title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-335 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

summary: This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

ReferenceCitation: McClure MW, Berliba E, Tsertsvadze T, Streinu-Cercel A, Vijgen L, Astruc B, Patat A, Westland C, Chanda S, Zhang Q, Kakuda TN, Vuong J, Khorlin N, Beigelman L, Blatt LM, Fry J. Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects. PLoS One. 2018 Oct 16;13(10):e0204974. doi: 10.1371/journal.pone.0204974. eCollection 2018.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

location_facility: Arensia, Research Institute of Clinical Medicine


type: EudraCT Number

title: A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

acronym: OPTIMA

summary: This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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 pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Georg Thieme

lead_sponsor: Ferring Pharmaceuticals

location_country: Germany Netherlands France

location_facility: Gastroenterologie am Bayerischen Platz (there may be other sites in this country)

location_facility: Medisch Centrum Alkmaar (there may be other sites in this country)

location_facility: Ed Herriot Hopital (there may be other sites in this country)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

acronym: AP Hybrid

summary: The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

primary_purpose: Treatment

ReferenceCitation: Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Montpellier

location_country: Italy Netherlands France

location_facility:
University of Amsterdam
CHU Montpellier
University of Padova

intervention_type: Device

lead_sponsor_type: academique


title: Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

summary: The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.

design_allocation: Non-Randomized

lead_sponsor: Bial - Portela C S.A.

location_country:
Russian Federation
France

location_facility:
Biotrial, 7-9 rue Jean-Louis Bertrand
City clinical Hospital N°64
City clinical Hospital N°3


title: A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

summary: The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.

ipd_sharing: No

lead_sponsor: Rhizen Pharmaceuticals SA

location_country: Italy France

location_facility:
Rhizen Trial Site
Rhizen Trial Site 1
Rhizen Trial Site 2


title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

summary: Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Philipp Schuetz

sponsor_collaborators:
Philipp Schuetz
Thermo Fisher Scientific, Inc

location_country: Germany Switzerland France

location_facility: Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)

location_facility: Pitié Salpetrière. Groupement hospitalière universitaire Est


title: A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State

summary:
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).

lead_sponsor: Novo Nordisk A/S

location_country: Germany Israel France


title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

summary: This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

lead_sponsor: Hoffmann-La Roche


summary: This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.


title: ETAMI-Study: Early Thienopyridine Treatment to Improve Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

acronym: ETAMI

summary: Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium.

ReferenceCitation: Zeymer U, Mochmann HC, Mark B, Arntz HR, Thiele H, Diller F, Montalescot G, Zahn R. Double-blind, randomized, prospective comparison of loading doses of 600 mg clopidogrel versus 60 mg prasugrel in patients with acute ST-segment elevation myocardial infarction scheduled for primary percutaneous intervention: the ETAMI trial (early thienopyridine treatment to improve primary PCI in patients with acute myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):147-154. doi: 10.1016/j.jcin.2014.09.007. Epub 2014 Nov 4.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Stiftung Institut fuer Herzinfarktforschung

location_country: Germany France

location_facility: Charité Campus Benjamin Franklin, Med. Klinik II


summary:
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.

lead_sponsor: Integra LifeSciences Services

location_country: Italy Greece France

location_facility: Aristotle University of Thessaloniki - Papageorgiou General Hospital


title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

summary:
In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.

However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics:

plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness;
anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution.

The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.

The purpose of this study is to collect and publish data from several centers, several users.

location_country:
United Kingdom
Lebanon
France

location_facility: Centre Hospitalier universitaire Notre Dame de secours


title: Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study

summary:
Background of the study:

Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.

A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.

Objective of the study:

The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.

Study design:

This study is a multicenter, single-blinded, randomized, placebo-controlled trial.

Primary study parameters/outcome of the study:

The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.

Secondary study parameters/outcome of the study (if applicable):

Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)

Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)

Subject's and Physician's Global Impression

ReferenceCitation: van der Wilt AA, Giuliani G, Kubis C, van Wunnik BPW, Ferreira I, Breukink SO, Lehur PA, La Torre F, Baeten CGMI. Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence. Br J Surg. 2017 Aug;104(9):1167-1176. doi: 10.1002/bjs.10590.

publisher_dissemination: Oxford University Press

lead_sponsor: Maastricht University Medical Center

location_facility: Università degli Studi di Roma "La Sapienza"


lead_sponsor: Novartis Pharmaceuticals

summary: This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.

title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma

source: euctr

location_country: Germany Italy France


title: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

summary: Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

time_perspective: Retrospective

lead_sponsor: University of Zurich

location_country: Spain Switzerland France

location_facility: Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital

location_facility: Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital


title: Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.

acronym: REST

summary:
The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

status: Terminated

lead_sponsor: Sanofi

location_country: Spain Sweden France

status_simplified: Unknown


title: An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

summary: This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

location_country:
Spain
United Kingdom
France


title: An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.

summary: The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

ReferenceCitation: Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.

publisher_dissemination: Springer

location_country: Italy Switzerland France

location_facility:
Investigational Site Number 756001
Investigational Site Number 380001
Investigational Site Number 250001


title: A Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056

summary: This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.

