title: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study

acronym: METALAP

summary: The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.

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ReferenceCitation: Montalti R, Berardi G, Laurent S, Sebastiani S, Ferdinande L, Libbrecht LJ, Smeets P, Brescia A, Rogiers X, de Hemptinne B, Geboes K, Troisi RI. Laparoscopic liver resection compared to open approach in patients with colorectal liver metastases improves further resectability: Oncological outcomes of a case-control matched-pairs analysis. Eur J Surg Oncol. 2014 May;40(5):536-544. doi: 10.1016/j.ejso.2014.01.005. Epub 2014 Feb 2.

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ReferenceCitation: Allard MA, Cunha AS, Gayet B, Adam R, Goere D, Bachellier P, Azoulay D, Ayav A, Navarro F, Pessaux P; Colorectal Liver Metastases-French Study Group. Early and Long-term Oncological Outcomes After Laparoscopic Resection for Colorectal Liver Metastases: A Propensity Score-based Analysis. Ann Surg. 2015 Nov;262(5):794-802. doi: 10.1097/SLA.0000000000001475.

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lead_sponsor: Institut Mutualiste Montsouris

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil


title: Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate

acronym: Methoscan

summary: The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Association HGE CHU Bordeaux Sud

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Haemophilia and Bone Loss PHILEOS Study

acronym: PHILEOS

summary: Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot formation, causing excessive bleeding (mainly haemarthrosis). Osteoporosis is a systemic bone disease characterized by a low bone mineral density (BMD). A decrease of mean BMD has been described in haemophilic patients compared to healthy controls in several studies. So, osteoporosis could be an underestimated haemophilia-related comorbidity. None of the following risk factors (reduced physical activity, joint damage, vitamin D deficiency and /or hepatitis C virus (HCV) infection) has been retained as a cause of osteoporosis in haemophilic patients. Another hypothesis is that bone loss could be directly linked to fVIII or fIX and/or thrombin deficiency. The aim of this study is to evaluate the prevalence of the bone loss in HA and B patients, according to the type, the severity and the presence (or not) of a prophylactic treatment (depending on the age at which it was began) and to compare it to a control population. The investigators will also evaluate the relation between BMD and FVIII, fIX and thrombin potential.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Tardy-Poncet B, Play B, Montmartin A, Damien P, Ollier E, Presles E, Garcin A, Tardy B. PHILEOS (haemoPHILia and ostEoporOSis) Study: protocol of a multicentre prospective case-control study. BMJ Open. 2021 Jan 13;11(1):e042283. doi: 10.1136/bmjopen-2020-042283.

family: Tardy‐Poncet

full_name: Brigitte Tardy‐Poncet

given: Brigitte

sequence: first

family: Play

full_name: Barbara Play

given: Barbara

sequence: additional

family: Montmartin

full_name: Aurélie Montmartin

given: Aurélie

family: Damien

full_name: Pauline Damien

given: Pauline

family: Ollier

full_name: Edouard Ollier

given: Edouard

family: Presles

full_name: Emilie Presles

given: Emilie

family: Garcin

full_name: Arnauld Garcin

given: Arnauld

family: Tardy

full_name: Bernard Tardy

given: Bernard

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: PHILEOS (haemoPHILia and ostEoporOSis) Study: protocol of a multicentre prospective case–control study

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country: Romania Belgium France

location_facility:
Chu de Bordeaux
CHU de ROUEN
Centre Hospitalier Metropole Savoie
Chu Cth Estaing Clermont Ferrand
CHU de Saint-Etienne
BELGIUM - Brussels
CHU Caen
Chu Rennes Hopital Pontchaillou
ROMANIA - Bucharest
Chu de Dijon
Chu La Timone Marseille
Chu Strasbourg - Hôpital de Hautepierre
CHU Lille
CHU Nancy
Chu Grenoble Alpes
Chu Necker Paris
Chu Brest Hopital Morvan

intervention_type: Radiation

status_simplified: Ongoing


title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)

acronym: SPOC

summary:
A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol.

The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

location_facility: Pneumology departement, Saint-Antoine hospital

location_facility: Pneumology Clinic - Albert Calmette hospital- CHU Rouen

location_facility: Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims

location_facility: Pneumology departement CHU Saint-Etienne

location_facility: Pneumology departement, Sainte Marguerite hospital

location_facility: Endoscopy unit, Thoracic surgery department, Foch Hospital

intervention_type: Device

status_simplified: Unknown


title: Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )

acronym: NEOSarcomics

summary: This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

location_facility:
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Centre Georges François Leclerc
Institut Paoli Calmettes
Institut Curie
Institut Claudius Regaud - IUCT-0
AP-HM _ Hôpital de la Timone
Institut Bergonié
Institut Gustave Roussy

intervention_type: Other

lead_sponsor_type: industriel


intervention_type: Drug

lead_sponsor: Institut Curie

location_facility:
CHU Poitiers
CHU Clermont-Ferrand
CHU La Timone Marseille
Institut Curie
CHU Nantes
Centre Henri Becquerel
CHU Amiens
CHRU Lille
CHU Créteil
CHU Dijon
CHU Limoges
CH Colmar
Hôpital Cochin
CHU Besançon
CHU Nancy
Institut Bergonié
IUCT -Oncopole
CHU Angers
CHU Caen
CHU Lyon
Centre Lacassagne
CHU Tours
CHU Pitié-Salpêtrière
CHU Grenoble
CHU Rennes

type: EudraCT Number

source: euctr

title: LOC-R01: Randomized Phase Ib/II Study of Escalating Doses of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV) as a Targeted Induction Treatment for Patients Aged 18 to 60 With a Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL).

summary: This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT).


title: Prospective Study of Omission of Whole-breast Radiotherapy Following Breast-conserving Surgery in Patients With Very Low Risk Ductal Carcinoma in Situ of the Breast

acronym: ROMANCE

summary:
Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences.

Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p <0.001). Sixty percent of the patients received tamoxifen in both groups.

Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk.

Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut de Cancérologie de l'Ouest -Site Paul Papin

location_facility: Institut De Cancerologie De Lorraine Alexis Vautrin

location_facility: Institut Regional Du Cancer Montpellier Val D Aurelle


title: Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver (NoFlic Study)

acronym: NoFlic

summary: The main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).

lead_sponsor: University Hospital, Bordeaux

location_facility:
AP-HP Hopital Saint Antoine
CHI Créteil
AP-HP Cochin
AP-HP Jean Verdier
Hospices Civiles de Lyon
CHU Caen
Hopital Edouard Herriot
CHU Villejuif
AP-HP Hopital Antoine Béclère
CHU Bordeaux
AP-HP Hopital Beaujon
CHU Grenoble
AP-HP Hopital Henri Mondor
CHU Amiens


title: PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

acronym: NIRVANA-LUNG

summary:
Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy.

Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (="abscopal effect").

IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion.

Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al [2017] tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p<0.001). An increase of OS is consequently expected.

However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung.

ReferenceCitation: Doyen J, Besse B, Texier M, Bonnet N, Levy A. PD-1 iNhibitor and chemotherapy with concurrent IRradiation at VAried tumor sites in advanced Non-small cell lung cAncer: the Prospective Randomized Phase 3 NIRVANA-Lung Trial. Clin Lung Cancer. 2021 Oct 24. pii: S1525-7304(21)00269-2. doi: 10.1016/j.cllc.2021.10.008. [Epub ahead of print]

family: Doyen

full_name: Jérôme Doyen

given: Jérôme

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Texier

full_name: Matthieu Texier

given: Matthieu

family: Bonnet

full_name: Naima Bonnet

given: Naima

family: Levy

full_name: Antonin Levy

given: Antonin

journal_name: Clinical Lung Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility: Pôle départemental de Cancérologie Libérale 37

location_facility: Centre Hospitalier Universitaire De Caen - Hôpital Cote De Nacre

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Centre de cancérologie du grand Montpellier-Clinique Clementville

location_facility: Centre Hospitalier Intercommunal De Creteil


title: Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management

acronym: EFFADOL-K

summary:
Pain is one of the most feared and burdensome symptoms experienced by cancer patients. Its prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer treatment, and unrelieved pain is directly associated with significantly reduced quality of life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related barriers. Patient barriers are multifactorial and often result from a lack of knowledge about cancer pain and its self-management. They mainly consist of misconceptions about opioids and their side effects, nonadherence, and reluctance to alert health care providers to unrelieved pain. Patient education enables people with chronic disease to manage their illness, and has been considered in the field of cancer research as an important strategy to achieve optimal pain control.

In Basse-Normandie french region, the "Health Regional Plan, pain aspect" has identified the theme " pain education program " as a priority.

The main endpoint is the decrease of pain interference with daily life (using the Brief Pain Inventory). The experimental group, consisting of cancer pain patients, will benefit from the education program by previously trained health care providers. It will be compared with the control group, consisting with patients whose pain will be conventionally managed before the professional training in therapeutic education.

ReferenceCitation: Prevost V, Heutte N, Leconte A, Licaj I, Delorme C, Clarisse B; EFFADOL-Group. Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial. BMC Cancer. 2019 Jul 8;19(1):673. doi: 10.1186/s12885-019-5836-5.

apc_source: openAPC

family: Prevost

full_name: Virginie Prevost

given: Virginie

family: Heutte

full_name: Natacha Heutte

given: Natacha

family: Leconte

full_name: Alexandra Leconte

given: Alexandra

family: Licaj

full_name: Idlir Licaj

given: Idlir

family: Delorme

full_name: Claire Delorme

given: Claire

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Francois Baclesse

location_facility: Hopital Européen Georges Pompidou (HEGP)


title: Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence

summary:
The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks.

Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women.

The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments

status: Active, not recruiting

location_facility: Centre Galilée - Hôpital Privé La Louvière

location_facility: Institut de Cancerologie de L'Ouest-Paul Papin

location_facility: Institut de Cancerologie de L'Ouest-Rene Gauducheau


title: Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.

acronym: PREDICTOR

summary:
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value.

The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use.

To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores.

Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.

lead_sponsor: University Hospital, Toulouse

location_country: Monaco France

location_facility: Hôpital saint vincent de paul - Institut Catholique


title: A Randomized Cross-over Trial Evaluating the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Palliative Stage of Cancer

summary:
While some authors recommend diuretics as the first treatment to initiate for symptoms caused by malignant ascites (MA), their prescription is variable. No randomized, controlled study has assessed their benefit in this context. According to literature, diuretics may bring relief in about 40% of cases, regardless of primary tumor.

The purpose of our study is to assess the effectiveness of diuretic treatment according to Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the time elapsed between recurrent MA that requires paracentesis. The investigators will also examine whether SAAG and serum levels of renin and aldosterone can predict symptom response to diuretics.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Intercommunal Compiègne-Noyon


title: A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .

acronym: E-DIS

summary:
Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

ReferenceCitation: Kotecki N, Hiret S, Etienne PL, Penel N, Tresch E, François E, Galais MP, Ben Abdelghani M, Michel P, Dahan L, Ghiringelli F, Bedenne L, Samalin E, Piessen G, Bennouna J, Peugniez C, El Hajbi F, Clisant S, Kramar A, Mariette C, Adenis A. First-Line Chemotherapy for Metastatic Esophageal Squamous Cell Carcinoma: Clinico-Biological Predictors of Disease Control. Oncology. 2016;90(2):88-96. doi: 10.1159/000442947. Epub 2016 Jan 20.

family: Kotecki

full_name: Nuria Kotecki

given: Nuria

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Etienne

full_name: Pierre-Luc Etienne

given: Pierre-Luc

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Tresch

full_name: Emmanuelle Tresch

given: Emmanuelle

family: François

full_name: Eric François

given: Eric

family: Galais

full_name: Marie Pierre Galais

given: Marie Pierre

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Michel

full_name: Pierre Michel

given: Pierre

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Ghiringelli

full_name: François Ghiringelli

given: François

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

family: Samalin

full_name: Emmanuelle Samalin

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: Bennouna

full_name: Jafaar Bennouna

given: Jafaar

family: Peugniez

full_name: Charlotte Peugniez

given: Charlotte

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Clisant

full_name: Stéphanie Clisant

given: Stéphanie

family: Kramar

full_name: Andrew Kramar

given: Andrew

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Adenis

full_name: Antoine Adenis

given: Antoine

journal_name: Oncology

publisher: S. Karger AG

location_facility:
Centre Eugène Marquis
Centre Antoine Lacassagne
Centre Alexis Vautrin
Centre Val d'Aurelle
Centre Oscar Lambret
CHU Rouen
Centre Georges François Leclerc
Centre Hospitalier Intercommunal
Centre Paul Strauss
CHU La Timone
CHU Dijon
CHU Lille
Centre René Gauducheau
Clinique de la Theuillerie
CHU Brest
Centre François BACLESSE
Clinique de l'Armoricaine


title: A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer

summary:
This is a 2x2 factorial randomized, multicenter, international, open phase III trial.

The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: France Switzerland

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases

acronym: STEREO-OS

summary:
Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).

The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.

Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy.

The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).

Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.

In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 3 metastases) in solid tumor patients is able to improve the survival without progression.

ReferenceCitation: Thureau S, Marchesi V, Vieillard MH, Perrier L, Lisbona A, Leheurteur M, Tredaniel J, Culine S, Dubray B, Bonnet N, Asselain B, Salleron J, Faivre JC. Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). BMC Cancer. 2021 Feb 4;21(1):117. doi: 10.1186/s12885-021-07828-2.

family: Thureau

full_name: Sébastien Thureau

given: Sébastien

family: Marchesi

full_name: Vincent Marchesi

given: Vincent

family: Vieillard

full_name: Marie-Hélène Vieillard

given: Marie-Hélène

family: Perrier

full_name: Lionel Perrier

given: Lionel

family: Lisbona

full_name: Albert Lisbona

given: Albert

family: Leheurteur

full_name: Marianne Leheurteur

given: Marianne

family: Tredaniel

full_name: Jean Tredaniel

given: Jean

family: Culine

full_name: Stéphane Culine

given: Stéphane

family: Dubray

full_name: Bernard Dubray

given: Bernard

family: Bonnet

full_name: Naïma Bonnet

given: Naïma

family: Asselain

full_name: Bernard Asselain

family: Salleron

full_name: Julia Salleron

given: Julia

family: Faivre

full_name: Jean-Christophe Faivre

given: Jean-Christophe

location_facility: Centre de Cancérologie du Grand Montpellier


title: Tracking Triple-negative Breast Cancer Evolution Through Therapy

acronym: TRACERX-TNBC

summary: A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.

primary_purpose: Diagnostic

location_facility: Hopitaux universitaire de strasbourg - Hopital civil

intervention_type: Procedure


title: GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .

acronym: GENSARC

summary: The clinical and histological diagnosis of sarcomas is often very difficult. The identification of chromosomal and molecular anomalies, such as amplifications, deletions or fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their benign counterparts. However, the cost of the cytogenetic and molecular techniques for the detection of these alterations is often a limitation to their use. The aim of our study is to evaluate the direct cost of the molecular techniques in comparison to the cost that would be generated by an appropriate therapy and care management of the patient in case of an erroneous diagnosis.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Unité de Biologie Moléculaire, CHU de Hautepierre

location_facility: Département d'Anantomie et de Cytologie Pathologie, Centre Léon Berard

location_facility: Département de biologie et de pathologie médicales, Institut Gustave roussy

location_facility: Departement de Pathologie de l'Institut Bergonié

location_facility: Laboratoire de Biochimie et Biologie Moléculaire, CHRU de Lille

location_facility: Laboratoire de Génétique des Tumeurs Solides

location_facility: Service d'Anatomo-Pathologie, Centre Paul Strauss


title: Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity

acronym: TOMOGYN

summary: Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

location_facility:
René Gauducheau Center
Paul Strauss Center
Institut Jean Godinot
Oscar Lambret Center
François Baclesse Center
Centre Leon Berard
Bergonie Institut


title: Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

acronym: CKNO-PRO

summary: hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

ReferenceCitation: Pasquier D, Nickers P, Peiffert D, Maingon P, Pommier P, Lacornerie T, Martinage G, Tresch E, Lartigau E. Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO). PLoS One. 2017 Nov 30;12(11):e0187794. doi: 10.1371/journal.pone.0187794. eCollection 2017.

family: Pasquier

full_name: David Pasquier

given: David

family: Nickers

full_name: Philippe Nickers

given: Philippe

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Maingon

full_name: Philippe Maingon

family: Pommier

full_name: Pascal Pommier

given: Pascal

family: Lacornerie

full_name: Thomas Lacornerie

given: Thomas

family: Martinage

full_name: Geoffrey Martinage

given: Geoffrey

family: Tresch

full_name: Emmanuelle Tresch

given: Emmanuelle

family: Lartigau

full_name: Eric Lartigau

given: Eric

currency_apc_doaj: USD

journal_name: PLOS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility:
Centre Léon Bérard
Centre Alexis Vautrin
Centre Paul Papin
Centre Georges François Leclerc
Centre Hospitalier Lyon Sud
Centre Oscar LAMBRET
Val d'Aurelle-Paul Lamarque


title: Treatment of Severe and Resistant Obsessive-compulsive Disorder by High-frequency Stimulation of the Ventral Striatum and the Subthalamic Nucleus

summary: Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

ReferenceType: background

ReferenceCitation: Aouizerate B, Cuny E, Bardinet E, Yelnik J, Martin-Guehl C, Rotge JY, Rougier A, Bioulac B, Tignol J, Mallet L, Burbaud P, Guehl D. Distinct striatal targets in treating obsessive-compulsive disorder and major depression. J Neurosurg. 2009 Oct;111(4):775-9. doi: 10.3171/2009.2.JNS0881.

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

family: Mallet

full_name: Luc Mallet

given: Luc

family: Polosan

full_name: Mircea Polosan

given: Mircea

family: Jaafari

full_name: Nematollah Jaafari

given: Nematollah

family: Baup

full_name: Nicolas Baup

given: Nicolas

family: Welter

full_name: Marie-Laure Welter

given: Marie-Laure

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Montcel

full_name: Sophie Tezenas du Montcel

given: Sophie Tezenas du

family: Yelnik

full_name: Jérôme Yelnik

given: Jérôme

family: Chéreau

full_name: Isabelle Chéreau

given: Isabelle

family: Arbus

full_name: Christophe Arbus

given: Christophe

family: Raoul

full_name: Sylvie Raoul

given: Sylvie

family: Aouizerate

full_name: Bruno Aouizerate

given: Bruno

family: Damier

full_name: Philippe Damier

family: Chabardès

full_name: Stephan Chabardès

given: Stephan

family: Czernecki

full_name: Virginie Czernecki

given: Virginie

family: Ardouin

full_name: Claire Ardouin

given: Claire

family: Krebs

full_name: Marie-Odile Krebs

given: Marie-Odile

family: Bardinet

full_name: Eric Bardinet

family: Chaynes

full_name: Patrick Chaynes

given: Patrick

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

family: Cornu

full_name: Philippe Cornu

family: Derost

full_name: Philippe Derost

family: Bougerol

full_name: Thierry Bougerol

given: Thierry

title: Subthalamic Nucleus Stimulation in Severe Obsessive–Compulsive Disorder

location_facility:
Sainte-Anne Hospital
Strasbourg University Hospital
Lyon University Hospital
Clermont-Ferrand University Hospital
Rennes University Hospital
Lille University Hospital
Henri Mondor Hospital
Grenoble University Hospital
Nice University Hospital
Marseille University Hospital
Pitié-Salpêtrière Hospital
Poitiers University Hospital
Bordeaux University Hospital
Toulouse University Hospital


title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

acronym: QuickTrans

summary: The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

lead_sponsor: University Hospital, Lille

location_country: Belgium France

location_facility: Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)


title: Evaluation of the Characteristics, Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease: Study ETENDARD.

acronym: ETENDARD

summary: Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet (TRJ) velocity > or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)> or equal at 25 mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac output (CO) but normal pulmonary vascular resistance (PVR <160 dynes), or postcapillary PH (pulmonary capillary wedge pressure PCWP >15 mmHg), or precapillary pulmonary arterial hypertension (PAH) defined by mPAP > or equal at 25 mmHg, PCWP< or equal at 15 mmHg and PVR > or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults with sickle cell disease the characteristics, prevalence and prognosis of pulmonary hypertension.

status: Unknown status

ReferenceCitation: Simonneau G, Galiè N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. Review.

ReferenceCitation: Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002 Mar 21;346(12):896-903. Erratum in: N Engl J Med 2002 Apr 18;346(16):1258.

ReferenceCitation: Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004 Sep 30;351(14):1425-36. Review.

ReferenceCitation: Lechapt E, Habibi A, Bachir D, Galacteros F, Schaeffer A, Desvaux D, Brochard L, Housset B, Godeau B, Maitre B. Induced sputum versus bronchoalveolar lavage during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1373-7. Epub 2003 Sep 11.

ReferenceCitation: Maitre B, Habibi A, Roudot-Thoraval F, Bachir D, Belghiti DD, Galacteros F, Godeau B. Acute chest syndrome in adults with sickle cell disease. Chest. 2000 May;117(5):1386-92.

ReferenceCitation: Parent F, Bachir D, Inamo J, Lionnet F, Driss F, Loko G, Habibi A, Bennani S, Savale L, Adnot S, Maitre B, Yaïci A, Hajji L, O'Callaghan DS, Clerson P, Girot R, Galacteros F, Simonneau G. A hemodynamic study of pulmonary hypertension in sickle cell disease. N Engl J Med. 2011 Jul 7;365(1):44-53. doi: 10.1056/NEJMoa1005565.

family: Parent

full_name: Florence Parent

given: Florence

family: Bachir

full_name: Dora Bachir

given: Dora

family: Inamo

full_name: Jocelyn Inamo

given: Jocelyn

family: Lionnet

full_name: François Lionnet

given: François

family: Driss

full_name: Françoise Driss

given: Françoise

family: Loko

full_name: Gylna Loko

given: Gylna

family: Habibi

full_name: Anoosha Habibi

given: Anoosha

family: Bennani

full_name: Soumiya Bennani

given: Soumiya

family: Savale

full_name: Laurent Savale

given: Laurent

family: Adnot

full_name: Serge Adnot

given: Serge

family: Maitre

full_name: Bernard Maitre

given: Bernard

family: Yaïci

full_name: Azzedine Yaïci

given: Azzedine

family: Hajji

full_name: Leila Hajji

given: Leila

family: O'Callaghan

full_name: Dermot S. O'Callaghan

given: Dermot S.

family: Clerson

full_name: Pierre Clerson

family: Girot

full_name: Robert Girot

given: Robert

family: Galacteros

full_name: Frederic Galacteros

given: Frederic

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

journal_name: New England Journal of Medicine

oa_host_type: repository

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

repository_normalized: HAL

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

title: A Hemodynamic Study of Pulmonary Hypertension in Sickle Cell Disease


title: Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital

acronym: dHEPass

summary:
A high number of people are infected by viral hepatitises B and C without knowing it, especially vulnerable population such as the ones who come in consultation in continuous health care access center (Permanence d'accès aux soins, PASS). Now that these infections can be rapidly treated, it is essential to diagnose them the quickest possible. The Identification and Diagnostic Orientation Test (Test de repérage et d'orientation diagnostique, TROD) technique is a rapid tool allowing to screen for hepatitis B and C by a simple capillary sample.

The study aims to evaluate the accptability of a systematic screening using TROD for hepatitis B and C in adults in a PASS consultation in Montpellier.

We also want to estimate the prevalence of theses infections in the population, to describe the HBV and HCV care cascades, to evaluate the acceptability of vaccinal catch-up for HBV, and to describe people with hepatits.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Montpellier


title: International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

acronym: Adherence-SLE

summary:
The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12.

Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Guern VL, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Vollenhoven RV, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2019 Aug;106(2):374-382. doi: 10.1002/cpt.1194. Epub 2018 Sep 2.

name: Internal Medicine DepartmentCentre de Référence Maladies Auto‐Immunes et Systémiques RaresAP‐HPCochin Hospital Paris France

name: Center for Epidemiology and StatisticsINSERM U 1153Sorbonne Paris Cité (CRESS) Paris France

family: Costedoat‐Chalumeau

full_name: Nathalie Costedoat‐Chalumeau

given: Nathalie

name: Service de RhumatologieCliniques Universitaires Saint‐LucPôle de Pathologies Rhumatismales Inflammatoires et SystémiquesUniversité catholique de Louvain Brussels Belgium

family: Houssiau

full_name: Frédéric Houssiau

given: Frédéric

name: Division of RheumatologyDepartment of MedicineNew York University School of Medicine New York New York USA

family: Izmirly

full_name: Peter Izmirly

given: Peter

family: Guern

full_name: Véronique Le Guern

given: Véronique Le

name: University of Santo Tomas Hospital Manila Philippines

family: Navarra

full_name: Sandra Navarra

given: Sandra

name: Rush University Medical CenterRush Lupus Clinic Chicago Illinois USA

family: Jolly

full_name: Meenakshi Jolly

given: Meenakshi

name: Autoimmune Diseases Research UnitDepartment of Internal MedicineBioCruces Health Research InstituteHospital Universitario CrucesUniversity of the Basque Country Barakaldo Spain

family: Ruiz‐Irastorza

full_name: Guillermo Ruiz‐Irastorza

given: Guillermo

name: Centre d'Epidémiologie CliniqueAP‐HPHôpitalHôtel‐DieuUniversité Paris Descartes‐Sorbonne Paris Cité Paris France

family: Baron

full_name: Gabriel Baron

given: Gabriel

name: Claude Huriez HospitalInternal Medicine DepartmentCentre de Référence Maladies Auto‐immunes et Systémiques raresUniversité de Lille Lille France

family: Hachulla

full_name: Eric Hachulla

given: Eric

name: Sheba Medical CenterZabludowicz Center for Autoimmune Diseases Tel‐Hashomer Israel

family: Agmon‐Levin

full_name: Nancy Agmon‐Levin

given: Nancy

family: Shoenfeld

full_name: Yehuda Shoenfeld

given: Yehuda

name: Rheumatology and Clinical Immunology UnitSpedali Civili and Department of Clinical and Experimental ScienceUniversity of Brescia Brescia Italy

family: Dall'Ara

full_name: Francesca Dall'Ara

given: Francesca

family: Buyon

full_name: Jill Buyon

given: Jill

name: Internal Medicine DepartmentPierre‐Zobda‐Quitman Hospital Martinique France

family: Deligny

full_name: Christophe Deligny

given: Christophe

name: Department of Autoimmune DiseasesHospital Clínic de Barcelona Barcelona Spain

family: Cervera

full_name: Ricard Cervera

given: Ricard

name: Internal Medicine DepartmentHaut Lévêque Hospital Pessac France

family: Lazaro

full_name: Estibaliz Lazaro

given: Estibaliz

name: Internal Medicine DepartmentDupuytren Hospital Limoges France

family: Bezanahary

full_name: Holy Bezanahary

given: Holy

name: Internal Medicine DepartmentAP‐HPPitié‐Salpêtrière HospitalUniversité Pierre et Marie Curie Paris France

family: Leroux

full_name: Gaëlle Leroux

given: Gaëlle

family: Morel

full_name: Nathalie Morel

family: Viallard

full_name: Jean‐François Viallard

given: Jean‐François

name: Montreal General HospitalLupus Clinic Montreal Canada

family: Pineau

full_name: Christian Pineau

given: Christian

name: Clinical Immunology DepartmentAP‐HPSt Louis Hospital Paris France

family: Galicier

full_name: Lionel Galicier

given: Lionel

name: Department of MedicineUnit for Clinical Research TherapyInflammatory DiseasesKarolinska University Hospital Stockholm Sweden

family: Vollenhoven

full_name: Ronald Van Vollenhoven

given: Ronald Van

family: Tincani

name: Centre for RheumatologyUniversity College London London UK

name: Pharmacology DepartmentAP‐HPHopital Pitié‐Salpêtrière Paris France

name: Internal Medicine DepartmentEuropean Georges Pompidou Hospital Paris France

name: Johns Hopkins University School of Medicine Baltimore Maryland USA

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

repository_institution: University College London - UCL Discovery

title: A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE : Assessment by Drug Levels and Self‐Administered Questionnaires

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9. Corrected and republished in: Clin Pharmacol Ther. 2019 Aug;106(2):374-382.

title: Note of Republication: A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self‐Administered Questionnaires


title: iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway

acronym: iDEFCO

summary: Social inequalities in the face of cancer are significant in all countries. They are characterized by higher mortality among people may be in the lower socioeconomic category. The care pathway may also be a source of inequality or accentuate inequalities. Socially vulnerable patients must be provided with appropriate care. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and to take them into account throughout the care process. To meet this need, the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") was designed and conducted by the Centre Hygée at the Lucien Neuwirth Cancer Institute (ICLN) in 2014 and 2015, in partnership with an industrial engineering research laboratory, the DISP ("Décision & Information pour les Systèmes de Production"). Its objective was to develop a tool for systematic screening of social fragility, involving few caregivers and making it possible to identify patients most at risk of social maladjustment. The choice was made to develop a self-administered questionnaire using tablets connected to a neural network. Since its implementation, the deployment of the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") tool at the Lucien Neuwirth Cancer Institute (ICLN) has required several training and awareness-raising activities to strengthen the motivation of the various stakeholders. These same actors have also implemented different strategies to optimize the functioning of the tool. Developed in a specialized institution, this tool must demonstrate, in this second stage of the project, it transferability and it possibilities of implementation in other structures. It is also necessary to evaluate it in terms of it is impact, particularly on the fluidity of care pathways and on the social consequences of the disease.

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie


title: Long Term Natural History of PTS and Other Adverse Outcomes After Venous Thromboembolism in the Optimev Study (SPOT)

acronym: SPOT

summary:
Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein thrombosis (DVT). In the absence of curative treatment of established PTS, its management is based on the prevention of its occurrence thanks to anticoagulants and compression stockings.

So far, predictors of disabling PTS are unknown precluding from optimally selecting patients for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little is known on the incidence of PTS in the very long-term.

Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event, Primary objective: incidence and severity of PTS after a lower limb DVT.

Main Secondary objectives:

Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT).
Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years) of patients recruited in the large, multicentre, prospective, observational OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical Trials NCT00670540).

All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients without any history of VTE after the 3 years of follow-up) will first benefit from a phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a selection of controls will undergo a clinical follow-up visit with clinical and Compleat Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of life.

Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of usual treatment. Better selecting patients eligible for invasive/innovative/expensive preventative procedures.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Pernod G, Quere I, Bosson JL. Is it useful to also image the asymptomatic leg in patients with suspected deep vein thrombosis?: comment. J Thromb Haemost. 2015 Nov;13(11):2127-30. doi: 10.1111/jth.13123. Epub 2015 Sep 30.

ReferenceCitation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quéré I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

family: Arnoult

full_name: Anne Cécile Arnoult

given: Anne Cécile

family: Sevestre

full_name: Marie-Antoinette Sevestre

given: Marie-Antoinette

family: Genty

full_name: Céline Genty

given: Céline

family: Bonaldi

full_name: Michael Bonaldi

given: Michael

family: Guyard

full_name: Audrey Guyard

given: Audrey

family: Giordana

full_name: Pascal Giordana

given: Pascal

family: Pichot

full_name: Olivier Pichot

given: Olivier

family: Colonna

full_name: Marc Colonna

given: Marc

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Galanaud

full_name: Jean-Philippe Galanaud

given: Jean-Philippe

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

family: Le Moigne

full_name: Emmanuelle Le Moigne

given: Emmanuelle

full_name: Celine Genty

given: Celine

family: Meunier

full_name: Julie Meunier

given: Julie

full_name: Anne-Cecile Arnoult

given: Anne-Cecile

family: Righini

full_name: Marc Righini

family: Bressollette

full_name: Luc Bressollette

given: Luc

family: Le Gal

full_name: Gregoire Le Gal

given: Gregoire

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Kahn SR, Pernod G, Rolland C, Diard A, Dupas S, Jurus C, Diamand JM, Quere I, Bosson JL; OPTIMEV-SFMV investigators. Incidence and predictors of venous thromboembolism recurrence after a first isolated distal deep vein thrombosis. J Thromb Haemost. 2014 Apr;12(4):436-43. doi: 10.1111/jth.12512.

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Maufus M, Bosson JL, Genty C, Delluc A, Imbert P, Gagne P, Rolland C, Bressollette L, Le Gal G. [Validation of a deep vein thrombosis prediction rule in primary care]. J Mal Vasc. 2012 Feb;37(1):9-14. doi: 10.1016/j.jmv.2011.10.005. Epub 2011 Dec 12. French.

ReferenceCitation: Galanaud JP, Genty C, Sevestre MA, Brisot D, Lausecker M, Gillet JL, Rolland C, Righini M, Leftheriotis G, Bosson JL, Quere I; OPTIMEV SFMV investigators. Predictive factors for concurrent deep-vein thrombosis and symptomatic venous thromboembolic recurrence in case of superficial venous thrombosis. The OPTIMEV study. Thromb Haemost. 2011 Jan;105(1):31-9. doi: 10.1160/TH10-06-0406. Epub 2010 Sep 30.

ReferenceCitation: Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.

ReferenceCitation: Johnson SA, Stevens SM, Woller SC, Lake E, Donadini M, Cheng J, Labarère J, Douketis JD. Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA. 2010 Feb 3;303(5):438-45. doi: 10.1001/jama.2010.43. Review.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quéré I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

ReferenceCitation: Sevestre MA, Quashié C, Genty C, Rolland C, Quéré I, Bosson JL; Optimev study investigators. Clinical presentation and mortality in pulmonary embolism: the Optimev study. J Mal Vasc. 2010 Jul;35(4):242-9. doi: 10.1016/j.jmv.2010.05.004. Epub 2010 Jul 2.

ReferenceCitation: Sevestre MA, Labarère J, Casez P, Bressollette L, Haddouche M, Pernod G, Quéré I, Bosson JL. Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study. Am J Med. 2010 Feb;123(2):158-65. doi: 10.1016/j.amjmed.2009.05.034.

ReferenceCitation: Casez P, Labarère J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, François P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.

ReferenceCitation: Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.

ReferenceCitation: Sevestre MA, Labarère J, Casez P, Bressollette L, Taiar M, Pernod G, Quéré I, Bosson JL. Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting. A prospective cohort study. Thromb Haemost. 2009 Jul;102(1):166-72. doi: 10.1160/TH09-01-0048.

ReferenceCitation: Constans J, Salmi LR, Sevestre-Pietri MA, Perusat S, Nguon M, Degeilh M, Labarere J, Gattolliat O, Boulon C, Laroche JP, Le Roux P, Pichot O, Quéré I, Conri C, Bosson JL. A clinical prediction score for upper extremity deep venous thrombosis. Thromb Haemost. 2008 Jan;99(1):202-7. doi: 10.1160/TH07-08-0485.

ReferenceCitation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.

lead_sponsor: Association des Médecins Vasculaires Hospitaliers


title: Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds

acronym: EMGEL

summary: This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.

location_facility:
Hôpital Louis Mourier
Hôpital Jean-Jaurès
Groupe Hospitalier Bichat
Institut Curie
Institut Curie - Hôpital René Huguenin


title: Individual and Socio-economic Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers

acronym: DELOGAST

summary: This study evaluates the role of socioeconomic and individual factors in the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) in oeso-gastric cancer.

primary_purpose: Prevention

location_facility:
centre Léonard de Vinci
Centre Hospitalier de Boulogne sur mer
Centre d 'oncologie Dunkerquois
Centre hospitalier de Roubaix
Centre hospitalier de valenciennes
Centre oscar Lambret
Centre Hospitalier de Seclin
CHRU, Hôpital Claude Huriez
Centre hospitalier de Calais
Centre hospitalier de Béthune


title: Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area

acronym: PariS-TBI

summary:
The primary objective of the protocol is to study the long-term outcome of a large group of traumatic brain injury patients.

This outcome is to be described in terms of activity, participation, quality of life, SOCIO-professional outcome and impact on caregivers, and in relation to health care provision.

The secondary outcome is to measure the impact on functional outcome of several predictive factors, and their relative importance on outcome. Our principal hypothesis is that SOCIO-professional and health provision factors play a major role on long-term outcome, further even than initial severity of brain injury.

time_perspective: Retrospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CRFTC Centre Ressources Francilien du Traumatisme Crânien


title: Effectiveness of the First French Psychoeducational Program for Suicidal Behavior : a Randomized Controlled Trial

acronym: PEPSUI

summary:
The aims of the recent World Health Organization report, highlighting that every 40 seconds a person dies from suicide somewhere in the world, are to increase awareness on the public health significance of suicide and make suicide prevention a greater priority within the global public health agenda. Across age groups, less than half of individuals at elevated suicide risk interface with some form of mental health services. Several barriers to help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which are key targets in knowledge-based interventions on suicide. Psychoeducational programs have shown effectiveness in prevention relapse for several mental disorders such as schizophrenia, bipolar disorder or recurrent depressive disorder, improving treatment adherence and self-confidence in coping with symptoms of the disease. They are highly recommended for addressing adherence problems in patients with serious and persistent mental illness. Only one team has published a study protocol for a controlled trial assessing a 10 group sessions psychoeducational program for prevention in patients having a suicide history, in a one-year follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than an unspecific intervention add-on routine care, on the suicide prevention and compliance for severe psychiatric disorders. Those psychoeducational-specific elements are namely the interactive transfer of illness and treatment-related knowledge and management/coping - cognitive/behavioral - strategies, as defined by the National Institute for Health and Care Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with suicidal behavior (SB), coping strategies have to target processes that overlap among these psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy (ACT), a "third wave" behavioral therapy, targets experiential avoidance and psychological flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history of suicidal depression, training in mindfulness can help to weaken suicidal thinking associated with depressive symptoms , and thus reduce an important vulnerability for relapse to suicidal depression. ACT would also increase intrinsic motivation for daily life action (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT seems to be an useful tool to help patient in decision making, a neuropsychological factor impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most validated therapy for borderline personality disorder, the mental disorder the most associated with SB . Notably, group skills training is the most effective component in DBT for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore, interventions based on positive psychology have suggested efficacy in reducing depressive symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains improvement in optimism and hopelessness. Finally, as altered social link and sense of belonging have been widely involved in SB, relationship skills are an interesting positive psychology area for suicide prevention program.

Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention.

Investigators developed the first French program of suicide psychoeducation called "PEPSUI". The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions. Thus, the objective is to conduct the patients to become experts and actors of their disease, increasing adherence to treatment. Besides, the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts (including suicidal thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life. Thus, this program will include skills from ACT, DBT and positive psychology. Finally, this primary care research is about a program which aim at improving accessibility to mental health services, care adherence and continuity for suicidal patients.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.

name: Psychiatric Research Unit; Psychiatry of Region Zealand; Slagelse Denmark

name: Child and Adolescent Psychiatric Department; Region Zealand; Roskilde Denmark

name: Department of Psychology; University of Southern Denmark; Odense Denmark

family: Storebø

full_name: Ole Jakob Storebø

given: Ole Jakob

name: Department of Psychiatry and Psychotherapy; University Medical Center Mainz; Mainz Germany

family: Stoffers-Winterling

full_name: Jutta M Stoffers-Winterling

given: Jutta M

name: Department of Forensic Psychiatry, Center for Neurology; University Rostock; Rostock Germany

family: Völlm

full_name: Birgit A Völlm

given: Birgit A

name: Psychiatric Research Unit; Region Zealand Psychiatry; Slagelse Denmark

name: Department of Psychology, Faculty of Health Science; University of Southern Denmark; Odense Denmark

family: Kongerslev

full_name: Mickey T Kongerslev

given: Mickey T

family: Mattivi

full_name: Jessica T Mattivi

given: Jessica T

family: Jørgensen

full_name: Mie S Jørgensen

given: Mie S

family: Faltinsen

full_name: Erlend Faltinsen

given: Erlend

family: Todorovac

full_name: Adnan Todorovac

given: Adnan

name: Duncan MacMillan House; Nottinghamshire Healthcare NHS Foundation Trust; Nottingham UK

name: Institute of Mental Health; Department of Psychiatry & Applied Psychology; Nottingham UK

family: Sales

full_name: Christian P Sales

given: Christian P

family: Callesen

name: Leibniz Institute for Resilience Research (LIR); Mainz Germany

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

url: https://nottingham-repository.worktribe.com/916765/1/storeb psychol borderline protocol cochrane 2018.pdf

url_for_landing_page: https://nottingham-repository.worktribe.com/916765/1/Storeb Psychol borderline protocol Cochrane 2018.pdf


title: Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.

summary:
This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.

Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.

ReferenceCitation: Haut SR, Shinnar S, Moshé SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9.

ReferenceCitation: Dreifuss FE, Rosman NP, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998 Jun 25;338(26):1869-75.

ReferenceCitation: Mitchell WG, Conry JA, Crumrine PK, Kriel RL, Cereghino JJ, Groves L, Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999 Nov;40(11):1610-7.

ReferenceCitation: Shorvon SD, Löwenthal A, Janz D, Bielen E, Loiseau P. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia. 2000 Sep;41(9):1179-86.

ReferenceCitation: Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-42.

lead_sponsor: University Hospital, Grenoble

location_facility:
Neurology department
Neurology Department
Etablissement la Teppe


title: ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b

acronym: ALCHEMIST

summary: This study is designed to etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The primary endpoint will be the time to onset of the first incident.

ReferenceCitation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2:CD013109. doi: 10.1002/14651858.CD013109.pub2.

name: Showa University Research Administration Center (SURAC); Showa University; Tokyo Japan

name: Division of Nephrology, Department of Medicine, School of Medicine; Showa University; Tokyo Japan

family: Hasegawa

full_name: Takeshi Hasegawa

given: Takeshi

name: Division of Nephrology, Department of Medicine; Showa University Fujigaoka Hospital; Yokohama Japan

family: Nishiwaki

full_name: Hiroki Nishiwaki

given: Hiroki

name: Global Health Nursing, Graduate School of Nursing Science; St. Luke's International University; Tokyo Japan

family: Ota

full_name: Erika Ota

given: Erika

name: Rehabilitation Teaching and Research Unit, Department of Medicine; University of Otago; Wellington New Zealand

family: Levack

full_name: William MM Levack

given: William MM

name: Department of Data Science; The Institute of Statistical Mathematics; Tokyo Japan

family: Noma

full_name: Hisashi Noma

given: Hisashi

lead_sponsor: University Hospital, Brest

location_country: Monaco Belgium France

location_facility: Hôpitaux Privés de Metz- Hôpital Robert Schuman