title: Diuretic Versus Placebo in Pulmonary Embolism With Right Ventricular Enlargement: a Double-blind Randomized Controlled Study

acronym: DiPER

summary:
Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related to an acute right ventricular (RV) failure due to the increase in right ventricular afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in case of shock. However several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilatation and ischemia and left ventricular compression by RV dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of fluid expansion. In a preliminary study published by our group, we showed that diuretic treatment in the setting of PE with RV dilatation is safe and is associated with an increase in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients with oliguria. This may be related to the decrease of ventricular interdependence and enhancement of both LV and RV function.

The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in patients referred for acute PE with RV dilatation compared to placebo. The combination of urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it indicates the disappearance of pre-shock symptoms and is therefore associated with a lower event risk. Thus, it allows early discharge of the patients from the intensive care unit.

ReferenceCitation: Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. Chest. 2002 Mar;121(3):877-905. Review.

ReferenceCitation: Lee FA. Hemodynamics of the right ventricle in normal and disease states. Cardiol Clin. 1992 Feb;10(1):59-67. Review.

ReferenceCitation: Perlroth DJ, Sanders GD, Gould MK. Effectiveness and cost-effectiveness of thrombolysis in submassive pulmonary embolism. Arch Intern Med. 2007 Jan 8;167(1):74-80.

ReferenceCitation: Goldhaber SZ, Haire WD, Feldstein ML, Miller M, Toltzis R, Smith JL, Taveira da Silva AM, Come PC, Lee RT, Parker JA, et al. Alteplase versus heparin in acute pulmonary embolism: randomised trial assessing right-ventricular function and pulmonary perfusion. Lancet. 1993 Feb 27;341(8844):507-11.

ReferenceCitation: Lim P, Delmas C, Sanchez O, Meneveau N, Rosario R, Bouvaist H, Bernard A, Mansourati J, Couturaud F, Sebbane M, Coste P, Rohel G, Tardy B, Biendel C, Lairez O, Ivanes F, Gallet R, Dubois-Rande JL, Fard D, Chatelier G, Simon T, Paul M, Natella PA, Layese R, Bastuji-Garin S. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):2-9. doi: 10.1093/ehjacc/zuab082.

ReferenceCitation: Gallet R, Meyer G, Ternacle J, Biendel C, Brunet A, Meneveau N, Rosario R, Couturaud F, Sebbane M, Lamblin N, Bouvaist H, Coste P, Maitre B, Bastuji-Garin S, Dubois-Rande JL, Lim P. Diuretic versus placebo in normotensive acute pulmonary embolism with right ventricular enlargement and injury: a double-blind randomised placebo controlled study. Protocol of the DiPER study. BMJ Open. 2015 May 22;5(5):e007466. doi: 10.1136/bmjopen-2014-007466.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery Grade II or III of Goligher

summary:
Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery.

The aim is to evaluate the efficacy of this technic and note the post surgery pain and events

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique

status_simplified: Completed


title: Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction

summary: The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.

time_perspective: Retrospective

enrollment_type: Actual

intervention_type: Procedure


title: Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot

summary: The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Sigvaris France

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Study Evaluating the Effect of Compression Stockings at Constant Pressure for 28 Days on the Number of Apneas/Hypopneas Per Hour of Sleep (Index of Apneas/Hypopneas) in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment

summary:
The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea).

The main symptoms of sleep apnea-hypopnea syndrome are daytime sleepiness (caused by the fragmentation and breakdown of sleep) and nocturnal snoring; possibly accompanied by the following symptoms: non-restorative sleep, difficulty concentrating, nocturia, cognitive disorders, libido disorders.

The consequences of sleep apnea-hypopnea syndrome are multiple for the patient both in the short term and in the long term.

The short-term manifestations are as follows: daytime sleepiness, reduced alertness, difficulty driving (risk of road accidents), difficulty performing tasks (risk of accidents at work), memory and concentration problems , learning difficulties (especially in children), mood disorders. In the end, there is an alteration in the quality of life of the patient.

Sleep apnea-hypopnea syndrome also has long-term consequences: a link between sleep apnea-hypopnea syndrome and cardiovascular morbidity and mortality has been explored by several cohort studies.

Nasal ventilation by continuous positive airway pressure is considered the reference treatment for sleep apnea-hypopnea syndrome. The use of nasal ventilation by continuous positive airway pressure, compared to no treatment, is not associated with a reduced risk of cardiovascular outcomes or death in patients with sleep apnea according to a recent meta-analysis.

Mandibular advancement devices are an alternative treatment for nasal ventilation by continuous positive airway pressure. The acceptability of its treatments, whether nasal ventilation by continuous positive airway pressure or mandibular advancement devices, is not very good and some patients do not start treatment or abandon it because of the constraints related to these treatments. There is therefore a need to find other treatments.

The overnight rostral fluid displacement from the legs, related to prolonged sitting can generate edema in the neck, more precisely in the upper airways, and therefore obstructive respiratory dysfunctions responsible for sleep apnea-hypopnea syndrome. Correlations between nocturnal fluid shifts and the number of apneas/hypopneas have been demonstrated Previous studies has shown a reduction in the apnea-hypopnea index by the daytime preventive wearing of medical compression, which can reduce the extent of leg edema and the displacement of nocturnal fluids.

The aim of the present study is to show that daytime wearing of medical compression developed specifically to optimize its effect in this indication for 28 days versus not wearing it reduces the number of apneas/hypopneas in patients with sleep apnea-hypopnea syndrome.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

location_facility: Service des Pathologies du Sommeil Bâtiment EOLE GH Pitié-Salpêtrière

intervention_type: Device


title: DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

summary:
Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis.

Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.


title: Operating Check List During Consultation for Dental Implant

summary:
Various studies showed how extent elements not directly linked to the state of the patient were involved in the failures in particular in surgery. That's why it's common to use check list system to avoid human mistakes or any other situation which could impact on the surgery.

Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ; it's a check list which cover all the treatment phases concerning dental implant surgery.

primary_purpose: Other

intervention_type: Other


title: Modeling of Patient-patient Expert-caregiver Interactions During the Addiction Care Pathway

acronym: IPEXA

summary:
"In France and abroad, patient involvement is increasingly encouraged through the development of experiences involving patients in their care or that of their peers.

The Association of PEs in Addictology (APEA) and the Addictology Department of the Bichat Hospital (APHP- Nord, University of Paris) have established a partnership in which PEs volunteer to work with patients throughout the course of their care. To date, no study has evaluated the impact of the PE program in addictology. A preliminary study within the department and the APEA is needed to evaluate the benefits to patients and caregivers, the feasibility and the cost in terms of staff time of implementing the PE program.

The main objective of the project is to describe the care pathways of patients through their interactions with the PEs and the overall addiction care system, over a period of one year, within the Psychiatry-Addictology Department of the Bichat Hospital and then in the outpatient setting.

The secondary objectives are to characterize and describe the patients' profiles according to these pathways; as well as to describe the contribution of EPs in the process of coordinating the care of these patients (interaction between patients - EPs - health professionals).

This is a non-interventional monocentric cohort study in the Psychiatry-Addictology Department of the Bichat Hospital.

In practice, data concerning interactions between patients and EPs and caregivers and EPs will be collected by EPs directly on an eCRF after each contact, for 12 months from inclusion. Patients will be followed during their care pathway for a total of one year, by two telephone assessments at 3 months and 6 months of hospital discharge. A final visit will be made 12 months after hospital discharge by face-to-face interview. Participation will end at the time of the debriefing interview, one year after inclusion.

Modeling the interactions between patients and EPs, and between caregivers and EPs during a course of care in addictology, will lead to a better knowledge of the EP system and the place of EPs in the trajectories of addictology care.

The effectiveness of the PE system can thus be recognized in the management of addictions, in complementarity with the caregivers. The driving factors for implementation will be identified in order to improve the dissemination of the PE system to other centers."


title: Professional Rescuers Cardiopulmonary Resuscitation Performance After Implementation of a Defibrillation Algorithm for Early Treatment of Refibrillation, an Observational Study.

summary:
In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease.

On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion.

The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred

The aim of the study

Study Design:

This is a prospective observational study.

The eligibility criteria are as follows:

Patients in Out-Of-Hospital Cardiac Arrest.
Basic Life support care with an AED.

The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))

ReferenceType: background

ReferenceCitation: Baker PW, Conway J, Cotton C, Ashby DT, Smyth J, Woodman RJ, Grantham H; Clinical Investigators. Defibrillation or cardiopulmonary resuscitation first for patients with out-of-hospital cardiac arrests found by paramedics to be in ventricular fibrillation? A randomised control trial. Resuscitation. 2008 Dec;79(3):424-31. doi: 10.1016/j.resuscitation.2008.07.017. Epub 2008 Nov 4.

ReferenceCitation: Berdowski J, ten Haaf M, Tijssen JG, Chapman FW, Koster RW. Time in recurrent ventricular fibrillation and survival after out-of-hospital cardiac arrest. Circulation. 2010 Sep 14;122(11):1101-8. doi: 10.1161/CIRCULATIONAHA.110.958173. Epub 2010 Aug 30.

ReferenceCitation: Berdowski J, Tijssen JG, Koster RW. Chest compressions cause recurrence of ventricular fibrillation after the first successful conversion by defibrillation in out-of-hospital cardiac arrest. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):72-8. doi: 10.1161/CIRCEP.109.902114. Epub 2009 Dec 30.

ReferenceCitation: Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.

ReferenceCitation: Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7.

ReferenceCitation: Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L; Resuscitation Outcomes Consortium (ROC) Investigators. Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation. 2011 Jul 5;124(1):58-66. doi: 10.1161/CIRCULATIONAHA.110.010736. Epub 2011 Jun 20.

ReferenceCitation: Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.

ReferenceCitation: Fumagalli F, Silver AE, Tan Q, Zaidi N, Ristagno G. Cardiac rhythm analysis during ongoing cardiopulmonary resuscitation using the Analysis During Compressions with Fast Reconfirmation technology. Heart Rhythm. 2018 Feb;15(2):248-255. doi: 10.1016/j.hrthm.2017.09.003. Epub 2017 Sep 14.

ReferenceCitation: Gliner BE, White RD. Electrocardiographic evaluation of defibrillation shocks delivered to out-of-hospital sudden cardiac arrest patients. Resuscitation. 1999 Jul;41(2):133-44.

ReferenceCitation: Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.

ReferenceCitation: Hu Y, Tang H, Liu C, Jing D, Zhu H, Zhang Y, Yu X, Zhang G, Xu J. The performance of a new shock advisory algorithm to reduce interruptions during CPR. Resuscitation. 2019 Oct;143:1-9. doi: 10.1016/j.resuscitation.2019.07.026. Epub 2019 Aug 1.

ReferenceCitation: Jost D, Degrange H, Verret C, Hersan O, Banville IL, Chapman FW, Lank P, Petit JL, Fuilla C, Migliani R, Carpentier JP; DEFI 2005 Work Group. DEFI 2005: a randomized controlled trial of the effect of automated external defibrillator cardiopulmonary resuscitation protocol on outcome from out-of-hospital cardiac arrest. Circulation. 2010 Apr 13;121(14):1614-22. doi: 10.1161/CIRCULATIONAHA.109.878389. Epub 2010 Mar 29.