ReferenceCitation: Jacquemont S, Curie A, des Portes V, Torrioli MG, Berry-Kravis E, Hagerman RJ, Ramos FJ, Cornish K, He Y, Paulding C, Neri G, Chen F, Hadjikhani N, Martinet D, Meyer J, Beckmann JS, Delange K, Brun A, Bussy G, Gasparini F, Hilse T, Floesser A, Branson J, Bilbe G, Johns D, Gomez-Mancilla B. Epigenetic modification of the FMR1 gene in fragile X syndrome is associated with differential response to the mGluR5 antagonist AFQ056. Sci Transl Med. 2011 Jan 5;3(64):64ra1. doi: 10.1126/scitranslmed.3001708.

lead_sponsor: Novartis


title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

summary: The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings

lead_sponsor: Eli Lilly and Company

location_country: Germany Greece France

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


title: "Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

enrollment_type: Anticipated

ReferenceCitation: Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

lead_sponsor: Pharmexa A/S

location_country: Germany Spain France

location_facility:
Tim F. Greten
Michel Beaugrand
Jordi Bruix

intervention_type: Biological


title: Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

summary: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.

primary_purpose: Prevention

ReferenceCitation: Brink E, Coxam V, Robins S, Wahala K, Cassidy A, Branca F; PHYTOS Investigators. Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women: a randomized, double-blind, placebo controlled study. Am J Clin Nutr. 2008 Mar;87(3):761-70. doi: 10.1093/ajcn/87.3.761.

lead_sponsor: TNO

collaborators: National Institute for Research on Food and Nutrition

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Institute National de la Recherche Agronomique

location_facility: National Institute for Research on Food an Nutrition


title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

acronym: GREAT

summary: The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

ReferenceType: result

ReferenceCitation: Zahringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Beregi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8. doi: 10.1177/152660280701400405.

lead_sponsor: Cordis Corporation

location_facility:
Erasmus MC Rotterdam
Universitätskliniken Köln
Hopital Européen Georges Pompidou


title: Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation

summary: The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation [TBI]/high dose cytarabine [ARA-C]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan [Dexa-BEAM]/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Dreyling M, Lenz G, Hoster E, Van Hoof A, Gisselbrecht C, Schmits R, Metzner B, Truemper L, Reiser M, Steinhauer H, Boiron JM, Boogaerts MA, Aldaoud A, Silingardi V, Kluin-Nelemans HC, Hasford J, Parwaresch R, Unterhalt M, Hiddemann W. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005 Apr 1;105(7):2677-84. doi: 10.1182/blood-2004-10-3883. Epub 2004 Dec 9.

ReferenceCitation: Lenz G, Dreyling M, Hoster E, Wormann B, Duhrsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. doi: 10.1200/JCO.2005.08.133. Epub 2005 Jan 24.

ReferenceCitation: Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hanel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Duhrsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-X. Epub 2016 Jun 14.

ReferenceCitation: Delfau-Larue MH, Klapper W, Berger F, Jardin F, Briere J, Salles G, Casasnovas O, Feugier P, Haioun C, Ribrag V, Thieblemont C, Unterhalt M, Dreyling M, Macintyre E, Pott C, Hermine O, Hoster E; European Mantle Cell Lymphoma Network. High-dose cytarabine does not overcome the adverse prognostic value of CDKN2A and TP53 deletions in mantle cell lymphoma. Blood. 2015 Jul 30;126(5):604-11. doi: 10.1182/blood-2015-02-628792. Epub 2015 May 28.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.

lead_sponsor: European Mantle Cell Lymphoma Network

sponsor_collaborators:
European Mantle Cell Lymphoma Network
German Low Grade Lymphoma Study Group
Lymphoma Study Association

location_country: Germany Poland France

location_facility: Groupe D´Etudes des Lymphomes De l´Adulte (GELA)

location_facility: The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology


title: Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases

summary: The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
United Kingdom
Netherlands
France

location_facility:
Birmingham Children's Hospital
Institut Gustave-Roussy
Emma Kinderziekenhuis AMC


title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study

summary: The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

lead_sponsor: University Hospital, Geneva

location_country: Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Division of Gastroenterology, University Hospital


title: 12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus

summary: The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.

location_country: Germany Netherlands France

location_facility:
Hospital de Rangueil
Sanofi-aventis Administrative Office


acronym: ALPINE

lead_sponsor: Gilead Sciences

summary:
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

ReferenceCitation: Tiddens HA, De Boeck K, Clancy JP, Fayon M, H G M A, Bresnik M, Derchak A, Lewis SA, Oermann CM; ALPINE study investigators. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015 Jan;14(1):111-9. doi: 10.1016/j.jcf.2014.06.003. Epub 2014 Aug 1.

