title: Satisfaction Survey on the Tolerability of Surgical Masks for Protection Against the Spread of SARS-CoV2 in Patients With Chronic Respiratory Diseases

acronym: TOLMASK

summary: The study is conducted in the context of the COVID-19 pandemic in general, and more specifically in the context of the evaluation of the use of protective masks as a barrier to the spread of the virus. The wearing of masks is one of the recommended barrier measures to limit the spread of the SARS-CoV-2 virus responsible for COVID-19. It is recommended in all circumstances, and mandatory in some. Regardless of the type of mask used (noting that the so-called "surgical" masks are by far the most common), there are various disadvantages associated with wearing them. Dyspnoea (unpleasant or upsetting perception of respiratory activity) is one of these disadvantages. It can lead to reluctance to wear the mask, or to the adoption of inappropriate practices that reduce its effectiveness. This "side effect" of the mask is more pronounced in patients with underlying respiratory diseases. However, not all mask designs are equivalent in terms of their physical properties, which can theoretically generate varying levels of dyspnoea. It is therefore important to determine which mask designs are more or less dyspnogenic, in order to guide the preferential use of certain designs in certain patient categories. The TOLMASK study (Tolerance of SARS-CoV2 Surgical Masks in Patients with Chronic Respiratory Diseases) is a prospective, randomised, triple-blind, single-centre study comparing several surgical masks in a crossover design. The primary objective of the study is to evaluate the respiratory tolerance of different surgical masks and the secondary objective is to evaluate their general tolerance.

ReferenceCitation: Serresse L, Simon-Tillaux N, Decavele M, Gay F, Nion N, Lavault S, Guerder A, Chatelet A, Dabi F, Demoule A, Morelot-Panzini C, Moricot C, Similowski T. Lifting dyspnoea invisibility: COVID-19 face masks, the experience of breathing discomfort, and improved lung health perception - a French nationwide survey. Eur Respir J. 2022 Mar 31;59(3):2101459. doi: 10.1183/13993003.01459-2021. Print 2022 Mar.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Département R3S, Hôpital Pitié-Salpêtrière


type: Other Identifier

title: Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.

acronym: AGEHEAR

summary:
Hearing aids restore efficiently some auditory functions in age-related hearing loss (ARHL or presbycusis) providing to the elderly an access to oral communication and a return to social life. However, a most of the assessments of their efficacy focus on speech recognition. Spatial hearing and localization are anothers important auditory functions merely evaluated.

The purpose of this study is to evaluate the hearing aids benefits for spatial hearing.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.

ReferenceCitation: Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.

ReferenceCitation: Vannson N, James CJ, Fraysse B, Lescure B, Strelnikov K, Deguine O, Barone P, Marx M. Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity. Neuropsychologia. 2017 Jul 28;102:135-143. doi: 10.1016/j.neuropsychologia.2017.06.013. Epub 2017 Jun 13.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)

acronym: EDIPE

summary:
Breast irradiation is known to cause radiation-induced heart disease (RIHD) many years later after radiotherapy. Recent studies suggest that RIHD could be an earlier complication and that subclinical cardiac injury can be detected such as myocardial perfusion defects. Myocardial perfusion single photon emission computed tomography (SPECT) is a sensitive and specific technique able to detect perfusion abnormalities which are more frequent in left-sided breast cancer patients because of the cardiac exposure.

The most used technique for breast cancer irradiation is tangential opposed field, but this technique exposes the left anterior descending coronary artery to high dose during left breast irradiation.

There are different cardiac sparing techniques to reduce heart exposure such as:

Deep inspiration breath-hold (DIBH) which displaces the heart out of the radiation beam
Intensity-modulated radiation therapy (IMRT) which decreases heart exposure to high doses but changes the dose distribution in the heart and increases lower doses.

primary_purpose: Prevention

ReferenceCitation: Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

ReferenceCitation: Cheng YJ, Nie XY, Ji CC, Lin XX, Liu LJ, Chen XM, Yao H, Wu SH. Long-Term Cardiovascular Risk After Radiotherapy in Women With Breast Cancer. J Am Heart Assoc. 2017 May 21;6(5):e005633. doi: 10.1161/JAHA.117.005633.

ReferenceCitation: Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.

ReferenceCitation: Taylor C, Correa C, Duane FK, Aznar MC, Anderson SJ, Bergh J, Dodwell D, Ewertz M, Gray R, Jagsi R, Pierce L, Pritchard KI, Swain S, Wang Z, Wang Y, Whelan T, Peto R, McGale P; Early Breast Cancer Trialists' Collaborative Group. Estimating the Risks of Breast Cancer Radiotherapy: Evidence From Modern Radiation Doses to the Lungs and Heart and From Previous Randomized Trials. J Clin Oncol. 2017 May 20;35(15):1641-1649. doi: 10.1200/JCO.2016.72.0722. Epub 2017 Mar 20.

ReferenceCitation: Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20.

ReferenceCitation: Boda-Heggemann J, Knopf AC, Simeonova-Chergou A, Wertz H, Stieler F, Jahnke A, Jahnke L, Fleckenstein J, Vogel L, Arns A, Blessing M, Wenz F, Lohr F. Deep Inspiration Breath Hold-Based Radiation Therapy: A Clinical Review. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):478-92. doi: 10.1016/j.ijrobp.2015.11.049. Epub 2015 Dec 17.

ReferenceCitation: Lauche O, Kirova YM, Fenoglietto P, Costa E, Lemanski C, Bourgier C, Riou O, Tiberi D, Campana F, Fourquet A, Azria D. Helical tomotherapy and volumetric modulated arc therapy: New therapeutic arms in the breast cancer radiotherapy. World J Radiol. 2016 Aug 28;8(8):735-42. doi: 10.4329/wjr.v8.i8.735.

ReferenceCitation: Eber J, Leroy-Freschini B, Antoni D, Noel G, Pflumio C. Increased cardiac uptake of (18F)-fluorodeoxyglucose incidentally detected on positron emission tomography after left breast irradiation: How to interpret? Cancer Radiother. 2022 Sep;26(5):724-729. doi: 10.1016/j.canrad.2021.10.010. Epub 2022 Feb 12.

ReferenceCitation: Marks LB, Yu X, Prosnitz RG, Zhou SM, Hardenbergh PH, Blazing M, Hollis D, Lind P, Tisch A, Wong TZ, Borges-Neto S. The incidence and functional consequences of RT-associated cardiac perfusion defects. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):214-23. doi: 10.1016/j.ijrobp.2005.01.029.

ReferenceCitation: Gyenes G, Fornander T, Carlens P, Glas U, Rutqvist LE. Detection of radiation-induced myocardial damage by technetium-99m sestamibi scintigraphy. Eur J Nucl Med. 1997 Mar;24(3):286-92. doi: 10.1007/BF01728765.

ReferenceCitation: Sioka C, Exarchopoulos T, Tasiou I, Tzima E, Fotou N, Capizzello A, Ragos V, Tsekeris P, Fotopoulos A. Myocardial perfusion imaging with (99 m)Tc-tetrofosmin SPECT in breast cancer patients that received postoperative radiotherapy: a case-control study. Radiat Oncol. 2011 Nov 8;6:151. doi: 10.1186/1748-717X-6-151.

ReferenceCitation: Seddon B, Cook A, Gothard L, Salmon E, Latus K, Underwood SR, Yarnold J. Detection of defects in myocardial perfusion imaging in patients with early breast cancer treated with radiotherapy. Radiother Oncol. 2002 Jul;64(1):53-63. doi: 10.1016/s0167-8140(02)00133-0.

ReferenceCitation: Eftekhari M, Anbiaei R, Zamani H, Fallahi B, Beiki D, Ameri A, Emami-Ardekani A, Fard-Esfahani A, Gholamrezanezhad A, Seid Ratki KR, Roknabadi AM. Radiation-induced myocardial perfusion abnormalities in breast cancer patients following external beam radiation therapy. Asia Ocean J Nucl Med Biol. 2015 Winter;3(1):3-9.

ReferenceCitation: Jacob S, Pathak A, Franck D, Latorzeff I, Jimenez G, Fondard O, Lapeyre M, Colombier D, Bruguiere E, Lairez O, Fontenel B, Milliat F, Tamarat R, Broggio D, Derreumaux S, Ducassou M, Ferrieres J, Laurier D, Benderitter M, Bernier MO. Early detection and prediction of cardiotoxicity after radiation therapy for breast cancer: the BACCARAT prospective cohort study. Radiat Oncol. 2016 Apr 7;11:54. doi: 10.1186/s13014-016-0627-5.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Darby SC, Cutter DJ, Boerma M, Constine LS, Fajardo LF, Kodama K, Mabuchi K, Marks LB, Mettler FA, Pierce LJ, Trott KR, Yeh ET, Shore RE. Radiation-related heart disease: current knowledge and future prospects. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):656-65. doi: 10.1016/j.ijrobp.2009.09.064.

ReferenceCitation: Gillette EL, McChesney SL, Hoopes PJ. Isoeffect curves for radiation-induced cardiomyopathy in the dog. Int J Radiat Oncol Biol Phys. 1985 Dec;11(12):2091-7. doi: 10.1016/0360-3016(85)90089-6.

ReferenceCitation: Ghita M, Gill EK, Walls GM, Edgar KS, McMahon SJ, Osorio EV, Bergom C, Grieve DJ, Watson CJ, McWilliam A, Aznar M, van Herk M, Williams KJ, Butterworth KT. Cardiac sub-volume targeting demonstrates regional radiosensitivity in the mouse heart. Radiother Oncol. 2020 Nov;152:216-221. doi: 10.1016/j.radonc.2020.07.016. Epub 2020 Jul 12.

ReferenceCitation: Eber J, Nannini S, Chambrelant I, Le Fevre C, Noel G, Antoni D. [Impact of thoracic irradiation on cardiac structures]. Cancer Radiother. 2022 May;26(3):526-536. doi: 10.1016/j.canrad.2021.08.022. Epub 2021 Oct 30. French.

ReferenceCitation: Feng M, Moran JM, Koelling T, Chughtai A, Chan JL, Freedman L, Hayman JA, Jagsi R, Jolly S, Larouere J, Soriano J, Marsh R, Pierce LJ. Development and validation of a heart atlas to study cardiac exposure to radiation following treatment for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):10-8. doi: 10.1016/j.ijrobp.2009.10.058. Epub 2010 Apr 24.

ReferenceCitation: Maffei N, Fiorini L, Aluisio G, D'Angelo E, Ferrazza P, Vanoni V, Lohr F, Meduri B, Guidi G. Hierarchical clustering applied to automatic atlas based segmentation of 25 cardiac sub-structures. Phys Med. 2020 Jan;69:70-80. doi: 10.1016/j.ejmp.2019.12.001. Epub 2019 Dec 10.

lead_sponsor: Institut de cancérologie Strasbourg Europe

lead_sponsor_type: industriel


title: Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

acronym: ANI-CARE

summary:
Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety.

So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients.

That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study

acronym: OESOLUS

summary:
The perioperative management of esophageal cancer has evolved considerably in recent years.

Over the last 30 years, postoperative mortality has been steadily decreasing. However, respiratory morbidity remains high (30-40%). This is due to the procedure itself requiring a thoracic approach and intraoperative unipulmonary ventilation. The postoperative pulmonary complications (PPCs) are multiple: bronchial congestion, atelectasis, pneumopathy, acute respiratory distress syndrome (ARDS), liquid pleural effusion, pneumothorax.

In general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.

Chest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.

Thoracic computed tomography (CT) is the gold standard because it is sensitive and can discriminate among differential diagnoses. This is difficult to perform: it requires intra-hospital transport of patient, who is often in acute respiratory failure, and the availability of an examination area.

Lung ultrasound is used at the bedside for diagnosis of lung infection in intensive care unit. This has a sensitivity close to thoracic CT and has the advantage of being feasible at any time, does not require transport of the patient and is not irradiating.

Lung ultrasound allows early detection of the need for ventilatory support in postoperative major abdominal surgery . In addition, the sensitivity of lung ultrasound is close to that of CT, allowing this examination to be relied upon.

The main objective of the study is to determine the role of lung ultrasound in the prediction of postoperative pulmonary complications within one hour after extubation.


title: Attachment Style and Mentalization Impact Among Women Victims of Domestic Violence

acronym: FEMATAM

summary: Attachment and mentalization with a population of domestic violence victims Domestic violence is one of the most common forms of domestic violence. Multiform and complex, it affects all backgrounds and all ages. According to a survey instituted by the government of Emmanuel Macron, 219,000 women were recognized as victims of domestic violence in 2017. This phenomenon is not without questioning the scientific scene. Also, this study focus on the quality of the attachment because if this bond is insecure, it can constitute a point of vulnerability in self-construction and impact on future relational modalities.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Behavioral


title: Autotransfusion Versus Transfusion in Cancer Surgery

acronym: ATTRACS

summary:
Acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate.

The only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects.

Nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions.

time_perspective: Retrospective

ReferenceCitation: Klein AA, Bailey CR, Charlton AJ, Evans E, Guckian-Fisher M, McCrossan R, Nimmo AF, Payne S, Shreeve K, Smith J, Torella F. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018. Anaesthesia. 2018 Sep;73(9):1141-1150. doi: 10.1111/anae.14331. Epub 2018 Jul 10.

ReferenceCitation: Waters JH, Yazer M, Chen YF, Kloke J. Blood salvage and cancer surgery: a meta-analysis of available studies. Transfusion. 2012 Oct;52(10):2167-73. doi: 10.1111/j.1537-2995.2011.03555.x. Epub 2012 Feb 10.

ReferenceCitation: Ubee SS, Manikandan R, Gudimetla AR, Singh G. Cost benefits of intraoperative cell salvage in radical cystectomy. Indian J Urol. 2010 Apr;26(2):196-9. doi: 10.4103/0970-1591.65386.

ReferenceCitation: Araujo RL, Pantanali CA, Haddad L, Rocha Filho JA, D'Albuquerque LA, Andraus W. Does autologous blood transfusion during liver transplantation for hepatocellular carcinoma increase risk of recurrence? World J Gastrointest Surg. 2016 Feb 27;8(2):161-8. doi: 10.4240/wjgs.v8.i2.161.

lead_sponsor: Centre Leon Berard


title: Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma

acronym: MMSPORADGEN

summary: There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

intervention_type: Genetic


title: Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

summary:
In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation.

During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed.

At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon

intervention_type: Biological


title: Randomized Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula

acronym: SOPA

summary:
In patients with Crohn's disease, anal fistulas are usually treated in three stages: 1) close examination of the fistula and drainage with a seton, 2) pharmacological treatment of the inflammatory component, and 3) closure of the fistulous tract by a sphincter-sparing technique. Setons are used to ensure the permeability of the fistulous tract, to decrease the rate of re-intervention due to the formation of new abscesses or tracts. A seton is a small, often elastic, thread used for drainage. It is inserted into the fistulous tract, passing from the external orifice of the fistula (close to the anus or, in some cases, the vaginal) through the fistula and exiting via the anal orifice.

Seton use seems to minimize colonization of the mucosa of the fistulous tract by the intestinal flora, leukocyte infiltration, and the spread of inflammation within the fistulous tract. Most clinical practice guidelines advocate the use of a seton, but the level of evidence for the efficacy of this approach remains low (D, EL5). Indeed, only a few open studies have reported seton use to be potentially beneficial. In the retrospective study of 32 patients by Regueiro et al., a surgery group with seton insertion before treatment with infliximab was compared with a group on infliximab, without a seton, from the outset. Response rates were better in the group of patients with a seton, with a lower rate of recurrence and a longer time to recurrence than for the seton-less group. Another retrospective study by Schwartz et al. compared two groups - seton (n = 326) and no seton (n = 1519) - in patient with at least six months of biotherapy in three states of the USA. There were more hospitalizations and higher costs generated by greater use of the healthcare system in the group treated without a seton than in those with a seton.

The systematic use of setons in the context of Crohn's disease was inspired by the management of cryptoglandular fistula. However, the protective value of setons in this context remains far from clear, due to a lack of studies providing high-level evidence. Furthermore, the impact of seton use on patient quality of life has been little evaluated.

Investigators aim to determine whether the insertion of one or more setons in anal fistulas in Crohn's disease patients significantly alters patient quality of life. Investigators will perform a randomized controlled trial comparing two strategies: drainage surgery with and without seton use.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Torres J, Bonovas S, Doherty G, Kucharzik T, Gisbert JP, Raine T, Adamina M, Armuzzi A, Bachmann O, Bager P, Biancone L, Bokemeyer B, Bossuyt P, Burisch J, Collins P, El-Hussuna A, Ellul P, Frei-Lanter C, Furfaro F, Gingert C, Gionchetti P, Gomollon F, Gonzalez-Lorenzo M, Gordon H, Hlavaty T, Juillerat P, Katsanos K, Kopylov U, Krustins E, Lytras T, Maaser C, Magro F, Marshall JK, Myrelid P, Pellino G, Rosa I, Sabino J, Savarino E, Spinelli A, Stassen L, Uzzan M, Vavricka S, Verstockt B, Warusavitarne J, Zmora O, Fiorino G. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2020 Jan 1;14(1):4-22. doi: 10.1093/ecco-jcc/jjz180. No abstract available.

ReferenceCitation: Adamina M, Bonovas S, Raine T, Spinelli A, Warusavitarne J, Armuzzi A, Bachmann O, Bager P, Biancone L, Bokemeyer B, Bossuyt P, Burisch J, Collins P, Doherty G, El-Hussuna A, Ellul P, Fiorino G, Frei-Lanter C, Furfaro F, Gingert C, Gionchetti P, Gisbert JP, Gomollon F, Gonzalez Lorenzo M, Gordon H, Hlavaty T, Juillerat P, Katsanos K, Kopylov U, Krustins E, Kucharzik T, Lytras T, Maaser C, Magro F, Marshall JK, Myrelid P, Pellino G, Rosa I, Sabino J, Savarino E, Stassen L, Torres J, Uzzan M, Vavricka S, Verstockt B, Zmora O. ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment. J Crohns Colitis. 2020 Feb 10;14(2):155-168. doi: 10.1093/ecco-jcc/jjz187.

ReferenceCitation: Bouchard D, Abramowitz L, Bouguen G, Brochard C, Dabadie A, de Parades V, Eleouet-Kaplan M, Fathallah N, Faucheron JL, Maggiori L, Panis Y, Pigot F, Roumeguere P, Senejoux A, Siproudhis L, Staumont G, Suduca JM, Vinson-Bonnet B, Zeitoun JD. Anoperineal lesions in Crohn's disease: French recommendations for clinical practice. Tech Coloproctol. 2017 Sep;21(9):683-691. doi: 10.1007/s10151-017-1684-y. Epub 2017 Sep 19.

ReferenceCitation: Lee MJ, Heywood N, Sagar PM, Brown SR, Fearnhead NS; pCD Collaborators. Surgical management of fistulating perianal Crohn's disease: a UK survey. Colorectal Dis. 2017 Mar;19(3):266-273. doi: 10.1111/codi.13462.

ReferenceCitation: Gecse KB, Bemelman W, Kamm MA, Stoker J, Khanna R, Ng SC, Panes J, van Assche G, Liu Z, Hart A, Levesque BG, D'Haens G; World Gastroenterology Organization, International Organisation for Inflammatory Bowel Diseases IOIBD, European Society of Coloproctology and Robarts Clinical Trials; World Gastroenterology Organization International Organisation for Inflammatory Bowel Diseases IOIBD European Society of Coloproctology and Robarts Clinical Trials. A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn's disease. Gut. 2014 Sep;63(9):1381-92. doi: 10.1136/gutjnl-2013-306709. Epub 2014 Jun 20.

lead_sponsor: Fondation Hôpital Saint-Joseph


type: Registry Identifier

title: Pilot Study of Renal Function by a Reference Isotopic Technique in Malnourished Patients With Anorexia Nervosa

acronym: ANKID

summary: Anorexia nervosa (AN) is an eating disorder that can lead to severe medical complications. Kidney injuries are unknown in patients with extremely malnourished AN (BMI <13). The primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. The secondary objective is to evaluate the evolution of kidney injuries after a phase of refeeding. Guidelines for medical treatments and dietary intakes will be recommended to avoid severe or irreversible renal disease.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir

location_facility: Department of Nutrition, Paul Brousse hospital, APHP


title: ENVI-MI (Environment and Myocardial Infarction) : Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival

acronym: ENVI-MI

summary:
Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to "natural" areas on various conditions. However, very few studies have focused on the "post-diagnosis" follow-up of patients after hospitalization for an ischemic cardiovascular episode and, to our knowledge, none have examined patient evolution at one year after myocardial infarction. Thus, the real influence of factors and pollutants widely represented in the urban environment, in particular air pollution, noise pollution, and proximity and accessibility to natural areas ("green" or "blue" spaces), on the evolution of post-myocardial infarction at one year remains to be identified and quantified.

The objective of the ENVI-MI project is to evaluate the impact of environmental exposure in the place of residence (noise, air pollution, proximity to "natural" spaces) on the evolution of post-myocardial infarction at one year within the Dijon metropolitan area.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Completed


title: Comparison of the 1-min Sit-to-Stand Test to the 6-minute Walk Test in the Respiratory Functional Assessment of Pulmonary Fibrosis: a Cross-over Trial

summary:
Fibrosing interstitial lung diseases or pulmonary fibrosis represent a heterogeneous group of progressive pulmonary pathologies, responsible for a significant morbi-mortality. They are defined by an infiltration of the pulmonary interstitium associating in a variable way an inflammatory component (deposit of inflammatory cells) and a fibrosing component (deposit of collagen). Idiopathic pulmonary fibrosis (IPF) is the most common and most severe pulmonary fibrosis. Other pulmonary fibroses are mainly represented by non-specific interstitial lung disease, pulmonary fibroses associated with connectivites, hypersensitivity pneumonitis, certain pneumoconiosis (occupational diseases) and sarcoidosis. The process of fibrosis is responsible for a loss of elasticity of the lung, leading to a decrease in lung volumes associated with an alteration of gas exchange.

In these diseases, the clinician must be able to rely on reliable means to assess the severity of the disease based mainly on the measurement of lung volumes and gas exchange, at diagnosis and in the follow-up of the patient, in order to propose the most appropriate management. Lung volumes are assessed by respiratory function tests. Forced vital capacity is the reference volume value used. Impaired gas exchange is assessed at rest by measuring carbon monoxide diffusion capacity, arterial oxygen saturation and arterial blood gases.

The functional capacity to exercise is also a very important evaluation criterion in terms of prognosis and in the follow-up of the patient. It is assessed by means of ergocycle tests which mainly determine the maximal oxygen consumption. These are relatively complex tests that require special equipment and are not routinely performed. Simpler field tests have been developed to assess functional capacity during exercise, the most widely used and validated being the 6-minute Walk Test (TM6).

Other field tests to assess functional capacity to exercise have been developed, such as the 30-second, 1-minute, and 3-minute chair lift tests, stepper tests, and step and stair tests. Among them, the 1-minute chair lift test (TLC1) is the best evaluated. It consists of sitting down and getting up from a chair as many times as possible in 1 minute. The criteria measured are mainly the number of lifts and desaturation. Thus, the fundamental advantage of the TLC1 over the TM6 is the exemption from temporal and spatial constraints since it takes only a few minutes and can be performed in a medical office. While TLC1 seems to be the most suitable, there are still a few pitfalls in substituting TLC1 for TM6 during diffuse interstitial lung disease.

First, there is only one study reporting the results of TLC1 in a healthy population. It provides a chart of results according to age. Unfortunately, only the number of lifts is reported without any data on heart rate, SaO2 or sensation of dyspnea.

In respiratory pathologies, TLC1 has been studied mainly in patients with chronic obstructive pulmonary disease (COPD) and little in PID. Unlike TM6, TLC1 is reproducible and has no learning effect in this population. Interestingly, one study found that peak desaturation and peak oxygen consumption occurred during the recovery phase some seconds after the end of the test.

Studies on TLC1 during SID do not allow us to conclude that this test can substitute for TM6. However, investigators may note certain limitations, in particular the small number of patients studied and the retrospective nature of the 2 largest of them. Above all, it seems that the use of TLC1 could be optimized by taking into account the recovery phase in the evaluation of desaturation.

The hypothesis of our study is that the TLC1 taking into account the recovery phase can replace the TM6 in the management of fibrosing PID for prognostic evaluation, patient follow-up and indication of oxygen therapy. It is more accessible and its use by all practitioners in face-to-face or telemedicine would allow a better management of these patients. Finally, the investigators hypothesize that the TLC1 will result in lower costs in the management of these patients.

ReferenceCitation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: UHasselt - Document Server@UHasselt

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ReferenceCitation: Nathan SD, du Bois RM, Albera C, Bradford WZ, Costabel U, Kartashov A, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis. Respir Med. 2015 Jul;109(7):914-22. doi: 10.1016/j.rmed.2015.04.008. Epub 2015 Apr 24.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.

ReferenceCitation: Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.

ReferenceCitation: AARC clinical practice guideline. Exercise testing for evaluation of hypoxemia and/or desaturation. American Association for Respiratory Care. Respir Care. 1992 Aug;37(8):907-12. No abstract available.

ReferenceCitation: du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med. 2011 May 1;183(9):1231-7. doi: 10.1164/rccm.201007-1179OC. Epub 2010 Dec 3.

ReferenceCitation: Cottin V, Bonniaud P, Cadranel J, Crestani B, Jouneau S, Marchand-Adam S, Nunes H, Wemeau-Stervinou L, Bergot E, Blanchard E, Borie R, Bourdin A, Chenivesse C, Clement A, Gomez E, Gondouin A, Hirschi S, Lebargy F, Marquette CH, Montani D, Prevot G, Quetant S, Reynaud-Gaubert M, Salaun M, Sanchez O, Trumbic B, Berkani K, Brillet PY, Campana M, Chalabreysse L, Chatte G, Debieuvre D, Ferretti G, Fourrier JM, Just N, Kambouchner M, Legrand B, Le Guillou F, Lhuillier JP, Mehdaoui A, Naccache JM, Paganon C, Remy-Jardin M, Si-Mohamed S, Terrioux P; OrphaLung. [French practical guidelines for the diagnosis and management of IPF - 2021 update, short version]. Rev Mal Respir. 2022 Mar;39(3):275-312. doi: 10.1016/j.rmr.2022.01.005. Epub 2022 Mar 15. French.

ReferenceCitation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.

ReferenceCitation: Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.

ReferenceCitation: Gephine S, Bergeron S, Tremblay Labrecque PF, Mucci P, Saey D, Maltais F. Cardiorespiratory Response during the 1-min Sit-to-Stand Test in Chronic Obstructive Pulmonary Disease. Med Sci Sports Exerc. 2020 Jul;52(7):1441-1448. doi: 10.1249/MSS.0000000000002276.


title: Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life

summary:
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.

The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma, a Phase 2b Randomized Trial

acronym: ABE-LIVER

summary: The study will assess the efficacy of Ezurpimtrostat in association with standard of care (Atezolizumab-Bevacizumab), compared to standard of care alone, as first line treatment in patients with unresectable hepatocellular carcinoma.The study drug which is tested is the Ezurpimtrostat in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Genoscience Pharma

intervention_type: Drug


title: Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital

acronym: NOVECAR-A

summary: the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers


title: AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine, a Randomized Non Inferiority Trial

acronym: AGINASAL

summary: This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

collaborators: Lariboisière-Saint Louis clinical research unit

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: AGINASAL

titre: prise en charge du patient agité: midazolam intranasal vs. loxapine intramusculaire: essai randomisé en ouvert

discipline_principale: médecine d'urgence

nom_porteur: ADNET

prenom_porteur: Frederic


title: Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty

acronym: OFFLOW

summary:
General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioids may be related to a many different complications, like respiratory distress, hyperalgesia.

Opioid free anesthesia (OFA) aim is to control de cardiovascular nociceptive response to the surgical stimulation. The scientific literature is not clear yet on the cardiovascular effect of the OFA. Optimization of the cardiac index proved its worth in reducing morbidity and mortality.

The purpose of this study is to increase our understanding of the impact of opioid free anesthesia on the cardiovascular system and to evaluate the effectiveness and the security of the technic.

ReferenceCitation: Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.

ReferenceCitation: Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914.

ReferenceCitation: Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632.

ReferenceCitation: Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.

ReferenceCitation: Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.

ReferenceCitation: Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26.

ReferenceCitation: Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.

ReferenceCitation: Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4.

ReferenceCitation: Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.

ReferenceCitation: Kharasch ED, Clark JD. Opioid-free Anesthesia: Time to Regain Our Balance. Anesthesiology. 2021 Apr 1;134(4):509-514. doi: 10.1097/ALN.0000000000003705. No abstract available.

ReferenceCitation: Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.

ReferenceCitation: Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

ReferenceCitation: Tempe DK, Sawhney C. Opioid-Free Anesthesia for Thoracic Surgery: A Step Forward. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3041-3043. doi: 10.1053/j.jvca.2020.07.022. Epub 2020 Jul 10. No abstract available.

ReferenceCitation: Siu EY, Moon TS. Opioid-free and opioid-sparing anesthesia. Int Anesthesiol Clin. 2020 Spring;58(2):34-41. doi: 10.1097/AIA.0000000000000270. No abstract available.

ReferenceCitation: Chakravarthy M. Opioid free cardiac anesthesia - A flash in the pan? Ann Card Anaesth. 2020 Apr-Jun;23(2):113-115. doi: 10.4103/aca.ACA_68_19. No abstract available.

lead_sponsor: Centre Hospitalier de Montauban


title: Prospective Study Assessing the Laparoscopic Totally ExtraPeritoneal (TEP) Hernia Repair Without Curare and Without Orotracheal Intubation (Free Curare TEP Study).

summary:
Laparoscopic treatment of inguinal hernia with the totally extraperitoneal approach (TEP) is indicated for simple and bilateral inguinal hernias. It consists of placing a large prosthesis in the posterior position by direct access to the extra-peritoneal space. This prosthesis is interposed between the defective wall and the peritoneum. Unlike the transperitoneal laparoscopic method, the strictly extraperitoneal approach reduces complications related to contact with the intestinal loops and preserves the peritoneal layer intact.

TEP approach is traditionally performed under general anesthesia with curare and orotracheal intubation.

In the study, we would like to assess this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation.

ReferenceCitation: Fitzgibbons RJ, Richards AT, Quinn TH. Open hernia repair. In: Souba WS, Mitchell P, Fink MP, Jurkovich GJ, Kaiser LR, Pearce WH, et al., editors. ACS surgery: principles and practice. 6th ed. Philadelphia, USA: Decker Publishing Inc.; 2002. p. 828-49.

ReferenceCitation: Meyer A, Dulucq JL, Mahajna A. Laparoscopic totally extraperitoneal hernioplasty with nonfixation of three-dimensional mesh: Dulucq's technique. Arq Bras Cir Dig. 2013 Jan-Mar;26(1):59-61. doi: 10.1590/s0102-67202013000100013. English, Portuguese.

ReferenceCitation: Miserez M, Alexandre JH, Campanelli G, Corcione F, Cuccurullo D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB. The European hernia society groin hernia classification: simple and easy to remember. Hernia. 2007 Apr;11(2):113-6. doi: 10.1007/s10029-007-0198-3. Epub 2007 Mar 13. Erratum In: Hernia. 2008 Jun;12(3):335.

ReferenceCitation: Baillard C, Bourgain JL, Bouroche G, et al. Actualisations de recommandations - Curarisation et décurarisation en anesthésie. Société Française d'Anesthésie et de Réanimation, 2018.

ReferenceType: result

ReferenceCitation: Meyer A, Dulucq JL, Mahajna A. Laparoscopic hernia repair: nonfixation mesh is feasibly? Arq Bras Cir Dig. 2013 Jan-Mar;26(1):27-30. doi: 10.1590/s0102-67202013000100006. English, Portuguese.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: closed

publisher_dissemination: FapUNIFESP (SciELO)

ReferenceCitation: Meyer A, Blanc P, Balique JG, Kitamura M, Juan RT, Delacoste F, Atger J. Laparoscopic totally extraperitoneal inguinal hernia repair: twenty-seven serious complications after 4565 consecutive operations. Rev Col Bras Cir. 2013 Jan-Feb;40(1):32-6. doi: 10.1590/s0100-69912013000100006. English, Portuguese.

ReferenceCitation: Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.

oa_host_type: closed

publisher_dissemination: Springer

ReferenceCitation: Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.

ReferenceCitation: Ozgun H, Kurt MN, Kurt I, Cevikel MH. Comparison of local, spinal, and general anaesthesia for inguinal herniorrhaphy. Eur J Surg. 2002;168(8-9):455-9. doi: 10.1080/110241502321116442.

lead_sponsor: Elsan

intervention_type: Procedure


title: Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

summary: The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

lead_sponsor: Polyclinique Bordeaux Nord Aquitaine

sponsor_collaborators:
Polyclinique Bordeaux Nord Aquitaine
Bard Ltd


title: Study of New Potential Biomarkers of Lymphangioleiomyomatosis: Determination of Cathepsin K, Cystatin C, Collagen Telopeptides and Chondroitin Sulfates

acronym: LAM-CAK

summary: This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.

lead_sponsor: University Hospital, Tours


title: Evaluation of Basal Tryptasemia According to Age in a Pediatric Control Population

acronym: KID-Tryp

summary:
The National REference Center for MASTocytosis (CEREMAST), located at the Necker-Enfants Malades Hospital, is particularly interested in two groups of rare diseases whose common point is excessive activation of mast cells: mastocytosis and mast cell activation syndromes (MCAS). Unlike MCAS, whose symptoms result solely from this aberrant mast cell activation, in mastocytosis there is, in addition, an expansion and a clonal accumulation of mast cells in different target organs. These two diseases are heterogeneous in their clinical presentation and can begin in early childhood. While the diagnostic criteria for mastocytosis are well established, those for MCAS are unclear, causing major diagnostic error and therefore poor patient care.

To date, there is no study evaluating tryptase standards in children less than 18 years of age.

The research focuses on the dosage of tryptase in a control population of children aged 0 to 18 years.

Each patient receiving a complete blood count (CBC) in a surgery department of the Necker-Enfants Malades hospital will be selected to participate in the study. After the CBC analysis, the rest of the sample will be kept for this research instead of being discarded.

Knowing the norms of tryptase according to age would be an important tool for dermatologists, allergists and pediatricians caring for patients suspected of MCAS or mastocytosis. A blood test could thus avoid a few years of diagnostic wandering in the MCAS and mastocytosis.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D Ultrasound System

acronym: FOCUS-BOOST

summary: The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors

acronym: B-cube

summary: B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of an Addiction Intervention in Candidates for Liver Transplantation

acronym: Addictolive

summary:
Addiction care is "a la carte treatment", adapted to the motivation and time constrains of users. Thus, various types of psychotherapeutic follow-up can be considered, different addictolytic medications or opioid maintenance therapies can be offered during treatment and hospitalization must be adaptable. In liver transplantation (LT), sustained alcohol relapse is a critical issue because it increases medium and long-term morbidity and mortality. In recent years, the issue of severe acute alcoholic hepatitis as an indication for LT has necessitated increased focus on appropriate alcohol monitoring around liver transplantation. Previously, alcohol consumption in pre- and post-LT period was mainly self-reported. More recently, the biological markers of excessive alcohol consumption have been validated in liver disease and can play a role in liver transplant recipients follow-up.

The investigator hypothesize that standardized targeted addiction monitoring of LT patients decreases the rates of sustained alcohol relapse one year post liver transplantation.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of hepato-gastroenterology and liver transplantation


title: Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.

acronym: PENTI-MIDAS

summary:
The aim of our study is to confirm the relevance of PET using [68Ga]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years.

The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga-PentixaFor/FDG discordances explored.

status: Withdrawn

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

status_simplified: Unknown


title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Finland

acronym: PIONEER REAL

summary: The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

status: Enrolling by invitation

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S


title: A Multicentric, Single Arm, Phase II Trial Assessing the Efficacy of Niraparib as First Line Therapy for Patients With Metastatic Homologous Repair-deficient Pancreatic Cancer

acronym: PARPi-PANC

summary: This trial is a single arm open-label, phase II aiming to assess the clinical activity of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
GlaxoSmithKline


title: Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences

acronym: SAHARA

summary: The purpose of this study is to assess the long term urinary, sexual, cosmetic and psycho-social outcomes of adult patients operated for hypospadias during childhood

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates

acronym: Speed-Enso

summary:
Main objective of this clinical trial is to compare the oxidation rates of main carbohydrate and lipid substrates during exercises carried out in eccentric dynamic pedaling mode on a cycloergometer compared to concentric exercises (classic pedaling) at the same oxygen consumption (VO2).

The hypothesis is that lipid oxidation during an eccentric exercise is higher than lipid oxidation during a concentric exercise, done in humans at the capacity of 30% of VO2max.

status: Unknown status

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Phase 0 Study to Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cells (PBMC) From Subjects With Retinal Dystrophy, Optic Nerve Edema, Splenomegaly, Anhidrosis and Headache (ROSAH) Syndrome.

acronym: ROSAH

summary:
Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome.

Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for treating this disease. To test our hypothesis, we designed an experiment in which ex vivo peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome patient samples that are exposed DF-003.

lead_sponsor: Hospices Civils de Lyon


title: Determinants of Use of Mobile Apps for Smoking Cessation

summary: The development of mobile applications ("mobile apps") is steadily increasing and appears to be a promising treatment method to help people change unwanted behaviors or maintain a regular relationship with the medical system. Mobile apps aimed at smoking cessation have been shown to be effective. However, if a treatment is not used regularly, it will not have the desired effect. The main objective of this study is to identify what makes a person decide to use a smoking cessation app and to do so regularly. The second objective is to determine what is necessary to achieve long-term change with a mobile app.

ReferenceCitation: Taylor GMJ, Dalili MN, Semwal M, Civljak M, Sheikh A, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev. 2017 Sep 4;9(9):CD007078. doi: 10.1002/14651858.CD007078.pub5.

ReferenceCitation: Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.

ReferenceCitation: Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y, Dobson R. Mobile phone text messaging and app-based interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Oct 22;10(10):CD006611. doi: 10.1002/14651858.CD006611.pub5.

ReferenceCitation: Regmi K, Kassim N, Ahmad N, Tuah NA. Effectiveness of Mobile Apps for Smoking Cessation: A Review. Tob Prev Cessat. 2017 Apr 12;3:12. doi: 10.18332/tpc/70088. eCollection 2017.

ReferenceCitation: Hoeppner BB, Hoeppner SS, Seaboyer L, Schick MR, Wu GW, Bergman BG, Kelly JF. How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. Nicotine Tob Res. 2016 May;18(5):1025-31. doi: 10.1093/ntr/ntv117. Epub 2015 Jun 4.

ReferenceCitation: Rajani NB, Weth D, Mastellos N, Filippidis FT. Adherence of popular smoking cessation mobile applications to evidence-based guidelines. BMC Public Health. 2019 Jun 13;19(1):743. doi: 10.1186/s12889-019-7084-7.

ReferenceCitation: Cho J, Quinlan MM, Park D, Noh GY. Determinants of adoption of smartphone health apps among college students. Am J Health Behav. 2014 Nov;38(6):860-70. doi: 10.5993/AJHB.38.6.8.

ReferenceCitation: Cotten SR, Gupta SS. Characteristics of online and offline health information seekers and factors that discriminate between them. Soc Sci Med. 2004 Nov;59(9):1795-806. doi: 10.1016/j.socscimed.2004.02.020.

ReferenceCitation: Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.

ReferenceCitation: Rajani NB, Mastellos N, Filippidis FT. Self-Efficacy and Motivation to Quit of Smokers Seeking to Quit: Quantitative Assessment of Smoking Cessation Mobile Apps. JMIR Mhealth Uhealth. 2021 Apr 30;9(4):e25030. doi: 10.2196/25030.

ReferenceCitation: Rahimi B, Nadri H, Lotfnezhad Afshar H, Timpka T. A Systematic Review of the Technology Acceptance Model in Health Informatics. Appl Clin Inform. 2018 Jul;9(3):604-634. doi: 10.1055/s-0038-1668091. Epub 2018 Aug 15.

lead_sponsor: Paris Nanterre University


title: Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women

acronym: ALPHA-SEP

summary:
Multiple sclerosis (MS) is the leading non-traumatic cause of severe acquired disability in young people. The disease is defined by relapses, which can affect all neurological functions depending on the location of the new inflammatory lesion(s). The disease can thus manifest itself through bladder and bowel disorders (BWS), which affect approximately 80% of MS patients in all stages. Lower urinary tract dysfunction has a significant negative impact on the quality of life of patients and places a significant burden on the healthcare system in terms of resource allocation. In addition, there is a risk of long-term chronic renal failure, an infectious risk (recurrent cystitis and/or pyelonephritis, sometimes life-threatening) and a lithiasis risk.

The most frequently observed urinary symptoms are: urinary frequency, urgency with or without urinary incontinence, dysuria and chronic retention of urine. These disorders most often combine bladder hyperactivity and dysuria. This dysuria may be responsible for recurrent urinary tract infections, lithiasis, alteration of renal function.

The only therapeutic class currently used to treat dysuria in MS is alpha-blockers. Tamsulosin, alfusozin and doxazosin induce relaxation of the urethral smooth sphincter and prostatic urethral muscle fibers, facilitating the removal of subvesical obstruction and bladder emptying.

The study investigators hypothesize that treatment with tamsulosin 0.4 mg daily in adult MS patients with dysuria will result in symptom improvement as assessed by the International Prostate Symptom Score (IPSS) and Urinary Symptom Profile (USP) scores, a decrease in post-void residual, and an improvement in urine flow and quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study

acronym: CICAMODA

summary:
In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD).

To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies.

However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term.

Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students

summary:
Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.

Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric).

lead_sponsor: Centre de l'arthrose, Paris

intervention_type: Diagnostic Test


title: Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis

acronym: QUAMUS

summary:
Internal carotid artery (ICA) is intended to supply blood to brain. The carotid bulb located upstream of ICA origin is prone to atherosclerosis. This is an accumulation of fat and calcium in the wall forming a plaque that gradually thickens and leads to carotid stenosis (CS), which causes a decrease in blood flow. The risk of CS is stroke caused either by carotid artery thrombosis (occlusion) or by atherosclerotic plaque fragmentation, some components of which may leak into the brain (embolism).

When diagnosing CS, an Echo-Doppler is performed to determine bulb and ICA origin obstruction rates. The reference method of quantifying CS is based on hemodynamic criteria that only allow the diagnosis of high grade stenosis thresholds (50%-70%). Below 50%, low-grade stenosis, patient follow-up is limited and could be based on morphological criteria; ultrasound imaging being a reference technique for human body structures morphological assessment, especially vessels.

Two methods of CS morphological quantification with Doppler ultrasound currently exist. Calibre reduction at the maximum of stenosis can be measured by relating the smallest luminal diameter to the vessel diameter at stenosis site (ECST method) or to the downstream ICA diameter (NASCET method). As bulb diameter measures ≈1.8 times that of ICA, ECST appears to be more suitable for CS quantification. For high-grade stenosis, morphological quantification performance is impaired due to extensive calcification of large atheromatous plaques. However, it is possible that less calcified nature of low-grade stenosis and the use of a rigorous methodology will allow reproducible assessment in routine practice. This technique has not yet been evaluated, although it is a frequent situation in patient follow-up.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Effectiveness of Functional Rehabilitation With HUBER Platform Compared to a Standard Program, on the Flexion/Extension Ratio of the Spine, in Patients With Non-specific Chronic Low Back Pain

summary: The objective of this study is to evaluate the effectiveness of centre-based program of 6 weeks with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s, pain and trunk flexibility in individuals with chronic low back pain (CLBP). A total of 70 individuals with Non-specific Chronic Low Back Pain will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week.

lead_sponsor: Thibaut Guiraud

location_facility: CLINEA - Centre de Rééducation fonctionnelle de Treboul


title: TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation -- SafetY and Clinical Performance

summary:
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic severe or greater TR in patients who are deemed high risk for tricuspid surgery.

Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach.

A total of 93 subjects will be enrolled at up to 20 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site.

Up to an additional 42 roll-in subjects, up to 3 per site, may be enrolled by operators without prior experience with the LuX-Valve Plus system to gain hands-on experience. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and effectiveness results of roll-in subjects will be reported separately.

All subjects will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure

lead_sponsor: Jenscare Scientific

location_facility: Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux


title: Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

acronym: NaviKnee

summary: Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

summary: Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients

summary: This clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

lead_sponsor: Association de Musicothérapie Applications et Recherches Cliniques


title: Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout

acronym: TIGER

summary: The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
Auckland University


title: Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life

acronym: QUARLAMI

summary:
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility.

In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery.

The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort).

The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de L'Ouest (Ico)


title: Substance Use and Eating Disorders : Food Craving and Addiction Transfer

acronym: SUED

summary: Substance Use Disorder (SUD) and Eating Disorders (ED) are severe and persistent disturbances that are associated with significant harm. These two disorders have many clinical similarities, including craving and behavioral loss of control. Recently, craving for food has been described in newly abstinent patients with SUD. the aim of the study is to verify the hypothesis of addiction transfer based on common neurobiological mechanisms between substance craving and food craving, that postulates that food craving would correspond to an attempt to regulate substance craving (or vice versa).

ReferenceCitation: Atkinson TJ. Central and peripheral neuroendocrine peptides and signalling in appetite regulation: considerations for obesity pharmacotherapy. Obes Rev. 2008 Mar;9(2):108-20. doi: 10.1111/j.1467-789X.2007.00412.x.

ReferenceCitation: Avena NM, Murray S, Gold MS. Comparing the effects of food restriction and overeating on brain reward systems. Exp Gerontol. 2013 Oct;48(10):1062-7. doi: 10.1016/j.exger.2013.03.006. Epub 2013 Mar 25.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Bydlowski S, Corcos M, Jeammet P, Paterniti S, Berthoz S, Laurier C, Chambry J, Consoli SM. Emotion-processing deficits in eating disorders. Int J Eat Disord. 2005 May;37(4):321-9. doi: 10.1002/eat.20132.

ReferenceCitation: Calero-Elvira A, Krug I, Davis K, Lopez C, Fernandez-Aranda F, Treasure J. Meta-analysis on drugs in people with eating disorders. Eur Eat Disord Rev. 2009 Jul;17(4):243-59. doi: 10.1002/erv.936.

ReferenceCitation: Canan F, Karaca S, Sogucak S, Gecici O, Kuloglu M. Eating disorders and food addiction in men with heroin use disorder: a controlled study. Eat Weight Disord. 2017 Jun;22(2):249-257. doi: 10.1007/s40519-017-0378-9. Epub 2017 Apr 22.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer

acronym: MSPD

summary: The aim of this study is to assess the impact of music therapy on the pain of patients cared at the Montpellier Cancer Institute (ICM) for advanced cancer in a palliative situation and requiring full hospitalization or on an outpatient basis.

ReferenceCitation: Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x.

ReferenceCitation: Beck SL. The therapeutic use of music for cancer-related pain. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1327-37.

ReferenceCitation: Huang ST, Good M, Zauszniewski JA. The effectiveness of music in relieving pain in cancer patients: a randomized controlled trial. Int J Nurs Stud. 2010 Nov;47(11):1354-62. doi: 10.1016/j.ijnurstu.2010.03.008. Epub 2010 Apr 18.

ReferenceCitation: Krishnaswamy P, Nair S. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study. Indian J Palliat Care. 2016 Jul-Sep;22(3):307-11. doi: 10.4103/0973-1075.185042.

ReferenceCitation: Alcantara-Silva TR, de Freitas-Junior R, Freitas NMA, de Paula Junior W, da Silva DJ, Machado GDP, Ribeiro MKA, Carneiro JP, Soares LR. Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial. Integr Cancer Ther. 2018 Sep;17(3):628-635. doi: 10.1177/1534735418757349. Epub 2018 Apr 10.

ReferenceCitation: Boyde C, Linden U, Boehm K, Ostermann T. The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Glob Adv Health Med. 2012 Nov;1(5):24-9. doi: 10.7453/gahmj.2012.1.5.009. Epub 2012 Nov 1.

ReferenceCitation: Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.

ReferenceCitation: Lesiuk T. The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Healthcare (Basel). 2016 Aug 9;4(3):53. doi: 10.3390/healthcare4030053.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Retinal Microvascular Network and Coronary Revascularization Surgery at the Dijon University Hospital: Pilot Study

acronym: MRCC

summary:
When coronary artery disease cannot be treated with medication, revascularization surgery can be performed. Although there have been many advances in recent years, this surgery is still associated with a high incidence of cardiovascular complications.

These complications are more frequent in patients with microscopic vessel damage. In clinical practice, microvascular status is difficult to characterize. Several models have been proposed, but they remain imprecise and are difficult to reproduce.

However, the study of the retinal microvascular network has recently emerged as a promising model. It is simple, quick and non-invasive thanks to the use of photographs or CT scans of the fundus (by optical coherence tomography angiography = OCT-A). Thus, the retinal vasculature is very often presented as an in vivo access that provides a window into systemic peripheral vasculature.

Despite the systematic assessment of cardiovascular risk by the usual risk factors (diabetes, hypertension, sex, etc.), risk stratification remains imperfect in coronary revascularization surgery and remains associated with a high incidence of complications, the most frequent being acute kidney injury (AKI).

Preoperative screening for retinal microvascular data could improve surgical risk stratification and better predict the potential occurrence of severe renal complications. Patient management could thus tailored to avoid such complications.

The main objective of the study is to investigate, in patients scheduled for coronary revascularization surgery with extracorporeal circulation, the discriminative capacity of retinal vascular density to predict the occurrence of AKI within 7 days after surgery.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects

summary:
Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters.

Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments.

No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.

lead_sponsor: Laboratoires Pronutri

collaborators:
Clin-Experts
Plateforme Cocolab

sponsor_collaborators:
Laboratoires Pronutri
Clin-Experts
Plateforme Cocolab

location_facility: Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est, 24, avenue des Diables Bleus, Campus Saint Jean d'Angély

intervention_type: Dietary Supplement


title: Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie

acronym: PROSTABDO

summary: the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Complex Ocular Infection, Optimization of Microbiological Diagnosis

acronym: ICODIA

summary:
The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.

Metagenomic for the endophtalmitis
Multiplex polymerase chain reaction for corneal abscesses

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Equipe mobile d'infectiologie, Cochin hospital


title: Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)

acronym: PREMIAM

summary:
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child.

However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown.

PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Le Laboratoire de Psychopathologie et Processus de Santé

location_facility: Centre Hospitalier Intercommunal Créteil


title: Evaluation of the Effect of a Soluble Fiber Consumption on the Immune Response Post-influenza Vaccination in Healthy Subjects Aged 50 to 70 Years

acronym: NUTIVAC

summary:
At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies directed against the H3N2 viral strain. The increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic capacities. The effect of prebiotics and probiotics on the immune response to influenza virus vaccination has been studied in two systematic reviews and meta-analyses. The authors show that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher, respectively, compared to placebo).

The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic fibre. The prebiotic properties have been demonstrated in humans in several studies for doses ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of a preclinical study conducted in mini-pigs.

The main objective of these study is to demonstrate that these prebiotic properties could help stimulate the post-vaccination immune response, and more specifically the production of antibodies directed against seasonal influenza viruses (following vaccination), and modulate the pro- and anti-inflammatory responses.

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
Roquette Freres


title: Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit

acronym: CRAC

summary:
The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness.

Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful.

To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity).

The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring.

Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases.

There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism.

The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output.

The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot, Anesthésie-réanimation


title: Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study

summary: The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

sponsor_collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome : A French Multicentric Retrospective Study (PASS)

acronym: PASS

summary: To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data.

lead_sponsor: University Hospital, Brest


title: Study of In Vivo and in Vitro Transcriptomic and Proteomic Signatures in Unhereditary Ichtyosis

acronym: OMICHTYOSE

summary: The goal of this study is to identify important biological pathways involved in a variety of ichtyosis, using transcriptomic and proteomic techniques, with the aim of guiding the development of new therapeutis.


title: Observatory of the Efficacy and Safety of Vaccination Against SARS-CoV-2 in Neuromuscular Patients

acronym: VA-C-NEMUS

summary:
The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and in severe cases and long hospital stays, the disability of some neuromuscular patients may worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as myasthenia gravis can worsen after an infection such as COVID-19.

Thanks to an unprecedented research effort, vaccines are now available and others still in development. The first studies published in medical journals are reassuring about the efficacy and safety of these vaccines. However, they have been studied in the general population and we do not yet have specific information in neuromuscular patients.

This is the reason why the Va-C-NEMUS observatory was launched.

lead_sponsor: University Hospital, Bordeaux


title: Effect of Two Isoenergetic Modes of High-Intensity Interval Training on Total and Abdominal Fat Mass Loss in Men With Overweight or Obesity.

acronym: RIESLING

summary:
The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with overweight or obesity.

The investigators hypothesized that both programs could decrease total, abdominal and visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and blood flow, and that running could favors greater fat mass losses.

lead_sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques


title: La désensibilisation Aux Venins d'hyménoptères : Quelle Est Son efficacité à Long Terme ? (EFLOTITA2)

summary:
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less common in the paediatric population. It can be severe or even fatal.

Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe systemic reactions.

Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies evaluating longer-term efficacy are scarce.

At the University Hospital of Angers, hundreds of patients are treated each year, and its allergology unit has been providing VIT for over 15 years.

The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.

lead_sponsor: University Hospital, Angers


title: Effectiveness of a One-day Psychoeducation Program on Internalized Stigmatization for Borderline Personality Disorder (BPD) Patients

acronym: EDUC-BPD

summary: Education day on borderline personality disorder (BPD), including a transmission of current scientific knowledge on the disease. A dimensional understanding of BPD is delivered as well as disidentification of oneself to the symptoms of borderline personality disorder (Ducasse 2020 Eur Arch Psychiatry Clin Neurosci). The main objective is to evaluate the impact of borderline education day on self-stigma.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Assessment of the Reliability of Changes in Plethysmography Variability Index During Tidal Volume Challenge for Predicting Fluid Responsiveness in Intensive Care Unit Patients

summary: The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

ReferenceCitation: Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.

ReferenceCitation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

ReferenceCitation: Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

ReferenceCitation: Alvarado Sanchez JI, Caicedo Ruiz JD, Diaztagle Fernandez JJ, Amaya Zuniga WF, Ospina-Tascon GA, Cruz Martinez LE. Predictors of fluid responsiveness in critically ill patients mechanically ventilated at low tidal volumes: systematic review and meta-analysis. Ann Intensive Care. 2021 Feb 8;11(1):28. doi: 10.1186/s13613-021-00817-5.

ReferenceCitation: Feissel M, Teboul JL, Merlani P, Badie J, Faller JP, Bendjelid K. Plethysmographic dynamic indices predict fluid responsiveness in septic ventilated patients. Intensive Care Med. 2007 Jun;33(6):993-9. doi: 10.1007/s00134-007-0602-6. Epub 2007 Mar 29.

ReferenceCitation: Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.

ReferenceCitation: Natalini G, Rosano A, Taranto M, Faggian B, Vittorielli E, Bernardini A. Arterial versus plethysmographic dynamic indices to test responsiveness for testing fluid administration in hypotensive patients: a clinical trial. Anesth Analg. 2006 Dec;103(6):1478-84. doi: 10.1213/01.ane.0000246811.88524.75.

ReferenceCitation: Cannesson M, Attof Y, Rosamel P, Desebbe O, Joseph P, Metton O, Bastien O, Lehot JJ. Respiratory variations in pulse oximetry plethysmographic waveform amplitude to predict fluid responsiveness in the operating room. Anesthesiology. 2007 Jun;106(6):1105-11. doi: 10.1097/01.anes.0000267593.72744.20.

ReferenceCitation: Cannesson M, Desebbe O, Hachemi M, Jacques D, Bastien O, Lehot JJ. Respiratory variations in pulse oximeter waveform amplitude are influenced by venous return in mechanically ventilated patients under general anaesthesia. Eur J Anaesthesiol. 2007 Mar;24(3):245-51. doi: 10.1017/S026502150600161X. Epub 2006 Oct 23.

ReferenceCitation: Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.

ReferenceCitation: Landsverk SA, Hoiseth LO, Kvandal P, Hisdal J, Skare O, Kirkeboen KA. Poor agreement between respiratory variations in pulse oximetry photoplethysmographic waveform amplitude and pulse pressure in intensive care unit patients. Anesthesiology. 2008 Nov;109(5):849-55. doi: 10.1097/ALN.0b013e3181895f9f.

ReferenceCitation: Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.

ReferenceCitation: Monnet X, Guerin L, Jozwiak M, Bataille A, Julien F, Richard C, Teboul JL. Pleth variability index is a weak predictor of fluid responsiveness in patients receiving norepinephrine. Br J Anaesth. 2013 Feb;110(2):207-13. doi: 10.1093/bja/aes373. Epub 2012 Oct 26.

ReferenceCitation: Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.

ReferenceCitation: Taccheri T, Gavelli F, Teboul JL, Shi R, Monnet X. Do changes in pulse pressure variation and inferior vena cava distensibility during passive leg raising and tidal volume challenge detect preload responsiveness in case of low tidal volume ventilation? Crit Care. 2021 Mar 18;25(1):110. doi: 10.1186/s13054-021-03515-7.

lead_sponsor: Bicetre Hospital

location_facility: Service de médecine intensive-réanimation, Hôpital de Bicêtre


title: Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery

acronym: OFAT

summary: Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.

lead_sponsor: Nantes University Hospital


title: A Two-part, Open-label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 in Combination With Low-dose Subcutaneous Interleukin-2 in Patients With Advanced Solid Tumors (EVICTION-2)

summary:
This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors.

Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2.

Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.

ReferenceCitation: De Gassart A, Le KS, Brune P, Agaugue S, Sims J, Goubard A, Castellano R, Joalland N, Scotet E, Collette Y, Valentin E, Ghigo C, Pasero C, Colazet M, Guillen J, Cano CE, Marabelle A, De Bonno J, Hoet R, Truneh A, Olive D, Frohna P. Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vgamma9Vdelta2 T cell-mediated antitumor immune response. Sci Transl Med. 2021 Oct 20;13(616):eabj0835. doi: 10.1126/scitranslmed.abj0835. Epub 2021 Oct 20.

lead_sponsor: ImCheck Therapeutics

collaborators:
ILife Consulting
Exystat

sponsor_collaborators:
ImCheck Therapeutics
ILife Consulting
Exystat