ReferenceCitation: Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE Jr, Bae J, Collier K, Cherian M, O'Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):603-608. doi: 10.1001/jamaoncol.2020.7310.

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts

family: Filho

full_name: Otto Metzger Filho

given: Otto Metzger

name: Department of Medicine, The Ohio State University College of Medicine, Columbus

name: Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus

family: Stover

full_name: Daniel G. Stover

given: Daniel G.

family: Asad

full_name: Sarah Asad

given: Sarah

family: Ansell

full_name: Peter J. Ansell

given: Peter J.

name: Washington University, St Louis, Missouri

family: Watson

full_name: Mark Watson

given: Mark

name: German Breast Group, Neu-Isenburg, Germany

family: Loibl

full_name: Sibylle Loibl

given: Sibylle

name: Massey Cancer Center, Virginia Commonwealth University, Richmond

name: Now with Houston Methodist Cancer Center, Houston, Texas

family: Geyer

full_name: Charles E. Geyer

given: Charles E.

suffix: Jr

family: Bae

full_name: Junu Bae

given: Junu

family: Collier

full_name: Katharine Collier

given: Katharine

family: Cherian

full_name: Mathew Cherian

given: Mathew

name: Texas Oncology–Baylor Charles A. Sammons Cancer Center, Dallas

family: O’Shaughnessy

full_name: Joyce O’Shaughnessy

given: Joyce

name: Helios Klinikum Berlin-Buch, Berlin, Germany

family: Untch

full_name: Michael Untch

given: Michael

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

name: University Medical Center Ulm, Ulm, Germany

name: Now with Department of Interdisciplinary Medical Services, Breast Center, Cantonal Hospital St Gallen, St Gallen, Switzerland.

family: Huober

full_name: Jens B. Huober

given: Jens B.

name: Division of Breast Surgery, Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts

name: Breast Oncology Program, Dana-Farber/Brigham and Women’s Cancer Center, Boston, Massachusetts

name: Now with Yale Cancer Center, New Haven, Connecticut

family: Golshan

full_name: Mehra Golshan

given: Mehra

family: Sikov

full_name: William M. Sikov

given: William M.

family: von Minckwitz

full_name: Gunter von Minckwitz

given: Gunter

name: University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, Pennsylvania

family: Rastogi

full_name: Priya Rastogi

given: Priya

family: Maag

full_name: David Maag

given: David

family: Wolmark

full_name: Norman Wolmark

given: Norman

name: Institute of Physiology and Pathophysiology, Department of Medicine, Philipps-University Marburg and University Hospital of Giessen and Marburg, Marburg, Germany

family: Denkert

full_name: Carsten Denkert

given: Carsten

name: The University of Texas MD Anderson Cancer Center, Houston

family: Symmans

full_name: W. Fraser Symmans

given: W. Fraser

journal_name: JAMA Oncology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Golshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):e195410. doi: 10.1001/jamasurg.2019.5410. Epub 2020 Mar 18. Erratum in: JAMA Surg. 2021 May 1;156(5):503.

name: Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Boston, Massachusetts

name: Department of Medical Oncology, German Breast Group, Neu-Isenburg, Germany

name: Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada

name: Department of Medical Oncology, University of Ulm, Ulm, Germany

name: Department of Medical Oncology, Texas Oncology–Baylor Sammons Cancer Center, US Oncology, Dallas

name: Department of Medical Oncology, University of California, San Francisco

name: Department of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania

name: Department of Medical Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond

name: Department of Medical Oncology, Women and Infants Hospital of Rhode Island, Providence

name: Department of Breast Surgery, Helios Klinikum Berlin-Buch, Berlin, Germany

ReferenceCitation: Golshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial. Eur J Surg Oncol. 2020 Feb;46(2):223-228. doi: 10.1016/j.ejso.2019.10.002. Epub 2019 Oct 5.

ReferenceCitation: Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Hungary
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: University of Illinois - Chicago /ID# 134329

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855

location_facility: St. John of God Hosp - Murdoch /ID# 131788

location_facility: Columbia Univ Medical Center /ID# 141588

location_facility: Christiana Care Health Service /ID# 137823

location_facility: Hospital General Universitario Alicante /ID# 135115

location_facility: Oncology Hematology Care, Inc - Blue Ash /ID# 120478

location_facility: Pyatigorsk Oncology Dispensary /ID# 120945

location_facility: National Institute of Oncology /ID# 120828

location_facility: Lehigh Valley Health Network /ID# 133372

location_facility: Seoul National University Hospital /ID# 116698

location_facility: Minnesota Oncology Hematology, PA /ID# 126144

location_facility: Korea University Anam Hospital /ID# 118857

location_facility: Hospital Universitario Miguel Servet /ID# 119195

location_facility: Vrije Universiteit Medisch Centrum /ID# 126302

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 120457

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 135108

location_facility: Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979

location_facility: Florida Cancer Specialists - Fort Myers /ID# 126379

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 135112

location_facility: St. John of God Subiaco Hosp /ID# 120717

location_facility: Loyola University Medical Ctr /ID# 120455

location_facility: Stanford University School of Med /ID# 130316

location_facility: Indiana Univ School Medicine /ID# 118215

location_facility: Leningrad Reg Onc Dispensery /ID# 120938

location_facility: Northwestern University Feinberg School of Medicine /ID# 133848

location_facility: Hospital General Universitario de Valencia /ID# 135111

location_facility: OSF St. Anthony Medical Center /ID# 139424

location_facility: Western Health Sunshine Hosp. /ID# 120715

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 137275

location_facility: Hopital Universitaire Purpan /ID# 120731

location_facility: Misericordia General Hospital /ID# 119536

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818

location_facility: Hospital Parc de Salut del Mar /ID# 135110

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 116681

location_facility: Texas Oncology - Medical City Dallas /ID# 126140

location_facility: Community Rgnal Cancer Care N /ID# 120456

location_facility: Novant Health Oncology Special /ID# 139890

location_facility: Hosp European, Georges Pompid /ID# 120736

location_facility: Univ Hosp Bristol NHS Foundati /ID# 120989

location_facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472

location_facility: The Ctr for Cancer and Blood D /ID# 120479

location_facility: Kyungpook National University Chilgok Hospital /ID# 118855

location_facility: Wilke/Wagner/Petzoldt, Fuerth /ID# 133481

location_facility: Solinksy Center for Cancer Care /ID# 131970

location_facility: Miami Cancer Institute - Baptist Health South Florida /ID# 126145