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheilkunde - Abteilung Allg. Kinderheilkunde/Neuropaediatrie

location_facility: Longziekten Universitair Medisch (PEDIATRIC), Ultrecht

location_facility: Centre de Ressources et de Compétences sur la Mucoviscidose ( CRCM), Roscoff, France

location_facility: CHU de Boredaux Hôpital des Enfants - Pellegrin CEDRE

location_facility: Division of Respiratory Medicine and Allergology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands

location_facility: Service pédiatrie II Hôpital Necker Enfants Malades

location_facility: Azienda Ospedaliero-Universitaria di Catania, Dipartimento di Pediatria, UO Broncopneumologia Pediatrica

location_facility: Instytut Matki i Dziecka Klinika Pediatrii

location_facility: Hospital Materno-Infantil Carlos Haya, Servicio de Neumología Pediatrica

location_facility: Pediatric Pulmonology, Dept Pediatrics University Hospital Gasthuisberg

location_facility: Universitaetsklinikum Bonn-Zentrum fuer Kinderheikunde

location_facility: Hospital Vall D' Hebron Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Medizinische Universität Innsbruck Abt. für Kinder- und Jugendheilkunde, Pädiatrie III (Zystische Fibrose)

location_facility: Pediatric Respiratory Department, Ghent University Hospital

location_facility: Centro Fibrosi Cistica di Verona, Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Centre hospitalier Robert Bissons CRCM - service pédiatrie

location_facility: Christiane Herzog CF-Center, Goethe University Hospital

location_facility: Cystic Fibrosis Centre Paediatric Department, A. Meyer Children Hospital Florence

location_facility: Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Fondazione IRCCS, Ospedale Pediatrico, Bambino Gesu' di Roma

location_facility: PennState Milton S. Hershey Medical Center

location_facility: Instytut Gruźlicy i Chorób Płuc, Klinki Pneumologii i Mukowiscydozy

location_facility: Hôpital Universitaire des Enfants Reine Fabiola Brussels

location_facility: Klinik fur Kinder- und Jugendmedizinim St Josef-Hopsital

location_facility: Toledo Children's Hospital CF Research Center

location_facility: Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunolgie Prof. Wahn

location_facility: Paediatrics, University Hospital Brussels (UZB)

location_facility: Hospital infantil Universitario Niño Jesus, Servicio de Neumología Pediatrica

title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)

location_country:
Germany
Italy
Poland
Netherlands
Austria
Belgium
United States
Spain
France


title: Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy

acronym: IRIS 2

summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.

lead_sponsor: Pixium Vision SA

location_country:
Germany
United Kingdom
Austria
Spain
France

location_facility: Dept. of Ophthalmology, University of Bonn

location_facility: Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf

location_facility: Universitäts KlinikumKlinik für Augenheilkunde Freiburg

location_facility: CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)

location_facility: Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild

location_facility: Clinique Ophtalmologique du CHU de Nantes


title: An Open-Label Proof of Concept Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

summary: The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Italy
United Kingdom
Japan
Brazil
United States
France

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP


study_start_date_type: Actual

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

ReferenceCitation: Cohen AD, Mateos MV, Cohen YC, Rodriguez-Otero P, Paiva B, van de Donk NWCJ, Martin T, Suvannasankha A, De Braganca KC, Corsale C, Schecter JM, Varsos H, Deraedt W, Wang L, Vogel M, Roccia T, Xu X, Mistry P, Zudaire E, Akram M, Nesheiwat T, Pacaud L, Avivi I, San-Miguel J. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents. Blood. 2023 Jan 19;141(3):219-230. doi: 10.1182/blood.2022015526.

oa_colors: green hybrid

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Washington University School of Medicine

location_facility: King Faisal Specialist Hospital & Research Center

status: Active, not recruiting

title: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

type: Other Identifier

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
France
Netherlands
Belgium
United States
Saudi Arabia
Spain
Israel

ipd_sharing: Yes

status_simplified: Ongoing


title: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation

acronym: CHAMPION-AF

summary: The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Japan
Netherlands
Switzerland
Belgium
United States
Saudi Arabia
Spain
Canada
France

location_facility: King Fahed Medical City- Prince Salman Cardiac Center

location_facility: Providence Regional Medical Center Everett

location_facility: Novant Health Presbyterian Medical Center

location_facility: Memorial Health University Medical Center

location_facility: Christus Trinity Mother Frances Health System

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Virginia Commonwealth University Health System

location_facility: Memorial Hermann Memorial City Medical Center

location_facility: OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

location_facility: Sparrow Health System - Sparrow Hospital

location_facility: University of Massachusetts Memorial Medical Center

location_facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

location_facility: University of Iowa Hospitals and Clinics


title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

summary: The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of Progressive Supranuclear Palsy.

ReferenceCitation: Hoglinger GU, Schope J, Stamelou M, Kassubek J, Del Ser T, Boxer AL, Wagenpfeil S, Huppertz HJ; AL-108-231 Investigators; Tauros MRI Investigators; Movement Disorder Society-Endorsed PSP Study Group. Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials. Mov Disord. 2017 Jun;32(6):842-852. doi: 10.1002/mds.26973. Epub 2017 Apr 24.

oa_host_type: repository

version: acceptedVersion

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Hoglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators. Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.

repository_institution: University of California - eScholarship University of California

lead_sponsor: Allon Therapeutics

location_country:
Germany
United Kingdom
Australia
United States
Canada
France

location_facility: Clinical Ageing Research Unit (CARU) Newcastle University

location_facility: The Frances J. Zesiewicz Foundation for Parkinson's Disease at USF

location_facility: Universitätsklinikum Carl Carus an der Technischen Universität

location_facility: University of Kansas Medical Center Parkinson Disease & Movement Disorders Center

location_facility: Parkinson's Disease & Movement Disorders Clinic

location_facility: UMDNJ - Robert Wood Johnson Medical Center

location_facility: University of Louisville Division of Movement Disorders

location_facility: Toronto Western Hospital University Health Network

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: University of Minnesota Department of Neuology

