title: Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients

acronym: NEMOLOC

summary: This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.


title: Stimulation cérébrale Profonde et Empreinte Tissulaire : Une Nouvelle stratégie Pour la Recherche Biologique in Vivo Dans la Maladie de Parkinson, Les TOC, la Dystonie, le Tremblement Essentiel et le Syndrome Gilles de la Tourette.

acronym: BTI

summary:
This exploratory study aims to validate the collection and analysis of brain tissue imprints during the DBS by using a CE marked Medical Device in patients presenting one of the following five disorders: Parkinson's disease (PD), essential tremor (ET), dystonia (DYS), Obsessive compulsive disorder (OCD) and Tourette Syndrome (TS).

The Brain Tissue Imprint project is focused on the DBS surgical procedure, which constitutes an appropriate method to collect brain tissue imprints by taking advantage of the direct and transitory contact at the extremity of the dilator with adjacent brain tissue. Indeed, during this step, micro-fragments of brain material spontaneously adhere to the dilator tip. It is this imprinting process that allows to collect what is defined as "brain tissue imprints. This approach is part of the standard surgical procedure of the SCP without major change or complications.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6.

ReferenceCitation: Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. Review.

ReferenceCitation: Holtzheimer PE, Mayberg HS. Deep brain stimulation for psychiatric disorders. Annu Rev Neurosci. 2011;34:289-307. doi: 10.1146/annurev-neuro-061010-113638. Review.

ReferenceCitation: Hariz M, Blomstedt P, Zrinzo L. Future of brain stimulation: new targets, new indications, new technology. Mov Disord. 2013 Nov;28(13):1784-92. doi: 10.1002/mds.25665. Epub 2013 Oct 7. Review.

ReferenceCitation: Fontaine D, Lanteri-Minet M, Ouchchane L, Lazorthes Y, Mertens P, Blond S, Geraud G, Fabre N, Navez M, Lucas C, Dubois F, Sol JC, Paquis P, Lemaire JJ. Anatomical location of effective deep brain stimulation electrodes in chronic cluster headache. Brain. 2010 Apr;133(Pt 4):1214-23. doi: 10.1093/brain/awq041. Epub 2010 Mar 17.

ReferenceCitation: Laxton AW, Tang-Wai DF, McAndrews MP, Zumsteg D, Wennberg R, Keren R, Wherrett J, Naglie G, Hamani C, Smith GS, Lozano AM. A phase I trial of deep brain stimulation of memory circuits in Alzheimer's disease. Ann Neurol. 2010 Oct;68(4):521-34. doi: 10.1002/ana.22089.

ReferenceCitation: Boëx C, Seeck M, Vulliémoz S, Rossetti AO, Staedler C, Spinelli L, Pegna AJ, Pralong E, Villemure JG, Foletti G, Pollo C. Chronic deep brain stimulation in mesial temporal lobe epilepsy. Seizure. 2011 Jul;20(6):485-90. doi: 10.1016/j.seizure.2011.03.001. Epub 2011 Apr 12.

ReferenceCitation: Lozano AM, Giacobbe P, Hamani C, Rizvi SJ, Kennedy SH, Kolivakis TT, Debonnel G, Sadikot AF, Lam RW, Howard AK, Ilcewicz-Klimek M, Honey CR, Mayberg HS. A multicenter pilot study of subcallosal cingulate area deep brain stimulation for treatment-resistant depression. J Neurosurg. 2012 Feb;116(2):315-22. doi: 10.3171/2011.10.JNS102122. Epub 2011 Nov 18.

ReferenceCitation: Torres N, Chabardes S, Piallat B, Devergnas A, Benabid AL. Body fat and body weight reduction following hypothalamic deep brain stimulation in monkeys: an intraventricular approach. Int J Obes (Lond). 2012 Dec;36(12):1537-44. doi: 10.1038/ijo.2011.271. Epub 2012 Feb 21.

ReferenceCitation: Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20. Review.

ReferenceCitation: Benabid AL, Chabardes S, Mitrofanis J, Pollak P. Deep brain stimulation of the subthalamic nucleus for the treatment of Parkinson's disease. Lancet Neurol. 2009 Jan;8(1):67-81. doi: 10.1016/S1474-4422(08)70291-6. Review.

ReferenceCitation: Zaccaria A, Bouamrani A, Chabardès S, El Atifi M, Seigneuret E, Lobrinus JA, Dubois-Dauphin M, Berger F, Burkhard PR. Deep brain stimulation-associated brain tissue imprints: a new in vivo approach to biological research in human Parkinson's disease. Mol Neurodegener. 2016 Jan 28;11:12. doi: 10.1186/s13024-016-0077-4.

ReferenceCitation: Crecelius A, Götz A, Arzberger T, Fröhlich T, Arnold GJ, Ferrer I, Kretzschmar HA. Assessing quantitative post-mortem changes in the gray matter of the human frontal cortex proteome by 2-D DIGE. Proteomics. 2008 Mar;8(6):1276-91. doi: 10.1002/pmic.200700728.

ReferenceCitation: Mexal S, Berger R, Adams CE, Ross RG, Freedman R, Leonard S. Brain pH has a significant impact on human postmortem hippocampal gene expression profiles. Brain Res. 2006 Aug 23;1106(1):1-11. doi: 10.1016/j.brainres.2006.05.043. Epub 2006 Jul 14.

ReferenceCitation: Chariot P, Witt K, Pautot V, Porcher R, Thomas G, Zafrani ES, Lemaire F. Declining autopsy rate in a French hospital: physician's attitudes to the autopsy and use of autopsy material in research publications. Arch Pathol Lab Med. 2000 May;124(5):739-45.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: The Visuo-attentional Mediator of Social Facilitation

acronym: VAMOS

summary:
Social psychology has long established that the mere presence of others influences the investigator's individual behavior and performance. "Social facilitation" refers to any improvement or deterioration of performance due to the presence of others. For more than a century, social psychology has acquired a solid knowledge of the principles governing this fundamental form of social influence.

But the underlying mechanism of social facilitation remains debated, as behavior alone cannot identify it with certainty. This major unresolved problem makes it particularly difficult to translate laboratory results on social facilitation into real applications in areas such as school or work, where others are ubiquitous. The purpose of this study will therefore be to identify the mediator of social facilitation.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neuroscience de Lyon

intervention_type: Behavioral

status_simplified: Ongoing


title: Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life

acronym: ACTISEP

summary: This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)

acronym: ASTRAU

summary:
Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also to prevent the detrimental consequences of traumatic rhabdomyolysis. Isotonic saline (NaCl 0.9%), called "physiological serum" is the standard fluid for the resuscitation of severely injured patients. However, the formulation of NaCl 0.9% is not really physiological since its chloride concentration is 1.5 higher than the one of human plasma. This excessive chloride concentration leads to hyperchloremic acidosis and to a drop in renal perfusion after isotonic saline infusion. For this reason, we wonder whether fluid resuscitation with Plasmalyte would be beneficial for renal function of trauma patients in comparison with NaCl 0.9%. Our research question is:

In a population of trauma patients at high risk of acute kidney injury, does a fluid resuscitation with Plasmalyte Viaflo lower the incidence of severe acute kidney injury (stage 2 or 3 according to the KDIGO classification) compared with a resuscitation with isotonic saline (NaCl 0.9%)?

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte® 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. Erratum in: Ann Surg. 2013 Dec;258(6):1118.

ReferenceCitation: Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.

ReferenceCitation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

ReferenceCitation: Shaw AD, Raghunathan K, Peyerl FW, Munson SH, Paluszkiewicz SM, Schermer CR. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014 Dec;40(12):1897-905. doi: 10.1007/s00134-014-3505-3. Epub 2014 Oct 8.

ReferenceCitation: Raghunathan K, Shaw A, Nathanson B, Stürmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.

ReferenceCitation: Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19:334. doi: 10.1186/s13054-015-1045-z. Erratum in: Crit Care. 2016;20:17.

ReferenceCitation: Krajewski ML, Raghunathan K, Paluszkiewicz SM, Schermer CR, Shaw AD. Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015 Jan;102(1):24-36. doi: 10.1002/bjs.9651. Epub 2014 Oct 30. Review.

ReferenceCitation: Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334. Erratum in: JAMA. 2015 Dec 15;314(23):2570.

ReferenceCitation: Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.

ReferenceCitation: Bihorac A, Delano MJ, Schold JD, Lopez MC, Nathens AB, Maier RV, Layon AJ, Baker HV, Moldawer LL. Incidence, clinical predictors, genomics, and outcome of acute kidney injury among trauma patients. Ann Surg. 2010 Jul;252(1):158-65. doi: 10.1097/SLA.0b013e3181deb6bc.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Département d'Anesthésie Réanimation - Kremlin Bicêtre

intervention_type: Drug


title: General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments

acronym: ATB-IU

summary: Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

intervention_type: Other

status_simplified: Completed


title: BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND

acronym: sclerabio

summary:
The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.

The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.

A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Direction de la Recherche Clinique et Innovation

intervention_type: Biological


title: Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing

acronym: EPRAoV

summary:
Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.

The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Registry Identifier

title: Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution

summary:
Sarcomas are aggressive malignant tumors issued from mesenchymatous cells. Their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. Surgical margins remain a major prognosis factor and are directly linked to recurrence risk. Curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative Magnetic resonance imaging(MRI). Resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. Resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. Such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. A new MRI offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional MRI, which might explain some of the observed recurrences. Ultra-high field MRI, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. This is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery.

It will be propose in this project to determine the contribution of ultra-high field MRI in Soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 Tesla imaging over routine MRI through usual data comparison in 20 patients between 1,5Tesla and 7 Tesla MRI.

primary_purpose: Diagnostic

location_facility: Assistance Publique Hôpitaux de Marseille


title: 4DFlow Magnetic Resonance Imaging in Patients With Pulmonary Hypertension Associated With Congenital Heart Disease

summary:
Congenital heart disease is the most common congenital anomaly. The life expectancy of children with congenital heart disease has increased considerably in recent years.

Nevertheless, the evolution of these patients is marked by an increased risk of complications. Arrhythmias, heart failure, pulmonary arterial hypertension (PAH) and endocarditis may be promoted by the absence or delay of management in childhood, by residual lesions or post-operative cardiac scars and by the presence of prosthetic materials.

PAH is a common complication of congenital heart disease, especially in non-operated shunts.

PAH corresponds to an increase in pulmonary vascular resistance and mean pulmonary arterial pressure that becomes greater than 25mmHg at rest, leading to right ventricular failure and ultimately to the patient's death.

Eisenmenger's syndrome corresponds to a non-reversible pulmonary arterial hypertension with a left-right shunt initially left open, then right-left secondary to the increase in pulmonary vascular resistance, leading to cyanosis, polycythemia and multivisceral involvement. It is the most advanced form of PAH with congenital heart disease.

PAH will be suspected during echocardiographic follow-up of any patient with congenital heart disease, on the analysis of the velocity of tricuspid and/or pulmonary regurgitation flow.

Echocardiography allows the monitoring of the VD (right ventricle) function, which is the major prognostic element in PAH. Cardiac catheterization is systematically recommended and remains the gold standard to confirm the diagnosis of PAH, establish its pathophysiology and prognosis but also for the follow-up under medical treatment of these patients in tertiary centres every 6 months. Although this tool is the gold standard, rigorously performed, it remains an invasive examination often poorly experienced by patients.

4D Flow MRI is a promising imaging that allows the acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information in a single step with 2D (only 8 minutes extra), in free breathing and totally autonomous mode. Thus, at the same time as the realization of a 2D MRI, essential for the diagnosis and follow-up of PAH, with an additional 8 minutes for 4D flow, the investigators could have additional fundamental information on pulmonary cardiac output but also prognostic markers of right ventricular dysfunction turning dramatic in pulmonary vascular disease.

design_allocation: Non-Randomized

lead_sponsor: Centre Chirurgical Marie Lannelongue

lead_sponsor_type: industriel


title: Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial

acronym: CRYOENDOMET

summary: The aim of this study is to evaluate for the first time prospectively the efficacy on the symptoms and the tolerance of percutaneous cryoablation performed under radiological guidance of endometriosis of the abdominal wall in alternative to surgery after validation in multidisciplinary meeting.

intervention_type: Procedure


title: Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study

acronym: PSMA

summary:
A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery.

The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases.

Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can:

To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed.

Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.

location_facility: Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon


title: The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding

acronym: VANILLE

summary:
Pain is a frequent occurrence during the early life of premature newborns. Studies on the short term effects of pain, and potential for long-term ones, have shown that pain affects various physiological and behaviorial parameters. Sucrose during a painful procedure reduce behaviorial and cardiac manifestations in preterm infant, but a recent study casts doubt on its efficacy. Analgesic treatments are available, but a large number of experimental studies in animals ended up with questioning the safety of their use in neonates, particularly in premature ones. Soothing and analgesic methods have been developed such nonnutritive suckling, sucrose, skin to skin contact, and breastfeeding. Therefore, it is important to explore other methods of analgesia. Recently, the role of olfaction as a soothing tool in full term newborns was examined in several studies. The olfactory system is more mature at birth than the others senses. The neonates reacted with significant facial and respiratory changes to low concentration of olfactory stimuli during the various behaviorial states. The analysis of olfacto-facial configurations revealed that behaviorial markers of disgust discriminated between some odors judged as pleasant and unpleasant by adults rather.

Objective The study was designed to assess the analgesic effect of vanilla odor on preterm neonates. The primary outcome was the Premature Infant Pain Profile (PIPP) score. The secondary outcomes were: the French scale Faceless Acute Neonatal pain Scale (FANS), salivary cortisol.

Study design This is a prospective, randomized, controlled, double-blind and monocentric trial. It is conducted in a level III maternity unit at the North Hospital in Marseille. The infant will feed without their own mother's breast milk, clinically stable, born between 30 and 36 weeks and 6 days gestational age, and of less than 10 days postnatal age. In both groups, the painful stimulus is a venipuncture for blood collection. In the experimental group, called "vanilla odor" group, the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water. In the control group, the venipuncture will be performed with an odorless diffuser and ingestion of sucrose. Both group have non nutritive sucking. The diffuser will place under a Hood with an air-flow of 7 l/min. It will manually switch on 3 minutes before the venipuncture and switch off 3 minutes later. The type and quantity of vanillin to be used were determined during a pre-testing phase. Assessment Scale shows significant improvement in the neonates, with good interobserver agreement.

Attempt results A current randomized study compare effects of breast milk and vanilla odors, on premature neonate's pain during and after venipuncture. Our previous study has shown that maternal breast milk odor in preterm neonates reduces PIPP scores during a venipuncture and markedly reduces crying after this procedure. Therefore, from a clinical perspective, the odor of mother's own breast milk has an analgesic effect on the premature neonate. Olfactory stimulation using maternal breast milk odor could have other clinical implications in neonatal medicine in addition to pain prevention, as does olfactory stimulation with a pleasant vanilla-based odor. It could be integrated into developmental care of premature neonates.


title: Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State

acronym: EXERCISE

summary:
Cirrhosis is a condition in which the liver does not function properly due to long-term damage. This damage is characterized by the replacement of normal liver tissue by scar tissue.

The liver carries out several necessary functions, including synthesis of proteins participating in blood coagulation process. Some of these proteins contribute to coagulation and others make blood more fluid. In healthy people there is a balance between the two.

In cirrhotic patient, there is an imbalance inducing hypercoagulation (hypercoagulability state). Cirrhotic patients are so known to be at risk of vein thrombosis (for example portal vein thrombosis: clot in hepatic vein).

Mechanisms leading to this imbalance are unclear. Studies need to be completed to improve patient's management.

The EPCRs (Endothelial Protein C Receptor soluble) takes part in blood coagulation process. Previous studies have shown that blood levels of EPCRs are increased in patients with cirrhosis.

The primary purpose of the study is to evaluate if the EPCRs could play a role in cirrhosis-associated hypercoagulability state.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension

acronym: PROPULS

summary: The main objective of this study is to analyze the survival of a cohort of patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension and to establish the prognostic value of biomarkers.


title: Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer

acronym: CAMARA

summary:
In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.

In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Gluszak C, de Vries-Brilland M, Seegers V, Baroin C, Kieffer H, Delva R, Cornuault-Foubert D. Impact of Iron-Deficiency Management on Quality of Life in Patients with Cancer: A Prospective Cohort Study (CAMARA Study). Oncologist. 2022 Apr 5;27(4):328-333. doi: 10.1093/oncolo/oyac005.

lead_sponsor: Institut Cancerologie de l'Ouest


title: A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads

acronym: PROCOL

summary: The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique

primary_purpose: Health Services Research

lead_sponsor: Clinique Beau Soleil


title: Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

summary:
The main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. A second aim is to assess the direct contribution of cortical lesions - independent of WM injury - on the diffuse grey matter damage.

Thirty MS patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal MRI study at 7T to assess cortical MS injury. Clinical (EDSS) and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. MRI protocol is designed to increase the detection rate of CL using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. Thus, MRI acquisition will include MP2RAGE, T2*, FLAIR and DIR as previously published but also recent MRI technique like FLAWS, focusing on the grey matter by attenuating the white matter and CSF signal. Finally, QSM sequences will be performed. QSM measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. Due to physical properties of the technique (bipolarity), we suppose that high resolution QSM will be more sensitive that previous used sequences to depict cortical lesions. Using this multi-contrast approach with relevant MRI sequence and with a high resolution whole brain exploration might improve the detection of CL in early MS.

Furthermore, MRI protocol allow us to estimate neuronal loss (T1 relaxation time), myelin and iron content (QSM and T2* relaxation time) within and outside cortical lesions in GM.

The present study is an opportunity to assess cortical pathology in MS from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.

location_facility: Assistance Publique Hopitaux de Marseille


title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease

acronym: HYPNOCROHN

summary: Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;


title: Optimizing the Management of Patients With Oral Therapy: a Randomized Trial Evaluating the Impact of Management on the Occurrence of Side Effects

acronym: IPAC

summary:
Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many side effects and patients are reluctant to report them because they are afraid that their treatment will be changed. But when these side effects are poorly managed, they can reduce adherence to treatment.

The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of oral anticancer treatments decreases the rate and duration of side effects.

The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy.

This randomized study is realized in patients with kidney or breast cancer.

lead_sponsor: Centre Georges Francois Leclerc


title: Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity

acronym: OBES-DYSP

summary: Obesity, defined as a Body Mass Index greater than or equal to 30 kg/m2, represents a significant public health issue. Dyspnea is a very common and crippling symptom in obesity. About 80% of people with obesity experience dyspnea in daily living. Bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. Nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.

ReferenceCitation: Boissière L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslée G, Launois C. Improvement of dyspnea after bariatric surgery is associated with increased Expiratory Reserve Volume: A prospective follow-up study of 45 patients. PLoS One. 2017 Sep 20;12(9):e0185058. doi: 10.1371/journal.pone.0185058. eCollection 2017.

lead_sponsor: CHU de Reims


title: Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care

acronym: MUSANX

summary: The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness

lead_sponsor: Nantes University Hospital


title: Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism

summary:
The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.

The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.

lead_sponsor: Hôpital le Vinatier


title: Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

acronym: RESPECT

summary: Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier


title: Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)

summary:
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.

The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.

intervention_type: Genetic


title: Epileptiform Activity During REM Sleep in Alzheimer's Disease

acronym: EREMAD

summary: Recent clinical data showed that patients with Alzheimer Disease (AD) might present epilepsy at early stages of the disease (Cretin et al., 2016, Vossel et al., 2016). In mice models of Alzheimer disease, preclinical researchers observed an increase of epileptic events during Rapid Eye Movement (REM) sleep, which is very unusual. This study aims at testing if patients with AD present an exacerbation of epileptic events during REM sleep, which could constitute an early biomarker of the disease. Investigators will evaluate the incidence of epilepsy during each sleep stage in 40 patients with early or moderate forms of AD and in 40 healthy subjects. Investigators will also look for a link between epilepsy during sleep in AD participants and memory performances, brain damage (by using MRI scans) and in the case of patients, the phenotype of the Apolipoprotein E(ApoE) gene.

lead_sponsor: University Hospital, Toulouse


title: Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients

acronym: LTO-BLOXY

summary:
Acute respiratory distress syndrome (ARDS) is a serious disease with high mortality. In patients who survive ARDS, respiratory, neurological and motor sequelae are frequent, negatively impacting on the patient's quality of life, and engendering substantial healthcare costs (rehabilitation, long-term care, delayed return to work). There may also be repercussions on the patient's family and entourage. The severity of ARDS and the burden it represents have underpinned intensive research to identify treatment strategies that could improve mortality. However, it is important to ensure that any improvement in mortality does not come at the price of an excess of sequelae and disability in survivors.

The oxygenation strategy used to treat ARDS may have an impact on mortality in these patients. The CLOSE study, in which our group participated, recently demonstrated the feasibility of two oxygenation strategies in intensive care unit (ICU) patients with ARDS. We have also initiated the LOCO-2 study (NCT02713451), whose aim is to show a reduction in mortality in ARDS using a "conservative" oxygenation strategy (PaO2 maintained between 55 and 70 mmHg) as compared to a classical "liberal" oxygenation strategy (PaO2 between 90 and 105 mmHg).

The LTO-BLOXY study is a substudy of the on-going LOCO-2 study


title: Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center

summary: Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)


title: Descriptive Study of the Physiological and Oral Parameters of the Young Child to the Adolescent

acronym: PhyDentchild

summary: The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.

time_perspective: Cross-Sectional


title: Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface

summary:
The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.

The secondary objectives are to evaluate:

Predictive factors of dry eye syndrome during cataract surgery:
The characteristics of dry eye syndrome
Implications for the patient's quality of life

intervention_type: Diagnostic Test


title: Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry

acronym: AVOCETTE

summary: This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

lead_sponsor: University Hospital, Caen


title: Voice Tessitura and Size of the Required Laryngeal Mask

acronym: EVG

summary:
The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Study of the Effects of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent Provirus in Circulating CD4 + T Cells Isolated From Patients With Undetectable HIV Viremia Under cART

acronym: FXReservoir

summary:
The Farnesoid X receptor (FXR) is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism. A recent study opens the hypothesis that Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes. This hypothesis implied that modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus replication. The results of in vitro studies with Human Immunodeficiency Virus-infected cell lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death; the overall effect is therefore antiviral. Farnesoid X receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies. This last data raises the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus.

It is therefore crucial to confirm on quiescent CD4 + T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models.

Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome. The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains. It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 + T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART. Human Immunodeficiency Virus-positive patients will be any patients, irrespective of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of antiretrovirals, away from primary infection, when they already had a complete western blot, indicating an evolution of the infection without treatment and constitution of an already evolved reservoir. Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 + T lymphocytes / mm3.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service des maladies infectieuses et tropicales - Hôpital de la Croix Rousse - GHN


title: Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours

acronym: AVAAS

summary:
Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study

acronym: GOALDAN

summary:
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain.

The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.

ReferenceCitation: Michalot A, Bazin JÉ, Richebé P, Allaouchiche B, Boselli E. Effect of GOAL-Directed ANalgesia using ANI (Analgesia/Nociception Index) during general anesthesia on immediate postoperative pain and intraoperative hemodynamics in adult patients (GOALDAN study): a study protocol for randomized, controlled, multicenter trial. Trials. 2022 Apr 25;23(1):353. doi: 10.1186/s13063-022-06273-1.


title: Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study

summary:
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.

This is a monocentric, randomized, parallel group, prospective and open-label study.

ReferenceCitation: Garnier L, Tonetti J, Bodin A, Vouaillat H, Merloz P, Assaker R, Court C; French Society for Spine Surgery. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures. Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S112-9. doi: 10.1016/j.otsr.2012.03.018. Epub 2012 Aug 28.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse

acronym: PeSaCUP

summary:
Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate.

The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

ReferenceCitation: Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007 Apr;196(4):405.e1-8.

ReferenceCitation: Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL. Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2004 Apr;190(4):1025-9.

ReferenceCitation: Patel M, Mellen C, O'Sullivan DM, LaSala CA. Impact of pessary use on prolapse symptoms, quality of life, and body image. Am J Obstet Gynecol. 2010 May;202(5):499.e1-4. doi: 10.1016/j.ajog.2010.01.019. Epub 2010 Feb 20.

ReferenceCitation: Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14.

ReferenceCitation: Clemons JL, Aguilar VC, Sokol ER, Jackson ND, Myers DL. Patient characteristics that are associated with continued pessary use versus surgery after 1 year. Am J Obstet Gynecol. 2004 Jul;191(1):159-64.

ReferenceCitation: Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15.

ReferenceCitation: Markle D, Skoczylas L, Goldsmith C, Noblett K. Patient characteristics associated with a successful pessary fitting. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):249-52. doi: 10.1097/SPV.0b013e31822f00ae.

ReferenceCitation: Mutone MF, Terry C, Hale DS, Benson JT. Factors which influence the short-term success of pessary management of pelvic organ prolapse. Am J Obstet Gynecol. 2005 Jul;193(1):89-94.

ReferenceCitation: Geoffrion R, Zhang T, Lee T, Cundiff GW. Clinical characteristics associated with unsuccessful pessary fitting outcomes. Female Pelvic Med Reconstr Surg. 2013 Nov-Dec;19(6):339-45. doi: 10.1097/SPV.0b013e3182a26174.

ReferenceCitation: Kuhn A, Bapst D, Stadlmayr W, Vits K, Mueller MD. Sexual and organ function in patients with symptomatic prolapse: are pessaries helpful? Fertil Steril. 2009 May;91(5):1914-8. doi: 10.1016/j.fertnstert.2008.02.142. Epub 2008 Apr 14.

ReferenceCitation: Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61.

ipd_sharing_description: The IPD will be shared with the researchers working with me for the study, i.e. Dr Villot and Miss Renouf


acronym: First-BLINDOS

title: Evaluation of a Strategy for Systematic Screening for Vitamin D Deficiency and Treatment in Case of Deficiency, on the Improvement of the Maximum Walking Distance in Patients With Stage 2 Lower Limb Arterial Disease.

lead_sponsor: University Hospital, Angers

source: euctr

summary:
The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year.

Most clinical evidence supports the idea that having normal vitamin D reduces cardiovascular risk. The data suggests that normalizing vitamin D levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease.

There is also a plausible physiological theory, supported by numerous observational studies, that vitamin D supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events.

The investigators hypothesize that routine screening for vitamin D deficiency and supplementation in case of hypovitaminosis D is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 PAD patients .


title: Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study

acronym: TOX-AKI

summary: The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck

acronym: ELAN-ONCOVAL

summary: Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )

summary:
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.

The primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.

Included patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 <30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score> 23).

PtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.

lead_sponsor: University Hospital, Rouen

location_facility: Physiology department of Rouen University Hospital,


title: Left Ventricular 2D and 3D Strain in Healthy Subject : Comparative Study Between Two Echocardiograph (Vivid 9 General Electric et Epiq 7 Philips)

acronym: RBHPCLERFOND

summary: The aim of the C3S study is research an equivalence with longitudinal, radial and circumferential, global and segmental strain value, in left Ventricular in 2 and 3 dimension between two echograph General Electric Vivid 9 (GE Vingmed, Horton, Norway) et Philips Epiq 7.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

acronym: DISPOSITIF LAR

summary: The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer

acronym: DISCOVER

summary: To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers


title: Evaluation of Immunization Coverage of Premature Infants Leaving CHU d'Angers According to the Recommended Regimen During the First 4 Months (VACCIPREM)

acronym: VACCIPREM

summary:
Premature children are particularly vulnerable in terms of infection and vaccinated in a specific, reinforced vaccination schedule. However, the beginning of the vaccination of these children is often postponed and the vaccination schedule little followed.Concerning the vaccination of premature children, the national recommendations of the High Council of Public Health (HCSP) are different from those of the French experts in pediatric vaccinology. The HCSP recommends a vaccination schedule beginning at the age of 8 weeks postnatal, including, as for full-term infants, two injections at 2-month intervals of vaccine against diphtheria, tetanus, poliomyelitis, haemophilus influenzae B type, whooping cough and hepatitis B. Anti-pneumococcal vaccination is recommended at 2, 3 and 4 months of life.

The French experts of the Infectious Pediatric Pathology Group (GPIP) of the French Pediatric Society recommend a primary vaccination against whooping cough, diphtheria, tetanus, poliomyelitis, Haemophilus Influenzae B (DTPCoqHIB) and hepatitis B at 2, 3 and 4 months for children born before 33 weeks of amenorrhea (WA), and at 2 and 4 months for those born between 33 and 36 weeks + 6 days. Primary anti-pneumococcal vaccination is recommended at 2, 3 and 4 months for all children born prematurely before 37WA.

On the other hand, the cocooning vaccination of the parents against whooping cough is recommended in case of birth at term as of premature birth. This cocooning strategy has not been sufficiently applied, justifying a recall in 2008 for all adults who have not received pertussis vaccination during the last ten years.

The investigators seek to evaluate the follow-up of the recommended vaccination schedule of premature children leaving Angers University Hospital and the reasons associated with the non-monitoring of the calendar in order to identify possible lines of work to improve immunization compliance.

ipd_sharing_description: Study openning only in CHU Angers


title: Performance of Non-targeted and/or Non-invasive Respiratory Samples for the Rapid Diagnosis of Pneumocystis Pneumonia Using the BDMAX TM Molecular Biology Platform (Becton Dickinson)

acronym: DANIPOP

summary:
Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.

In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).


title: Randomized Phase II Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab in Locally Advanced Cervical Cancer

acronym: ATEZOLACC

summary: The primary objective of this randomized phase II trial is to evaluate the clinical benefits of the addition of atezolizumab to standard chemoradiotherapy (CRT) (first given concurrently with CRT, then continued as adjuvant treatment), compared with CRT alone, on investigator-assessed progression-free survival (PFS), as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

intervention_type: Radiation


title: Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever

acronym: ECHOPERY

summary: Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. In order to support this hypothesis, ankle musculoskeletal ultrasound will be performed within 24 hours of onset of ELE in 15 patients diagnosed with FMF. Results will be correlated with clinical parameters, serum inflammatory markers, and ankle radiography.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.

acronym: OCRP

summary: The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.

ReferenceCitation: Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16. Review.

ReferenceCitation: Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.

lead_sponsor: Quanta Medical


title: Quantification de l'immunité T Anti-CMV à l'Aide d'un Test IGRA Chez Des Patients greffés rénaux et Des Patients dialysés, Comparaison Avec Une Population de témoins

acronym: Quantiferon

summary: Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

ReferenceCitation: Radha R, Jordan S, Puliyanda D, Bunnapradist S, Petrosyan A, Amet N, Toyoda M. Cellular immune responses to cytomegalovirus in renal transplant recipients. Am J Transplant. 2005 Jan;5(1):110-7.

ReferenceCitation: Lisboa LF, Kumar D, Wilson LE, Humar A. Clinical utility of cytomegalovirus cell-mediated immunity in transplant recipients with cytomegalovirus viremia. Transplantation. 2012 Jan 27;93(2):195-200. doi: 10.1097/TP.0b013e31823c1cd4.

ReferenceCitation: Kumar D, Chernenko S, Moussa G, Cobos I, Manuel O, Preiksaitis J, Venkataraman S, Humar A. Cell-mediated immunity to predict cytomegalovirus disease in high-risk solid organ transplant recipients. Am J Transplant. 2009 May;9(5):1214-22. doi: 10.1111/j.1600-6143.2009.02618.x.

ReferenceCitation: Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.

ReferenceCitation: Cantisán S, Lara R, Montejo M, Redel J, Rodríguez-Benot A, Gutiérrez-Aroca J, González-Padilla M, Bueno L, Rivero A, Solana R, Torre-Cisneros J. Pretransplant interferon-γ secretion by CMV-specific CD8+ T cells informs the risk of CMV replication after transplantation. Am J Transplant. 2013 Mar;13(3):738-45. doi: 10.1111/ajt.12049. Epub 2013 Jan 11.

ReferenceCitation: Walker S, Fazou C, Crough T, Holdsworth R, Kiely P, Veale M, Bell S, Gailbraith A, McNeil K, Jones S, Khanna R. Ex vivo monitoring of human cytomegalovirus-specific CD8+ T-cell responses using QuantiFERON-CMV. Transpl Infect Dis. 2007 Jun;9(2):165-70.


title: Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

acronym: OPALE

summary: Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration


title: Effects of Thigh Cuffs to Prevent the Deconditioning Induced by 5 Days of Dry Immersion Used as a Ground-based Model to Study the Effects of Weightlessness

acronym: DI-Cuff

summary:
The objective of the study is to investigate whether thigh cuffs help to prevent and/or reduce the deconditioning induced by 5 days of dry immersion and in particular the fluid shift and its related ophthalmological disorders. During a randomized 5 day dry-immersion study in 20 healthy male adults the two following aims will be undertaken:

Ten scientific protocols will assess the changes in the cerebral, ocular, cardiovascular, metabolism, cognitive, muscle and bone systems.
In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

ReferenceCitation: Arbeille P, Herault S, Fomina G, Roumy J, Alferova I, Gharib C. Influences of thigh cuffs on the cardiovascular system during 7-day head-down bed rest. J Appl Physiol (1985). 1999 Dec;87(6):2168-76.

ReferenceCitation: Balasubramanian S, Tepelus T, Stenger MB, Lee SMC, Laurie SS, Liu JHK, Feiveson AH, Sadda SR, Huang AS, Macias BR. Thigh Cuffs as a Countermeasure for Ocular Changes in Simulated Weightlessness. Ophthalmology. 2018 Mar;125(3):459-460. doi: 10.1016/j.ophtha.2017.10.023. Epub 2017 Nov 16.

ReferenceCitation: De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

ReferenceCitation: Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

ReferenceCitation: Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14. Review.

lead_sponsor: Centre National d'Etudes Spatiales


title: In Vitro Study Of the Effects of the Menthoxypropanediol, an Anti-TRPM8, in the Atopic Dermatitis Pruritus

summary: The aim of the study is to analyse the effect of the menthoxypropanediol, a derivative of menthol, on the pruritus of atopic dermatitis (ex vivo study).

lead_sponsor: University Hospital, Brest


title: Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy

acronym: IPEC

summary: This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.

location_facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL


title: Splenectomy During Whole Liver Transplantation

summary: Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.


title: Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term

summary:
Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.

status: Not yet recruiting


title: Combined Detection of Interleukin-6 and Insulin-like Growth Factor Binding Protein-1 Total and Native (Premaquick) for the Prediction of Delivery in Women With Threatened Preterm Labor

acronym: PREMAQUICK

summary: The primary purpose of the protocol is to compare the diagnostic accuracy in terms of positive and negative predictive values of Premaquick © (combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native) and Quikcheck fFN ™ (fibronectin detection) tests for prediction of spontaneous delivery within 7 days in women with threatened preterm labor. The study hypothesis is that combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native dice the admission will improve the prediction of delivery compared to the detection of fetal fibronectin alone in women with threatened preterm labor.

ReferenceCitation: Compan C, Rossi A, Piquier-Perret G, Delabaere A, Vendittelli F, Lemery D, Gallot D. [Prediction of spontaneous preterm birth in symptomatic patients: A review]. J Gynecol Obstet Biol Reprod (Paris). 2015 Oct;44(8):740-51. doi: 10.1016/j.jgyn.2015.06.008. Epub 2015 Jun 29. Review. French.

ReferenceCitation: Deplagne C, Maurice-Tison S, Coatleven F, Vandenbossche F, Horovitz J. [Sequential use of cervical length measurement before fetal fibronectin detection to predict spontaneous preterm delivery in women with preterm labor]. J Gynecol Obstet Biol Reprod (Paris). 2010 Nov;39(7):575-83. doi: 10.1016/j.jgyn.2010.08.001. Epub 2010 Sep 29. French.

ReferenceCitation: Eleje GU, Ezugwu EC, Eke AC, Eleje LI, Ikechebelu JI, Ezebialu IU, Obiora CC, Nwosu BO, Ezeama CO, Udigwe GO, Okafor CI, Ezugwu FO. Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor. J Perinat Med. 2017 Nov 27;45(8):915-924. doi: 10.1515/jpm-2016-0339.

ReferenceCitation: Sentilhes L, Sénat MV, Ancel PY, Azria E, Benoist G, Blanc J, Brabant G, Bretelle F, Brun S, Doret M, Ducroux-Schouwey C, Evrard A, Kayem G, Maisonneuve E, Marcellin L, Marret S, Mottet N, Paysant S, Riethmuller D, Rozenberg P, Schmitz T, Torchin H, Langer B. [Prevention of spontaneous preterm birth (excluding preterm premature rupture of membranes): Guidelines for clinical practice - Text of the Guidelines (short text)]. J Gynecol Obstet Biol Reprod (Paris). 2016 Dec;45(10):1446-1456. doi: 10.1016/j.jgyn.2016.09.011. Epub 2016 Nov 9. Review. French.


title: Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target

acronym: VKA

summary: Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Patient and Partner Perception After Remission of Cushing's Syndrome - Parathyroid 3 Cushing Study

acronym: CUSHING

summary:
Hypercortisolism leads to long term physical and cognitive sequelae. This also holds true for quality of life, even several years after remission. This altered quality of life, highly subjective, is however, badly evaluated by the family of the patient. This could lead to misunderstanding, avec worsen the general physical and mental health of the patient. To our knowledge, this theoretical difference of perception has never been evaluated up to now.

The aim of our study is to evaluate the difference of perception of the quality of life and body image between patients in remission of hypercortisolism, and their caregivers. Secondary objectives will be to evaluate the quality of life of the caregivers, the coping strategies, and the depression/anxiety parameters of both the patient and the caregiver. Patients and methods: the study is Observative, prospective and non-randomized. Inclusion criteria will be patients, aged more than 18, with hypercortisolism in remission for at least 1 year. Self-questionnaires on quality of life, body image, coping, depression and anxiety will be provided to the patient and his/her caregiver. Fulfilling will be blind between the patient and his/her caregiver. Inclusion period will be 12 months.

Results will be compared between the patient and his/her caregiver. Expected results: investigators anticipate that some caregivers will have a different perception of the general physical and mental condition as stated by the patient. The first time that the quality of life of the caregiver would be also altered.

This original project might lead to modify the management of Cushing's syndrome, by considering both the patient and his/her caregiver on a long term basis after remission.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study

summary: this project will allow us to evaluate and understand the impact of SLE on the couple's life and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

location_facility: Assitance Publique Hôpitaux de Marseille


title: Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Intermediate Risk Prostate Cancer Candidates for Radical Prostatectomy

acronym: PROSTATEP

summary:
Patients with primary intermediate risk prostate cancer for whom radical prostatectomy is indicated, will be invited to participate to the present study.

Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled.

lead_sponsor: University Hospital, Bordeaux


title: Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.

acronym: DCPO Sein

summary: Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.

ReferenceType: result

ReferenceCitation: Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

ReferenceCitation: Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

ipd_sharing_description: Will not be shared

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Claudius Regaud - IUCT-Oncopole


title: Interest of Flow Cytometry in Infectious Point of Care: Feasibility Study

summary:
The purpose of this project is to validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.

This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers.


title: Multi-scale Analysis of Physiological and Pathological Brain Networks by Simultaneous EEG-MEG-SEEG Recordings

acronym: SCALES

summary: The SEEG implantation is performed on purely clinical criteria for preoperative diagnosis. Magnetoencephalography and EEG are purely passive techniques that do not involve any additional risk. This project is a continuation of an existing project in which it was demonstrated the feasibility of simultaneous SEEG and MEG/EEG recordings.


title: Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study

acronym: IMAHTEP

summary: To estimate the intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping in locally advanced and trace mestastatic non-small cell lung cancer (NSCLC).


title: Observational Study in Patients Receiving a Digestive Microbiota Transplant According to a Standardized Protocol

summary:
The digestive microbiota graft is performed in three clinical circumstances:

Clostridium difficile colitis is responsible for numerous deaths each year showing a severe prognosis. In 2013, fecal microbiote (or digestive microbiota) transplantation showed its superiority compared to the reference treatment in recurrences of C. difficile colitis. Our team has demonstrated the value of early grafting in C. difficile-associated colitis associated with ribotype 027. This strain is associated with severe cases and high mortality. In view of the major benefit observed in these particular clinical situations, investigators have implemented since 2013 in C. difficile O27 colitis and then in 2014 in severe C. difficile colitis and since May 2016 for all patients. More than 100 transplants were performed in the department dividing the risk of mortality by 5. The investigators also demonstrated the value of early fecal grafting in severe colitis irrespective of the ribotype involved. In addition, The investigators want to evaluate our protocol of fecal microbiote transplant from the first episode of C. difficile colitis in the "Unit of contagion at IHU".

2- Antibiotic-resistant bacteria In the case of digestive colonization with emergent multi-resistant bacteria, the fecal transplant has proved its effectiveness..

3- Chronic diarrhea without etiologies Finally, and after the other etiologies have been eliminated, the fecal graft may be used in this indication.

The purpose of this study is to study the characteristics of patients who have undergone treatment by grafting of digestive microbiota according to a protocol standardized either by nasogastric tube or by freeze-dried digestive microbiota capsules in 3 indications: clostridium difficile Diarrhea, multidrug resistance bacteria and chronic unexplained diarrhea without altering patient management elsewhere.

200 patients (adults) hospitalized for an episode of C. difficile colitis, multidrug resistant bacteria or chronic diarrhea without etiologies will be recruited during a period of 3 Years.

After treatment by grafting of digestive microbiota, and after signed consent, data were collected during their hospitalization and followed up at one month, 3 months, 6 month and 2 years. Data were analysed in order to determine the characteristics of patients benefiting from a digestive microbiota transplant according to a standardized protocol.


title: Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

acronym: SPIP

summary:
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.

Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.

Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.

The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).

Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.

status: Active, not recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de gynecologie Hôpital Femme mère enfant


title: Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome

acronym: DIADYSAS

summary: The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.

status: Terminated


title: Hemorrhagic Risk and Transfusion Practice Evaluation in Elective Head, Neck and Spine Surgery.

acronym: THANKS

summary:
During elective surgery, the decision to transfuse a patient to correct anemia or an unstable hemodynamic state is often determined on a case by case basis according to personal and hospital transfusion practice. There is wide variability in these practices. Literature suggests that a restrictive transfusion practice is equivalent, if not better, than a liberal practice in terms of morbidity and mortality. However, these data may not be generalizable to specific head, neck, and spine surgeries.

At the head and neck department of Montpellier University Hospital, the hemorrhagic risk has not been precisely measured for certain surgical procedures. Thus hemorrhagic risk tends to be overestimated and unnecessary blood tests tend to be ordered.

In our single center, retrospective, observational study the investigators will determine the hemorrhagic risk related to each elective surgical procedure performed in our center. The investigators will also analyze the transfusion triggers used, and will compare them to national and international recommendations. The results of this study will inform transfusion and laboratory practice for patients undergoing head, neck, or spine surgery.


title: Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery

acronym: PAPA

summary:
The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment.

The goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis

time_perspective: Other


type: Other Grant/Funding Number

title: Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions

acronym: BIMEDOC

summary: In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.

lead_sponsor: University Hospital, Toulouse


title: Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)

acronym: TIC-EEG

summary:
Tourette's syndrome (TS) is a debilitating and severe syndrome whose pathophysiology remains unclear.

In order to precise the cortical regions involved in the generation of tics, investigators will realize an electroencephalogram (EEG) recording in the frontal cortex of TS patients in ecological conditions (EEG-holter). Activity changes will be correlated with event markers of tics and neurovegetative parameters. Statistical analyses will be compared between epochs of EEG recording with tics and without tics. The aim is to define the cortical regions involved in the genesis of tics in order to consider new targets for cortical stimulation.


type: EudraCT Number

title: Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)

acronym: TRAVERS

summary:
Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance).

This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.

lead_sponsor: Auris Medical AG


title: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

summary: Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie


title: Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier

summary: The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.

lead_sponsor: Nestlé

intervention_type: Combination Product


title: Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study

acronym: BACCHUS

summary:
The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major.

The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

ReferenceCitation: Zouboulis CC, Makrantonaki E. Clinical aspects and molecular diagnostics of skin aging. Clin Dermatol. 2011 Jan-Feb;29(1):3-14. doi: 10.1016/j.clindermatol.2010.07.001. Review.

ReferenceCitation: Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5.

ReferenceCitation: Shin MH, Rhie GE, Park CH, Kim KH, Cho KH, Eun HC, Chung JH. Modulation of collagen metabolism by the topical application of dehydroepiandrosterone to human skin. J Invest Dermatol. 2005 Feb;124(2):315-23.

ReferenceCitation: Röck K, Grandoch M, Majora M, Krutmann J, Fischer JW. Collagen fragments inhibit hyaluronan synthesis in skin fibroblasts in response to ultraviolet B (UVB): new insights into mechanisms of matrix remodeling. J Biol Chem. 2011 May 20;286(20):18268-76. doi: 10.1074/jbc.M110.201665. Epub 2011 Mar 17.

ReferenceCitation: Varani J, Spearman D, Perone P, Fligiel SE, Datta SC, Wang ZQ, Shao Y, Kang S, Fisher GJ, Voorhees JJ. Inhibition of type I procollagen synthesis by damaged collagen in photoaged skin and by collagenase-degraded collagen in vitro. Am J Pathol. 2001 Mar;158(3):931-42.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of SENS-401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

acronym: AUDIBLE-S

summary: Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

lead_sponsor: Sensorion


title: Impact of a Procalcitonin-based Algorithm on Quality of Management in Patients With Uncomplicated Adhesion-related Small Bowel Obstruction Assessed by Textbook Outcome: a Multicenter Cluster-randomized Open-label Controlled Trial. (ALPROC)

acronym: ALPROC

summary: Adhesion-related small bowel obstruction is a common digestive emergency that can be managed either conservatively or surgically. However, the choice between these two approaches can be difficult due to the absence of specific signs. The objective of this study is to evaluate the clinical impact of a procalcitonin-based algorithm.

ReferenceCitation: Sabbagh C, Mauvais F, Tuech JJ, Tresallet C, Ortega-Debalon P, Mathonnet M, Lefevre JH, Lakkis Z, Fuks D, Muscari F, Dron B, Couderc P, Alves A, Regimbeau JM. Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial. BMC Gastroenterol. 2022 Mar 2;22(1):90. doi: 10.1186/s12876-022-02144-w.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model

acronym: ROI

summary:
Use lay language.

According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

BPD (Borderline Personality Disorder) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

Borderline Personality Disorder is also the psychopathology the most related to suicidal attempts.

Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a Borderline Personality Disorder

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a Borderline Personality Disorder are highly sensitive to it.

Moreover, neuropeptides such as oxytocin (OXT), vasopressin and opioid are known to be involved in the regulation of the emotions, especially those linked to relationship.

The purpose of this study is to improve knowledge in suicidal behaviors.

After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD will be compared to healthy controls (HC).

Clinical data reflecting how the participant is feeling will be collected as well.