title: Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)

summary: The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.

ReferenceCitation: Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders

acronym: S'TIM 1

summary: This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Ramsay Générale de Santé

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

acronym: MIMIC

summary:
Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.

Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.

The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological

lead_sponsor_type: academique


title: Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

acronym: COMET

summary:
Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.

The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency

summary: CTLA4 and LRBA deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. It ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. Neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. Early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Schindler MK, Pittaluga S, Enose-Akahata Y, Su HC, Rao VK, Rump A, Jacobson S, Cortese I, Reich DS, Uzel G. Haploinsufficiency of immune checkpoint receptor CTLA4 induces a distinct neuroinflammatory disorder. J Clin Invest. 2020 Oct 1;130(10):5551-5561. doi: 10.1172/JCI135947.

ReferenceCitation: Ayrignac X, Goulabchand R, Jeziorski E, Rullier P, Carra-Dallière C, Lozano C, Portales P, Vincent T, Viallard JF, Menjot de Champfleur N, Rieux-Laucat F, Besnard C, Koenig M, Guissart C, Labauge P, Guilpain P. Two neurologic facets of CTLA4-related haploinsufficiency. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(4). pii: e751. doi: 10.1212/NXI.0000000000000751. Print 2020 Jul.

ReferenceCitation: Schubert D, Bode C, Kenefeck R, Hou TZ, Wing JB, Kennedy A, Bulashevska A, Petersen BS, Schäffer AA, Grüning BA, Unger S, Frede N, Baumann U, Witte T, Schmidt RE, Dueckers G, Niehues T, Seneviratne S, Kanariou M, Speckmann C, Ehl S, Rensing-Ehl A, Warnatz K, Rakhmanov M, Thimme R, Hasselblatt P, Emmerich F, Cathomen T, Backofen R, Fisch P, Seidl M, May A, Schmitt-Graeff A, Ikemizu S, Salzer U, Franke A, Sakaguchi S, Walker LSK, Sansom DM, Grimbacher B. Autosomal dominant immune dysregulation syndrome in humans with CTLA4 mutations. Nat Med. 2014 Dec;20(12):1410-1416. doi: 10.1038/nm.3746. Epub 2014 Oct 20.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Prevalence of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in Occitania

acronym: CYPPOT

summary:
The aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital.

Some Gibberellin-regulated protein (GRP) in fruits and pollens have been identified as allergen, and peach GRP (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. Multiple fruit allergies might be related to cross-reactivity between GRPs. Peamaclein shares 82% identity with snakin-1 from potato. Thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.


title: Monocentric Observational Study to Determine the Relationship Between Arterial Hypertension and Hypervolaemia, Defined by Self-measurement of Impedancemetry in Kidney Transplant Recipients Under 6 Months Old

acronym: HTAôConnect

summary:
The working hypothesis is that hypertension during the first post-transplant trimester is partly explained by the patient's hypervolemia. The main objective of the single-center observational study "HTA ô Connect" is to study the relationship between hypertension and extracellular hyperhydration, thanks to repeated self-measurements of blood pressure and impedancemetry between the 30th and the 90th day post-transplant, in 150 incident kidney transplant patients from our department, the ITUN (Institute of Urology-Nephrology Transplantation).

The study population involves 150 incident kidney transplant patients, presenting to the Nantes University Hospital Transplant Institute for 1 month (D30), and presenting with hypertension ≥ 140/90mmHg and not treated with a diuretic.

Data collected at the patients' homes will be used to establish a relationship between blood pressure and extracellular water volume. The data collected will not be used to follow up patients who participated in the study in this first stage of exploration.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.

acronym: Early Dry

summary:
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.

We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital cardiologique Louis Pradel - HCL


title: Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

acronym: BIOTOUL

summary: The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.

lead_sponsor: University Hospital, Toulouse


title: Interstitial Fluid Composition in Patients With Septic Versus Non-septic Shock: an Exploratory Pilot Study

acronym: INTERSEP

summary:
Septic shock is a common reason for admission to intensive care units and severe infections are responsible for 6 million deaths a year worldwide. Fluid management appears to be a major issue in resuscitation and particularly in septic shock, where generalised oedema is almost systematic and is a major factor in poor prognosis during sepsis. The formation of oedema corresponds to an imbalance, according to Frank-Starling's law of the heart, between the vascular compartment and the interstitial compartment, which is composed of the interstitial liquid and an extracellular matrix. This extracellular matrix consists essentially of a network of collagen and fibroblast fibres. Even though all of the plasma in the body transits through the interstitium in 24 hours and desite its major importance in the microenvironment and intercellular communication, the interstitial compartment has not been fully described. In oncology, interstitial tissue seems to contribute to tumour growth through changes in matrix composition and pressure in the interstitium. This pressure actively contributes to the regulation of transcapillary filtration, and thus to the oedema and hypovolemia observed during sepsis. In usual conditions, the fibroblasts exert a tension on the collagen fibres of the matrix via integrin Beta-1 (ITGB1). This tension is released under the action of pro-inflammatory mediators, resulting in negative pressure which potentiates the formation of oedema.

It has been shown in an endotoxemia model that there is a thousandfold higher concentration of ITGB1 in the interstitium compared to the vascular compartment, suggesting a local secretion of this cytokine. The alteration of the extracellular matrix could also play a role in the perpetuation of oedema during septic shock. Considered as an organ in its own right, interstitial tissue is far from playing a passive role between the vascular compartment and the cells. The hypothesis is that interstitial fluid analysis could improve our understanding of the physiopathology of sepsis, in particular on the alteration of the mechanisms of fluid movement regulation, which remains very poorly understood while being closely associated with prognosis in patients with sepsis.


title: Blinded Independent Central Review (BICR) in New Therapeutic Lung Cancer Trials

summary: Double reads in blinded independent central reviews (BICRs) are recommended to control the quality of trials but they are prone to discordances. We analyzed inter-reader discordances in a pool of lung cancer trials using RECIST 1.1.

status: Active, not recruiting

lead_sponsor: Median Technologies


title: Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

summary: The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

lead_sponsor: Smart Immune SAS

location_facility: CIC Paris Est, Hôpital Pitié Salpêtrière

intervention_type: Procedure


title: Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation

acronym: STRAIN ETO

summary:
Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome.

Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion.

Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications.

In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output.

Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time.

Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software.

Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation.

ipd_sharing_description: The individual participant data will not be shared


title: ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES

acronym: LBA-PI

summary:
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.

The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.

Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.

primary_purpose: Health Services Research

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

acronym: SKIN-ICU

summary:
Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not.

The objectives of the study are :

To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes
To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

ReferenceType: background

ReferenceCitation: Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. Review.

ReferenceCitation: Urbina T, Canoui-Poitrine F, Hua C, Layese R, Alves A, Ouedraogo R, Bosc R, Sbidian E, Chosidow O, Dessap AM, de Prost N; Henri Mondor Hospital Necrotizing Fasciitis Group. Long-term quality of life in necrotizing soft-tissue infection survivors: a monocentric prospective cohort study. Ann Intensive Care. 2021 Jul 2;11(1):102. doi: 10.1186/s13613-021-00891-9.

ReferenceCitation: Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014 Jul 15;59(2):147-59. doi: 10.1093/cid/ciu296. Epub 2014 Jun 18.

ReferenceCitation: Peetermans M, de Prost N, Eckmann C, Norrby-Teglund A, Skrede S, De Waele JJ. Necrotizing skin and soft-tissue infections in the intensive care unit. Clin Microbiol Infect. 2020 Jan;26(1):8-17. doi: 10.1016/j.cmi.2019.06.031. Epub 2019 Jul 5. Review.

ReferenceCitation: Madsen MB, Skrede S, Bruun T, Arnell P, Rosén A, Nekludov M, Karlsson Y, Bergey F, Saccenti E, Martins Dos Santos VAP, Perner A, Norrby-Teglund A, Hyldegaard O. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT): protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2018 Feb;62(2):272-279. doi: 10.1111/aas.13024. Epub 2017 Oct 29.

lead_sponsor: Henri Mondor University Hospital


title: Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

acronym: EYEBRID

summary:
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.

This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Caen


title: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care

acronym: IDSein

summary: The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

intervention_type: Behavioral


title: Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.

acronym: Daphné

summary: Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination

lead_sponsor: Poitiers University Hospital


title: ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure

acronym: I-SWEAR

summary: Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Efficacy, Tolerance and Acceptability of Pulsed Dye Laser on Telangiectasias of the Face and Neckline in Systemic Scleroderma: a Prospective Single-center Open-label Study of 21 Patients

acronym: PDL

summary:
This single-center, prospective, open-label, quasi-experimental, intra-individual comparative study will include a consecutive cohort of 21 patients with diffuse or limited, minimally active scleroderma with 3 to 30 years of evolution.

Patients will have 4 sessions of pulsed dye laser 595 nm spaced 8 weeks apart. The final quadruple evaluation by several evaluators will be 2 months after the last session, on the following criteria: evolution of the number of telangiectasia; subjective improvement score (LINKERT scale); impact on quality of life (SKINDEX score); visual analog pain scale (VAS); adverse events (AEs), including discontinuation of treatment due to post-session purpura (AT-PPS); patient satisfaction (yes or no).

ReferenceCitation: Mayo TT, Khan F, Hunt C, Fleming K, Markus R. Comparative study on bruise reduction treatments after bruise induction using the pulsed dye laser. Dermatol Surg. 2013 Oct;39(10):1459-64. doi: 10.1111/dsu.12293. Epub 2013 Jul 30.

ReferenceCitation: Yalcinkaya Y, Pehlivan O, Omma A, Alpay N, Erer B, Kamali S, Ocal L, Inanc M. The relationship between nailfold capillaroscopic assessment and telangiectasia score with severity of peripheral vascular involvement in systemic sclerosis. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 91):S92-7. Epub 2015 Mar 23.


type: Other Identifier

title: From Micro- to Macro-vessels : Water, Salt, Heart and Kidneys

acronym: ConcentRatio

summary: Hypertension is a public health concern and affects nearly a third of the French population. It can be complicated by visceral impact (including brain, heart and kidney complications) as well as on vessels especially large arteries, responsible for arterial stiffening. There are close interactions between heart and kidneys, as well as between large arteries and micro-vessels. These relationships also involve the water and salt balance and its regulatory mechanisms. Urinary concentration abilities are closely linked to the renal medullary blood flow, which in itself depends on the integrity of renal micro vessels, thus influencing the water and salt balance. Few previous studies evaluated the interconnections between renal urinary concentration abilities and blood pressure. A previous-one reported a positive relation between pulse pressure and urinary concentration in men, suggesting that subjects with higher urinary osmolarity could present a higher cardiovascular risk. Carotid-femoral pulse wave velocity represents the gold standard for non-invasive arterial stiffness assessment and constitutes an arteriosclerosis infra-clinical marker recommended by the European Society of Cardiology- European Society of Hypertension. It is considered as an independent predictor for global and cardiovascular mortality, coronary heart disease and fatal stroke among patients with hypertension, diabetes or end stage kidney disease. The purpose of this study is to evaluate the relations between fasting urinary osmolarity and arterial stiffness assessed by carotid-femoral pulse wave velocity (CF-PWV) among patients with hypertension.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Interdisciplinaire de Thérapeutique et d'Education APHP- Hôtel Dieu Hospital


title: Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY

acronym: NewbornDS

summary: The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)


title: Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.

acronym: VECODON

summary: The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.

lead_sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape


title: Biomarker Research in Inherited Movement Disorders

acronym: BIOMOV

summary:
Inherited movement disorders are rare conditions, whose cumulative prevalence are in the order of 5-10/100,000 inhabitants, in most cases progressive and can lead to a significant loss of autonomy after one or more decades of evolution. They include spinocerebellar ataxias and hyperkinetic disorders (dystonias, choreas, tremor, parkinsonism and myoclonus with variable combination of those, or more complex alteration of movements). The existence of the National Reference Centre (CMR) for Rare Diseases (CMR Neurogenetics, devoted to ataxias and spastic paraparesis, dystonia and rare movement disorders and CMR Huntington, devoted to Huntington Disease) has allowed a more integrated vision of these diseases. This is illustrated, in the same family, by the occurrence of different clinical expressions of spinocerebellar ataxias and hyperkinetic disorders that share the same genetic background. Conversely, different causal mutations within the same gene may have very different ages at onset and a wide range of clinical expression, and the spectrum of new phenotypes linked to a single gene is still expanding . Many ataxia and dystonia genes are involved in similar pathways. There are numerous arguments supporting a share pathogenesis including synaptic transmission and neurodevelopment .

BIOMOV project aims to :

establish the clinical spectrum and natural history of these diseases,
understand the role of genetic and familial factors on the phenotype,
elucidate the molecular basis of these disorders and evaluate diagnostic strategies involving molecular tools for clinical and genetic management,
develop multimodal biomarkers both for physiopathological studies and for accurate measures of disease progression,
develop trial ready cohorts of well characterized genetic patients,
test new therapies either symptomatic or based on pathophysiological mechanisms.


title: Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program

acronym: INTREC

summary:
Emotional regulation (ER) appears today as a fundamental skill for the adaptation of an individual to his environment. Indeed, functional and efficient ER is crucial for mental well-being, but also for physical health, for the maintenance of satisfying social relationships , and for work performance. Many research studies have shown that difficulties with ER are central to the development of many mental disorders. Consequently, this skill can be the target of psychological interventions , the effectiveness of which can be tested as well as the mechanisms underlying that effectiveness. Various "mechanisms of effectiveness" have been advanced in the literature. Of these, this project will specifically test cognitive flexibility and feelings of self-efficacy.

Although a growing number of interventions attempt to target emotional regulation, few are evaluated in subclinical populations and few are protocolized. Similarly, there is little research evaluating the effectiveness processes of these interventions. To date, two types of interventions show particular promise: emotion competence based interventions and compassion focused therapy. This research will therefore be based on the evaluation of two interventions in a randomized controlled trial: Emotion Competence Training Program and Compassion Focused Program that will take place over 12 two-hour sessions in a subclinical and clinical population.

lead_sponsor: University Grenoble Alps


title: Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device

acronym: SIGMA

summary:
The electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices.

The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.

Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects.

These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist.

The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required.

Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings.

We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.

primary_purpose: Basic Science

lead_sponsor: Urgotech


type: EudraCT Number

title: Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger: a Randomized, Double-blind Controlled Study (SAUTYLO)

acronym: SAUTYLO

summary: The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger

intervention_type: Drug


title: AI for Allograft Diseases Diagnosis and Prognosis After Kidney Transplantation

summary:
Kidney transplantation is the treatment of choice for patients with end stage renal disease. One of the major challenges is to better diagnose the attacks undergone by the kidney transplant in order to increase its longevity. Multiple attacks are caused by non-immune and immune mechanisms, first and foremost the acute rejection of the transplant.

Biopsy, an invasive method, remains the "Gold Standard" for diagnosing rejection and other pathologies affecting the kidney transplant.

The invasive nature of these biopsies limits their use and alternative biomarkers have been evaluated in order to diagnose kidney transplant pathologies in a non-invasive manner. It is in this context that the nephrology and renal transplantation department of the Necker hospital and Inserm U1151 have carried out several studies leading to the identification of the diagnostic and prognostic potential of acute rejection, by the determination of urinary concentrations of two chemokines, CXCL9 and CXCL10.

The most recent study conducted within these teams demonstrated that the diagnostic potential of urinary chemokines could be improved by taking into account standard clinicobiological parameters in multiparametric models.

The main objective of the study is to develop, train and validate artificial intelligence models including urinary chemokines, efficient, robust, explainable and interpretable for the diagnosis and non-invasive prognosis of acute renal transplant rejection, trained on a data set made up of clinical and biological parameters.


title: Follow-up of Children With Severe Asthma at Adult Age

summary:
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored.

In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood.

This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational


title: A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection

summary: The problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Previous studies have shown that in patients at high risk of bleeding, the use of (PuraStat®), a simple and easily applicable solution, decreases the rate of delayed bleeding by promoting wound healing. Various preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. The main objective is to compare the efficacy of PuraStat® to the standard treatment in reducing delayed bleeding after colorectal ESD in patients at high risk of delayed bleeding. The secondary objectives are to compare the same two strategies in terms of effectiveness and side effects. The primary outcome measure is the percentage of delayed bleeding at 30 days after surgery (ESD).

lead_sponsor: Mathieu Pioche


title: Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital

acronym: Ana-Ped

summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital


title: Trace Elements Concentration in Dialysis

acronym: EMTDialyse

summary:
In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality.

Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes.

In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

ReferenceCitation: Tonelli M, Wiebe N, Bello A, Field CJ, Gill JS, Hemmelgarn BR, Holmes DT, Jindal K, Klarenbach SW, Manns BJ, Thadhani R, Kinniburgh D; Alberta Kidney Disease Network. Concentrations of Trace Elements in Hemodialysis Patients: A Prospective Cohort Study. Am J Kidney Dis. 2017 Nov;70(5):696-704. doi: 10.1053/j.ajkd.2017.06.029. Epub 2017 Aug 31.

ReferenceCitation: Prodanchuk M, Makarov O, Pisarev E, Sheiman B, Kulyzkiy M. Disturbances of trace element metabolism in ESRD patients receiving hemodialysis and hemodiafiltration. Cent European J Urol. 2014;66(4):472-6. doi: 10.5173/ceju.2013.04.art23. Epub 2014 Jan 27.

ReferenceCitation: Orr SE, Bridges CC. Chronic Kidney Disease and Exposure to Nephrotoxic Metals. Int J Mol Sci. 2017 May 12;18(5). pii: E1039. doi: 10.3390/ijms18051039. Review.

ReferenceCitation: Messner B, Knoflach M, Seubert A, Ritsch A, Pfaller K, Henderson B, Shen YH, Zeller I, Willeit J, Laufer G, Wick G, Kiechl S, Bernhard D. Cadmium is a novel and independent risk factor for early atherosclerosis mechanisms and in vivo relevance. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1392-8. doi: 10.1161/ATVBAHA.109.190082. Epub 2009 Jun 25.

ReferenceCitation: Lee CC, Weng CH, Huang WH, Yen TH, Lin JL, Lin-Tan DT, Chen KH, Hsu CW. Association Between Blood Cadmium Levels and Mortality in Peritoneal Dialysis. Medicine (Baltimore). 2016 May;95(19):e3717. doi: 10.1097/MD.0000000000003717.

ReferenceCitation: Sotomayor CG, Groothof D, Vodegel JJ, Eisenga MF, Knobbe TJ, IJmker J, Lammerts RGM, de Borst MH, Berger SP, Nolte IM, Rodrigo R, Slart RHJA, Navis GJ, Touw DJ, Bakker SJL. Plasma cadmium is associated with increased risk of long-term kidney graft failure. Kidney Int. 2021 May;99(5):1213-1224. doi: 10.1016/j.kint.2020.08.027. Epub 2020 Sep 14.

ReferenceCitation: Larsson SC, Wolk A. Urinary cadmium and mortality from all causes, cancer and cardiovascular disease in the general population: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2016 Jun;45(3):782-91. doi: 10.1093/ije/dyv086. Epub 2015 May 20. Review.

ReferenceCitation: Satarug S, C Gobe G, A Vesey D, Phelps KR. Cadmium and Lead Exposure, Nephrotoxicity, and Mortality. Toxics. 2020 Oct 13;8(4). pii: E86. doi: 10.3390/toxics8040086. Review.

ReferenceCitation: Roozbeh J, Sharifian M, Sagheb MM, Shabani S, Hamidian Jahromi A, Afshariani R, Pakfetrat M, Salehi O. Comment on: does zinc supplementation affect inflammatory markers in hemodialysis patients? Ren Fail. 2011;33(4):466-7. doi: 10.3109/0886022X.2011.568144.


title: Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

acronym: MYCATRES

summary:
Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects.

This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Effects of Long-term Remote Health Monitoring Through Bright Light Exposure, Physical Adapted Activity and Galvanic Vestibular Stimulation on the Sleep of the Elderly: Study Protocol for a Randomised Controlled Trial

acronym: velocce

summary: This study investigates the effects of remote interventions based on the exposure to one or more zeitgebers (i.e. adapted physical activity alone or combined with bright light exposure, or galvanic vestibular stimulation) performed several times a week during three months on older adults' sleep and quality of life.

lead_sponsor: Université de Caen Normandie


title: Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study

acronym: E-merge

summary: The purpose of this study is to compare mepolizumab-based regimen to conventional therapeutic strategy for remission induction in patients with Eosinophilic Granulomatosis with Polyangiitis.

location_facility: Service de Médecine Interne, Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques "Hôpital Cochin


title: Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment

acronym: COLEMAN

summary:
COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care.

The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation.

100 patients will be included and followed during 5 years.


title: Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty

acronym: ERATO

summary:
Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty.

A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

acronym: RESTECH

summary:
The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome.

It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.

primary_purpose: Diagnostic

lead_sponsor: Elsan

location_facility: Centre du Sommeil de la Polyclinique de Poitiers


title: Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program

summary: The objectives are to describe the transition from traditional care to an enhanced recovery program for the management of total knee arthroplasty, and to evaluate the effect on patient outcomes.

ipd_sharing_description:
Data will be made available with publication. Keywords are Arthroplasty, Replacement, Knee, Enhanced Recovery After Surgery. The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication. Medical Subject Headings (MESH) terms will be used to describe clinical data.

Methodology for will be provided in the publication. International standard unit will be used.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: New Recommendations for Robertsonian Translocation Management After Preimplantation Genetic Testing of Structural Rearrangement (PGT-SR) Attempts: What Should be Done With Mosaic Embryos?

summary: to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis

lead_sponsor: University Hospital, Montpellier


title: Identification of Factors Associated With the Occurrence of Severe Forms of COVID-19 Infection in Patients With Inflammatory Rheumatism or Autoimmune Diseases

acronym: CovAID

summary: Factors associated with severe forms of COVID-19 infection in patients with inflammatory rheumatic diseases (IRD) or Autoimmune Diseases (AID) are unknown. This unprecedented situation leads to empirical and potentially erroneous advice and recommendations for care. Identifying factors associated with severity, in the context of this pandemic, which is expected to last many months, and possibly years, is crucial for future patients. The objective of this work is to identify the factors associated with the occurrence of severe forms of COVID-19 infection in patients with IRD or AID, by combining analysis of 2 large databases.


title: Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment

acronym: SEQUOIA

summary: The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du Cancer de Montpellier


title: Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

summary: To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.

intervention_type: Diagnostic Test


title: Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)

acronym: COFTASD

summary: The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.


title: Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre

acronym: PVP-StepPEP

summary:
Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.

Prospective multicentre open-label study of mechanically ventilated intensive care patients.

primary_purpose: Prevention


acronym: OBEREM

title: Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients With Two Doses of Remifentanil: a Pilot Study

lead_sponsor: University Hospital, Toulouse

source: euctr

summary:
This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.

During the induction of general anesthesia, Propofol - Remifentanil combination will be used.

The patients will be randomized in 2 groups with different doses of Remifentanil.


title: Measurement of Brain Perfusion by a Magnetic Resonance (MR) Perfusion Imaging Called eASL in Children's Cerebral Arteriopathies.

acronym: PEACE

summary:
The MR sequence called MR-ASL is used to measure cerebral perfusion in children. This ASL sequence is used with a unique post-labeling delay (PLD) due to the technical impossibility of setting different post-labeling delays. The use of a single post-labeling, chosen by the pediatric radiology department of the Necker hospital, optimal in children without arteriopathy, may not be suitable for the lengthened arterial transit time of the spins marked in the pathological carotid network of a child with arterial disease.

Recently, ASL sequences with multiple delays (multi-PLD, called eASL) have been developed to overcome this limitation in arterial disease. To date, their use in the pre- and post-treatment evaluation of a child with acute or chronic arterial disease has not been evaluated.

The study hypothesis is that this eASL sequence is more efficient than single-delay ASL in measuring cerebral perfusion. The study will be performed in a population of children with acute or chronic arterial disease.


title: BKVIR Project: Predictive Biological Method of BKvirus Associated Nephropathy Risk by the NEPHROVIR Method

acronym: BK-VIR

summary:
BKvirus associated nephropathy (BKvAN) is a major complication in kidney transplantation. Due to BKvirus (BKv) intra-graft replication, BKvAN affects nearly 10% of patients and causes graft loss in more than 50% of cases. Without current antiviral therapy, the treatment consists of minimizing immunosuppression, secondarily exposing the patient to a graft rejection risk. Impaired BKv specific T cell response plays a crucial role in the BKvAN pathophysiology. Several teams, including ours, have demonstrated a profound impairment of BKv specific T cell response during BKvAN. Immunovirological monitoring allows an individual assessment of viral reactivation risk based on the anti-viral immune response. Our group has developed the NEPHROVIR method. This non-invasive biological method for BKvAN allows the identification of BKvAN risk level. The aim of this work is to evaluate, by the NEPHROVIR method, the risk to develop a BKvAN with renal impairment in kidney transplant recipients with sustained BKv viremia.

The investigators propose the BKVIR study. This is a prospective multicentric study involving 100 kidney transplant recipients with sustained BKv viremia. The aim of this work is to evaluate the NEPHROVIR method as an innovative immunovirological surveillance method for predicting the risk of BKvAN occurrence. The characterization of individual BKvAN risk level could help in the individualized follow-up and management of immunosuppression in patients. The long-term objective would be to diagnose very early, or even anticipate, the occurrence of BKvAN and to allow early readjustment of the immunosuppressive treatment.


title: Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours

acronym: NTRK Fusion

summary: This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.


title: Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging

acronym: Echo-QF-IRM

summary:
A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.

We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.

lead_sponsor: Hospices Civils de Lyon

location_facility: Paediatric intensive care - Hospices Civils de Lyon


title: AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

acronym: AAREN

summary: The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction

acronym: DPNI-RCIU

summary:
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.

This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy

acronym: ACTIV'MARCHE

summary: In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.

lead_sponsor: Fondation Ellen Poidatz


title: Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions Developed by Deep-Learning Compared to the Classic Apnea Cine-MRI Sequence in the Assessment of Ischemic Heart Disease.

acronym: CINEDL

summary:
Today, MRI is the gold standard for the precise assessment of left ventricular volume and function, but presents the drawback of having a long acquisition time and of generating motion artifacts, in particular respiratory artifacts, requiring repeated sequences in apnea to cover the whole cardiac volume. These apneas are difficult to achieve in patients with ischemic heart disease and may lead to degradation of the images, an increase in the duration of the examination by repeated acquisitions and therefore to diagnostic inaccuracies.

Artificial intelligence, already used in practice in cardiac MRI for automatic segmentation of the heart chambers, improves radiological interpretation with rapid and precise measurements. Deep-learning, which is part of artificial intelligence, would allow the reconstruction of cine-MRI sequences in free breathing, in order to overcome the artifacts from respiratory motions, and the improvement of diagnostic performance while improving examination conditions for patients.

Patients coming for a cardiac MRI for the assessment of ischemic heart disease will be eligible to the protocol. If the patient agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be added to the usual protocol.

No follow-up will be required in this study.


title: Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome

acronym: IAPRP

summary:
The prevalence of low back pain is estimated at 90% . Recent studies have shown that 15% to 52% of back pain is attributable to facet joint syndrome .

Being the only vertebral joints provided with a synovial membrane, the posterior inter-apophyseal joints are subject, like all other peripheral joints, to degenerative arthritis phenomena.

These phenomena most often result in the release of pro-inflammatory cytokines resulting in cartilage degradation.

PRP or platelet rich plasma is an autologous blood product obtained after centrifugation of a peripheral blood sample. The PRP has many anti-inflammatory properties. Numerous studies have shown the interest of intra-articular infiltration of PRP in osteoarthritis of the knee but also in tendinopathies of the shoulder and a few studies also suggest the use of PRP in the spine "intra-disc, epidural and posterior joints) .

Corticosteroid infiltrations in the posterior lumbar joints constituting the standard treatment in posterior inter-apophyseal osteoarthritis.

The goal is to obtain a new therapeutic weapon in the management of this frequent and invalid disease for patients who are often elderly and with other comorbidity.

lead_sponsor: CHU de Reims


title: Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy

acronym: SpecTum

summary:
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome

acronym: NOSPECKLE

summary:
Acute cor pulmonale is one of deadly complications of mechanically ventilated acute respiratory distress syndrome (ARDS), which can lead to right ventricular dysfunction and worsen the hemodynamics of the patient. For several years, transthoracic (TTE) and transesophageal echocardiography (TEE) have replaced the pulmonary artery catheter to monitor cardiac function reliably and non-invasively.

Speckle tracking is an echocardiographic technique that allows a two-dimensional strain (2D) analysis of right ventricular systolic function. Right ventricular global strain (RVGLS) is a strain parameter, allowing an early and more accurate diagnosis of right ventricular dysfunction than conventional parameters.

This project will consist of performing TTE and TEE measurements at H0, 30min, H1, H2, and H24 after iNO administration in patient with ARDS under mechanical ventilation. The patient will be declared responder to iNO, if there is an increase of more than 20% of the PaO2/FiO2. 30 minutes after a dose of 10ppm of iNO.


title: Impact of Osteopathic Manipulative Treatment on External Lateral Ocular Pursuit, Measured in Healthy Human Adults: a Randomized, Double-blind, Controlled Study

summary: The idea that osteopathic manipulative treatments (OMTs) should have an impact on the human visual system is not new. Nevertheless, there is a lack of scientific, objective, and experimental evidence. Our goal is to conduct a randomized, double-blind, controlled study to evaluate the effect of OMT on ocular pursuit. Eye movements will be measured by an infra-red video-based eye tracking system with a high spatial and temporal resolution. OMTs will be similar to regular treatments given by osteopaths in their daily practice. We hypothesize that OMT will improve the quality of ocular pursuit.

ReferenceCitation: Bordoni B, Zanier E. Clinical and symptomatological reflections: the fascial system. J Multidiscip Healthc. 2014 Sep 18;7:401-11. doi: 10.2147/JMDH.S68308. eCollection 2014.

lead_sponsor: Ecole d'ostéopathie de Paris


title: Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation

summary: Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined

lead_sponsor: Federation Francophone de Cancerologie Digestive


title: A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Study to Investigate the Relative Bioavailability of Binimetinib 3 x15 mg and 45 mg Tablets in Healthy Participants

summary:
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated.

In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the relative bioavailability of the 45 mg tablet in comparison to three 15 mg tablets intake is therefore required.

lead_sponsor: Pierre Fabre Medicament


title: Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

summary:
Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.

The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.

Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.

Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.

For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.

acronym: KPL

summary: As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.

lead_sponsor: Biotech Dental


title: 4D Flow Cardiac MRI Velocity Mapping in Patients With Pulmonary Hypertension: Estimation of Pulmonary Arterial Pressure and Comparison With Right Heart Catheterization and Doppler Echocardiography

acronym: HTPFLUW

summary:
Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH.

Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Benefits of a Music-based Self-relaxing Program Application (MUSIC-CARE) Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery : A Randomized Trial

summary:
Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. But, backed by a movement aiming at reducing the use of pharmacological products, alternative interventions, including music therapy, have gained some steam in recent years. These interventions may have the ability to reduce pain and anxiety while increasing relaxation, coping skills and the overall experience of the procedure. For orthopedic surgery, anesthetics could propose general anesthesia or locoregional anesthesia. The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure. However, with the known exacerbating effects of stress and anxiety on pain, the affective experience of the patient can be negatively influenced. In order to mitigate these problems, various types of sedatives and anxiolytics and even low-dose propofol can be used.

The Montpellier Regional University Hospital, along with the Music Care Company developed a software so as to standardize this technique around these recommendations. This model demonstrated its efficacy in both acute and chronic pain settings. Indeed, a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention period in intubated patients during weaning phase. Also, a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological (e.g., depression) and physiological (e.g., pain and discomfort) outcomes and, very importantly, to reduce the consumption of medication in patients with chronic pain due to lumbar pain, fibromyalgia, inflammatory or neurological diseases.

Given the recent availability of a standardized and proven delivery method of music therapy (i.e. MUSIC-CARE), the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters, pain, anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia.

ReferenceCitation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12. Review. Erratum in: Lancet. 2015 Oct 24;386(10004):1630.

ReferenceCitation: Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

ReferenceCitation: Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18. pii: rapm-2018-100251. doi: 10.1136/rapm-2018-100251. [Epub ahead of print]

ReferenceCitation: Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.

ReferenceCitation: Zengin S, Kabul S, Al B, Sarcan E, Doğan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.

lead_sponsor: American Hospital of Paris


title: Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease

summary: The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of platelets/Von Willebrand Factor aggregates. Interestingly, several patients present nonspecific neurological symptoms (nystagmus, headaches, memory disorder, …) which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes.

lead_sponsor: University Hospital, Caen


title: Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating.

acronym: ETNA

summary:
Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating.

Retrospective study

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

acronym: ERAMIS

summary:
Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme.

The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).


title: Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem

acronym: ATHENS

summary:
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.

Retrospective and prospective multicentric study.


title: Sprint Interval Training (SIT) on the Endurance, Strength and Velocity Capacities of Healthy Sedentary Subjects

acronym: BénéfiSIT

summary: The present study aims to analyse first, the acute effects generated by a single bout of Sprint Interval Training (SIT) and, secondly, the effects of a long-term intervention on sedentary participants.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of Chemotherapeutic Treatments on Functional Autonomy and Quality of Life in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy

acronym: LYMPHOLD

summary: The aim of the study is to assess the prevalence of functional decline in elderly patients treated with chemotherapy or immunochemotherapy for lymphoid hematologic malignancies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion.


title: Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder

acronym: CICASCAP

summary: This study is based on the hypothesis that the functional result is better if the subscapularis is reinserted and healed. The originality of the study therefore consists in systematically monitoring the healing of this tendon postoperatively, with sufficient follow-up, by ultrasound and by an intra-tendon marker, in order to differentiate the result depending on whether the tendon is healed or not.

lead_sponsor: Ramsay Générale de Santé


title: Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout

acronym: BURNOUT ADVICE

summary:
Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. According to a 2019 survey by Malakoff, 56% of employees are in "professional or personal fragility", but the statistics are incomplete.

In the medical community, the burnout rate is doubled compared to the general population.

The diagnosis of pre-burnout can precede a burnout by several months, an early treatment can then reduce complications and improve the quality of life at work.

On a study model on health data already carried out as part of a cancer detection application in smokers which involved 7000 users and which showed the ability to of such an application to detect curable symptomatic cancers from questionnaires (24% with application against 9% without application), we will carry out a descriptive evaluation of the use of an application to detect pre-burnout, burnout and depressive syndrome in a worker population. In the event of a risk alert of pre-burnout, burnout or depressive syndrome, the application will display a message to the user suggesting that he consult his general practitioner or put him in contact with a doctor through a teleconsultation via a dedicated platform.

This first study will assess the feasibility and acceptability of an early detection approach among professionals of a state of "fragility" (pre-burnout, burnout or depressive syndrome). Subsequently, a larger study will evaluate the effectiveness of this application for the early detection of burnout among professionals, its management and the reduction of costs for the healthcare system and society.

lead_sponsor: Weprom


title: Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

acronym: Fixakin

summary: We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.


title: Combining Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia : a Single Case Experimental Design -SCED Preliminary Study

acronym: ETAT PSA

summary: Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.

acronym: ERASME

summary:
On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.

Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.


title: The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables

acronym: REPROTOX 2

summary: The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.


title: CD160 Ans Corneal Graft: Expression in Corneal Vessels

summary: Despite improvements in corneal transplantation, anti-angiogenic and anti-lymphangiogenic factors remain to be be identified. CD160 is an anti-angiogenic target: its expression seems to be restricted to some immune cells and to activated endothelial cells. We hypothesized that CD160 is expressed in blood and lymphatic human corneal neovessels and is involved in corneal graft rejection pathogenesis


title: Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children

acronym: CHEVIPED

summary:
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations.

The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Effect of Non-nutritive Sweeteners on Vascular Function in Humans

acronym: SOSweet

summary: In recent decades, low-to-null caloric, non-nutritive sweeteners (NNS) have been increasingly used, replacing and offering an alternative to food and beverages sweetened by high-energy, added sugars. Indeed, by providing consumers with products that have a sweet taste with low energy content, NNS appear to be the magic bullet to enhance weight loss and reduce cardio-metabolic diseases. However, a recent meta-analysis of randomized trials does not show any benefit of NNS consumption on body weight loss. Moreover, epidemiological, descriptive and experimental studies have recently reported that NNS consumption is paradoxically associated with weight gain, glucose intolerance and increased risk of type 2 diabetes and/or cardiovascular events. Among the approved NNS, sucralose and AceK, both high intensity (respectively ~500-600 and 200 times sweeter than sugar) are the most widely used in foods and drinks, accounting more than 62 % of the global artificial sweetener market. Recent experimental data show an effect of sucralose and AceK (and other NNS) consumption on vascular reactivity in response to a physiological stress (hyperglycemic load) in rats. Since sweet taste receptors (T1R) have been recently found in the endothelium, investigators hypothesize that NNS, and especially sucralose and AceK, a potent T1R agonist, impairs micro- and macrovascular reactivity in humans, which, to the best of our knowledge, has never been explored.

ipd_sharing_description: Data can be requested by contacting Prof. Roustit mroustit@chu-grenoble.fr

lead_sponsor: University Hospital, Grenoble

intervention_type: Dietary Supplement


title: Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection

acronym: SIBERIE

summary:
Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are :

To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome
To compare OAI of urinary origin with those with another origin

ReferenceCitation: Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30. Review.

ReferenceCitation: Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29. Review.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Department of Rheumatology, Hospital René Dubos, Pontoise


title: Measurement of Water-soluble Vitamins and Trace Elements Loss With Maintenance Post-dilution Haemodiafiltration Patient

acronym: VITAFLUX

summary:
End stage renal disease is a severe pathology in which some toxic waste and an excessive amount of water can accumulate in the human body with life threatening consequences. Maintenance hemodialysis is one of the possible treatment for this disease.

Hemodialysis filter the blood through a membrane according to a dialysis bath and so can be able to purify the blood of the toxic waste.

Otherwise, since the 1980s, the investigator know that patient in maintenance hemodialysis can have some deficiency in water soluble vitamins and trace elements. Mechanisms of the deficiency are multiple (a decreased of food intake, a diminution of the appetite, digestive malabsorption du to medics and comorbidities and loss in hemodialysis).

Impact of this deficiency have an important impact on vital prognosis for these patients. These nutrients are essential for AND synthesis, mechanism of inflammation, cells membranes synthesis, etc. DOPPs study in 2004 have shown a decreased of 16% in the mortality within 4 years with supplemented patients. Also, since this study, international recommendations were wrote in 2009, then in 2020, in order to supplement in vitamins and trace elements patients in maintenance conventional hemodialysis.

Despite these recommendations, some supplementary efforts are necessary, especially since online hemodiafiltration, a new process, is widely available and used in particular in Europe. This process combines 2 phenomena, diffusion and convection, through high-flux membranes. This process can remove a large quantity of molecule present in blood and especially the middle-molecule. In return, a more important quantity of water soluble vitamins and oligo-elements could be removed by this technique.

Also, the investigator would like to measure this loss of vitamins and trace-elements in patients with maintenance online post-dilution hemodiafiltration process with dialysate sample and blood concentrations measured (usual patient monitoring) during the session.

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon


title: Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.

acronym: CHALAXIE

summary:
The main objective of this study is to determine the benefit of the Chalaxie pedagogical evaluation tool in the management of overweight or obese children with intellectual disability.

Chalaxie is a software developped as a pedagogical evaluation tool. It is used in the therapeutic education of overweight and obese children and allow the clinican to explore several skills of the child, such as self-esteem.

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


acronym: PROTO-BRAIN

title: Nitrous Oxide for Late-Life Depression : a Randomized Controlled Trial With Comparator - PROTO-BRAIN

lead_sponsor: University Hospital, Tours

summary:
Resistant Depression is a common condition in older adults and there is an urgent need for novel antidepressant in this population. Nitrous Oxide (N2O) has recently shown rapid antidepressant effect in midlife depression but no study has currently investigated the efficacy and safety of N2O in Late-Life Depression (LLD), while N2O may prove to be an ideal treatment for LLD because of glutamatergic antagonism and cerebrovascular effects and also a relatively good safety profile.

The goal of our study is to compare changes in depressive symptoms after 2 hours, 24 hours, 1 week and 2 week of a 1-hour exposure to EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) versus Medical Air.

Secondary Objectives include comparing differences in neuroimaging measures between 3 groups (responders and non-responders in the EMONO group, and patients in the control group).


title: Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration

summary: A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm


title: Interest of Speech Therapy in Children With Epilepsy: What Impairments of Cognitive Functions?

summary:
Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.

The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.


title: Impact of the Lockdown Due to the COVID Pandemic in French Wilson's Disease Patients

acronym: WILL-Ecco

summary:
Wilson's disease is a rare genetic disorder that causes copper to build up in the body. This overload is initially localized in the liver and the brain, but can spread throughout the body and cause systemic damage if copper chelation or zinc salt therapy is not implemented quickly. Treatment should be taken daily and continued all the lifelong.

Patients usually have a follow-up (clinical examination, ultrasound of the liver, blood and urine samples) every six months in the maintenance phase of the disease and more frequently in the event of destabilization of the disease which requires adaptation of the doses of treatment or when initiating treatment. Some patients also benefit from regular psychological follow-up and patients with a disabling neurological form may have physiotherapy, and speech therapy. The Covid 19 pandemic has imposed the lockdown of the entire population, including patients with Wilson's disease. The non-urgent care of these patients was therefore suspended. Medical consultations and paramedical care (physiotherapy, speech therapy, psychologist, etc.) have been postponed. Only very urgent hospitalizations in the event of imbalance of their illness with life-threatening risk were maintained.

Wilson's disease patients could in this situation be particularly anxious and present disturbances of their quality of life. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is a worsening of the disease. The consequences of inactivity and the end of specific treatments (physiotherapy and speech therapy) could also be sources of aggravation. The behavioral and cognitive characteristics of the disease and the major difficulties in adherence to treatment already observed in this chronic disease, may suggest a repercussion of the pandemic in this population.

The consequences of the COVID pandemic in these fragile patients with a rare disease must be assessed. It will be important to look at the consequences of the lockdown on the adherence to treatment and on the course of the disease.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study

acronym: TRIPAN

summary:
Acute pancreatitis (AP) is a one of the potentially life-threatening complication of severe hypertriglyceridemia (HTG), with mortality around to 30%.

HTG-associated PA and their complications management has to be the same as the other pancreatitis, but they are associated with the worse clinical outcomes. Triglycerides levels are correlated with the risk of pancreatitis and severity.

Therapeutic plasma exchange (TPE) could provide positive effects in reducing triglyceridemia plasma levels during the acute phase of HTG-AP, and in prevention of recurrence. There is currently no difference about mortality in studies. Some authors have recommended its use only in severe HTG-AP and have precised the need of early initiation to have positive results.

Despite such promising findings from studies, the effects of therapeutic plasma exchange on HTG-associated PA have never been specifically assessed and its benefits in critically ill patients with AP remains uncertain.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score

acronym: POSiF

summary:
Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.

The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.

The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.

Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.


title: Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army

acronym: PREPAR

summary:
Post-Traumatic Stress Disorder (PTSD) is a mental health condition that's triggered by a terrifying event perceived as a life threatening - either experiencing it or witnessing it. Lifetime prevalence of PTSD in the European population is between 0.7% and 1.9%. According to the "dose-response" model, the individuals most exposed to traumatic events (TEs) are those who are most at risk of developing this disorder. This is why it is not surprising to observe a higher prevalence of this disorder in the military population, ranging from 10% to 18% or even 45%, depending on the studies.

In the 1980s, the practice of evidence-based preventive medicine (EBM-Evidence Based Medicine) was developed. It involves the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. Health condition prevention includes several levels of action: primary, secondary or tertiary, depending on the timing of the intervention in the course of the disease.

The aim of this project is to explore the efficiency of primary prevention actions in strengthening the resilience capacities of at-risk professionals, such as the military, in order to prevent the development of PTSD and to improve it prognosis.

The objectives of this project are (i) to design a primary prevention program for PTSD specific to the military population studied and compatible with the operational constraints of field soldiers, (ii) then, to implement / validate it within the operational staff of the Mountain Infantry Brigade (MIB).

Our approach is based on an integrative reading of the processes in the risk of developing PTSD. This biopsychosocial approach targets both the factors specific to the individual (on the physiological and psychological level) and the contextual and social factors relating to his professional environment.

Three dimensions are addressed: (i) biophysiology (by integrating the study of key biomarkers of the neurobiological response to stress, and by strengthening the flexibility of the autonomic nervous system), (ii) psychology (by facilitating and measuring the development of the flexibility of coping strategies to cope with stress as well as by evaluating the moderating role of the sense mission in the development of PTSD) and (iii) the social (by facilitating community strategies aimed at reducing stigmatization and facilitating the use of care for professionals in difficulty in the institutional context).

lead_sponsor: Direction Centrale du Service de Santé des Armées