title: Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone

summary: 30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V Inhibitor therapy, which is presently considered as the first choice treatment for most ED patients. Recent reports stated a high prevalence of low serum testosterone levels in such non responders, and an improvement of their response by combining testosterone therapy with the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo controlled studies have added support to this hypothesis but one involved only 20 patients while in the other the benefit of combining testosterone was transient. This is a multi-centric study, double blind placebo controlled and randomized as concerns testosterone administration, that aims to objectively assess the efficacy of co-administering testosterone with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily, in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a 12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study visit. Safety assessments will be performed in addition during the last visit (physical examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel + Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated according to suboptimal clinical response of the patient, the dose of study medication will be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind treatment phase.

lead_sponsor: SELARL du Dr Jacques BUVAT


title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

summary: Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.

lead_sponsor: Hospices Civils de Lyon

location_facility: Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.

acronym: SmartCriseS

summary:
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used.

EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors.

1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts.

An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

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

ReferenceCitation: Berrouiguet S, Barrigón ML, Castroman JL, Courtet P, Artés-Rodríguez A, Baca-García E. Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the Smartcrises study protocol. BMC Psychiatry. 2019 Sep 7;19(1):277. doi: 10.1186/s12888-019-2260-y.

lead_sponsor: University Hospital, Montpellier

location_country: France Spain

location_facility:
Fundacion Jimenez Diaz Hospital
CHU Montpellier

intervention_type: Other

status_simplified: Ongoing


type: Registry Identifier

title: Effects of a Long-term and Regular Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism : a Cross-over Designed Study to Determine the Specific Role of Naringin

summary:
Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

ReferenceCitation: Krga I, Corral-Jara KF, Barber-Chamoux N, Dubray C, Morand C, Milenkovic D. Grapefruit Juice Flavanones Modulate the Expression of Genes Regulating Inflammation, Cell Interactions and Vascular Function in Peripheral Blood Mononuclear Cells of Postmenopausal Women. Front Nutr. 2022 May 26;9:907595. doi: 10.3389/fnut.2022.907595. eCollection 2022.

ReferenceCitation: Habauzit V, Verny MA, Milenkovic D, Barber-Chamoux N, Mazur A, Dubray C, Morand C. Flavanones protect from arterial stiffness in postmenopausal women consuming grapefruit juice for 6 mo: a randomized, controlled, crossover trial. Am J Clin Nutr. 2015 Jul;102(1):66-74. doi: 10.3945/ajcn.114.104646. Epub 2015 May 27.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.

acronym: FASHE

summary:
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.

In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.

The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.

An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Proust F, Gérardin E, Derrey S, Lesvèque S, Ramos S, Langlois O, Tollard E, Bénichou J, Chassagne P, Clavier E, Fréger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754.

ReferenceCitation: Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Bergé J, Vignes JR, Irthum B, Gabrillargues J, Chazal J, Bataille B, Drouinau J, Mourier K, Ricolfi F, Gay E, Bessou P, Lonjon M, Sedat J, David P, Lajaunias P, Morandi X, Gauvrit JY, Pelissou I, Turjman F, Roche PH, Dufour H, Levrier O, Emery E, Courthéoux P, Laguarrigue J, Cognard C, Civit T, Lejeune JP. [Aneurismal subarachnoid hemorrhage in the elderly subject. Should this patient participate in a randomized clinical trial?]. Neurochirurgie. 2010 Feb;56(1):67-72. doi: 10.1016/j.neuchi.2009.11.002. Epub 2010 Jan 8. French.

lead_sponsor: University Hospital, Rouen

location_facility:
PROUST
Rouen University Hospital


title: Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis

summary:
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family, develop an inflammatory syndrome with the characteristics of human psoriasis.

To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the investigators intend to develop a clinical study to analyze the expression, cleavage and activity of Lyn and the activation of caspases from skin biopsies of patients with this disease.

This study will be conducted on a cohort of patients with different forms of psoriasis (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated with chronic inflammation. Thus, the investigators will evaluate the expression and activity of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the level of caspase activation and apoptotic inflammatory.

Thus, the investigators will verify that the cleavage by caspases of Lyn is associated specifically with psoriasis, as the investigators believe, or more generally to the skin inflammation. The investigators work would then define the cleavage by caspases of Lyn as a new potential marker of human psoriasis.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceCitation: Aira LE, Gonçalves D, Bossowski JP, Rubio-Patiño C, Chiche J, Paul-Bellon R, Mondragón L, Gesson M, Lecucq-Ottavi P, Obba S, Colosetti P, Luciano F, Bailly-Maitre B, Boyer L, Jacquel A, Robert G, Ricci JE, Ortonne JP, Passeron T, Lacour JP, Auberger P, Marchetti S. Caspase 1/11 Deficiency or Pharmacological Inhibition Mitigates Psoriasis-Like Phenotype in Mice. J Invest Dermatol. 2019 Jun;139(6):1306-1317. doi: 10.1016/j.jid.2018.11.031. Epub 2018 Dec 17.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Assistance Publique - Hôpitaux de Marseille

status_simplified: Unknown


title: Impact of a Therapeutic Education Program Specifically Adapted to the Precarious People Supported in Therapeutic Coordination Apartments on the Acceptance of Their Disease and the Management of Their Care

acronym: EDUPACT

summary:
Through its patient-centered approach and focus on developing coping skills and coping strategies, Health Education could be an effective approach in therapeutic coordination apartments to reduce the perceived treatment burden among people in precarious situations with one or more chronic diseases. Decreasing perception of burden would improve their quality of life and adherence to treatment.