location_facility: Studiengesellschaft Onk Bielef /ID# 133471

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 133454

location_facility: Cleveland Clinic Main Campus /ID# 126378

location_facility: Nottingham Univ Hospitals NHS /ID# 122218

location_facility: Istituto Europeo di Oncologia /ID# 120845

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944

location_facility: Comprehensive Cancer Ctrs Neva /ID# 126136

location_facility: Sanford Roger Maris Cancer Cen /ID# 132394

location_facility: Arizona Oncology Associates, PC-HOPE /ID# 126137

location_facility: University Hospitals Case Medical Center /ID# 141691

location_facility: Kursk Regional Oncology Dispen /ID# 116688

location_facility: Petz Aladar Megyei Oktato Korh /ID# 120835

location_facility: Hospital Clinico Universitario San Carlos /ID# 119959

location_facility: Florida Cancer Specialists - Fort Myers /ID# 121835

location_facility: Hospital Universitario Ramon y Cajal /ID# 135113

location_facility: UT Southwestern Medical Center /ID# 133849

location_facility: Hospital Clinico Universitario de Valencia /ID# 123076

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 135116

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834

location_facility: Rutgers Cancer Institute of NJ /ID# 120477

location_facility: Klinikum recht der Isar der TU /ID# 133449

location_facility: Medical Radiological Res Ctr /ID# 124017

location_facility: IRCCS Fondazione Salva Maugeri /ID# 120848

location_facility: Cliniques Universitaires Saint Luc /ID# 120719

location_facility: Hospital Santa Creu i Sant Pau /ID# 145400

location_facility: Texas Oncology - Memorial City /ID# 126139

location_facility: Texas Oncology - Medical City Dallas /ID# 126141

location_facility: Sunnybrook Health Sciences Ctr /ID# 123312

location_facility: Johanniter-Krankenhaus Genthin /ID# 133463

location_facility: Univ Maryland School Medicine /ID# 119235

location_facility: Hospital Universitario Virgen del Rocio /ID# 135114

location_facility: Virginia Oncology Associates /ID# 127260

location_facility: Horizon Oncology Research Center /ID# 116815

title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

summary: This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.


title: Simulation of a Mission Aboard the International Space Station by a Long Duration Anti-Orthostatic Bed Confinement at - 6° (90 Days) on Healthy Subjects:1/Perfecting of Preventive Methods (Muscular Exercise and Biphosphonates) and Evaluation of the Effects on the Locomotion and Cardiovascular Systems and on the Lipid and Energy Metabolisms. 2/Pharmacokinetic Assessment: Effects of Position on the Absorption Mechanisms: Pharmacokinetics of Paracetamol Used as Model to Study Oral Absorption in Simulated Weightlessness

summary:
Microgravity during space flight induces physiological changes that affect astronauts' health and performance. Space flight simulations such as prolonged bed rest can mimic some of these changes and provide study conditions that are more accessible than during space flight. The European Space Agency, ESA together with the French national space agency, CNES and the Japanese national space agency, NASDA are performing extensive studies using long duration bed rest.

Previous studies including several long and short term bed rest campaigns have yielded significant medical data on the physiological changes induced by space flight. These data can be used to study the effect of countermeasures, methods helping to prevent these physiological changes.

The long duration bed rest, lasting 3 months undertakes a variety of investigations involving 28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue stabilisation medication and resistive exercises to determine their suitability for use during long duration stays on ISS.

The physiological changes recorded during space flight and bed rest mimic those observed in some diseases and in the aging process. Significant clinical applications are expected as a direct result of this experiment and future equivalent studies.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Rittweger J, Frost HM, Schiessl H, Ohshima H, Alkner B, Tesch P, Felsenberg D. Muscle atrophy and bone loss after 90 days' bed rest and the effects of flywheel resistive exercise and pamidronate: results from the LTBR study. Bone. 2005 Jun;36(6):1019-29. Epub 2005 Apr 2.

ReferenceCitation: Watanabe Y, Ohshima H, Mizuno K, Sekiguchi C, Fukunaga M, Kohri K, Rittweger J, Felsenberg D, Matsumoto T, Nakamura T. Intravenous pamidronate prevents femoral bone loss and renal stone formation during 90-day bed rest. J Bone Miner Res. 2004 Nov;19(11):1771-8. Epub 2004 Aug 23.

ReferenceCitation: Rittweger J, Felsenberg D. Patterns of bone loss in bed-ridden healthy young male subjects: results from the Long Term Bed Rest Study in Toulouse. J Musculoskelet Neuronal Interact. 2003 Dec;3(4):290-1; discussion 292-4.

ReferenceCitation: Gallagher P, Trappe S, Harber M, Creer A, Mazzetti S, Trappe T, Alkner B, Tesch P. Effects of 84-days of bedrest and resistance training on single muscle fibre myosin heavy chain distribution in human vastus lateralis and soleus muscles. Acta Physiol Scand. 2005 Sep;185(1):61-9.

ReferenceCitation: Rudnick J, Püttmann B, Tesch PA, Alkner B, Schoser BG, Salanova M, Kirsch K, Gunga HC, Schiffl G, Lück G, Blottner D. Differential expression of nitric oxide synthases (NOS 1-3) in human skeletal muscle following exercise countermeasure during 12 weeks of bed rest. FASEB J. 2004 Aug;18(11):1228-30. Epub 2004 Jun 4.

ReferenceCitation: Trappe S, Trappe T, Gallagher P, Harber M, Alkner B, Tesch P. Human single muscle fibre function with 84 day bed-rest and resistance exercise. J Physiol. 2004 Jun 1;557(Pt 2):501-13. Epub 2004 Apr 2.

ReferenceCitation: Belin de Chantemèle E, Pascaud L, Custaud MA, Capri A, Louisy F, Ferretti G, Gharib C, Arbeille P. Calf venous volume during stand-test after a 90-day bed-rest study with or without exercise countermeasure. J Physiol. 2004 Dec 1;561(Pt 2):611-22. Epub 2004 Aug 26.

ReferenceCitation: Belin de Chantemele E, Blanc S, Pellet N, Duvareille M, Ferretti G, Gauquelin-Koch G, Gharib C, Custaud MA. Does resistance exercise prevent body fluid changes after a 90-day bed rest? Eur J Appl Physiol. 2004 Aug;92(4-5):555-64. Epub 2004 May 29.

ReferenceCitation: Reeves NJ, Maganaris CN, Ferretti G, Narici MV. Influence of simulated microgravity on human skeletal muscle architecture and function. J Gravit Physiol. 2002 Jul;9(1):P153-4.

ReferenceType: derived

ReferenceCitation: Belavý DL, Ohshima H, Rittweger J, Felsenberg D. High-intensity flywheel exercise and recovery of atrophy after 90 days bed--rest. BMJ Open Sport Exerc Med. 2017 Jul 24;3(1):e000196. doi: 10.1136/bmjsem-2016-000196. eCollection 2017.

family: Belavý

full_name: Daniel L Belavý

given: Daniel L

sequence: first

family: Ohshima

full_name: Hiroshi Ohshima

given: Hiroshi

sequence: additional

family: Rittweger

full_name: Jörn Rittweger

given: Jörn

family: Felsenberg

full_name: Dieter Felsenberg

given: Dieter

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open Sport & Exercise Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: Deakin University - Deakin Research Online

evidence: oa repository (via pmcid lookup)

license_normalized: no license

version: acceptedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: High-intensity flywheel exercise and recovery of atrophy after 90 days bed-rest

lead_sponsor: Centre National d'Etudes Spatiales

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Effects of Sodium Intake on Pharmacokinetic/Pharmacodynamic Relationship of a Single Dose of a Renin Angiotensin System-Blocker, or a Beta-Blocker in Normotensive Sodium-Depleted or Replated Volunteers in a Cross-Over Study

summary: The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Azizi M, Ménard J, Bissery A, Guyenne TT, Bura-Rivière A, Vaidyanathan S, Camisasca RP. Pharmacologic demonstration of the synergistic effects of a combination of the renin inhibitor aliskiren and the AT1 receptor antagonist valsartan on the angiotensin II-renin feedback interruption. J Am Soc Nephrol. 2004 Dec;15(12):3126-33.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou

intervention_type: Drug


title: Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children

summary: The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults

status: Unknown status

design_allocation: Non-Randomized

status_simplified: Unknown


title: Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression

summary: The main hypothesis is that the therapeutic response and pharmacological resistance to ADs in depressed patients can be associated with a polymorphism for the BDNF gene. The research of allelic forms associated to lesser efficiency or inefficiency of ADs could add to the body of evidence that BDNF mediates the mechanism of action of ADs, and could have important practical implications. We propose to compare in a group of patients with major depression, the allelic variability of the BDNF gene between responders and non-responders after a 3-week period and a 6-week period of SSRI treatment.

lead_sponsor: University Hospital, Tours

intervention_type: Genetic


title: Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings

summary:
Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome.

