title: Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

acronym: conneXion

summary:
Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system.

Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures.

So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.

lead_sponsor: Rennes University Hospital


title: New, Easy and Efficient Ways to CLassify AcetabulaR Fractures

summary:
Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.

Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult.

So the the aim of this study is:

Evaluate the efficacy of four "special" 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel.
Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures.
Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique

status_simplified: Completed


title: Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease

summary:
Lower respiratory tract infections are one of the main hospitalization or mortality cause in idiopathic Parkinson's disease. Because of akinesia and articular rigidity these patient develop restrictive syndrome by reduction in the thoraco-lung compliance.The consequence is a progressive loss of the aerobic physical abilities and infection.

The myotensive technique of active muscular stretching seem to increase the range of motion in healthy subject but also in patient with chronic bronchiotisis . These technics also increase the vital respiratory capacity and re enforce the muscles.So adding these technics during the period when the Parkinson's disease patient is stable would be a way of improvement .

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

intervention_type: Procedure


title: Treatment of Acetabular Fracture: the Contribution of the 3D Impression

summary:
Acetabular fracture are common in elder patients and high energy trauma in younger one.

However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .

3D printing ease the process of operating planification or implant fabrication. The 3D impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.

time_perspective: Prospective


title: Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)

acronym: CAMPOS-TAVI

summary:
Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone.

Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: CHU de Reims

intervention_type: Radiation

status_simplified: Ongoing


title: Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients

summary:
The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year.

This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci


title: Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description

summary:
Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof.

In this experience the particular fracture is probably under-diagnosed. The purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.


title: Information During Maternity

summary:
During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the couple about the medical, non medical informations and explain the physiological changes . As usual, medical staff and doctors explain and inform by oral and with a booklet patient.

In order to cluster and make more accessible these informations, the maternity team of GHPSJ has developed an application on smartphone . If this application has been evaluated on his contents and accordance to recommendations, there is no evaluation about the satisfaction of patient.

The aim is to study the impact of this kind of application on pregnant women satisfaction.

primary_purpose: Other

intervention_type: Other


title: Musculo-scrawny Manifestation Associated With the Endometriosis

summary: The endometriosis is defined by the presence of endometriosic tissue outside of the womb and the prevalence is estimated to be 10% of women.Here is a project aimed to compare musculo-scrawny pains between patients with endometriosis and whose don't suffer of this pathology;


title: Current Situation of the Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment in GHPSJ (St Joseph's Hospital)

summary:
Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are indispensable, the haemorragic risk is high.That's why it's the main reason of hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug intake, drugs interaction and the lack of understanding the treatment.Moreover, the antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This increases the haemorragic risk.Different means were used to minimize the risk , like INR follow up.

The purpose of the study is to evaluate smartphone use to follow the patients'treatment.


title: Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients

summary:
Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. This prevalence didn't change since 15-20 years The fact is that the present undernutrition in the admission deteriorates during the hospitalization.

Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the link between the undernutrition the entrance and the evolution of the AVC is at the moment only little known. The purpose is to study the impact of the undernutrition in the entrance to the hospital (undernutrition previous to the AVC), on the gravity and the evolution


title: Assessment of the Production of Uremic Toxins by the Gut Microbiota of Patients With Chronic Kidney Disease: in Vitro Test

acronym: GUTCOL

summary: Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of TUs in patients not yet in dialysis. The dysregulation of the intestinal microbiota observed during CKD increases the generation of UTs in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of UTs and the comorbidities associated with CKD. Some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of UTs, but the effects remain unclear. In order to test the interest of probiotics during CKD, the investigators have, in collaboration with the Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. For this the investigators would need a collection of fresh stools. The fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on UTs production.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

lead_sponsor: Hospices Civils de Lyon


title: Fistula Laser Closure

summary:
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.

For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.

Recently there is one of them , named FiLAC using a clip system not yet evaluated.

The purpose is to assess the success rate of his new surgery technique.

ipd_sharing: Undecided


title: Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis

summary: It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .

ipd_sharing: No

intervention_type: Diagnostic Test


title: Therapeutic CARE of the Bronchial Cancer Not in Small Cell: Security of the Dispensation of Medicine by the Implementation of a Card of Coordination of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization

summary:
The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. This is clearly the case of cancer coverage.

The optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.That's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient.

A specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient.

The aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an IT link (flea datamatrix) for the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.


title: Digestion: Building a Better Health and Better Understanding the Digestive Processes Thanks to Magnetic Resonance Imaging

acronym: DECOUVRIR-M

summary: The results of our in vitro studies strengthen the hypothesis that the contribution of salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play an important role in this process. As a result, its inhibition could constitute an opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of this study is to verify whether inhibiting salivary alpha-amylase upon the consumption of starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Freitas D, Boué F, Benallaoua M, Airinei G, Benamouzig R, Lutton E, Jourdain L, Dubuisson RM, Maître X, Darrasse L, Le Feunteun S. Glycemic response, satiety, gastric secretions and emptying after bread consumption with water, tea or lemon juice: a randomized crossover intervention using MRI. Eur J Nutr. 2022 Apr;61(3):1621-1636. doi: 10.1007/s00394-021-02762-2. Epub 2022 Jan 11.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche sur Volontaires (CRV), Hospital Avicenne


title: Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid

summary:
The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.

Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.

However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.