ReferenceCitation: Kerber RE, Becker LB, Bourland JD, Cummins RO, Hallstrom AP, Michos MB, Nichol G, Ornato JP, Thies WH, White RD, Zuckerman BD. Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997 Mar 18;95(6):1677-82.

ReferenceCitation: Krasteva V, Jekova I, Dotsinsky I, Didon JP. Shock advisory system for heart rhythm analysis during cardiopulmonary resuscitation using a single ECG input of automated external defibrillators. Ann Biomed Eng. 2010 Apr;38(4):1326-36. doi: 10.1007/s10439-009-9885-9. Epub 2010 Jan 13.

ReferenceCitation: Roh YI, Jung WJ, Hwang SO, Kim S, Kim HS, Kim JH, Kim TY, Kang HS, Lee JS, Cha KC. Shorter defibrillation interval promotes successful defibrillation and resuscitation outcomes. Resuscitation. 2019 Oct;143:100-105. doi: 10.1016/j.resuscitation.2019.08.022. Epub 2019 Aug 20.

ReferenceCitation: Vaillancourt C, Everson-Stewart S, Christenson J, Andrusiek D, Powell J, Nichol G, Cheskes S, Aufderheide TP, Berg R, Stiell IG; Resuscitation Outcomes Consortium Investigators. The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation. Resuscitation. 2011 Dec;82(12):1501-7. doi: 10.1016/j.resuscitation.2011.07.011. Epub 2011 Jul 18.

ReferenceType: result

ReferenceCitation: Affatato R, Li Y, Ristagno G. See through ECG technology during cardiopulmonary resuscitation to analyze rhythm and predict defibrillation outcome. Curr Opin Crit Care. 2016 Jun;22(3):199-205. doi: 10.1097/MCC.0000000000000297. Review.

ReferenceCitation: van Alem AP, Post J, Koster RW. VF recurrence: characteristics and patient outcome in out-of-hospital cardiac arrest. Resuscitation. 2003 Nov;59(2):181-8.

lead_sponsor: French Defence Health Service


title: Study On Discopathie With Modic 1

summary: The chronic lumbago can be associated with an active discopathie, objectified on the MRI by the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing the pathological vertebral disk The treatment recommended by t consists in particular of a local infiltration of corticoids which the efficiency is variable according to the patients. The objective of this study is to estimate the efficiency of the local treatment and to highlight some of the factors associated to the advantage of the infiltration by corticoids.

status: Terminated

status_simplified: Unknown


title: Investigation About Advance Directives

summary:
Advance directives are again in the heart of debate since the Leonetti-Claeys's law . These pieces of legislation allow everyone to decide by advance their wishes of the end of life.However, it does not seem that to legislate on a subject is enough to apply the text of law. High authority of health suggest that medical and paramedical staff have to participate to the elaboration of the questionnaire and the redaction of advance directives.

So the aim is that ,before asking patient about their knowledge on these advance directive, to evaluate if the staff knows about the law .


title: Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program

acronym: EQUAPRAP

summary:
In 2008, the Handicap-Santé survey counted 10 million people with hearing difficulties in France, i.e. 16% of the national population. For 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life.

In 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others.

Hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. It can also limit the quality of exchanges, communication and information taking.

Several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety.

Currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. Hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. However, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting.

Current treatment seems to deal mainly with auditory-cognitive problems. To date, no multidisciplinary rehabilitation services seem to be offered in France to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.

status: Active, not recruiting

ReferenceCitation: Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15. Review.

ReferenceCitation: Brodie A, Smith B, Ray J. The impact of rehabilitation on quality of life after hearing loss: a systematic review. Eur Arch Otorhinolaryngol. 2018 Oct;275(10):2435-2440. doi: 10.1007/s00405-018-5100-7. Epub 2018 Aug 23. Review.


title: Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men

acronym: HYPERCHEM

summary:
Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

Evaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.

Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.

status: Unknown status

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis

acronym: DTS

summary:
Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary from 6 weeks to several months depending on the medical habits. The study hypothesis is that a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.

We run a prospective multi-centric, non inferiority open label trial, randomised in two parallel groups.

The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks versus 12 weeks, on the rate of cure in this indication.

The study concerns 400 patients more than 18 years, 70 centres in France are involved.

The duration of the study is 4 years.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Desoutter S, Cottier JP, Ghout I, Issartel B, Dinh A, Martin A, Carlier R, Bernard L; Duration of Treatment for Spondylodiscitis Study Group. Susceptibility Pattern of Microorganisms Isolated by Percutaneous Needle Biopsy in Nonbacteremic Pyogenic Vertebral Osteomyelitis. Antimicrob Agents Chemother. 2015 Dec;59(12):7700-6. doi: 10.1128/AAC.01516-15. Epub 2015 Oct 5.

ReferenceCitation: Zervou FN, Zacharioudakis IM, Mylonakis E. ACP Journal Club. 6 weeks of antibiotics was noninferior to 12 weeks for clinical cure in pyogenic vertebral osteomyelitis. Ann Intern Med. 2015 May 19;162(10):JC7. doi: 10.7326/ACPJC-2015-162-10-007.

ReferenceCitation: Bernard L, Dinh A, Ghout I, Simo D, Zeller V, Issartel B, Le Moing V, Belmatoug N, Lesprit P, Bru JP, Therby A, Bouhour D, Dénes E, Debard A, Chirouze C, Fèvre K, Dupon M, Aegerter P, Mulleman D; Duration of Treatment for Spondylodiscitis (DTS) study group. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial. Lancet. 2015 Mar 7;385(9971):875-82. doi: 10.1016/S0140-6736(14)61233-2. Epub 2014 Nov 5.

intervention_type: Drug


title: Cardiotoxicity of Selective Estrogen Receptor Modulators and Aromatase Inhibitors in the European Pharmacovigilance Database

acronym: SERENA

summary: Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: L02 in the European pharmacovigilance database, Eudravigilance.

ReferenceCitation: Grouthier V, Lebrun-Vignes B, Glazer AM, Touraine P, Funck-Brentano C, Pariente A, Courtillot C, Bachelot A, Roden DM, Moslehi JJ, Salem JE. Increased long QT and torsade de pointes reporting on tamoxifen compared with aromatase inhibitors. Heart. 2018 Nov;104(22):1859-1863. doi: 10.1136/heartjnl-2017-312934. Epub 2018 May 2.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière


title: Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)

acronym: ARBITRAGE

summary:
Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.

CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.

This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.


acronym: SADR

summary:
Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

ReferenceCitation: Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.

lead_sponsor: CHU de Reims


type: Other Identifier

title: WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

acronym: WINTHER

summary: An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Cardiotoxicity of Androgenic Agonists and Antagonists in the National French Pharmacovigilance Database and EudraCT Database

acronym: TORNICS

summary: Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C) and sex hormones used in treatment of neoplastic diseases (L02) in the French pharmacovigilance database and European Clinical Trials (EudraCT) database.

ReferenceCitation: Salem JE, Yang T, Moslehi JJ, Waintraub X, Gandjbakhch E, Bachelot A, Hidden-Lucet F, Hulot JS, Knollmann BC, Lebrun-Vignes B, Funck-Brentano C, Glazer AM, Roden DM. Androgenic Effects on Ventricular Repolarization: A Translational Study From the International Pharmacovigilance Database to iPSC-Cardiomyocytes. Circulation. 2019 Sep 24;140(13):1070-1080. doi: 10.1161/CIRCULATIONAHA.119.040162. Epub 2019 Aug 5.

ReferenceCitation: Salem JE, Waintraub X, Courtillot C, Shaffer CM, Gandjbakhch E, Maupain C, Moslehi JJ, Badilini F, Haroche J, Gougis P, Fressart V, Glazer AM, Hidden-Lucet F, Touraine P, Lebrun-Vignes B, Roden DM, Bachelot A, Funck-Brentano C. Hypogonadism as a Reversible Cause of Torsades de Pointes in Men. Circulation. 2018 Jul 3;138(1):110-113. doi: 10.1161/CIRCULATIONAHA.118.034282.

ReferenceCitation: Barber M, Nguyen LS, Wassermann J, Spano JP, Funck-Brentano C, Salem JE. Cardiac arrhythmia considerations of hormone cancer therapies. Cardiovasc Res. 2019 Apr 15;115(5):878-894. doi: 10.1093/cvr/cvz020. Review.

ReferenceCitation: Salem JE, Yang T, Moslehi JJ, Waintraub X, Gandjbakhch E, Bachelot A, Hidden-Lucet F, Hulot JS, Knollmann BC, Lebrun-Vignes B, Funck-Brentano C, Glazer AM, Roden DM. Androgenic effects on ventricular repolarization: A translational study from the international pharmacovigilance database to iPSC-cardiomyocytes. Ann Endocrinol (Paris). 2021 Jun;82(3-4):132-133. doi: 10.1016/j.ando.2020.02.008. Epub 2020 Feb 29.


title: Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study

acronym: I-Nursing

summary:
Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.

The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.

primary_purpose: Supportive Care

ReferenceCitation: Bialais E, Wittebole X, Vignaux L, Roeseler J, Wysocki M, Meyer J, Reychler G, Novotni D, Sottiaux T, Laterre PF, Hantson P. Closed-loop ventilation mode (IntelliVent®-ASV) in intensive care unit: a randomized trial. Minerva Anestesiol. 2016 Jun;82(6):657-68. Epub 2016 Mar 8.

ReferenceCitation: Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV™) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.

ReferenceCitation: Clavieras N, Wysocki M, Coisel Y, Galia F, Conseil M, Chanques G, Jung B, Arnal JM, Matecki S, Molinari N, Jaber S. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation. Anesthesiology. 2013 Sep;119(3):631-41. doi: 10.1097/ALN.0b013e3182952608.

ReferenceCitation: Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV®) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.

ReferenceCitation: Chelly J, Mazerand S, Jochmans S, Weyer CM, Pourcine F, Ellrodt O, Thieulot-Rolin N, Serbource-Goguel J, Sy O, Vong LVP, Monchi M. Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING). Crit Care. 2020 Jul 22;24(1):453. doi: 10.1186/s13054-020-03155-3.

lead_sponsor: Hopital of Melun


title: Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

acronym: PaneLux PTCA

summary: The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.

ReferenceCitation: Roncalli J, Godin M, Boughalem K, Shayne J, Piot C, Huret B, Belle L, Cayla G, Faurie B, Amor M, Karsenty B, Leclercq F. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J Invasive Cardiol. 2019 Apr;31(4):94-100.

lead_sponsor: Biotronik France


title: Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject

acronym: NDMS

summary: This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and young adults by using static and dynamic measures. Static informations are obtained from full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI for muscular data. Dynamics stability is calculated from 3D gait analysis.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria.

acronym: TDR-PALU

summary: The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

ReferenceCitation: Musset L, Bouchaud O, Matheron S, Massias L, Le Bras J. Clinical atovaquone-proguanil resistance of Plasmodium falciparum associated with cytochrome b codon 268 mutations. Microbes Infect. 2006 Sep;8(11):2599-604. Epub 2006 Aug 10.


title: Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).

acronym: Masq-Aute

summary:
The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices by healthcare personnel to limit their contamination.

