title: Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

acronym: ENTRACT

summary:
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.

The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.

We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study

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lead_sponsor: Versailles Hospital

location_facility: Dupuytren hospital, Medical intensive care unit

location_facility: Cotentin Hospital, Medical intensive care unit

location_facility: Cochin Hospital, Médical intensive care unit

location_facility: Sud Francilien Hospital, Medicla care unit

location_facility: Henri Mondor Hospital, Medical Intensive care unit

location_facility: Orléans Hospital, Medical intensive care unit

location_facility: André Mignot Hospital, Intensive care unit


ReferenceType: derived

ReferenceCitation: Abrahamsson PA, Boccon-Gibod L, Morote J, de Jong IJ, Malmberg A, Neijber A, Albers P. Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy. Eur Urol Focus. 2017 Oct;3(4-5):470-479. doi: 10.1016/j.euf.2015.12.008. Epub 2016 Jan 22.

family: Abrahamsson

full_name: Per-Anders Abrahamsson

given: Per-Anders

sequence: first

family: Boccon-Gibod

full_name: Laurent Boccon-Gibod

given: Laurent

sequence: additional

family: Morote

full_name: Juan Morote

given: Juan

family: de Jong

full_name: Igle Jan de Jong

given: Igle Jan

family: Malmberg

full_name: Anders Malmberg

given: Anders

family: Neijber

full_name: Anders Neijber

family: Albers

full_name: Peter Albers

given: Peter

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Urology Focus

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Boccon-Gibod L, Albers P, Morote J, van Poppel H, de la Rosette J, Villers A, Malmberg A, Neijber A, Montorsi F. Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer. Eur Urol. 2014 Oct;66(4):655-63. doi: 10.1016/j.eururo.2014.05.037. Epub 2014 Jun 18.

family: van Poppel

full_name: Hendrik van Poppel

given: Hendrik

family: de la Rosette

full_name: Jean de la Rosette

given: Jean

family: Villers

full_name: Arnauld Villers

given: Arnauld

family: Montorsi

full_name: Francesco Montorsi

given: Francesco

journal_name: European Urology

title: Degarelix as an Intermittent Androgen Deprivation Therapy for One or More Treatment Cycles in Patients with Prostate Cancer

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Ferring Pharmaceuticals

enrollment_type: Actual

primary_purpose: Treatment

location_country: Italy Netherlands France Belgium Spain Germany

location_facility: Praxisgemeinschaft f. Onkologie & Urologie

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Erasme Hospital, University Clinics of Brussels

location_facility: Hospital Universitario Principe de Asturias

location_facility: Azienda Policlinico Universitario G. Martino

location_facility: Gemeinschaftspraxis Dres. Rudolph, Wörner

location_facility: Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

summary: The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

lead_sponsor_type: industriel

status_simplified: Completed


title: Biventricular Tachycardias Outcome Trial

acronym: BITAC

summary:
This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

design_allocation: Randomized

lead_sponsor: LivaNova

location_country:
Italy
Sweden
Spain
France
Belgium
Portugal
Germany
United Kingdom
Canada

location_facility: Universitatsklinik Med. Klinik Heidelberg

intervention_type: Device


title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

acronym: PRISM

summary:
Primary objective:

To assess the efficacy of I10E in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Italy
France
Tunisia
Spain
Turkey
United Kingdom

location_facility: Uludag University Medical School Neurology

location_facility: Hospital clinico Universitario de Santiago

location_facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi

location_facility: Istanbul UniversityCerrahpasa Medical School Neurology

location_facility: Azienda Ospedaliere Universitaria di Padova

location_facility: Hospital Universitario i Politècnico La Fe

location_facility: Azienda Ospedaliere Universitaria san Giovanni

location_facility: University Hospital of North Straffordshire

location_facility: Hacettepe University Medical School Neurology

location_facility: Ankara University medical School Neurology

location_facility: IRRCS Istituto Nazionale Neurologico Besta


title: Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

acronym: IDASPHERE II

summary:
The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and epirubicin (12%). But until recently, there were no obvious reasons to use one product over another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular carcinoma], which does not allow any argument in favour of the product. Moreover, 2 randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative in terms of survival.

Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was noted especially on the SNU-449 line, which is known for its resistance to several chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1) idarubicin has a better intracellular penetration than the other anthracyclines. This is probably due to its more considerable lipophily, facilitating thus its passage through the membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane pumps transporting the molecule outside the cell. These two particularities could explain a more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its toxicity profile (especially, haematological and cardiac) is known.

On these grounds, A pilot study has been conducted in order to assess the tolerance and efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and less toxic.

Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21 patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m². There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) = approx. 10 mg of idarubicin.

It has been already demonstrated that hepatic extraction of idarubicin is better than those of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC 0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was 35% higher.

The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised trial on CHE published. The PRECISION V data can be thus used to compare the other studies in terms of efficacy and tolerance.

To continue our preliminary study and the phase I IDASPHERE study, investigators wish to assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Guiu B, Chevallier P, Assenat E, Barbier E, Merle P, Bouvier A, Dumortier J, Nguyen-Khac E, Gugenheim J, Rode A, Oberti F, Valette PJ, Yzet T, Chevallier O, Barbare JC, Latournerie M, Boulin M. Idarubicin-loaded Beads for Chemoembolization of Hepatocellular Carcinoma: The IDASPHERE II Single-Arm Phase II Trial. Radiology. 2019 Jun;291(3):801-808. doi: 10.1148/radiol.2019182399. Epub 2019 Apr 30.

family: Guiu

full_name: Boris Guiu

given: Boris

family: Chevallier

full_name: Patrick Chevallier

given: Patrick

family: Assenat

full_name: Eric Assenat

given: Eric

family: Barbier

full_name: Emilie Barbier

given: Emilie

family: Merle

full_name: Philippe Merle

given: Philippe

family: Bouvier

full_name: Antoine Bouvier

given: Antoine

family: Dumortier

full_name: Jérôme Dumortier

given: Jérôme

family: Nguyen-Khac

full_name: Eric Nguyen-Khac

family: Gugenheim

full_name: Jean Gugenheim

family: Rode

full_name: Agnès Rode

given: Agnès

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Valette

full_name: Pierre-Jean Valette

given: Pierre-Jean

family: Yzet

full_name: Thierry Yzet

given: Thierry

full_name: Olivier Chevallier

given: Olivier

family: Barbare

full_name: Jean-Claude Barbare

given: Jean-Claude

family: Latournerie

full_name: Marianne Latournerie

given: Marianne

family: Boulin

full_name: Mathieu Boulin

given: Mathieu

journal_name: Radiology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: Radiological Society of North America (RSNA)

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hôpital Edouard Herriot
Hôpital de l'Archet II
CHU St Eloi
Hôpital La Croix Rousse
CHU - Hôpital François Mitterand
CHU Amiens
CHU d'ANGERS


title: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

acronym: Radiointer

summary:
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.

Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,

This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :

Arm A: Percutaneous vertebroplasty
Arm B: External radiotherapy

This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

status: Terminated

study_completion_date_type: Anticipated

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Paul Strauss
Institut Curie
Centre Leon Berard
Institut Bergonié
HCL- Hopital Edouard Herriot
Institut Gustave Roussy

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Unknown


title: A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.

acronym: ThyrQol

summary: The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility:
Lyon University Hospital
La Pitié-Salpétrière - AP-HP
Nancy University Hospital
Limoges University Hospital
CHD La Roche sur Yon
Angers University Hospital
Nantes University Hospital


title: IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes

acronym: IMAGE

summary: Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.

primary_purpose: Screening

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8

location_facility: Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie

location_facility: CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition

location_facility: CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition

location_facility: Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition

intervention_type: Other


title: Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease

acronym: VICCOINBODI

summary:
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.

This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.

If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.

Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.

primary_purpose: Prevention

location_facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux

location_facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP

location_facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP

location_facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes

location_facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

location_facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille


title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

acronym: RINO

summary: The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

ReferenceType: background

ReferenceCitation: Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

ReferenceCitation: Chaudhuri D, Granton D, Wang DX, Einav S, Helviz Y, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson C, Jaber S, Brochard L, Burns KEA, Rochwerg B. Moderate Certainty Evidence Suggests the Use of High-Flow Nasal Cannula Does Not Decrease Hypoxia When Compared With Conventional Oxygen Therapy in the Peri-Intubation Period: Results of a Systematic Review and Meta-Analysis. Crit Care Med. 2020 Apr;48(4):571-578. doi: 10.1097/CCM.0000000000004217.

family: Chaudhuri

full_name: Dipayan Chaudhuri

given: Dipayan

family: Granton

full_name: David Granton

given: David

family: Wang

full_name: Dominic Xiang Wang

given: Dominic Xiang

family: Einav

full_name: Sharon Einav

given: Sharon

family: Helviz

full_name: Yigal Helviz

given: Yigal

family: Mauri

full_name: Tommaso Mauri

given: Tommaso

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Jog

full_name: Sameer Jog

given: Sameer

family: Hernandez

full_name: Gonzalo Hernandez

given: Gonzalo

family: Maggiore

full_name: Salvatore M. Maggiore

given: Salvatore M.

family: Hodgson

full_name: Carol Hodgson

given: Carol

family: Jaber

full_name: Samir Jaber

given: Samir

family: Brochard

full_name: Laurent Brochard

given: Laurent

family: Burns

full_name: Karen E. A. Burns

given: Karen E. A.

family: Rochwerg

full_name: Bram Rochwerg

given: Bram

journal_name: Critical Care Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Catholic University of the Sacred Heart

location_country: Italy Spain France Greece

location_facility: Università del Piemonte Orientale, Ospedale della Carità

location_facility: La Pitie-Salpetriere University Hospital

location_facility: Catholic University of the Sacred Heart, A. Gemelli Hospital

location_facility: Università del Piemonte Orientale, Sant'Andrea Hospital


title: Medico-economic Evaluation of the Management of Weight Regain After Gastric Bypass by Gastrointestinal Narrowing of Jejunal Anastomosis by Endoscopic Suturing: Apollo Endosurgery OverStitch Technical

summary: Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment

lead_sponsor: University Hospital, Montpellier

location_facility:
HEGP Hospital
Nice Hospital
Villeurbanne clinic
Montpellier Hospital
Strasbourg Hospital
Lille Hospital
Louis Mourier Hospital


title: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

acronym: PEP

summary: A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Nord
CHU Clermont-Ferrand
CH de Cornouaille Quimper
CHRU de Brest
Hôpital Européen Georges Pompidou
CHU
HIA


type: Other Grant/Funding Number

title: Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.

acronym: PRE-MUSICAL

summary:
The primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with AD or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the Neuropsychiatric Inventory (NPI).

The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

primary_purpose: Supportive Care

ReferenceCitation: Aalten P, de Vugt ME, Jaspers N, Jolles J, Verhey FR. The course of neuropsychiatric symptoms in dementia. Part I: findings from the two-year longitudinal Maasbed study. Int J Geriatr Psychiatry. 2005 Jun;20(6):523-30.

ReferenceCitation: Aldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5.

ReferenceCitation: Benoit M, Robert PH, Staccini P, Brocker P, Guerin O, Lechowski L, Vellas B; REAL.FR Group. One-year longitudinal evaluation of neuropsychiatric symptoms in Alzheimer's disease. The REAL.FR Study. J Nutr Health Aging. 2005;9(2):95-9.

ReferenceCitation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84.

lead_sponsor: University Hospital, Toulouse

location_facility:
EHPAD KORIAN Grand Maison
Centre Hospitalier Gérard Marchant
EHPAD La Villegiale
Residence Christian Bressole
EHPAD L'Oustal d'en Thibaud
University Hospital Toulouse
EHPAD Les Quietudes

intervention_type: Behavioral


title: A European Multicentre Double-blind Placebo-controlled Phase III Trial of Nilvadipine in Mild to Moderate Alzheimer's Disease

acronym: NILVAD

summary:
Alzheimer's disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).

Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.

ReferenceCitation: Brogden RN, McTavish D. Nilvadipine. A review of its pharmacodynamic and pharmacokinetic properties, therapeutic use in hypertension and potential in cerebrovascular disease and angina. Drugs Aging. 1995 Feb;6(2):150-71. Review. Erratum in: Drugs Aging 1995 Aug;7(2):116.

ReferenceCitation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83.

ReferenceCitation: Facchinetti F, Fasolato C, Del Giudice E, Burgo A, Furegato S, Fusco M, Basso E, Seraglia R, D'Arrigo A, Leon A. Nimodipine selectively stimulates beta-amyloid 1-42 secretion by a mechanism independent of calcium influx blockage. Neurobiol Aging. 2006 Feb;27(2):218-27.

ReferenceCitation: Fleckenstein A. Specific pharmacology of calcium in myocardium, cardiac pacemakers, and vascular smooth muscle. Annu Rev Pharmacol Toxicol. 1977;17:149-66. Review.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Birkenhäger WH, Babarskiene MR, Babeanu S, Bossini A, Gil-Extremera B, Girerd X, Laks T, Lilov E, Moisseyev V, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Fagard R. Prevention of dementia in randomised double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial. Lancet. 1998 Oct 24;352(9137):1347-51.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Babarskiene MR, Babeanu S, Bossini A, Fagard R, Gil-Extremera B, Laks T, Kobalava Z, Sarti C, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Birkenhäger WH; Systolic Hypertension in Europe Investigators. The prevention of dementia with antihypertensive treatment: new evidence from the Systolic Hypertension in Europe (Syst-Eur) study. Arch Intern Med. 2002 Oct 14;162(18):2046-52. Erratum in: Arch Intern Med. 2003 Jan 27;163(2):241..

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Furuichi Y, Takakura S, Satoh H, Mori J, Kohsaka M. The effect of nilvadipine, a dihydropyridine type calcium channel blocker, on local cerebral blood flow in rats. Jpn J Pharmacol. 1992 Apr;58(4):457-60.

ReferenceCitation: Gélinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81.

ReferenceCitation: Hanyu H, Hirao K, Shimizu S, Sato T, Kiuchi A, Iwamoto T. Nilvadipine prevents cognitive decline of patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2007 Dec;22(12):1264-6.

ReferenceCitation: Inouye M, Mio T, Sumino K. Nilvadipine protects low-density lipoprotein cholesterol from in vivo oxidation in hypertensive patients with risk factors for atherosclerosis. Eur J Clin Pharmacol. 2000 Apr;56(1):35-41.

ReferenceCitation: Khachaturian AS, Zandi PP, Lyketsos CG, Hayden KM, Skoog I, Norton MC, Tschanz JT, Mayer LS, Welsh-Bohmer KA, Breitner JC. Antihypertensive medication use and incident Alzheimer disease: the Cache County Study. Arch Neurol. 2006 May;63(5):686-92. Epub 2006 Mar 13.

ReferenceCitation: Kagawa H, Nomura S, Ozaki Y, Nagahama M, Fukuhara S. Effects of nilvadipine on cytokine-levels and soluble factors in collagen disease complicated with essential hypertension. Clin Exp Hypertens. 1999 Oct;21(7):1177-88.

ReferenceCitation: López-Arrieta JM, Birks J. Nimodipine for primary degenerative, mixed and vascular dementia. Cochrane Database Syst Rev. 2002;(3):CD000147. Review.

ReferenceCitation: Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13.

ReferenceCitation: Maxwell CJ, Hogan DB, Ebly EM. Calcium-channel blockers and cognitive function in elderly people: results from the Canadian Study of Health and Aging. CMAJ. 1999 Sep 7;161(5):501-6. Erratum in: CMAJ 1999 Nov 30;161(11):1396.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44.

ReferenceCitation: Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983;19(3):448-50.

ReferenceCitation: Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50.

ReferenceCitation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4.

ReferenceCitation: Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65.

ReferenceCitation: Ogasawara K, Noda A, Yasuda S, Kobayashi M, Yukawa H, Ogawa A. Effect of calcium antagonist on cerebral blood flow and oxygen metabolism in patients with hypertension and chronic major cerebral artery occlusion: a positron emission tomography study. Nucl Med Commun. 2003 Jan;24(1):71-6.

ReferenceCitation: Ohtsuka M, Ono T, Hiroi J, Esumi K, Kikuchi H, Kumada S. Comparison of the cardiovascular effect of FR34235, a new dihydropyridine, with other calcium antagonists. J Cardiovasc Pharmacol. 1983 Nov-Dec;5(6):1074-82.

ReferenceCitation: Parry SW, Steen N, Baptist M, Fiaschi KA, Parry O, Kenny RA. Cerebral autoregulation is impaired in cardioinhibitory carotid sinus syndrome. Heart. 2006 Jun;92(6):792-7. Epub 2006 Jan 31.

ReferenceCitation: Rosenthal J. Nilvadipine: profile of a new calcium antagonist. An overview. J Cardiovasc Pharmacol. 1994;24 Suppl 2:S92-107. Review.

ReferenceCitation: Shimamoto H, Shimamoto Y. Nilvadipine increases cerebral blood flow in elderly hypertensives: comparison with nifedipine. J Hum Hypertens. 1995 Apr;9(4):271-9.

ReferenceCitation: Tollefson GD. Short-term effects of the calcium channel blocker nimodipine (Bay-e-9736) in the management of primary degenerative dementia. Biol Psychiatry. 1990 May 15;27(10):1133-42.

ReferenceCitation: Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16.

ReferenceCitation: Yasar S, Corrada M, Brookmeyer R, Kawas C. Calcium channel blockers and risk of AD: the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 2005 Feb;26(2):157-63.

ReferenceCitation: Dyer AH, Lawlor B, Kennelly SP; NILVAD Study Group. Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD. BMC Geriatr. 2020 Mar 30;20(1):117. doi: 10.1186/s12877-020-01531-w.

family: Dyer

full_name: Adam H. Dyer

given: Adam H.

family: Lawlor

full_name: Brian Lawlor

given: Brian

family: Kennelly

full_name: Sean P. Kennelly

given: Sean P.

currency_apc_doaj: GBP

journal_name: BMC Geriatrics

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repositories_institution: CERN European Organization for Nuclear Research - Zenodo

repositories_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Abdullah L, Crawford F, Tsolaki M, Börjesson-Hanson A, Olde Rikkert M, Pasquier F, Wallin A, Kennelly S, Ait-Ghezala G, Paris D, Hendrix S, Blennow K, Lawlor B, Mullan M. The Influence of Baseline Alzheimer's Disease Severity on Cognitive Decline and CSF Biomarkers in the NILVAD Trial. Front Neurol. 2020 Mar 6;11:149. doi: 10.3389/fneur.2020.00149. eCollection 2020.

ReferenceCitation: de Heus RAA, Olde Rikkert MGM, Tully PJ, Lawlor BA, Claassen JAHR; NILVAD Study Group. Blood Pressure Variability and Progression of Clinical Alzheimer Disease. Hypertension. 2019 Nov;74(5):1172-1180. doi: 10.1161/HYPERTENSIONAHA.119.13664. Epub 2019 Sep 23.

name: From the Department of Geriatric Medicine, Radboud umc University Medical Center, Radboudumc Alzheimer Center, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, the Netherlands (R.A.A.d.H., M.G.M.O.R., J.A.H.R.C.)

name: School of Medicine, The University of Adelaide, Australia (P.J.T.)

name: Mercer’s Institute for Research on Ageing, St. James’s Hospital, Dublin, Ireland (B.A.L.)

name: Department of Medical Gerontology, Trinity College Institute of Neuroscience, Dublin, Ireland (B.A.L.).

ReferenceCitation: de Jong DLK, de Heus RAA, Rijpma A, Donders R, Olde Rikkert MGM, Günther M, Lawlor BA, van Osch MJP, Claassen JAHR. Effects of Nilvadipine on Cerebral Blood Flow in Patients With Alzheimer Disease. Hypertension. 2019 Aug;74(2):413-420. doi: 10.1161/HYPERTENSIONAHA.119.12892. Epub 2019 Jun 17.

name: From the Department of Geriatric Medicine, Donders Institute for Brain Cognition and Behaviour (D.L.K.d.J., R.A.A.d.H., A.R., M.G.M.O.R., J.A.H.R.C.), Radboud University Medical Center, Nijmegen, the Netherlands

name: Radboudumc Alzheimer Center, Nijmegen, the Netherlands (D.L.K.d.J., R.A.A.d.H., A.R., M.G.M.O.R., J.A.H.R.C.)

name: Department of Health Evidence (R.D.), Radboud University Medical Center, Nijmegen, the Netherlands

name: Frauenhofer Institute for Medical Imaging Computing MEVIS, Bremen, Germany (M.G.)

name: Department of Radiology, C.J. Gorter Center for High Field MRI, Leiden University Medical Center, the Netherlands (M.J.P.v.O.).

ReferenceCitation: de Heus RAA, Donders R, Santoso AMM, Olde Rikkert MGM, Lawlor BA, Claassen JAHR; Nilvad Study Group. Blood Pressure Lowering With Nilvadipine in Patients With Mild-to-Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension. J Am Heart Assoc. 2019 May 21;8(10):e011938. doi: 10.1161/JAHA.119.011938.

name: Department of Geriatric Medicine Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands

name: Radboudumc Alzheimer Center Nijmegen The Netherlands

name: Department for Health Evidence Radboud University Medical Center Nijmegen The Netherlands

name: Mercer's Institute for Research on Ageing St. James's Hospital Dublin Ireland

name: Department of Medical Gerontology Trinity College Institute of Neuroscience Dublin Ireland

journal_name: Journal of the American Heart Association

title: Blood Pressure Lowering With Nilvadipine in Patients With Mild‐to‐Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension

ReferenceCitation: Lawlor B, Segurado R, Kennelly S, Olde Rikkert MGM, Howard R, Pasquier F, Börjesson-Hanson A, Tsolaki M, Lucca U, Molloy DW, Coen R, Riepe MW, Kálmán J, Kenny RA, Cregg F, O'Dwyer S, Walsh C, Adams J, Banzi R, Breuilh L, Daly L, Hendrix S, Aisen P, Gaynor S, Sheikhi A, Taekema DG, Verhey FR, Nemni R, Nobili F, Franceschi M, Frisoni G, Zanetti O, Konsta A, Anastasios O, Nenopoulou S, Tsolaki-Tagaraki F, Pakaski M, Dereeper O, de la Sayette V, Sénéchal O, Lavenu I, Devendeville A, Calais G, Crawford F, Mullan M; NILVAD Study Group. Nilvadipine in mild to moderate Alzheimer disease: A randomised controlled trial. PLoS Med. 2018 Sep 24;15(9):e1002660. doi: 10.1371/journal.pmed.1002660. eCollection 2018 Sep.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Limerick - University of Limerick Institutional Repository

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Geneva - Archive ouverte UNIGE

location_country:
Italy
Sweden
Netherlands
France
Greece
Hungary
Ireland
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire d'Amiens (CHU Amiens)

location_facility: Centre Hospitalier Regional et Universitaire de Lille (CHRU Lille)

location_facility: Centre Hospitalier Universitaire de Saint Philibert (GHICL)

location_facility: Centre Hospitalier Universitaire de Calais (CHU Calais)

location_facility: Centre Hospitalier Universitaire de Bethune (CH Bethune)

location_facility: Centre Hospitalier Universitaire de Lens (CHU Lens)

location_facility: Centre Hospitalier Universitaire de Caen (CHU Caen)


acronym: NeuroSenSS

summary:
Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. Fifteen to twenty percent of patients with the primary Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (SFN). A recent study proved that more than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.

The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. Moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy.

Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU Toulouse
CHU de Lille
CH d'Albi
CHU Bordeaux
University Hospital, Limoges
CH de Rodez
CH de Brive


title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period

summary: This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

primary_purpose: Other

ReferenceCitation: Wijsenbeek MS, Bendstrup E, Valenzuela C, Henry MT, Moor CC, Jouneau S, Fois AG, Moran-Mendoza O, Anees S, Mirt M, Bengus M, Gilberg F, Kirchgaessler KU, Vancheri C. Disease Behaviour During the Peri-Diagnostic Period in Patients with Suspected Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2021 Jul;38(7):4040-4056. doi: 10.1007/s12325-021-01790-y. Epub 2021 Jun 11.

family: Wijsenbeek

full_name: Marlies S. Wijsenbeek

given: Marlies S.

family: Bendstrup

full_name: Elisabeth Bendstrup

given: Elisabeth

family: Valenzuela

full_name: Claudia Valenzuela

given: Claudia

family: Henry

full_name: Michael T. Henry

given: Michael T.

family: Moor

full_name: Catharina C. Moor

given: Catharina C.

family: Jouneau

full_name: Stéphane Jouneau

given: Stéphane

family: Fois

full_name: Alessandro G. Fois

given: Alessandro G.

family: Moran-Mendoza

full_name: Onofre Moran-Mendoza

given: Onofre

family: Anees

full_name: Syed Anees

given: Syed

family: Mirt

full_name: Mirela Mirt

given: Mirela

family: Bengus

full_name: Monica Bengus

given: Monica

family: Gilberg

full_name: Frank Gilberg

given: Frank

family: Kirchgaessler

full_name: Klaus-Uwe Kirchgaessler

given: Klaus-Uwe

family: Vancheri

full_name: Carlo Vancheri

given: Carlo

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repositories:
HAL
PubMed Central
repub.eur.nl

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Wijsenbeek M, Bendstrup E, Valenzuela C, Henry MT, Moor C, Bengus M, Perjesi A, Gilberg F, Kirchgaessler KU, Vancheri C. Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2019 Jan;36(1):232-243. doi: 10.1007/s12325-018-0845-3. Epub 2018 Nov 30.

full_name: Marlies Wijsenbeek

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repository_institution: University College Cork - Cork Open Research Archive

location_country:
Italy
Netherlands
France
Ireland
Russian Federation
Canada

location_facility: Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia

location_facility: SBIH "Chelyabinsk Regional Clinical Hospital"

location_facility: Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

location_facility: Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

location_facility: Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia

location_facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare

location_facility: SBIH at Vladimir Region "Regional Clinical Hospital"

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia

location_facility: Kingston Health Sciences Centre; research Kingston General Health Research Institute

location_facility: SBI at Rostov Region "Regional Clinical Hospital #2"

location_facility: Hopital Arnaud De Villeneuve; Pneumologie A

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

location_facility: Ospedale Policlinico S. Matteo; S.C. Pneumologia

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere


ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Sweden
Netherlands
France
Norway
Argentina
Spain
Germany
United Kingdom
Canada

ipd_sharing: Yes

title: A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome

summary:
This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of belimumab/ rituximab co-administration and of belimumab monotherapy; and to evaluate whether either co-administration therapy or belimumab monotherapy has a substantive effect on disease activity.

This study will consist screening period, double blind treatment period, a general follow-up period and individualized follow-up period. Approximately 70 subjects will be recruited into the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24, interim analyses and sample size re-estimation will be conducted. The total number of subjects randomized may increase following sample size re-estimation up to a maximum of 120 recruited into the study.

Subjects in all arms will receive investigational product (IP) until Week 52 (completion of the treatment phase). All subjects will enter a 16-week general follow-up period after the Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the treatment phase visits prior to Week 52.

After completing the general follow-up period, subjects with cluster of differentiation (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of baseline, if baseline value was below lower limit of normal [LLN]) will enter an individualized safety follow-up phase and return to the clinic for visits every 12 weeks with monthly calls between visits to evaluate subjects for any serious adverse events (SAEs) related to IP or study participation, fatal SAEs, and designated adverse event of special interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and to check concomitant medications.

The total duration of participation of a subject in this study will be approximately up to a maximum of 2 years (i.e., up to Week 104).


title: A Multicenter Randomized, Open-Label Phase II/III Study, To Compare The Efficacy Of NBTXR3, Implanted As Intratumor Injection And Activated By Radiotherapy, Versus Radiotherapy Alone In Patients With Locally Advanced Soft Tissue Sarcoma Of The Extremity And Trunk Wall

summary:
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.

ReferenceCitation: Bonvalot S, Rutkowski PL, Thariat J, Carrère S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baère T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Vergés R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovée JVMG, Le Péchoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8. Erratum in: Lancet Oncol. 2019 Sep;20(9):e468.

family: Bonvalot

full_name: Sylvie Bonvalot

given: Sylvie

family: Rutkowski

full_name: Piotr L Rutkowski

given: Piotr L

family: Thariat

full_name: Juliette Thariat

given: Juliette

family: Carrère

full_name: Sébastien Carrère

given: Sébastien

family: Ducassou

full_name: Anne Ducassou

given: Anne

family: Sunyach

full_name: Marie-Pierre Sunyach

given: Marie-Pierre

family: Agoston

full_name: Peter Agoston

given: Peter

family: Hong

full_name: Angela Hong

given: Angela

family: Mervoyer

full_name: Augustin Mervoyer

given: Augustin

family: Rastrelli

full_name: Marco Rastrelli

given: Marco

family: Moreno

full_name: Victor Moreno

given: Victor

family: Li

full_name: Rubi K Li

given: Rubi K

family: Tiangco

full_name: Béatrice Tiangco

given: Béatrice

family: Herraez

full_name: Antonio Casado Herraez

given: Antonio Casado

family: Gronchi

full_name: Alessandro Gronchi

given: Alessandro

family: Mangel

full_name: László Mangel

given: László

family: Sy-Ortin

full_name: Teresa Sy-Ortin

given: Teresa

family: Hohenberger

full_name: Peter Hohenberger

family: de Baère

full_name: Thierry de Baère

given: Thierry

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Helfre

full_name: Sylvie Helfre

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Borkowska

full_name: Aneta Borkowska

given: Aneta

title: NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2–3, randomised, controlled trial

location_country:
Italy
South Africa
Hong Kong
Philippines
France
Poland
Norway
Hungary
Belgium
Australia
Romania
Spain
Germany

location_facility: Capital Region Cancer Service, Canberra Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Medical Centre, Hungarian Defence Forces

location_facility: Spitalului Universitar de Urgenta Militar Central

location_facility: START MADRID, Hospital Fundacion Jimenez Diaz

location_facility: Centre Regional de Lutte Contre Le Cancer Paul Lamarque

location_facility: Hospital Clinico Universitario San Carlos

location_facility: START MADRID, Hospital Universitario Madrid Norte Sanchinarro


title: Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

summary: The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Austria France Poland Lithuania Hungary Spain Germany Latvia

location_facility: Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

location_facility: Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

location_facility: ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

location_facility: Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

location_facility: Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

location_facility: Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

location_facility: Hôpital Nord - Dept. of Gastroenterology

location_facility: Centro Medico Teknon Servicio de Aparato Disgestivo

location_facility: Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

location_facility: Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

location_facility: Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

location_facility: Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

location_facility: Hospital Universitario La Paz Servico de Gastroenterologia

location_facility: Paula Stradina Clinical University Hospital Gastroenterology Centre

location_facility: Hospital Universitario Marques de Valdecilla Servicio de Digestivo

location_facility: Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

location_facility: Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

location_facility: Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

location_facility: Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

location_facility: Universitätsmedizin Mannheim II. Medizinische Klinik

location_facility: Klaipedos jurininku ligonine Diagnostikos skyrius

location_facility: Fundación Hospital de Alcorcón Servicio de Gastroenterología

location_facility: Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

location_facility: Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

location_facility: Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

location_facility: Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

location_facility: Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

location_facility: Hôpital Brabois Service de gastro-enterologie

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

location_facility: Gastroenterologische Fachpraxis am Germania Campus

location_facility: Corporació Sanitaria Parc Taulí Servicio de Digestivo

location_facility: Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

location_facility: Semmelweis Egyetem II. sz. Belgyógyászati Klinika

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

location_facility: Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

location_facility: Hôpital Rangueil Service de gastro-enterologie

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

location_facility: Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

location_facility: Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie


title: Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial

acronym: TAVAREC

summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma.

PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma.

ReferenceCitation: van den Bent MJ, Klein M, Smits M, Reijneveld JC, French PJ, Clement P, de Vos FYF, Wick A, Mulholland PJ, Taphoorn MJB, Lewis J, Weller M, Chinot OL, Kros JM, de Heer I, Verschuere T, Coens C, Golfinopoulos V, Gorlia T, Idbaih A. Bevacizumab and temozolomide in patients with first recurrence of WHO grade II and III glioma, without 1p/19q co-deletion (TAVAREC): a randomised controlled phase 2 EORTC trial. Lancet Oncol. 2018 Sep;19(9):1170-1179. doi: 10.1016/S1470-2045(18)30362-0. Epub 2018 Aug 13.

family: van den Bent

full_name: Martin J van den Bent

given: Martin J

family: Klein

full_name: Martin Klein

given: Martin

family: Smits

full_name: Marion Smits

given: Marion

family: Reijneveld

full_name: Jaap C Reijneveld

given: Jaap C

family: French

full_name: Pim J French

given: Pim J

family: Clement

full_name: Paul Clement

given: Paul

family: de Vos

full_name: Filip Y F de Vos

given: Filip Y F

family: Wick

full_name: Antje Wick

given: Antje

family: Mulholland

full_name: Paul J Mulholland

given: Paul J

family: Taphoorn

full_name: Martin J B Taphoorn

given: Martin J B

family: Lewis

full_name: Joanne Lewis

given: Joanne

family: Weller

full_name: Michael Weller

given: Michael

family: Chinot

full_name: Olivier L Chinot

given: Olivier L

family: Kros

full_name: Johan M Kros

given: Johan M

family: de Heer

full_name: Iris de Heer

given: Iris

family: Verschuere

full_name: Tina Verschuere

given: Tina

family: Coens

full_name: Corneel Coens

given: Corneel

family: Golfinopoulos

full_name: Vassilis Golfinopoulos

given: Vassilis

family: Gorlia

full_name: Thierry Gorlia

family: Idbaih

full_name: Ahmed Idbaih

given: Ahmed

journal_name: The Lancet Oncology

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

ReferenceCitation: Ediebah DE, Reijneveld JC, Taphoorn MJ, Coens C, Zikos E, Aaronson NK, Heimans JJ, Bottomley A, Klein M; EORTC Quality of Life Department and Patient Reported Outcome and Behavioral Evidence (PROBE). Impact of neurocognitive deficits on patient-proxy agreement regarding health-related quality of life in low-grade glioma patients. Qual Life Res. 2017 Apr;26(4):869-880. doi: 10.1007/s11136-016-1426-z. Epub 2016 Oct 15.

name: on behalf of the EORTC Quality of Life Department and Patient Reported Outcome and Behavioral Evidence (PROBE)

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: Impact of neurocognitive deficits on patient–proxy agreement regarding health-related quality of life in low-grade glioma patients

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

location_country:
Italy
Austria
Switzerland
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

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

location_facility: University Of Dundee - Ninewells Hospital

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Freeman Hospital, Northern Centre For Cancer Care

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital


intervention_type: Biological

lead_sponsor: University Hospital, Tours

acronym: AFORA

location_facility:
CHRU de Nantes
CHR du Mans
CHR d'Orléans
CHRU de Poitiers
CHRU de Tours
CHRU de Brest
CHRU de Rennes

type: Other Identifier

title: Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

summary:
Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α) approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.

However, almost one third of patients have no response and approximately 15% develop antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a relationship between adalimumab concentration and clinical response obtained after 6 month of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to predict the clinical response at 6 months.

There is an important inter individual pharmacokinetic variability of adalimumab. Side effects may occur at the recommended dose and more than 3 months of treatment are generally required to estimate the clinical response.

A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the response and to avoid dose related side effects. To date there is no definite adalimumab target concentration predictive of the clinical response to allow such a pharmacologic monitoring.


title: Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)

acronym: VAPS REHAB

summary:
Background : The general experience with the Virtual Reality application approach suggests that this treatment concept is promising in stroke rehabilitation
Purpose : In shopping activity in a real supermarket and in simulated with the investigators virtual shopping simulation (VAP-S = virtual action planning supermarket), the investigators will compare people who had undergone a stroke who receive conventional rehabilitation or virtual training in VAP-S.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT


title: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

acronym: effecT

summary: EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup and AF.

lead_sponsor: Biotronik SE & Co. KG

location_country:
Sweden
United Kingdom
Netherlands
France
Belgium
Germany
Czech Republic

location_facility: Karolinska University Hospital Stockholm


title: CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer

summary: Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

ReferenceCitation: Cabel L, Berger F, Cottu P, Loirat D, Rampanou A, Brain E, Cyrille S, Bourgeois H, Kiavue N, Deluche E, Ladoire S, Campone M, Pierga JY, Bidard FC. Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial. Br J Cancer. 2021 Mar;124(7):1207-1213. doi: 10.1038/s41416-020-01227-3. Epub 2021 Jan 21.

family: Cabel

full_name: Luc Cabel

given: Luc

family: Berger

full_name: Frédérique Berger

given: Frédérique

family: Cottu

full_name: Paul Cottu

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Rampanou

full_name: Aurore Rampanou

given: Aurore

family: Brain

full_name: Etienne Brain

given: Etienne

family: Cyrille

full_name: Stacy Cyrille

given: Stacy

family: Bourgeois

full_name: Hugues Bourgeois

given: Hugues

family: Kiavue

full_name: Nicolas Kiavue

given: Nicolas

family: Deluche

full_name: Elise Deluche

given: Elise

family: Ladoire

full_name: Sylvain Ladoire

given: Sylvain

family: Campone

full_name: Mario Campone

given: Mario

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Bidard

full_name: Francois-Clement Bidard

given: Francois-Clement

journal_name: British Journal of Cancer

ReferenceCitation: Helissey C, Berger F, Cottu P, Diéras V, Mignot L, Servois V, Bouleuc C, Asselain B, Pelissier S, Vaucher I, Pierga JY, Bidard FC. Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial. Cancer Lett. 2015 May 1;360(2):213-8. doi: 10.1016/j.canlet.2015.02.010. Epub 2015 Feb 17.

family: Helissey

full_name: C. Helissey

given: C.

full_name: F. Berger

given: F.

full_name: P. Cottu

given: P.

family: Diéras

full_name: V. Diéras

given: V.

family: Mignot

full_name: L. Mignot

given: L.

family: Servois

full_name: V. Servois

family: Bouleuc

full_name: C. Bouleuc

title: Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: The observational step of the CirCe01 phase III trial

location_facility:
Institut Rene Huguenin Curie
Hopital Saint Louis
Chu Limoges
Institut de Canacerologie de L'Ouest
Institut Curie
Centre Georges Francois Leclerc
Clinique Victor Hugo


title: Post-stroke Cognitive Impairment and Dementia: Frequency and Anatomical Correlates With the French Version of the National Institute of Neurological Disorders and Stroke (NINDS)-Canadian Stroke Network Battery

acronym: GRECogVASC

summary:
Projections from epidemiological studies suggest that, among the Western adult population, one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a North America working group which are under validation. It is essential to adapt these standard for French-speaking population, and especially to define cutoff scores of the cognitive battery to determine cognitive deficit.

The investigators propose a study coordinated by the University-Hospital of Amiens for french speaking centers. This study will investigate this battery with 906 controls to define the standards and 302 stroke affected patients to define the frequency and cognitive mechanisms. This step is essential for people to benefit from these new standards.

ReferenceCitation: Godefroy O, Fickl A, Roussel M, Auribault C, Bugnicourt JM, Lamy C, Canaple S, Petitnicolas G. Is the Montreal Cognitive Assessment superior to the Mini-Mental State Examination to detect poststroke cognitive impairment? A study with neuropsychological evaluation. Stroke. 2011 Jun;42(6):1712-6. doi: 10.1161/STROKEAHA.110.606277. Epub 2011 Apr 7.

ReferenceCitation: Godefroy O, Just A, Ghitu A, Leclercq C, Garcia PY, Lamy C, Canaple S, Bugnicourt JM. The Rankin scale with revised structured interview: effect on reliability, grading of disability and detection of dementia. Int J Stroke. 2012 Feb;7(2):183. doi: 10.1111/j.1747-4949.2011.00743.x.

ReferenceCitation: Godefroy O; GRECOG-VASC study group, Leclercq C, Bugnicourt JM, Roussel M, Moroni C, Quaglino V, Beaunieux H, Taillia H, Nédélec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F. Neuropsychological assessment and cerebral vascular disease: the new standards. Rev Neurol (Paris). 2013 Oct;169(10):779-85. doi: 10.1016/j.neurol.2013.07.009. Epub 2013 Aug 30. Review.

family: Godefroy

full_name: O. Godefroy

given: O.

family: Leclercq

full_name: C. Leclercq

family: Bugnicourt

full_name: J.-M. Bugnicourt

family: Roussel

full_name: M. Roussel

given: M.

family: Moroni

full_name: C. Moroni

family: Quaglino

full_name: V. Quaglino

family: Beaunieux

full_name: H. Beaunieux

given: H.

family: Taillia

full_name: H. Taillia

family: Nédélec-Ciceri

full_name: C. Nédélec-Ciceri

family: Bonnin

full_name: C. Bonnin

family: Thomas-Anterion

full_name: C. Thomas-Anterion

family: Varvat

full_name: J. Varvat

given: J.

family: Aboulafia-Brakha

full_name: T. Aboulafia-Brakha

given: T.

family: Assal

full_name: F. Assal

journal_name: Revue Neurologique

title: Neuropsychological assessment and cerebral vascular disease: The new standards

ReferenceCitation: Godefroy O, Leclercq C, Roussel M, Moroni C, Quaglino V, Beaunieux H, Tallia H, Nédélec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F; GRECOG-VASC Neuropsychological Committee. French adaptation of the vascular cognitive impairment harmonization standards: the GRECOG-VASC study. Int J Stroke. 2012 Jun;7(4):362-3. doi: 10.1111/j.1747-4949.2012.00794.x.

name: Department of Neurology, Amiens University Hospital, Amiens, France

full_name: Olivier Godefroy

given: Olivier

full_name: Claire Leclercq

given: Claire

full_name: Martine Roussel

given: Martine

name: Department of Psychology, Lille University, Lille, France

full_name: Christine Moroni

given: Christine

name: Department of Psychology, Amiens University, Amiens, France

full_name: Véronique Quaglino

given: Véronique

name: Department of Psychology, Caen University, Caen, France

full_name: Hélène Beaunieux

given: Hélène

name: Department of Neurology, Val de Grâce Hospital, Paris, France

family: Tallia

name: Department of Neurology, La Rochelle Hospital, La Rochelle, France

name: Department of Neurology, St Etienne University Hospital, St Etienne, France

name: Department of Neurology, Hopitaux Universitaire de Genève, Geneva, Switzerland

name: on behalf of the GRECOG-VASC Neuropsychological Committee

title: French Adaptation of the Vascular Cognitive Impairment Harmonization Standards: The GRECOG-VASC Study

ReferenceCitation: Godefroy O, Yaïche H, Taillia H, Bompaire F, Nédélec-Ciceri C, Bonnin C, Varvat J, Vincent-Grangette F, Diouf M, Mas JL, Canaple S, Lamy C, Arnoux A, Leclercq C, Tasseel-Ponche S, Roussel M, Barbay M; GRECogVASC Study Group. Who should undergo a comprehensive cognitive assessment after a stroke? A cognitive risk score. Neurology. 2018 Nov 20;91(21):e1979-e1987. doi: 10.1212/WNL.0000000000006544. Epub 2018 Oct 17.

ReferenceCitation: Barbay M, Taillia H, Nédélec-Ciceri C, Bompaire F, Bonnin C, Varvat J, Grangette F, Diouf M, Wiener E, Mas JL, Roussel M, Godefroy O; GRECOG-VASC Study Group. Prevalence of Poststroke Neurocognitive Disorders Using National Institute of Neurological Disorders and Stroke-Canadian Stroke Network, VASCOG Criteria (Vascular Behavioral and Cognitive Disorders), and Optimized Criteria of Cognitive Deficit. Stroke. 2018 May;49(5):1141-1147. doi: 10.1161/STROKEAHA.117.018889. Epub 2018 Apr 11.

name: From the Laboratory of Functional Neurosciences, Department of Neurology, Amiens University Hospital, France (M.B., E.W., M.R., O.G.)

name: Department of Neurology, Val-de-Grâce Hospital, Paris, France (H.T., F.B.)

name: Department of Neurology, La Rochelle Hospital, France (C.N.-C., C.B.)

name: Department of Neurology, University Hospital, Saint-Étienne, France (J.V., F.G.)

name: Department of Biostatistics (M.D.), Amiens University Hospital, France

name: Department of Neurology, Sainte Anne Hospital, Paris, France (J.-L.M.).

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHRU Lille
HIA Val de Grâce
CHU Saint Etienne
CHU Amiens
CHU Dijon
CHU Brest
CH La Rochelle


title: Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination

summary: This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.

design_allocation: Non-Randomized

ReferenceCitation: Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.

family: Kovac

full_name: Martina Kovac

given: Martina

family: Rathi

full_name: Niraj Rathi

given: Niraj

family: Kuriyakose

full_name: Sherine Kuriyakose

given: Sherine

family: Hardt

full_name: Karin Hardt

given: Karin

family: Schwarz

full_name: Tino F. Schwarz

given: Tino F.

journal_name: Vaccine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria–tetanus–acellular pertussis and inactivated poliovirus booster vaccine (dTpa–IPV) in healthy adults

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.

location_country: Germany France


type: Registry Identifier

title: An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

acronym: HOSCAR

summary: This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy Switzerland France Poland Portugal

location_facility:
Novarts Investigative Site
Novartis Investigative Site


title: Development and Implementation of a Cancer Fatigue Education Program

summary:
The purpose of the present project is to develop, implement and evaluate a pilot regional patient education program on the management of one of the main side effects of chemotherapy in cancer patients, that is fatigue.

A carer (doctor or nurse) trained in educational techniques will be responsible for the patient. The carer will first identify modes of behavior and competences that the patient must acquire in order to optimize his/her management of fatigue ("educational diagnosis"). An education program, based on a contract of goals will be proposed after this diagnosis phase. The expected results are, in the short-term, a significant reduction in the mean level of fatigue in patients receiving chemotherapy who benefited from individual educational management. In the longer term, the aim is to evaluate the impact of this program on patient quality of life and use of healthcare structures in comparison with conventional management.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility:
ZANETTA
LAFONT
CLAVREUL
CHOLLET
BLAY
PIVOT
BACHELOT Thomas


ReferenceCitation: Kjellman C, Maldonado AQ, Sjöholm K, Lonze BE, Montgomery RA, Runström A, Lorant T, Desai NM, Legendre C, Lundgren T, von Zur Mühlen B, Vo AA, Olsson H, Jordan SC. Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2021 Jul 8. doi: 10.1111/ajt.16754. [Epub ahead of print]

family: Kjellman

full_name: Christian Kjellman

given: Christian

family: Maldonado

full_name: Angela Q. Maldonado

given: Angela Q.

family: Sjöholm

full_name: Kristoffer Sjöholm

given: Kristoffer

name: NYU Langone Transplant Institute New York New York USA

family: Lonze

full_name: Bonnie E. Lonze

given: Bonnie E.

family: Montgomery

full_name: Robert A. Montgomery

given: Robert A.

family: Runström

full_name: Anna Runström

given: Anna

name: Department of Surgical Sciences Uppsala University Uppsala Sweden

family: Lorant

full_name: Tomas Lorant

given: Tomas

name: Johns Hopkins University Baltimore Maryland USA

family: Desai

full_name: Niraj M. Desai

given: Niraj M.

name: Hôpital Necker & Paris Descartes University Paris France

family: Legendre

full_name: Christophe Legendre

given: Christophe

name: Department of Transplantation Surgery Karolinska Institutet Stockholm Sweden

family: Lundgren

full_name: Torbjörn Lundgren

given: Torbjörn

family: Zur Mühlen

full_name: Bengt Zur Mühlen

given: Bengt

name: Cedars‐Sinai Medical Center Comprehensive Transplant Center Los Angeles California USA

family: Vo

full_name: Ashley A. Vo

given: Ashley A.

family: Olsson

full_name: Håkan Olsson

given: Håkan

family: Jordan

full_name: Stanley C. Jordan

given: Stanley C.

journal_name: American Journal of Transplantation

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Outcomes at 3 years post‐transplant in imlifidase‐desensitized kidney transplant patients

ReferenceCitation: Jordan SC, Legendre C, Desai NM, Lorant T, Bengtsson M, Lonze BE, Vo AA, Runström A, Laxmyr L, Sjöholm K, Schiött Å, Sonesson E, Wood K, Winstedt L, Kjellman C, Montgomery RA. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.

family: Bengtsson

full_name: Mats Bengtsson

given: Mats

repository_institution: Uppsala University - Uppsala University Publications

location_facility:
Uppsala University Hospital
New York University School of Medicine
Necker Hospital
Cedars-Sinai Medical Center
The Johns Hopkins Hospital

title: A Phase II Study to Evaluate the Efficacy of IdeS (IgG Endopeptidase) to Desensitize Transplant Patients With a Positive Crossmatch Test

summary: The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.


title: A Clinical Investigation Determining the Discriminative Ability of the NIOX VERO NASAL to Differentiate Subjects With Primary Ciliary Dyskinesia From Healthy Controls

summary:
This is a multi-centre, single visit clinical investigation involving patients with known PCD vs. age matched healthy volunteers. This study involves 1 visit which will last one (1) to two (2) hours. Participants (and parent as applicable) will be asked for their consent to participate in the study. A brief medical history will be recorded, including information such as age, gender, height, weight, race, current medications and living environment. If the participant is a PCD patient, they will also be asked about their disease history. Prior to performing the nasal measurements, participants will receive instructions from study personnel and have the opportunity to practice. All participants will have a brief nasal exam and will also have to blow their nose before starting the measurements. Participants will be asked to perform nasal nitric oxide measurements using the tidal breathing method followed by the velum closed with expiration against resistance method.

The primary objective is to determine the feasibility and capability of the NIOX VERO to discriminate participants with PCD from those that are healthy. Information collected in this study will help researchers understand more about the diagnosis of and identification of patients with PCD.

lead_sponsor: Aerocrine AB

location_country:
Denmark
United States
Germany
France

location_facility:
St Louis
Chapel Hill
Denmark
Germany
Paris


title: A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel

ReferenceCitation: Martin-Liberal J, Hollebecque A, Aftimos P, Jungels C, Martin-Romano P, Rodon J, Kremer JD, Zhang W, Bendell J. First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. Br J Cancer. 2020 Oct;123(8):1235-1243. doi: 10.1038/s41416-020-1011-7. Epub 2020 Aug 3.

family: Martin-Liberal

full_name: Juan Martin-Liberal

given: Juan

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Aftimos

full_name: Philippe Aftimos

given: Philippe

family: Jungels

full_name: Christiane Jungels

given: Christiane

family: Martin-Romano

full_name: Patricia Martin-Romano

given: Patricia

family: Rodon

full_name: Jordi Rodon

given: Jordi

family: Kremer

full_name: Jill Dolores Kremer

given: Jill Dolores

family: Zhang

full_name: Wei Zhang

given: Wei

family: Bendell

full_name: Johanna Bendell

given: Johanna

lead_sponsor: Eli Lilly and Company

location_country:
United States
Belgium
France
Spain

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: Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

acronym: OPTIMA

summary: The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

ReferenceCitation: Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quéré S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.

family: Guerci

full_name: B. Guerci

given: B.

family: Monnier

full_name: L. Monnier

given: L.

family: Serusclat

full_name: P. Serusclat

given: P.

family: Petit

full_name: C. Petit

given: C.

family: Valensi

full_name: P. Valensi

family: Huet

full_name: D. Huet

given: D.

family: Raccah

full_name: D. Raccah

family: Colette

full_name: C. Colette

family: Quéré

full_name: S. Quéré

given: S.

family: Dejager

full_name: S. Dejager

journal_name: Diabetes & Metabolism

title: Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: Results from the randomized Optima study

ReferenceCitation: Monnier L, Colette C, Comenducci A, Vallée D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. Epub 2012 Jul 9.

lead_sponsor: Novartis


title: A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement

acronym: ONICO

summary: The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility:
Cabinet Medical
Hopital Purpan
Cabinet Médical