The general hypothesis explored in this project is that the experience of the disease, the perception of the burden of treatment, the autonomy and the quality of life of the residents improve more importantly in therapeutic coordination apartments having implemented a formalized and structured Health Education approach (experimental group) than in those who did not set up formalized and structured Health Education approach (control group).

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
Act Acothe
Act Passerelle
Act Aurore
ACT Louis Guilloux
ACT Le Logis Montjoie


title: Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study

acronym: COCCA

summary: The purpose of this randomized controlled trial is to evaluate the hemodynamic effect of low dose corticosteroid therapy (hydrocortisone and fludrocortisone) in the treatment of adult cardiogenic shock.

primary_purpose: Treatment

ReferenceCitation: Mekontso Dessap A, Bagate F, Delmas C, Morichau-Beauchant T, Cholley B, Cariou A, Lattuca B, Moussa M, Mongardon N, Fard D, Schmidt M, Bouglé A, Kerneis M, Vivier E, Roubille F, Duprey M, Decalf V, Genet T, Merzoug M, Audureau E, Squara P. Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):4. doi: 10.1186/s13063-021-05947-6.

ipd_sharing: Undecided

lead_sponsor: CMC Ambroise Paré

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: CH Intercommunal de Villeneuve Saint Georges

location_facility: Centre cardiologique du nord saint denis

location_facility: Hôpitaux Universitaires Pitié Salpêtrière


title: Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

summary: Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

lead_sponsor_type: industriel


title: QT on RIBociclib measuRed by ArTificial INteliGence

acronym: QT-RIBRATING

summary:
"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility.

The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting.

location_facility: CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE


title: Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets: the BAT-VTE

acronym: BAT-VTE

summary:
Venous ThromboEmbolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients.

Their management requires use of antithrombotic agents: Anticoagulant (AC) for secondary prevention of Venous ThromboEmbolism (VTE) recurrence, antiplatelet (AP) for secondary prevention of Major Adverse ischemic Cardiovascular and Cerebrovascular Event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease).

Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of Anticoagulant (AC) with antiplatelet (AP) strongly increases this risk.

Up to one third of Venous ThromboEmbolism (VTE) patients receive concomitant antiplatelet (AP) therapy, with conflicting results on patient outcomes. Concomitant therapy (Anticoagulant + antiplatelet) has been associated with a higher risk of bleeding (up to 3-fold) when aspirin was associated with vitamin-K antagonist (VKA) in a multicenter cohort study, or with direct oral anticoagulants (DOACs) for acute Venous ThromboEmbolism (VTE) in a post-hoc subgroup analysis. Conversely, patients with acute Venous ThromboEmbolism (VTE) in whom clinicians decided to maintain Anticoagulant (AC) + antiplatelet (AP) were found to have an increased risk of Major Adverse ischemic Cardiovascular and Cerebrovascular Event (MACCE) without any higher risk of bleeding, in a multicenter registry. However, in most cases, the type (aspirin or another) and indication (primary versus secondary prevention) of antiplatelet (AP) was unknown, as was the duration of the combination anticoagulant (AC) + antiplatelet (AP), and therefore these observational results may be confounded. Therefore, there is persistent equipoise regarding the benefit/risk of combining an antiplatelet therapy with anticoagulation in patients undergoing treatment for Venous ThromboEmbolism (VTE), when there is a prior history of atherosclerotic cardiovascular disease. This may explain why clinical practice varies widely.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied

location_facility: APHP - Hôpital Européen Georges Pompidou HEGP

intervention_type: Drug


title: Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA Vasculitis: A Prospective, Randomized, Controlled, Double-blind Study

acronym: RIGA

summary:
Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile.

Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV.

Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.

lead_sponsor: Hopital Foch

location_facility:
CHU Nantes
CHRU Bretonneau
Hôpital André Grégoire
Hôpital Edouard Herriot
CHU Strasbourg
Hôpital Foch
CHU Clermont Ferrand
CHU Toulouse
Hôpital Cochin
CHU Nîmes (Caremeau)
CHU Marseille
APHM de La Timone
Hopital La Cavale Blanche


acronym: THERAMAG

title: Rituximab Therapy in Anti-MAG Patients With Characteristics of Good Responders:

type: EudraCT Number

source: euctr

location_facility:
CHU Brest - La cavale blanche
CHU Toulouse - Pierre-Paul Riquet
CHU Grenoble - La tronche
APHP Pitié Salpêtrière
CHU Tours - Bretonneau
HCL lyon
CHU Lille - Roger Salengro
CHU La Timone - APHM
CHU Nancy- Hôpital central
CHU Strasbourg - Hautepierre
CHU Limoges - Dupuytren
CHU de Saint-Etienne
CHU Nice - Pasteur
APHP - Kremlin-Bicêtre

summary: Anti-MAG neuropathy is a progressively disabling orphan rare disorder due to a monoclonal immunoglobulin M(IgM) gammopathy displaying reactivity toward MAG, a glycoprotein of the peripheral nervous system. Its prevalence is around 1/100000 and to date, no treatment has proven efficacy in this disease, including rituximab in 2 Randomized Controlled Trails(RCTs).


ipd_sharing: Yes

acronym: DiabOUT

intervention_type: Dietary Supplement

title: Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: Other Grant/Funding Number

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: CH de Saint-Denis - hôpital Delafontaire

location_facility: AP-HP - hôpital européen Georges-Pompidou

summary: This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.


title: Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator

acronym: START

summary:
START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.

The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.

primary_purpose: Health Services Research

location_facility:
Dijon University Hospital
Montpellier University Hospital
Strasbourg University Hospital
Toulouse University Hospital
Brest University Hospital
Tours University Hopsital
AP-HM
Nancy University Hospital
Rennes University Hospital
Saint-Etienne University Hospital
Lyon University Hospital
Angers University Hospital
Grenoble University Hospital
AP-HP, La Pitié Salpétrière

intervention_type: Procedure


acronym: ROC-SPA

intervention_type: Biological

title: Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

location_country: France Monaco

location_facility: CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires

summary:
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.


title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)

summary: The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

ReferenceCitation: Sentilhes L, Sénat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbrière R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananès N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstétrique et Gynécologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.

ReferenceCitation: Sentilhes L, Daniel V, Deneux-Tharaux C; TRAAP2 Study Group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG). TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Intercommunal Poissy-Saint Germain

location_facility: Hôpital universitaire Necker-Enfants malades


status: Active, not recruiting

acronym: FAIR-ALS II

title: Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis: Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone

lead_sponsor: University Hospital, Lille

location_facility:
Chu Cote de Nacre - Caen
Aphm Hopital La Timone
Chu de Nice Hopital Pasteur
Chu de Tours
Chu Toulouse
Chr Angers
Chu de Bordeaux - Talence
Chu de Clermont-Ferrand
Chru Brest
C H U Dupuytren Limoges
Chu de Nancy
Hôpital Roger Salengro, CHU
Hu Pitie Salpetriere Aphp
Hopital de Hautepierre
Hopital Pierre Wertheimer - Hcl - Bron

summary: The alteration of iron metabolism is reported in animal models of amyotrophic lateral sclerosis (ALS) as well as in sporadic and genetic forms (SOD1 and C9orf72) of ALS. The high iron concentration of the brain, due to its high energy demand (high oxygen consumption), makes motor neurons particularly vulnerable to energy deficit and oxidative stress. Post-mortem examinations and MRI scans in patients with ALS have found signs of iron accumulation in the central motor tract; and a high level of serum ferritin, which is a marker of iron levels, is associated with a lower prognosis. In ALS mouse models, the use of iron chelators has demonstrated neuroprotection and increased life expectancy, suggesting that elimination of excess iron from the brain can prevent neuronal loss and, consequently, a slow progression of the disease. Conservative chelation of iron refers to a modality whereby much of the iron that binds to the chelator is redistributed in the body rather than exhausted. Using a chelator, deferiprone, with this feature, in a safety pilot study, a very good safety profile was observed. Deferiprone eliminated excess iron from brain regions, reduced oxidative damage and cell death associated with regional iron deposits with no apparent negative impact on the iron levels needed. Now, the efficacy of this new therapeutic modality of neuroprotection is being evaluated in a randomized, double-blind, placebo-controlled, multicenter study.


acronym: FLUNEXT

title: Validation of the Efficiency of Molecules Reproposed on the Basis of Their Cellular Transcriptomic Signature, Antagonist of the Signature Determined in Infection Due to Virus Influenza A.

type: Other Identifier

location_facility: Hôpital Edouard Herriot Hospices Civils de Lyon

location_facility: Gpe Hosp Cochin Saint Vincent de Paul - Paris

location_facility: Centre Hospitalier de Versailles - Le Chesnay Rocquencourt

summary: The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral ones, based on their ability to reverse the transcriptomic signature of the infected cells. This strategy has to be considered is the context of emerging viral diseases and of increase of resistance to antivirals. Concerning infection by Influenza viruses, the main drugs were identified and evaluated on in vitro and in vivo models: diltiazem. Therefore, it will be assess the efficacy of these the drug, compared to placebo, to treat severe flu.


title: Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation

acronym: RESPIRE

summary: Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations.

time_perspective: Retrospective

ReferenceCitation: Fayon M, Beaufils F, Esteves P, Campagnac M, Maurat E, Michelet M, Siao-Him-Fa V, Lavrand F, Simon G, Begueret H, Berger P. Bronchial Remodeling-based Latent Class Analysis Predicts Exacerbations in Severe Preschool Wheezers. Am J Respir Crit Care Med. 2022 Sep 15. doi: 10.1164/rccm.202205-0913OC. [Epub ahead of print]

location_facility:
CHU de Toulouse
CHU de Bordeaux


title: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs

acronym: SAMBA

summary:
The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group).