Besides, the risk factors of severity of the AAC are little studied.


title: Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region

acronym: ICOPE 29

summary:
Frailty is a geriatric syndrome resulting from a decrease in physiological reserve capacities altering the mechanisms of adaptation to stress with, in the absence of diagnosis and management, a short-term risk of falls, hospitalization, loss of autonomy and death.

In 2019, the World Health Organization has taken up this subject with the objective of reducing the number of dependent people in the world by 15 million, i.e. 150,000 in France. For this purpose, recommendations for integrated care for seniors (Integrated Care for Older People = ICOPE) have been published.

6 functions are essential to maintain autonomy: mobility, memory, sight, hearing, mental health and nutrition. The first step of the ICOPE program consists of screening for a decline in one of these functions using a tool made up of questions or tests that can be carried out in 8 to 10 minutes in primary care by trained non-professionals. The second step is a thorough evaluation of the person screened, leading to the creation of a personalized care plan. In the current state of affairs, despite its recommendations, this identification is not carried out in Brittany.

The objective of this study is to demonstrate the feasibility of implementing the first stage of the ICOPE program by seizing the opportunity of the creation in the Brest region of two Territorial Health Professional Communities (CPTS) : Brest Santé Océane and Iroise santé.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Cpts Brest Sante Oceane
Cpts Pays D'Iroise


title: Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry

acronym: RIPOSTE

summary: The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

ReferenceCitation: Suc G, Estagnasie P, Brusset A, Procopi N, Squara P, Nguyen LS. Effect of BNP on risk assessment in cardiac surgery patients, in addition to EuroScore II. Sci Rep. 2020 Jul 2;10(1):10865. doi: 10.1038/s41598-020-67607-0.

ipd_sharing_description: non-applicable.

lead_sponsor: CMC Ambroise Paré


title: Presence of a Clinical Pharmacist in a Cardiology Department: What Impact on the Management of Diabetic Patients Within Care Pathways? Example of Inpatient Cardiac Patients at GHPSJ

summary:
The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment.

Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.

By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .

primary_purpose: Health Services Research


title: Evaluation of Sores Treatment by Oxygenotherapy

summary:
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.

The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.

status: Active, not recruiting

intervention_type: Device


type: Other Identifier

title: Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder

acronym: IMPACT

summary:
Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.

The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.

status: Unknown status

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral

status_simplified: Unknown


type: Registry Identifier

title: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial

acronym: PrevHPV

summary: This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.

primary_purpose: Prevention

ReferenceCitation: Bocquier A, Michel M, Giraudeau B, Bonnay S, Gagneux-Brunon A, Gauchet A, Gilberg S, Le Duc-Banaszuk AS, Mueller JE, Chevreul K, Thilly N; PrevHPV Study group. Impact of a school-based and primary care-based multicomponent intervention on HPV vaccination coverage among French adolescents: a cluster randomised controlled trial protocol (the PrevHPV study). BMJ Open. 2022 Mar 24;12(3):e057943. doi: 10.1136/bmjopen-2021-057943.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Secondary schools and GPs' practices of the participating municipalities


title: Long-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi Syndrome

summary:
This study is a prospective, multicentre, interventional cohort study in children with PWS over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years.

Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre de réfrence Prader-Willi, Hospital of infants


title: Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

acronym: MELATETRA

summary: To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

lead_sponsor_type: industriel


title: Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology

summary: Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.

lead_sponsor: Biotronik France


title: Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery

acronym: BECSuP

summary:
After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late.

An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day.

The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps.

A secondary objective is to determine perioperative predictors of the physical resumption.

ReferenceType: result

ReferenceCitation: Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016 Aug;22(4):386-92. doi: 10.1097/MCC.0000000000000319. Review.

ReferenceCitation: Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M16-0652. Epub 2016 Aug 23. Review.

ReferenceCitation: Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014 Apr;97(4):1220-5. doi: 10.1016/j.athoracsur.2013.10.040. Epub 2013 Dec 21.

ReferenceCitation: Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11:CD010118. doi: 10.1002/14651858.CD010118.pub2. Review.

ReferenceCitation: Mainini C, Rebelo PF, Bardelli R, Kopliku B, Tenconi S, Costi S, Tedeschi C, Fugazzaro S. Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence? SAGE Open Med. 2016 Oct 19;4:2050312116673855. eCollection 2016. Review.

ReferenceCitation: Hauguel-Moreau M, Naudin C, N'Guyen L, Squara P, Rosencher J, Makowski S, Beverelli F. Smart bracelet to assess physical activity after cardiac surgery: A prospective study. PLoS One. 2020 Dec 1;15(12):e0241368. doi: 10.1371/journal.pone.0241368. eCollection 2020.


title: Characteristics and the Future of the City Chilblains

summary:
Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.

This pathology is currently poorly understood while it's frequent.

The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.


title: Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment

acronym: FERTIBTIU

summary:
Today, few data are available on the patient's fertility following intrauterine tamponade balloon (BTIU) used for postpartum hemorrhage (PPH) after vaginal delivery (AVB). Several studies have concluded that there are no fertility disorders after conservative surgical treatment or embolization. BTIU is an essential treatment in the management of PPH. The aim was to evaluate post-BTIU fertility and the appearance of gynecological symptoms.

This is a bicentric retrospective study (Valenciennes, Lille, France), between 2012 and 2017. The data will be collected by telephone interview on fertility and various gynecological functional symptoms.

lead_sponsor: University Hospital, Lille


title: Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

acronym: ROMANCE

summary:
The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.

Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.

In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.

It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40.

ReferenceCitation: Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91.

ReferenceCitation: Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2. Review.

ReferenceCitation: Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21.

ReferenceCitation: Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94.

ReferenceCitation: O'Neill P, Duarte F, Ribeiro I, Centeno MJ, Moreira J. Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: a randomized controlled trial. Anesth Analg. 2012 Jan;114(1):179-85. doi: 10.1213/ANE.0b013e3182368e87. Epub 2011 Oct 24.

ReferenceCitation: Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5.

ReferenceCitation: Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.

lead_sponsor: University Hospital, Grenoble

intervention_type: Drug


title: Impact MRSA -PCR on Patient Management

summary:
Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).

With the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.

The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.


title: Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Population

summary: The main objective of this study is to compare the interpretation of health news items reporting results of randomized controlled trials (RCTs) with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect, having highest number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of RCTs with and without spin will be interpreted by French-speaking population.

status: Withdrawn

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients

summary: The main objective of this study is to compare the interpretation of health news items reporting results of randomized controlled trials (RCTs) with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect, having highest number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of RCTs with and without spin will be interpreted by French-speaking patients.


title: Impact of Hydrogen Sulfide on Lung Health: Study of Chronic Exposure of the Population Living on the Atlantic Coast and on the Caribbean Coast, in Martinique, During the Stranding Period and Outside the Stranding Period of Sargassum Seaweeds

acronym: SÉSAR

summary:
Sargassum are pelagic brown sea algae. Two species grow on the surface of the ocean and drift freely with ocean currents in the form of slicks: the pelagic Sargassum fluitans and Sargassum natans.

Since 2011, massive strandings of Sargassum seaweed in the French West Indies are to be deplored. In recent years, strandings have increased. In Martinique, sargassum stranding occurs mainly on the Atlantic coast. The duration of stranding from one year to another is variable, but the period during which the stranding is maximum is between April and October.

The accumulation of strandings causes the compaction of algae and limits access to oxygen, which leads to anaerobic degradation which quickly results in the release of various gases, in particular hydrogen sulphide (H2S).

Acute H2S poisoning is well characterized clinically according to exposure (cutaneous, respiratory, ophthalmological, digestive, neurological symptoms, etc.). On the other hand, there are very few data available on the clinical effects of prolonged, repeated exposure and most often at low doses.

Among the toxic effects for which there are still uncertainties regarding long-term exposure to H2S are lung function, measured by spirometry, and airway inflammation, appreciable by measurement of FeNO (fractional exhaled nitric oxide).

The investigators consider it relevant to focus on the clinical and biological characteristics of the population exposed to sargassum in Martinique, in the field, assuming that exposure to sargassum H2S causes pulmonary effects measurable by spirometry and by FeNO, during the stranding period and outside this period.

lead_sponsor: University Hospital Center of Martinique


title: Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique

acronym: QVP-Dia

summary: The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.

location_facility: University Hospital Center of Martinique


title: Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Population

summary: The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect on human health, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of phase I/II (non-randomized) trials with and without spin will be interpreted by French-speaking population.


title: Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients

summary: The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (nonrandomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of phase I/II (non-randomized) trials with and without spin will be interpreted by French-speaking patients.


title: Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older

acronym: CRUSHAGE

summary:
Elderly people frequently take several medications and are exposed to iatrogenic risks.

The oral route is the preferred route of administration. The effectiveness and the safety of the drugs depend in particular on the modes of administration (frequency of the intake, respect of the doses and the galenic ...).

However, these modalities are very little known concerning the treatments intake at home in the elderly population.

In a health facility welcoming geriatric patients, the rupture of galenic is frequent and favored by swallowing disorders, dependence, the increase in age, the presence of cognitive disorders or psycho-behavioral disorders.

The consequences of the rupture of galenic are numerous, concern the patients but also the caregivers who administer the treatments.


title: Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Population*

summary: The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of phase I/II (non-randomized) trials with and without spin will be interpreted by English-speaking population.


title: Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination

acronym: MMENSEA

summary:
The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).

The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.

The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

status: Terminated


title: Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Patients

summary: The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by French-speaking patients.


title: Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units

acronym: PERSEPOLIS

summary: The study aims to construct and validate a self-administrated questionnaire to assess the patients' perception of patient safety in surgical care units. The originality of the study is to perform sociological interviews of hospitalized patients to assess their own perception on the safety of their care and to create corresponding items which will be included in a new questionnaire. In a second step, patients' perception of patient safety will be assessed in numerous surgical care units in France, in order to analyze the psychometric properties of the questionnaire and consequently to validate the questionnaire. The patients' perception will be compared to the healthcare professionals' perception on patient safety and to the patient safety strategies in place in the care units.

ReferenceCitation: Occelli P, Mougeot F, Robelet M, Buchet-Poyau K, Touzet S, Michel P. Feelings of Trust and of Safety Are Related Facets of the Patient's Experience in Surgery: A Descriptive Qualitative Study in 80 Patients. J Patient Saf. 2022 Aug 1;18(5):415-420. doi: 10.1097/PTS.0000000000000950. Epub 2021 Dec 17.

location_facility: Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche


title: Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population

summary: The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by French-speaking population.


title: Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among English-speaking Population

summary: The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by English-speaking population.


title: Effect of Spinal Surgery on Stable Force Platform Parameters Estimating the Posture and the Balance of the Patients Reached of Spinal Pathologies

summary:
Many studies are in favour of the importance of the rachis on the postural balance of the body.It is possible to study the upright posture by determining the center of pressure using a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By deformation correction and stabilizing vertebral stages via arthrodesis, it seems to hypothesize that surgery can modify postural balance.

This study aim to evaluate spinal surgery effect on posture using that plaftorm .


title: Validation of Hemorrhoidal Bleeding Score

summary:
The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included.

Even if there was some rare score including bleeding in literature , none of them were validated.

The aim of the study is first validation of bleeding score .


title: Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System

acronym: ELENA-SNDS

summary:
Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).

The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.

ipd_sharing_description: NC


title: Parental Real-life Experience During the Neonatal Transfer From Intensive Care Unit to Maternity Service of St Joseph Hospital

summary: The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.


title: The circTeloDIAG: a New Approach of Liquid Biopsy for the Diagnosis and Follow-up of Patients With Glioma Tumor

acronym: circTeloDIAG

summary:
Gliomas represent the most frequent primary brain tumor, with 2,500 to 3,000 new cases per year in France. Their diagnosis, although highly complex, is essential for determining patient management. While grade I gliomas (infrequent) are curable by surgery or present a slow progression, grades II to IV require heavy treatment (surgery and radio-chemotherapy), and are associated with a prognosis ranging from 10-15 years for grade II to only 15 months for glioblastoma.

One of the key processes in glioma oncogenesis is the activation of a telomeric maintenance mechanism (TMM). Two TMMs ensure the maintenance of a telomere size compatible with intense cell proliferation (TERT mutation and ATRX loss).

Liquid biopsy is used for the routine diagnosis and monitoring of treatment efficacy of different cancers. To date, no routine clinical testing of liquid biopsies is available for gliomas.

The detection of glioma-specific oncogenic processes, by liquid biopsy, in peripheral blood (ctDNA) could improve diagnosis and follow-up and then avoid surgery for patients with suspected lesions.

Three oncogenic markers can be used to detect gliomas: IDH mutation, TERT mutation, and a marker correlated with ATRX loss on total blood cells.

We hypothesized that the circTeloDIAG will improve and accelerate the diagnostic/prognostic value of the actual classification and provide a new tool to manage patient response to treatment via liquid biopsy. It will combine detection of three markers in liquid biopsy, to produce a versatile tool for all types of gliomas.

Patients with suspected newly diagnosed or recurrent glioma will be included.

location_facility: East Group Hospital, Hospices Civils de Lyon

intervention_type: Biological


title: Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis

summary: Tuberculosis (TB) is a major cause of death among the "communicable" diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of contagious pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

ReferenceCitation: Lopes A, Mougari F, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Raskine L, Evans J, Mouly S, Cambau E, Bergmann JF, Sellier P. Prospective study comparing the conventional and same-day strategies to diagnose pulmonary tuberculosis. Med Mal Infect. 2020 Feb;50(1):36-42. doi: 10.1016/j.medmal.2019.03.010. Epub 2019 Apr 11.

lead_sponsor: Hopital Lariboisière


summary:
State of the question Over the past decade, the incidence of melanoma (MM) has steadily increased in France and in most developed countries. This increased incidence was concerned mainly MM thin while the incidence of MM thick that represent the true "killers", and mortality from MM remained stable or increased slightly over the same period. These epidemiological data and observations from everyday medical practice dermatologists suggest the existence of different growth patterns within MM. Indeed, some MM progressing slowly sometimes for decades before diagnosis but are thin at the time of resection. Conversely, others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the relative mortality in MM, as improved screening failed to influence to this day.

Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to calculate the growth rate, an Australian team recently studied the growth rate in a population of patients suffering from MM. In this population 1/3 of MM had a growth of more than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The European and Australian people are very different in particular regarding the prevention policy, these results can not be extrapolated to the French population.The main objective is to identify risk factors for FGMM in French propulation

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Interest of Skin Graft Pellets in the Management of Ulcers Algic

acronym: ULCERALGIQUE

summary:
Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing.

In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years.

The sex ratio is generally 3 females to 1 male. It is in most cases a complication of vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and microcirculatory.

In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions (sleep disorders, eating, work stoppages) and major economic (individual and collective costs of absorptions).

The treatment of a chronic wound uses validated techniques for several years as the skin graft in tablets, associated with the etiological treatment.

The latest recommendations HAS implemented to date from 2006 and concerns the management of leg ulcers predominantly venous.

Few articles in the literature address the possibility of an analgesic effect of the transplant pellets in the treatment of chronic ulcers algic.

In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg ulcer patients and feet and showed that there was a reduction in pain post transplant.

We propose to evaluate the analgesic effect of the skin graft in pellet on a patient population having one or more Algic ulcers.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort

acronym: MARTHARecidive

summary:
Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date.

In the last ten years, so-called "genome-whole" or "genome wide" association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence.

The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE.

The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. .

These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Description of Perianal Lesions in a Cohort of Crohn's Disease Patients

acronym: LAPCROHN

summary: The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.


title: Adjunction of Hydroxychloroquine in Patients With a Metastatic Melanoma Who Are Resistant to BRAF and MEK Inhibitors : a Retrospective Case-control Study.

acronym: CHLORO-DATRAM

summary:
Patients with a BRAF mutated melanoma are usually treated in France by a first line of immunotherapy followed by a second line that combines a BRAF inhibitor (dabrafenib, vemurafenib, encorafenib) and a MEK inhibitor (trametinib, cobimetinib, binimetinib).

The combination dabrafenib/trametinib is initially very efficient but it is unfortunately limited because acquired resistances usually occur after a year of treatment. Patients who become resistant to dabrafenib/trametinib and immunotherapy, unfortunately do not have an approved effective treatment at their disposal. They usually receive a palliative chemotherapy by dacarbazine or fotemustine, and they have a mean overall survival that is less than three months.

Activation of autophagy in presence of BRAF and MEK inhibitors is a known mechanism of resistance to BRAF/MEK inhibitors. Hydroxychloroquine is an autophagy inhibitor and it has been suggested in vitro that it could decrease resistance to BRAF/MEK inhibitors.

Following the positive results in 2018 of a phase I/II study in the USA that showed the efficacy and the absence of toxicity of the association of Dabrafenib, Trametinib and hydroxychloroquine when used as a first line treatement, we proposed to our patients who had become resistant to the dabrafenib/trametinib combination, to pursue their treatment beyond progression and to receive in addition hydroxychloroquine.

This prescription was initiated in patients for whom no further therapeutic options were available, after validation by a multidisciplinary tumor board. All patients were informed that the combination dabrafenib/trametinib/hydroxychloroquine was not approved by a regulatory agency.


title: Support for the Rhabdomyolysis in an Emergency Department

acronym: RHABDURGENCE

summary:
Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities.

The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.

Acute renal failure and hyperkalemia are the major complications that worsen the prognosis.
In most cases, acute renal failure is reversible. Acute renal failure caused by renal vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct cytotoxic action of myoglobin.

If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion. Reperfusion will not only cause the release into the bloodstream of the cell contents myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the myocyte will cause significant production of free radicals, increasing their toxic effects.

Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral alkaline solution) but not used to this day.

The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of the free radicals during reperfusion by decreasing their toxicity is still not considered clinically.


title: A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.

summary:
Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.

Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler

lead_sponsor: Poitiers University Hospital


title: Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular

acronym: PESCIATIQUE

summary: Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also providers of neurological complications with rates, significant, have recently been precisely detailed by a cohort study published by Lehmann et al. (2): In a series of 2073 patients, the authors reported an overall complication rate of neurological related to the initial trauma of the order of 4%. In this series, 1395 patients were operated with a rate of iatrogenic neurological complications of 2 to 3%. Regarding the first routes (and therefore the types of fractures), the Kocher-Langenbeck path is the path that leads to the greatest number of neurological complications: 3 to 4% in this series (2). However, this cohort study does not specify what truncal achievement it is. Obviously violations posterior acetabular are preferentially providers of sciatic injury while violations prior acetabular are more providers of obturator or femoral lesions. But this is not always the case. Moreover, this study does not specify the type or severity of neurological involvement.

primary_purpose: Screening


title: Impact of Using Cumulative SUM (CUSUM) Control Chart in Maternity Department on Mother and Infant Health: a Cluster Randomized Trial

acronym: MATICUS

summary:
Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity.

Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity.

Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.

Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period.

Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method.

Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.

location_facility:
Robert Debré Hospital
Boulkedid


title: Can the Vascular Physician Sensitize Patients to Redaction of Advance Directives on End of Life?

acronym: DIRFIN

summary:
The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the opportunity for "all adults" to write advance directives in case she would one day be "unable to express their will." If this right is enshrined in the hospitalized patient's charter, brought to the attention of any patient entering a hospital, the fact remains that only 2.5% of the deceased have written advance directives (study National Institute of demographic studies published in 2012).

Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the conditions of the end of life are insufficiently discussed with patients and their families and can lead to difficult situations conflicting view. Now, thinking about advance directives should allow an exchange on the conditions of the end of life desired by patients.

Sicard report of December 2012 concluded that such legislation is known neither patients nor doctors. This is the first obstacle to its use, even if major psychological barriers exist both in patients that their doctors.

It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new bill on the subject. The bill provides that advance directives will no longer be valid for 3 years, but until changed or until the patient's death, and they can be invoked against doctors except emergency or illegality. In addition, to complete the bill, the Ministry of Health commissioned the National Health Authority (HAS) writing a form of advance directives, as well as a doctor's information guide and patient on the subject. The working group is chaired by Professor Sicard. Among the recommendations made to physicians (and by extension health professionals), the investigators accept that talk of advance directives as often as possible and as early as possible, even in the absence of commitment in the short or medium term prognosis .


title: Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

summary:
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.

time_perspective: Cross-Sectional

ReferenceCitation: Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Utility of Samples in Bacteriological Prospective Series of Ulcers Leg Infected Clinically

acronym: ULCERINFECTE

summary:
Leg ulcers are defined as wounds lasting for more than a month. They would receive 0.2% of the population of Western countries. In Europe, the cost per episode of leg ulcers is estimated at 6650 euros (10 000 euros for a foot ulcer). The cost of treatment of wounds would be 2 to 4% of the health budget. Infection is the most common complication of chronic wounds: in most cases, it results in delayed healing, at most, it can result in amputation or serious general complications Bacterial contamination of ulcers is constant. Over time for over 25 years, various studies have shown about relatively identical results. The bacteria are present in over 90% of the etiology of venous leg ulcers. These bacteria are divided into four most common classes: Staphylococcus aureus, Enterococcus, Streptococcus, Pseudomonas. The bacterial ecology changes over time. Indeed Staphylococcus aureus appears first, while the Pseudomonas is associated with ulcers lasting for several months. Anaerobic more difficult to find, are found in 30% of cases Cohabitation between leg ulcers and bacteria often without clinical consequence: These are the stages of infection and colonization.

The infection is related to the proliferation of bacteria and their invasion into the skin, by increasing their virulence (virulence genes acquisition). The increase in the number of bacteria and the multiplicity of bacterial genera are one reason for the increased virulence of bacteria. When bacteria proliferate, because the host defenses are inadequate, or because there is a vascular disease which promotes the proliferation, clinical signs appear


title: Congenital Aniridia Patient Questionnaire

acronym: Aniridia-Quizz

summary:
Congenital aniridia is a pan-ocular genetic disease characterized by a partial or complete absence of the iris, hence its name. The prevalence ranges from 1 / 40,000 to 1 / 96,000 births, but it may be underestimated. This condition combines several types of eye damage and could associate systemic manifestations, with a variable phenotype and genotype.

This study aims to identify eye and systemic manifestations in congenital aniridia and to determine the patients' knowledge of their own disease through a survey prepared by ophthalmologists from the Ophthalmology Department of Necker-Enfants Malades Hospital, reference center in France for this pathology. The patient fills it out only once.


title: Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation

acronym: CYPHORACHI

summary:
The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used.

All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series.

The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data.

Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery.

Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day.

The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.


title: Effect on Fatigue of Light (Lux) Therapy in Patients With Cancer

acronym: EFFLUX

summary:
Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and persists for years after treatment in more than 35% of patients. Fatigue is the earliest and most important symptom described by cancer patients. Its prevalence in cancer chemotherapy patients is between 70 and 100%. Fatigue is more common to cancer patients and to the general population or other types of patients. Typically described as a lack of energy associated with mental disorders, fatigue related to cancer can be extremely debilitating. The causes are many, mainly including the cancer itself, side effects due to treatment, sleeplessness due to pain, anxiety or depression. The cancer-related fatigue has a negative and significant direct impact on all aspects of the patient's quality of life, especially the physical, social and behavioral. Despite the availability of certain treatments and the advanced biomedical research, fatigue remains an inevitable consequence of cancer and its treatment.

The therapeutic use of natural light in medicine dates back to the late nineteenth century. Its remarkable effect on the stimulation of the immune system and fight against infections caused the development of the first therapy techniques (also called luxthérapie) awarded in 1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the regulation of circadian rhythms and homeostatic. The mechanism of action passes through a path "non-visual" involving melanopsin ganglion cells located in the retina. Activation of the pineal gland (epiphysis) by melanopsin cells allows transduce information "shadow and light" in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is well established for treating fatigue-related disorders such as chronic fatigue, seasonal depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism is disturbed. Light therapy, by its mechanism of action, allows reprogramming "of the biological clock and improved synchronization of circadian rhythms.


title: Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells

acronym: DETeCTOR

summary:
Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus), nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some myeloid leukemias.

This study aims to evaluate the combined effect of the scanner and the search for circulating tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation and addressing the psychological impact this approach.

ReferenceCitation: Yannoutsos A, Fontaine M, Galloula A, Damotte D, Chatellier G, Paterlini-Bréchot P, Meyer G, Pastre J, Duchatelle V, Marini V, Schwering KL, Lazareth I, Ghaffari P, Stansal A, Sanson H, Labrousse C, Beaussier H, Nasr NB, Zins M, Salmeron S, Messas E, Lajonchère JP, Emmerich J, Priollet P, Trédaniel J. Peripheral arterial disease and systematic detection of circulating tumor cells: rationale and design of the DETECTOR prospective cohort study. BMC Cardiovasc Disord. 2019 Sep 13;19(1):212. doi: 10.1186/s12872-019-1193-1.


title: Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation

acronym: TWOTECH

summary:
The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation .

The study is a Cross-over, monocentric and open label study

ReferenceCitation: Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997 Oct;112(4):1024-8.

ReferenceCitation: Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6.

ReferenceCitation: Gomez-Merino E, Bach JR. Duchenne muscular dystrophy: prolongation of life by noninvasive ventilation and mechanically assisted coughing. Am J Phys Med Rehabil. 2002 Jun;81(6):411-5.

ReferenceCitation: Soudon P, Steens M, Toussaint M. A comparison of invasive versus noninvasive full-time mechanical ventilation in Duchenne muscular dystrophy. Chron Respir Dis. 2008;5(2):87-93. doi: 10.1177/1479972308088715.

ReferenceCitation: Gómez-Merino E, Sancho J, Marín J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83.

ReferenceCitation: Leger P, Paulus J. [Recommendations of HAS: Practical issues in home non-invasive ventilation in patients with neuromuscular disease]. Rev Mal Respir. 2006 Sep;23(4 Suppl):13S141-3. French.

ReferenceCitation: Finder JD, Birnkrant D, Carl J, Farber HJ, Gozal D, Iannaccone ST, Kovesi T, Kravitz RM, Panitch H, Schramm C, Schroth M, Sharma G, Sievers L, Silvestri JM, Sterni L; American Thoracic Society. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am J Respir Crit Care Med. 2004 Aug 15;170(4):456-65. Review.

ReferenceCitation: Kang SW, Bach JR. Maximum insufflation capacity. Chest. 2000 Jul;118(1):61-5.

ReferenceCitation: Bach JR. Update and perspective on noninvasive respiratory muscle aids. Part 2: The expiratory aids. Chest. 1994 May;105(5):1538-44. Review.

ReferenceCitation: Boitano LJ. Management of airway clearance in neuromuscular disease. Respir Care. 2006 Aug;51(8):913-22; discussion 922-4. Review.

ReferenceCitation: Irwin RS, Boulet LP, Cloutier MM, Fuller R, Gold PM, Hoffstein V, Ing AJ, McCool FD, O'Byrne P, Poe RH, Prakash UB, Pratter MR, Rubin BK. Managing cough as a defense mechanism and as a symptom. A consensus panel report of the American College of Chest Physicians. Chest. 1998 Aug;114(2 Suppl Managing):133S-181S. Review.

ReferenceCitation: Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphaël JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300.

ReferenceCitation: Toussaint M, Boitano LJ, Gathot V, Steens M, Soudon P. Limits of effective cough-augmentation techniques in patients with neuromuscular disease. Respir Care. 2009 Mar;54(3):359-66.

ReferenceCitation: Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44.

ReferenceCitation: Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8.

ReferenceCitation: Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91.

ReferenceCitation: Servera E, Sancho J, Zafra MJ, Catalá A, Vergara P, Marín J. Alternatives to endotracheal intubation for patients with neuromuscular diseases. Am J Phys Med Rehabil. 2005 Nov;84(11):851-7.

ReferenceCitation: Chatwin M, Simonds AK. The addition of mechanical insufflation/exsufflation shortens airway-clearance sessions in neuromuscular patients with chest infection. Respir Care. 2009 Nov;54(11):1473-9.

ReferenceCitation: Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62.

ReferenceCitation: Lacombe M, Del Amo Castrillo L, Boré A, Chapeau D, Horvat E, Vaugier I, Lejaille M, Orlikowski D, Prigent H, Lofaso F. Comparison of three cough-augmentation techniques in neuromuscular patients: mechanical insufflation combined with manually assisted cough, insufflation-exsufflation alone and insufflation-exsufflation combined with manually assisted cough. Respiration. 2014;88(3):215-22. doi: 10.1159/000364911. Epub 2014 Aug 21.

ReferenceCitation: Brito MF, Moreira GA, Pradella-Hallinan M, Tufik S. Air stacking and chest compression increase peak cough flow in patients with Duchenne muscular dystrophy. J Bras Pneumol. 2009 Oct;35(10):973-9. English, Portuguese.

ReferenceCitation: Fauroux B, Guillemot N, Aubertin G, Nathan N, Labit A, Clément A, Lofaso F. Physiologic benefits of mechanical insufflation-exsufflation in children with neuromuscular diseases. Chest. 2008 Jan;133(1):161-8. Epub 2007 Dec 10.

ReferenceCitation: Kang SW, Kang YS, Sohn HS, Park JH, Moon JH. Respiratory muscle strength and cough capacity in patients with Duchenne muscular dystrophy. Yonsei Med J. 2006 Apr 30;47(2):184-90.

ReferenceCitation: Sancho J, Servera E, Díaz J, Marín J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5.

ReferenceCitation: Winck JC, Gonçalves MR, Lourenço C, Viana P, Almeida J, Bach JR. Effects of mechanical insufflation-exsufflation on respiratory parameters for patients with chronic airway secretion encumbrance. Chest. 2004 Sep;126(3):774-80.


title: Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV

summary: The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza A&B assay in comparison with the routine Xpert Flu/RSV assay.


title: Evaluation of Pharmacokinetic / Pharmacodynamic Data and Interest Individualized Therapeutic Drug Monitoring Glycopeptides and β-lactam-aminoglycoside ICU

summary:
Since the discovery of streptomycin in 1944, aminoglycosides retain a remarkable bactericidal activity vis-à-vis including aerobic gram-negative bacilli. Thus, their synergistic effect with beta-lactams and their rapid bactericidal on many make unavoidable pathogens and make it a cornerstone of the treatment of patients with severe sepsis or state of septic shock.

This is antibiotics exclusively parenteral administration. Their effectiveness is concentration-dependent and are administered by 30-minute infusion. Tolerance of venous is usually excellent. Their potential nephrotoxicity or cochleovestibular toxicity requires accurate monitoring of antibiotic residuals.

Moreover the fact that the effectiveness of the aminoglycosides is concentration dependent, the rate at the peak is decisive. A first sub-therapeutic dose leads to adaptively resistant bacteria compared to the aminoglycoside and therefore an increase of Minimal Inhibitory Concentrations (MIC). Many studies have been conducted in patients hospitalized in intensive care, highlighting underdoses in aminoglycosides when the prescribed dosages consistent with those used in non reanimated patients. Dr Moore showed in 89 ICU patients with bacteremia gram-negative bacilli, the relationship between the clinical course and obtaining whether therapeutic levels during the first administration of aminoglycosides. Thus, mortality in patients whose antibiotic concentrations to peak were subtherapeutic, amounted to 20.9% against 2.4% when concentrations were within the therapeutic range. In the context or an initial peak in the PK / PD ( Pharmacokinetic / Pharmacodynamic) objectives namely Cmax / MIC ≥ 8-10 desirable, individualized therapeutic drug monitoring and identification of factors that may cause a concentration of antibiotic at sub-therapeutic peak seems necessary , in patients for the majority an increased volume of distribution.

In addition to the β-lactams and glycopeptides, due to the increased volume of distribution in critically ill patients in sepsis, evaluation of serum 24 hours after starting treatment to check that the PK / PD goals for these molecules is achieved.


title: Causes of Low Digestive Bleeding in Proctology

acronym: CASPeR

summary: The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.


title: Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects

acronym: OroColi-HS

summary: In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal of predominant GNB colonization.


title: Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Hospital Subjects

acronym: OroColi

summary: In this prospective observational multicenter study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery) and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates; to compare the phylogentic characteristics of colonization and potential E. coli infection isolates; to compare the rectal and oropharyngeal colonization composition; description of oropharyngeal microbiote


title: Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia

acronym: CRIMI

summary:
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not subject to a clear consensus.

Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European working group) in a population of severe ischemia in patients in order to offer relevant simple and reproducible criteria. Secondly Investigators propose to monitor the medium and long term evolution of these patients ICC defined to clarify the prognosis.

diagnostic criteria of the different societies:

TASC: Transatlantic criteria: very characteristic pain, wound optional, variable hemodynamic criteria as the presence of a wound or not
VALMI: French criteria derived vascular medical college: characteristic pain, sore, hemodynamic reproducible, reliable criteria
European working group: European definition of criteria, including a characteristic pain, requires no wound, different hemodynamic criteria of 2 others.


title: Satisfaction Survey of Patients Over Hypnoanalgesia or Hypnosedation at a Digestive Endoscopy or Surgery

acronym: SEDuCE

summary:
The use of hypnosedation in the context of anesthesia is validated. This is a technique that combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with local anesthesia surgical site. It can favorably replace general anesthesia if surgery or endoscopy allows but doctors will always need local anesthesia surgical site where surgery The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to the operating room and in the various services of conventional and ambulatory hospitalizations.

The goal of the investigators is to evaluate these parameters on a prospective cohort of patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or surgery.


title: Postoperative Kinesio Taping Effect on Pain and Edema in Patients Who Underwent Total Hip Arthroplasty

summary:
The hip is a commonly performed operation corresponding to a prosthetic joint replacement surgery whose effectiveness depends on the quality of architectural and mechanical reconstruction of the artificial hip, integrity and balance of the periarticular musculature. To achieve this dual purpose, two elements are essential: access to the hip that best meets the musculature and is able to restore the balance, and adequate prosthesis. Despite the move towards a surgery less invasive hip replacement is a procedure that causes tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in about 30% of cases.

Several studies have shown that there are risk factors for chronic post-surgical pain. They are both related to patients but also to surgery. It is thus advantageous to reduce the postoperative pain, localized mainly in the trochanteric region, to decrease the risk of developing chronic post surgical pain. Now medical comunity know that the post-operative bruising and tissue damage are partly responsible for these pains.

The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s It is water resistant and retains its properties up to 5 days. It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.

Its designers also claim it would have a beneficial effect on the lymphatic and venous circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the pressure in the dermis and promoting lymphatic drainage through its mechanical action during movement.

The lymphatic system is responsible for the capture of waste from venous blood (catabolites, plasma proteins) and thus can promote the absorption of edema.

In his study, Donec highlights a significant decrease in pain and a higher absorption of postoperative edema in the Kinésiotape® group than in the control group in surgical patients with total knee arthroplasty .

The Curetape® band is used in the orthopedic surgery department since 2010 in current care.

Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients with a total hip replacement.


title: Analysis of the Impact of the Fragility of the Over 70 Years of TIA (Transient Ischemic Attack) Prognosis

summary:
Fragility, geriatric concept recent identification is defined by simple physical indicators. The literature suggests that it is related to the risk of hospitalization, falls, institutionalization and death. Some studies have shown a link with heart disease, including heart failure. The link with the TIA (transient ischemic attack) has however never been studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is unknown.

Several questions need to be asked: Among older patients hospitalized for TIA, what proportion of those completing the criteria of frailty? In this same population, is there a correlation between fragility and scores ABCD2 score itself predictive of the risk of subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher risk of ischemic stroke (which could cause a strengthening of prevention measures)?


title: Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach: Interest Using the SUDOSCAN® Machine

acronym: CANALOXA

summary:
Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer. However, the development of neuropathic pain under treatment limits its use. These are manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.

It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms of neurotoxicity are multifactorial and still imperfectly described.

Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose challenge is to quantify / measure NAION and explained by a biochemical approach, specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that the expected results will be complementary to those of LIPIDOXA.

ReferenceCitation: Delmotte JB, Tutakhail A, Abdallah K, Reach P, D'Ussel M, Deplanque G, Beaussier H, Coudoré F. Electrochemical Skin Conductance as a Marker of Painful Oxaliplatin-Induced Peripheral Neuropathy. Neurol Res Int. 2018 Sep 27;2018:1254602. doi: 10.1155/2018/1254602. eCollection 2018.


title: Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis

summary: The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.


title: Newborn in Helathy Birthroom: Assessment of Pratical Home and Mother Lived

acronym: EPAVM

summary:
Motherhood Our Lady of Good Help is from the 2006 merger of three hospitals, St. Joseph, Our Lady of Good Help and Saint-Michel. She was transferred to a new building in the heart of Paris Saint-Joseph Hospital Group website in March 2011. The premises of the birth room are spacious and nice. All delivery rooms are supposed to welcome the mother and child when the birth goes smoothly. There is a resuscitation room (called "Nursery") for newborns requiring medical care. But since the installation in the new building, the investigators had the impression that a number of children born without pathology futures and with good adaptation at birth passed through this room for no apparent medical reason.

The investigators wanted to make an inventory of home practice healthy newborns in our maternity, evaluate the reasons for a possible separation and appreciate the feelings of mothers cope with this separation.