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Universität Rostock Zentrum für Nervenheilkunde und Poliklinik

location_facility: Colorado Neurological Institute - Rocky Mountain Movement Disorders Ctr, PC

location_facility: Muhammed Ali Parkinson Center and Movement Disorders Clinic

location_facility: Univeristy of North Carolina Department of Neurology

location_facility: London Sciences Health Center University Hospital

location_facility: Neurologisch Klinik der Ruhr-Universität im St. Josef-Hospital

location_facility: CHUM-Notre Dame Hospital Unité de Troubles du Mouvement

location_facility: University Hospitals Case Medical CenterNI Movement Disorders Center

location_facility: Universitäts- und Rehabilitationskliniken Ulm

location_facility: University of Utah Center for Alzheimer's Care, Imaging &Research

location_facility: University of Texas Southwestern Medical Center


title: Prospective, Multicenter, Post-market, Single Arm Study to Confirm the Performance of the RenzanTM Peripheral Stent System in Treating Superficial Femoral and/or Popliteal Artery Disease

acronym: PRIZER

summary:
The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.

This trial plans to include 135 patients in (up to) 10 locations around in Europe.

lead_sponsor: Terumo Europe N.V.

location_country: Germany Netherlands Belgium Spain France

location_facility: Klinikum Hochsauerland Karolinen-Hospital Hüsten


type: U.S. NIH Grant/Contract

title: Natural History Study in Retinitis Pigmentosa Caused by Mutations in the BEST1 Gene

summary:
The purpose of this study is to establish the natural history of of participants with BESTROPHIN 1 Vitelliform Macular Dystrophy.

The blinding disorder Best Vitelliform Macular Dystrophy (VMD) is caused by any one of more than 250 different mutations in the BEST1 gene.

As new treatments are developed, a clear understanding of the natural history of disease progression of BEST1 VMD is necessary. The goals of this natural history study are to:

Report the natural history of retinal degeneration in participants with a clinical diagnosis of VMD with molecular confirmation of a pathogenic BEST1 mutation(s).
Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of BESTROPHIN 1 VMD.
Compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment
Identify well-defined patient populations for future clinical trials of investigative treatments for BEST1 VMD.

status: Recruiting

lead_sponsor: Columbia University

collaborators: Centre Hospitalier National d'Ophtalmologie

location_country:
United States
Germany
France

location_facility: Institut de la Vision/Centre de maladies rares du Centre Hospitalier National Ophtalmologique des Quinze-Vingts

location_facility: Columbia University Irving Medical Center

intervention_type: Other


title: The SHINE Study: An Open Label, Interventional, Multicentre, Prospective Feasibility Study, Designed to Evaluate the Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects

summary: The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.

primary_purpose: Device Feasibility

lead_sponsor: Indigo Diabetes NV

location_country: Slovenia Belgium France

location_facility: Lapeyronie Montpellier University Hospital


title: Neurodevelopmental Impact of Epilepsy on Autonomic Function in Dravet Syndrome

acronym: AUTONOMIC

summary:
Dravet Syndrome (DS) is a severe epileptic encephalopathy, which main cause is mutations of SCN1A, the gene coding for the Nav1.1 voltage-gated sodium channel. DS is characterized by childhood onset, severe cognitive deficit and drug-resistant seizures, including several generalized convulsive seizures per day, frequent status epilepticus and high seizure-related mortality rate. Sudden and unexpected death in epilepsy (SUDEP) represents the major cause of premature deaths. The risk of SUDEP is thus about 9/1000-person-year in comparison with about 5/1000-person-year in the whole population of patients with drug-resistant epilepsies.

Experimental and clinical data suggest that SUDEP primarily result from a postictal central respiratory dysfunction. SUDEP in DS, might be the result of a seizure-induced fatal apnea in a patient who had developed epilepsy-related vulnerability to central autonomic and/or respiratory dysfunction. However, a key clinical issue which remains to be addressed is the temporal dynamics of the onset and evolution of the autonomic vulnerability in these patients. The main clinical risk factor of SUDEP is the frequency of convulsive seizures and the SUDEP risk can vary along the evolution of epilepsy. Although non-fatal seizure-induced ataxic breathing can be observed in patients with DS, whether or not repetition of seizures results in long-term alterations of breathing remains unclear.

In the AUTONOMIC project, it will be investigate in a homogenous population of patients with DS the exact interplay between epilepsy-related cardiac and respiratory alterations on the one hand and the relation between the underlying neurodevelopmental disease, the repetition of seizure per se and these epilepsy-related autonomic alterations on the other hand.

Autonomic functions will be investigated in the inter-ictal period (i.e. in the absence of immediate seizures, Work Package 1 (WP1)) and in the peri-ictal period, i.e. in the immediate time before, during (if possible) and after seizures (WP2). A multicenter cohort will be constituted, allowing to collect the inter-ictal and ictal cardio-respiratory data required in the 2 WP. The study will be sponsored by the Lyon's University Hospital.

Patients will be recruited over a period of 24 months in one of the three participating clinical center. All patients will first enter in a prospective baseline period of 3 to 6 months duration in order to collect seizure frequency. After this period, all patients will then undergo a 24-48 hours video-EEG recordings as part of the routine clinical care. The monitoring will also include a full-night polysomnography. This patients will be eligible for inclusion in an extension follow-up study will monitor vital status every year in order to investigate long-term mortality, including SUDEP.