However, there is currently a shortage of masks in France due to insufficient national stocks while the disease is spreading.

There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to provide care in complete safety. Contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. Caregiver protection is also intended to contain the risk of nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks provide optimal security against the risk of aerosolization of contaminated biological liquids. They are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and Chemical) atmosphere.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

acronym: IDEA-PE

summary: Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.

ipd_sharing: Undecided

lead_sponsor: European Georges Pompidou Hospital


title: Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery : a Randomized Controlled Trial

acronym: MECANO

summary:
BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. To this date, there are no recommendations regarding mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary outcomes when LTV is performed but no proper prospective trial with large inclusion of all types of cardiac surgery has been published.

DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed. They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cells transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge.

SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome including death, respiratory failure and pneumoniae.

ReferenceCitation: Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

ReferenceCitation: Bignami E, Guarnieri M, Saglietti F, Belletti A, Trumello C, Giambuzzi I, Monaco F, Alfieri O. Mechanical Ventilation During Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2016 Dec;30(6):1668-1675. doi: 10.1053/j.jvca.2016.03.015. Epub 2016 Mar 9. Review.

ReferenceCitation: Schreiber JU, Lancé MD, de Korte M, Artmann T, Aleksic I, Kranke P. The effect of different lung-protective strategies in patients during cardiopulmonary bypass: a meta-analysis and semiquantitative review of randomized trials. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):448-54. doi: 10.1053/j.jvca.2012.01.034. Epub 2012 Mar 28. Review.

ReferenceCitation: Nguyen LS, Estagnasie P, Merzoug M, Brusset A, Law Koune JD, Aubert S, Waldmann T, Naudin C, Grinda JM, Gibert H, Squara P. Low Tidal Volume Mechanical Ventilation Against No Ventilation During Cardiopulmonary Bypass in Heart Surgery (MECANO): A Randomized Controlled Trial. Chest. 2021 May;159(5):1843-1853. doi: 10.1016/j.chest.2020.10.082. Epub 2020 Nov 17.

ReferenceCitation: Nguyen LS, Merzoug M, Estagnasie P, Brusset A, Law Koune JD, Aubert S, Waldmann T, Grinda JM, Gibert H, Squara P. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):582. doi: 10.1186/s13063-017-2321-9.

lead_sponsor: CMC Ambroise Paré


title: Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study

acronym: SoluWest

summary:
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.

This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:

evaluation of the palatability and user-friendliness of the new treatment,
evaluation of the pharmacokinetic parameters of the new formulation,
PK parameters,
evaluation of the tolerance,
measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.

lead_sponsor: Orphelia Pharma

location_facility: Service de neuropédiatrie - Hôpital Purpan

location_facility: Service de neurologie pédiatrique - Hôpital de la Timone

location_facility: Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant

location_facility: Service de neuropédiatrie - CHU Pellegrin Enfants

location_facility: Service de neurologie infantile - Hôpital Salengro

location_facility: Service de neurologie pédiatrique - Hôpital Necker Enfants Malades

location_facility: Service de neurologie pédiatrique - Hôpital Sud

location_facility: Service de neuropédiatrie - Hôpital Robert Debré

location_facility: Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre

location_facility: Service de neuropédiatrie - Hôpital de Clocheville


acronym: EDUCARTPED

summary:
Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers

lead_sponsor: Poitiers University Hospital

location_facility:
La rochelle
POITIERS
NIORT

intervention_type: Behavioral


title: Interpretation of Health News Items Reporting Results of Randomized Controlled 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 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 English-speaking population.

study_start_date_type: Anticipated

status: Withdrawn


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

ReferenceCitation: Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients'/caregivers' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9. Erratum in: BMC Med. 2019 Jul 27;17(1):147.


title: Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study

acronym: Synch Fit

summary:
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs.

The SB could represent a pathway for the development of new therapeutic strategies for motor symptoms in PD.

Being a seemingly unpredictable phenomenon and a great variability daily, inter- and intra-subject, the SB study requires multiple and repeated assessments of mobility for several days. An experimental home setting would be optimal for this purpose in terms of cost-effectiveness and patient acceptability.

In addition, since the extent and nature of SB have not been well characterized so far, and the magnitude of its variability is unknown, a reliable assessment method, independent of observers and situation, the SB is a requirement of further research in this area.

A recently developed technique combining machine learning algorithms with wireless portable sensors (accelerometers and gyroscopes) and software applications could be particularly promising for characterizing the complexity and multiplicity of SBs in. With this technique, repeated and multiple assessments of mobility can be performed in the homes of patients without the constant presence of a researcher.

This approach offers several advantages in terms of cost-effectiveness, feasibility and acceptability of study protocols by patients. It also improves the ecological validity of subjective and objective estimates of mobility in these patients.

The investigators chose to conduct this preliminary study on patients with PD rather than on healthy subjects, because SB is a phenomenon that has been described so far only in this population. Investigators also consider that the feasibility of the study will depend mainly on the patients' ability to move and the context of their own illness.

SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the coordinated interaction of the duration of the previous awakening (homeostatic process) and a circadian signal (circadian process). In order to better understand SB, it is necessary to study the reciprocal influences of the circadian and homeostatic process.

Investigators have devised a new paradigm to "shift" the circadian process phase around the homeostatic process, maintained under constant conditions, in order to observe the effect of the synchronism or desynchronization of these two processes on the awakening mobility of patients with an MP. This experimental approach was approved by Professor Aleksandar Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian rhythmicity in the MP and scientific collaborator of this study.

As a first step, the investigators plan to implement a technology-assisted home-based methodology, to validate it in PD patients and to verify the logistic feasibility of this method-assisted approach in a small group of patients, in order to to be able to apply this paradigm in larger scientific projects.

lead_sponsor: 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 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.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Optic Neuritis Differential Diagnosis Study (ONDDS)

acronym: ONDDS

summary: Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term sight- and life-threatening condition causing potential relapses, which may require plasma exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used in MS, which can worsen the natural history of NMO. Early differential diagnosis of these diseases is thus crucial for preventing severe visual loss and disability.

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


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


title: Lupus and Observance

acronym: LUPOBS

summary:
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

Measure the observance rate of patients with systemic lupus in Martinique.
Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.

intervention_type: Biological


title: Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women

acronym: MONCAP

summary:
Pregnancy is associated with an increase in nutrient requirements. During this period, women would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet. Eighty pregnant women will be included in the study and randomized either in the "control" group, or in the "intervention" group. The control group will receive generic dietary advice based on a booklet edited by the French Institute for Health Promotion and Health Education (INPES). The intervention group will receive the same generic dietary advice plus tailored dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will be evaluated online using a 3 days food record, at baseline and 6 weeks after patients received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of the diet could be evaluated before and after the intervention in both groups.

The dietary follow-up for one patient will last 12 weeks only, but data will be collected at delivery.

"Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants (5 by group) will be contacted to participate in a qualitative interview. This interview will aim at understanding barriers and motivators to implement dietary advice (generic and/or tailored) in the diet of pregnant women in the study.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")

acronym: RECOP

summary:
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.

The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.

This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.

lead_sponsor: University Hospital, Toulouse


title: Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes

acronym: VACCIGRIPPE

summary: Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza is a viral infection that has a significant impact on the health care system. However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country. Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.

lead_sponsor: Tourcoing Hospital


title: Prospective Identification of Predictors of Neonatal Respiratory Distress for Newborns With Prenatally Diagnosed Congenital Lung Malformations : A Population-based, Nationally Representative Study

acronym: MALFPULM

summary:
This research focuses on lung malformations detected in fetuses during prenatal ultrasound exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved knowledge is needed, to give families better information, and to better standardize treatment decisions The main goal is to better predict neonatal complications associated with these malformations, by identifying key predictive markers during the fetal period.

To achieve this objective, it is planned to include 400 pregnant women with prenatal diagnosis of pulmonary malformation in 45 health centers in France. This is the largest study on this topic at the international level.

ReferenceCitation: Delacourt C, Bertille N, Salomon LJ, Rahshenas M, Benachi A, Bonnard A, Choupeaux L, Fouquet V, Goua V, Hameury F, Hervieux E, Jouannic JM, Khen-Dunlop N, Le Bouar G, Massardier J, Roditis L, Rosenblatt J, Sartor A, Thong-Vanh C, Lelong N, Khoshnood B; , for the MALFPULM study group; members of the MALFPULM study group:. Predicting the risk of respiratory distress in newborns with congenital pulmonary malformations. Eur Respir J. 2022 Feb 3;59(2). pii: 2100949. doi: 10.1183/13993003.00949-2021. Print 2022 Feb.

ReferenceCitation: Delacourt C, Bertille N, Salomon LJ, Benachi A, Henry E, Massardier J, Mottet N, Rosenblatt J, Sartor A, Thong-Vanh C, Valat-Rigot AS, Winer N, Lelong N, Khoshnood B; Prenatal MALFPULM Study Group. Prenatal natural history of congenital pulmonary malformations: MALFPULM population-based cohort study. Ultrasound Obstet Gynecol. 2019 Sep;54(3):381-388. doi: 10.1002/uog.20130.


title: Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study

acronym: VATED

summary: The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade. However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France. The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents. This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life. A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers. This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process. transition process.


title: Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

acronym: FUSETM-Colon

summary: The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

ReferenceCitation: Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

ReferenceCitation: Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.

ReferenceCitation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8.

ReferenceCitation: Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23.

ReferenceCitation: Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.

lead_sponsor: Institut Paoli-Calmettes


title: French Observatory of Familial Hypercholesterolemia in Cardiology

acronym: FH Care

summary:
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.

The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.

Main objectives:

Establish a monitoring patients with hypercholesterolemia Family cardiology in France
Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.

ReferenceCitation: Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. Review.

lead_sponsor: French Cardiology Society


title: Epidemiology of New Born Child Pain in the Delivery Room

summary:
The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy. During the delivery the baby is exposed to multiple exterior factors and he is capable to memorize the pain .Recent epidemiologic studies showed that the coverage of pain was insuffcient and also an increase of analgesic means. Normally the pain coverage have to be managed and group every painful gesture. In fact all these recommandations are not followed by medical team.

The aim of the study is to evaluate the prevalence of this type of pain as to set up an adequate coverage.


title: Choroidal Thickness Association With Primary Angle Closure

summary: A chinese study shows that chinese population eyes with a primary angle closure have a greater choroidal thickness than normal eyes.The increase of choroidal thickness would be associated to this primary angle closure.


title: The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)

acronym: SFINESS-QoLEco

summary:
BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects women (90%) between 40 and 60 years of age and main manifestations are generalized sicca syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is associated with peripheral neuropathies, and the most common form is painful small fiber neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%), numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also autonomic disorders (50 to 70%).

However, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on:

The impact of SFN on the quality of life of patients with Sjögren's syndrome.
The medico-economic impact of the SFN taking into account the repercussions on the quality of life, including professional life, usual care cost (analgesics, medical and paramedical consultations, hospitalizations or emergency).

