title: Early Phase Study Comparing the Effectiveness of a Dairy Product, Co-developed by Besancon University Hospital and the National School of Dairy Industry (ENIL), With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

acronym: LactoXeros

summary:
Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency).

The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.

This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals.

This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.


title: Endofibrose Vasculaire et génétique

acronym: GOSSER

summary: search for a genetic cause of vascular endofibrose

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment

acronym: CARDIOSPACE

summary:
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:

ECG
Brachial blood pressure
Continuous finger blood pressure
Ultrasound
Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.

primary_purpose: Basic Science

ipd_sharing: No

location_facility: Centre de Recherche Clinique, CHU d'Angers

intervention_type: Device


title: Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

acronym: STIMSYM

summary: Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Meoni S, Debȗ B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure

status_simplified: Unknown


acronym: PROPHYLOXITINE

summary:
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.

The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.

This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.

They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.

The primary endpoints are:

Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
Urinary concentrations of cefoxitin

primary_purpose: Other

ReferenceCitation: Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Grégoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.

lead_sponsor: Poitiers University Hospital

intervention_type: Drug


title: Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

acronym: ECLAH

summary: This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

lead_sponsor: Laboratoires Genévrier

lead_sponsor_type: industriel


primary_purpose: Prevention

acronym: LEFORTEXACYL

title: Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

lead_sponsor: University Hospital, Lille

type: EudraCT Number

source: euctr

summary: Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.


title: Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis

summary:
Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a progressive decline in lung function.

School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle strength is also impaired.

No studies assessed aerobic capacities during children's gait while carrying a backpack.

The investigators hypothesized that backpack carrying will induce an acute decline in lung function in children with cystic fibrosis compared to healthy children. Investigators also hypothesized that aerobic capacities will be impaired.

ReferenceType: background

ReferenceCitation: Vieira AC, Ribeiro F. Impact of backpack type on respiratory muscle strength and lung function in children. Ergonomics. 2015;58(6):1005-11. doi: 10.1080/00140139.2014.997803. Epub 2015 Jan 13.

ReferenceCitation: Dockrell S, Simms C, Blake C. Schoolbag carriage and schoolbag-related musculoskeletal discomfort among primary school children. Appl Ergon. 2015 Nov;51:281-90. doi: 10.1016/j.apergo.2015.05.009. Epub 2015 Jun 11.

ReferenceCitation: Thobani A, Alvarez JA, Blair S, Jackson K, Gottlieb ER, Walker S, Tangpricha V. Higher mobility scores in patients with cystic fibrosis are associated with better lung function. Pulm Med. 2015;2015:423219. doi: 10.1155/2015/423219. Epub 2015 Feb 18.

ReferenceCitation: Ramsey KA, Ranganathan S. Interpretation of lung function in infants and young children with cystic fibrosis. Respirology. 2014 Aug;19(6):792-9. doi: 10.1111/resp.12329. Epub 2014 Jun 19. Review.

ReferenceCitation: Pastré J, Prévotat A, Tardif C, Langlois C, Duhamel A, Wallaert B. Determinants of exercise capacity in cystic fibrosis patients with mild-to-moderate lung disease. BMC Pulm Med. 2014 Apr 30;14:74. doi: 10.1186/1471-2466-14-74.

lead_sponsor: Groupe Hospitalier du Havre

intervention_type: Behavioral


title: Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk Melanoma

acronym: MELA-SAS

summary:
Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

status: Withdrawn

primary_purpose: Screening

lead_sponsor: AGIR à Dom


title: Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients

acronym: TRITITOX

summary:
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

intervention_type: Other


title: Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Upper Limb Function in Stroke

acronym: Armautotox

summary: To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic hemiparesis following stroke.

ReferenceCitation: Maulet T, Pouplin S, Bensmail D, Zory R, Roche N, Bonnyaud C. Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101450. doi: 10.1016/j.rehab.2020.10.004. Epub 2020 Dec 17.


title: Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

acronym: RemCog-TC

summary: The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.

lead_sponsor: University Hospital, Toulouse

intervention_type: Radiation


title: Individual Following in Anal Cancer With PET/CT

acronym: IFACT

summary:
Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement.

The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.

status: Recruiting

lead_sponsor: Centre Antoine Lacassagne

status_simplified: Ongoing


type: Other Identifier

title: The Metabolic Syndrome Among Childhood Acute Leukemia Survivors: Physiopathological Analysis

acronym: LEAMS

summary:
Along with the improvement of childhood acute leukemia treatment, survival rates have increased. Therefore, the number of long term childhood leukemia survivors has increased progressively over the last decades. So, the assessment of long term health status in this population becomes very important. Many studies have shown an increased risk of life threatening late complications and early mortality. Cardiovascular morbidity and mortality are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an important concern since it is associated with cardiovascular morbidity and mortality. The overall MS prevalence in the French prospective cohort of survivors of childhood acute leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia treatment. Since the median age at MS evaluation was 21 years, this prevalence was very high. Anyway, the MS pathophysiology in this population is still poorly understood. One of the most recent hypothesis about the MS mechanism is based on the adipose tissue inability to store fatty acids: when adipose tissue cannot expanse further to store excess nutriments then lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin resistance and MS.

The investigators hypothesized that the adipose tissue could be damaged by treatments received during childhood acute leukemia treatment (particularly TBI). This leads to morphological and functional abnormalities that could promote the insulin resistance and MS.

This ectopic adipose tissue contains less preadipocytes, which could impair its functional properties.

The primary endpoint of this study is to compare the morphological and functional characteristics of adipose tissue in patients with a MS who received or not TBI during childhood leukemia treatment . This comparison will focus on:

The adipose tissue repartition and evaluation of the ectopic adipose tissue
Fibrosis and inflammation of the adipose tissue
Preadipocytes quantification

The secondary endpoint is to describe:

for the whole cohort of included patients,
the clinical and biological characteristics associated with the MS.
Cardiovascular risk factors and nutritional statement
Anthropometric measurements
Detection of other endocrinal abnormalities possibly associated with the MS
Analysis of inflammation blood markers and adipokines quantification.

design_allocation: Non-Randomized

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.

acronym: TOH-HTIC

summary:
Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.

The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.

lead_sponsor: Hospices Civils de Lyon


title: Renal Hemodynamic, Functional and Metabolic Changes After AGEs (Advanced Glycation End Products) Load by Positron Emission Tomography (PET) and Blood Oxygen Level-Dependent (BOLD) - MRI. The AGE- Functional Reserve Study.

acronym: AGE-FR

summary:
Renal functional reserve is defined as the glomerular hyper filtration induced by a protein load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein load. Renal functional reserve loss is associated with a persistent hyper filtration state, seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney Disease (CKD). This observation has lead to larger clinical studies that demonstrated the positive effects of protein restriction on kidney function, and allowed the scientific community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat), were in fact responsible for an AGEs load, based on recent published data.

The aim of this study is to determine whether AGEs alone or proteins in general are responsible for the mobilization of renal functional reserve, leading to the progression of CKD.

ReferenceCitation: Normand G, Lemoine S, Villien M, Le Bars D, Merida I, Irace Z, Troalen T, Costes N, Juillard L. AGE Content of a Protein Load Is Responsible for Renal Performances: A Pilot Study. Diabetes Care. 2018 Jun;41(6):1292-1294. doi: 10.2337/dc18-0131. Epub 2018 Apr 2.

location_facility: Service de Néphrologie - Hôpital Edouard Herriot


title: Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial

acronym: PROPOP

summary: Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.

ReferenceCitation: Blanc J, Castel P, Mauviel F, Baumstarck K, Bretelle F, D'Ercole C, Haumonte JB. Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial. Am J Obstet Gynecol. 2021 Oct;225(4):444.e1-444.e8. doi: 10.1016/j.ajog.2021.05.020. Epub 2021 May 24.


title: Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children

acronym: OPTIBAYE

summary:
Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy. The relationship between exposure to vancomycin and efficacy is admitted but because of an important intersubject variability, therapeutic exposure isn't usually achieved.

The primary aim of this randomized controlled trial is to evaluate a new early dosage adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.

Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic exposure to vancomycin.

The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach will allow patients to achieve the vancomycin pharmacological target faster than with the usual treatment strategy.

ReferenceCitation: Le J, Bradley JS, Murray W, Romanowski GL, Tran TT, Nguyen N, Cho S, Natale S, Bui I, Tran TM, Capparelli EV. Improved vancomycin dosing in children using area under the curve exposure. Pediatr Infect Dis J. 2013 Apr;32(4):e155-63. doi: 10.1097/INF.0b013e318286378e.

ReferenceCitation: Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4. Erratum in: Clin Infect Dis. 2011 Aug 1;53(3):319.

ReferenceCitation: Hoang J, Dersch-Mills D, Bresee L, Kraft T, Vanderkooi OG. Achieving therapeutic vancomycin levels in pediatric patients. Can J Hosp Pharm. 2014 Nov;67(6):416-22.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Monocentric, Biological, Uncontrolled, Prospective Study on the Feasibility of Plasma FLT3 Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated With Intensively for Acute Leukemia

acronym: FLAM/FLAL

summary: Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Some studies have shown that Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an increase of this marker in the blood of patients responding to treatment. The aim of our prospective, non-interventional study is to measure the plasma levels of FLT3-L at different times of the management of patients with acute lymphoblastic leukemia but also myeloid. For this, analyzes of the samples collected in the usual care will be conducted to study the relationship between the plasma concentration of FLT3-L and outcomes. If there is any link, the FLT3-L could serve as a predictor of treatment response.

lead_sponsor: Nantes University Hospital


title: Impact of Art Therapy on Anxiety Identified During the Quarterly Update of Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13 - Pilot Study

acronym: MUCO-ART

summary: Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. In line with the recommendations of the High Authority of Health, the multidisciplinary team of Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University Hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . The aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.


title: Assessment of Executive and Socio-cognitive Functions in Child and Adult Survivors of Primary Brain Tumor: Impact on Patients' and Relatives' Quality of Life.

acronym: NEUROCOG-QOL

summary:
Significant advances in primary malignant brain tumors (PBT) treatment have led to dramatically improved survival, both in children and adults. However, survival has not come without a cost and aggressive treatment methods associated with significant long-term adverse effects, often referred to as "late effects" (Panigrahy & Blüml, 2009). These effects are the medical, physical, cognitive and psychosocial sequelae associated with cancer and its treatments that generally emerge two to five years after treatment ends (e.g., Landier & Bhatia, 2008).

The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.

ReferenceCitation: Frith CD, Singer T. The role of social cognition in decision making. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3875-86. doi: 10.1098/rstb.2008.0156. Review.

ReferenceCitation: Landier W, Bhatia S. Cancer survivorship: a pediatric perspective. Oncologist. 2008 Nov;13(11):1181-92. doi: 10.1634/theoncologist.2008-0104. Epub 2008 Nov 5. Review.

ReferenceCitation: Lezak, M.D., Howieson, D.B., & Loring, D.W. (2004). Neuropsychological Assessment. New York, NY: Oxford University Press.

ReferenceCitation: Panigrahy A, Blüml S. Neuroimaging of pediatric brain tumors: from basic to advanced magnetic resonance imaging (MRI). J Child Neurol. 2009 Nov;24(11):1343-65. doi: 10.1177/0883073809342129. Review.

ReferenceCitation: Tamnes CK, Østby Y, Walhovd KB, Westlye LT, Due-Tønnessen P, Fjell AM. Neuroanatomical correlates of executive functions in children and adolescents: a magnetic resonance imaging (MRI) study of cortical thickness. Neuropsychologia. 2010 Jul;48(9):2496-508. doi: 10.1016/j.neuropsychologia.2010.04.024. Epub 2010 Apr 29.

ReferenceCitation: Caissie A, Nguyen J, Chen E, Zhang L, Sahgal A, Clemons M, Kerba M, Arnalot PF, Danjoux C, Tsao M, Barnes E, Holden L, Danielson B, Chow E. Quality of life in patients with brain metastases using the EORTC QLQ-BN20+2 and QLQ-C15-PAL. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1238-45. doi: 10.1016/j.ijrobp.2011.09.025. Epub 2011 Dec 13.

ReferenceCitation: Pulenzas N, Khan L, Tsao M, Zhang L, Lechner B, Thavarajah N, Barnes E, Danjoux C, Holden L, Lauzon N, Sheehan P, Bedard G, Chow E. Fatigue scores in patients with brain metastases receiving whole brain radiotherapy. Support Care Cancer. 2014 Jul;22(7):1757-63. doi: 10.1007/s00520-014-2140-4. Epub 2014 Feb 9.

ReferenceCitation: Samson, D. (2012). Neuropsychologie de la théorie de l'esprit chez l'adulte : Etat de l'art et implications cliniques. In P. Allain, G. Aubin & D. L. Gall (Eds.), Cognition sociale et neuropsychologie (pp. 47-63). Marseille: Solal

ReferenceCitation: Stone VE, Baron-Cohen S, Knight RT. Frontal lobe contributions to theory of mind. J Cogn Neurosci. 1998 Sep;10(5):640-56.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Cantisano N, Menei P, Roualdes V, Seizeur R, Allain P, Le Gall D, Roy A, Dinomais M, Laurent A, Besnard J. Relationships between executive functioning and health-related quality of life in adult survivors of brain tumor and matched healthy controls. J Clin Exp Neuropsychol. 2021 Dec;43(10):980-990. doi: 10.1080/13803395.2022.2040432. Epub 2022 Mar 1.


title: Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

acronym: IBDOT

summary: This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).

intervention_type: Biological


title: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft

acronym: TAILOR

summary:
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms.

Objectives of this post-market registry are:

Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.

status: Active, not recruiting

lead_sponsor: JOTEC GmbH


title: Validation and Pertinence of Anxiety Analogic Visual Scale in Pain Management by Mobile Acute Pain Team

acronym: ANXYDOL

summary:
Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The actual tools for evaluation of this specific part are complex and time consuming.

To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety analogic visual scale by comparison with the actual reference the self-assessment questionnaire State Trait Inventory Anxiety Y-A form.

primary_purpose: Health Services Research


title: Fragility Multidisciplinary Evaluation and Adapted Physical Activity

summary: Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Frailty is generally considered as a state that precedes dependent status and, unlike the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and quantify the indicators above the dependence of the elderly from a multidisciplinary approach to frailty, is a critical public health issue for developing non-drug therapeutic interventions adapted to delay the institutionalization. Through this study, it is to identify risk and protective factors of frailty and their relationships with physical activity, evaluate them and propose an appropriate care to the patient. This study should enable the production of new scientific knowledge to improve the health and quality of life of older people.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: VEINEX : Venous Investigations During Exercise

acronym: VEINEX

summary: Successfully develop and confirm with the Higher School of Electronics West Plethysmographic a multichannel recorder to perform measurements staggered volume of the lower limbs at rest, walking and recovery (6 storied measures on members lower).


title: Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma

acronym: SURF

summary:
Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off "

As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:

Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

acronym: POMPRENELLE

summary:
Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders.

Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night.

Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment

acronym: CADENCE

summary: The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

lead_sponsor: Edwards Lifesciences


title: TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity

acronym: TEMIS

summary:
Physical inactivity is a major public health issue. Prescription of physical activity appears necessary in some situation with cardiovascular risk. It is important to both qualify and quantify daily physical activity.

The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt) performance in 12 healthy subjects, wearing this system over the daytime during one week.

lead_sponsor: University Hospital, Angers


title: CLinical Assessment of WEB® Device in Ruptured aneurYSms

acronym: CLARYS

summary: An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

lead_sponsor: Microvention-Terumo, Inc.


title: Determinants of Body Composition at Discharge and Fat-Free Mass as an Indicator of Neurological Development at 2 Years in Very Preterm Infants : OPTIPREMA Study

acronym: OPTIPREMA

summary: This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.

ReferenceCitation: Larcade J, Pradat P, Buffin R, Leick-Courtois C, Jourdes E, Picaud JC. Estimation of Fat-free Mass at Discharge in Preterm Infants Fed With Optimized Feeding Regimen. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):115-118. doi: 10.1097/MPG.0000000000001261.

lead_sponsor: Hôpital de la Croix-Rousse


title: Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old

acronym: PRESAGE

summary: Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. Few data are available regarding the prevalence and severity of these comorbidities in elderly RA patients. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA.

status: Suspended

time_perspective: Cross-Sectional

ReferenceCitation: Soubrier M, Tatar Z, Couderc M, Mathieu S, Dubost JJ. Rheumatoid arthritis in the elderly in the era of tight control. Drugs Aging. 2013 Nov;30(11):863-9. doi: 10.1007/s40266-013-0122-8. Review.

ReferenceCitation: Widdifield J, Bernatsky S, Paterson JM, Gunraj N, Thorne JC, Pope J, Cividino A, Bombardier C. Serious infections in a population-based cohort of 86,039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):353-61. doi: 10.1002/acr.21812.


title: Effects of Bright Light to Improve Agitation and Sleep Disorders in Patients With Alzheimer's Disease

acronym: ALZ-Light

summary:
Background: Management of patients with Alzheimer's disease associated with behavioral disturbances is difficult especially in those with agitation/aggression and insomnia and nighttime behaviors. No treatment has shown any efficacy to control these disturbances and psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects.

Objective: Assess the effect of bright light therapy on behavioral disturbances of patients with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and nighttime behaviours.

Study design: Multicenter non pharmacological intervention trial, controlled, randomized, open, two-arm design : control group and intervention group.

Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards.

Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric inventory, nurse scale (NPI-nurse).

Treatments: Intervention group: patients will participate in a program of bright light therapy realised during a one-hour sessions of occupational therapy,. These sessions will be realised for groups of 6 patients and will be done every week day, at late morning, for 4 consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light. Patients of control group will participate in a program of occupational therapy of same duration and rhythm, realised in standard light conditions (about 300 lux).

Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total sleep length, nocturnal wake episodes and nocturnal motor agitation).

Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale. Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield, total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry.

Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann and Whitney test.

Expected results and perspectives; If bright light exposure is efficient, professional caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological approach to improve behaviour and sleep of these patients. This study might contribute to better define the place of a non invasive and promising technique, wrist actigraphy, to assess sleep and behaviour disturbances in psychogeriatric patients


title: Effect of GLP-1 on Angiogenesis, Angiosafe Type 2 Diabetes Study 1

acronym: ANGIOSAFE 1

summary: GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

ReferenceCitation: Gaborit B, Julla JB, Besbes S, Proust M, Vincentelli C, Alos B, Ancel P, Alzaid F, Garcia R, Mailly P, Sabatier F, Righini M, Gascon P, Matonti F, Houssays M, Goumidi L, Vignaud L, Guillonneau X, Erginay A, Dupas B, Marie-Louise J, Autie M, Vidal-Trecan T, Riveline JP, Venteclef N, Massin P, Muller L, Dutour A, Gautier JF, Germain S. Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz069. doi: 10.1210/clinem/dgz069.

location_facility: Nutrition department, pole ENDO - Assistance Publique Hôpitaux Marseille


title: In-line Filtration to Reduce Systemic Inflammatory Response Syndrome in Babies Born Very prEtErm

acronym: FRISBEE

summary:
While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001).

Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid. While not all infections lead to septicaemia, immuno-compromised patients such as neonates are at greater risk, and infection becomes a major problem (Ng 1989) and a major risk factor for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated that endotoxins may be involved in the pathogenesis of a proportion of cases of periventricular leukomalacia, the most frequent brain damage associated with neurocognitive handicaps in the human neonate (Volpe 2001).

The presence of calcium in parenteral nutrition mixture leads to precipitation due to its incompatibility with the other components of the admixtures and leads to high concentration of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a common finding in necrotizing enterocolitis another serious complication flowing preterm birth (Ballance 1990). Particle contamination of infusion solutions exists despite a stringent infusion regiment. The number and composition of particles depends on the complexity of the applied admixtures (Jack 2010).

Particulate contamination is due to drug incompatibility reactions or their incomplete reconstitution during the preparation process (Schroder 1994). Various studies have demonstrated the contamination of infusion solutions with glass particles from opening glass ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition components (Ball 2003). Particles have also been shown to be inherent to generic drug formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one million infused particles per day, increasing with the complexity and quantity of the administered infusions (Walpot 1989).

There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous solutions, and the 1.2 micron filter is recommended for larger molecule solutions such as lipids. The 0.2 micron filter has also been reported to remove air, microorganisms and particulate matter. In addition, endotoxin retention is reportedly achieved by using a positively charged filter membrane; toxic macro-molecules are released by gram-negative bacteria and are claimed to be effective for up to ninety six hours (Bethune 2001).

In-line IV filters are currently claimed to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball 2003) and particularly effective in the removal of particles caused from drug precipitate such as antibiotics (Chee 2002; Ball 2003).

However, evidence of the beneficial effect of in-line IV filters in children and neonates is much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the population of preterm infants, no study is currently available while particulate contamination due to infusion therapy carries a higher health risk in this subpopulation.

The benefits of using IV in-line filters in critically-ill preterm neonates remains to be demonstrated. This intervention in adults has also been challenged by several authors (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may be retained in the filters causing a reduction in potency (Friedland 1985). On the other hand, there are no known adverse effects from the use of IV in-line filters.


title: Prognostic Factors, Morbidity, Mortality and Long Term Survival in Patients With Neuromuscular Disorders Admitted in Intensive Care Unit

summary: Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long term follow up after ICU discharge.

time_perspective: Retrospective


title: S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department

summary:
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.

For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.

If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.

The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction

acronym: DIPOD

summary: The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined.

ReferenceCitation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. Review.

ReferenceCitation: Calandra T, Cohen J; International Sepsis Forum Definition of Infection in the ICU Consensus Conference. The international sepsis forum consensus conference on definitions of infection in the intensive care unit. Crit Care Med. 2005 Jul;33(7):1538-48. Review.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.

acronym: RHEOMUCO

summary:
This is a proof of concept study. The aim of this study is to assess a device measuring rheological properties of human sputum of four populations :

10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)
10 patients with asthma
10 patients with cystic fibrosis
10 healthy volunteers.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre d'Investigation Clinique - INSERM 1406


title: Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant.

summary: The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Estrade A, Montastier E, Turnin MC, Buisson JC, du Rieu MC, Tuyeras G, Hernandez G, Bérard E, Ritz P. An Application May Help Improve Protein Consumption after Bariatric Surgery. Obes Surg. 2019 Jun;29(6):1982-1983. doi: 10.1007/s11695-019-03816-5.

lead_sponsor: University Hospital, Toulouse


title: How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy

summary: The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Randomized Double-blind Phase II Trial Evaluating Maintenance Olaparib Versus Placebo in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer

acronym: PIPSeN

summary:
This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy and involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the SLCG).

Six hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered prior to receiving the first line platinum-based chemotherapy or during or at the end of the first 6 cycles of inducation platinium based chemotherapy and provide consent for retrieving archival tissue collection and providing translational blood samples and tumor biopsies.

- Induction chemotherapy phase All patients will initially be treated with 6 cycles of platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet (preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted. Translational blood samples will be taken at the beginning of induction chemotherapy for all patients.

Patients displaying progressive disease or stable disease after induction chemotherapy will be withdrawn and further optimally managed according to local practice. For them, an optional tumour biopsy will be performed at the end of the induction treatment.

- Randomisation and maintenance phase Only patients who respond to platinum-based induction chemotherapy will be further randomised between olaparib and placebo. These patients must have been treated with 6 cycles of chemotherapy. However, patients who haven't received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3 or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1 (NCI CTCAE v4.0).

Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg [2 tablets of 150 mg] taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will be assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and treatment will be administered until disease progression or unacceptable toxicity. Patients will then be optimally managed according to local practice. Follow-up will be for a minimum of 15 months from the time of randomization, and until last venue. All randomised patients will be asked to provide translational blood samples at randomization, on treatment and at the end of the treatment. Optional tumour biopsies will be performed at randomization, at the end of the treatment (or at disease progression if available).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.

acronym: SIMMAX

summary: The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

ReferenceCitation: Lelaidier R, Balança B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmelé T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.

lead_sponsor: CEJKA Jean-Christophe

location_facility: Centre Lyonnais d'Enseignement par la Simulation en Santé


title: Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

acronym: PreDeARM

summary: The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.


acronym: FancoMob

title: Pilot Study Assessing the Feasibility of CD34+ Cells Mobilization and Collection After Treatment With G-CSF and Plerixafor in Patients With Fanconi Anemia for Subsequent Treatment by Gene Therapy

lead_sponsor: Assistance Publique - Hôpitaux de Paris

ReferenceCitation: Diana JS, Manceau S, Leblanc T, Magnani A, Magrin E, Bendavid M, Couzin C, Joseph L, Soulier J, Cavazzana M, Lefrère F. A new step in understanding stem cell mobilization in patients with Fanconi anemia: A bridge to gene therapy. Transfusion. 2022 Jan;62(1):165-172. doi: 10.1111/trf.16721. Epub 2021 Nov 9.

summary: The purpose of this study is to assess the feasibility of Plerixafor used in combination with G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize and collect a sufficient number of peripheral blood CD34+ cells for peripheral blood apheresis, for further gene therapy study.


title: Contribution of the Quantitative Analysis of the Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)

acronym: PUCE

summary:
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

Quantitative analysis of the ultrasound exam with doppler of those masses could identify diagnostic criteria, especially for the lacrimal gland, easily explorable.


title: Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres

summary:
Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT).

Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes (~12°C to ~35°C) ratio), selected randomly.

Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.

lead_sponsor: University of Franche-Comté


title: Fiber Tolerability In Children Aged 3-7 Year

acronym: Fiber - TIC

summary: Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.

lead_sponsor: Nestlé


title: Assessment of the Impact of Food Carbohydrate and Insulin Dose Computing by an Application on Smart Phone on Glucose Control in Patients With Type 1 Diabetes

acronym: GLUCAL

summary: During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months. They will complete two one-month study phases, using the application in one phase and counting carbohydrate and insulin doses without the application in the other phase, with randomized order of each phase. Visits are scheduled at the start and at the end of each phase to collect data on glucose control and insulin doses. Questionnaires assessing health-related quality of life and ability of self-management of diabetes will also be filled by patients before and after each study phase.

lead_sponsor: University Hospital, Montpellier


title: Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale

acronym: TROUILLOMETRE

summary: Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.

ReferenceCitation: Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.

lead_sponsor: University Hospital, Limoges


acronym: HIPPIE

summary: This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.

lead_sponsor: University Hospital, Bordeaux


title: Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm

acronym: TIC-TAC

summary: Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study

acronym: BioAge

summary:
Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.

However, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.

In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

ReferenceCitation: Barthélémy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.

acronym: PELVI-EOS

summary: The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.


title: Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes

acronym: GLP1 et Goût

summary:
This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.

Distribution in groups

30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)
30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)
30 healthy subjects (non-diabetics) (group 3)

This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

ReferenceCitation: Brindisi MC, Brondel L, Meillon S, Barthet S, Grall S, Fenech C, Liénard F, Schlich P, Astruc K, Mouillot T, Jacquin-Piques A, Leloup C, Vergès B, Pénicaud L. Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients. Diabetes Metab Syndr. 2019 Jul - Aug;13(4):2489-2494. doi: 10.1016/j.dsx.2019.06.021. Epub 2019 Jun 29.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System

summary: To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter

ReferenceCitation: Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.

lead_sponsor: B.Braun Médical - CoE Chasseneuil


summary: The aims of this prospective cross over study was to compare the gastric emptying of 250 ml water in fasting volunteers, in two situations : without chewing gum or while chewing gum during 45 min

ReferenceCitation: Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.

lead_sponsor: Lionel Bouvet

location_facility: Hopital Femme Mère Enfant - Hospices Civils de Lyon


title: Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction

acronym: MARCI

summary:
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.

The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.

The aim is also to study the rate of complications, cosmetic results and quality of life.

ReferenceCitation: Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.


title: Non Invasive Detection of Acute Rejection by Circulating microRNAs in Cardiac Transplantation: a Multicenter Prospective Study

acronym: MIRRACLE

summary: The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that expression of these microRNAs could discriminate patients with a histologically proven rejection from patient displaying a normal endomyocardial biopsy. The signature must be confirmed in unselected patients and its stability evaluated according to clinical, biological and immunological parameters of included patients.

ReferenceCitation: Duong Van Huyen JP, Tible M, Gay A, Guillemain R, Aubert O, Varnous S, Iserin F, Rouvier P, François A, Vernerey D, Loyer X, Leprince P, Empana JP, Bruneval P, Loupy A, Jouven X. MicroRNAs as non-invasive biomarkers of heart transplant rejection. Eur Heart J. 2014 Dec 1;35(45):3194-202. doi: 10.1093/eurheartj/ehu346. Epub 2014 Aug 31.

location_facility: PARCC/ INSERM U970, Team 4, Xavier Jouven, Cardiovascular epidemiology and sudden death, Georges Pompidou European Hospital,


title: A Randomized Phase III Trial Comparing Trabectedin (Yondelis®) to the Best Supportive Care in Patients With Advanced Soft Tissue Sarcoma

acronym: TSAR

summary:
As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed.

For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival data for patients with advanced or metastatic STS are of poor prognosis despite improvement of results this last years. For example, median overall survival increased from 12,3 months (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).

Considering the latest results with and without Trabectedin, the investigators may consider that comparing Trabectedin with best supportive care is ethically acceptable as long as patients consent to enter the trial.

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

acronym: CP-ICU

summary: This study evaluates the diagnostic performances of Point of Care P. gingivalis test in saliva with serum IgG P. gingivalis, in reference to dental examination as a gold standard in patients hospitalised in intensive care unit (ICU)

lead_sponsor: University Hospital, Brest


title: Simulation-based Education for Managing Stress in ICU Nurses

acronym: SISTRESSREA

summary:
I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined as the presence of job strain as defined by Karasek.

II. Main secondary outcomes

ICU nurses stress at one year
Burnout
Intent-to-leave the ICU
Quality of life

III. Design

Prospective, randomized, open study comparing 2 groups of ICU nurses:

Simulation group and Control group

Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to take into account differences between the ICUs regarding organization, activity, patients…).

This study is observational because nurses can participate to this training when they want. The fact that nurses are in control group delays their participation to this training but does not forbid them to particpate. The nurses from control group will participate to training at the end of study.

IV. Specific measures Control group: none

Simulation group: 5-day specific training with dedicated scenario done by an ICU expert simulation team

V. Study duration 48 months

VI. Ethical aspects - Reglementary concerns

Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de l'Informatique et des Libertés (CNIL)
Information to the participants prior inclusion

VII. Study population Job strain evaluated in a French study was 59% . The same rate was observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We therefore hypothesized that the intervention (simulation) should be able to reduce the job strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this study needs to include 185 patients per arm. To take into account few participants who will not complete the study, we aimed to include a total of 400 ICU nurses.

VIII Results An interim analysis will be performed after 200 inclusions

ReferenceCitation: El Khamali R, Mouaci A, Valera S, Cano-Chervel M, Pinglis C, Sanz C, Allal A, Attard V, Malardier J, Delfino M, D'Anna F, Rostini P, Aguilard S, Berthias K, Cresta B, Iride F, Reynaud V, Suard J, Syja W, Vankiersbilck C, Chevalier N, Inthavong K, Forel JM, Baumstarck K, Papazian L; SISTRESSREA Study Group. Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1988-1997. doi: 10.1001/jama.2018.14284.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Monitoring Chronic Urticaria Basophil Irritability by Cytometry (Monocentric Study)

acronym: CUBIC

summary: A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells / basophils without any identified cause. It is considered that Mast cell/basophil have an abnormally high sensitivity in CU and can be triggered with almost nothing (high irritability). In allergy, basophils degranulation can be reproduced in vitro with allergens. Anti-IgE (immunoglobulin E) antibody mimics allergen triggering of basophils in a dose dependent manner. If basophils are abnormally sensitive in CU, it should be reproduced in vitro at very low stimulation. The main objective of this project is to set up a method to evidence abnormal basophil irritability and look for clinical significance. As many markers characterize basophils in different states, researchers shall also look for a profile possibly associated with CU basophile irritability. Such tests could be useful in CU monitoring.


title: Brainstem Assesment in a Cohort of Very Preterm Babies (Less Than 28 Weeks)

summary:
Although significant advances in neonatal care have increased survival rates of preterm infants born before 28 weeks gestation, a concomitant decrease in neuro developmental disorders has not been achieved. Cerebral injuries, well documented during the previous years, in preterm babies are particularly deleterious since they occur in a developing brain. They affect both white and grey matter by complex mechanisms and the principal targets are the developing oligodendrocytes and neurons of the subplate. All these criteria define the encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of the brainstem are not very well known and may explain neuro-developmental disorders with normal MRI.

The assessment of the motor repertoire is complementary to the neurological examination and may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the development due to the feedback that they send to cortical neurons and reflect the maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by prematurity may induce alterations of the motor repertoire.

Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently in very preterm babies reflect brainstem abnormalities. These symptoms are also described in other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these pathologies deficits of the 5-HT system have been described and associated with dysautonomia. It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm babies.

The serotonergic system develops very early during gestation and is one of the first neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the respiratory network. Moreover, previous studies have shown that 5-HT projections to the spinal cord are involved in posture and in the coordination. It is tempting to think that 5-HT deficits may have some repercussions on the development of the CNS, changing activity dependent processes, such as spontaneous activity recorded at the spinal level in rodents.

In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior fossa, GMs and dysautonomia different parameters such as heart rate variability, suction-swallowing and different breathing techniques will be established

location_facility: Assistance Publique Hôpitaux de Marseille


title: Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties : Pilot Study, Interventional, Prospective, Longitudinal.

acronym: NEUROVIB

summary: It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24 sessions) whereas the control group will not be training. The primary outcome is the maximal voluntary strength.


title: Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic (IHC)

acronym: IHC

summary:
Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology.

Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.

ReferenceCitation: Marchaudon V, Devisme L, Petit S, Ansart-Franquet H, Vaast P, Subtil D. Chronic histiocytic intervillositis of unknown etiology: clinical features in a consecutive series of 69 cases. Placenta. 2011 Feb;32(2):140-5. doi: 10.1016/j.placenta.2010.11.021. Epub 2010 Dec 22.

lead_sponsor: University Hospital, Lille


title: Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin

acronym: ISOTOVE

summary:
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor.

A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009).

However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%.

To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally.

The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity.

Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival. Armstrong shows in addition a decreased risk of recurrence.

It must be remembered that:

The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions).
There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy.

Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.

ReferenceCitation: Harter P, Hilpert F, Mahner S, Kommoss S, Heitz F, Pfisterer J, du Bois A. Prognostic factors for complete debulking in first- and second-line ovarian cancer. Int J Gynecol Cancer. 2009 Dec;19 Suppl 2:S14-7. doi: 10.1111/IGC.0b013e3181bffb3f. Review.

ReferenceCitation: de Forni M, Boneu A, Otal P, Martel P, Shubinski R, Bugat R, Lucot H. Anatomic changes in the abdominal cavity during intraperitoneal chemotherapy: prospective study using scintigraphic peritoneography. Bull Cancer. 1993 Apr;80(4):345-50.

ReferenceCitation: Varia MA, Stehman FB, Bundy BN, Benda JA, Clarke-Pearson DL, Alvarez RD, Long HJ; Gynecologic Oncology Group. Intraperitoneal radioactive phosphorus (32P) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003 Aug 1;21(15):2849-55.

ReferenceCitation: Young RC, Brady MF, Nieberg RK, Long HJ, Mayer AR, Lentz SS, Hurteau J, Alberts DS. Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin--a gynecologic oncology group study. J Clin Oncol. 2003 Dec 1;21(23):4350-5.

ReferenceCitation: Dawson SJ, Hicks RJ, Johnston V, Allen D, Jobling T, Quinn M, Rischin D. Intraperitoneal distribution imaging in ovarian cancer patients. Intern Med J. 2011 Feb;41(2):167-71. doi: 10.1111/j.1445-5994.2009.02112.x.

ReferenceCitation: Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5.

ReferenceCitation: Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43.

lead_sponsor: Centre Jean Perrin


title: Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia

acronym: SCIT-VF

summary: Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.

lead_sponsor: Hôpital le Vinatier

location_facility: Centre Hospitalier de Clermont de l'Oise


title: 5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients : HIVOL 2 Study.

summary: The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.


title: Phase II, Multicenter, Trial, Exploring "Chemo-free" Treatment (GA101+Ibrutinib) and MRD-driven Strategy in Previously Untreated Symptomatic B-chronic Lymphocytic Leukemia Medically Fit A Study From the Goelams/GCFLLC/MW Intergroup

summary:
Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months /

Study Part 1:

All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days

Study Part 2:

After evaluation at D1 of month 9:

If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of 420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation of M16

ReferenceCitation: Michallet AS, Letestu R, Le Garff-Tavernier M, Aanei C, Ticchioni M, Dilhuydy MS, Subtil F, Rouille V, Mahe B, Laribi K, Villemagne B, Salles G, Tournilhac O, Delmer A, Portois C, Pegourie B, Leblond V, Tomowiak C, De Guibert S, Orsini Piocelle F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan-Graczyk M, Vilque JP, Aurran T, Cymbalista F, Lepretre S, Levy V, Nguyen-Khac F, Feugier P. A fixed-duration, measurable residual disease-guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial. Blood. 2021 Feb 25;137(8):1019-1023. doi: 10.1182/blood.2020008164.

ReferenceCitation: Michallet AS, Dilhuydy MS, Subtil F, Rouille V, Mahe B, Laribi K, Villemagne B, Salles G, Tournilhac O, Delmer A, Portois C, Pegourie B, Leblond V, Tomowiak C, de Guibert S, Orsini F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan Graczyk M, Vilque JP, Aurran T, Cymbalista F, Lepretre S, Lévy V, Nguyen-Khac F, Le Garff-Tavernier M, Aanei C, Ticchioni M, Letestu R, Feugier P. Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease-driven strategy in patients with chronic lymphocytic leukaemia (ICLL07 FILO): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2019 Sep;6(9):e470-e479. doi: 10.1016/S2352-3026(19)30113-9. Epub 2019 Jul 16.

lead_sponsor: French Innovative Leukemia Organisation


title: Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast

acronym: VARIA-DCE-US

summary: RECIST criteria for evaluating tumor response are often inadequate for the evaluation of anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response through the analysis of 7 different parameters. Several studies (four at IGR, involving 117 patients, and a multicenter study involving 400 patients) showed that CEUS allows early evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly interesting for the early identification of patients responding (or not) to treatment. Those are area under curve , and area under the wash-out. To further validate the use of these parameters, it is essential to measure and describe the level of their intra-patient variability.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Study of Iatrogenic Effects of Treatment for Childhood Cancer - Constitution of a Biological Samples Bank as Part of a Cohort of Patients (Cohort FCCSS)

acronym: BIO-F

summary: The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.


title: Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer

acronym: Liquid Biopsy

summary: Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.


title: Mélisses Garden: Effect of the Mediation by Care-garden on Anxious State in Adult Patients Hospitalized in Psychiatry (Prospective, Monocentric, Controlled, Randomized, Open in Two Parallel Groups Study)

acronym: JDM

summary:
Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation". That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.

These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses.

That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks.


title: Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders

summary:
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.

Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy.

The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.

location_facility: Service ORL Assistance Publique Hôpitaux de Marseille


title: Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated With Hypogonadism in HIV + Men

acronym: HYPOG

summary:
Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life.

Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand, abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular invasion by lymphoma or Kaposi's syndromes have also been described.

The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless of the antiretroviral therapy and CD4-T cell count.

No study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients in the European population.

ipd_sharing: Yes

ipd_sharing_description: data are reported on a informatic folder centralized at Tourcoing Hospital with anonymous number for each patient Each patient receive by their own practician the biologics data

lead_sponsor: Tourcoing Hospital


title: Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent

summary: In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (> 70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner the same day. The effect on food intake of the distribution of this exercise into two sessions during 24h remains to be determined. In addition, a multidisciplinary load of obesity generates a loss of body weight in the short term, which we do not know the effects on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of muscle exercise is unknown.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial

acronym: CEPIA

summary:
Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.

Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.

Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.

This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.

The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.

ReferenceCitation: Bouman A, van Rossum E, Nelemans P, Kempen GI, Knipschild P. Effects of intensive home visiting programs for older people with poor health status: a systematic review. BMC Health Serv Res. 2008 Apr 3;8:74. doi: 10.1186/1472-6963-8-74. Review.

ReferenceCitation: Kuo HK, Scandrett KG, Dave J, Mitchell SL. The influence of outpatient comprehensive geriatric assessment on survival: a meta-analysis. Arch Gerontol Geriatr. 2004 Nov-Dec;39(3):245-54. Review.

ReferenceCitation: Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6.

ReferenceCitation: Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002 Feb 27;287(8):1022-8. Review.

ReferenceCitation: Frese T, Deutsch T, Keyser M, Sandholzer H. In-home preventive comprehensive geriatric assessment (CGA) reduces mortality--a randomized controlled trial. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):639-44. doi: 10.1016/j.archger.2012.06.012. Epub 2012 Jul 11.

ReferenceCitation: Ellis G, Whitehead MA, O'Neill D, Langhorne P, Robinson D. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD006211. doi: 10.1002/14651858.CD006211.pub2. Review. Update in: Cochrane Database Syst Rev. 2017 Sep 12;9:CD006211.

ReferenceCitation: Li CM, Chen CY, Li CY, Wang WD, Wu SC. The effectiveness of a comprehensive geriatric assessment intervention program for frailty in community-dwelling older people: a randomized, controlled trial. Arch Gerontol Geriatr. 2010 Feb;50 Suppl 1:S39-42. doi: 10.1016/S0167-4943(10)70011-X.

ReferenceCitation: Ferrat E, Bastuji-Garin S, Paillaud E, Caillet P, Clerc P, Moscova L, Gouja A, Renard V, Attali C, Breton JL, Audureau E. Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study). BMJ Open. 2018 Apr 12;8(4):e020597. doi: 10.1136/bmjopen-2017-020597.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Faculté de Médecine, Université Paris Est Créteil (UPEC)


title: Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation

acronym: PANEL

summary: Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.

lead_sponsor: University Hospital, Rouen


title: Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)

acronym: ANI-ALGO

summary:
A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.

The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).

lead_sponsor: Hopital Foch


type: Registry Identifier

title: Feasibility Study of the Quantification of Glutathione Concentrations in Muscle and Liver Using in Vivo Proton Magnetic Resonance Spectroscopy (1H MRS)in Human

summary: Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized in the liver during the postprandial phase, which establishes a stock that is mobilized for the other tissues (muscle)during the postabsorptive period. It is of common knowledge that the decrease in glutathione concentrations associated with ageing could be involved in the development of the degenerative pathologies linked to the old age. These changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous synthesis of GSH. The development of nutritional strategies aiming at an improvement of the status glutathione requires the determination of its concentration within tissues, where it is active. The quantification of tissue concentrations of glutathione by biochemical techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method to quantify muscle and liver glutathione.