The AUTONOMIC project will provide important results which will pave the way to develop and eventually validate therapeutic intervention to prevent SUDEP. By deciphering the exact interplay between epilepsy-related cardiac and respiratory alterations on the one hand and the relation between the underlying neurodevelopmental disease, the repetition of seizure per se and these epilepsy-related autonomic alterations on the other hand, the project will primarily deliver clinically relevant biomarkers.

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_country: Germany Belgium France

location_facility: Klinik und Poliklinik für Epileptologie, Universitätsklinikum

location_facility: Department of Paediatrics and Paediatric Neurology, Antwerp University Hospital

location_facility: Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon


title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

summary: The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in relapsed or refractory DLBCL.

lead_sponsor: Xencor, Inc.

location_country:
United States
Spain
France

location_facility: Hospital Universitario Virgen de las Nieves


title: Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

summary: This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.

lead_sponsor: Guerbet

location_country: Switzerland Austria France

location_facility:
Univ.-Klinik für Radiologie
CHUV
CHU-Hôpital François Mitterrand


title: A Phase 1-2 Multicenter Study (2-stages) to Evaluate the Safety and Efficacy of Intravenous GNT0006, Adeno-associated Viral Vector Carrying the FKRP Gene, in Patients With FKRP-related Limb-girdle Muscular Dystrophy (LGMDR9, Formerly LGMD2I)

summary: Phase 1-2 study including a dose escalation safety and proof of concept phase (Stage 1, open label), followed by a double-blind, randomized, placebo-controlled confirmatory phase (Stage 2)

lead_sponsor: Atamyo Therapeutics

location_country:
Denmark
United Kingdom
France

location_facility: Royal Victoria Infirmary Queen Victoria Road Level 6 Leazes Wing

location_facility: Rigshospitalet, University of Copenhagen Blegdamsvej 9

location_facility: Institute of Myology Pitié-Salpêtrière Hospital 47 Bd de l'Hôpital


title: Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study

acronym: POSACOVID

summary: COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.

ipd_sharing: Undecided

lead_sponsor: Medical University of Graz

sponsor_collaborators:
Medical University of Graz
Merck Sharp & Dohme LLC

location_country: Italy Austria France

location_facility:
University of Rennes
San Martino Polyclinic Hospital IRCCS
Medical University of Graz


title: FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

acronym: FEMOSEAL CLOSE

summary: The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department

location_facility: Hôpital Paris St Joseph, Vascular and endovascular surgical center


lead_sponsor: Novartis Pharmaceuticals

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

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

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

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

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


title: An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared With the Diabeloop Closed-loop Glucose Control With the Declaration of Meals, in Adolescent Patients With Type 1 Diabetes Poorly Controlled.

summary: An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.

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

location_facility: Diabetes Center for Children and Adolescents Auf Der Bult


title: An External Control, Observational, Retrospective Study Assessing the Effect of Pralsetinib Compared With Best Available Therapy for Patients With RET-Fusion Positive Advanced Non-Small Cell Lung Cancer

summary: This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.

lead_sponsor: Blueprint Medicines Corporation

sponsor_collaborators:
Blueprint Medicines Corporation
Analysis Group, Inc.

location_country:
United States
Switzerland
France

location_facility: University Hospital Center of Toulouse - Larrey Hospital


lead_sponsor: Abeona Therapeutics, Inc

summary: This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).

location_facility:
Armand-Trousseau Hospital
Nationwide Children's Hospital
University Hospital Hamburg-Eppendorf

title: A Long-term Follow-up Study of Patients With MPS IIIB From Gene Therapy Clinical Trials Involving the Administration of ABO-101 (rAAV9.CMV.hNAGLU)

ipd_sharing_description: There is no plan to share data


title: Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.

summary: Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.

lead_sponsor: Mayo Clinic

location_country:
United States
Hungary
France

location_facility:
Mayo Clinic in Florida
University of Debrecen
Université de Lorraine, CHU de Brabois


title: An Open-Label Adaptive-Design Study of Intracisternal Adenoassociated Viral Vector Serotype rh.10 Carrying the Human β-Galactosidase cDNA for Treatment of GM1 Gangliosidosis

summary: LYS-GM101 is a gene therapy for GM1 gangliosidosis intended to deliver a functional copy of the GLB1 gene to the central nervous system. This study will assess, in a 2-stage adaptive-design, the safety and efficacy of treatment in subjects with infantile GM1 gangliosidosis.

lead_sponsor: LYSOGENE

location_country:
United States
United Kingdom
France

location_facility: Hôpital Armand-Trousseau, Centre de Référence des Maladies Lysosomales (CRML), Service de Neuropédiatrie

location_facility: Children's Hospital of Orange County (CHOC)

location_facility: Manchester University NHS Foundation Trust

intervention_type: Genetic


title: Decision Support System to Evaluate VENTilation in ARDS (DeVENT)

acronym: DeVENT

summary:
Patients with Acute Respiratory Distress Syndrome (ARDS) residing in the intensive care unit (ICU) often require support for their breathing from a mechanical ventilator to provide adequate gas exchange, and although it is life-saving in this setting, it is also known to contribute to the morbidity and mortality in the condition.