These Two strategies have never been prospectivally evauated.

Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American thoracic guidelines
Type of study randomized multicentric controlled open study

primary_purpose: Diagnostic

intervention_type: Procedure


title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

acronym: CORTAGE

summary: The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.

ReferenceCitation: Pagnoux C, Quéméneur T, Ninet J, Diot E, Kyndt X, de Wazières B, Reny JL, Puéchal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Aït el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.

name: National Referral Center for Necrotizing Vasculitides and Systemic Sclerosis, Hôpital Cochin, AP-HP, and Université Paris Descartes; Paris, France

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

name: Centre Hospitalier de Valenciennes; Valenciennes France

family: Quéméneur

full_name: Thomas Quéméneur

given: Thomas

family: Ninet

full_name: Jacques Ninet

given: Jacques

name: Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours; Tours France

family: Diot

full_name: Elisabeth Diot

given: Elisabeth

family: Kyndt

full_name: Xavier Kyndt

given: Xavier

name: Centre Hospitalier Universitaire Carémeau; Nîmes France

family: de Wazières

full_name: Benoît de Wazières

given: Benoît

family: Reny

full_name: Jean-Luc Reny

given: Jean-Luc

family: Puéchal

full_name: Xavier Puéchal

name: Hôpital Robert Debré, Centre Hospitalier Universitaire; Reims France

family: le Berruyer

full_name: Pierre-Yves le Berruyer

given: Pierre-Yves

name: Hôpital Bichat-Claude Bernard; Paris France

family: Lidove

full_name: Olivier Lidove

given: Olivier

family: Vanhille

full_name: Philippe Vanhille

given: Philippe

name: Centre Hospitalier Bretagne Atlantique; Vannes France

family: Godmer

full_name: Pascal Godmer

given: Pascal

family: Fain

full_name: Olivier Fain

name: University Hospital Gasthuisberg; Leuven Belgium

family: Blockmans

full_name: Daniel Blockmans

given: Daniel

family: Bienvenu

full_name: Boris Bienvenu

given: Boris

family: Rollot

full_name: Florence Rollot

given: Florence

family: Aït el Ghaz-Poignant

full_name: Séverine Aït el Ghaz-Poignant

given: Séverine

family: Mahr

full_name: Alfred Mahr

given: Alfred

family: Cohen

full_name: Pascal Cohen

family: Mouthon

full_name: Luc Mouthon

given: Luc

name: Hôpital Hôtel-Dieu and Université Paris Descartes, INSERM U738; Paris France

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Ravaud

full_name: Philippe Ravaud

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

title: Treatment of Systemic Necrotizing Vasculitides in Patients Aged Sixty-Five Years or Older: Results of a Multicenter, Open-Label, Randomized Controlled Trial of Corticosteroid and Cyclophosphamide-Based Induction Therapy


title: A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

summary: The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

lead_sponsor: CytRx

location_country:
Italy
United States
Chile
Netherlands
France
Poland
Israel
Hungary
Australia
Russian Federation
Spain
Denmark
Canada

location_facility: Wake Forest University Baptist Medical Center

location_facility: Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: University Hospitals Case Medical Center

location_facility: Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan

location_facility: Azienda Ospedaliero-Universitaria di Bologna-Policlinico S Orsola-Malpighi

location_facility: Centre Hospitalier Regional et Universitaire - Hospital Bretonneau

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Instituto Clinico Oncologica del Sur (ICOS)

location_facility: Sharet Institute of Oncology Hadassah Ein Karem Medical Center

location_facility: The James Cancer Hospital and Solove Research Institute

lead_sponsor_type: industriel


title: Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

summary: Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.

ReferenceCitation: Droitcourt C, Rybojad M, Porcher R, Juillard C, Cosnes A, Joly P, Lacour JP, D'Incan M, Dupin N, Sassolas B, Misery L, Chevrant-Breton J, Lebrun-Vignes B, Desseaux K, Valeyre D, Revuz J, Tazi A, Chosidow O, Dupuy A. A randomized, investigator-masked, double-blind, placebo-controlled trial on thalidomide in severe cutaneous sarcoidosis. Chest. 2014 Oct;146(4):1046-1054. doi: 10.1378/chest.14-0015.

family: Droitcourt

full_name: Catherine Droitcourt

given: Catherine

family: Rybojad

full_name: Michel Rybojad

given: Michel

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

family: Juillard

full_name: Caroline Juillard

given: Caroline

family: Cosnes

full_name: Anne Cosnes

given: Anne

family: Joly

full_name: Pascal Joly

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

family: D'Incan

full_name: Michel D'Incan

family: Dupin

full_name: Nicolas Dupin

given: Nicolas

family: Sassolas

full_name: Bruno Sassolas

given: Bruno

family: Misery

full_name: Laurent Misery

given: Laurent

family: Chevrant-Breton

full_name: Jacqueline Chevrant-Breton

given: Jacqueline

family: Lebrun-Vignes

full_name: Bénédicte Lebrun-Vignes

given: Bénédicte

family: Desseaux

full_name: Kristell Desseaux

given: Kristell

family: Valeyre

full_name: Dominique Valeyre

given: Dominique

family: Revuz

full_name: Jean Revuz

given: Jean

family: Tazi

full_name: Abdellatif Tazi

given: Abdellatif

family: Chosidow

full_name: Olivier Chosidow

family: Dupuy

full_name: Alain Dupuy

given: Alain

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: A Randomized, Investigator-Masked, Double-Blind, Placebo-Controlled Trial on Thalidomide in Severe Cutaneous Sarcoidosis

location_facility: HOPITAL Saint Louis, Service de Dermatologie


title: A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib

summary:
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.

ReferenceCitation: Pérol M, Chouaid C, Pérol D, Barlési F, Gervais R, Westeel V, Crequit J, Léna H, Vergnenègre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Ségura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2012 Oct 1;30(28):3516-24. Epub 2012 Sep 4.

lead_sponsor: Hospices Civils de Lyon


title: Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.

summary:
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.

The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.

The side selection will be determined by the randomization.

status: Terminated

ReferenceCitation: Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. J Oral Maxillofac Surg. 2002 Jun;60(6):630-5.

ReferenceCitation: Carlson ER. Bone grafting the jaws in the 21st century: the use of platelet-rich plasma and bone morphogenetic protein. Alpha Omegan. 2000 Aug-Sep;93(3):26-30.

ReferenceCitation: Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61.

ReferenceCitation: Lebeau J, Savariaux C, Perrier P, Bettega G, Raphaël B. [Functional evaluation of intraoral reconstructive surgery. A valuable tool: articulatory evaluation of the acoustic signal]. Rev Stomatol Chir Maxillofac. 2000 Apr;101(2):60-4. French.

lead_sponsor: University Hospital, Grenoble


title: Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study

summary: The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy

enrollment_type: Anticipated

lead_sponsor: Poitiers University Hospital


title: Transplantation d'Ilots Pancreatiques Allogeniques Adultes Pour le Traitement du Diabete Insulino-dependant: Etude GRAGIL 2.

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

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

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

family: Borot

full_name: Sophie Borot

given: Sophie

family: Wojtusciszyn

full_name: Anne Wojtusciszyn

family: Bayle

full_name: Francois Bayle

given: Francois

family: Tétaz

full_name: Rachel Tétaz

given: Rachel

family: Badet

full_name: Lionel Badet

given: Lionel

family: Thivolet

full_name: Charles Thivolet

given: Charles

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Frimat

full_name: Luc Frimat

given: Luc

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Kessler

full_name: Laurence Kessler

given: Laurence

family: Brault

full_name: Coralie Brault

given: Coralie

family: Colin

full_name: Cyrille Colin

given: Cyrille

family: Tauveron

full_name: Igor Tauveron

given: Igor

family: Bosco

full_name: Domenico Bosco

given: Domenico

family: Berney

full_name: Thierry Berney

given: Thierry

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

location_country: France Switzerland

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital, Department of Surgery


title: Pilot Study to Evaluate Two Different Non-Invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-Clinical), When Treated With Aldara 5% (Imiquimod) Cream

summary: The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.

lead_sponsor: MEDA Pharma GmbH & Co. KG

intervention_type: Other


title: PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis

summary:
The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate chance of response in metastatic renal cell carcinoma.

Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2.

The primary objective of the study is overall survival; secondary objectives are progression-free survival, response rate, toxicity, and quality of life.

ReferenceCitation: Negrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Français d'Immunothérapie. N Engl J Med. 1998 Apr 30;338(18):1272-8.

ReferenceCitation: Ravaud A, Delva R, Gomez F, Chevreau C, Douillard JY, Peny J, Coudert B, Négrier S; Groupe Français d'Immunothérapie. Subcutaneous interleukin-2 and interferon alpha in the treatment of patients with metastatic renal cell carcinoma-Less efficacy compared with intravenous interleukin-2 and interferon alpha. Results of a multicenter Phase II trial from the Groupe Français d'Immunothérapie. Cancer. 2002 Dec 1;95(11):2324-30.

ReferenceCitation: Négrier S, Escudier B, Gomez F, Douillard JY, Ravaud A, Chevreau C, Buclon M, Pérol D, Lasset C. Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Français d'Immunothérapie. Ann Oncol. 2002 Sep;13(9):1460-8.

lead_sponsor: Centre Leon Berard


status: Active, not recruiting

study_start_date_type: Actual

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
United States
Netherlands
France
Poland
Israel
Hungary
Belgium
Canada
United Kingdom
Ukraine

acronym: Hubble Zoom

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Children's Center for Digestive Healthcare

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

location_facility: Nemours Childrens Specialty Care - Jacksonville

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: Schneider Children's Medical Center of Israel

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust

location_facility: London Health Sciences Centre University Hospital

location_facility: Kharkiv Regional Clinical Children's Hospital

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

type: Other Identifier

type: Registry Identifier

source: euctr

title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

summary: The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

status_simplified: Ongoing


location_country:
United States
Netherlands
Germany
France
Poland
Israel
Hungary
Belgium
Canada
United Kingdom
Ukraine

acronym: Hubble

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Children's Center for Digestive Healthcare

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Children's and Women's Health Centre of British Columbia

location_facility: Universitatsmedizin Rostock - Kinder und Jugendklinik

location_facility: National Scientific Center of Radiological Medicine of NAMS of Ukraine

location_facility: Children's Specialty Group - Medical Center Location

location_facility: Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: University Hospitals Rainbow Babies & Children's Hospital

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: McGill University Health Centre Glen Site

location_facility: Great Ormond Street Hospital for Children NHS Trust

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

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Hopital Universitaire des Enfants Reine Fabiola

title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

summary: The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.


title: Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.

summary: To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.

lead_sponsor: University Hospital, Montpellier


title: Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

summary: To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation in 12 healthy male subjects.

ReferenceCitation: Chevassus H, Farret A, Gagnol JP, Ponçon CA, Costa F, Roux C, Galtier F, Petit P. Psychological and physiological effects of bupropion compared to methylphenidate after prolonged administration in healthy volunteers (NCT00285155). Eur J Clin Pharmacol. 2013 Apr;69(4):779-87. doi: 10.1007/s00228-012-1418-z. Epub 2012 Oct 9.

family: Chevassus

full_name: Hugues Chevassus

given: Hugues

family: Farret

full_name: Anne Farret

given: Anne

family: Gagnol

full_name: Jean-Pierre Gagnol

given: Jean-Pierre

family: Ponçon

full_name: Claire-Anne Ponçon

given: Claire-Anne

family: Costa

full_name: Françoise Costa

given: Françoise

family: Roux

full_name: Clarisse Roux

given: Clarisse

family: Galtier

full_name: Florence Galtier

given: Florence

family: Petit

full_name: Pierre Petit

given: Pierre

journal_name: European Journal of Clinical Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer


title: Assessment of the Effect of Rosiglitazone on Insulin Secretion in Healthy Volunteers

summary:
To evaluate :

acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)
on insulin secretion and
insulin sensitivity in 12 healthy male subjects.

ReferenceCitation: Farret A, Chevassus H, Roux B, Petit P, Galtier F. Direct rosiglitazone-induced modifications in insulin secretion, action and clearance: a single-dose hyperglycaemic clamp study. Diabetologia. 2007 Jul;50(7):1384-7. Epub 2007 May 8.


title: Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels (110- 129 g/L and 130 - 149 g/L) on Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes and With Chronic Kidney Disease

summary:
In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use, control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake restriction, smoking cessation.

Correcting anaemia in these patients may prevent impairment of renal function. International guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct an interventional randomized trial to evaluate the potential benefit of an haemoglobin level of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a Cockcroft's creatinine clearance of 25 - 60 ml/min.

ReferenceCitation: Villar E, Lièvre M, Kessler M, Lemaître V, Alamartine E, Rodier M, François M, Zaoui P, Moranne O, Choukroun G, Guerraoui A, Jolivot A, Janin G, Branger B, Heng AE, Boudray C, Bissery A, Rabilloud M, Pouteil-Noble C. Anemia normalization in patients with type 2 diabetes and chronic kidney disease: results of the NEPHRODIAB2 randomized trial. J Diabetes Complications. 2011 Jul-Aug;25(4):237-43. doi: 10.1016/j.jdiacomp.2011.03.003. Epub 2011 May 20.

family: Villar

full_name: Emmanuel Villar

given: Emmanuel

family: Lièvre

full_name: Michel Lièvre

given: Michel

full_name: Michèle Kessler

given: Michèle

family: Lemaître

full_name: Vincent Lemaître

given: Vincent

family: Alamartine

full_name: Eric Alamartine

given: Eric

family: Rodier

full_name: Michel Rodier

family: François

full_name: Maud François

given: Maud

family: Zaoui

full_name: Philippe Zaoui

given: Philippe

family: Moranne

full_name: Olivier Moranne

given: Olivier

family: Choukroun

full_name: Gabriel Choukroun

given: Gabriel

family: Guerraoui

full_name: Abdallah Guerraoui

given: Abdallah

family: Jolivot

full_name: Anne Jolivot

family: Janin

full_name: Gérard Janin

given: Gérard

family: Branger

full_name: Bernard Branger

given: Bernard

family: Heng

full_name: Anne-Elisabeth Heng

given: Anne-Elisabeth

family: Boudray

full_name: Catherine Boudray

given: Catherine

family: Bissery

full_name: Alvine Bissery

given: Alvine

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Pouteil-Noble

full_name: Claire Pouteil-Noble

given: Claire

journal_name: Journal of Diabetes and its Complications


title: Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

summary: Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).

ReferenceCitation: Wissel J, Müller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9.

lead_sponsor: University Hospital, Clermont-Ferrand


title: The Effects of Transcranial Electrical Stimulation (TCES) on Cerebral Blood Flow (CBF) With Xenon Under Computerized Tomography (Xe/CT)

summary: Direct stimulation of the cerebral cortex induces an increase in cerebral blood flow. Although this information is known, it has never been documented during Transcranial Cerebral Electrical Stimulation (TCES), which is a non invasive technique. It is used to modulate the opiate endogenous system, mainly in opioid users but no cerebral blood flow mapping of the anatomic regions involved in this modulation of the opiate system under electrical stimulation has been performed in functional Computerized Tomography.

ReferenceCitation: Gense de Beaufort D, Sesay M, Stinus L, Thiebaut R, Auriacombe M, Dousset V. Cerebral blood flow modulation by transcutaneous cranial electrical stimulation with Limoge's current. J Neuroradiol. 2012 Jul;39(3):167-75. doi: 10.1016/j.neurad.2011.06.001. Epub 2011 Aug 10.

family: Gense de Beaufort

full_name: D. Gense de Beaufort

given: D.

family: Sesay

full_name: M. Sesay

given: M.

family: Stinus

full_name: L. Stinus

given: L.

family: Thiebaut

full_name: R. Thiebaut

given: R.

family: Auriacombe

full_name: M. Auriacombe

family: Dousset

full_name: V. Dousset

given: V.

journal_name: Journal of Neuroradiology

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Neuro-radiologie, hôpital Pellegrin

intervention_type: Device


title: A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)

summary:
Primary : To determine the safety profile of each treatment group.
Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.

lead_sponsor: Sanofi

intervention_type: Radiation


title: A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients

acronym: VARIABILITE

summary:
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.

·Secondary objectives:

Efficacy:

To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
To compare the glycaemic profiles (7 points)
To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.

Tolerance:

To record undesirable events
To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

ReferenceCitation: Renard E, Dubois-Laforgue D, Guerci B; Variability Study Group. Non-inferiority of insulin glargine versus insulin detemir on blood glucose variability in type 1 diabetes patients: a multicenter, randomized, crossover study. Diabetes Technol Ther. 2011 Dec;13(12):1213-8. doi: 10.1089/dia.2011.0063. Epub 2011 Aug 2.

name: Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital and INSERM Clinical Investigation Centre 1001, Montpellier, France.

family: Renard

full_name: Eric Renard

given: Eric

name: Immunology & Diabetology, Cochin Hospital, Paris, France.

family: Dubois-Laforgue

full_name: Danièle Dubois-Laforgue

given: Danièle

name: Diabetology, Nutrition, Metabolic Disorders and Centre of Clinical Investigation, Hospital Jeanne d'Arc, University Hospital Center of Nancy, Toul, France.

family: Guerci

full_name: Bruno Guerci

given: Bruno

family: on behalf of the Variability Study

full_name: on behalf of the Variability Study

journal_name: Diabetes Technology & Therapeutics

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Non-Inferiority of Insulin Glargine Versus Insulin Detemir on Blood Glucose Variability in Type 1 Diabetes Patients: A Multicenter, Randomized, Crossover Study


title: Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive.

acronym: LIZ-BONE

summary: The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.

location_country: Italy France Spain

location_facility: Azienda Opedaliera Universitaria San Maria della Misericordia

location_facility: Centre de Chirurgie Orthopédique et de la Main

location_facility: Hospital General Universitario Gregorio Maranon


title: Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

summary:
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:

Repair of root or furcation perforations.
Repair of root resorptions (internal and external).
Root-end filling in endodontic surgery (retrograde filling).
Apexification (tooth with open apex).

Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.

status: Recruiting

study_type: Observational

time_perspective: Other

ipd_sharing: No

lead_sponsor: Septodont

location_facility:
CHU de Reims
CHU de Nantes
Private dental care office
AP-HP, Hôpital Louis Mourier
HCL de Lyon
CHU de Toulouse


title: Prospective, Open-label, Single-arm, Exploratory Study of the Effect and Safety of rhGAA in Patients With Advanced Late-onset Pompe Disease Who Are Receiving Respiratory Support

summary: Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety and efficacy of rhGAA in patients with advanced Late-onset Pompe disease.

lead_sponsor: Genzyme, a Sanofi Company

intervention_type: Biological


lead_sponsor: Pharnext SA

location_country:
United States
Netherlands
France
Belgium
Spain
Canada
United Kingdom

acronym: PLEO-CMT-FU

location_facility: Centro de Diagnostico y Tratamiento, Hospital Universitario Virgen del Rocio

location_facility: Centre de Reference des Maladie Neuromusculaires, CHU la Timone

location_facility: Service de Neurologie, Hopital Kremlin Bicetre

location_facility: Servicio de Neurologia, Hospital Universitario La Paz

location_facility: Centre de Reference des Neuropathies Peripheriques Rare, Hopital Dupuytren, CHU Limoges

location_facility: Peripheral Neuropathy Center, Neurological Institue Building, Columbia University Medical Center

location_facility: Department of Neurology, University of Minnesota

location_facility: Service de Neurologie et du Sommeil, CHU Lyon Sud

location_facility: Department of Neurology, Cedars-Sinai Medical Center

location_facility: Cntre de Reference des Maladies Neuromusculaires, Hopital Swynghedauwl, CHU Lille

location_facility: Department of Neurology, McKnight Brain Institute

location_facility: Servicio de Neurologia, Hospital Universitario i Politécnic La Fe

location_facility: Departement of Neurology, Academic Medical Center

location_facility: Department of Neurology and Psichiatry, Saint Louis University

location_facility: Centre de Reference des Maladie Neuromusculaires, Hotel Dieu, CHU de Nantes

location_facility: Department of Neurology, Salford Royal NHS Foundation Trust

location_facility: Department of neurology, Hospital Univesitario de Bellvitge

title: International, Multi-center, Open Label, Follow-up Extension Study Assessing the Long-term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

summary:
All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary study CLN-PXT3003-02, i.e. treatment with PXT3003 or placebo, are eligible to continue in the extension study CLN-PXT3003-03.

Period 1: Patients randomised to PXT3003 dose 1 or placebo in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 1 (5 mL). Patients randomised to PXT3003 dose 2 (5 mL) in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 2 or PXT3003 twice dose 1 (2x5 mL).

Period 2: All patients continue on twice dose 1 (2X5mL).


title: Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Treatment Taken 4 Consecutive Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Therapy

acronym: QUATUOR

summary: The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre Hospitalier Général de Saint Nazaire


title: Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

acronym: DIPLOMAT

summary: The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

lead_sponsor: Cordis Corporation


title: Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors

summary: To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.

lead_sponsor: MedImmune LLC


title: Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory (ARAMIS: Apport d'un Recrutement Alveolaire Sur Les Marqueurs de l'Inflammation Dans le SDRA)

summary:
Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which could be worsened by mechanical ventilation.This included a proteasis - antiproteasis imbalance which could participate to a fibrosis process.

Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (< 30 cm H2O) has been proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg) ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.

Using recruitment maneuvers (i.e. the application during a short time of high pressures with the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve oxygen and to reduce bio-trauma.

However, the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown.

Therefore we have planned a randomized, monocentric, controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference.

They will be randomized in two groups: standard low-volume ventilation vs. recruitment maneuvers.

The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation.

The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.

Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics and visceral dysfunction scores.

lead_sponsor: University Hospital, Tours


title: Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia

summary:
Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure.

The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia.

ReferenceCitation: Grünig E, Mereles D, Hildebrandt W, Swenson ER, Kübler W, Kuecherer H, Bärtsch P. Stress Doppler echocardiography for identification of susceptibility to high altitude pulmonary edema. J Am Coll Cardiol. 2000 Mar 15;35(4):980-7.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou


title: Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

summary: Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will test the safety and efficacy of rituximab in the treatment of patients with anti-MAG polyneuropathy.

ReferenceCitation: Léger JM. A review of the medical management of chronic inflammatory demyelinating polyradiculoneuropathy. Expert Opin Pharmacother. 2005 Apr;6(4):569-82. Review.

location_facility: Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski


title: In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

summary: Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.


title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis

acronym: PDOne

summary: The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.

lead_sponsor: Fresenius Medical Care Deutschland GmbH

location_country:
Sweden
France
Denmark
Germany
United Kingdom

location_facility: University of North Staffordshire - Renal Medicine - Royal Infirmary

location_facility: KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

location_facility: KfH-Nierenzentrum am Krankenhaus Oststadt


title: A Multi-Center, Multinational, Randomized, Double-Blind, Parallel Group Study of the Effects of Ciclesonide Hfa-Mdi 640 μg/Day and Beclomethasone Hfa-Mdi 640 μg/Day on Lens Opacification in Adult Subjects With Moderate to Severe Persistent Asthma

summary: The primary objective is to demonstrate the non-inferiority of ciclesonide compared to beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months. Secondary objectives are to compare ciclesonide and beclomethasone with respect to class II and class III best corrected visual acuity and intraocular pressure from baseline to 12 months.

ReferenceCitation: Chylack LT Jr, Gross GN, Pedinoff A; Ciclesonide Lenticular Safety Study Group. A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. J Asthma. 2008 Dec;45(10):893-902. doi: 10.1080/02770900802353636.

family: Chylack

full_name: Leo T. Chylack

given: Leo T.

suffix: Jr.

family: Gross

full_name: Gary N. Gross

given: Gary N.

family: Pedinoff

full_name: Andrew Pedinoff

given: Andrew

family: The Ciclesonide Lenticular Safety S

full_name: The Ciclesonide Lenticular Safety S

journal_name: Journal of Asthma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: A Randomized, Controlled Trial to Investigate the Effect of Ciclesonide and Beclomethasone Dipropionate on Eye Lens Opacity


title: Morphofunctional Imaging and Developmental Dyslexia

summary: Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.

time_perspective: Prospective


title: A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)

acronym: CONSORT

summary: Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

ReferenceCitation: Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204.

ReferenceCitation: Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.

family: Olivennes

full_name: F Olivennes

given: F

family: Howies

full_name: CM Howies

given: CM

family: Borini

full_name: A Borini

given: A

family: Germond

full_name: M Germond

given: M

family: Trew

full_name: G Trew

given: G

family: Wikland

full_name: M Wikland

family: Zegers-Hochschild

full_name: F Zegers-Hochschild

family: Saunders

full_name: H Saunders

given: H

family: Alam

full_name: V Alam

given: V

journal_name: Reproductive BioMedicine Online

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device

acronym: PROMIR

summary:
I.SPACE® is a hyaluronic acid injectable gel CE (European Conformity) marketed since 2010. It is indicated for use as a surgical aid in ophthalmic anterior segment surgery. The aim is to protect the corneal endothelium and maintains the intraocular space.The product should be instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour.

In this study, 80 patients aged from 18 to 84 years' old at inclusion, who have at least one eye with cataract (mild to moderate severity) based on subjective ophthalmic examination by the investigator, who have given his/her informed consent and meet all the eligibility criteria, will be enrolled.

Subjects will come to a total of 7 visits over a period of 3 months. Protection of corneal endothelium (Mean percent change of CEC density) after baseline injection will be assessed. Surgeon's satisfaction during cataract surgery, mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, corneal thickness, intraocular inflammation, Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and safety will be also assessed.

study_start_date_type: Anticipated

lead_sponsor: Laboratoires Vivacy

location_facility: Clinique d'ANJOU Pôle de consultation Tassigny


title: Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

summary:
EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

lead_sponsor: EUROS

location_facility:
Centre Hospitalier SECLIN
Clinique de L'Atlantique
Clinique Esquirol Saint Hilaire
Clinique St Roch


title: Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment

acronym: DEFISTEP

summary: The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.

status: Not yet recruiting

ReferenceCitation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

ReferenceCitation: Barreto LC, Oliveira FS, Nunes PS, de França Costa IM, Garcez CA, Goes GM, Neves EL, de Souza Siqueira Quintans J, de Souza Araújo AA. Epidemiologic Study of Charcot-Marie-Tooth Disease: A Systematic Review. Neuroepidemiology. 2016;46(3):157-65. doi: 10.1159/000443706. Epub 2016 Feb 6. Review.

ReferenceCitation: Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S, Razak NA. Transtibial prosthesis suspension systems: systematic review of literature. Clin Biomech (Bristol, Avon). 2014 Jan;29(1):87-97. doi: 10.1016/j.clinbiomech.2013.10.013. Epub 2013 Oct 29. Review.

ReferenceCitation: Zucker DR, Ruthazer R, Schmid CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol. 2010 Dec;63(12):1312-23. doi: 10.1016/j.jclinepi.2010.04.020. Epub 2010 Sep 22.

ReferenceCitation: Spieler JF, Amarenco P. [Socio-economic aspects of stroke management]. Rev Neurol (Paris). 2004 Nov;160(11):1023-8. Review. French.

lead_sponsor: Thuasne

location_facility:
Hôpital Rothschild
CHU Strasbourg
centre Louis PIERQUIN
CHU Lille


title: Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

summary:
To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. The signals are analysed and processed by software which computes a number of parameters describing the movements.

Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. The final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

ReferenceCitation: Hammacher K, Hüter KA, Bokelmann J, Werners PH. Foetal heart frequency and perinatal condition of the foetus and newborn. Gynaecologia. 1968;166(4):349-60.

ReferenceCitation: Karlsson B, Berson M, Helgason T, Geirsson RT, Pourcelot L. Effects of fetal and maternal breathing on the ultrasonic Doppler signal due to fetal heart movement. Eur J Ultrasound. 2000 Mar;11(1):47-52.

ReferenceCitation: Melendez TD, Rayburn WF, Smith CV. Characterization of fetal body movement recorded by the Hewlett-Packard M-1350-A fetal monitor. Am J Obstet Gynecol. 1992 Sep;167(3):700-2.

ReferenceCitation: Timor-Tritsch I, Zador I, Hertz RH, Rosen MG. Classification of human fetal movement. Am J Obstet Gynecol. 1976 Sep 1;126(1):70-7.

ReferenceCitation: Shinozuka N, Yamakoshi Y. Measurement of fetal movements using multichannel ultrasound pulsed Doppler: autorecognition of fetal movements by maximum entropy method. Med Biol Eng Comput. 1993 Jul;31 Suppl:S59-66.

ReferenceCitation: Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. Review.


title: Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

summary:
This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.

This real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.

An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.

To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).

This agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.

ReferenceCitation: Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51.

ReferenceCitation: Watermann D, Madjar H, Sauerbrei W, Hirt V, Prömpeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.

ReferenceCitation: Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. Review.

ReferenceCitation: Hansen S, Grabau DA, Rose C, Bak M, Sørensen FB. Angiogenesis in breast cancer: a comparative study of the observer variability of methods for determining microvessel density. Lab Invest. 1998 Dec;78(12):1563-73.

ReferenceCitation: Hansen S, Grabau DA, Sørensen FB, Bak M, Vach W, Rose C. The prognostic value of angiogenesis by Chalkley counting in a confirmatory study design on 836 breast cancer patients. Clin Cancer Res. 2000 Jan;6(1):139-46.

ReferenceCitation: Smith IC, Welch AE, Hutcheon AW, Miller ID, Payne S, Chilcott F, Waikar S, Whitaker T, Ah-See AK, Eremin O, Heys SD, Gilbert FJ, Sharp PF. Positron emission tomography using [(18)F]-fluorodeoxy-D-glucose to predict the pathologic response of breast cancer to primary chemotherapy. J Clin Oncol. 2000 Apr;18(8):1676-88.

ReferenceCitation: Schelling M, Avril N, Nährig J, Kuhn W, Römer W, Sattler D, Werner M, Dose J, Jänicke F, Graeff H, Schwaiger M. Positron emission tomography using [(18)F]Fluorodeoxyglucose for monitoring primary chemotherapy in breast cancer. J Clin Oncol. 2000 Apr;18(8):1689-95.

ReferenceCitation: Denis F, Bougnoux P, Paon L, le Floch O, Tranquart F. Radiosensitivity of rat mammary tumors correlates with early vessel changes assessed by power Doppler sonography. J Ultrasound Med. 2003 Sep;22(9):921-9.

ReferenceCitation: Denis F, Colas S, Chami L, Louisot P, Le Floch O, Tranquart F, Bougnoux P. Changes in tumor vascularization after irradiation, anthracyclin, or antiangiogenic treatment in nitrosomethyl ureas-induced rat mammary tumors. Clin Cancer Res. 2003 Oct 1;9(12):4546-52.

ReferenceCitation: Kook SH, Kwag HJ. Value of contrast-enhanced power Doppler sonography using a microbubble echo-enhancing agent in evaluation of small breast lesions. J Clin Ultrasound. 2003 Jun;31(5):227-38.

ReferenceCitation: Solesvik OV, Rofstad EK, Brustad T. Vascular changes in a human malignant melanoma xenograft following single-dose irradiation. Radiat Res. 1984 Apr;98(1):115-28.


acronym: DYS-AUT

summary: Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.


title: Optical Genome Mapping in Hematological Malignancies

acronym: CARTOGEN

summary: Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer

time_perspective: Retrospective

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH Morlaix, service d'hémato clinique
CHIC, service d'hémato clinique
CH St Brieuc, service d'hémato clinique
CHRU de Brest


title: Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

acronym: Sleevepexie

summary:
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.

This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.

Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).

The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Clinique Santé Atlantique
Hopital Pontchaillou
CHU Nantes
CHD Vendée


title: Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

summary:
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

location_facility:
CHU Gabriel Montpied
Clinique montagard
Hôpital Saint Joseph-Saint Luc
Clinique Montagard


title: Mechanisms fo Clopidogrel Resistance in Older Adults

acronym: CEPAGE

summary: A clopidogrel resistance rate of 40-50% has been found in the population over 70 years of age, whereas biological resistance, associated with an increased risk of cardiovascular events, is observed in about 20-30% of younger patients. One hypothesis is that the active metabolite is less available in resistant patients. Indeed, 85% of the absorbed clopidogrel undergoes inactivation by esterases. Then the remaining fraction undergoes two steps of metabolisation to the active thiol metabolite by CYP450, essentially the isoform 2C19. In older adults, increased esterase activity and/or decreased CYP450 2C19 activity may lead to a decreased concentration of the active metabolite. Multiple chronic conditions and polypharmacy encountered in older individuals are associated with basal platelet hyperactivity, and may also contribute to a poor response to clopidogrel. No data on the relationship between platelet response and circulating metabolite levels, or on the determinants of response to clopidogrel, are currently available in the geriatric population. Therefore, we propose to analyse the relationship between age and platelet and extra-platelet mechanisms potentially involved in the variability of response to clopidogrel.

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital Charles Foix
CHU de RENNES
Hôpital Européen Georges Pompidou,
Hôpital Lariboisière


title: Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population

acronym: PSYGEN

summary:
The treatment of depression, anxiety disorders and post-traumatic stress disorder (PTSD) is a main public health problem due to the frequency of these pathologies and the very partial effectiveness of the existent therapies. These illnesses generally require the prescription of several successive lines of antidepressant treatments before the treatments actually become effective, leading to a several week delay during which the patient suffers from the symptoms of his/her pathology and is also likely to experience the side effects of the treatment.

Pharmacogenetics is an individualized prescribing modality that aims to predict the most favorable treatment for a given individual based on the study of genetic variants of cytochromes.

The main hypothesis of this research is that the use of pharmacogenetics in routine practice in a population of military personnel requiring a first prescription of an antidepressant is of interest to improve the tolerance and effectiveness of the treatment.

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Hôpital d'Instruction des Armées Laveran


title: Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

summary:
Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.

Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.


title: The Arginine Vasopressin aXis as a Potential Therapeutic Target for Posterior REverSible Encephalopathy SyndromE (XPRESSE)

acronym: XPRESSE

summary:
XPRESSE is a multicenter observational prospective biomarker study in which critically ill patients with MRI-based PRES diagnosis will have copeptin kinetics from a daily blood sample for 6 days and a 3-month follow-up. This study aims to investigate the relationship between copeptin and PRES in order to establish the optimal therapeutic time window for vaptan treatment against PRES.

Data collection using an electronic case report form will include demographic data, medical history and data related to PRES: onset modalities and date of symptoms control, radiological features of PRES, biological investigations, results of etiological investigations and therapeutic management (e.g., anticonvulsants, antihypertensive drugs, supportive treatments). Outcomes will include modified Rankin scale score and Glasgow Outcome Scale score at ICU discharge, 3-month modified Rankin Scale score and 3-month mortality.

location_facility:
Hospital
University hospital


title: Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

summary:
The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

ReferenceCitation: Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65.

ReferenceCitation: Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan;35(1):65-71.

ReferenceCitation: Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. Review.


title: RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy

summary:
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.

Secondary objective :

To evaluate the resorbable device ergonomy versus Titanium.
To evaluate the clinical tolerance of resorbable device versus Titanium.

Hypothesis :

Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.

Study duration : 14 months for each patient.

Study treatment :

Group I : Resorbable device PLLA/PGA.
Group II : Titanium device.

Study visits :

- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.

Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.

lead_sponsor: Hospices Civils de Lyon


title: Effect of Domperidone on QT Interval in Premature Infants

summary: 30 premature infants treated by domperidone upon decision of the attending neonatologist will have a daily recording of electrocardiogram for the first 7 seven days of treatment, and pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature infants, matched for gestational age, postnatal age and sex.

lead_sponsor: Nantes University Hospital


title: Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

acronym: THS

summary: Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

ReferenceCitation: Colditz GA, Willett WC, Stampfer MJ, Rosner B, Speizer FE, Hennekens CH. Menopause and the risk of coronary heart disease in women. N Engl J Med. 1987 Apr 30;316(18):1105-10.

ReferenceCitation: Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53.

ReferenceCitation: Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33.

ReferenceCitation: Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. Review.

ReferenceCitation: Scarabin PY, Alhenc-Gelas M, Plu-Bureau G, Taisne P, Agher R, Aiach M. Effects of oral and transdermal estrogen/progesterone regimens on blood coagulation and fibrinolysis in postmenopausal women. A randomized controlled trial. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):3071-8.

ReferenceCitation: Teede HJ, McGrath BP, Smolich JJ, Malan E, Kotsopoulos D, Liang YL, Peverill RE. Postmenopausal hormone replacement therapy increases coagulation activity and fibrinolysis. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1404-9.

ReferenceCitation: Conard J, Basdevant A, Thomas JL, Ochsenbein E, Denis C, Guyene TT, Degrelle H. Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol. Fertil Steril. 1995 Nov;64(5):957-62.

ReferenceCitation: Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43.

ReferenceCitation: Mallat Z, Heymes C, Ohan J, Faggin E, Lesèche G, Tedgui A. Expression of interleukin-10 in advanced human atherosclerotic plaques: relation to inducible nitric oxide synthase expression and cell death. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):611-6.

ReferenceCitation: Mallat Z, Hugel B, Ohan J, Lesèche G, Freyssinet JM, Tedgui A. Shed membrane microparticles with procoagulant potential in human atherosclerotic plaques: a role for apoptosis in plaque thrombogenicity. Circulation. 1999 Jan 26;99(3):348-53.

ReferenceCitation: Mallat Z, Benamer H, Hugel B, Benessiano J, Steg PG, Freyssinet JM, Tedgui A. Elevated levels of shed membrane microparticles with procoagulant potential in the peripheral circulating blood of patients with acute coronary syndromes. Circulation. 2000 Feb 29;101(8):841-3.

ReferenceCitation: Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6.

ReferenceCitation: Cushman M, Legault C, Barrett-Connor E, Stefanick ML, Kessler C, Judd HL, Sakkinen PA, Tracy RP. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation. 1999 Aug 17;100(7):717-22.

ReferenceCitation: Scarabin PY, Alhenc-Gelas M, Oger E, Plu-Bureau G. Hormone replacement therapy and circulating ICAM-1 in postmenopausal women--a randomised controlled trial. Thromb Haemost. 1999 May;81(5):673-5.

ReferenceCitation: van Baal WM, Smolders RG, van der Mooren MJ, Teerlink T, Kenemans P. Hormone replacement therapy and plasma homocysteine levels. Obstet Gynecol. 1999 Oct;94(4):485-91.


title: Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial

acronym: VAPEUR RCT

summary: The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

lead_sponsor: Boston Scientific Corporation

location_facility:
Clinique Saint Hilaire
CHU de Rennes
Centre Hospitalier Privé Saint Grégoire
Centre Hospitalier du Pays d'Aix


title: "Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"

acronym: LUTARTERIAL

summary: The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).

lead_sponsor: University Hospital, Bordeaux

location_facility: Institut de cancérologie du Gard (ICG) - CHU de Nîmes

location_facility: Institut universitaire du cancer de Toulouse (IUCT) Oncopole


title: ETADAPT- Evaluation of the Impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and Dietetic on the Reproducibility of Radiotherapy Sessions for Prostate Cancers.

acronym: ETADAPT

summary:
The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe).

The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits.

For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.

primary_purpose: Other

lead_sponsor: Centre Leon Berard

location_facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau


title: Evaluation of Effect and Tolerance of the Association of Baricitinib (4 mg) and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized, Double-blind, Prospective, Non-comparative Phase II Study.

acronym: BARVIT

summary: The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of Baricitinib in combination with phototherapy in adult participants with non-segmental progressive vitiligo.

location_facility: Service de dermatologie - Hôpital Henri Mondor - EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques)

location_facility: Centre Hospitalier Universitaire de Nice - Service de Dermatologie

location_facility: Service de Dermatologie - Hôpital Saint-André

location_facility: Service de dermatologie Centre de Référence des Maladies Rares de la Peau et des muqueuses d'origine génétique - Hôpital Larrey


title: Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

acronym: ONDELA

summary: Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.

lead_sponsor: Hopital Foch

location_facility:
Foch hospital
Hôpital Rangueil
Centre d'Urologie du Polygone
Hôpital Pasteur 2


title: Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

summary: The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms.


title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?

acronym: ADONIS

summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.

ReferenceCitation: Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR. High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. JAMA. 1995 Nov 1;274(17):1353-8.

ReferenceCitation: Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.

family: Berlin

full_name: Ivan Berlin

given: Ivan

family: Singleton

full_name: Edward G. Singleton

given: Edward G.

family: Heishman

full_name: Stephen J. Heishman

given: Stephen J.

journal_name: Drug and Alcohol Dependence

ReferenceCitation: Berlin I, Singleton EG, Heishman SJ. Predicting smoking relapse with a multidimensional versus a single-item tobacco craving measure. Drug Alcohol Depend. 2013 Oct 1;132(3):513-20. doi: 10.1016/j.drugalcdep.2013.03.017. Epub 2013 Apr 23.

ReferenceCitation: Berlin I, Jacob N, Coudert M, Perriot J, Schultz L, Rodon N. Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities. Addiction. 2011 Apr;106(4):833-43. doi: 10.1111/j.1360-0443.2010.03306.x. Epub 2011 Feb 14.

family: Jacob

full_name: Nelly Jacob

given: Nelly

family: Coudert

full_name: Mathieu Coudert

given: Mathieu

family: Perriot

full_name: Jean Perriot

given: Jean

family: Schultz

full_name: Laurette Schultz

given: Laurette

family: Rodon

full_name: Nicolas Rodon

given: Nicolas

journal_name: Addiction

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique


title: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

summary: Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière