title: Effects of Low Frequency Deep Brain Stimulation of the Pedunculopontine Nucleus on Gait and Balance Disorders of Parkinson's Disease

summary:
The appearance of postural instability and gait disorders is a major turning point in the evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced outside mobility. There is no effective pharmacological treatment available for these symptoms, and their pathophysiology is not well known : it is currently assumed that non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the origin of these axial symptoms, since the PPN participates in the maintenance of posture and motion in primates. In PD patients, recent reports have suggested that low frequency stimulation of the PPN may equally improve gait and posture. However, these results are debatable due to methodological limitations, insufficient clinical evaluation and uncertain anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable for this operation due to gait and posture disorders. We will perform a randomized, double-blind and cross over design (two months periods with and without DBS randomly assigned to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each patient. Evaluations will comprise 1 month before surgery and in "Off" and "On" stimulation condition:

clinical motor assessment in both "Off" and "On" drug state, including cardinal parkinsonian signs, gait and balance
gait initiation physiological evaluation
cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN stimulation may well represent a substantial improvement of our therapeutic options for advanced PD patients suffering from debilitating gait and posture disorders unresponsive to L-Dopa.

lead_sponsor: Pitié-Salpêtrière Hospital


title: Long-term Follow-up of Patients With Sanfilippo Type A Syndrome Who Have Previously Been Treated in the P1-SAF-301 Clinical Study Evaluating the Tolerability and Safety of the Intracerebral Administration of SAF-301.

summary:
P2-SAF-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The primary objective is to collect additional safety and tolerability data on intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The secondary objective is to further collect data to assess the effects of SAF-301 on neurological and psychological status, and potential biological markers.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: LYSOGENE

location_facility: Hôpitaux Universitaires Paris Sud (Bicêtre)

intervention_type: Genetic

lead_sponsor_type: industriel

status_simplified: Completed


title: Co-LEsions in Alzheimer Disease and Related Disorders

acronym: CLEM

summary:
One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic approaches in elderly is to target the main pathological process responsible for disability and dependency. However, a progressive cognitive impairment occurring after the age of 70 is often related to mixed lesions of neurodegenerative and vascular origins. Whereas young patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases being different to that observed in patients with AD alone. Vascular dementia (VD) and AD with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone. Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to their clinical, pathological heterogeneity and the multiple pathological subtypes.

We do not know the precise role and weight of each brain lesion type in the disability progression in elderly. To target the actual pathological process, we need to disclose the functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies report on functional and clinical abnormalities in patients with pure pathologies. Thus, co-morbid processes involved in the transition from an independent functional status to disability in the elderly with co-lesions still remain to be elucidated. Neuropathological examination often performed at late stages cannot answer this question at mild or moderate stages.

Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible for dementia. The topography of the atrophy in MRI helps to provide information about the etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF biological markers has led recently to their inclusion in the research diagnosis criteria of AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to be the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in other neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial temporal atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF biomarkers seem to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.

The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their combination, that are the most predictive of functional disability in elderly presenting with a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Screening

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Boublay N, Fédérico D, Pesce A, Verny M, Blanc F, Paccalin M, Desmidt T, Grosmaître P, Moreaud O, Relland S, Bravant E, Bouet R, Krolak-Salmon P. Study protocol on Alzheimer's disease and related disorders: focus on clinical and imaging predictive markers in co-existing lesions. BMC Geriatr. 2018 Nov 14;18(1):280. doi: 10.1186/s12877-018-0949-2.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Unknown


title: AnalyST & Brugada Syndrome - Feasibility Study

summary:
Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ECG over a long period of time.

The objective of the study is to evaluate the correlation between ST elevation on the electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled in the study are patients already implanted with a defibrillator for their Brugada syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.

primary_purpose: Diagnostic

lead_sponsor: Abbott Medical Devices

intervention_type: Device


title: Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

acronym: Compli-STARR

summary:
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.

The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.

This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.

Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.

No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.

Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.

The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.

Twenty-eight patients will be enrolled in this study over a period of 36 months.

Preoperative assessment will include

clinical examination
the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.

If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.

primary_purpose: Prevention

lead_sponsor: University Hospital, Rouen


title: Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo

acronym: REA-FO

summary:
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.

We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.

This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.

The purpose of this study is to evaluate the stiffness during open heart surgery.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Caen


type: Other Identifier

title: Impact of Type 1 Diabetes and Glycated Haemoglobin Levels on Oxygen Delivery and Release to Active Muscle During Exercise and on Muscle Oxidation Capacity - Possible Impact on Aerobic Fitness

acronym: OXYDIAB

summary: Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor long term glycaemic control. To explain this relationship, the indirect effect of chronically high blood glucose levels on cardiovascular complications - and hence on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes. Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and use and hence on aerobic fitness.

time_perspective: Cross-Sectional

ReferenceCitation: Lespagnol E, Tagougui S, Fernandez BO, Zerimech F, Matran R, Maboudou P, Berthoin S, Descat A, Kim I, Pawlak-Chaouch M, Boissière J, Boulanger E, Feelisch M, Fontaine P, Heyman E. Circulating biomarkers of nitric oxide bioactivity and impaired muscle vasoreactivity to exercise in adults with uncomplicated type 1 diabetes. Diabetologia. 2021 Feb;64(2):325-338. doi: 10.1007/s00125-020-05329-8. Epub 2020 Nov 21.

ReferenceCitation: Heyman E, Daussin F, Wieczorek V, Caiazzo R, Matran R, Berthon P, Aucouturier J, Berthoin S, Descatoire A, Leclair E, Marais G, Combes A, Fontaine P, Tagougui S. Muscle Oxygen Supply and Use in Type 1 Diabetes, From Ambient Air to the Mitochondrial Respiratory Chain: Is There a Limiting Step? Diabetes Care. 2020 Jan;43(1):209-218. doi: 10.2337/dc19-1125. Epub 2019 Oct 21.

ReferenceCitation: Tagougui S, Fontaine P, Leclair E, Aucouturier J, Matran R, Oussaidene K, Descatoire A, Prieur F, Mucci P, Vambergue A, Baquet G, Heyman E. Regional cerebral hemodynamic response to incremental exercise is blunted in poorly controlled patients with uncomplicated type 1 diabetes. Diabetes Care. 2015 May;38(5):858-67. doi: 10.2337/dc14-1792. Epub 2015 Feb 9.

ReferenceCitation: Tagougui S, Leclair E, Fontaine P, Matran R, Marais G, Aucouturier J, Descatoire A, Vambergue A, Oussaidene K, Baquet G, Heyman E. Muscle oxygen supply impairment during exercise in poorly controlled type 1 diabetes. Med Sci Sports Exerc. 2015 Feb;47(2):231-9. doi: 10.1249/MSS.0000000000000424.

lead_sponsor: University Hospital, Lille

intervention_type: Dietary Supplement


acronym: PROFIL

intervention_type: Drug

title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)

lead_sponsor: University Hospital, Grenoble

type: EudraCT Number

source: euctr

design_allocation: Randomized

ReferenceCitation: Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.

location_facility: Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

summary: The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.


title: Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant

summary:
Kidney transplantation is the treatment of choice for end stage renal disease (ESRD) improving the quantity and quality of life for dialysis patients. Although prolongation of graft survival in the short term by preventing the release is observed by immunosuppression (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a direct deleterious effect on the kidney transplant , but too weak IS can promote rejection, and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function , leading to a loss of the graft followed by a premature return to dialysis in at least 50 % of cases. Plasma BKV reactivation was observed mainly during the first year of transplantation in 15% of patients and complications annually BKVAN concern about 5 % of recipients . Currently , treatment options are very limited , only the decrease in IS shows a partially effective when care is early . There is no specific antiviral effective treatment of this disease . In addition, there is no way to predict which patients will develop BKV reactivation BKVAN despite lower tax.

The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR ( qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV viremia is the direct antiviral immune response quality based primarily on a very effective anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte activation induced by IS blocks the establishment of T-cell responses anti- BKV in most transplant, a very low presence of T lymphocytes is generally observed in these patients anti- BKV (LYT - BKV) blood .

Our preliminary studies have validated in vitro a sensitive test to measure the functionality of blood LYT - BKV. This test is used to evaluate the concentration and functionality of LYT - BKV present in small volume of blood by measuring their specific proliferation after stimulation with peptide cocktails BKV. Proof of concept of the feasibility of this test was established on a small series of samples and highlights significant differences in lymphocyte anti-BKV different patients.

Put to good use during the post-transplant follow-up, this type of test can provide the clinician with valuable data to assess the quality of anti- BKV T response compared to the intensity and type of IS treatment. Early identification of patients at risk of reactivation of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response and monitoring arrangements at the fair. The objective of this project is to conduct a feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T response of BKV viremic patients during the first year post- transplant. Immunological data will be analyzed in relation to virological data and bioclinical data.

study_start_date_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Other


title: A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

acronym: SEVOBURN

summary: Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

design_allocation: Non-Randomized

ReferenceCitation: Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.

acronym: TOUTETDOU

summary:
The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches.

In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children.

In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale > or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Limoges


title: Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure

summary:
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.

In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

acronym: PITA 3

summary: The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy

ReferenceCitation: Michaud E, Evrard B, Pereira B, Rochette E, Bernard L, Rouzaire PO, Gourdon-Dubois N, Merlin E, Fauquert JL. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y.


title: Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients

summary:
Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes.
We also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably SREBP factors. The activation of these factors could cause an increase in the expression of LDL receptors, leading to increased LDL catabolism.
Chronological description of the study During an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. Once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).

As well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1, Apolipoprotein A - II).

IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.


summary: Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors

ReferenceCitation: Lemetais G, Melander O, Vecchio M, Bottin JH, Enhörning S, Perrier ET. Effect of increased water intake on plasma copeptin in healthy adults. Eur J Nutr. 2018 Aug;57(5):1883-1890. doi: 10.1007/s00394-017-1471-6. Epub 2017 Jun 3.

lead_sponsor: Danone Research


title: A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

acronym: CABA-DOC

summary:
Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles.

Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting.

The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib.

A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future.

Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.

primary_purpose: Other

ReferenceCitation: Baciarello G, Delva R, Gravis G, Tazi Y, Beuzeboc P, Gross-Goupil M, Bompas E, Joly F, Greilsamer C, Hon TNT, Barthelemy P, Culine S, Berdah JF, Deblock M, Ratta R, Flechon A, Cheneau C, Maillard A, Martineau G, Borget I, Fizazi K; Groupe d'Etude des Tumeurs Uro-Genitales (GETUG). Patient Preference Between Cabazitaxel and Docetaxel for First-line Chemotherapy in Metastatic Castration-resistant Prostate Cancer: The CABADOC Trial. Eur Urol. 2022 Mar;81(3):234-240. doi: 10.1016/j.eururo.2021.10.016. Epub 2021 Nov 14.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)

summary:
The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.

the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.

summary: HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.

time_perspective: Retrospective

ReferenceCitation: Sellier PO, Maylin S, Brichler S, Berçot B, Lopes A, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Evans J, Gordien E, Simon F, Bergmann JF. Hepatitis B Virus-Hepatitis D Virus mother-to-child co-transmission: A retrospective study in a developed country. Liver Int. 2018 Apr;38(4):611-618. doi: 10.1111/liv.13556. Epub 2017 Sep 12.

ipd_sharing: No

lead_sponsor: Hopital Lariboisière


title: Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.

summary: Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.


title: Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics

summary:
Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they lower blood glucose level (by enhancement of glucose-dependent insulin secretion and suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease systolic blood pressure, improve endothelial function and have beneficial effects on myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on myocardial function in type 2 obese diabetic.

Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1) receptor agonist in obese diabetics on myocardial TG content.

Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an important risk factor for cardiac diseases. We and others have already evidenced a correlation between the volume of epicardial adipose tissue and the presence or the severity of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of EAT is mostly unknown.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

acronym: CISEVOB

summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients


title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

acronym: SEVOKID

summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure


title: Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty

summary:
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".

To this end, the study will take place as follows:

Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis

ReferenceCitation: Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.


title: TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression

acronym: TMSFOS

summary:
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000].

According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe:

either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment,
or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment.

In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if:

this genetic effect is specific to rTMS or common rTMS and medical antidepressants
this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants
this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression)
the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.


title: STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY

summary:
Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.


title: Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

summary:
This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.


title: Interest of Preoperative Immunonutrition in Liver Resection for Cancer

acronym: PROPILS

summary: To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.

ReferenceCitation: Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire


title: Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy

acronym: SHEARWAVE

summary: The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

intervention_type: Procedure


title: Evaluating the Impact of Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation (KVNI) Pilot Study

acronym: KVNI

summary:
The main objective is to show by a randomised controled therapeutic trial comparing in two parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the duration of non invasive respiratory support in the group treated by chest physiotherapy as compared to the control group. The secondary objectives are to evaluate the duration of oxygen dependence, the duration of hospitalisation and the proportional advent of bronchopulmonary dysplasia.

These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic, treated by non invasive respiratory support after weaning off from mechanical endotracheal ventilation benefitting form a social security system and for whom the appropriate parental authority are non opposed.


title: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

acronym: SAMIRA

summary: Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

intervention_type: Biological


title: Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors

acronym: HASIPRO

summary: The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.


title: Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.

acronym: CLASH

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.

In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.

This study is a prospective, cross-sectional study in exercise pathophysiology.

The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.

Secondary goals are :

To determine the nature of the relationship between the recovery duration and subsequent walking performance.
To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
To study the influence of recovery duration on walking capacity from community-based measurement.

lead_sponsor: Rennes University Hospital


title: Assessment of the the ETView Double-lumen Tube

summary: The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

status: Terminated

lead_sponsor: Hopital Foch


title: Evaluation of the Interest of a Nurse-implemented Sedation Protocol for the Reduction of the Duration of Mechanical Ventilation Complication Associated With Extended Sedation in Pediatric Intensive Care Unit.

acronym: PEDIASED

summary:
Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.

An inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.

We hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.

lead_sponsor: Nantes University Hospital


title: Phase I, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Tremelimumab in Combination With Gefitinib in EGFR Mutant NSCLC Patients

acronym: GEFTREM

summary:
This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to establish a recommended phase 2 dose. Secondary objectives include evaluation of, pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab combination. The exploratory objectives are to evaluate biomarkers that may correlate with activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.

The biological rationale for such a study is that even though the disease is progressing it is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover, patients may have received chemotherapy and the likelihood of chemosensitivity is very low. So, the association of Gefitinib with immune checkpoint blockade is very attractive and may result in clinical benefit in NSCLC with EGFRmut.

ReferenceCitation: Riudavets M, Naigeon M, Texier M, Dorta M, Barlesi F, Mazieres J, Varga A, Cassard L, Boselli L, Grivel J, NgoCamus M, Lacroix L, Mezquita L, Besse B, Chaput N, Planchard D. Gefitinib plus tremelimumab combination in refractory non-small cell lung cancer patients harbouring EGFR mutations: The GEFTREM phase I trial. Lung Cancer. 2022 Apr;166:255-264. doi: 10.1016/j.lungcan.2021.11.018. Epub 2021 Dec 3.


title: Phase I/II Open-label Randomized Multicenter Trial to Assess Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates (MVA HIV-B/ LIPO-5; LIPO-5/MVA HIV-B; GTU®-MultiHIV B / LIPO-5; GTU®-MultiHIV B/MVA HIV-B) in Healthy Volunteers at Low Risk of HIV Infection

summary: The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus relevant to pursue the development of different candidate vaccines in prime-boost vaccine strategies to identify the most promising prime-boost combinations and to integrate scientific inquiry into trial protocols from the beginning to maximize learning opportunities.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Immunologie Clinique 51, avenue du Marechal de Lattre de Tassigny


title: Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

acronym: CompensationPD

summary: Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer


title: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.

summary:
Purpose:

Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
Comparison of the ultrasound semiology of enthesitis in the 3 populations
Comparison of the MASEI scores in the 3 populations


title: Clinico-biological Correlation of Severe Asthma in Children

summary:
Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli.

Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation.

Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.


title: Implementation of Innovative Techniques in Routine Diagnosis of Childhood Acute Leukemia: Analysis of Genome and Transcriptome by Micro-array

summary:
Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid lineage. The repertoire of mutations that determine the leukemic transformation, complex and variable depending on the tumor type and progression of the disease, combined in the same cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic abnormalities.

The project presented here is part of a comprehensive approach to diagnosis of hematologic malignancies of children. Using comparative genomic hybridization on microarray (or array- CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive analysis of the genome and transcriptome , offer new perspectives identifying molecular defects . These techniques provide new elements in the identification of acute leukemia at diagnosis may identify new prognostic factors to optimize the care of patients.

This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the identification of genomic abnormalities associated with childhood leukemia , the Laboratory of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow of children with hematologic malignancies . The following project is mainly focused on the identification of genomic abnormalities (deletions and duplications) and abnormalities in gene expression to identify a genetic profile ensuring a better classification within the different groups risk .

The project we propose is centered on the identification of genomic abnormalities , changing the number of copies of certain regions of the genome or determining loss of heterozygosity , and the identification of changes in the level of gene expression by using two analytical techniques, comparative genomic hybridization on microarray (or array- CGH) and expression studies with microarrays . The data generated will , for the identification of " molecular signatures " , the classification of patients according to prognosis , variations in treatment response and survival.

The originality of this project lies in the use of these new tools in the diagnosis of hematological malignancies in children. This pilot study will be conducted with commercial Affymetrix , will develop the chips ' processing' , dedicated , enriched probes corresponding to genes involved in leukemogenesis , with high discriminatory power in identifying these signatures.

The data published in the specialized literature from the study of large series of patients show that microarrays provide important information for the diagnosis and therapeutic management of patients. It is for this reason that in the end we hope to integrate these analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of fusion genes and sequencing) in order to further characterize the abnormal cells leukemia and establish an " identity card of leukemia .

location_facility: Assistance Publique Hôpitaux de Marseille


title: Persistent Platelet Reactivity in Acute Coronary Syndrome

summary: Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

location_facility: Department of Cardiology - Lariboisiere Hospital


title: Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

acronym: Cognides

summary:
The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.


title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

summary: The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

ReferenceCitation: Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.

lead_sponsor: University Hospital, Toulouse


title: Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers

acronym: APELINS

summary:
The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.

ReferenceType: result

ReferenceCitation: Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.


title: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

summary: The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.

intervention_type: Behavioral


title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

acronym: RESPPEDHEM

summary: Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.


acronym: SEDULC

summary: The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

ReferenceCitation: Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Lainé F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.

lead_sponsor: Institute For European Expertise in Physiology

location_facility: Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes


title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

acronym: Etaplus

summary: The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis


title: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People

acronym: REFLEX-IR

summary:
It is known that the care that is offered to overweigh of class I obese people leads to an initial weight loss.

However, after 12 months, people start to gain their weight back. French National Authority for Health suggests that physicians warn their patients against restrictive diets that can are the origin of weight's fluctuation can be health threatening. This weight regain is linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf, 2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).

Due to the difficulties to keep the weight loss, it seems interesting to consider alternatives like reflexotherapy. This method seems to act in reducing the dietary urges causes by stress, by cravings or by frustration.

This technique would allow to re-establish normal hormones' or neurotransmitters' concentrations mainly involved in the food intake.

This could be a complementary response to the limits of the classic treatments for weight maintenance management, but it needs to be confirmed by a specific study.

lead_sponsor: Institut Pasteur de Lille


title: Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study

acronym: epigac

summary:
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.

We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.


title: Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

summary:
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.

The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.

The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.

ReferenceCitation: Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.


title: LIDA-B: Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

summary:
Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function.

The rationale for this treatment can be resumed as follows:

HCC are vascularised via the hepatic artery system
The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations
The absence of embolisation reduces toxicity
the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia
idarubicin is the most cytotoxic drug for tumor cell lines.
The in vitro cytotoxicity of idarubicin is 100% at low concentrations
Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug
The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection
The emulsion is more stable with idarubicin than with other anticancer molecules
Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.


title: Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study

acronym: Fijus Raisol

summary:
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.

The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.


title: Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion

acronym: EMPHILINE

summary: The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.

lead_sponsor: University Hospital, Tours


title: Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma

acronym: HR MB-5

summary:
The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase II trial, and ii) a dose-finding part.

The Phase II trial is an open label, non-randomized, multicentre trial without control group. A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in the trial will be recorded, the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes' theorem, which yields an estimated EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim analyses are planned to monitor the efficacy data (early stopping rules for futility or inefficacy).

The final analysis of efficacy will be made on an intention to treat basis, including all recruited patients, 3 years after recruitment of the last patient.

Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment, a dose-finding subtrial will be performed to address this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework.

status: Active, not recruiting

status_simplified: Ongoing


type: Registry Identifier

title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

lead_sponsor: Laboratoires Thea


title: Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics

acronym: FAMYLY

summary: Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

ReferenceCitation: Gyan E, Pigneux A, Hunault M, Peterlin P, Carré M, Bay JO, Bonmati C, Gallego-Hernanz MP, Lioure B, Bertrand P, Vallet N, Ternant D, Darrouzain F, Picou F, Béné MC, Récher C, Hérault O. Adjunction of a fish oil emulsion to cytarabine and daunorubicin induction chemotherapy in high-risk AML. Sci Rep. 2022 Jun 13;12(1):9748. doi: 10.1038/s41598-022-13626-y.

ReferenceCitation: Picou F, Debeissat C, Bourgeais J, Gallay N, Ferrié E, Foucault A, Ravalet N, Maciejewski A, Vallet N, Ducrocq E, Haddaoui L, Domenech J, Hérault O, Gyan E. n-3 Polyunsaturated fatty acids induce acute myeloid leukemia cell death associated with mitochondrial glycolytic switch and Nrf2 pathway activation. Pharmacol Res. 2018 Oct;136:45-55. doi: 10.1016/j.phrs.2018.08.015. Epub 2018 Aug 22.

ReferenceCitation: Gyan E, Raynard B, Durand JP, Lacau Saint Guily J, Gouy S, Movschin ML, Khemissa F, Flori N, Oziel-Taieb S, Bannier Braticevic C, Zeanandin G, Hebert C, Savinelli F, Goldwasser F, Hébuterne X; NutriCancer2012 Investigator Group. Malnutrition in Patients With Cancer: Comparison of Perceptions by Patients, Relatives, and Physicians-Results of the NutriCancer2012 Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):255-260. doi: 10.1177/0148607116688881. Epub 2017 Dec 11.

lead_sponsor: French Innovative Leukemia Organisation


title: Prospective Monocentric Study on the Efficacy of Lidocain Spray for Patient Comfort During Nasogastric Tube Insertion in Enteral Nutrition: the Xylonut Trial

acronym: Xylonut

summary:
Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.

The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.

The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Hypertension of Our Patients: Knowledge, Control, Comorbidity

summary:
Numerous studies highlight the insufficiency of blood pressure control in treated hypertensive population [1].

As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared to other french regions. The incidence and prevalence of diabetes and obesity are likely explanatory factors leading to this excess mortality [2].

Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure (ESRD) is also higher than the national average. The high prevalence of diabetes, hypertension and obesity in this population is also probably responsible for the high prevalence of ESRD [3].

Opportunities to prevent the progression of kidney disease involve an optimal control of treatable evolutionary factors.

Beyond control of diabetes and obesity, optimization of blood pressure control are an important factor to consider, as national and international guidelines recommend lower blood pressure targets in this population [4]. Knowledge of the disease and treatment goals are a key component of hypertensive patient management. Studies have shown that the knowledge of hypertensive disease and therapeutic targets were correlated with treatment compliance and with the rate of blood pressure control [5]. Patient education and participation of non-medical actors (nurses, pharmacists, …) are likely to improve the management and treatment compliance of these patients [6]. To our knowledge, no investigation has been performed in our region to determine the epidemiological characteristics, the knowledge level and blood pressure control in the population of hypertensive patients. The main objectives of this observational study are to evaluate, in a treated hypertensive population:

the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on this blood pressure control, the potential impact of the patient's comorbidities on his blood pressure control.

Such a study should provide the basis for the feasibility of a large survey.

ReferenceType: background

ReferenceCitation: Mancia G, Sega R, Milesi C, Cesana G, Zanchetti A. Blood-pressure control in the hypertensive population. Lancet. 1997 Feb 15;349(9050):454-7.

ReferenceCitation: Bérard E, Bongard V, Arveiler D, Amouyel P, Wagner A, Dallongeville J, Haas B, Cottel D, Ruidavets JB, Ferrières J. Ten-year risk of all-cause mortality: assessment of a risk prediction algorithm in a French general population. Eur J Epidemiol. 2011 May;26(5):359-68. doi: 10.1007/s10654-010-9541-6. Epub 2010 Dec 28.

ReferenceCitation: Registre REIN Rapport annuel 2010

ReferenceCitation: Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clément D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468.

ReferenceCitation: Atallah A, Papouin G, Mimran C, Braunstein C, Ganty J, Larifla L, Djaballah K, Inamo J. [Knowledge of hypertension among hypertensive patients in general practice, and its relation to achieving therapeutic goals: The Co-HACT study, French West Indies]. Ann Cardiol Angeiol (Paris). 2011 Feb;60(1):21-6. doi: 10.1016/j.ancard.2010.06.001. Epub 2010 Jul 16. French.

ReferenceCitation: M Ashok Kumar. Improving medication adherence and clinical outcomes of hypertensive patients through patient counseling. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2011; 2: 232-241

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.

summary: Recent studies show that overweight people have a greater sensitivity to the rewarding aspect of food due to the disturbance of the dopaminergic system. These perturbations lead to a greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food would also facilitate food intake related to emotions, whether they are positive or negative. However, the food intake in response to emotions can be modulated by physical activity. But, there are no interventional studies in the literature examining the behavioral and biological factors related to emotional eating together with the fact, there are few data on the explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of emotional eating 6 months after a behavior change program adapted to the motivational state and to identify the its underlying mechanisms

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier-Hopital La colombière


title: Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project

acronym: TOY

summary:
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Other teams have suggested treating these allergies (in particular peanut allergies) by controlled and progressive reintroduction of the allergenic food. A good tolerance and a prevention of allergic reactions consecutive to the ingestion of the same allergenic food were observed. The immunological mechanisms of this type of treatment are not well known.

A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg allergies after this kind of treatment. Certain experiments realized in mice models testing the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating allergies by the reintroduction of the allergenic food, the immunological mechanism of acquisition of tolerance is associated to variations in populations of lymphocytes and in the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children without antecedents of allergy or familiar atopy.

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: The Proposed Study is to Validate a New Non-invasive Imaging Technique for Evaluation of Cardiac Microciculation in Coronary Artery Disease With a Comparison With Validated Technique Invasive, Which is Measure of Index of Myocardial Resistance

acronym: EVACORY

summary: The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

lead_sponsor: University Hospital, Grenoble


title: Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients

summary: The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.

primary_purpose: Health Services Research

ReferenceCitation: Deschamps T, Thomas-Ollivier V, Sauvaget A, Bulteau S, Fortes-Bourbousson M, Vachon H. Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study. Gait Posture. 2015 Oct;42(4):590-3. doi: 10.1016/j.gaitpost.2015.07.057. Epub 2015 Jul 31.

lead_sponsor: Laboratory Motricité, Interactions, Performance


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities

summary: The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine Auvergne


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities in Free-living Conditions (eMouve 2)

summary: The aim of this study was to validate functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.


title: A Cohort to Quantify and to Predict Treatment Related Chronic Toxicities in Patients With Non-metastatic Breast Cancer

acronym: CANTO

summary:
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic breast cancer.

The project will include four specific aims :

To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
To describe incidence, clinical presentation, and outcome of chronic toxicities over a maximum of 8 years.
To describe the psychological, the social and the economic impacts of chronic toxicities.
To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.

The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.

Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)

status: Recruiting

ReferenceCitation: Soldato D, Havas J, Crane TE, Presti D, Lapidari P, Rassy N, Pistilli B, Martin E, Del Mastro L, Martin AL, Jacquet A, Coutant C, Cottu P, Merimeche A, Lerebours F, Tredan O, Vanlemmens L, André F, Vaz-Luis I, Di Meglio A. Coffee and tea consumption, patient-reported, and clinical outcomes in a longitudinal study of patients with breast cancer. Cancer. 2022 Oct 1;128(19):3552-3563. doi: 10.1002/cncr.34401. Epub 2022 Aug 1.

ReferenceCitation: Presti D, Havas J, Soldato D, Lapidari P, Martin E, Pistilli B, Jouannaud C, Emile G, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Campone M, Guillermet S, Martin AL, Everhard S, Di Meglio A. Factors associated with enrolment in clinical trials among women with early-stage breast cancer. ESMO Open. 2022 Jun;7(3):100513. doi: 10.1016/j.esmoop.2022.100513. Epub 2022 Jun 17.

ReferenceCitation: Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.

ReferenceCitation: Di Meglio A, Havas J, Gbenou AS, Martin E, El-Mouhebb M, Pistilli B, Menvielle G, Dumas A, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Joly F, Delaloge S, Ganz PA, André F, Partridge AH, Jones LW, Michiels S, Vaz-Luis I. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy. J Clin Oncol. 2022 Sep 20;40(27):3190-3204. doi: 10.1200/JCO.21.00277. Epub 2022 Apr 21.

ReferenceCitation: Vaz-Luis I, Di Meglio A, Havas J, El-Mouhebb M, Lapidari P, Presti D, Soldato D, Pistilli B, Dumas A, Menvielle G, Charles C, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Dauchy S, Delaloge S, Lin NU, Ganz PA, Partridge AH, André F, Michiels S. Long-Term Longitudinal Patterns of Patient-Reported Fatigue After Breast Cancer: A Group-Based Trajectory Analysis. J Clin Oncol. 2022 Jul 1;40(19):2148-2162. doi: 10.1200/JCO.21.01958. Epub 2022 Mar 15.

ReferenceCitation: Di Meglio A, Charles C, Martin E, Havas J, Gbenou A, Flaysakier JD, Martin AL, Everhard S, Laas E, Chopin N, Vanlemmens L, Jouannaud C, Levy C, Rigal O, Fournier M, Soulie P, Scotte F, Pistilli B, Dumas A, Menvielle G, André F, Michiels S, Dauchy S, Vaz-Luis I. Uptake of Recommendations for Posttreatment Cancer-Related Fatigue Among Breast Cancer Survivors. J Natl Compr Canc Netw. 2022 Feb 7:1-13. doi: 10.6004/jnccn.2021.7051. [Epub ahead of print]

ReferenceCitation: Di Meglio A, Havas J, Soldato D, Presti D, Martin E, Pistilli B, Menvielle G, Dumas A, Charles C, Everhard S, Martin AL, Coutant C, Tarpin C, Vanlemmens L, Levy C, Rigal O, Delaloge S, Lin NU, Ganz PA, Partridge AH, André F, Michiels S, Vaz-Luis I. Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care. J Clin Oncol. 2022 Apr 1;40(10):1111-1123. doi: 10.1200/JCO.21.01252. Epub 2022 Jan 21.

ReferenceCitation: Caumette E, Vaz-Luis I, Pinto S, Havas J, Bovagnet T, Ruiz de Azua G, Di Meglio A, Martin AL, Everhard S, Cottu P, Vanlemmens L, Jouannaud C, Lerebours F, Dumas A, Menvielle G. The Challenge of Return to Work after Breast Cancer: The Role of Family Situation, CANTO Cohort. Curr Oncol. 2021 Oct 1;28(5):3866-3875. doi: 10.3390/curroncol28050330.

ReferenceCitation: Di Meglio A, Gbenou AS, Martin E, Pistilli B, Ligibel JA, Crane TE, Flaysakier JD, Minvielle E, Vanlemmens L, Guenancia C, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Boiffard F, Guillermet S, Everhard S, Martin AL, Giacchetti S, Petit T, Dalenc F, Rouanet P, Arnaud A, Andre F, Vaz-Luis I. Unhealthy behaviors after breast cancer: Capitalizing on a teachable moment to promote lifestyle improvements. Cancer. 2021 Aug 1;127(15):2774-2787. doi: 10.1002/cncr.33565. Epub 2021 Apr 22.

ReferenceCitation: Di Meglio A, Menvielle G, Dumas A, Gbenou A, Pinto S, Bovagnet T, Martin E, Ferreira AR, Vanlemmens L, Arsene O, Ibrahim M, Wassermann J, Martin AL, Lemonnier J, Del Mastro L, Jones LW, Partridge AH, Ligibel JA, Andre F, Michiels S, Vaz Luis I. Body weight and return to work among survivors of early-stage breast cancer. ESMO Open. 2020 Nov;5(6):e000908. doi: 10.1136/esmoopen-2020-000908.

ReferenceCitation: Pistilli B, Paci A, Ferreira AR, Di Meglio A, Poinsignon V, Bardet A, Menvielle G, Dumas A, Pinto S, Dauchy S, Fasse L, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Jouannaud C, Levy C, Everhard S, Arveux P, Martin AL, Dima A, Lin NU, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Serum Detection of Nonadherence to Adjuvant Tamoxifen and Breast Cancer Recurrence Risk. J Clin Oncol. 2020 Aug 20;38(24):2762-2772. doi: 10.1200/JCO.19.01758. Epub 2020 Jun 22.

ReferenceCitation: Kaboré EG, Guenancia C, Vaz-Luis I, Di Meglio A, Pistilli B, Coutant C, Cottu P, Lesur A, Petit T, Dalenc F, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Boileau-Jolimoy G, Martin AL, Lemonnier J, André F, Arveux P. Association of body mass index and cardiotoxicity related to anthracyclines and trastuzumab in early breast cancer: French CANTO cohort study. PLoS Med. 2019 Dec 23;16(12):e1002989. doi: 10.1371/journal.pmed.1002989. eCollection 2019 Dec.

ReferenceCitation: Ferreira AR, Di Meglio A, Pistilli B, Gbenou AS, El-Mouhebb M, Dauchy S, Charles C, Joly F, Everhard S, Lambertini M, Coutant C, Cottu P, Lerebours F, Petit T, Dalenc F, Rouanet P, Arnaud A, Martin A, Berille J, Ganz PA, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Differential impact of endocrine therapy and chemotherapy on quality of life of breast cancer survivors: a prospective patient-reported outcomes analysis. Ann Oncol. 2019 Nov 1;30(11):1784-1795. doi: 10.1093/annonc/mdz298.

ipd_sharing: Yes

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER


title: Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis

acronym: PAG

summary: Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).

location_facility: Odontology Department, Nice Unversity Hospital


title: Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement

summary: The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in the evaluation of the experimental sensitivity to mechanical pain (pressure application on the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days), and to put the results in relation to the clinical improvement and the psychometric evaluations (depression,fibromyalgia impact questionnaire, catastrophism).

lead_sponsor: Centre Hospitalier Esquirol


title: Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center

acronym: OCAR

summary: The purpose of this study is to measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls.

lead_sponsor: Fire Brigade Of Paris Emergency Medicine Dept


title: Etude de l'Expression Des Micro-RNA Comme Biomarqueur Diagnostic et Pronostic Dans la Sclérose Latérale Amyotrophique

acronym: MIRSLA

summary: The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and blood sample) collected in three control populations: definite ALS patients according to El Escorial diagnostic criterion, control patients without any neurological disease having an orthopedic surgery for shoulder disease, and control patient explored for peripheral neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity and/or progression rate of the motor neurons define as the progression rate of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.

lead_sponsor: University Hospital, Bordeaux


title: A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

acronym: INPAKT

summary: In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different tumor types with molecular alterations. This may validate the anti-tumor activity of the LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.

ReferenceCitation: Angevin E, Cassier PA, Italiano A, Gonçalves A, Gazzah A, Terret C, Toulmonde M, Gravis G, Varga A, Parlavecchio C, Paci A, Poinsignon V, Soria JC, Drubay D, Hollebecque A. Safety, tolerability and antitumour activity of LY2780301 (p70S6K/AKT inhibitor) in combination with gemcitabine in molecularly selected patients with advanced or metastatic cancer: a phase IB dose escalation study. Eur J Cancer. 2017 Sep;83:194-202. doi: 10.1016/j.ejca.2017.06.036. Epub 2017 Jul 24.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.

summary:
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.

The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.

Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.

The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.

lead_sponsor: Assistance Publique Hopitaux De Marseille


summary: The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).


title: Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

summary: Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

lead_sponsor: Hospital Ambroise Paré Paris