Mechanical ventilation delivers a volume and pressure of gas for each breath and can vary oxygen levels. Selecting the correct oxygen, pressure and volume levels is important, as incorrect levels can harm the patient, and result in an increased time connected to the ventilator.

Recently, a system has been developed (the Beacon Caresystem) which advises the healthcare practitioner by the bedside as to how to best set the ventilator. This system is based on mathematics which describes the patients disease and may therefore provide ventilator settings which better suit the individual.

The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care to investigate whether the use of the system results in improved ventilation in all severities and phases of ARDS and thus reducing morbidity in ARDS. The investigators plan to recruit 110 patients (50 in the UK and 30 in each of the other 2 sites). The study also aims to examine the biological and physiological factors that determine the worsening of ARDS and the processes involved in recovery from ARDS with the aim to develop new therapies to help detect the condition and improve recovery.

The investigators will utilise all raw data will be collected from the Beacon Caresystem to physiologically characterise the progression and resolution phases of ARDS.

Additionally blood and Urine samples will be taken from healthy volunteers (100 in total) as a control comparison group for the biological analyses carried out in the DeVENT study.

primary_purpose: Diagnostic

ReferenceCitation: Patel B, Mumby S, Johnson N, Falaschetti E, Hansen J, Adcock I, McAuley D, Takata M, Karbing DS, Jabaudon M, Schellengowski P, Rees SE; DeVENT study group. Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)-trial protocol. Trials. 2022 Jan 17;23(1):47. doi: 10.1186/s13063-021-05967-2.

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

repository_institution: Queen's University Belfast - Research Portal

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_normalized: Pure (Denmark)

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

publisher_dissemination: Springer-Nature

lead_sponsor: Imperial College London

sponsor_collaborators:
Imperial College London
European Commission
Mermaid A/C
Aalborg University
Université d'Auvergne
Medical University of Vienna
Sorbonne University
Queen's University, Belfast

location_country:
United Kingdom
Austria
France

location_facility: Imperial College London, Royal Brompton Hospital campus


title: Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy

acronym: EarlyHABIT-ILE

summary: Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

ReferenceCitation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repository_institution: Université de Lausanne - SERVAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: University of Geneva - Archive ouverte UNIGE

lead_sponsor: Université Catholique de Louvain

sponsor_collaborators:
Université Catholique de Louvain
University Hospital, Brest
University of Pisa
University Hospital, Angers
University of Lausanne Hospitals
University of the Balearic Islands
Fondation Paralysie Cérébrale

location_country: Italy Belgium France

location_facility: Institute of Neuroscience, Université catholique de Louvain

intervention_type: Behavioral


lead_sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

summary:
Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU patients, including ventilator-associated pneumonia and ventilator-associated tracheobronchitis, where decreased susceptibility of the etiological organisms is observed worldwide and pharmacokinetic alterations frequently observed.

No routine drug monitoring is available for betalactams at the point of care in a useful time frame (i.e., within a few hours after having collected the blood specimens).

The purpose of this study is to compare MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional meropenem dose.

location_facility:
Hospital Ramón y Cajal
Université Libre de Bruxelles
Pitié Salpêtrière Hospital

title: Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection MON4STRAT Study

location_country: Spain Belgium France


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Limb-Girdle Muscular Dystrophy 2I

summary: Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

lead_sponsor: Genethon

location_facility:
Pr John Vissing
Pr Volker Straub
Dr Tanya Stojkovic


summary: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

lead_sponsor: Bioprojet

location_country:
Bulgaria
Russian Federation
France

location_facility: State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism


title: A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

acronym: PIONEER

summary: The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa

lead_sponsor: GenSight Biologics

location_facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

location_facility: Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts

intervention_type: Combination Product


title: A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.

summary: The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

ReferenceCitation: Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyen XL, Lewis R, Campbell MC, Petelle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.

license: cc-by-nc

license_normalized: cc-by-nc

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University of Wollongong - Research Online

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;ro.uow.edu.au

publisher_dissemination: European Respiratory Society

lead_sponsor: Nyxoah S.A.

location_country:
United Kingdom
Australia
France

location_facility: Royal National Throat, Nose and Ear Hospital - London

location_facility: Hollywood Private UWA Centre for Sleep Science Facility


title: Drug Utilization Study for Olodaterol

summary: This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.

time_perspective: Cross-Sectional

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
RTI health solutions, US

location_country: Denmark Netherlands France

location_facility:
Pharmo Institute
Aarhus Universitetshospital Skejby
IMS Health Information solutions


title: MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)

acronym: MOBIDIC

summary:
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.

At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.

lead_sponsor: Enterome

sponsor_collaborators:
Enterome
Eurofins Optimed

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


title: REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety

acronym: REPRISE EDGE

summary: The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

lead_sponsor: Boston Scientific Corporation

location_country: Denmark Sweden France

location_facility:
Skåne University Hospital
Clinique Pasteur
Rigshospitalet


title: A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation

summary: The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.

ReferenceCitation: Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.

lead_sponsor: Adagio Medical

location_country: Netherlands Belgium France

location_facility:
Cardiology Hospital of Haut-Lévêque
OLV Hospital
St. Antonius Hospital


title: Phase III Multicentric Study Evaluating the Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care

summary:
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations.

The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_facility: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Bruxelles


title: A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.

To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926

Secondary Objectives:

To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.

To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.

To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).

lead_sponsor: Sanofi

location_country: Denmark Spain France

location_facility:
Investigational Site Number 2080001
Investigational Site Number 2500001
Investigational Site Number 7240001


title: Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm

acronym: OWED

summary: Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a patient is ready to be weaned from the ventilator based on breathing pattern measurements. The T-piece technique allows clinicians to calculate breathing patterns accurately but many prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern. The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt) supposedly represents what the patient really wants: without disconnecting the patient from the ventilator, it may be possible to determine what is the real need and whether the patient is able to maintain Vt without support. The aims of the study are as follows: to test whether the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical patients expected to be extubated within 12 hours will be excluded. After a baseline inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate the patient according to standard criteria and blinded to the ΔVt results. Ultimately, patients will be classified as "success" or "failure" and the ΔVt will be compared between these two groups.

ReferenceCitation: Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.

ReferenceCitation: Bellani G, Mauri T, Coppadoro A, Grasselli G, Patroniti N, Spadaro S, Sala V, Foti G, Pesenti A. Estimation of patient's inspiratory effort from the electrical activity of the diaphragm. Crit Care Med. 2013 Jun;41(6):1483-91. doi: 10.1097/CCM.0b013e31827caba0.

lead_sponsor: Unity Health Toronto

location_country: Italy Canada France

location_facility: Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia


lead_sponsor: Ferring Pharmaceuticals

summary: The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.

location_facility: Universitaetsklinikum Freiburg (there may be other sites in this country)

location_facility: Tampereen yliopistollinen sairaala (there may be other sites in this country)

location_facility: Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)

title: A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

location_country: Finland Germany France


title: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

acronym: COMETE

summary: The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

ReferenceCitation: Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.

lead_sponsor: United Pharmaceuticals

location_facility:
Centre Hospitalier Régional
University of Naples Federico II
Necker Children's Hospital

intervention_type: Dietary Supplement


title: Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases

acronym: METACARDIS

summary: Supported by state-of-the-art systems medicine competences including integrative computational and functional genomics, the overarching goal of the trial is to investigate the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective will be to translate the clinical and fundamental based discoveries into new diagnosis and preventive actions paving the way to novel modes of treatment in the successive stages of CMD progression.

primary_purpose: Screening

ReferenceCitation: Belda E, Voland L, Tremaroli V, Falony G, Adriouch S, Assmann KE, Prifti E, Aron-Wisnewsky J, Debedat J, Le Roy T, Nielsen T, Amouyal C, Andre S, Andreelli F, Bluher M, Chakaroun R, Chilloux J, Coelho LP, Dao MC, Das P, Fellahi S, Forslund S, Galleron N, Hansen TH, Holmes B, Ji B, Krogh Pedersen H, Le P, Le Chatelier E, Lewinter C, Manneras-Holm L, Marquet F, Myridakis A, Pelloux V, Pons N, Quinquis B, Rouault C, Roume H, Salem JE, Sokolovska N, Sondertoft NB, Touch S, Vieira-Silva S; MetaCardis Consortium; Galan P, Holst J, Gotze JP, Kober L, Vestergaard H, Hansen T, Hercberg S, Oppert JM, Nielsen J, Letunic I, Dumas ME, Stumvoll M, Pedersen OB, Bork P, Ehrlich SD, Zucker JD, Backhed F, Raes J, Clement K. Impairment of gut microbial biotin metabolism and host biotin status in severe obesity: effect of biotin and prebiotic supplementation on improved metabolism. Gut. 2022 Dec;71(12):2463-2480. doi: 10.1136/gutjnl-2021-325753. Epub 2022 Jan 11.

evidence: open (via page says license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Chalmers University of Technology - Chalmers Research

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;edoc.mdc-berlin.de;research.chalmers.se;spiral.imperial.ac.uk

publisher_dissemination: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
European Union

location_country: Germany Denmark France

location_facility:
Hôpital Pitié-Salpétrière
University of Leipzig
University of Copenhagen


title: Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens

summary: The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.

lead_sponsor: University Hospital, Montpellier

location_country: Czechia Italy France

location_facility: Institute for Clinical and Experimental Medicine


title: Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

summary:
Interactive games (virtual reality) have recently been the center of interest and scientific discussion in the field of cognitive and functional rehabilitation. From their entertaining and contextual aspects, off-the-shelf video games are potentially interesting tools as adjunct to the patient care, especially for maintaining instrumental activities of daily living (IADL) autonomy.

Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing health related quality of life (HRQL). This decrease in cognitive and functional abilities can be slowed down using adapted rehabilitation program.

However, there is no randomized controlled study comparing usual physical therapy to virtual reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.

Off-the-shelf gaming consoles offer a large range of games where cognitive and functional abilities from geriatric patients could be stimulated and consequently HRQL improved.

However, a better knowledge of the potential cognitive and functional improvement processes from virtual reality rehabilitation in institutional routine is needed to enhance the quality and the range of the available care in old adults.

This study will not only be a validation platform of virtual reality as stand alone rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming consoles in HRQL improvement of old adults.

The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL changes of patients with Alzheimer disease and related disorders.

•Method

This study is a randomized controlled trial that comprises two study phases :

Phase one; comparing three parallel groups where therapists and assessors will be kept blind of study objectives, and Phase two, the investigators will take the most cost-effective gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will use it as an adjunct to physical therapy compared to physical therapy alone, with respect to the same amount of rehabilitation time.

The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after intervention.

Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or physical therapy as the 'gold' standard condition.

All groups will receive the same amount of rehabilitation time. Power and sample calculation for phase two will be based on phase one results.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Australia Netherlands France

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

location_facility: Radboud University Nijmegen Medical Centre


summary: This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

lead_sponsor: Allergan

location_country:
United States
Netherlands
France


type: Registry Identifier

title: Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial

acronym: AMEP

summary: The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man.

lead_sponsor: Valerio Therapeutics

location_country: Slovenia Denmark France

location_facility:
Institute of Oncology Ljubljana
Copenhagen University Hospital Herlev
Gustave Roussy Institute


title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

summary: This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.

lead_sponsor: Genentech, Inc.


title: A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally in Adult Patients With Advanced Solid Malignancies

summary: This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.

lead_sponsor: Novartis Pharmaceuticals

location_country: Spain Canada France


title: An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma

summary: This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

location_country:
United States
United Kingdom
France


title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

summary: Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Rekhtman G, Masliak Z, Robak P, Esseltine DL, Feng H, Deraedt W, van de Velde H, Arnulf B. Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study. Haematologica. 2015 May;100(5):e207-10. doi: 10.3324/haematol.2014.118182. Epub 2015 Jan 16. No abstract available.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18. Erratum In: Lancet Oncol. 2011 Jun;12(6):522.

lead_sponsor: Millennium Pharmaceuticals, Inc.

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country: Germany Belgium France

location_facility: UZ Brussel Department Medical Oncology Laarbeeklaan 101

location_facility: Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33

location_facility: Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU


title: A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas

summary: There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

lead_sponsor: LEO Pharma

location_country:
United Kingdom
Canada
France

location_facility:
Ninewells Hospital & Medical School
Probity Medical Research
Hôpital de l'Archet


title: An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

summary: The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

location_country:
United States
Spain
France


title: A Randomized, Double-blind, Placebo-controlled, 4 Period Incomplete Block Cross-over, Multi-center, Multiple Dose (7 Days) Dose-ranging Study to Assess the Efficacy and Safety of 4 Doses of NVA237 in Patients With Stable COPD, Compared to Seven Days Treatment With Tiotropium (18μg Once Daily, Open Label) as an Active Control

summary: This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.

ReferenceCitation: Verkindre C, Fukuchi Y, Flemale A, Takeda A, Overend T, Prasad N, Dolker M. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir Med. 2010 Oct;104(10):1482-9. doi: 10.1016/j.rmed.2010.04.006. Epub 2010 Jun 11.

location_country: Japan Belgium France

location_facility:
Novartis Investigator Site
Novartis Investigator site


title: Efficacy and Safety of R-hLH (Luveris ®) Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET

summary:
In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad range of developmental and implantation potential.

The aim of the study was to determine whether, treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte is the most important determinant of embryo quality. Early follicles, containing immature eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates these cells to produce factors essential for normal follicular development.

The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles, so that they can all mature together, thus increasing the proportion of high grade oocytes and their subsequent embryos

ReferenceCitation: Durnerin CI, Erb K, Fleming R, Hillier H, Hillier SG, Howles CM, Hugues JN, Lass A, Lyall H, Rasmussen P, Thong J, Traynor I, Westergaard L, Yates R; Luveris Pretreatment Group. Effects of recombinant LH treatment on folliculogenesis and responsiveness to FSH stimulation. Hum Reprod. 2008 Feb;23(2):421-6. doi: 10.1093/humrep/dem388. Epub 2007 Dec 15.

lead_sponsor: NHS Greater Glasgow and Clyde

location_country:
Denmark
United Kingdom
France

location_facility: Assisted Conception Unit., Royal Infirmary of Edinburgh

location_facility: Reproductive Medicine Unit, Department of Gynaecology and Obstetrics, Jean Verdier Hospital, University Paris XIII

location_facility: Fertility Clinic, Department of Obstetrics and Gynaecology, University Hospital of Odense, 5000

intervention_type: Procedure


title: A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia

summary:
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.

lead_sponsor: Vion Pharmaceuticals

location_facility: Jonsson Comprehensive Cancer Center at UCLA


title: A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

summary: Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the "therapeutic dose," subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.

ReferenceCitation: Quackenbush RC, Horner TJ, Williams VC, Giampietro P, Lin TS. Patients with relapsed follicular lymphoma treated with rituximab versus tositumomab and iodine I-131 tositumomab. Leuk Lymphoma. 2015 Mar;56(3):779-81. doi: 10.3109/10428194.2014.927461. Epub 2014 Jul 23. No abstract available.

publisher_dissemination: Informa

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

lead_sponsor: GlaxoSmithKline


title: Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes

acronym: ADAPT

summary: This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

ReferenceCitation: Le Floch JP, Levy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. doi: 10.2337/dc08-0332. Epub 2008 Oct 22.

lead_sponsor: Novo Nordisk A/S

location_country: Luxembourg Belgium France


title: Phase I Study of Lonafarnib (SCH66336) in Combination With Herceptin Plus Paclitaxel in HER 2 NEU Overexpressing Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.

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

location_country: Netherlands Belgium France

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital