title: EVALUATION OF PRACTICES: RETROSPECTIVE AND PROSPECTIVE MONOCENTRIC SURVEY ON THE SATISFACTION OF PATIENTS UNDERGOING CARDIAC SURGERY WHO WERE ABLE TO BENEFIT FROM ADDITIONAL MANAGEMENT BY ERICKSONIAN MEDICAL HYPNOSIS DURING THEIR STAY.

acronym: OCEANIC

summary: Evaluation of practices: retrospective and prospective monocentric survey on the satisfaction of patients undergoing Cardiac Surgery who were able to benefit from additional management by Ericksonian Medical Hypnosis during their stay.

time_perspective: Other

ReferenceType: result

ReferenceCitation: Ashton RC Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. The effects of self-hypnosis on quality of life following coronary artery bypass surgery: preliminary results of a prospective, randomized trial. J Altern Complement Med. 1995 Fall;1(3):285-90. doi: 10.1089/acm.1995.1.285.

ReferenceCitation: de Klerk JE, du Plessis WF, Steyn HS, Botha M. Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. Am J Clin Hypn. 2004 Oct;47(2):79-92. doi: 10.1080/00029157.2004.10403627.

ReferenceCitation: Schnur JB, Kafer I, Marcus C, Montgomery GH. HYPNOSIS TO MANAGE DISTRESS RELATED TO MEDICAL PROCEDURES: A META-ANALYSIS. Contemp Hypn. 2008 Aug 21;25(3-4):114-128. doi: 10.1002/ch.364.

ReferenceCitation: Akgul A, Guner B, Cirak M, Celik D, Hergunsel O, Bedirhan S. The Beneficial Effect of Hypnosis in Elective Cardiac Surgery: A Preliminary Study. Thorac Cardiovasc Surg. 2016 Oct;64(7):581-588. doi: 10.1055/s-0036-1580623. Epub 2016 Apr 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Georg Thieme

ReferenceCitation: Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: University of Liège - Open Repository and Bibliography

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;orbi.ulg.ac.be

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.

ReferenceCitation: Acikel MET. Evaluation of Depression and Anxiety in Coronary Artery Bypass Surgery Patients: A Prospective Clinical Study. Braz J Cardiovasc Surg. 2019 Aug 27;34(4):389-395. doi: 10.21470/1678-9741-2018-0426.

oa_colors: green diamond

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: scielo

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

evidence: oa repository (via OAI-PMH title and first author match)

unpaywall_oa_status: gold

publisher_dissemination: Sociedade Brasileira de Cirurgia Cardiovascular

ReferenceCitation: Ashton C Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Weinberg AD, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. Self-hypnosis reduces anxiety following coronary artery bypass surgery. A prospective, randomized trial. J Cardiovasc Surg (Torino). 1997 Feb;38(1):69-75.

ipd_sharing_description:
Analyses of the primary and secondary endpoints will be descriptive. Continuous variables will be described using the mean and standard deviation, as well as the median and interquartile range. Qualitative variables will be described in terms of numbers and associated percentages.

All analyses will be carried out on a frozen database, in accordance with current good practice at Grenoble Alpes University Hospital.

The analyses will be carried out under the supervision of a statistical engineer from the Data Engineering Unit.


title: Biomarkers in the Etiology of Idiopathic Intracranial Hypertension

acronym: BEHIND

summary:
Idiopathic intracranial hypertension (IIH) is a condition characterized by an increase in intracranial pressure (ICP), papilledema with a risk of permanent visual loss, and severe headaches that profoundly affect quality of life.

To date the exact pathophysiology of IIH remains unknown. IIH is considered a complex neurometabolic and neuroendocrine disorder, favored by female gender, and obesity.

In the majority of patients (80% of the cases) IIH is associated with obstruction of cerebral venous drainage with stenosis of the transverse sinus. This stenosis may be the main underlying cause in the so-called "venogenic" form of IIH. Equally, in the absence of a stenosis, obstruction may occur when otherwise normal venous sinuses are compressed by the increased ICP, the so-called "non-venogenic" form of IIH. An innovative treatment of IIH with associated venous stenosis includes stenting of the transverse sinus stenosis. This strategy may allow resolution of papilledema and ICP reduction rates up to 80%.

Although the pathogenesis of IIH is still poorly understood, inflammatory mechanisms, autoimmune reactions, and hormonal abnormalities of notably androgens, have been proposed to contribute to its pathophysiology. The function of the blood-brain barrier (BBB) has been studied by determining the prevalence of extravasation of endogenous proteins such as fibrinogen.

A growing body of the literature shows a correlation between increased ICP and metabolic/hormonal changes.

The improvement of IIH treated with acetazolamide and/or stenting appears to correlate with the reduction of ICP. Yet the association of this reduction with metabolic changes at the peripheral and central blood level as well as the CSF remains unclear. The search for specific inflammatory, immunological and hormonal biomarkers in patients with IIH and their variation in relation to the ICP should provide a better understanding of its etiology.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Markey KA, Mollan SP, Jensen RH, Sinclair AJ. Understanding idiopathic intracranial hypertension: mechanisms, management, and future directions. Lancet Neurol. 2016 Jan;15(1):78-91. doi: 10.1016/S1474-4422(15)00298-7. Epub 2015 Dec 8.

ReferenceCitation: Mollan SP, Aguiar M, Evison F, Frew E, Sinclair AJ. The expanding burden of idiopathic intracranial hypertension. Eye (Lond). 2019 Mar;33(3):478-485. doi: 10.1038/s41433-018-0238-5. Epub 2018 Oct 24.

ReferenceCitation: Riggeal BD, Bruce BB, Saindane AM, Ridha MA, Kelly LP, Newman NJ, Biousse V. Clinical course of idiopathic intracranial hypertension with transverse sinus stenosis. Neurology. 2013 Jan 15;80(3):289-95. doi: 10.1212/WNL.0b013e31827debd6. Epub 2012 Dec 26.

ReferenceCitation: Toscano S, Lo Fermo S, Reggio E, Chisari CG, Patti F, Zappia M. An update on idiopathic intracranial hypertension in adults: a look at pathophysiology, diagnostic approach and management. J Neurol. 2021 Sep;268(9):3249-3268. doi: 10.1007/s00415-020-09943-9. Epub 2020 May 27.

ReferenceCitation: Dhungana S, Sharrack B, Woodroofe N. Cytokines and chemokines in idiopathic intracranial hypertension. Headache. 2009 Feb;49(2):282-5. doi: 10.1111/j.1526-4610.2008.001329.x.

ReferenceCitation: Zanello SB, Tadigotla V, Hurley J, Skog J, Stevens B, Calvillo E, Bershad E. Inflammatory gene expression signatures in idiopathic intracranial hypertension: possible implications in microgravity-induced ICP elevation. NPJ Microgravity. 2018 Jan 11;4:1. doi: 10.1038/s41526-017-0036-6. eCollection 2018.

ReferenceCitation: Nicholson P, Brinjikji W, Radovanovic I, Hilditch CA, Tsang ACO, Krings T, Mendes Pereira V, Lenck S. Venous sinus stenting for idiopathic intracranial hypertension: a systematic review and meta-analysis. J Neurointerv Surg. 2019 Apr;11(4):380-385. doi: 10.1136/neurintsurg-2018-014172. Epub 2018 Aug 30.

ReferenceCitation: Fahmy EM, Rashed LA, Mostafa RH, Ismail RS. Role of tumor necrosis factor-alpha in the pathophysiology of idiopathic intracranial hypertension. Acta Neurol Scand. 2021 Nov;144(5):509-516. doi: 10.1111/ane.13482. Epub 2021 Jun 15.

ReferenceCitation: Samanci B, Samanci Y, Tuzun E, Altiokka-Uzun G, Ekizoglu E, Icoz S, Sahin E, Kucukali CI, Baykan B. Evidence for potential involvement of pro-inflammatory adipokines in the pathogenesis of idiopathic intracranial hypertension. Cephalalgia. 2017 May;37(6):525-531. doi: 10.1177/0333102416650705. Epub 2016 May 18.

ReferenceCitation: Hasan-Olive MM, Hansson HA, Enger R, Nagelhus EA, Eide PK. Blood-Brain Barrier Dysfunction in Idiopathic Intracranial Hypertension. J Neuropathol Exp Neurol. 2019 Sep 1;78(9):808-818. doi: 10.1093/jnen/nlz063.

ReferenceCitation: Eide PK, Eidsvaag VA, Nagelhus EA, Hansson HA. Cortical astrogliosis and increased perivascular aquaporin-4 in idiopathic intracranial hypertension. Brain Res. 2016 Aug 1;1644:161-75. doi: 10.1016/j.brainres.2016.05.024. Epub 2016 May 14.

ReferenceCitation: Ball AK, Sinclair AJ, Curnow SJ, Tomlinson JW, Burdon MA, Walker EA, Stewart PM, Nightingale PG, Clarke CE, Rauz S. Elevated cerebrospinal fluid (CSF) leptin in idiopathic intracranial hypertension (IIH): evidence for hypothalamic leptin resistance? Clin Endocrinol (Oxf). 2009 Jun;70(6):863-9. doi: 10.1111/j.1365-2265.2008.03401.x. Epub 2008 Sep 2.

ReferenceCitation: Markey KA, Uldall M, Botfield H, Cato LD, Miah MA, Hassan-Smith G, Jensen RH, Gonzalez AM, Sinclair AJ. Idiopathic intracranial hypertension, hormones, and 11beta-hydroxysteroid dehydrogenases. J Pain Res. 2016 Apr 19;9:223-32. doi: 10.2147/JPR.S80824. eCollection 2016.

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier - Gui de Chauliac

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Cohort Project of Patients With Inflammatory Rheumatism (Rheumatoid Arthritis, Axial and Peripheral Spondyloarthritis Including Psoriatic Arthritis)

acronym: SMAP

summary:
Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints.

Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain.

Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases.

It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Other


title: A Multicentric, Single Arm, Open-label, Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer

acronym: PRadR

summary:
This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 4 IV injections of 177Lu-PSMA-1 in patients with metastatic clear cell renal cancer.

This trial is divided in 2 parts:

A safety run-in part aiming to assess the safety of 177Lu-PSMA-1 (with 6 patients treated at the starting activity = 7.4 GBq of 177Lu-PSMA-1, every 6 weeks (Q6W) for 4 administrations). If more than one patient experiences a ST during the first cycle of therapy (6 weeks), then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq). The 6 patients from this safety run-in step, treated at the activity selected for phase II, will be included in the evaluation of Phase II part.
A Phase II part aiming to assess the clinical activity of 177Lu-PSMA-1

study_start_date_type: Actual

status: Recruiting

primary_purpose: Treatment

lead_sponsor: Centre Leon Berard

intervention_type: Drug


title: Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline

acronym: PrediCog

summary: This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse NeuroImaging Centre (ToNIC - UMR1214 Inserm/UT3)


title: Evaluation of Changes in Adherence to the Mediterranean Diet in Cancer Patients Undergoing Treatment

acronym: MyPrefMed

summary:
This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients undergoing treatment for cancer, in relation to sensory alterations that occur during treatment.

The primary strength of this project lies in the consideration of a large number of variables that scientific literature has shown to play a significant role in the dietary behavior of patients. The project's multidisciplinary approach, which takes into account both sensory perception and psychological dimensions, can enrich scientific knowledge on the subject, enabling a better understanding of the dietary behaviors of cancer patients undergoing treatment.

One of the main strengths of the project is that taste and smell reactivity will be tested using a combined approach that includes the evaluation of responses to PROP (Propylthiouracil - a bitter compound), selected aromas and odors, responses to model foods belonging to the Mediterranean diet in which the intensities of selected sensory properties are expected to be affected by chemotherapy (e.g., sweetness and freshness).

To date, no study has investigated adherence to the Mediterranean diet in such a wide range of patients. The choice of a Mediterranean diet framework is based on evidence defining this type of diet as a health promoter, improving health and preventing diseases and health complications. The Mediterranean diet includes the food variety present in the specific region chosen for the study, ensuring variety and availability of local products. The selection of the Antoine Lacassagne Center in Nice is based on the need to study the dietary preferences of a Mediterranean population familiar with Mediterranean diet products.

This project could serve as the foundation for a dietary development aspect, in which foods adapted to cancer patients will be created and tested to mitigate issues of malnutrition.

Expected Benefits Addressing the scientific question regarding the impact of sensory and psychological variables on adherence to the Mediterranean Diet and dietary behavior of cancer patients undergoing treatment will help identify individual variables to consider in assisting patients in adopting health-promoting behavior and reducing malnutrition.

Expected Risks The research project does not involve maneuvers or the implementation of care procedures other than those to which patients would be subjected if they were not participating in the study. This research involves no specific risks, except for possible risks of allergies or food intolerances related to the sensory testing session. The dietary models used only include food ingredients normally available in markets.

In order to test the taste sensitivity index, the response to propylthiouracil (PROP) will be evaluated using paper discs previously soaked in a solution composed of water and PROP according to the method of Zhao et al. (2003). This procedure has been safely used in children as well as in several studies (including patients undergoing chemotherapy) approved by ethics committees in multiple institutes from various countries.

Scientific Impact The project will provide information about the variables that impact the dietary behavior of patients undergoing chemotherapy. This knowledge will be useful in developing principles that contribute to reducing malnutrition rates in oncology patients.

Methodology This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients with cancer undergoing treatment, who may experience changes in their relationship with food as well as their dietary behavior. Adherence to the Mediterranean diet will be studied in cancer patients at T0 (before the start of treatment) and at T1 (after 9 weeks of treatment). A comparison will be made between patients without sensory alterations and patients with taste and/or smell alterations at T1. The psychological and sensory variables impacting dietary behavior will also be measured and correlated with adherence to the Mediterranean diet and the presence or absence of sensory alterations.

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Centre Antoine Lacassagne

collaborators: University of Firenze and Siena, Napoli, Italy

lead_sponsor_type: industriel


title: Effects of Probiotics Formulation on Stress and Skin Health in Younger Adult Females: A Holistic Approach to Skin Health, an Open-Label Proof-of-Concept Study

acronym: Cosmebiome

summary: The goal of this clinical trial is to test to efficacy of a probiotic blend on stress and skin appearance in young females. It is hypothesized that those taking the probiotic blend will have decreased levels of perceived stress and this will be reflected positively on their skin appearance.

status: Active, not recruiting

lead_sponsor: Lallemand Health Solutions

sponsor_collaborators:
Lallemand Health Solutions
Laboratoire Cosderma

intervention_type: Dietary Supplement


title: Retrospective Study of Protocol-based Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized at UPOG for Fracture of the Upper Extremity of the Femur in 2022

acronym: ALGOGER

summary:
Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions.

Surgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic.

Adequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them.

Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes.

Pain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management.

The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: Registry Identifier

title: Surgical Complications of Enterocystoplasty in Children: A Retrospective Monocentric Study About 39 Cases

acronym: AVPED

summary:
The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question[s] it aims to answer are:

what kind of complications are there
the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

status: Enrolling by invitation

ReferenceCitation: Molina CA, Lima GJ, Cassini MF, Andrade MF, Facincani I, Tucci Junior S. Complications after bladder augmentation in children. Acta Cir Bras. 2016;31 Suppl 1:8-12. doi: 10.1590/S0102-86502016001300003.

ipd_sharing_description: In the name of anonymization we won't share individual participant data

lead_sponsor: Dr Christelle DESTINVAL

status_simplified: Unknown


title: Low-Pressure Laparoscopy Using the AirSeal® System Versus Standard Insufflation in Appendicular Peritonitis in Children: a Monocentric Retrospective Study

acronym: APPAS

summary:
The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures.

The investigators would like to know if these allegations also apply to children.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.

ReferenceCitation: Rebuck DA, Zhao LC, Helfand BT, Casey JT, Navai N, Perry KT, Nadler RB. Simple modifications in operating room processes to reduce the times and costs associated with robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jun;25(6):955-60. doi: 10.1089/end.2010.0534. Epub 2011 Apr 2.

ReferenceCitation: Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.

intervention_type: Device

status_simplified: Completed


title: Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain. Randomised Controlled Trial

acronym: END-LC

summary:
Proposing ways to effectively counter chronic low back pain through non-drug intervention is a major public health issue due to the prevalence and health costs of this condition. The back school (BS) is based on spinal economics and a biomechanical model. A convergence of evidence indicates that this type of program does not bring any mid- or long-term benefit. Faced with this observation, a Pain Neuroscience Education (PNE) has been developed based on a biopsychosocial model. Chronic low back pain is the consequence of a complex dynamic of multifactorial origin where the body lesion is no longer the only cause of the pain. Studies have shown that PNE has a positive effect on pain perception. One of the limitations of these studies is that they do not allow objective measurement of physical activity performed at a distance from a therapeutic program for patients who have benefited from these educational programs. Yet, physical activity is an essential variable in health and more specifically in the fight against pain in patients with chronic low back pain.

The investigators believe that physical activity is a key factor in improving the condition of patients with chronic low back pain. Consequently, physical activity is an indicator of success but also a guarantee for a lasting effect of educational treatment. In order to measure this physical activity, the use of activity monitor (connected watch) developed in recent years now makes it possible to collect data in an ecological manner that is more objective than the data collected via self-questionnaires.

The main objective of the study is to measure the effectiveness of a PNE on physical activity three months after the intervention compared to BS in patients with chronic low back pain receiving a multidisciplinary rehabilitation program.

The secondary aims are to compare effectiveness of PNE versus BS on pain, quality of life, kinesiophobia, pain catastrophizing, central sensitization at 3 months and at one year after the intervention. In addition, an exploratory analysis will be conducted to determine predictors of physical activity maintenance.

The investigators expect to observe greater physical activity in patients who have received a PNE program compared to the physical activity of patients who have completed an BS program.

design_allocation: Randomized


type: Other Identifier

title: Evaluation of the Effect of Training in the SBAR (Situation Background Assessment Recommendation) Tool on the Feeling of Self-efficacy of Carers of Patients With Lung Cancer in the Face of a Situation of Simulated Respiratory Distress.

acronym: SAECURE

summary:
Dyspnea is defined as a subjective feeling of discomfort in breathing. In respiratory pathologies, dyspnea can be indicative of lung cancer or its aggravation, or even be the most important symptom of the end of life. The prevalence of dyspnea is high in patients with lung cancer, ranging from 50 to 87%. Dyspnea can exacerbate at any time in the course of care for the patient with lung cancer, causing respiratory distress or Acute Respiratory Failure (ARF) and putting the prognosis at stake. ARF justifies urgent and effective care, and in pre-hospital, it is based on the call to the Emergency Medical Aid Service (SAMU). The communication of information on the patient's condition in ARF to the SAMU must be as clear and precise as possible in order to avoid medical errors, inappropriate decisions and therefore a loss of opportunity for the patient. In Oncology, caregivers often assume the role of "decision maker" and provide monitoring and assessment of symptoms, including dyspnea.

A qualitative study on the experience of caregivers during dyspnea occurring in patients with lung cancer or obstructive bronchopneumopathy revealed an altered emotional state of caregivers, such as anxiety, stress and feeling of helplessness, especially when respiratory deterioration occurs suddenly at night. The unmet need for information could compromise the sense of self-efficacy among caregivers.

In this context of monitoring symptoms in lung cancer at home, caregivers are the first witnesses of respiratory distress in their loved ones. However, faced with the sudden deterioration of breathing, they risk forgetting to communicate essential information when calling the SAMU. Since 2014, the High Authority for Health (HAS) has been recommending the use of the SBAR tool (Situation, Background, Assessment Recommendation) to facilitate communication between professionals. Its effectiveness has been proven both in improving knowledge and in the quality of communication. This is why training in the use of the SBAR (Situation, Background, Assessment Recommendation) tool could be extrapolated to caregivers with regard to the responsibilities they must assume in the management of home care, including lung cancer to deal with respiratory distress.The Serious Game (SG) is an innovative educational tool adapted to training in the field of health.It is an interactive web-based software allowing the repetitive training of medical procedures in a virtual environment, in the form of video games for active, experiential and problem-based learning, without the need to involve patients and therefore without risk.The aim of the research is to provide training in the SBAR (Situation, Background, Assessment Recommendation) tool in the form of a Serious Game for carers of patients with lung cancer in order to improve the feeling of self-efficacy in the management of respiratory distress at home.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Standardized Evaluation of Long-term Neurocognitive Development of Children From Age 3 With Pyridoxine Dependent Epilepsy by Antiquitine Deficiency

summary: This study aims to evaluate with the VINELAND II scale the long-term neurocognitive development of children above age 3 years with pyridoxine dependent epilepsy related to antiquitine deficiency.

time_perspective: Cross-Sectional

ReferenceCitation: Coughlin CR 2nd, Swanson MA, Spector E, Meeks NJL, Kronquist KE, Aslamy M, Wempe MF, van Karnebeek CDM, Gospe SM Jr, Aziz VG, Tsai BP, Gao H, Nagy PL, Hyland K, van Dooren SJM, Salomons GS, Van Hove JLK. The genotypic spectrum of ALDH7A1 mutations resulting in pyridoxine dependent epilepsy: A common epileptic encephalopathy. J Inherit Metab Dis. 2019 Mar;42(2):353-361. doi: 10.1002/jimd.12045. Epub 2019 Feb 22.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Wilson MP, Plecko B, Mills PB, Clayton PT. Disorders affecting vitamin B6 metabolism. J Inherit Metab Dis. 2019 Jul;42(4):629-646. doi: 10.1002/jimd.12060. Epub 2019 Mar 20.

evidence: open (via crossref license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
LIRIAS (KU Leuven)
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);UCL Discovery

ReferenceCitation: Basura GJ, Hagland SP, Wiltse AM, Gospe SM Jr. Clinical features and the management of pyridoxine-dependent and pyridoxine-responsive seizures: review of 63 North American cases submitted to a patient registry. Eur J Pediatr. 2009 Jun;168(6):697-704. doi: 10.1007/s00431-008-0823-x. Epub 2008 Sep 2.

ReferenceCitation: Baxter P. Epidemiology of pyridoxine dependent and pyridoxine responsive seizures in the UK. Arch Dis Child. 1999 Nov;81(5):431-3. doi: 10.1136/adc.81.5.431.

ReferenceCitation: Coughlin CR 2nd, Tseng LA, Abdenur JE, Ashmore C, Boemer F, Bok LA, Boyer M, Buhas D, Clayton PT, Das A, Dekker H, Evangeliou A, Feillet F, Footitt EJ, Gospe SM Jr, Hartmann H, Kara M, Kristensen E, Lee J, Lilje R, Longo N, Lunsing RJ, Mills P, Papadopoulou MT, Pearl PL, Piazzon F, Plecko B, Saini AG, Santra S, Sjarif DR, Stockler-Ipsiroglu S, Striano P, Van Hove JLK, Verhoeven-Duif NM, Wijburg FA, Zuberi SM, van Karnebeek CDM. Consensus guidelines for the diagnosis and management of pyridoxine-dependent epilepsy due to alpha-aminoadipic semialdehyde dehydrogenase deficiency. J Inherit Metab Dis. 2021 Jan;44(1):178-192. doi: 10.1002/jimd.12332. Epub 2020 Dec 1.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: UCL Discovery;pure.rug.nl

ReferenceCitation: Tourrette C., Evaluer les enfants avec déficiences ou troubles du développement. PARIS : Dunod, 2006

ReferenceCitation: Fombonne E. ; Achard S. ; Tuffreau R. L'évaluation du comportement adaptatif : l'échelle de Vineland. In Handicap et inadaptations. Les Cahiers du CTNERHI, n° 67-68, juil. / déc. 1995. p. 79-90.3

ReferenceCitation: Gioia GA, Isquith PK, Guy SC, Kenworthy L. The Behaviour Rating Inventory of Executive Function. Lutz, FL: Psychological Assessment Resources; 2000.

ReferenceCitation: Gibaud M, Barth M, Lefranc J, Mention K, Villeneuve N, Schiff M, Maurey H, Barthez MA, Caubel I, Chouchane M, Doummar D, Kossorotoff M, Lamblin MD, Roubertie A, Nabbout R, Van Bogaert P. West Syndrome Is an Exceptional Presentation of Pyridoxine- and Pyridoxal Phosphate-Dependent Epilepsy: Data From a French Cohort and Review of the Literature. Front Pediatr. 2021 Mar 5;9:621200. doi: 10.3389/fped.2021.621200. eCollection 2021.

oa_colors: green gold

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL


title: Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

acronym: ISOBK

summary: Tuberculosis is the third leading infectious killer. In 2021, an estimated 10,6 million people fell ill with tuberculosis worldwide. Drug resistance emerges with the increase of antibiotherapy use. Among the four antimicrobial drugs used for tuberculosis, isoniazid is a first line treatment. It has a bactericidal activity against the tuberculosis complex. Nevertheless, the hepatic metabolism of isoniazid shows variation between individuals. There is a real risk of hepatotoxicity and neurotoxicity induced by isoniazid. The peak measurement (Cmax) of serum isoniazid is recommended to adjust the treatment and to allow recovery. Moreover, several samples allow a kinetics of isoniazid elimination so as to distinguish slow and fast acetylators. Few data are available on isoniazid acetylation. It could be useful to know the proportion of patients treated by isoniazid at a standard dose, associated with a risk of overdosing or underdosing. Inadequate exposures should be studied to understand if there is an impact in the medical care.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting

acronym: VR-REACT

summary:
This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.

Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.

The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.

This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.

During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.

lead_sponsor: FondationbHopale

location_facility: FONDATION HOPALE - Centre de rééducation Ste Barbe


title: Psychological Follow-up in a Protected Hematology Unit as a Transitional Device Between Hospitalization and Return Home

acronym: RAH HD

summary:
Objective :

To study and support the hospitalization and the return home of patients with the help of a psychological follow-up started in a hospital institution and which will continue in the patient's home, based on the concepts of transitionality and narrativity.

Material and method To do this, the subjects will benefit from psychological interviews where they will freely discuss what concerns them, whether it is illness, treatment, returning home, or any other personal subject.

They will be divided into two groups of 5 patients each, one of the groups will benefit from follow-up in an institution as contracted for several years between the Institute of Hematology and the psychologists of the UMDSP, another from the same follow-up but with the presence of the psychologist at the time of discharge extended to the patient's home after leaving the hospital for a period of 2 months.

To ensure a certain consistency in the evaluation criteria, these will be standardized in the form of questionnaires completed blindly by the patient, a caregiver and the investigator, at 3 key times of the research (entry, discharge from hospital, two months after this discharge)

Device tested:

The aim of this work is to test the benefits of a device based on transitionality, which can limit, thanks to the restoration of the symbolization process, the deleterious effects of each of the stages imposed by the disease, the care and the resumption of autonomy once the active phase of care has passed.

Narrativity is also at the heart of this transitional device. It makes it possible to evoke the present experience of the patient in connection with future projects and in the continuity of past, potentially traumatic events. It opens onto a dynamic temporal perspective where the trauma freezes.

The whole process promotes the subjective reappropriation of the experience and a psychic well-being.

lead_sponsor: University Hospital, Caen


title: Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

summary:
Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients.
Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon
500 patients will be included:
COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk
COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk

design_allocation: Non-Randomized

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Radiation


title: Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.

acronym: DECIdE

summary:
The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the use of a decision aid.

General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision on whether to take it or choose another alternative.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Investigating the Prognostic Role of Brain MRI in Anti-LGI1 Encephalitis

summary: The term "autoimmune encephalitis" denotes an heterogenous group of diseases commonly associated with autoantibodies targeting neural or glial antigens. Patients harboring antibodies against the leucine-rich glioma-inactivated protein 1 (LGI1) usually respond well to immunotherapy, but a significant percentage develop cognitive sequelae and disability nonetheless. These patients would likely benefit for more aggressive and prolonged immunotherapy, aiming to prevent permanent neurological deficits. Identifying features predicting poor outcome would be crucial to guide treatment decisions. Brain magnetic resonance imaging is a key diagnostic tool in the acute phase, but radiological changes may also appear in follow-up studies, including global brain atrophy, hippocampal atrophy and mesial temporal sclerosis. We hypothesize that specific changes identifiable in the acute and chronic phase underlie a higher risk of poor outcome and persistent neurological deficits.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes


title: Investigating Stress-Induced Dopamine Release: a fMRI-PET Study

acronym: ISIDORE

summary:
The stress response is mediated by the activation of the hypothalamo-pituitary-adrenal axis and the sympathetic nervous system, leading to glucocorticoid and catecholamines release respectively. This stress response is regulated by feedback loops, involving cortical and subcortical structures.

Non-invasive brain stimulation applied over the dorsolateral prefrontal cortex modulates the subcortical dopaminergic transmission at rest and can reduce the hormonal and cognitive alterations induced by stress. This study aims to investigate the Non-invasive brain stimulation -induced modulation of dopamine transmission in an acute stress situation.

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Evolution of Pulsed Oxygen Saturation Throughout an Interval Training Session Compared to a Continuous Training Session in Patients With Chronic Obstructive Pulmonary Disease With Exercise-induced Oxygen Desaturation.

summary:
A problem often observed during exercise training is oxygen desaturation exclusively during exercise in some patients. In the case of exercise-induced desaturation, it may be suggested to train these patients in interval training to limit exercise-induced desaturation. Interval training consists of alternating active phases of short duration (often 30 seconds to 1 minute) followed by a short active or passive recovery phase of equivalent duration to the previous phase. Investigators therefore hypothesise that interval training on a cycloergometer or treadmill can limit exercise-induced desaturation in COPD patients.

The aim of the study is to observe the evolution of pulsed oxygen saturation between a continuous training session and a interval training session.

ipd_sharing: Yes

ipd_sharing_description: deidentified participtant data

lead_sponsor: Groupe Hospitalier du Havre

sponsor_collaborators:
Groupe Hospitalier du Havre
Medrinal Clement
Combret Yann
Machefert Margaux


acronym: OFICU

summary: ICU patients experience moderate to severe pain. Studies and guidelines point out the benefits of multimodal analgesia on pain control, opioid spare and on lowering its adverse effects. However, no recommendation about drugs or protocol has been formulated. In our study, we studied the feasibility and the impact on Remifentanil spare of a standardized protocol using multimodal analgesia (Paracetamol, Nefopam, Tramadol, Ketamine, Remifentanil) compared to the standard-of-care strategy using Paracetamol and Remifentanil. We conducted a prospective, ''proof of concept'', randomized, double-blind, parallel group, placebo-controlled trial. We studied multimodal analgesia versus standard-of-care in ICU patients requiring sedation-analgesia for invasive mechanical ventilation.We hypothesized that Remifentanil consumption decrease by 15% with the use of a standardized multimodal analgesia strategy

ReferenceCitation: Wheeler KE, Grilli R, Centofanti JE, Martin J, Gelinas C, Szumita PM, Devlin JW, Chanques G, Alhazzani W, Skrobik Y, Kho ME, Nunnally ME, Gagarine A, Ergan BA, Fernando S, Price C, Lewin J, Rochwerg B. Adjuvant Analgesic Use in the Critically Ill: A Systematic Review and Meta-Analysis. Crit Care Explor. 2020 Jul 6;2(7):e0157. doi: 10.1097/CCE.0000000000000157. eCollection 2020 Jul.

ReferenceCitation: Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

title: OPIOID-FREE ANALGESIA IN INTENSIVE CARE UNIT : A PROSPECTIVE, MONOCENTRIC, RANDOMIZED, DOUBLE-BLIND, FEASIBILITY CLINICAL TRIAL

type: EudraCT Number

source: euctr


title: Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.

acronym: CRIMCAS

summary:
Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines.

In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy.

The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.


title: Pressure Opening With Electrical Impedance Tomography

acronym: POET

summary: Acute lung injury and ARDS (acute respiratory distress syndrome) are characterized by lung inhomogeneity, leading to a different distribution of the tidal volume (and pressure) within the lung. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, but it reflects a global behaviour of the lung. The electrical impedance tomography (EIT) is a non-invasive and radiation-free tool, monitoring dynamic changes in gas distribution. Images from EIT can be divided in several regions of interest, allowing to measure regional changes in compliance. The regional derived-EIT PV curve could provide valuable information on airway closure and AOP (airway opening pressure). Recent studies suggest that AOP measured by the ventilator seems to correspond to the AOP of the lowest injured lung. The investigators will perform one pressure-volume (PV) curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. During the low-flow insufflation, both ventilator and EIT-derived PV curves will be recorded. All PV curves will be analysed offline by the investigator to detect complete and regional airway closures, and measure AOPs.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients

acronym: HYDRODIFF

summary: Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.

primary_purpose: Diagnostic


title: PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.

summary:
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "enhanced care" model involving healthcare providers and pharmacists. The study compares standard and enhanced care for Type 1 adults, focusing on the pharmacist's role.

The main question it aims to answer is : In patients with type 1 diabetes treated with pump or closed-loop therapy, does the improved enhanced care versus conventional layout improve diabetes-related distress at 12 months?

Participants will complete a monthly online questionnaire to assess their diabetes-related distress as well as their frequency of use of standard and enhanced care as well as the associated patient satisfaction.

lead_sponsor: timkl

sponsor_collaborators: timkl Sanoia


title: PAncreatic Disease Cohort of TOuLouse

acronym: PACTOL

summary: This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.


title: Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448

summary: Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.

ReferenceCitation: Wauquier F, Boutin-Wittrant L, Krisa S, Valls J, Langhi C, Otero YF, Sirvent P, Peltier S, Bargetto M, Cazaubiel M, Sapone V, Bouchard-Mercier A, Roux V, Macian N, Pickering G, Wittrant Y. Circulating Human Metabolites Resulting from TOTUM-070 Absorption (a Plant-Based, Polyphenol-Rich Ingredient) Improve Lipid Metabolism in Human Hepatocytes: Lessons from an Original Ex Vivo Clinical Trial. Nutrients. 2023 Apr 14;15(8):1903. doi: 10.3390/nu15081903.

lead_sponsor: Valbiotis

sponsor_collaborators:
Valbiotis
Clinic'n'Cell
University Hospital, Clermont-Ferrand


title: Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.

acronym: FIBROSIS-MRI

summary:
Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.

The hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.

In addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior

acronym: IBBBiS

summary:
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder.

The investigators hypothesize that peripheral inflammation may alter the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients.

They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Oral Soy Isoflavone Concentrates on Skin Ageing Parameters: a Double-blind Randomised Placebo-controlled Trial

acronym: ISOSKIN

summary: This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women.

primary_purpose: Prevention

lead_sponsor: The Archer-Daniels-Midland Company

sponsor_collaborators:
The Archer-Daniels-Midland Company
Eurofins Dermscan Pharmascan


title: Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study

acronym: RES-HBV

summary:
Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation).

The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection.

The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.

location_facility: Hepatology Department - Hospices Civils de Lyon


title: Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG

acronym: PATCH-MMG

summary: Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Angers


title: The Consequences of Child Verbal and Eating Disorders on Family Dynamics in the Context of Ear Nose and Throat (ENT) Pathologies - Integration of Non-verbal Communication and Parental Support

acronym: ERTO

summary:
As part of the Reference Center for Rare Diseases of the Robert Debré Hospital, many children have eating and verbal oral disorders. In this doctoral research, we question the psychological impact of oral disorders on the dynamics of family functioning.Our research entitled: Evaluation and Remediation of Orality Disorders (ERTO) aims to evaluate the impact of psychological care of the child and a support program for parents.

We hypothesized that this comprehensive management could contribute to improving disorders and consequently modify parental representations of the child and his disorders.

In addition, care focused on intra-family relations and communication would allow a decentralization and a repositioning of the problem of disorders within the family dynamic.

The results of this research will have concrete applications for the management of children suffering from oral disorders.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evolution of Left Ventricular Ejection Fraction After Treatment of Out-of-hospital Cardiac Arrest by Extracorporeal Cardiopulmonary Resuscitation

acronym: FEVGECMO

summary:
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published.

After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population.

It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.

ReferenceCitation: Luc G, Baert V, Escutnaire J, Genin M, Vilhelm C, Di Pompeo C, Khoury CE, Segal N, Wiel E, Adnet F, Tazarourte K, Gueugniaud PY, Hubert H; On behalf GR-ReAC. Epidemiology of out-of-hospital cardiac arrest: A French national incidence and mid-term survival rate study. Anaesth Crit Care Pain Med. 2019 Apr;38(2):131-135. doi: 10.1016/j.accpm.2018.04.006. Epub 2018 Apr 21.

ReferenceCitation: Registre électronique des arrêts cardiaques. Données du 1 er juillet 2011 au 31 mai 2021. Adresse : https://registreac.org/.

ReferenceCitation: Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24. Erratum In: Resuscitation. 2021 Oct;167:105-106.

ReferenceCitation: Hutin A, Abu-Habsa M, Burns B, Bernard S, Bellezzo J, Shinar Z, Torres EC, Gueugniaud PY, Carli P, Lamhaut L. Early ECPR for out-of-hospital cardiac arrest: Best practice in 2018. Resuscitation. 2018 Sep;130:44-48. doi: 10.1016/j.resuscitation.2018.05.004. Epub 2018 May 5.

ReferenceCitation: Gupta A, Gupta A, Saba S. Change in myocardial function after resuscitated sudden cardiac arrest and its impact on long-term mortality and defibrillator implantation. Indian Pacing Electrophysiol J. 2019 Jul-Aug;19(4):150-154. doi: 10.1016/j.ipej.2019.04.005. Epub 2019 Apr 22.


title: Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors. Monocentric Retrospective Study of 170 Tumors

summary:
Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature.

In addition to RCM, we currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Diagnostic Test


title: Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone

acronym: ANGELLO

summary:
The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.

Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.

Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
COMPAGNIE EUROPEENNE DES BAINS


title: Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

acronym: WAVESUPEX

summary:
The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

can a significant increase in oxygen pressure be observed at 3 weeks?
can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?

primary_purpose: Screening

ReferenceCitation: STRANDNESS DE Jr, BELL JW. AN EVALUATION OF THE HEMODYNAMIC RESPONSE OF THE CLAUDICATING EXTREMITY TO EXERCISE. Surg Gynecol Obstet. 1964 Dec;119:1237-42. No abstract available.

ReferenceCitation: Gardner AW. Reliability of transcutaneous oximeter electrode heating power during exercise in patients with intermittent claudication. Angiology. 1997 Mar;48(3):229-35. doi: 10.1177/000331979704800305.

ReferenceCitation: Spronk S, den Hoed PT, de Jonge LC, van Dijk LC, Pattynama PM. Value of the duplex waveform at the common femoral artery for diagnosing obstructive aortoiliac disease. J Vasc Surg. 2005 Aug;42(2):236-42; discussion 242. doi: 10.1016/j.jvs.2005.04.048.

ReferenceCitation: Mahe G, Boulon C, Desormais I, Lacroix P, Bressollette L, Guilmot JL, Le Hello C, Sevestre MA, Pernod G, Constans J, Boissier C, Bura-Riviere A. Statement for Doppler waveforms analysis. Vasa. 2017 Aug;46(5):337-345. doi: 10.1024/0301-1526/a000638. Epub 2017 May 19.

ReferenceCitation: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13. Erratum In: Circulation. 2017 Mar 21;135(12 ):e791-e792.

ReferenceCitation: Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.


title: Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective

acronym: ANGE

summary:
Cardiac surgery and cardiopulmonary bypass can lead to systemic organ failure trough excess inflammation and endothelial injury. The angiopoietin family represented by angiopoietin 1 and 2 can reflect endothelial injury by a decrease in angiopoietin 1 and an increase in angiopoietin 2. The investigators hypothesized that angiopoietin dysregulation could reflect organ failure related to cardiac surgery.

The purpose of this project is to assess the association between angiopoietin dysregulation and adverse outcomes on cardiac surgery.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Post-ICU Consultation : a Time to Discuss Advance Directives

acronym: CoPRADA

summary: The aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation.

ReferenceCitation: Rousseau AF, Prescott HC, Brett SJ, Weiss B, Azoulay E, Creteur J, Latronico N, Hough CL, Weber-Carstens S, Vincent JL, Preiser JC. Long-term outcomes after critical illness: recent insights. Crit Care. 2021 Mar 17;25(1):108. doi: 10.1186/s13054-021-03535-3.

ReferenceCitation: Andreu P, Dargent A, Large A, Meunier-Beillard N, Vinault S, Leiva-Rojas U, Ecarnot F, Prin S, Charles PE, Fournel I, Rigaud JP, Quenot JP. Impact of a stay in the intensive care unit on the preparation of Advance Directives: Descriptive, exploratory, qualitative study. Anaesth Crit Care Pain Med. 2018 Apr;37(2):113-119. doi: 10.1016/j.accpm.2017.05.007. Epub 2017 Aug 4.

ReferenceCitation: Lone NI, Walsh TS. Impact of intensive care unit organ failures on mortality during the five years after a critical illness. Am J Respir Crit Care Med. 2012 Oct 1;186(7):640-7. doi: 10.1164/rccm.201201-0059OC. Epub 2012 Jul 26.

lead_sponsor: University Hospital, Brest


title: Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database

summary:
Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.

Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.

lead_sponsor: University Hospital, Caen


title: Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation

acronym: ENDO-FIV

summary: Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.

intervention_type: Biological


title: SKAMo-1: Characterization of the Upper Layers of Skin

summary:
Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling.

Recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days.

Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.

lead_sponsor: Eclypia


title: Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons

acronym: Microbiosthme

summary:
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.

Exploring and understanding these data is to improve patient care and discover new therapeutic targets.

The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.

lead_sponsor: University Hospital, Rouen


title: Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography

acronym: COPENBASE

summary: Optical coherence tomography angiography (OCT-A) is a determinant progress to study retinal and choroidal vasculature without using a dye injection. OCT-A yields interesting results in different pathologies such as diabetes mellitus, age-related macular degeneration, hypertension blood pressure, particularly by affecting vascular density. Normative database are necessary to compare OCT-A parameters between patients and controls. However, OCT-A devices from different manufactures may give different values for the same subject. It seems to be obvious that each OCT-A device should have its own normative database. In the literature, OCT-A normative databases are developing using different types of devices, but none is available for Heidelberg OCT-A in Caucasians. The purpose of this project is to create a normative database of retinal microvascularisation using Spectralis Heidelberg optical coherence tomography angiography (OCT-A) ® in normal controls.

collaborators:
GHPSO de Creil
Hôpital Saint Vincent de Paul, Lille


title: Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study

acronym: STOPFLUID

summary: Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.

ReferenceCitation: Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. Erratum In: N Engl J Med. 2012 Aug 2;367(5):481.

ReferenceCitation: Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

ReferenceCitation: Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

ReferenceCitation: Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, Kaufman DA, Khan A, Levy MM, Martin GS, Sahatjian JA, Seeley E, Self WH, Weingarten JA, Williams M, Hansell DM. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431-1445. doi: 10.1016/j.chest.2020.04.025. Epub 2020 Apr 27.

ReferenceCitation: Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.

ReferenceCitation: Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.

ReferenceCitation: Lichtenstein DA, Meziere GA, Lagoueyte JF, Biderman P, Goldstein I, Gepner A. A-lines and B-lines: lung ultrasound as a bedside tool for predicting pulmonary artery occlusion pressure in the critically ill. Chest. 2009 Oct;136(4):1014-1020. doi: 10.1378/chest.09-0001.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of the Quality of Life and Tolerance of Patients Treated With Vectorized Internal Radiotherapy (RIV) for a Neuro Endocrine Tumor (NET) in the Auvergne-Rhône-Alpes Region.

acronym: AURA-RIV-TNE

summary:
The study consists of having participants complete quality of life questionnaires (PROMs) at the time of the cures +/- one week and in the middle of the intercure time +/- one week.

As all the collection times do not correspond to a consultation or a visit to a medical service, The investigator wanted to develop a remote, computerized data collection solution.

Researchers have programmed an AURA-RIV-TNE care pathway (MOCAs: Engine for the organization and coordination of health acts) on the myHCL patient environment, taking up the course of the study presented in the form of a table in paragraph 6.2. Once the patient consents to participate in the study, he must create an account on the patient interface of his investigation center (myHCL, myCHUGA etc) as much as possible to facilitate data extraction.

Once the patient consents to participate in the study, the MOCAs AURA-RIV-TNE course will be associated with him in the Easily software, by defining the date week 0 (baseline) of the first treatment. This will allow automated sending of MAIL and SMS reminders at each questionnaire time. The MAILs will contain an internet link allowing the participant to be directly written to the questionnaires to be completed. A reminder system will be possible if the patient does not complete the questionnaire.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hopital Lyon Sud


title: Representation of Congenital Birthmarks in Newborns by Angers Maternity Unit Health Professionals

acronym: ReCONNAISSANCE

summary:
This descriptive cross-sectional single center study will be conducted at Angers Maternity Unit.

It pertains to the ways in which healthcare professionals represent congenital birthmarks found in newborns.

It is our assumption that health professionals may have a tendency to engage in inappropriate behavior when dealing with congenital birthmarks due to lack of knowledge. We make the presumption that insufficient knowledge causes difficulties in managing these birthmarks.

Data as to representation of birthmarks in newborns by health professionals will be collected using a semi-quantitative questionnaire.

This study constitutes preliminary research work, with a view to creating a professional development plan if necessary.

ReferenceCitation: Kelly KA, Balogh EA, Kaplan SG, Feldman SR. Skin Disease in Children: Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis Patients. Children (Basel). 2021 Nov 16;8(11):1057. doi: 10.3390/children8111057.

ReferenceCitation: Vivar KL, Kruse L. The impact of pediatric skin disease on self-esteem. Int J Womens Dermatol. 2017 Dec 12;4(1):27-31. doi: 10.1016/j.ijwd.2017.11.002. eCollection 2018 Mar.

location_facility: Department of Dermatology, University Hospital of Angers


title: Determination of a Profile of Patients With Renal Failure to be Supported as a Priority in the Care Pathway in Order to Avoid Emergency Hospitalizations.

acronym: DETERPROFIPA

summary: The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study

summary:
Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.

This project is based on the hypothesis that there could be a benefit in meditating together.

lead_sponsor: Centre Francois Baclesse

intervention_type: Behavioral


title: Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

acronym: SPINLESS

summary:
The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly.

The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated.

Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
NeuroSphinx


title: Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

acronym: KidTrain

summary:
In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life.

The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI.

The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training.

The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations.

Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening).

Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie & Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.

ReferenceCitation: Coudert A, Gaveau V, Gatel J, Verdelet G, Salemme R, Farne A, Pavani F, Truy E. Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements. Ear Hear. 2022 Jan/Feb;43(1):192-205. doi: 10.1097/AUD.0000000000001090.

repository_institution: Università degli Studi di Trento - Institutional Research Information System

repositories_concat: PubMed Central;iris.unitn.it

ReferenceCitation: Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.

ReferenceCitation: Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.

location_facility: Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre


title: WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial

acronym: WALAB

summary:
Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. For this surgery of the upper extremity, regional anesthesia (RA) is the strategy that should be systematically preferred because it is associated with shorter postanesthetic care and less pain compared to general anesthesia. Multiple approaches to block the brachial plexus are available for the surgery of the upper extremity below the elbow, but the axillary block (BAX) remains the most common approach as it is associated with low side effects.

One of the most significant recent advances in the surgery of the upper extremity has been the emergence of Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique. WALANT is an infiltration technique of a local anesthetic (LA) (lidocaine) and a hemostatic agent (epinephrine) directly into the operative site to induce anesthesia and hemostasis in the area of the surgical procedure to provide conditions suitable for hand surgery without sedation and tourniquet. Given its effectiveness and low side effects, WALANT could be a technique of choice in ambulatory surgery.

The main objective of this non-inferiority, prospective, randomized, open-label, parallel-group controlled trial is to assess the efficacy of WALANT technique compared to BAX in carpal tunnel release (CTR).

lead_sponsor: CMC Ambroise Paré


title: Point-of-care Ultrasound to Assess Hydronephrosis in Patients Presenting With Acute Kidney Injury in the Emergency Department: a Prospective Comparative Pragmatic Study

summary: Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. This observational study aims at assessing the accuracy of point-of-care ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation or distension of the kidney secondary to urinary tract obstruction, in emergency department patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS of the urinary tract by the EP followed by central imaging evaluation by a radiologist (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably diagnose renal tract obstruction at POCUS in the context of AKI.

lead_sponsor: University Hospital, Montpellier


title: The Impact of Outdoor Sports Practice on the Well-Being of Disabled People : a Cross-Sectional Study

summary: Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.

lead_sponsor: Institut de Sante Parasport Connecte Synergies

collaborators: Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)


title: Is There a Concordance Between the Cellvizio With an Intravenous Injection of Fluorescein and the Pathology to Determine the Microscopic Inflammation at the Ileal Resection Margins in Crohn's Ileal Disease

acronym: CELLVICROHN

summary:
Crohn disease is an inflammatory bowel disease. A surgical procedure is required in about 80% of cases. Surgery doesn't cure from Crohn's disease but the type of surgery remains important as there are several intraoperative risk factors for recurrence. Among these factors the microscopic inflammation at the resection margins. This is a crucial point, if the resection is too large there is a risk of short bowel syndrome, if the resection is too short (microscopic inflammation at resection site), there is a higher risk of postoperative recurrence (75% vs 46% at 18 months). Surgeons have to do a limited resection (2cm from macroscopic crohn disease). However this macroscopic non inflammatory resection margin can be microscopically inflammatory (up to 80%). Thus it is useful to evaluate if there is a microscopic inflammation at the resection margin. Moreover there is an increase interest for the role of the mesentery for recurrence but its role remains unclear. It is of interest to clarify the border between the inflammatory and non-inflammatory mesentery. Cellvizio is a confocal laser endomicroscopy providing the possibility of obtaining in vivo high-magnification images of the gut epithelium. This allows real-time examination of the gastrointestinal mucosa at the cellular and subcellular level. Cellvizio has never been used during surgery for Crohn disease.

The aim of this study is to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.


title: Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR

acronym: PROTECT-COEUR

summary:
The combination of epirubicin-cyclophosphamide (EC) and paclitaxel (Tax) is one of the main chemotherapy treatments used in breast cancer patients. These treatments, which can be combined with anti-HER2 therapy using trastuzumab, are frequently associated with side effects including cardiac toxicity. However, this cardiac toxicity has only been demonstrated several months after treatment and using global indices such as ejection fraction.

The assessment of myocardial dysfunction using regional deformations and the kinetic of this dysfunction during chemotherapy treatment has never been performed. In order to counteract these myocardial dysfunctions, it is essential to better describe the kinetic of the cardiac toxicity by initiating measurements since the beginning of the treatment, in order to be able to propose adapted countermeasures (e.g. exercise training) in parallel with the chemotherapy.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

acronym: TEBELID

summary:
Ametropia is the first cause of reversible visual trouble. Recently, laser refractive surgery has increased in popularity. Unfortunately, dry eye is a common side effect, representing about 25% of patients after LASIK and 20% after SMILE. Even if symptoms are usually released by artificial tears, there can be very uncomfortable for patients, decrease productivity and quality of life and be the source of unsatisfaction after surgery.

The goal of our study is to study the efficiency of a preventive associated treatment by intense-pulsed-light and low-level-light therapy with EYE-LIGHT® device before laser refractive surgery. Recent study confirmed the efficacity of this treatment in meibomian glund dysfunction, the predominant dry eye mecanism.

ReferenceCitation: Gomes JAP, Azar DT, Baudouin C, Efron N, Hirayama M, Horwath-Winter J, Kim T, Mehta JS, Messmer EM, Pepose JS, Sangwan VS, Weiner AL, Wilson SE, Wolffsohn JS. TFOS DEWS II iatrogenic report. Ocul Surf. 2017 Jul;15(3):511-538. doi: 10.1016/j.jtos.2017.05.004. Epub 2017 Jul 20.

ReferenceCitation: Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. Ophthalmology. 2015 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22.

ReferenceCitation: Kim TI, Alio Del Barrio JL, Wilkins M, Cochener B, Ang M. Refractive surgery. Lancet. 2019 May 18;393(10185):2085-2098. doi: 10.1016/S0140-6736(18)33209-4.

ReferenceCitation: Giannaccare G, Pellegrini M, Carnovale Scalzo G, Borselli M, Ceravolo D, Scorcia V. Low-Level Light Therapy Versus Intense Pulsed Light for the Treatment of Meibomian Gland Dysfunction: Preliminary Results From a Prospective Randomized Comparative Study. Cornea. 2023 Feb 1;42(2):141-144. doi: 10.1097/ICO.0000000000002997. Epub 2022 Feb 2.

ipd_sharing_description: All collected data that underlie results in a publication


title: Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study

acronym: APAMAdom

summary: The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
AGIR à Dom