title: Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA

acronym: SCHIZO'TRAUMA

summary:
Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia.

In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic patients and 30 healthy volunteers, the investigators shown a negative correlation between emotional neglect (important dimension in childhood trauma) and grey matter decrease. This strong correlation was significantly higher in schizophrenic patients than in healthy volunteers, suggesting a higher genetic predisposition to environmental factors in schizophrenic people.

Currently, interaction between genetic predisposition and environmental stress factors is the major model for understanding in schizophrenia. In order to analyze both effects on human body, particularly on brain, several studies currently focus on the product of genetic expression, the ribonucleic acid (ARN).

The purpose of this study is to provide an explanatory model of links between childhood trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic symptomatology. Using conceptual framework of stress vulnerability, structural equation modeling (SEM) will allow testing causal link between these different variables.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluate the Impact of the "Standing Patient" Pathway on Preoperative Anxiety.

acronym: ANXIPADE

summary:
For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to bring about a global care of the patient by establishing a safe and quality climate. With this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "Fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room.

The ambulatory surgery department of the CHU of Caen welcomes and supports adults and children over 8 years old. The following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since December 2015. It seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and not dependent, he is accompanied and not taken away. The preservation of autonomy improves their feelings, especially in terms of dignity. It also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up.

However, studies reporting the benefit of this technique have rather evaluated the feelings of patients. To the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with appropriate tools seems essential to determine a real impact.

We hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. We have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. We propose to carry out a randomized study comparing the anxiety score using the APAIS scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater.

The duration of this study is evaluated at 2 years.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom

acronym: STOUT

summary:
The measurement of the transcutaneous oxygen partial pressure (TCPO2) at exercise is, to our knowledge, the only method to estimate during the exercise the importance of ischemia segment of limb by segment of limb bilaterally and carry on. The diagnosis of thoracic outlet syndrome causing remains difficult and dependent operator in ultrasound because of the risk of false positive (loss of signal) or false negative (insufficient effort, inappropriate movement).

Our main hypothesis is the existence of significant measurable ischemia in the forearm by transcutaneous oximetry during the maneuvering of the "candlestick".

In the event of failure of this maneuver, the other maneuvers such as those of Wright, Roos, Tinel and Adson will be realized.

In this study we want to evaluate the possibility of using dynamic transcutaneous Oximetry as a tool for evaluating ischemia in case of suspicion of thoracic outlet syndrome causing.

study_start_date_type: Actual

status: Active, not recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hersant J, Ramondou P, Guilleron C, Picquet J, Henni S, Abraham P. A pilot study of forearm microvascular impairment and pain while using a telephone. Microvasc Res. 2020 May;129:103963. doi: 10.1016/j.mvr.2019.103963. Epub 2019 Nov 29.

lead_sponsor: University Hospital, Angers

status_simplified: Ongoing


type: Other Identifier

title: Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients

acronym: EXSUFLOW

summary:
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. The use of cough assistance is therefore essential in order to avoid acute situations such as bronchial superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique commonly used by therapists in a hospital or at the patient's home in order to facilitate the airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point because it conditions the effectiveness of the generated cough. It'is important to take into account the presence of any collapse in the use of IM / E in order to ensure the most effective cough given by the patient. Actually, except the common impression of the physiotherapist and the patient, there is no "simple" way for detecting and objectifying the threshold of collapse in the upper airways.

The aim of this study is to compare two modalities for the regulation of the level of the MI-E exsufflation, taking into account the presence of a collapse: a subjective "S" adjustment based on the clinical judgment of the therapist and the patient and an objective "O" adjustment based on the flow-volume curve generated during the cough.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Physiology and Functional Explorations, Raymond Poincaré Hospital


title: Efficacy of Long-term Parenteral Nutrition With SmofKabiven® E Concomitant to Chemo- and/or Immunotherapy: A Prospective, Randomised, Controlled, Open, Multicentre, Two-stage, Adaptive Clinical Trial in Metastatic Non-small Cell Lung Cancer

summary: The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Supportive Care

lead_sponsor: Fresenius Kabi

intervention_type: Drug

lead_sponsor_type: industriel


title: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.

summary:
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.

This new protocole was introduced in Montpellier University Hospital delivery room.

The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.

status: Completed

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

acronym: NAUVOLA

summary:
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.

We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Automatization of Counting Procedures in Children With Dyscalculia

acronym: PROCEDYS

summary: Researchers in numerical cognition usually think that the greatest and most common difficulty in children suffering from dyscalculia is retrieval of arithmetic facts from long-term memory. However, we have recently shown that retrieval might not be the optimum strategy in mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by automated and unconscious procedures. Therefore, we hypothesize that children with dyscalculia might not present deficit in retrieval but, instead, in counting procedure automatization. The aim of the current project is to test this challenging position. Through a longitudinal approach, we plan to precisely examine the behavior of children suffering from dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the beginning of the study and we will precisely observe the evolution of their solution times when they solve simple addition problems involving one-digit numbers. If children with dyscalculia still struggle with simple additions three years, their solution times plotted on the sum of the problems should still follow an exponential function. Indeed, if counting is not automated, difficulties necessarily increase with the progression on the number line or the verbal sequence, hence the exponential function. On the contrary, if counting procedures tend towards automatization, moves along a number line will progressively become as easy at the beginning of the line as at the end, hence the linear function. Importantly, a retrieval model would predict exactly the inverse pattern because, according to this model, the linear function, which is unanimously considered as the hallmark of counting procedures, should progressively be replaced by a non-linear function through practice.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life

acronym: NAP-REA

summary: The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.


title: Intervention Study to Identify Biomarkers of Processed Meat Intake

summary: The intake of processed meat products has been linked to several adverse health outcomes. However, estimation of their intake proves difficult. This study aims at identifying biomarkers of intake for processed meat products in blood and urine. For this, participants of a randomized cross-over dietary intervention will consume highly controlled diets containing non-processed pork, different processed meat products or no meat. Urine and plasma will be collected and analysed to identify sets of metabolites that are specific for the intake of the processed meat products.

primary_purpose: Basic Science

ReferenceCitation: Li C, Imamura F, Wedekind R, Stewart ID, Pietzner M, Wheeler E, Forouhi NG, Langenberg C, Scalbert A, Wareham NJ. Development and validation of a metabolite score for red meat intake: an observational cohort study and randomized controlled dietary intervention. Am J Clin Nutr. 2022 Aug 4;116(2):511-522. doi: 10.1093/ajcn/nqac094.

ReferenceCitation: Wedekind R, Kiss A, Keski-Rahkonen P, Viallon V, Rothwell JA, Cross AJ, Rostgaard-Hansen AL, Sandanger TM, Jakszyn P, Schmidt JA, Pala V, Vermeulen R, Schulze MB, Kühn T, Johnson T, Trichopoulou A, Peppa E, La Vechia C, Masala G, Tumino R, Sacerdote C, Wittenbecher C, de Magistris MS, Dahm CC, Severi G, Mancini FR, Weiderpass E, Gunter MJ, Huybrechts I, Scalbert A. A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood. Am J Clin Nutr. 2020 Aug 1;112(2):381-388. doi: 10.1093/ajcn/nqaa140.

ReferenceCitation: Wedekind R, Keski-Rahkonen P, Robinot N, Viallon V, Ferrari P, Engel E, Boutron-Ruault MC, Mahamat-Saleh Y, Mancini FR, Kühn T, Johnson T, Boeing H, Bergmann M, Karakatsani A, Trichopoulou A, Peppa H, Agnoli C, Santucci de Magistris M, Palli D, Sacerdote C, Tumino R, Gunter MJ, Huybrechts I, Scalbert A. Syringol metabolites as new biomarkers for smoked meat intake. Am J Clin Nutr. 2019 Dec 1;110(6):1424-1433. doi: 10.1093/ajcn/nqz222.

lead_sponsor: International Agency for Research on Cancer


title: Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study

acronym: CAROTEP

summary: This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components


title: Incremental Diagnostic Utility of Systematic Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

acronym: DTOM

summary: Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional "WBS plus single-bed targeted SPECT/CT" strategy.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest


title: Study of Sexual Dysfunction and Place of Sexuality in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne

acronym: SexualDysf

summary: Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop. The investigators conducted an observational multicenter prospective study for descriptive and analytical purposes after approval by the Institutional review board. An anonymous questionnaire was distributed from June 1 to September 1, 2017 in patients participating in a cardiac rehabilitation program in the various centers in the region.

time_perspective: Cross-Sectional

lead_sponsor: CHU de Reims


title: Are the Patients Having Pets at Greater Risk of Carrying Multidrug Resistance Bacteriae?

acronym: BRANITRANS

summary:
Introduction : The multidrug resistance (MDR) Bacteriae are growing and are a public health problem. The known risk factors to be expanding of MDR Bacteriae are: taken antibiotics, hospitalization, journey in a country at risk. Other risk factors are emitted in hypothesis as the presence of pets.

Aim : The primary objective is to study the association between the presence of a pet and the presence of a MDR bacteria. Methods : Cross sectional study will be performed in Reims University hospital in internal medicine ward.

status: Recruiting


type: Registry Identifier

title: Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach

acronym: SSParaDia

summary: Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: Gastric Assessment in Ambulatory Surgery : a Prospective Study

acronym: GAAS

summary:
The surgical procedures in outpatient surgery are in perpetual increase. However, the peri operative stress can reduce the gastric emptying. A patient's compliance for following the fasting rules cannot be controlled at home. Ambulatory surgery is currently proposed to fragile patients with many comorbidities known to slow gastric emptying. In day case surgery the airway management are often managed with supraglottic device ( laryngeal mask). This device does not protect the respiratory tract and may expose the patient to a risk of inhalation of gastric content (if not empty).

This study aim to mesure the prevalence of full stomachs in outpatient surgery and to observe any changes in anesthetic management secondary to the ultrasound assessment of gastric content. It will confront theoretical full stomach risk factors with ultrasound findings. The practical and clinical relevance of such a technique in the context of outpatient surgery will be assessed in this study. The ultimate goal is to improve the safety of the patient's anesthetic management by controlling the risk of pulmonary aspiration.


title: Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies

acronym: SAFARI

summary:
Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab

intervention_type: Biological


title: Evaluation of the Effect of Sensory Imagination on Choice of Food Portion Size in School-aged Children

summary: The objective of this intervention is to evaluate the effect of sensory imagination (i.e., imagining the sensory properties of an object) on the choice of food portion size in school-aged children. Previous research showed that it may help children to choose smaller portion size. The investigators would like to assess whether this effect can be reproduced with two types of food (one with a high energy-density and one with a low energy-density), and in older children.

ReferenceType: background

ReferenceCitation: Cornil Y and Chandon P (2016) Pleasure as a Substitute for Size: How Multisensory Imagery Can Make People Happier with Smaller Food Portions. Journal of Marketing Research: October 2016, Vol. 53, No. 5, pp. 847-864. https://doi.org/10.1509/jmr.14.0299

ReferenceCitation: Lange C, Schwartz C, Hachefa C, Cornil Y, Nicklaus S, Chandon P. Portion size selection in children: Effect of sensory imagery for snacks varying in energy density. Appetite. 2020 Jul 1;150:104656. doi: 10.1016/j.appet.2020.104656. Epub 2020 Mar 9.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery

acronym: SWEEPING

summary:
Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is altered.

ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.

Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.

The investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma.

The investigator will evaluate visual and optical coherence tomography improvement after surgery.

