title: Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand

acronym: HOT-WORK

summary:
Ocular trauma are a real public health issue. According to WHO, it is estimates at 750,000 hospital admissions per year in the world for ocular trauma, including 200,000 for open globe injuries in the world. Consequences can be severe with a significant number of definitive low vision or blindness which can lead to professionnal reclassifications for active patients. However, no study exists on professional consequences of those ocular trauma. Some studies showed that fonctionnal loss of an eye can also have psychological consequences such as post traumatic depression or can impair the quality of life but studies are scarce on this subject.

The primary objective is to study the professional reclassification of workers at least 6 months after their hospitalization for ocular trauma.

Secondary objectives are to assess, at least 6 months after an hospitalized ocular trauma, characteristics of eye injuries, characteristics of patients, mid-term consequences at work after eye injury and on personal aspects.

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type: Other Identifier

title: Emotion Assessment to Study Consciousness in Awakening Patients

acronym: EmotiCones

summary:
After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious.

The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness.

The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience.

In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Critically Ill Elderly Patients Admitted in Surgical ICU

acronym: IATROAGE

summary:
In order to optimize drug prescription and to reduce potentially inappropriate medications, a pharmaceutical analysis activity is conducted in our establishment for several years. Medical prescriptions are reviewed daily by pharmacists. This activity is developed in approximatively 84% of the hospital wards of the institution, and especially in the geriatric department. Drug induced adverse effects are frequently encountered in elderly people and ICU environment causes a high risk of iatrogenic events because of the complexity of care and of the severity of illness. The hypothesis of the study is that the intervention of pharmacists and geriatricians could improve the medical prescription in elderly patients by reducing avoidable drug interactions and thus by decreasing the risk of drug induced adverse effects.

The primary objective of this study is to evaluate the impact of the intervention of pharmacists and geriatricians on medical prescription and on iatrogenic risk in elderly critically ill patients admitted in surgical ICU. The secondary objectives are (i) to describe the elderly patients population in surgical ICU, (ii) to analyze the impact of the ICU stay on medical prescription, (iii) to analyze the opportunities suggested by the pharmacists to optimize drug therapies and (iv) to assess the impact of drug prescription in the ICU on long-term disability.

A prospective, observational, before-after study will be conducted from august 1, 2018 to February 1, 2020, in the surgical ICU of the hospital. Patients older than 70 years and admitted to surgical ICU will be eligible. This study will be conducted in 2 successive steps: (1) first step: without any intervention of pharmacists or and geriatricians (Baseline), (2) second step: all drug prescription during the ICU and the hospital stay will be analyzed by a pharmacist and a geriatrician, to decrease drug interaction and risk of drug related adverse effect. During each step, the demographic and medical data will be recorded. Medical prescriptions will be reviewed at ICU admission, at 96 hours after ICU admission and then every 4 days until discharge from the ICU. For each patient, the impact of the intervention on mid-term and long-term disability will be assessed during a geriatric evaluation by using adequate specific scale at hospital discharge and at 3 months after hospital discharge. All iatrogenic events will be collected and analyzed.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Besancon

status_simplified: Completed


title: Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)

acronym: ANALISA

summary: Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). The strategy to manage RDS relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. During recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (CPAP) has emerged as a new approach for treating neonates with respiratory failure. The main objectives of Less Invasive Surfactant Administration (LISA) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. The LISA premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. This reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. This study aims to optimize sedation during LISA procedure by evaluating pain score with Ketamine or Protofol sedation, in Neonatal intensive care unit (NICU) patients with RDS.

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Brotelande C, Milési C, Combes C, Durand S, Badr M, Cambonie G. Premedication with ketamine or propofol for less invasive surfactant administration (LISA): observational study in the delivery room. Eur J Pediatr. 2021 Sep;180(9):3053-3058. doi: 10.1007/s00431-021-04103-1. Epub 2021 May 6.

lead_sponsor: University Hospital, Montpellier


title: Comparison of Analgesic Efficiency Between IPACK Block (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) and Surgical Infiltration After Total Knee Arthroplasty

acronym: IPACK

summary: The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.

intervention_type: Other


title: Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

acronym: BPCObs

summary: The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.

acronym: HypnoFibro

summary:
Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. It allows the pneumologist to see the first divisions of the bronchial tree but also to take samples for microbiological or anatomopathological purposes. The two main sampling techniques are bronchoalveolar lavage and endobronchial biopsies. Two steps in the process can be unpleasant for the patient:

the crossing of the nasopharynx because of the narrow and curving passage,
the crossing of the vocal cords and exploration of the trachea, which sometimes causes nausea but especially a cough and a feeling of suffocation.

Depending on the patients, the experience of the examination can be very difficult. In addition, the experience of the examination is influenced by the psychological state of the patient, who is often anxious in the perspective of a diagnosis of a malignancy. It is therefore recommended to perform this examination under local anesthesia (LA) with xylocaine spray 5%. Several protocols, such as the use of atropine, hydroxyzine or benzodiazepines, have been proposed to improve test tolerance, but no pre-medication, other than the drugs indicated in general anesthesia, including midazolam and propofol, has demonstrated their efficacy. Moreover, these molecules are not without respiratory side effects.

Several recent studies have suggested that hypnotic analgesia improves the experience and course of diagnostic procedures that are quite similar to bronchial endoscopy and are usually performed with LA. This is particularly the case for gastroscopy or trans-oesophageal ultrasound. In addition, the effectiveness of hypnotic analgesia for the relief of acute or chronic pain is increasingly well established in the literature. However, the pathophysiology of dyspnea is close to that of pain.

The hypothesis is that adding hypnotic analgesia to the usual local anesthesia will relieve the dyspnea and pain experienced during the examination. There are no studies or data yet on the effect of hypnotic analgesia in bronchial endoscopy with LA. The objective of this work is to demonstrate its effectiveness in order to potentially offer this intervention to all patients and to improve the management of this procedure.

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Volume Estimation of Lower Limbs Before and After Endovascular Venous Intervention or Conventional Surgery in Venous Disease

acronym: VELVET

summary: Chronic venous disease encompasses a broad spectrum of clinical presentations and is considered the most common vascular disease. Its causes are diverse, including primary defects of the wall or valves, chronic venous insufficiency, or lesions secondary to thrombosis, a post-thrombotic venous disease, affecting the superficial or deep venous network or both. The major symptom of venous disease is the enlargement of the lower limbs, which can result in edema. The evaluation of the volume of the lower limbs is very important in the diagnosis and follow-up of the venous pathology. There is a great variability of clinical pictures making it difficult to choose the therapeutic gesture. Endovascular venous interventions and conventional venous surgery are major advances in the treatment of venous disease. The variation of lower limb volume in pre and post procedure is a determining factor; thus orienting clinicians for post interventional therapeutic monitoring. Indeed the management of venous disease is multidisciplinary, it involves the cooperation of several specialists as part of its monitoring and its therapeutic management. Our collaborative group includes the Adult and Child Vascular Investigations Department, the Vascular Clinic, the Cardiovascular and Thoracic Surgery Department, and the Interventional Radiology Department. The evaluation of the variation of the volumes of the lower limbs is a capital data for the various specialists for the care in pre and post procedure. A volumetric 3D scanner system guarantees a reliable measurement ensuring optimal evolution and therapeutic follow-up.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers

intervention_type: Device


title: Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

summary: To ascertain the possibilities to isolate the breast cancer olfactive signature.

lead_sponsor: Institut Curie

intervention_type: Diagnostic Test


title: Myocardial Effects of Volume Expansion Evaluated Using Speckle-Tracking (STRAIN) in Intensive Care Unit Patients

acronym: FLUID-STRAIN

summary: Volume expansion is the cornerstone of hemodynamic management of patients suffering from circulatory failure. The main objective of volume expansion is to increase stroke volume. This increase in stroke volume is due to myocardial contractility improvement. Nowadays, this improvement cannot be assessed using classical monitoring used at the bedside. The main objective of this study is to evaluate left ventricular contractility using Speckle-Tracking before and after volume expansion in intensive care unit patients, to determine if this technology is more sensitive than previous for left ventricular contractility assessment.

lead_sponsor: University Hospital, Bordeaux


title: Place of the Hevylite Test in the Evaluation of MRD in Myeloma

summary: Study aiming at testing the positive predictive value of the Hevylite blood test in detecting minimal residual disease in myeloma compared to an invasive method requiring bone marrow sample by multi-parametric flow cytometry

status: Unknown status

status_simplified: Unknown


title: Randomized Prospective Open-label Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

acronym: PRURI-MUSIC

summary:
Many clinical studies have shown the benefit of music therapy in various pathologies, including pain, and it is now established that the latter has a complementary therapeutic interest. Its most frequently identified indications are the fight against acute or chronic pains, the reduction of anxiety, depression and stress, as well as memory disorders such as Alzheimer's disease.

The main modes of action of music therapy involve sensory, cognitive, psychological and behavioral processes that are also found in pruritus.

Pruritus is defined as "an uncomfortable sensation causing the need to scratch. It has similarities with pain but also differences: relief by heat / cold, scratching / withdrawal behavior, localization on the skin, semi-mucous / ubiquitous ... etc.

The pathophysiology also has similarities, pruritus is born at the dermal-epidermal junction at the level of specific cutaneous receptors then follows the classical pathways through a 1st neuron, then the dorsal horn of the spinal cord and a second neuron. At the cerebral level, there is no single center of pruritus but several motor and sensory areas involved.

The similarities suggest that music therapy may have an interest in the management of chronic pruritus, especially since classical treatments (antihistamines, topical corticosteroids) have only partial efficacy in some dermatoses

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ReferenceCitation: Moncrieff G, Cork M, Lawton S, Kokiet S, Daly C, Clark C. Use of emollients in dry-skin conditions: consensus statement. Clin Exp Dermatol. 2013 Apr;38(3):231-8; quiz 238. doi: 10.1111/ced.12104. Review.

ReferenceCitation: Misery L. Itch Management: General Principles. Curr Probl Dermatol. 2016;50:35-9. doi: 10.1159/000446039. Epub 2016 Aug 23. Review.

ReferenceCitation: Takeuchi S, Oba J, Esaki H, Furue M. Pruritus of patients with atopic dermatitis in daily life and their experience of therapeutic effects: results of a web-based questionnaire survey. Br J Dermatol. 2015 Jul;173(1):250-2. doi: 10.1111/bjd.13557. Epub 2015 Mar 27.

ReferenceCitation: Weisshaar E, Szepietowski JC, Darsow U, Misery L, Wallengren J, Mettang T, Gieler U, Lotti T, Lambert J, Maisel P, Streit M, Greaves MW, Carmichael AJ, Tschachler E, Ring J, Ständer S. European guideline on chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):563-81. doi: 10.2340/00015555-1400.

ReferenceCitation: Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Study of Eating Behaviour and Sense of Taste Before and After Treatment With Nocturnal Continuous Positive Airway Pressure in Overweight Patients With Obstructive Sleep Apnoea Syndrome.

acronym: GOUSAS

summary:
Obstructive sleep apnea (OSA) is characterized by a repeated partial or complete obstruction of the airway that results in a intermittent hypoxia and sleep disturbance.

A complex and reciprocal link between obesity and OSA exists. On the one hand, obesity is one of the main risk factors for OSA. On the other hand, OSA seems to promote obesity. The changes in sleep patterns that characterize OSA alter energy metabolism and promote weight gain. In particular, OSA is associated with metabolic disturbances, decreased physical activity and changes in energy expenditure resulting in weight gain. OSA is characterized by resistance to leptin which reduces the feeling of satiety and an increase in ghrelin levels which increases the feeling of hunger.

There may be an increase in food intake, but very few studies have looked at this aspect. Our current knowledge is based on simple patient reports of the amount of food consumed per 24 hours.

First-line treatment of OSA is based on continuous positive airway pressure (CPAP) but this approach is not curative and weight loss is encouraged. CAPP could facilitate weight loss by restoring sleep quality. Paradoxically, recent studies show weight gain proportional to the duration of use of CPP. Randomized controlled trials offering apneic patients a return to physical activity and hygiene-dietary rules have shown an improvement in OSA after weight loss.

A better understanding of the influence of OSA and its treatment on the energy balance through food preferences and olfacto-gustatory sensoriality is an essential prerequisite for personalized nutritional management. In the face of unexpected weight gain under CPP, this type of intervention would be all the more beneficial as OSA and obesity are public health problems representing two independent risk factors for cardiovascular morbidity and mortality with increasing incidence.

We hypothesize that the treatment of OSA with CPAP changes food preferences in favour of fatty and sugary high-calorie foods.

intervention_type: Biological


title: Interdental Microbiota According to the Caries Risk Factors Among Adolescents Aged 15 to 17 Years.

acronym: MIARC

summary:
Adolescence remains a period during which tooth decay is still very active. There are few epidemiological studies in adolescents, and the majority of them were young people aged 15 and under. Early studies have characterized the interdental periodontal microbiota in healthy adults but, to our knowledge, no studies have analyzed the caries interdental microbiota in young people between 15 and 17 years of age. The main objective of this study is to describe the interdental microbiota in adolescents by a quantitative detection system using real-time PCR methodology. It will quantify 26 major interdental pathogens. The secondary objective is to analyse the distribution of these bacteria according to the level of caries risk and salivary risk.

Fifty Caucasian adolescents were recruited for this cross sectional study.

study_start_date_type: Anticipated

lead_sponsor: Université Montpellier


title: Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

summary: Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.

lead_sponsor: Nantes University Hospital


title: Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

summary: Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof executive functions is not described for preterm infants.


title: IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

acronym: IMPACT

summary: IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

primary_purpose: Treatment

lead_sponsor: Farapulse, Inc.

lead_sponsor_type: industriel


title: Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals

summary:
Simulation is an educational approach that has recently found an application in healthcare.acquire. Angers university hospital has decided to acquire, in December 2016, the high-fidelity Oocyte Pick up (OPU) simulator PickUpSimTM, and the investigators have put in place a training novel program containing different simulation based courses. It is essential to analyze its impact on the clinical practice before implementing it on a larger scale. Initial hypothesis was that the residents' lack of specific training and inexperience would result in suboptimal oocyte retrievals, especially for their first cases

The investigators will undertake a prospective comparative study at the In Vitro Fertilization (IVF) unit of the Angers University Hospital between May 2019 and April 2022. The investigators will include all voluntary residents in rotation at the IVF unit in that time period. The participants will be divided in two groups: Group A will undergo the PickUpSimTM simulation training program whereas group B will only have the classic training with no simulation.

The primary objective is to assess the benefits of an OPU simulation training program using the PickUpSimTM simulator for teaching residents in a university-affiliated IVF center. The main criterion the investigators will use is the "oocyte retrieval rate" (ORR) during the first month following 15 days of simulation training. The ORR is calculated as the number of oocytes retrieved divided by the number of follicles aspirated.

Our secondary objectives are:

To assess the residents' satisfaction with the simulation training program.
To evaluate the learning curve of residents during the two weeks of training.
To compare the OPU complication rate between residents with and without previous simulation training.
To analyze the oocyte retrieval rate in the second and third month of REI rotation for residents, and compare it between those with and those without simulation training.

intervention_type: Procedure


title: eFast Diagnosis Performance in Guiding First Aid Resuscitation at the Admission of Severe Trauma Injuries

acronym: eFAST Decision

summary:
A lesion work-up associating clinical examination, extended focused ultrasound (eFAST including abdominal ultrasound [right upper, left upper, and suprapubic quadrant], bilateral anterior and lateral pleuropulmonary ultrasound, sub-xyphoid pericardial ultrasound, transcranial Doppler), and possibly chest and pelvis x-ray, can early diagnose the most severe traumatic lesions and guide first aid resuscitation and haemostasis. The protocol does not modify the diagnostic and therapeutic strategies applied in the participant centers.

The objective of the study is to evaluate the diagnosis performance of an initial lesion assessment by extended focused ultrasound (eFAST) (possibly associated with chest and pelvis x-ray) at the early phase of a severe trauma patient care in guiding first aid resuscitation and haemostasis.

The relevance will be judged on the therapeutic decisions taken (thoracic or pericardial drainage, thoracotomy or laparotomy, pelvic embolization, posture of a pelvic girdle, and early optimization of cerebral perfusion pressure) based on the initial ultrasound scan.

ReferenceCitation: Peytel E, Menegaux F, Cluzel P, Langeron O, Coriat P, Riou B. Initial imaging assessment of severe blunt trauma. Intensive Care Med. 2001 Nov;27(11):1756-61. Epub 2001 Oct 17.

ReferenceCitation: Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review.

ReferenceCitation: Brooks A, Davies B, Smethhurst M, Connolly J. Emergency ultrasound in the acute assessment of haemothorax. Emerg Med J. 2004 Jan;21(1):44-6.

ReferenceCitation: Kirkpatrick AW, Sirois M, Laupland KB, Liu D, Rowan K, Ball CG, Hameed SM, Brown R, Simons R, Dulchavsky SA, Hamiilton DR, Nicolaou S. Hand-held thoracic sonography for detecting post-traumatic pneumothoraces: the Extended Focused Assessment with Sonography for Trauma (EFAST). J Trauma. 2004 Aug;57(2):288-95.

ReferenceCitation: Geeraerts T, Velly L, Abdennour L, Asehnoune K, Audibert G, Bouzat P, Bruder N, Carrillon R, Cottenceau V, Cotton F, Courtil-Teyssedre S, Dahyot-Fizelier C, Dailler F, David JS, Engrand N, Fletcher D, Francony G, Gergelé L, Ichai C, Javouhey É, Leblanc PE, Lieutaud T, Meyer P, Mirek S, Orliaguet G, Proust F, Quintard H, Ract C, Srairi M, Tazarourte K, Vigué B, Payen JF; French Society of Anaesthesia; Intensive Care Medicine; in partnership with Association de neuro-anesthésie-réanimation de langue française (Anarlf); French Society of Emergency Medicine (Société Française de Médecine d'urgence (SFMU); Société française de neurochirurgie (SFN); Groupe francophone de réanimation et d'urgences pédiatriques (GFRUP); Association des anesthésistes-réanimateurs pédiatriques d'expression française (Adarpef). Management of severe traumatic brain injury (first 24hours). Anaesth Crit Care Pain Med. 2018 Apr;37(2):171-186. doi: 10.1016/j.accpm.2017.12.001. Epub 2017 Dec 27. Review.

ReferenceCitation: Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. Epub 2005 Apr 16.

ReferenceCitation: Ract C, Le Moigno S, Bruder N, Vigué B. Transcranial Doppler ultrasound goal-directed therapy for the early management of severe traumatic brain injury. Intensive Care Med. 2007 Apr;33(4):645-51. Epub 2007 Feb 27.

ReferenceCitation: Shaukat NM, Copeli N, Desai P. The Focused Assessment With Sonography For Trauma (FAST) Examination And Pelvic Trauma: Indications And Limitations. Emerg Med Pract. 2016 Mar;18(3):1-20, 24; quiz 20-1. Epub 2016 Mar 1. Review.

ReferenceCitation: Bauman M, Marinaro J, Tawil I, Crandall C, Rosenbaum L, Paul I. Ultrasonographic determination of pubic symphyseal widening in trauma: the FAST-PS study. J Emerg Med. 2011 May;40(5):528-33. doi: 10.1016/j.jemermed.2009.08.041. Epub 2009 Nov 17.

ReferenceCitation: Ma OJ, Mateer JR, Ogata M, Kefer MP, Wittmann D, Aprahamian C. Prospective analysis of a rapid trauma ultrasound examination performed by emergency physicians. J Trauma. 1995 Jun;38(6):879-85.

ReferenceCitation: Boulanger BR, McLellan BA, Brenneman FD, Ochoa J, Kirkpatrick AW. Prospective evidence of the superiority of a sonography-based algorithm in the assessment of blunt abdominal injury. J Trauma. 1999 Oct;47(4):632-7.

lead_sponsor: University Hospital, Grenoble


title: Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study

acronym: SPIEVIE

summary: Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

lead_sponsor: University Hospital, Toulouse


title: Impact of New Interventional Imaging Modality Use (Angio-CT) on Patient Radiation Exposure in Transarterial Chemoembolization

summary:
Transarterial chemoembolization (TACE) is the most performed endovascular interventional radiology (IR) procedure. TACE procedures are performed in an IR suite, most of which are equipped with floor-based flat-panel robotic C-arm allowing two-dimensional imaging. Cone-beam computed tomography (CBCT) has been developed to allow three-dimensional navigation but has several limitations such as reduced signal to noise ratio and small field-of-view, and seems to have negative impact on patient radiation exposure. Another option to perform 3D imaging is called angio-CT which combines a CT-scan and a floor-based flat-panel robotic C-arm in a single IR suite. Even if some publications have shown benefit of angio-CT in TACE procedures in Japan, no study about angio-CT in liver IR procedures has been conducted in the occidental world so far. The purpose of our study was to assess the impact of angio-CT use on patient radiation exposure and treatment quality in TACE procedures compared to CBCT.

This before-after study consisted of a review of consecutive TACE procedures performed between January 2016 and September 2017 in our institution with two different imaging modalities, defining two study groups (C-arm with CBCT versus angio-CT).

ipd_sharing_description: NC


title: Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription

acronym: ENIGME

summary:
Some surgeries, such as tonsillectomies, are particularly painful postoperatively because they are not very accessible to a complementary technique of loco-regional anesthesia and require the use of opioids in the postoperative period.

The use of opioids, in combination with usual analgesics, is common after this surgery. However, some risks are associated with the use of morphine in children, including more frequent respiratory distress, nausea and vomiting, and can cause hemorrhagic complications and lengthen the duration of hospitalization. Decreasing the consumption of morphine drugs is therefore a real challenge.

Although there is no randomized controlled study on the use of standard analgesics with or without morphine to date, a number of studies suggest that the use of morphine should not be systematic after a surgery.

The need for opioids after tonsillectomy as well as the level of pain vary between patients. Some teams use morphine at the end of general anesthesia to prevent pain on waking and others use it only if needed, once the child is awake.

Pain assessment scales are used in the Post-interventional Monitoring Room (PIMR) to adapt these analgesic therapies according to the intensity of pain. One of the validated and frequently used scales in pediatric PIMR is FLACC (Face Legs Activity Cry Consolability). Monitoring tools are also available to evaluate the quality of intraoperative analgesia in unconscious children :

the analysis of the pupillary variation in response to a painful stimulus by videopupillometry,
and the ANI (Analgesia Nociception Index) which consists of estimating the sympathetic-parasympathetic balance by a complex analysis of cardiac rhythm variability.

These two types of monitoring could predict which children will require post-operative morphine treatment.

To date, no study has demonstrated the relationship between videopupillometry and postoperative morphine consumption. The average ANI has already been evaluated in children as correlated with FLACC but both monitoring devices have never been compared for a predictive purpose.

The investigators hypothesize that the use of the PPI® (Pain Pupillary Index) scale of Algiscan® and the average ANI measured by the PhysioDoloris® monitor in children still sedated at the end of the intervention could have a prognostic value on post-operative morphine prescription.

lead_sponsor: University Hospital, Limoges


title: Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.

acronym: KING

summary: The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).

primary_purpose: Basic Science

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients

summary: Chronic disease management is a public health problem that faces monitoring difficulties related to complex care pathways. This study will analyze the use of unscheduled or urgent care according to the continuity of care in multimorbid patients

lead_sponsor: University of Paris 5 - Rene Descartes


type: Registry Identifier

title: Modeling and Pharmacological Targeting of Genetic Cardiomyopathy in Children Via Cardiomyocytes Derived From Induced Pluripotent Stem Cells

acronym: DMDstem

summary: Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC), "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of cardiomyopathies of genetic origin.

ReferenceType: result

ReferenceCitation: Souidi M, Amédro P, Meyer P, Desprat R, Lemaître JM, Rivier F, Lacampagne A, Meli AC. Generation of three Duchenne Muscular Dystrophy patient-specific induced pluripotent stem cell lines DMD_YoTaz_PhyMedEXp, DMD_RaPer_PhyMedEXp, DMD_OuMen_PhyMedEXp (INSRMi008-A, INSRMi009-A and INSRMi010-A). Stem Cell Res. 2020 Dec;49:102094. doi: 10.1016/j.scr.2020.102094. Epub 2020 Nov 19.


title: Probabilistic Determination of the Ventro-intermediate Nucleus of the Thalamus (VIM) Coordinates From Radio-anatomical Landmarks on 1.5 Tesla MRI

acronym: PROBA-VIM

summary: After having included the most improved patients by DBS among those implanted in Bordeaux Hospital University, and having defined the most active plots on tremor by its prospective grading on Fahn-Tolosa-Marin (FTM) scale and accelerometry, coordinates of active plots and landmarks will be calculated on post-operative imaging. Association between landmarks and active plots coordinates will be modelled with machine-learning algorithms. The aim is to retrieve the position of the VIM on the basis of the landmarks coordinates.


title: Development of a Quality of Life Measurement Scale in Hereditary Haemorrhagic Telangiectasia (HHT) Disease.

acronym: ELECT-RO

summary:
Hereditary Haemorrhagic Telangiectasia (HHT) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of 1/6000. It is manifested by haemorrhages, mucocutaneous telangiectasias and visceral arteriovenous malformations. These symptoms significantly affect the daily lives of patients, their social relationships and their working lives.

HAS (Haute Autorité de Santé) national recommendations focus on assessing and improving the quality of life (QOL) of patients. Many scales for measuring QOL exist but they are most often general and therefore have the disadvantage of not taking into account the particularities of pathologies and their symptoms and do not allow to have a precise vision of their impact on QOL.

It is important to be able to evaluate this impact, to determine its nature and to quantify it so that health professional can adapt their proposal for the management of HHT patients. And only the development of a specific and validated QOL measurement scale will allow them to access this information.

The aim of this study is to develop a scale of measurement of quality of life in HHT disease and to validate it, a scale specific to HHT, simple and fast to fill by the patients themselves.

ReferenceCitation: Le TTT, Martinent G, Dupuis-Girod S, Parrot A, Contis A, Riviere S, Chinet T, Grobost V, Espitia O, Dussardier-Gilbert B, Alric L, Armengol G, Maillard H, Leguy-Seguin V, Leroy S, Rondeau-Lutz M, Lavigne C, Mohamed S, Chaussavoine L, Magro P, Seguier J, Kerjouan M, Fourdrinoy S. Development and validation of a quality of life measurement scale specific to hereditary hemorrhagic telangiectasia: the QoL-HHT. Orphanet J Rare Dis. 2022 Jul 19;17(1):281. doi: 10.1186/s13023-022-02426-2.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Référence pour la Maladie de Rendu-Osler - Service de Génétique Clinique - HOSPICES CIVILS DE LYON - Groupement Hospitalier Est


title: Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

acronym: NATIVTEP

summary: The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).


title: Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study

summary:
Main objective:

Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech

Secondary objectives:

Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results

status: Withdrawn

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

acronym: DELTOSUPEX

summary: The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

ReferenceCitation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6:CD000434. doi: 10.1002/14651858.CD000434.pub5. Review.

lead_sponsor: University Hospital, Clermont-Ferrand


type: EudraCT Number

title: Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.

summary: This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.

lead_sponsor: Aptabio Therapeutics, Inc.


title: Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity

acronym: SLEEP-PP

summary: This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.


title: Assessment of the Level of Precariousness in a Population of Patients With Symptomatic Peripheral Arterial Disease.

acronym: PRECAR

summary:
Atherosclerosis is a systemic disease that affects coronary, cerebral, and lower-extremity arteries. Peripheral artery disease (PAD) is the manifestation of atherosclerosis in the legs. Three different stages can be found: asymptomatic stage (stage 1), exercise ischemia stage (stage 2) and rest ischemia stage (stage 3). The risk factors for PAD are similar to those for coronary artery disease (CAD) and cerebrovascular disease (CBVD), like high blood pressure, diabetes, smoking, dyslipidemia and obesity. But cigarette smoking is the single most important risk factor for the development and progression of PAD.

PAD is a serious illness and an important predictor of cardiovascular disease with major medico-economic consequences.

A low socioeconomic status (SES) is associated with higher cardiovascular mortality and morbidity. In these vulnerable populations, there is an increase in the prevalence of cardiovascular risk factors, particularly for smoking.

The main objective of this study was to assess the level of precariousness in patients with symptomatic PAD and compare it to the level of precariousness in the general population.

Patients were recruited from vascular medicine and surgery department of Grenoble university hospital or therapeutic education outpatient consultation.

The analysis of socio-economic and environmental data resulted in:

- EPICES score: (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score). The EPICES score is a quick and validated questionnaire to assess precariousness at the individual level, developed by considering all the material and psychosocial dimensions of precariousness.

Precariousness, according to the EPICES score, in the general population is estimated at 40%.

- INSEE parameters. The investigators completed the EPICES score with more traditional indicators derived from The National Institute of Statistics and Economic Studies (INSEE) collects, analyses and disseminates information on the French economy and society. The investigators collected the level of education and professional practice based on the nomenclature of socio-professional categories defined by INSEE.

Cardiovascular risk factors were also collected to measure the links between the level of precariousness and cardiovascular risk factors.


title: Hippocampal Microstructure Assessed by a New MRI Sequence and Episodic Memory at the Early Stage of Multiple Sclerosis: Comparison Between Patients After a Clinically Isolated Syndrome (CIS) and Controls

acronym: Micro-MS

summary: Clinically isolated syndrome (CIS) can evolve into multiple sclerosis. In CIS patients, episodic memory is frequently impaired. Memory disorders could be preceded by microstructural abnormalities without visible atrophy in hippocampus. A recent MRI imaging of diffusion called NODDI (Neurite Orientation Dispersion and Density Imaging) can measure specifically microstructural abnormalities and map the axons in the white matter (WM) and dendrites in the grey matter (GM). The aim of this study is to evaluate microstructural abnormalities in the dentate gyrus of the hippocampus in CIS patients compared to controls.


title: Evolution of Lung 18FDG Uptake in Patients With Idiopathic Pulmonary Fibrosis and Receiving Pirfenidone

acronym: PET-Fibrosis

summary: Idiopathic pulmonary fibrosis (IPF) is a rare and fatal lung disease characterized by unpredictable changes with variable kinetics of progression. Changes in pulmonary function (FVC, DLCO) assessed at the time of diagnosis, or decline in pulmonary function within 12 months after diagnosis, are the best predictors of survival, but poorly predicted disease activity and evolution. 18FDG positron emission tomography (18FDG PETscan) provides the ability to quantify cell metabolism in vivo and non-invasively using a labeled non-metabolizable substrate. Several parameters can be measured in an automated and reproducible way, such as the mean fixation intensity (SUV mean), the maximum fixation intensity (SUV max), the hyperfixing volume measurement (MLV) or the glycolytic activity measurement tissue or TLG (total lesions glycolysis). Several studies have demonstrated an increase of glycolytic activity in lung fibroblast from IPF patient. In a recent study, the investigators demonstrated a strong correlation between the lung uptake parameters and the lung function tests results (LFTs) and prognostic score GAP. In addition, MLV and TLG were factors prognostic and independently associated with progression-free survival at 12 months. In a preliminary study, the investigators studied the change of these parameters in twelve patients treated with pirfenidone for IPF who performed an 18FDG PETscan before the initiation of treatment and about twelve weeks later. A mean decrease of 30% in TLG value between the two evaluations was observed. These preliminary data suggest that pirfenidone influences lung metabolism in patients with IPF. The investigators aim to conduct a prospective study to confirm and refine the preliminary data.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Pneumologie A Centre constitutif de référence des maladies pulmonaires rares Hôpital Bichat Claude Bernard

intervention_type: Radiation


title: Therapeutic Drug Monitoring of Corticosteroids/β2-agonists in Hair in Asthmatic Patients: an Open-label Feasibility Study

acronym: CorticHair

summary:
This feasibility study will be open-label with two dose groups: patients receiving budesonide/formoterol Turbuhaler® at a total daily dose [400 to 800 µg[ (group 1) and patients receiving a total daily dose ≥800 µg/day (group 2) to investigate whether there is a relationship between dose and hair concentration.

The objective of this feasibility study is to determine if the product administered to the patient is detectable and quantifiable in hair in order to have a mean to monitor adherence to the treatment. This study does not in any way evaluate the efficacy or safety of the medicinal product, which will be used in accordance with its marketing authorization.

ReferenceCitation: Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S, Halwani R, Al-Muhsen S. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. 2013 Mar 6;9(1):8. doi: 10.1186/1710-1492-9-8.

ReferenceCitation: Alonso L, Fuchs E. The hair cycle. J Cell Sci. 2006 Feb 1;119(Pt 3):391-3. Review.

ReferenceCitation: Alvarez JC, Abe E, Etting I, Le Guen M, Devillier P, Grassin-Delyle S. Quantification of remifentanil and propofol in human plasma: a LC-MS/MS assay validated according to the EMA guideline. Bioanalysis. 2015;7(13):1675-84. doi: 10.4155/bio.15.89.

ReferenceCitation: Alvarez JC, Charbit B, Grassin-Delyle S, Demolis JL, Funck-Brentano C, Abe E. Human plasma quantification of droperidol and ondansetron used in preventing postoperative nausea and vomiting with a LC/ESI/MS/MS method. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 15;879(2):186-90. doi: 10.1016/j.jchromb.2010.12.001. Epub 2010 Dec 16.

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title: Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells

acronym: LO-MAPT

summary: LO MAPT is an 18-month, phase III, multicenter, randomized, placebo-controlled, 2 parallel groups trial, followed by a 18-month open-label extension phase, to evaluate the efficacy of omega-3 supplementation on cognitive decline in older adults with low DHA/EPA status and subjective memory complaints or family history of Alzheimer disease.


title: A Retrospective Study of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)

acronym: CONCERTO

summary:
Hereditary Haemorrhagic Telangiectasia (HHT) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of about 1/5000. It is manifested by haemorrhage, mucocutaneous telangiectasia and visceral arteriovenous malformations (AVMs) (lung, liver and nervous system).

Severe complications during pregnancy in HHT are rare but considered high risk. Intracranial or pulmonary haemorrhage, stroke and heart failure have been reported in some women with HHT during pregnancy. These complications occur most often in the second and third trimesters when maternal physiological changes such as peripheral vasodilatation and increased cardiac output are at their peak.

Previous retrospective studies were conducted with numbers ranging from 40 to 97 patients and highlighted the importance of early screening of complications and specific management.

The aim of this study is to describe, on a larger number of patients, the obstetric and neonatal complications in patients with HHT and followed in the French Reference Center for HHT.

location_facility: Centre de Référence pour la maladie de Rendu-Osler Service Génétique Clinique Bâtiment A1 - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon


title: A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714

acronym: INN-MS

summary: Ocrelizumab is a humanized anti-CD20 monoclonal antibody that showed in phase III trials a powerful effect on relapse rate and lesion load accumulation in the relapsing form of multiple sclerosis (RMS). This therapeutic agent also showed for the first time a significant reduction of disability progression in Primary Progressive Multiple Sclerosis (PPMS) patients, whereas all other anti-inflammatory drugs had failed to do so in well-conducted studies. This raises the possibility that ocrelizumab, beyond its effects on the adaptive immune system activation underlying white matter lesions and clinical relapses, could beneficially influence other mechanisms involved in the progressive phase of the disease, such as the innate immune microglial cells activation, that has been described to persist in a diffuse manner in the Central Nervous system (CNS). To date the activation of these cells is not accessible to classical Magnetic Resonance Imaging (MRI) techniques, impeding the full investigation of the therapeutic efficacy of drugs such as ocrelizumab.

location_facility: Hôpital Saint-Antoine - Service de Neurologie

intervention_type: Drug


title: Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease

summary: Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild


title: Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy

acronym: LCPVIH

summary: This study aims at describing survival rates over time (Kaplan-Meier estimator) in patients suffering from AIDS-related primary central nervous system lymphoma who were diagnosed from 1996 to 2014 and treated with infusions of high-dose methotrexate and combined antiretroviral therapy.


title: Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain

acronym: RetroTIPIC

summary:
Some cases of acute antero-lateral cervical pain cannot be accurately classified by medical imaging (ultrasound and/or magnetic resonance imaging and/or CT-scan) : imaging rules out carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes and thus the pain is considered "of unknown origin".

The investigators hypothesize that in such cases perivascular inflammation of the carotid may be involved.

This study aims at systematically reviewing medical files (including imaging) of patients suffering from acute cervical pain in which carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes have been ruled out by ultrasound and/or magnetic resonance imaging and/or CT-scan


title: Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.

acronym: ENDOMETAB

summary:
It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility.

The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.

lead_sponsor: University Hospital, Angers


title: Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place

acronym: DEMELE

summary:
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail

The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):

(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives

This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.

This a 3 steps study:

200 patients will be enrolled and answer a questionnaire on knowledge of the disease
Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.

primary_purpose: Supportive Care


title: Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients

acronym: DOPABIEB

summary: the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Development of the Purification of Human Cardiac Mitochondria, Characterization of These Organelles and Validation of the Model in Acute Endocarditis and Obesity

acronym: MITHOM

summary: Data about human cardiac mitochondria are cruelly lacking in the literature. However, damages of the activity of these organelles are often the source of abnormal cardiac function in several pathologies. The purpose of this study is to develop a model of purified human cardiac mitochondria, to verify the purity of these organelles and to validate the authenticity of their function in acute endocarditis and obesity, two situations known to alter their activity. Animal studies have shown that microbial infection reduced mitochondrial metabolism whereas obesity increases it. The investigator's hypotheses are the following: 1) acute endocarditis, a form of cardiac microbial infection, reduces the function of human cardiac mitochondria; 2) obesity (body mass index > 30) activates the metabolism of human cardiac mitochondria.

ReferenceCitation: Mourmoura E, Rigaudière JP, Couturier K, Hininger I, Laillet B, Malpuech-Brugère C, Azarnoush K, Demaison L. Long-term abdominal adiposity activates several parameters of cardiac energy function. J Physiol Biochem. 2016 Sep;72(3):525-37. doi: 10.1007/s13105-015-0427-7. Epub 2015 Aug 10.