EXPECTED RESULTS

Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN
Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment.
Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.

location_facility: Département de Médecine Interne - Hôpital Lariboisière


title: Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner

summary:
Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve by crisis when the feet extremities become red hot and painful. There are several types of EM but this study concern the adult primitive form. For a long time, the physiopathology was not described but now we know that there is a vascular form, with microcirculatory dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography. Thermotest, a medical device which measure the thermic sensitivity is used to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions detect small nervous fiber in diabetic patients with good correlation with Thermotest.

The purpose of this study is to analyze the vascular side and the neurologic side on patients consulting for Erythromelalgy.


title: Treatment of Acetabulum Fracture With O'ARM Surgical Imaging

summary:
Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .

The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface


title: Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island

acronym: COLLIPAR

summary:
Cardiovascular disease (CVD) is the second leading cause of death in France and the leading cause of death on Reunion Island. Some modifiable risk factors for cardiovascular diseases are well identified and can be easily modulated, in particular by hygiene and dietetic measures (tobacco, sedentary lifestyle). Other risk factors such as high blood pressure, diabetes or dyslipidemia can also be pharmacologically modulated. On the other hand, there is a cardiovascular risk factor that we do not know how to modulate: a high level of lipoprotein (a) (Lp (a)), whose regulation remains largely unknown.

High plasma levels of Lipoprotein (a) remain a major risk for the development of cardiovascular disease and its clinical complications, which no drug can currently reduce. Understanding the biological and genetic determinants modulating Lp (a) levels remains a major challenge for treating subjects with hyper Lp (a). Several individuals and possibly Reunion families have been detected as having abnormally high rates of apo (a)

Thanks to the link between cardiovascular clinical picture, Lp (a) concentration and other biological markers, the study should allow a better understanding of the mechanisms underlying the cardiovascular risk in order to offer advice. prevention and care of at-risk subjects screened; or even avenues for adapted genetic counseling (DNA sequencing).

At the genetic level, several hypotheses could be explored making it possible to link the expression of the apo (a) protein to the genotype, in particular the presence of mutations in the gene, in the promoter region, polymorphisms, or epistatic regulation.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery

acronym: CHLOVEPI

summary: Implementation of perineural catheters may lead to infection by catheter colonization. Catheters may be colonized by the bacteria present on the skin. This is most often commensal organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).

ReferenceCitation: Harkouk H, Thibault-Sogorb T, Beauchet A, Espinasse F, Lawrence C, Martinez V, Fletcher D. Two per cent alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine for the prevention of perineural catheter colonisation: The CHLOVEPI randomised, controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100790. doi: 10.1016/j.accpm.2020.100790. Epub 2020 Dec 5.

lead_sponsor: Hôpital Raymond Poincaré


title: ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients

summary:
The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).

Over the last ten years, substantial improvements have been made both in terms of diagnostic (immunohistochemistry and molecular biology) and therapeutic. New treatments have been marketed and are now available in clinic.

New therapeutical strategies have been launched and have proved their efficacy in clinical studies or meta-analyses, generally increasing the survival rate of patients by a few months. However, little information still exists on the use and effectiveness of these molecules in clinical practice.

The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years of treatment. This study should improve knowledge of the PLC treatment management in General Hospital Centres.

location_facility: Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)


title: Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy

acronym: DRC

summary:
Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis.

There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical expressions; the most important being kyphosis with spinal stiffness associated with painful elements.

The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three adjacent vertebrae.

Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally, scalability because the curvature may increase the likelihood of degenerative lesions disc degeneration or lumbar spinal stenosis for example.

When the disease is diagnosed early, treatment is most often associated with orthopedic physiotherapy. However, for patients with active deformation, despite an orthopedic brace treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision can be taken.

The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes through a spinal fusion must be released from his column stiffness in a bad position, changing the equilibrium profile and ensure that it remains in a good position.

This surgery usually requires a prior operative time (thoracic surgery to remove the intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with a bone graft and osteosynthesis). Currently different surgical strategies are practiced there is no real consensus between the teams.


title: Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients

summary: The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle la Solane


title: Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture

acronym: EEXPLORE

summary: The project aims to assess the effect of a complete denture of new denture wearers on speech production using sensors placed inside a duplicate of the prosthesis according to the technique described in the PRESLA system. Secondly, it aims to assess the effect of a complete denture on swallowing for these new denture wearers. Thirdly it aims to describe a precise mapping of the mechanical pressures exerted by the tongue on the palate of complete denture user, been used in wearing denture, during speaking and swallowing. The experiments will take place in the department of treatments and dental consultations of the Hospices Civils de Lyon (Faculty of Odontology, Lyon, France).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon


title: Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly

acronym: BETALACUTANE

summary:
The route of subcutaneous administration of drugs has become a common practice in some specialties (palliative care, geriatrics).

This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by subcutaneous route but few clinical studies evaluating the level of scientific relevance justifies their use.

The purpose of this study is to assess:

/ Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD of Beta lactam objectives in a geriatric population.
/ The safety and lack of toxicity of administrations subcutaneously.

Advantages disadvantages

easy Of establishment
Simplicity Monitoring and manipulation
Reduced Risk of infection
No Risk of venous thrombosis
Lower cost Simple -Technique for support at home taking
Limitation Aggressive gestures
multiplicity Of all possible injection sites
Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL / 24 / site)
Use Impossible for some drugs
Risk Discomfort and intolerance at the injection site

A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the administration of antibiotics.

Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%); the absence of marketing authorization for the subcutaneous route (34.5%); the absence of serum assay available (2.1%).


title: Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review

acronym: TAMICI

summary: Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.


title: Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase

summary: The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

ReferenceCitation: Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Réa D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.

ReferenceCitation: Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Réa D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.


title: Securing and Optimizing the Patient's Drug Therapy With Cancer: Clinical Pharmacy and Articulation With the City

acronym: PRIMAC

summary:
The path of a patient depends largely on his health care network, that is to say of the interrelationships between health professionals who will be involved throughout his career. At the hospital, the transition points in the care process is a vulnerable time for the patient regarding the continuity of his medication. These transition points are the intake, the transfer and the outlet. In town, our health system must be able to build on the inter-city hospital, warranty essential guarantee of the continuity of care. However, there is often a breakdown in this relationship with more or less serious consequences ranging from simple dissatisfaction of the patient, to the realization of duplicate examinations or the use unjustified emergency and re-hospitalization. Medication errors can occur, resulting from incomplete information or poorly communicated in this city hospital interface.

The city hospital dysfunctions are mainly organizational, hospital being rather specialized therapeutic approach centered on pathology and medicine city instead focuses on a patient's overall approach.

The involvement of the pharmacist in the hospital, as the city is an interesting axis to develop. In town, the pharmaceutical nomadism, including in major cities remains low, patients generally have a dedicated pharmacies for the treatment of their serious or chronic pathologies. The development of the pharmaceutical folder today allows the pharmacies to access the history and the entire therapy of patients prescribed to town by different specialists and general practitioners, on the last 4 months. Its recent availability within our hospital Group allows us to consider its use to fully optimize the patient's drug monitoring.


title: Clinic And Biologic Efficiency And Tolerance Of Oral Immunotherapy Protocol In Hazelnut Allergic Children

acronym: ENOIME

summary:
Prevalence of food allergy in the world has been inscreasing in recent years. Among nut allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an alternatice to eviction. There are few published data concerning hazelnut OIT in Europe, where its consumption is nevertheless very high.

The main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.

The secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol.

The study is retrospective and observational, and is based on the collection of medical data from patient records.

ReferenceCitation: Sabouraud M, Biermé P, André-Gomez SA, Villard-Truc F, Payot F, Corréard AK, Garnier L, Braun C. Real-life experience with hazelnut oral immunotherapy. Ann Allergy Asthma Immunol. 2022 Apr;128(4):432-438. doi: 10.1016/j.anai.2022.01.002. Epub 2022 Jan 8.

location_facility: Pneumology allergology-paediatric department of the Mother and Child Hospital


title: Retrospective Evaluation of Total Hip Replacement After Acetabular Fractures

acronym: PTHPOSTCOTYL

summary:
In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still relevant and in use today.

Many studies have sought to determine if the treatment had to be surgical or orthopedic. Although the standard treatment of displaced fractures of the acetabulum is the reduction and osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of the articular surface and including bearing zone. All these treatments and those supported have been studied in the literature.

However the study of the laying of total hip remote trauma after acetabular fracture osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have been published in recent years.

Indeed, a recent review of the literature are nearly 11 series focusing on the results remotely hip prostheses for treatment of acetabular fracture. These two prospective series with between 21 and 63 patients. All authors report rates well above those reported complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.

Fractures of the acetabulum are covered in our service by one operator using the same release technique based on the stiffening. The objective of this study is to determine whether the systematic surgical treatment of these patients by an experienced operator reduces the high complication rate.


title: Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin

summary:
It is estimated to 7300 the number of new cases of gastric cancer each year in France.

According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66.

The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years.

Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity.

Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.

The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery.

lead_sponsor: Institut Sainte Catherine

intervention_type: Radiation


title: Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites

acronym: BEVASCITE

summary:
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.

Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.

VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.

The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.

Studies in humans are few and the doses used are not consistent from one study to another.


title: Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.

summary:
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).

Study centers A total of 20 subjects will be enrolled in 1 site in France.

Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.

There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.

Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.

The clinical investigation will be conducted in 2 parts.

Part 1 - SPF determination:

To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).

Part 2 - Sun exposure:

To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.

lead_sponsor: Galderma R&D


title: Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling

summary: Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.


title: Effect of Bilateral Transversus Thoracis Muscle Plane Block on Postoperative Morphine Consumption in Patients Undergoing Elective On-pump Coronary Artery Bypass Graft Surgery: a Retrospective Study.

acronym: PARACABS

summary:
Coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. However, there is no consensus on analgesic management in patients undergoing CABG.

The aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (TTMP) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump CABG surgery.

Our main hypothesis is that a bilateral TTMP block performed after CABG surgery could reduce morphine consumption during the first 48 hours.

The investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the Montpellier University Hospital (France).

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff

acronym: COVIDIM

summary:
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.

In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).

The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.

ReferenceCitation: Bonnet B, Chabrolles H, Archimbaud C, Brebion A, Cosme J, Dutheil F, Lambert C, Junda M, Mirand A, Ollier A, Pereira B, Regagnon C, Vidal M, Evrard B, Henquell C. Decline of Humoral and Cellular Immune Responses Against SARS-CoV-2 6 Months After Full BNT162b2 Vaccination in Hospital Healthcare Workers. Front Immunol. 2022 Mar 2;13:842912. doi: 10.3389/fimmu.2022.842912. eCollection 2022.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pharmaco-economical Study in Kidney Transplantation

acronym: EPHEGREN

summary:
The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases …).

According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.

EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.

lead_sponsor: University Hospital, Limoges


title: Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.

summary:
The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.

The aim of our project is to study its interest in diagnosis of scaphoid fractures.

Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.

Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.

Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.

MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.

The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.

Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital


title: Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

acronym: DYPAMAT

summary:
Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing.

Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening.

The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters.

So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis.

However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life.

To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan.

Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility.

The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest