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: The Institute for Liver Health - Chandler

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Toronto General Hospital - Clinical Trials Pharmacy

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Hunter Holmes McGuire Veterans Administration Medical Center

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: National Research Institute - Panorama City

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Walter Reed National Military Medical Center

location_facility: South Denver Gastroenterology - Swedish Medical Center Office

location_facility: Gastro One - Germantown - Centre Oak Way

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet

location_facility: Consorci Hospital General Universitari de València

location_facility: Saint George's University Hospitals NHS Foundation Trust

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Magyarország Egészségügyi Szolgáltató - Gyula

location_facility: National Research Institute - Los Angeles

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

location_facility: Texas Digestive Disease Consultants - Fort Worth

location_facility: Charité Universitätsmedizin Berlin - Campus Mitte

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Bon Secours St. Mary's Hospital of Richmond

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: University of Kansas Medical Center Research Institute

location_facility: Gastrointestinal Associates and Endoscopy Center - Madison

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil

location_facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin

location_facility: Texas Digestive Disease Consultants - Bay Area Gastroenterology

location_facility: The Institute for Liver Health - Glendale

location_facility: National Research Institute - Huntington Park

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg

location_facility: Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

location_facility: Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház


ReferenceCitation: Cohan S, Kappos L, Giovannoni G, Wiendl H, Selmaj K, Havrdová EK, Rose J, Greenberg S, Phillips G, Ma W, Wang P, Lima G, Sabatella G. Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Mult Scler. 2018 Dec;24(14):1883-1891. doi: 10.1177/1352458517735190. Epub 2017 Oct 6.

name: Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, Providence St. Joseph Health, Portland, OR, USA

family: Cohan

full_name: Stanley Cohan

given: Stanley

name: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University London, London, UK

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

name: Department of Neurology, University of Münster, Münster, Germany

family: Wiendl

full_name: Heinz Wiendl

given: Heinz

name: Department of Neurology, Medical University of Lodz, Lodz, Poland

family: Selmaj

full_name: Krzysztof Selmaj

given: Krzysztof

name: Department of Neurology and Center for Clinical Neuroscience, First Faculty of Medicine, Charles University, Prague, Czech Republic

family: Havrdová

full_name: Eva Kubala Havrdová

given: Eva Kubala

name: Department of Neurology, University of Utah and Neurovirology Research Laboratory VASLCHCS, Imaging and Neuroscience Center, Salt Lake City, UT, USA

family: Rose

full_name: John Rose

given: John

family: Greenberg

full_name: Steven Greenberg

given: Steven

family: Phillips

full_name: Glenn Phillips

given: Glenn

family: Ma

full_name: Wei Ma

given: Wei

family: Wang

full_name: Ping Wang

given: Ping

family: Lima

full_name: Gabriel Lima

given: Gabriel

family: Sabatella

full_name: Guido Sabatella

given: Guido

journal_name: Multiple Sclerosis Journal

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Benedict RH, Cohan S, Lynch SG, Riester K, Wang P, Castro-Borrero W, Elkins J, Sabatella G. Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study. Mult Scler. 2018 May;24(6):795-804. doi: 10.1177/1352458517707345. Epub 2017 May 9.

name: UBMD Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA

family: Benedict

full_name: Ralph HB Benedict

given: Ralph HB

name: Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, Portland, OR, USA

name: Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA

family: Lynch

full_name: Sharon G Lynch

given: Sharon G

family: Riester

full_name: Katherine Riester

given: Katherine

title: Improved cognitive outcomes in patients with relapsing–remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study

ReferenceCitation: Liu Y, Vollmer T, Havrdova E, Riester K, Lee A, Phillips G, Wang P, Sabatella G. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017 Jan;11:18-24. doi: 10.1016/j.msard.2016.11.005. Epub 2016 Nov 13.

journal_name: Multiple Sclerosis and Related Disorders

ReferenceCitation: Krueger JG, Kircik L, Hougeir F, Friedman A, You X, Lucas N, Greenberg SJ, Sweetser M, Castro-Borrero W, McCroskery P, Elkins J. Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis. Adv Ther. 2016 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 1.

ReferenceCitation: Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.

location_country:
Finland
Greece
Romania
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Poland
Argentina
Moldova, Republic of
Canada
Sweden
Switzerland
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Serbia
Mexico
Israel
Georgia
Spain

title: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

summary:
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.