title: Efficacy of Intracavernosal (Xeomin®) 100U as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors

acronym: MENOX

summary:
The primary objective of this study is to investigate the efficacy of intracavernosal (Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open-label run-in phase.

The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand:

to further assess efficacy using.

i) a log diary five-item questionnaire completed after each sexual attempt (Sexual Encounter Profile);
ii) a self-reporting measure that scores erection hardness on a 4 point scale completed after each sexual attempt;
iii) The Global Assessment Question.
to assess effect persistence at month 6 and month 9.
to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.

ReferenceCitation: Fisher WA, Gruenwald I, Jannini EA, Lev-Sagie A, Lowenstein L, Pyke RE, Reisman Y, Revicki DA, Rubio-Aurioles E. Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction. J Sex Med. 2017 Jan;14(1):3-18. doi: 10.1016/j.jsxm.2016.08.016.

ReferenceCitation: Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. Epub 2007 Sep 21.

ReferenceType: derived

ReferenceCitation: Giuliano F, Denys P, Joussain C. Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin(®)) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. Toxins (Basel). 2022 Apr 16;14(4). pii: 286. doi: 10.3390/toxins14040286.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Neuro-Urology-Andrology, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP


title: Optimization of Donor-Recipient Matching in Lung Transplantation

acronym: ADRTP

summary:
Lung transplantation is the curative treatment for end-stage respiratory failure involving highly selected patients. In 2018, the International Transplant Registry counts 69200 lung transplants among 260 transplant centers. Between 2010 and June 2017, the 3-month survival rate of patients after lung transplantation is 90%. The causes of early death are primary graft failure, renal failure, infections, acute rejection (cellular or humoral), surgical complications. The median survival is 6.7 years and the median conditioned survival at 1 year is 8.9 years. Bronchiolitis obliterans is the leading cause of death after 1 year; it affects 10% more patients each year and peaks at 5 years at more than 50% of transplanted patients. These results encourage transplant professionals to continue their efforts to improve the prognosis of transplantation. Among these, the optimization of graft matching, taking into account the characteristics of the donor and the recipient, constitute a relevant avenue of study. Several donor characteristics seem to play a role in the prognosis of the transplant. Survival at 12 months is significantly worse when the donor's age is greater than 50 years. There does not appear to be a significant difference in donor cause of death. Recipients of a graft exposed to smoking ≥ 20 pack-years have a 3% and 1.5% decreased survival at 1 and 5 years postoperatively.

Similarly, the 5-year survival of patients with conditional 1-year survival is poorer in case of other toxic exposures such as alcohol, cocaine, crack or marijuana. Analysis of international registry data also suggests a negative association between post-transplant survival and donor hypertension and diabetes. However, the biological mechanisms by which these factors affect survival remain unknown. Graft ischemia time is significantly associated with survival with a 5-year survival of 70% and 65% for grafts exposed to ischemia ≥ 4 hours or less. The cumulative effect of donor hypertension and ischemia time are appreciated by the fact that the best postoperative survival is observed in donors without hypertension and graft ischemia time ≥ 4 hours. Graft size is also associated with post-transplant prognosis, in front of a significant decrease in survival for patients with emphysema, chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, transplanted with a smaller graft size.

This result is not found in patients transplanted for pulmonary fibrosis. One study has also suggested the negative role of a gender mismatch between donor and recipient on post-transplant survival, but there is currently no clear explanation for this result. The presence of antibodies to the recipient's HLA system [DSA (donor-specific antibodies)] in pre-transplant is a risk factor for hyperacute rejection and chronic graft dysfunction. Thus, the choice of matching between the donor and the recipient appears complex in view of the number of criteria to be taken into account which impact the duration of post-transplant survival in the short and medium term. The objective of the project is to develop a decision support tool, using artificial intelligence algorithms, to assist the thoracic surgeon in identifying the patient, among those registered on the team's waiting list, who could benefit most from a bi-pulmonary graft offered by the Biomedicine Agency.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Leard LE, Holm AM, Valapour M, Glanville AR, Attawar S, Aversa M, Campos SV, Christon LM, Cypel M, Dellgren G, Hartwig MG, Kapnadak SG, Kolaitis NA, Kotloff RM, Patterson CM, Shlobin OA, Smith PJ, Solé A, Solomon M, Weill D, Wijsenbeek MS, Willemse BWM, Arcasoy SM, Ramos KJ. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2021 Nov;40(11):1349-1379. doi: 10.1016/j.healun.2021.07.005. Epub 2021 Jul 24.

ReferenceCitation: Chambers DC, Cherikh WS, Harhay MO, Hayes D Jr, Hsich E, Khush KK, Meiser B, Potena L, Rossano JW, Toll AE, Singh TP, Sadavarte A, Zuckermann A, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult lung and heart-lung transplantation Report-2019; Focus theme: Donor and recipient size match. J Heart Lung Transplant. 2019 Oct;38(10):1042-1055. doi: 10.1016/j.healun.2019.08.001. Epub 2019 Aug 8.

ReferenceCitation: Chambers DC, Zuckermann A, Cherikh WS, Harhay MO, Hayes D Jr, Hsich E, Khush KK, Potena L, Sadavarte A, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: 37th adult lung transplantation report - 2020; focus on deceased donor characteristics. J Heart Lung Transplant. 2020 Oct;39(10):1016-1027. doi: 10.1016/j.healun.2020.07.009. Epub 2020 Jul 30. Review.

ReferenceCitation: Demir A, Coosemans W, Decaluwé H, De Leyn P, Nafteux P, Van Veer H, Verleden GM, Van Raemdonck D. Donor-recipient matching in lung transplantation: which variables are important?†. Eur J Cardiothorac Surg. 2015 Jun;47(6):974-83. doi: 10.1093/ejcts/ezu340. Epub 2014 Sep 3.

ReferenceCitation: Frost AE, Jammal CT, Cagle PT. Hyperacute rejection following lung transplantation. Chest. 1996 Aug;110(2):559-62.

ReferenceCitation: Brugière O, Suberbielle C, Thabut G, Lhuillier E, Dauriat G, Metivier AC, Gautreau C, Charron D, Mal H, Parquin F, Stern M. Lung transplantation in patients with pretransplantation donor-specific antibodies detected by Luminex assay. Transplantation. 2013 Mar 15;95(5):761-5. doi: 10.1097/TP.0b013e31827afb0f.

ReferenceCitation: Snell GI, Yusen RD, Weill D, Strueber M, Garrity E, Reed A, Pelaez A, Whelan TP, Perch M, Bag R, Budev M, Corris PA, Crespo MM, Witt C, Cantu E, Christie JD. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction, part I: Definition and grading-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1097-1103. doi: 10.1016/j.healun.2017.07.021. Epub 2017 Jul 26. Review.

ReferenceCitation: Seely AJ, Ivanovic J, Threader J, Al-Hussaini A, Al-Shehab D, Ramsay T, Gilbert S, Maziak DE, Shamji FM, Sundaresan RS. Systematic classification of morbidity and mortality after thoracic surgery. Ann Thorac Surg. 2010 Sep;90(3):936-42; discussion 942. doi: 10.1016/j.athoracsur.2010.05.014.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique

status_simplified: Ongoing


title: AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS

acronym: ACHLYS

summary:
Immune-checkpoint-inhibitors (ICI) have revolutionized treatment for 20 cancer types. They unleash anti-tumor immune responses. Unfortunately, in 0.36-1.23% of patients, this activation can also lead to lethal immune-related adverse events (irAEs) that can affect any organ. Among those irAEs, ICI-induced myocarditis are the most frequently fatal with death rate reaching 50% in a large case-series of over 100 patients.

This study is a dose-finding Phase II trial where 3 abatacept IV regimen (A-10 mg/kg; B-20 mg/kg and C-25 mg/kg every week) will be tested aiming at reaching promptly (after the first dose) and sustainably a CD86RO≥80% during the first 3 weeks of ICI-myocarditis management. The main objective is to find the lowest dose required to achieve a circulating monocytes CD86RO≥80% within the first week of treatment and sustainably over three weeks. The target population is all adult patients with cancer (all cancer types) treated by immune checkpoint inhibitors (anti-PD1, anti-PDL1, anti-CTLA4 monotherapies or combination) and presenting drug-induced myocarditis.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug


type: Other Identifier

title: Evolution of the Quality of Life of Short Stature Children Treated With Growth Hormone : Evaluation at Adult Size

acronym: HF QoL

summary:
Short stature can lead to emotional and social stress in children and adolescents, as well as their parents. Children and their parents want to be able to identify the cause of stunted growth and address it with treatment. Mitigating the impact of short stature on quality of life is one of the main goals of treatment. The quality of life in children can be measured using adapted self-questionnaires.