In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.

status: Terminated

location_facility:
CSAPA Arc-en-Ciel
CSAPA CHRU - Le PARI
CHU Clermont-Ferrand
CHU Strasbourg
Les Apsyades
Csapa Anpaa63
CH Roubaix
CH Beziers
Csapa Anpaa66
CHU Nancy
CSAPA La Trame - ANPAA59
CH Boulogne
CH Lens - CSAPA Le Square
CH Alpes-Isère
CH Tourcoing
CH du Rouvray
CH Dunkerque
CH Perpignan
CHU Rouen
Centre LOGOS
CH Troyes
CHU Grenoble
CHU Créteil
CHU Nantes
CH Limoux
CHU Brest


title: Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC

acronym: IMOTEC

summary:
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions.

Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function.

A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense.

Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices.

The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test.

Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.

ReferenceCitation: Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.

location_facility:
Marseille AP-HM La Timone
Dijon University Hospital
HEGP, Hôpital Européen Georges Pompidou
Bordeaux University hospital
Strasbourg Universtiy Hospital
Tours University Hospital
Lille University hospital
Toulouse University Hospital
Saint-Etienne University Hospital
Angers University Hospital
Clermont-Ferrand University Hospital
Caen University Hospital
Nancy University Hospital
APHP, La Pitié Salpétrière
Rouen University Hospital


title: Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure

acronym: ICAME

summary: Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

primary_purpose: Other

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).

location_facility:
Lapeyronie Hospital
Arnaud de Villeneuve Hospital


title: Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants

acronym: VERDICT

summary:
In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC) anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is associated with an increased risk of thromboembolic and bleeding complications compared to patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate renally impaired patients were poorly represented and patients with severe renal insufficiency not at all. So no dose reduction was considered.

Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in patients with moderate and severe renal insufficiency.

We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE patients with moderate or severe renal insufficiency in terms of net clinical benefit (recurrent VTE and major bleeding) at 3 months.

ReferenceCitation: Wetmore JB, Herzog CA, Yan H, Reyes JL, Weinhandl ED, Roetker NS. Apixaban versus Warfarin for Treatment of Venous Thromboembolism in Patients Receiving Long-Term Dialysis. Clin J Am Soc Nephrol. 2022 May;17(5):693-702. doi: 10.2215/CJN.14021021. Epub 2022 Apr 25.

location_facility: Hôpital Charles Foix - APHP Ivry sur Seine


title: Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

acronym: m-Rehab COPD

summary:
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

ReferenceCitation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1:CD013040. doi: 10.1002/14651858.CD013040.pub2.

location_facility: Centre hopsitalier universitaire de Montpellier


acronym: PEAGE

title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE

location_facility: Hôpitaux Universitaires Louis Mourier Paris Nord

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

summary:
The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.

So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).

This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.

Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.


title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

acronym: PREDI-STIM

summary:
This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

ReferenceCitation: Boussac M, Arbus C, Colin O, Laurencin C, Eusebio A, Hainque E, Corvol JC, Versace N, Rascol O, Rousseau V, Harroch E, Ory-Magne F, Fabbri M, Moreau C, Rolland AS, Jarraya B, Maltête D, Drapier S, Marques AR, Auzou N, Wirth T, Meyer M, Giordana B, Tir M, Rouaud T, Devos D, Brefel-Courbon C; PREDISTIM study group. Personality assessment with Temperament and Character Inventory in Parkinson's disease. Parkinsonism Relat Disord. 2022 Oct;103:34-41. doi: 10.1016/j.parkreldis.2022.08.004. Epub 2022 Aug 19.

ReferenceCitation: Besse-Pinot E, Pereira B, Durif F, Fantini ML, Durand E, Debilly B, Derost P, Moreau C, Hainque E, Rouaud T, Eusebio A, Benatru I, Drapier S, Guehl D, Rascol O, Maltête D, Lagha-Boukbiza O, Giordana C, Tir M, Thobois S, Hopes L, Hubsch C, Jarraya B, Rolland AS, Corvol JC, Devos D, Marques A; Predistim Study Group. Preoperative REM Sleep Behavior Disorder and Subthalamic Nucleus Deep Brain Stimulation Outcome in Parkinson Disease 1 Year After Surgery. Neurology. 2021 Nov 16;97(20):e1994-e2006. doi: 10.1212/WNL.0000000000012862. Epub 2021 Oct 19.

ReferenceCitation: Betrouni N, Moreau C, Rolland AS, Carriere N, Chupin M, Kuchcinski G, Lopes R, Viard R, Defebvre L, Devos D. Texture-based markers from structural imaging correlate with motor handicap in Parkinson's disease. Sci Rep. 2021 Feb 1;11(1):2724. doi: 10.1038/s41598-021-81209-4.

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Croiset A, Ory-Magne F, Rascol O, Moreau C, Rolland AS, Maltête D, Rouaud T, Meyer M, Drapier S, Giordana B, Anheim M, Hainque E, Jarraya B, Benatru I, Auzou N, Belamri L, Tir M, Marques AR, Thobois S, Eusebio A, Corvol JC, Devos D, Brefel-Courbon C; PREDI-STIM study group. Personality dimensions of patients can change during the course of parkinson's disease. PLoS One. 2021 Jan 7;16(1):e0245142. doi: 10.1371/journal.pone.0245142. eCollection 2021.

ReferenceCitation: Santin MDN, Voulleminot P, Vrillon A, Hainque E, Béreau M, Lagha-Boukbiza O, Wirth T, Montaut S, Bardinet E, Kyheng M, Rolland AS, Voirin J, Drapier S, Durif F, Eusebio A, Giordana C, Auzou N, Houeto JL, Hubsch C, Jarraya B, Laurencin C, Maltete D, Meyer M, Rascol O, Rouaud T, Tir M, Moreau C, Corvol JC, Proust F, Grabli D, Devos D, Tranchant C, Anheim M; Predistim Study Group. Impact of Subthalamic Deep Brain Stimulation on Impulse Control Disorders in Parkinson's Disease: A Prospective Study. Mov Disord. 2021 Mar;36(3):750-757. doi: 10.1002/mds.28320. Epub 2020 Oct 6.

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Ory-Magne F, Rascol O, Moreau C, Maltête D, Rouaud T, Meyer M, Houvenaghel JF, Marsé C, Tranchant C, Hainque E, Jarraya B, Ansquer S, Bonnet M, Belamri L, Tir M, Marques AR, Danaila T, Eusebio A, Devos D, Brefel-Courbon C; PREDI-STIM study group*. Personality Dimensions Are Associated with Quality of Life in Fluctuating Parkinson's Disease Patients (PSYCHO-STIM). J Parkinsons Dis. 2020;10(3):1057-1066. doi: 10.3233/JPD-191903.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis

acronym: REMOD-TTR

summary:
Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response.

Materials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.

lead_sponsor: University Hospital, Caen

location_facility:
CHU de Caen
Clinique du Bois

intervention_type: Diagnostic Test


title: Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

acronym: ATOMIC

summary: The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

location_facility:
Hop Salengro - Hopital B
Hop Claude Huriez Chu Lille


title: A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

acronym: SARAH

summary: The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib which is now the standard treatment of advanced HCC.

ReferenceCitation: Zarca K, Mimouni M, Pereira H, Chatellier G, Vilgrain V, Durand-Zaleski I; SARAH Trial Group. Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma. Clin Ther. 2021 Jul;43(7):1201-1212. doi: 10.1016/j.clinthera.2021.04.018. Epub 2021 May 28.

ReferenceCitation: Hermann AL, Dieudonné A, Ronot M, Sanchez M, Pereira H, Chatellier G, Garin E, Castera L, Lebtahi R, Vilgrain V; SARAH Trial Group. Relationship of Tumor Radiation-absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with (90)Y in the SARAH Study. Radiology. 2020 Sep;296(3):673-684. doi: 10.1148/radiol.2020191606. Epub 2020 Jun 30.

ReferenceCitation: Vilgrain V, Pereira H, Assenat E, Guiu B, Ilonca AD, Pageaux GP, Sibert A, Bouattour M, Lebtahi R, Allaham W, Barraud H, Laurent V, Mathias E, Bronowicki JP, Tasu JP, Perdrisot R, Silvain C, Gerolami R, Mundler O, Seitz JF, Vidal V, Aubé C, Oberti F, Couturier O, Brenot-Rossi I, Raoul JL, Sarran A, Costentin C, Itti E, Luciani A, Adam R, Lewin M, Samuel D, Ronot M, Dinut A, Castera L, Chatellier G; SARAH Trial Group. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1624-1636. doi: 10.1016/S1470-2045(17)30683-6. Epub 2017 Oct 26.

ReferenceCitation: Vilgrain V, Abdel-Rehim M, Sibert A, Ronot M, Lebtahi R, Castéra L, Chatellier G; SARAH Trial Group. Radioembolisation with yttrium-90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial. Trials. 2014 Dec 3;15:474. doi: 10.1186/1745-6215-15-474.

location_facility:
Hôpital de L'Archet #11
CHRU Besançon Hôpital Jean Minjoz #21
CHU Amiens #2
Hôpital Jean Verdier #25
Hopital beaujon #1
Hotel Dieu #10
CHU Marseille Hôpital La Timone #23
Hôpital Edouard Herriot #6
Hôpital Côte de Nacre #4
Hôpital Saint Eloi #8
CHU Poitiers La Milétrie
Henri Mondor #24
CHU Dijon Hôpital Bocage #22
Lyon La croix Rousse #27
Paul Brousse #19
CHU Saint Etienne Hôpital Nord #17
Hôpital Haut Leveque #14
Hôpital de Hautepierre #18
Institut Paoli Calmettes #7
CHU Robert Debré #28
CHU Grenoble #5
Hôpital Européen Georges Pompidou #13
Hôpital de Brabois #9
CHU Angers #3
Hôpital Antoine Béclère #29
Institut Gustave Roussy #20


title: Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio

acronym: TIPS

summary:
This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.

A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients.

The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either < or >= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

ReferenceCitation: Jouve T, Fonrose X, Noble J, Janbon B, Fiard G, Malvezzi P, Stanke-Labesque F, Rostaing L. The TOMATO Study (Tacrolimus Metabolization in Kidney Transplantation): Impact of the Concentration-Dose Ratio on Death-censored Graft Survival. Transplantation. 2020 Jun;104(6):1263-1271. doi: 10.1097/TP.0000000000002920.

ReferenceCitation: Jouve T, Noble J, Rostaing L, Malvezzi P. An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization. Expert Opin Drug Saf. 2019 Apr;18(4):285-294. doi: 10.1080/14740338.2019.1599858. Epub 2019 Apr 1. Review.

ReferenceCitation: Thölking G, Fortmann C, Koch R, Gerth HU, Pabst D, Pavenstädt H, Kabar I, Hüsing A, Wolters H, Reuter S, Suwelack B. The tacrolimus metabolism rate influences renal function after kidney transplantation. PLoS One. 2014 Oct 23;9(10):e111128. doi: 10.1371/journal.pone.0111128. eCollection 2014.

ReferenceCitation: Egeland EJ, Robertsen I, Hermann M, Midtvedt K, Størset E, Gustavsen MT, Reisæter AV, Klaasen R, Bergan S, Holdaas H, Hartmann A, Åsberg A. High Tacrolimus Clearance Is a Risk Factor for Acute Rejection in the Early Phase After Renal Transplantation. Transplantation. 2017 Aug;101(8):e273-e279. doi: 10.1097/TP.0000000000001796.

lead_sponsor: University Hospital, Grenoble

location_facility:
Grenoble University Hospital
Saint Etienne University Hospital


title: Pharmacoeconomic and Clinical Prospective Comparison of PET-scan and MRI in Patients With de Novo Multiple Myeloma Less Than 65 Years of Age Treated According to IFM/DFCI 2009 Clinical Trial.

acronym: IMAJEM

summary: Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.

ReferenceCitation: Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodéré F. Standardization of (18)F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.

ReferenceCitation: Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodéré F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.

location_facility: Metz University Hospital "Hôpital de Mercy"

location_facility: Tours University Hospital "Hôpital Bretonneau"

location_facility: Nancy University Hospita "Hôpitaux de Brabois"

location_facility: Grenoble University Hospital "Hôpital Michallon"

location_facility: Brest University Hospital "CHU du Morvan"

location_facility: Lille University Hospital "Claude Huriez"


title: Physical Activity in Dialysis: Clinical and Biological Impact

summary:
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases.

The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away.

Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients.

With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.

primary_purpose: Supportive Care

ReferenceCitation: Pedersen BK. Muscles and their myokines. J Exp Biol. 2011 Jan 15;214(Pt 2):337-46. doi: 10.1242/jeb.048074.

ReferenceCitation: Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111/j.1476-5381.2012.01970.x. Review.

ReferenceCitation: Sietsema KE, Amato A, Adler SG, Brass EP. Exercise capacity as a predictor of survival among ambulatory patients with end-stage renal disease. Kidney Int. 2004 Feb;65(2):719-24.

ReferenceCitation: Kopple JD, Kim JC, Shapiro BB, Zhang M, Li Y, Porszasz J, Bross R, Feroze U, Upreti R, Kalantar-Zadeh K. Factors affecting daily physical activity and physical performance in maintenance dialysis patients. J Ren Nutr. 2015 Mar;25(2):217-22. doi: 10.1053/j.jrn.2014.10.017. Review.

ReferenceCitation: Panaye M, Kolko-Labadens A, Lasseur C, Paillasseur JL, Guillodo MP, Levannier M, Teta D, Fouque D. Phenotypes influencing low physical activity in maintenance dialysis. J Ren Nutr. 2015 Jan;25(1):31-9. doi: 10.1053/j.jrn.2014.07.010. Epub 2014 Oct 8.

ReferenceCitation: Matsuzawa R, Roshanravan B, Shimoda T, Mamorita N, Yoneki K, Harada M, Watanabe T, Yoshida A, Takeuchi Y, Matsunaga A. Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. J Ren Nutr. 2018 Jan;28(1):45-53. doi: 10.1053/j.jrn.2017.07.004. Epub 2017 Sep 8.

ReferenceCitation: Matsuzawa R, Matsunaga A, Wang G, Kutsuna T, Ishii A, Abe Y, Takagi Y, Yoshida A, Takahira N. Habitual physical activity measured by accelerometer and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol. 2012 Dec;7(12):2010-6. doi: 10.2215/CJN.03660412. Epub 2012 Sep 13.

ReferenceCitation: Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.

ReferenceCitation: Heiwe S, Jacobson SH. Exercise training in adults with CKD: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Sep;64(3):383-93. doi: 10.1053/j.ajkd.2014.03.020. Epub 2014 Jun 7. Review.

ReferenceCitation: Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barillà A, Battaglia Y, Rapanà RM, Zuccalà A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1. Erratum in: J Am Soc Nephrol. 2018 Jul;29(7):2028.

ReferenceCitation: Olvera-Soto MG, Valdez-Ortiz R, López Alvarenga JC, Espinosa-Cuevas Mde L. Effect of Resistance Exercises on the Indicators of Muscle Reserves and Handgrip Strength in Adult Patients on Hemodialysis. J Ren Nutr. 2016 Jan;26(1):53-60. doi: 10.1053/j.jrn.2015.06.006. Epub 2015 Aug 8.

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ReferenceCitation: Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.

ReferenceCitation: Matsuzawa R, Aoyama N, Yoshida A. Clinical Characteristics of Patients on Hemodialysis With Peripheral Arterial Disease. Angiology. 2015 Nov;66(10):911-7. doi: 10.1177/0003319715572678. Epub 2015 Feb 18.

ReferenceCitation: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. Review. Erratum in: J Am Coll Cardiol. 2017 Mar 21;69(11):1520.

lead_sponsor: Elsan

location_facility:
Clinique Bouchard
Polyclinique les Fleurs


title: Exploratory Study. Endothelium-dependent Vasodilatation and Other Biomarkers: Predictive Indicators of the Progression From Gestational Hypertension to Preeclampsia?

acronym: BIOVASC-PreHTA

summary:
Hypertension during pregnancy remains a leading cause of maternal and foetal morbidity and mortality. The frequency (5 to 10% of pregnancies) and potential severity of these diseases, both for the mother and the child, are reasons for standardizing and optimizing medical practices.

The cause of hypertension during pregnancy and in particular the pathophysiology of preeclampsia remains poorly understood. Guidelines distinguish these two entities by the existence of proteinuria from and after the 20th week of amenorrhea and by maternal-foetal complications, more serious in pre-eclampsia than in gestational hypertension.

During gestational hypertension and preeclampsia acute placental vasculature and blood flow abnormalities were observed, maybe due to generalized vascular endothelial activation and vasospasm resulting in systemic hypertension and organ hypoperfusion. Endothelial dysfunction and abnormal expression of several specific blood biomarkers are now well accepted as characteristics of preeclampsia.

However, the progression of gestational hypertension to preeclampsia is difficult to predict; between 15 and 40 % of gestational hypertension cases progress to preeclampsia, suggesting that it is the same worsening disease.

Endothelial dysfunction could be at the origin of gestational hypertension, and subsequent development of preeclampsia through an imbalance between pro- and anti-angiogenic factors.

The main objective of this research is to assess whether the alteration of endothelium-dependent vasodilatation in pregnant women with stable hypertension is correlated with the occurrence of preeclampsia later during pregnancy.

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location_facility: AP-HP Avicenne Hospital, Department of internal medicine

location_facility: AP-HP Jean Verdier Hospital, Gynecology and obstetrics Department


title: Development of Synthetic Metabolic and Genetic Networks for the Detection of Urogenital Cancers

acronym: SynBioDiag

summary: This is a category 3 human study, prospective, comparative, in parallel groups. A comparative qualitative and quantitative analysis of several markers in 250 samples is proposed.

location_facility:
Clinique Beau Soleil
University Hospital


title: Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial

acronym: RIGHT-CRT

summary: The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility:
AP-HP, Pitié-Salpétrière
Hôpital Marie-Lannelongue
CHU de Caen
CHU de Rouen
Hôpital La Timone
CHU de Nantes
CHU de Tours
CHU de Toulouse
CHU de Lille
Clinique Pasteur
CHU de Montpellier
Hôpital Louis Pradel


title: Liberal Versus Restrictive Transfusion Threshold in High-risk Oncologic surgerY: a Multicenter, Randomized, Controlled, Pilot Study

summary:
Anemia is common in oncology. Up to three-quarters of cancer patients are exposed to an episode of anemia. In oncology surgery, perioperative bleeding is a major risk factor for anemia. Indeed, 13 to 40% of patients are transfused in perioperative oncologic surgery.

There is an association between anemia and prognosis. Several epidemiological studies have shown a strong association between anemia and altered quality of life. In oncology cohort studies, anemic patients had a significantly lower quality of life compared to patients without anemia. In non-cardiac surgery, preoperative anaemia was significantly associated with post-operative mortality. There is also an association between preoperative anaemia and the occurrence of post-operative complications. In oncology surgery, cohort studies conducted in colorectal surgery and neurosurgery found an association between the occurrence of perioperative anemia and post-operative morbidity and mortality.

The optimal transfusion strategy is unknown in oncology patients. Several multicentre randomised trials, conducted in resuscitation patients or in perioperative settings, have compared a "restrictive" to a "liberal" transfusion strategy. These studies did not show a superiority of one strategy over another on patient outcomes but a lower exposure to red blood cell concentrates in patients transfused with the restrictive transfusion strategy. Thus, the French High Authority for Health (HAS) has adopted a haemoglobin level of 7 g/dl as the transfusion threshold for any transfusion of red blood cell concentrate carried out in the operating theatre and in intensive care in the absence of special cases such as the presence of acute coronary syndrome. For oncology patients, no recommendation could be made due to the lack of evidence-based literature and the optimal transfusion strategy for these patients remains unknown. Only 2 monocentric trials performed in oncology (critical care and perioperative) suggest a benefit of a liberal strategy (transfusion for a haemoglobin level < 9 g/dl) on the short-term vital prognosis, but these studies suffer from numerous limitations leaving the question unresolved.

Before conducting a large phase III trial, a pilot study is needed to validate the methodology of this multicentre clinical trial and to assess its feasibility.

ReferenceCitation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU d'Angers
CHRU de Brest


title: Predictive Value of Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies Stretches of 4 or More Segments on Non-cirrhotic Liver

acronym: SCINTIVOL

summary: Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the future remnant liver is just performed through its volumetric measurement by computed tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular function of the future remnant liver that can be disturbed in case of vascular and/or biliary obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients. Literature data (albeit originating from a single centre in Europe) have suggested that (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of the future remnant liver. The aim of this prospective multicentric study is to determine the predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.

primary_purpose: Screening

ReferenceType: result

ReferenceCitation: Bennink RJ, Tulchinsky M, de Graaf W, Kadry Z, van Gulik TM. Liver function testing with nuclear medicine techniques is coming of age. Semin Nucl Med. 2012 Mar;42(2):124-37. doi: 10.1053/j.semnuclmed.2011.10.003. Review.

ReferenceCitation: de Graaf W, Heger M, Spruijt O, Maas A, de Bruin K, Hoekstra R, Bennink RJ, van Gulik TM. Quantitative assessment of liver function after ischemia-reperfusion injury and partial hepatectomy in rats. J Surg Res. 2012 Jan;172(1):85-94. doi: 10.1016/j.jss.2010.06.038. Epub 2010 Jul 21.

ReferenceCitation: de Graaf W, Bennink RJ, Veteläinen R, van Gulik TM. Nuclear imaging techniques for the assessment of hepatic function in liver surgery and transplantation. J Nucl Med. 2010 May;51(5):742-52. doi: 10.2967/jnumed.109.069435. Epub 2010 Apr 15. Review.

ReferenceCitation: de Graaf W, Häusler S, Heger M, van Ginhoven TM, van Cappellen G, Bennink RJ, Kullak-Ublick GA, Hesselmann R, van Gulik TM, Stieger B. Transporters involved in the hepatic uptake of (99m)Tc-mebrofenin and indocyanine green. J Hepatol. 2011 Apr;54(4):738-45. doi: 10.1016/j.jhep.2010.07.047. Epub 2010 Oct 1.

ReferenceCitation: de Graaf W, van Lienden KP, van den Esschert JW, Bennink RJ, van Gulik TM. Increase in future remnant liver function after preoperative portal vein embolization. Br J Surg. 2011 Jun;98(6):825-34. doi: 10.1002/bjs.7456. Epub 2011 Apr 11.

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand


title: Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

acronym: pericardite

summary:
Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established.

PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial.

Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease).

Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities.

Secondary endpoint is: 6-month recurrence.

ReferenceCitation: Maisch B, Seferović PM, Ristić AD, Erbel R, Rienmüller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnóstico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiología. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. Spanish.

ReferenceCitation: Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6.

location_facility: Centre Hospitalier Intercommunal de Cornouaille


title: Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial

acronym: CARSPECT

summary: This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.

ReferenceCitation: Thivat E, Chanchou M, Mathieu S, Levesque S, Billoux T, Auzeloux P, Sas N, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Galmier MJ, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. Assessment of (99m)Tc-NTP 15-5 uptake on cartilage, a new proteoglycan tracer: Study protocol for a phase I trial (CARSPECT). Front Med (Lausanne). 2022 Oct 12;9:993151. doi: 10.3389/fmed.2022.993151. eCollection 2022.

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Jean Perrin
CHU Clermont-Ferrand


title: The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia

acronym: HADITRYOS

summary:
BACKGROUND It is demonstrated that strong associations between trauma suffered in childhood and having schizophrenia, and more specifically to experience acoustic-verbal hallucinations (AVH). A second generation of research is currently examining the cognitive and affective processes likely to play a mediating role in this association. These mediators appear to include early maladaptive personality patterns and dissociative experiences. Although these factors have most often been explored separately, recent research indicates that they could be associated, and thus contribute to AVH. More specifically, another study has shown that the association between childhood trauma and predisposition to AVH is not direct but depends on cognitive factors including the impact of violence suffered during childhood on early maladaptive schemas and dissociation. However, this study was carried out on a non-clinical sample of subjects with a predisposition to AVH.

OBJECTIVES: testing a structural model of AVH, childhood trauma, early maladaptive schemas and dissociative symptoms in large multicentric sample of inpatients diagnosed with schizophrenia and AVH (n=350). Secondary objectives are (i) test in the model the role of all the early patterns described by Jeffrey Young instead of targeting only the schemes that are part of the model tested in previous study as the one by Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model to the quality of the adjustment of the exploratory model.

METHODS: one single visit in which subjects will receive self-reported questionnaires (Childhood trauma questionnaire, The Young schema questionnaire short form, Dissociative experiences scale, Launay-Slade hallucination scale and Cardiff Anomalous Perceptions Scale.

ANALYSES: Structural equation model performed additional analysis using Partial Least Squares Structural Equation Modelling. The primary endpoint corresponds to significant associations between the variables. The quality of the model will be assessed using a fit quality measure. The secondary endpoints are significant associations between the different variables (p <0.05) and the model quality assessed with a quality measure of the fit.

MAIN HYPOTHESIS: the association between childhood trauma and predisposition to AVH is not direct, but depends on the impact of violence suffered during childhood on early maladaptive schemas and dissociative symptoms in patients with schizophrenia.

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location_facility:
Chu St Etienne
Grenoble University Hospital


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lead_sponsor: Institut Bergonié

location_facility:
CH de Pau
CHU Rangueil-Larrey
Hôpital de Tenon
Hôpital Européen Georges Pompidou
Hôpital Cochin
CHU de Strasbourg
Institut Gustave Roussy
CHU de Bordeaux
CHU de Rennes


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lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil


title: REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)

acronym: REPERFUSE

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lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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CHU Lyon
CHRU Nancy
Hôpital Fondation A de Rothschild
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CHU Toulouse
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