ReferenceCitation: Azuma K, Ueta T, Eguchi S, Aihara M. EFFECTS OF INTERNAL LIMITING MEMBRANE PEELING COMBINED WITH REMOVAL OF IDIOPATHIC EPIRETINAL MEMBRANE: A Systematic Review of Literature and Meta-Analysis. Retina. 2017 Oct;37(10):1813-1819. doi: 10.1097/IAE.0000000000001537. Review.

ReferenceCitation: Fang XL, Tong Y, Zhou YL, Zhao PQ, Wang ZY. Internal limiting membrane peeling or not: a systematic review and meta-analysis of idiopathic macular pucker surgery. Br J Ophthalmol. 2017 Nov;101(11):1535-1541. doi: 10.1136/bjophthalmol-2016-309768. Epub 2017 Mar 17. Review.

ReferenceCitation: Ripandelli G, Scarinci F, Piaggi P, Guidi G, Pileri M, Cupo G, Sartini MS, Parisi V, Baldanzellu S, Giusti C, Nardi M, Stirpe M, Lazzeri S. Macular pucker: to peel or not to peel the internal limiting membrane? A microperimetric response. Retina. 2015 Mar;35(3):498-507. doi: 10.1097/IAE.0000000000000330.

ReferenceCitation: Deltour JB, Grimbert P, Masse H, Lebreton O, Weber M. DETRIMENTAL EFFECTS OF ACTIVE INTERNAL LIMITING MEMBRANE PEELING DURING EPIRETINAL MEMBRANE SURGERY: Microperimetric Analysis. Retina. 2017 Mar;37(3):544-552. doi: 10.1097/IAE.0000000000001179.

lead_sponsor: Nantes University Hospital


title: Prediction of Risk of Hypotension in Hemodialysis

acronym: IMHOTEP

summary: The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.

summary:
The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older.

Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary).

In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches.

In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect


title: Evaluation of the Predictors of Clinical and Radiological Response to Gamma-Knife Radiosurgery in the Treatment of Intermediate Ventral Nucleus of the Thalamus (VIM) Thalamotomy Tremor.

acronym: GARP

summary:
Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM.

Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson tremor).

Clinical and radiological follow-up is demonstrating that 80% of these patients are presenting with a homogenous response complete or subtotal, the disappearance of the tremor mean delay of 6 months after radiosurgery. In neuroradiological responses on the MRI, is appearing roughly at the same time local contrast enhancement surrounding highty to signal no associated with clinical side effects.

In 15 to 20% of the patients, the clinical effets is not obtained and in the vast majority no MRI response or minimal MRI response is observed on images suggesting that these failures are related to specific resistance to radiosurgery of this subgroup.

In roughly 5% of the patients, at the contrary, hyper response is observe on the MRI rating clinically with side effects (hemiparesis or proprioceptive ataxia or dysarthria, hands problems….). The adverse effects are generally reversible either in whole or in part with the resorption of the perilesionnel oedema.

It would be extremely helpfull to be able to identify in advance these 2 groups of hyper and hypo respondeurs.

The capacity to identify in advance these patients at risk to hypo or hyper response would allow us to either contre-indicate radiosurgery or modify radiosurgery technicaly at the time of dose planing.

Sequently, these predictions would allow us to tailor individually mission management and information leading to improvment of the efficacy and tolerance of this kind of intervention.

The parameters suspected to be likely to influence the response are :

genetics
co-morbidities (diabetis, vascular…)
Main aspect of the brain (severe atrophy, vascular, micro-infacts…)
Chronobiological (timing during the day of the radiosurgical procedure)
Associated medication (potential radioprotector or radiosensitizer effect of some drugs)
Radiobiological (dose rate…)

The goal of this study is to collect all of these informations out of genetical one in the cohort of 700 patients having benefited ou will benefit from radiosurgery in the situation for essential tremor and parkinson disease. It will be test the predictive value of these parameters and the capacity to predict hyper or hypo response.

The work on the genetic material will take place in the second stage in the frame of a new different resarch project.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Device


title: Retrospective Study on TACE for HCC by TANDEM and Idarubicin

acronym: TANDEM-IDA

summary:
DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using doxorubicin result in about 50% objective response rate at 6 months (Precision V study, Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu et al.). This trial was stopped at interim analysis because the endpoint was reached.

Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic effects together with an optimal efficacy of the drug. We previously published that idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and a very interesting releasing profile of the drug (Guiu et al., JVIR 2015).

We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE (in-label use of beads and the drug).

No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our first paper published in JVIR in 2015, only 4 patients).

Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help to design a future multicentric randomized phase II trial


title: Impact of Systematic Pulmonary Follow-up After Hematopoietic Stem Cell Transplantation

summary: Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Impact of Cytomegalovirus (CMV) Status Prior Antiretroviral Therapy on HIV Viral Load Decay

summary:
Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV infection. No study to date has investigated the impact of CMV infection on HIV viral load decay during antiretroviral therapy.

Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were enrolled. Clinical, biological and virological data were collected from HIV antiretroviral therapy initiation to the day of HIV viral load undetectability if any.


title: Description and Evaluation of Care Practices Amongst Geriatric Oncology Unit in the Alpine Valley, in the Follow-up of Cancer Patients.

acronym: SONGAlp

summary:
As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects.

As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp) has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric evaluation and trying to establish adapted cares.

In order to evaluate the impact of those evaluation on patients' health, the investigators have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).

The investigators want to develop a common data base to these centres, in order to evaluate the care practices that were developped, and demonstrate the benefit for the patient on the dependence level and the overall survival.

lead_sponsor: University Hospital, Grenoble


title: Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)

acronym: THERMO-HTA

summary:
Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.

In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.

For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.

Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.

Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.


title: Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.

acronym: PNEUMOCARE

summary: hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. Nevertheless it seems that there are great differences in standard of care between hospitals. The investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia

ReferenceCitation: Roquilly A, Chanques G, Lasocki S, Foucrier A, Fermier B, De Courson H, Carrie C, Danguy des Deserts M, Gakuba C, Constantin JM, Lagarde K, Holleville M, Blidi S, Sossou A, Cailliez P, Monard C, Oudotte A, Mathieu C, Bourenne J, Isetta C, Perrigault PF, Lakhal K, Rouhani A, Asehnoune K, Guerci P, Tran Dinh A, Chousterman B, Cupaciu A, Dahyot-Fizelier C, Bellier R, Au Duong J, Mansour A, Morel J, Beauplet G, Vibet MA, Feuillet F, Sébille V, Leone M. Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1601-e1610. doi: 10.1093/cid/ciaa1441.


title: Study and Follow-up of Multiple Endocrine Neoplasia Type 1

acronym: GENEM

summary:
Multiple Endocrine Neoplasia type I (MEN1) or Wermer syndrome is an autosomal dominant disease that predisposes patients to the development of endocrine tumours, principally parathyroid, pituitary or duodenal-pancreatic tumours. It is due to mutations that abolish the function of the MEN1 gene, which contributes to tumour regulation. It is a rare disease, with an estimated prevalence in the general population of 1/30,000. Penetrance of the disease is late but very high (almost 100% at 50 years of age). The first clinical manifestations usually appear after the age of 30 or 40 years.

The three cardinal endocrine characteristics of MEN1 are secreting tumours of the parathyroid, the pituitary gland and the pancreas. Tumours of the adrenal glands, bronchial or thymic endocrine tumours, ependymoma and meningioma of the central nervous system, visceral leiomyomas, and certain cutaneous tumours can also be found as well as these cardinal tumours.

The diagnosis of MEN1 is essential to ensure 1) appropriate therapeutic management of the proven endocrine manifestations 2) screening for other endocrine and non-endocrine tumours (lesions), 3) family screening of affected relatives whether they are symptomatic or not 4) the surveillance of thus diagnosed patients. Studies on mortality in MEN1 have shown that the causes of death are mainly due to the disease. The non-diagnosis of MEN1 is a cause of therapeutic failure in the management of the endocrine lesions. For the success of the surgical treatment of an isolated endocrine lesion it is important for patients to be oriented towards a diagnosis of MEN1 as the management is different from that in usual situations. Detection is thus of major importance, as early diagnosis can improve the management.

Even though the syndrome was discovered in 1903 by Erdheim and correctly documented in 1954 by Wermer, it was only in the 1970s that we became aware of the variety of clinical forms and attempted to codify its treatment. Nonetheless, published studies are fragmented and concern selected populations of few patients. They only partially answer questions arising in clinical practice concerning the prognosis and optimal management of patients. The natural history of the disease in all of its clinical forms is still poorly understood. Although advances in genetics have helped in the diagnosis of MEN1, some clinical forms are still difficult to associate with the syndrome: atypical forms, forms with hardly any symptoms and no genetic diagnosis (10%). These clinical forms need to be clarified to ensure optimal care. Only a large cohort will make it possible to describe the different forms of this disease and to clarify its prognosis

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: The Pancreas and the Bilio-pancreatic Junction: Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?

summary: Limited pancreatic resections are increasingly performed, but the rate of postoperative fistula is higher than after classical resections. Pancreatic segmentation, anatomically and radiologically identifiable, may theoretically help the surgeon removing selected anatomical portions with their own segmental pancreatic duct and thus might decrease the postoperative fistula rate. Current pancreatic segmentation theories do not enable defining anatomical-surgical pancreatic segments. To our knowledge, no study has tried to describe pancreatic segmentation from the divisions of the pancreatic ducts to date. Hence, we hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts, using extensive reconstructions of pancreatic duct using micro-scanner on injected human pancreas.


title: Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

acronym: PERIFLOW

summary:
Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases.

The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

status: Withdrawn

location_facility: University Hospital Toulouse (Faculty of Dental Surgery)


title: Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy

summary: The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment


title: A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®

acronym: NEFI

summary:
Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one patient to another, with great heterogeneity in clinical, physical, social, psychological and therapeutic responses. . A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients; a collective expertise is led by INSERM to help in patient care. Faced with the heterogeneity of FM, several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which suggested four groups, but with methodological limitations, not taking into account the new criteria10 for evaluating FM.

Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of the autonomous system. Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN much simpler, faster and less invasive than the technique of ophthalmology or biopsy. Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19, no study has been used to assess the presence of SFN in FM.

The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this new non-invasive device, in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age, sex, BMI and by menopausal status for women.

ReferenceCitation: Perrot S, Choy E, Petersel D, Ginovker A, Kramer E. Survey of physician experiences and perceptions about the diagnosis and treatment of fibromyalgia. BMC Health Serv Res. 2012 Oct 10;12:356. doi: 10.1186/1472-6963-12-356.

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ReferenceCitation: Wilson HD, Robinson JP, Turk DC. Toward the identification of symptom patterns in people with fibromyalgia. Arthritis Rheum. 2009 Apr 15;61(4):527-34. doi: 10.1002/art.24163.

ReferenceCitation: de Souza JB, Goffaux P, Julien N, Potvin S, Charest J, Marchand S. Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study. Rheumatol Int. 2009 Mar;29(5):509-15. doi: 10.1007/s00296-008-0722-5. Epub 2008 Sep 27.

ReferenceCitation: Bergman S. Psychosocial aspects of chronic widespread pain and fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):675-83.

ReferenceCitation: Salaffi F, Mozzani F, Draghessi A, Atzeni F, Catellani R, Ciapetti A, Di Carlo M, Sarzi-Puttini P. Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res. 2016 May 13;9:279-86. doi: 10.2147/JPR.S100829. eCollection 2016.

ReferenceCitation: Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4. Review.

ReferenceCitation: Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: clinical and immunologic implications. Arthritis Rheumatol. 2014 Jul;66(7):1945-54. doi: 10.1002/art.38662.

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ReferenceCitation: Oaklander AL, Herzog ZD, Downs HM, Klein MM. Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. Pain. 2013 Nov;154(11):2310-2316. doi: 10.1016/j.pain.2013.06.001. Epub 2013 Jun 5.

ReferenceCitation: Üçeyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, Casanova-Molla J, Reiners K, Sommer C. Small fibre pathology in patients with fibromyalgia syndrome. Brain. 2013 Jun;136(Pt 6):1857-67. doi: 10.1093/brain/awt053. Epub 2013 Mar 9.

ReferenceCitation: Ramírez M, Martínez-Martínez LA, Hernández-Quintela E, Velazco-Casapía J, Vargas A, Martínez-Lavín M. Small fiber neuropathy in women with fibromyalgia. An in vivo assessment using corneal confocal bio-microscopy. Semin Arthritis Rheum. 2015 Oct;45(2):214-9. doi: 10.1016/j.semarthrit.2015.03.003. Epub 2015 Mar 19.

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ReferenceCitation: Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224. doi: 10.1371/journal.pone.0138224. eCollection 2015.

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ReferenceCitation: Mao F, Liu S, Qiao X, Zheng H, Xiong Q, Wen J, Liu L, Tang M, Zhang S, Zhang Z, Ye H, Lu B, Li Y. Sudoscan is an effective screening method for asymptomatic diabetic neuropathy in Chinese type 2 diabetes mellitus patients. J Diabetes Investig. 2017 May;8(3):363-368. doi: 10.1111/jdi.12575. Epub 2016 Oct 5.

ReferenceCitation: Pickering G, Achard A, Corriger A, Sickout-Arondo S, Macian N, Leray V, Lucchini C, Cardot JM, Pereira B. Electrochemical Skin Conductance and Quantitative Sensory Testing on Fibromyalgia. Pain Pract. 2020 Apr;20(4):348-356. doi: 10.1111/papr.12857. Epub 2019 Dec 24.


acronym: ATRIL

title: Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2

type: EudraCT Number

source: euctr

ReferenceCitation: Coarelli G, Heinzmann A, Ewenczyk C, Fischer C, Chupin M, Monin ML, Hurmic H, Calvas F, Calvas P, Goizet C, Thobois S, Anheim M, Nguyen K, Devos D, Verny C, Ricigliano VAG, Mangin JF, Brice A, Tezenas du Montcel S, Durr A. Safety and efficacy of riluzole in spinocerebellar ataxia type 2 in France (ATRIL): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2022 Mar;21(3):225-233. doi: 10.1016/S1474-4422(21)00457-9. Epub 2022 Jan 18.

summary:
ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42 SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be included.

Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months.

Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected patients and may increase survival.

Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To assess primary criterion, the percentage of patients with a decrease of at least 1 point of the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.


title: First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging

summary: This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.


title: Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis

acronym: CALIMERO 2

summary:
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.


title: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

acronym: IMPEC

summary:
Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods.

Hypothesis of our study is that [11C] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma

location_facility: Service de Médecine Nucléaire - Hospices Civils de Lyon


title: Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.

acronym: EFINO-C

summary: The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.


title: Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly

summary: The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.


title: Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects

summary: Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and long-term cardiovascular and metabolic tolerance associated with these drugs The primary objective of this study is to analyze the impact of anti-TNF treatment during the first year of administration on the energy metabolism of patients suffering from RA, assessed as an absolute value (before-after) and in comparison with a standard measured in healthy matched subjects.


title: Randomized Double Blind Parallel Groups Sequential, Placebo Controlled, Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome (RLS)

lead_sponsor: Bioprojet

location_facility: Clinical Neurophysiology Department - Hôpital Pellegrin

summary: This is a Group Sequential Test multicenter, randomized, double blind, placebo controlled phase II proof of concept trial with parallel groups to evaluate the efficacy and the safety of BP1.4979 15mg BID compared to placebo in RLS patients during 2 weeks double blind treatment.


title: Emotional Reactions of Mothers Facing Premature Births

acronym: mother's traum

summary:
Our intervention in the maternity and neonatal wards helped our sensibility to the immediate parental reaction to the premature birth. Among these reactions, what is called "stress" by the parents occurs most often and is at the origin of trauma. The investigators can cite the unexpected confrontation with a baby is far from corresponding to what the parents had anticipated; the stunned feeling while experiencing a chain of events rapidly taking place, an experience of emptiness when the baby is placed in the intensive care unit, the feeling of powerlessness when facing the real risk of the infant's death, the striking spectacle of invasive treatments, etc. The parents worry about the viability and future of their premature infant. Their parental impressions and more specifically those of the mother facing the premature birth could in and of themselves have repercussions on the development of the infant, by betting on a complex meeting and atypical interactions.

These observations have driven us to elaborate on a hypothesis that finds itself separate from the lesion model commonly applied to premature infants, and shifts the psychopathological approach to the post-traumatic reaction of the mother following the premature birth and repositions the question of behavioral disorders of the child in the interaction mother-infant field. The investigators think that the premature birth can bring about in a second phase and notably in the mother, post-traumatic symptoms as described in the post-traumatic stress state, and that this reaction could have effects on the mother-infant interactions. The investigators have carried out the current study to clarify the relationship between the mother's post-traumatic reaction triggered by the premature birth and the mother-infant interactions.


title: Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes : a Randomized, Double-blind, Placebo-controlled, Cross-over Trial"

acronym: EUTERPE

summary:
Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged over the past decade as a post-transcriptional regulator of the LDL receptor (LDL-R). PCSK9 acts as an endogenous natural inhibitor of the LDL-R pathway. Monoclonal antibodies (mAb) directed against PCSK9, such as Alirocumab, are the most common method of PCSK9 inhibition.

The goal of the present study is to assess, in the context of type 2 diabetes, a situation associated with an increased post-prandial hyperlipemia, whether PCSK9 inhibition with Alirocumab affects postprandial intestinal lipoprotein metabolism.


title: Evaluation of the Prevalence, Intensity and Consequences of Bortezomib-induced Neuropathic Disorders: Monocentric Observational and Cross-sectional Study.

acronym: PREVIB

summary:
Cancer-induced peripheral neuropathies (CIPN) remain a real problem in oncology (Balayssac et al., 2011). These CIPN are induced by certain classes of anticancer drugs such as taxanes (paclitaxel and docetaxel), platinum salts (cisplatin and oxaliplatin), alkaloids of Madagascar periwinkle (vincristine), bortezomib, thalidomide and eribulin (Balayssac et al., 2011; Vahdat et al., 2013). These CIPN essentially translate into sensory disorders such as paresthesia, dysesthetics or numbness. More rarely, these CIPN may be associated with motor or vegetative disorders (Balayssac et al., 2011). According to the recent meta-analysis by Hershman et al., no treatment can be proposed as a "gold standard" for preventing or treating CIPN (Hershman et al., 2014). As a result, oncologists reduce or stop doses of neurotoxic anticancer drugs because patients with CIPN have a marked deterioration in quality of life and co-morbidities such as anxiety, depression and sleep disorders (Hong et al., 2014; Mols et al., 2014). Therefore, understanding the pathophysiology of CIPN is essential to propose new therapeutic strategies.

Among neurotoxic anticancer drugs, bortezomib remains relatively little studied in terms of pathophysiology compared to platinum salts or taxanes, while the neurotoxicity of bortezomib remains a limiting factor in treatment. Since 2012, the FDA and EMA have validated the administration of bortezomib subcutaneously instead of intravenously in order to limit the neurotoxicity of bortezomib (Minarik et al., 2015). Indeed, a large study (N=222) reported that subcutaneous administration of bortezomib allowed the same therapeutic efficacy to be maintained while improving the safety profile and in particular limiting peripheral neuropathies (CIPN all grades: 38% vs. 53%, p=0.044, grade> 2: 24% vs. 41%, p=0.012 and grade> 3: 6% vs. 16%, p=0.026) However, a recent retrospective study (N=446) reports that the prevalence of bortezomib-induced peripheral neuropathies after subcutaneous administration remains relatively high: all grade: 41%, grade> 2: 18%, grade> 3: 4%, and above all that this prevalence is not different between subcutaneous and intravenous routes (Minarik et al., 2015).

ReferenceCitation: Giraudet F, Selvy M, Kerckhove N, Pereira B, Barreau F, Nguyen D, Busserolles J, Cabrespine A, Chaleteix C, Soubrier M, Bay JO, Lemal R, Balayssac D. Relation between auditory difficulties and bortezomib-induced peripheral neuropathy in multiple myeloma: a single-center cross-sectional study. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):2197-2201. doi: 10.1007/s00405-021-07234-1. Epub 2022 Jan 31.

ReferenceCitation: Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.


title: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep

acronym: VISA

summary:
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.

lead_sponsor: Poitiers University Hospital

intervention_type: Diagnostic Test


title: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice

acronym: Cuff-Bercy

summary:
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

ReferenceCitation: Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly

acronym: EVQ

summary: The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management

summary: The quality of life of elderly citizens is to a great extent related to the maintenance of independence. The risk of falling and the loss of autonomy are two frequent problems associated with ageing. Although the impact of falls on functional outcomes and morbi-mortality in the elderly is well-established, the pathophysiological mechanisms underlying these falls are poorly understood. To better assess the risk of falling, numerous studies have investigated the use of dynamic and static posturography. These studies sought to characterise populations of fallers and non-fallers using parameters from postural analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may be implicated in the age-related deterioration of posture. Even though it has been shown that this decrease occurs earlier and is more severe in fallers, the direct relationship between the strength of ankle movement muscles and balance parameters in elderly fallers has not yet been established. The existence of such a relationship would make it possible on the one hand to facilitate screening for those with a risk of falling, and on the other hand to enrich our understanding of the pathophysiology of the risk of falling. The perspective would therefore be to propose programmes focused on the strengthening of these deficient muscles.


title: Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients

acronym: COCON

summary:
This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.

The effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.

lead_sponsor: University Hospital, Lille


title: Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion

acronym: ODIPP

summary:
The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.

Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.

Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.

The study aims to:

to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
identify simple biological markers associated with the residual mass measured by OCT

lead_sponsor: University Hospital, Caen


title: Lexical Priming by Music in Alzheimer's Disease and Healthy Aging

acronym: PriMus

summary: While verbal memory is quickly reached in the wake of Alzheimer's disease, the musical memory remains preserved until a late stage of the disease. This observation encouraged the development of music-based therapies in the management of neurocognitive and behavioral disorders that characterize Alzheimer's disease. In order to develop rehabilitation programs that effectively target cognitive functions to stimulate, it is necessary to understand the mechanisms underlying this beneficial effect of music on cognition.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

summary: Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Croix-Rousse Hospital


title: Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders

acronym: CONNECT

summary: Severe mental illnesses have a significant social cost, as much by their impact on the sick as on their entourage. The Deinstitutionalization and care in the community of patients with severe mental illness result in increased families and loved ones (also known as "informal caregivers" or "informal caregivers") If psychoeducation programs have been developed to help caregivers better manage and cope with the illness of the person being helped (optimize the quality of care, manage anxiety and isolation, these initiatives appear minimal in view of the magnitude of the burden (notion of burden: "burden") and the suffering of caregivers. Quality of life levels remain extremely low compared to the general population, nearly 4 out of 10 caregivers show a sense of inability to cope with the "permanent anxiety" of this load, 1/3 feels depressed and over 1/10 feels isolated on a personal and professional level


title: Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis? Analysis From Two French Prospectives National Cohorts CIRRAL and CIRVIR of Patients With Alcoholic or Viral Cirrhosis Child Pugh A

acronym: ABOCIRRALVIR

summary:
The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations. A recent study suggests that non-O blood group may promote portal vein thrombosis in non cirrhotic patients.

In addition, in general population and chronic hepatitis C, non-O blood group combined with one or the other of the above genetic abnormalities is associated with an increased risk of liver fibrosis and accelerated fibrogenesis. The suspected mechanism could be an increased procoagulant factor VIII and an increased Willebrand plasma level, due to a low ADAMTS 13 activity, the result of which is an hypercoagulable state and a microthrombotic process.

In cirrhotic patients procoagulant factors and ADAMTS 13 which are respectively increased and decreased, have be shown to be prognostic markers of hepatocellular function and portal hypertension. It has been hypothesized that the hypercoagulable state and the microthrombotic process could contribute to the worsening of the disease and enoxaparin has been shown to positively modify the prognosis of cirrhosis.

The role of non-O blood group in decompensation of cirrhosis and occurrence of complications including non-tumor portal vein thrombosis has never been studied. The investigators plan a longitudinal observational study to determine the incidence of complications in alcoholic and viral cirrhosis in case of non-O blood group compared to O blood group. The aim of this study is to determine whether ABO blood group may promote complications in alcoholic or viral cirrhosis. This is an ancillary study of two national cohorts assessing natural history and hepatocellular carcinoma risk factors in alcoholic (CIRRAL) and viral (CIRVIR) cirrhosis.

ReferenceCitation: Ollivier-Hourmand I, Repesse Y, Nahon P, Chaffaut C, Dao T, Nguyen TTN, Marcellin P, Roulot D, De Ledinghen V, Pol S, Guyader D, Archambeaud I, Zoulim F, Oberti F, Tran A, Bronowicki JP, D'Alteroche L, Ouzan D, Peron JM, Zarski JP, Bourliere M, Larrey D, Louvet A, Cales P, Abergel A, Mathurin P, Mallat A, Blanc JF, Nguyen-Khac E, Riachi G, Alric L, Serfaty L, Antonini T, Moreno C, Attali P, Thabut D, Pilette C, Grange JD, Silvain C, Carbonell N, Bernard-Chabert B, Goria O, Wartelle C, Moirand R, Christidis C, Perlemuter G, Ozenne V, Henrion J, Hillaire S, Di Martino V, Amiot X, Sutton A, Barget N, Chevret S, Ganne-Carrie N; ANRS CO12 CIRVIR, CIRRAL groups. ABO blood group does not influence Child-Pugh A cirrhosis outcome: An observational study from CIRRAL and ANRS CO12 CIRVIR cohorts. Liver Int. 2022 Jun;42(6):1386-1400. doi: 10.1111/liv.15159. Epub 2022 Jan 17.

intervention_type: Genetic


title: Rebond d'adiposité précoce Chez l'Enfant de 4 Ans et Risque de Surpoids Chez l'Enfant de 11 Ans : troisième Temps d'Une Cohorte Franc-comtoise.

acronym: CoOP

summary: This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Soluble CD146 and Proteinuria in Chronic Renal Disease

acronym: CPinMRC

summary:
Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as cardiovascular risk factors in both diabetic and non-diabetic populations, independently of GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146 (CD146) is an endothelial adhesion molecule with preferential localization in the junction. Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to assay. The increase in CD146 levels was described during the MRC, especially in diabetic patients with significant proteinuria. In two independent cohorts of patients with CDR, CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria.

The aim of our study is to determine whether the blood concentration of CD146s is correlated with proteinuria independently of GFR. For this purpose, we propose this study in the kidney nephrology and transplantation center of Conception Hospital, with the objective of highlighting the link between proteinuria and serum CD146 levels in patients with CKD, whatever their renal function and / or underlying pathology. 205 patients will be included over two years with dosing of CD146s and proteinuria at the same time. These 205 patients will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker predicting the risk of renal function impairment or cardiovascular risk independent of renal function.


title: Predictive Factors of Violence in Prison, Retrospective Study in an French Incarcerated Male Population

summary:
Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.

That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.

lead_sponsor: University Hospital, Montpellier


title: Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin

acronym: SALTORL

summary: This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility: Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan

intervention_type: Radiation


title: Evaluation of the Use of an Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity After a Stay for Effort Retraining in Rehabilitation and Recuperative Care Facilities for Oncology Patients

summary: The purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (VELIS)

ReferenceCitation: Phillips SM, Alfano CM, Perna FM, Glasgow RE. Accelerating translation of physical activity and cancer survivorship research into practice: recommendations for a more integrated and collaborative approach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):687-99. doi: 10.1158/1055-9965.EPI-13-1355. Epub 2014 Mar 5.

ReferenceCitation: Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. Epub 2007 Aug 1.

ReferenceCitation: Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. Review.

ReferenceCitation: Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Ávila JM, Aranceta-Batrina J, Gil Á, Ortega RM, Serra-Majem L, Varela-Moreiras G, González-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.

ReferenceCitation: Pavey TG, Anokye N, Taylor AH, Trueman P, Moxham T, Fox KR, Hillsdon M, Green C, Campbell JL, Foster C, Mutrie N, Searle J, Taylor RS. The clinical effectiveness and cost-effectiveness of exercise referral schemes: a systematic review and economic evaluation. Health Technol Assess. 2011 Dec;15(44):i-xii, 1-254. doi: 10.3310/hta15440. Review.

ReferenceCitation: Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.

ReferenceCitation: Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.

ReferenceCitation: Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.

ReferenceCitation: Simons M, Van Es E, Hendriksen I. Electrically assisted cycling: a new mode for meeting physical activity guidelines? Med Sci Sports Exerc. 2009 Nov;41(11):2097-102. doi: 10.1249/MSS.0b013e3181a6aaa4.

ReferenceCitation: Falzon C, Sabiston C, Bergamaschi A, Corrion K, Chalabaev A, D'Arripe-Longueville F. Development and validation of the Cancer Exercise Stereotypes Scale. J Psychosoc Oncol. 2014;32(6):708-26. doi: 10.1080/07347332.2014.955237.

ReferenceCitation: Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.

lead_sponsor: Fondation Audavie


title: Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma

acronym: PharmacoCHC

summary:
To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription.

Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug.

Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.

Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.

This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.


title: Evaluation of Calcinosis Prevalence in Systemic Sclerosis : a Cross Sectional Study Evaluating Calcinosis Cutis Prevalence by Hand and Feet Radiographic Assessment in Systemic Sclerosis Patients and Study Their Correlation With Organ Injury

acronym: CALCIDERMIS

summary: Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.


title: Role of Senescence in the Development of Endometrial Cancer

summary:
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).

A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

lead_sponsor: CHU de Reims


title: Evaluation of Metamemory in Patients With Schizophrenia

summary:
The purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a generation strategy. 4 groups will be necessary to comparison:

Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 59.5 years) Aged controls (≥ 59.5 years)

The effects of age and the disease could lead to interaction in regulating metamemory. The effect of age would be aggravated by the disease.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.

summary: The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.


title: Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients

acronym: ACQUAVIP

summary: Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Interest of a Therapeutic Follow-up of the Cytarabine in the Acute Myeloid Leukaemia: Is There Constitutional Biomarkers

summary:
In this open-label, single-center, non-randomized patients with AML (Acute Myeloid Leukemia) and receiving all induction chemotherapy and consolidation consisting of cytarabine under the care usual for this pathology, will be included. Each patient will be followed and for the development of toxicities, treatment response and progression-free survival. In addition to the usual care set out above, each patient will undergo a series of constitutional genetic investigations conducted by NGS on markers related to pharmacokinetics cytarabine. Another set of blood samples will also calculate, according to a Bayesian approach, individual pharmacokinetics of cytarabine and its metabolite, arabinosine-uracil.

This study should allow the correlation between pharmacogenetics and patient plasma exposure, that would eventually balance improved efficacy / toxicity of this molecule through a customization regimens, achieved so far on a empirical basis. If validation of our data, a dosage of therapeutic pre CDA could help in predicting pharmacodynamics of cytarabine individual dose adjustment, as is done for the 5-FU and DPD.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille


title: Therapeutic Care and Education in Endocrinology-Diabetes-Nutrition: Evaluation of the Interest of the APA Educator (Adapted Physical Activity Educator) for the Establishment of Physical Activities in the Management and Prevention of Overweight and Obesity

acronym: APA

summary: An uncontrolled, non-randomized, open-plan, multi-centre study of treatment and therapeutic education in endocrinology-diabetes-Nutrition that seeks to assess the interest of an adapted physical activity educator for the implementation In place of physical activities in the management and prevention of overweight and obesity. The proposed study seeks to promote the physical activity (PA) to patients and employees, including the encouragement of physical activity in a guided and personalized way, through workshops on working time, and follow-up of the evolution of the PA through a Adapted questionnaire.

lead_sponsor: Nantes University Hospital


title: Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.

acronym: TMS VR

summary:
Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.

However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.

As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.

The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.


title: Feasibility and Acceptability of a Web-based Multidomain Intervention With Connected Devices Made to Maintain Cognitive Function in Older Adults: a Pilot Randomised Controlled Trial

acronym: eMIND

summary: The primary purpose of the protocol is to evaluate the feasibility and acceptability of a home-based (using information and communication technologies) intervention composed of nutritional counselling, exercise and cognitive training in older adults and its potential effect on various health outcomes.

ReferenceCitation: Andrieu S, Coley N, Lovestone S, Aisen PS, Vellas B. Prevention of sporadic Alzheimer's disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015 Sep;14(9):926-944. doi: 10.1016/S1474-4422(15)00153-2. Epub 2015 Jul 23. Review.

ReferenceCitation: Ngandu T, Lehtisalo J, Solomon A, Levälahti E, Ahtiluoto S, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

ReferenceCitation: Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashémi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults

acronym: CAMUS

summary:
P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used in the field of sarcopenia.

The aim of the CAMUS study is to investigate the feasibility a protocol of SRM P31 at rest, during and after a standardized physical task. The secondary objective is to compare the metabolism of tyhe skeletal muscle tissue assessed by SRM P31 in young and older individuals. A pilot study, cross-sectional study will be conducted. Ten healthy sedentary 70+ years males and 10 sedentary 25 to 30 years old male will be included.

Level of physical activity, physical performances, will be assessed at baseline. RMN (T1; tractography and SRM P31) will be performed. SRM P31 will be performed at rest, during and after an exhausting muscle task at 70% 1-RM. Feasibility will be judged on the rate of valuable variables recorded (>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of adenosine triphosphate (ATP : alfa, beta, gamma).

ReferenceCitation: Rolland Y, Lauwers-Cances V, Cournot M, Nourhashémi F, Reynish W, Rivière D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4.

ReferenceCitation: Bourdel-Marchasson I, Joseph PA, Dehail P, Biran M, Faux P, Rainfray M, Emeriau JP, Canioni P, Thiaudière E. Functional and metabolic early changes in calf muscle occurring during nutritional repletion in malnourished elderly patients. Am J Clin Nutr. 2001 Apr;73(4):832-8.