The investigative team published in 2019 the results of a preliminary study which shows that after one year of treatment with growth hormone, the quality of life improves in children, in particular on the scales emotional and social. These evaluations were carried out in particular thanks to the general questionnaire of quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0, but also via a specific questionnaire of the size: Quality of Life of Short Stature Youth questionnaire (QoLiSSY).

50 of the 74 patients who participated in this study have now reached their final height. The objective of the present study is to reassess this cohort using the QoLiSSY and PedsQL 4.0 questionnaires. The patient will be his own witness.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Prospective

ipd_sharing: No

intervention_type: Other


title: Evaluation of the Regeneration Capacity of Satellite Cells From the Quadriceps Compared to That of the Diaphragm

acronym: ECARS

summary:
Actually no treatment exists to prevent the loss of diaphragmatic function induced by mechanical ventilation during an intensive care unit stay. The consequence is a growing number of survivors with moderate to severe chronic respiratory disease so called Ventilation-Induced Diaphragmatic Dysfunction (VIDD). This study complements the BOTAN study (IRB Accreditation number: 198711, NCT02900300) on 24/11/2021 under number 2021_IRB-MTP_08-37), which aim was the constitution of a biological bank of diaphragmatic tissue in order to be able to propose an innovative tool for the in vitro screening of bioactive molecules of interest in human, to improve the regenerative capacity of this main and essential muscle for breathing. In this present study, in order to offer this evaluation tool in the screening of bioactive molecules of interest, without the need of the diaphragm biopsy, but simply of the quadriceps, the investigators propose, by adding a quadriceps muscular biopsy to patients already included in BOTAN study, to compare the regenerative capacity of quadriceps and diaphragmatic muscle in the same individual. Thus, this study is the first, which will propose a new minimally invasive tool for the evaluation and optimization of future pharmacological treatments targeted to limit the impact of VIDD.

Thus our main objective of thus study is to compare in the same patient the regenerative capacity of the muscular fiber of the quadriceps to that of the diaphragm in order to set up an in vitro model allowing to test in humans future pharmacological treatment devoted to limit the incidence of VIDD.

In this study will be recruited 10 patients treated surgically for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm and who have agreed to participate in the BOTAN study. This resection to be complete (R0) must pass within the diaphragmatic muscle allowing us to obtain without any constraint for the patient, diaphragmatic tissue. During this surgery, for the purposes of the present study, the investigators will perform a quadriceps biopsy. Quadriceps biopsies are widely used in biomedical research and no deleterious effects have been described. The surgical team is fully qualified for this type of sampling and all experiments necessary to compare regenerative capacity of quadriceps and diaphragmatic muscular fiber use laboratory techniques perfectly mastered by our research team.

For each patients, this study will be performed over two visits. The first, during a consultation will allow the inclusion of the patient, as well as the collection of clinical data and a second during the scheduled surgical intervention where quadriceps biopsy will be realised. The expected duration of inclusions will be one year.

No immediate individual benefit is expected for the patient. This study aims to improve, in the future, therapies that reduce the incidence of diaphragmatic dysfunction induced by mechanical ventilation. In fact, diaphragmatic dysfunction induced by ventilation is observed in at least 50% of patients in intensive care; this dysfunction has been implicated in the significant lengthening of the hospital stay, the difficulties in weaning from mechanical ventilation and in the increased risk of co-morbidity and mortality. The validation of the first in vitro model in humans of this dysfunction, from quadriceps biopsy, will allow us to pre-select antioxidant molecules and the most effective concentrations to use for a future therapeutic trial aimed at limiting the deleterious effects of mechanical ventilation on the diaphragm in humans.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier


title: A Randomized, Double-blind, Parallel Groups, Placebo-controlled, Proof-of-concept Study to Assess the Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination in Subjects With Sleep Complaints.

acronym: PHYTOSOM

summary:
Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep.

Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds.

This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Dietary Supplement


title: MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD

acronym: IRM-ET

summary: Most studies use static visual percepts that are less representative of joint attention versus an ecological environment. This has the consequence of decreasing the perception of an interaction with a social partner, which is an essential step in achieving joint attention. The originality of this study is to improve the design of visual percepts (in the form of video) in order to mimic an ecological environment as much as possible by using MRI-ET coupling. The second originality of this study is the longitudinal exploration of the neurodevelopment of social cognition in autistic children. Studies by the Redcay and Oberwelland teams observe different activations at different ages. The hypothesis is that the perception of joint attention varies over time in people with ASD. To date, there are no studies to determine the influence of childhood neurodevelopment in autistic people on the perception of joint attention. It would be unprecedented to use the MRI-ET pairing as a tool for assessing social cognition as a function of the development of children with ASD.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Monocentric, Open Study for the Evaluation of the Tolerance of Three Class I Medical Devices Under Dermatological Control.

summary: This is a monocentric, open and randomized study. The purpose is to evaluate the cutaneous tolerance of three medical masks (class I medical device) after 3 consecutive days of use on a population with normal or sensitive skin.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Groupe Kolmi Hopen

location_facility: Laboratoire Eurofins Dermscan Pharmascan

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

acronym: COVADIS-PREG

summary:
Few data are available on the management of critically ill pregnant women with pneumonia related to SARS-CoV-2. In the absence of clear recommendations for the management of delivery, clinicians are faced with the risk of pregnancy continuation against the risk of premature birth. In these multicenter retrospective study, the investigators want to describe clinicians attitude on delivery management in pregnant women requiring invasive mechanical ventilation for acute respiratory distress syndrome related to SARS-CoV-2.

Two strategies will be compared on maternal, obstetric and neonatal outcomes:

Wait strategy defined by no extraction within 24 hours of invasive venting
Early strategy defined by extraction within 24 hours of invasive ventin

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection

acronym: SwaLO

summary:
The literature describes recurrent nerve damage during thoracic surgery as a fairly complication (5 to 31% of patients). This nerve damage leads to paresis or paralysis of the ipsilateral vocal cord. This cord dysfunction no longer ensures the protective role of the airways during swallowing. This postoperative dysphagia is associated with complications such as aspiration pneumonia, the use of nasogastric tube feeding (adding difficulty to swallowing), delayed oral refeeding (risk of undernutrition, dehydration, decrease in the quality of life), and an increase in the length of hospitalization and mortality.

Identifying these patients at risk is essential to limit complications (pneumonia, reintubation, inadequate refeeding, etc.). The benchmark test to objectify vocal cord palsy is to perform a nasofibroscopy requiring equipment and the intervention of an ENT doctor or thoracic surgeon.

A physiotherapist can also perform a preliminary swallowing test by evaluating several criteria.

The aim of this study is to compare the concordance of results between nasofibroscopy and that by preliminary swallowing test, two procedures performed in the screening of vocal cord paralysis in a surgical intensive care unit and a thoracic surgery ward.

Patients will be included before the surgery. During this inclusion visit, we will perform a preoperative swallowing test.

Immediately after surgery (H2-H24 after extubation), we will perform a preliminary swallowing test, an ultrasound examination of the vocal cords and a nasofibroscopy to determine the mobility of the vocal cords. A physiotherapist will carry out the first two assessments. An ENT physician will perform the nasofibroscopy. The ENT physician performing the nasofibroscopy will not know the conclusions of the tests carried out by the physiotherapist immediately after the operation.

At last, on day 4 after extubation, we will repeat the preliminary swallowing test and the ultrasound examination to measure the evolution of cord mobility.

Initial evaluation and secondary evaluation (day 4) will be performed by two different physiotherapists in order to allow blinding between the two stages of the procedure.

45 days after the surgery, we will realize a follow-up on medical file and mark the end of the research.

We want to include 72 patients over an 18 months period.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen

intervention_type: Diagnostic Test


title: Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome

summary:
Stenotrophomonas maltophilia is a multi-resistant Gram-negative bacillus and is an opportunistic pathogen. Stenotrophomonas maltophilia infections are associated with a significant morbidity and mortality, particularly in immunocompromised patients. The mortality of infections (bacteremia, pneumonia) related to Stenotrophomonas maltophilia is variable and is estimated between 21 and 69%. Stenotrophomonas maltophilia pneumopathies have been mainly described in patients hospitalized in intensive care and benefiting from mechanical ventilation. The existence of immunosuppression seems to be a risk factor for the transition from Stenotrophomonas maltophilia pulmonary colonization to Stenotrophomonas maltophilia pulmonary infection. The reference treatment for Stenotrophomonas maltophilia-associated pneumonia is the combination of trimethoprim and sulfamthoxazole, a molecule that lung transplant patients routinely receive as a preventive treatment for Pneumocysitis jirovecii infection. There is no consensus on the value of routine dual-antibiotic therapy, and it varies from one center to another and from one country to another.

The main objective is to compare the clinical-microbiological evolution of lung transplant patients treated for Stenotrophomonas maltophilia pneumopathy according to the prescription of a mono- or bi-antibiotherapy.

The secondary objective is to evaluate the resistance rate of Stenotrophomonas maltophilia strains isolated from respiratory samples according to the anti-pneumocystis prophylactic molecule received by the patient.

ReferenceCitation: Denton M, Kerr KG. Microbiological and clinical aspects of infection associated with Stenotrophomonas maltophilia. Clin Microbiol Rev. 1998 Jan;11(1):57-80. Review.

ReferenceCitation: Senol E, DesJardin J, Stark PC, Barefoot L, Snydman DR. Attributable mortality of Stenotrophomonas maltophilia bacteremia. Clin Infect Dis. 2002 Jun 15;34(12):1653-6. Epub 2002 May 24.

ReferenceCitation: Prates M, Fernandes F, Proença F, Mussá Y, Tavares A, Pereira A. Oral Infection Caused by Stenotrophomonas maltophilia: A Rare Presentation of an Emerging Opportunistic Pathogen. Case Rep Infect Dis. 2020 Jan 29;2020:6346120. doi: 10.1155/2020/6346120. eCollection 2020.

ReferenceCitation: Hashimoto T, Komiya K, Fujita N, Usagawa Y, Yamasue M, Umeki K, Ando M, Nureki SI, Hiramatsu K, Kadota JI. Risk factors for 30-day mortality among patients with Stenotrophomonas maltophilia bacteraemia. Infect Dis (Lond). 2020 Jun;52(6):440-442. doi: 10.1080/23744235.2020.1734653. Epub 2020 Mar 3.

ReferenceCitation: Saugel B, Eschermann K, Hoffmann R, Hapfelmeier A, Schultheiss C, Phillip V, Eyer F, Laugwitz KL, Schmid RM, Huber W. Stenotrophomonas maltophilia in the respiratory tract of medical intensive care unit patients. Eur J Clin Microbiol Infect Dis. 2012 Jul;31(7):1419-28. doi: 10.1007/s10096-011-1459-8. Epub 2011 Nov 7.

ReferenceCitation: Flamm RK, Shortridge D, Castanheira M, Sader HS, Pfaller MA. In Vitro Activity of Minocycline against U.S. Isolates of Acinetobacter baumannii-Acinetobacter calcoaceticus Species Complex, Stenotrophomonas maltophilia, and Burkholderia cepacia Complex: Results from the SENTRY Antimicrobial Surveillance Program, 2014 to 2018. Antimicrob Agents Chemother. 2019 Oct 22;63(11). pii: e01154-19. doi: 10.1128/AAC.01154-19. Print 2019 Nov.

ReferenceCitation: Chang YT, Lin CY, Chen YH, Hsueh PR. Update on infections caused by Stenotrophomonas maltophilia with particular attention to resistance mechanisms and therapeutic options. Front Microbiol. 2015 Sep 2;6:893. doi: 10.3389/fmicb.2015.00893. eCollection 2015. Review.


title: Abces After Incision: Recurrence or Not?

acronym: ABCINCIS

summary:
The French School of Proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. The Anglo-Saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. In addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. High BMI, corticosteroid use, Crohn's disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". The objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation.

The main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.

status: Active, not recruiting

ReferenceCitation: Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-analysis of randomized clinical trials comparing drainage alone vs primary sphincter-cutting procedures for anorectal abscess-fistula. Int J Colorectal Dis. 2006 Sep;21(6):602-9. Epub 2005 Nov 30. Review.

ReferenceCitation: Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD006827. doi: 10.1002/14651858.CD006827.pub2. Review.

ReferenceCitation: Sahnan K, Askari A, Adegbola SO, Tozer PJ, Phillips RKS, Hart A, Faiz OD. Natural history of anorectal sepsis. Br J Surg. 2017 Dec;104(13):1857-1865. doi: 10.1002/bjs.10614. Epub 2017 Aug 31.

ReferenceCitation: Sahnan K, Askari A, Adegbola SO, Warusavitarne J, Lung PFC, Hart A, Faiz O, Phillips RKS, Tozer P. Persistent Fistula After Anorectal Abscess Drainage: Local Experience of 11 Years. Dis Colon Rectum. 2019 Mar;62(3):327-332. doi: 10.1097/DCR.0000000000001271.

ReferenceCitation: Sho S, Dawes AJ, Chen FC, Russell MM, Kwaan MR. Operative Incision and Drainage for Perirectal Abscesses: What Are Risk Factors for Prolonged Length of Stay, Reoperation, and Readmission? Dis Colon Rectum. 2020 Aug;63(8):1127-1133. doi: 10.1097/DCR.0000000000001653.

ReferenceCitation: Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010 Jan;93(1):61-5.

ReferenceCitation: He Z, Du J, Wu K, Chen J, Wu B, Yang J, Xu Z, Fu Z, Pan L, Wen K, Wang X. Formation rate of secondary anal fistula after incision and drainage of perianal Sepsis and analysis of risk factors. BMC Surg. 2020 May 6;20(1):94. doi: 10.1186/s12893-020-00762-3.

ReferenceCitation: Mocanu V, Dang JT, Ladak F, Tian C, Wang H, Birch DW, Karmali S. Antibiotic use in prevention of anal fistulas following incision and drainage of anorectal abscesses: A systematic review and meta-analysis. Am J Surg. 2019 May;217(5):910-917. doi: 10.1016/j.amjsurg.2019.01.015. Epub 2019 Jan 31.


title: Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia

summary:
Upper limb arterial disease is a rare condition compared to lower limb arterial disease. In the lower limb, chronic limb ischemia (CLI) is characterized by an intractable pain or an ulceration present for at least 2 weeks. Guidelines recommend to use Transcutaneous Oxygen pressure (TcPO2) measurement when a CLI is suspected to establish diagnostic with a threshold of 30 mmHg when ankle and toe systolic pressure are not available.

In the upper limb, there is no guideline to define CLI. When there is a wound preventing finger pressure measurement, TcPO2 is theoretically indicated. However, there is neither standardized site to measure nor threshold value of TcPO2.

The investigators hypothesized that normal TcPO2 may be different in the upper limb and that threshold value for CLI may also be different compared to lower limb.

The investigators planned a study with two parts:

Prospective study of normal TcPO2 value in healthy volunteers
Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb

time_perspective: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine Interne - UF Explorations Fonctionnelles Vasculaires, Hôpital Edouard Herriot


title: Respiratory Dysbiosis in Preschool Children With Asthma: Predictive of a Severe Form

acronym: DREAM

summary:
The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.

Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotyping" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.

The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.

primary_purpose: Prevention

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

intervention_type: Procedure


title: Correlation Between Seminal Vesicle Size and Duration of Sexual Abstinence

acronym: AbsVS

summary:
The seminal vesicles (SV) are glands that open into the prostatic urethra and secrete seminal fluid, which makes up 50 to 80% of semen. They play an essential role in the male reproductive function. In adults, the size of a seminal vesicle varies from one individual to another. On average, it is 5 to 6 cm long, 1.5 cm wide and 0.5 cm thick. It has a close anatomical relationship with Walsh's vascular-nervous pedicle, which extends the sacro-genital-pubic blades, and is responsible for erection. The reference treatment for localized prostate cancer can consist of two alternatives: either intensity-modulated pelvic radiotherapy with treatment of the entire prostate volume and VS, or surgical removal of the vesiculo-prostatic block in monobloc. It is therefore always extended to the VS.

Magnetic resonance imaging (MRI) is now routinely performed for the initial workup of prostate cancer, with a diagnostic and prognostic role, as invasion of the VS by cancer is recognized as a poor prognostic factor. Some radiology centers recommend 3 days of sexual abstinence to allow a proper seminal vesicle study. Various factors, such as serum testosterone levels, autosomal dominant polycystic kidney disease, smoking, and certain drugs such as SILODOSINE, have been identified as factors that can independently vary seminal vesicle size.

The duration of sexual abstinence since the last ejaculation also appears to be correlated with seminal vesicle volume. Two recent studies found a correlation between the duration of sexual abstinence and seminal vesicle volume measured on MRI in a young population (median age 35.9 and 46.45 years). This population is not superimposable to that of patients managed for prostate cancer whose average age at diagnosis is 70 years.

However, the control and knowledge of the volume of VS, in this specific population, could have an interest in the treatment of prostate cancer:

In case of pelvic radiotherapy in order to limit the volume of the organ to be irradiated, the toxicity induced to the adjacent organs being directly associated to the delivered dose.
In case of radical vesiculo-prostatectomy, by surgical way, the lateral dissection of the vasculo-nerveous bands is made more difficult in case of voluminous seminal vesicles with an increased risk of nerve damage.

Investigators hypothesize that the volume of the VS is correlated with the duration of abstinence. Thus, evacuation of seminal fluid by ejaculation at a defined time before curative treatment of prostate cancer, could improve the functional results of pelvic radiotherapy or surgery.

time_perspective: Cross-Sectional

ReferenceCitation: Barrett T, Turkbey B, Choyke PL. PI-RADS version 2: what you need to know. Clin Radiol. 2015 Nov;70(11):1165-76. doi: 10.1016/j.crad.2015.06.093. Epub 2015 Jul 29. Review.

ReferenceCitation: Qi X, Gao XS, Asaumi J, Zhang M, Li HZ, Ma MW, Zhao B, Li FY, Wang D. Optimal contouring of seminal vesicle for definitive radiotherapy of localized prostate cancer: comparison between EORTC prostate cancer radiotherapy guideline, RTOG0815 protocol and actual anatomy. Radiat Oncol. 2014 Dec 20;9:288. doi: 10.1186/s13014-014-0288-1.

ReferenceCitation: Lotti F, Corona G, Vitale P, Maseroli E, Rossi M, Fino MG, Maggi M. Current smoking is associated with lower seminal vesicles and ejaculate volume, despite higher testosterone levels, in male subjects of infertile couples. Hum Reprod. 2015 Mar;30(3):590-602. doi: 10.1093/humrep/deu347. Epub 2015 Jan 6.

ReferenceCitation: Lotti F, Corona G, Maseroli E, Rossi M, Silverii A, Degl'innocenti S, Rastrelli G, Forti G, Maggi M. Clinical implications of measuring prolactin levels in males of infertile couples. Andrology. 2013 Sep;1(5):764-71. doi: 10.1111/j.2047-2927.2013.00114.x.

ReferenceCitation: Bozkurt O, Demir O, Sen V, Esen A. Silodosin causes impaired ejaculation and enlargement of seminal vesicles in sexually active men treated for lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Urology. 2015 May;85(5):1085-1089. doi: 10.1016/j.urology.2015.01.011. Epub 2015 Mar 3.

ReferenceCitation: Joo I, Kim SH, Cho JY. A comparison of seminal vesicle size on CT between autosomal dominant polycystic kidney disease (ADPKD) patients and normal subjects. Acta Radiol. 2010 Jun;51(5):569-72. doi: 10.3109/02841851003652583.

ReferenceCitation: Barrett T, Tanner J, Gill AB, Slough RA, Wason J, Gallagher FA. The longitudinal effect of ejaculation on seminal vesicle fluid volume and whole-prostate ADC as measured on prostate MRI. Eur Radiol. 2017 Dec;27(12):5236-5243. doi: 10.1007/s00330-017-4905-x. Epub 2017 Jul 4.

ReferenceCitation: Yuruk E, Pastuszak AW, Suggs JM 3rd, Colakerol A, Serefoglu EC. The association between seminal vesicle size and duration of abstinence from ejaculation. Andrologia. 2017 Sep;49(7). doi: 10.1111/and.12707. Epub 2016 Sep 23.


title: Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

summary:
Magnetic susceptibility imaging is a magnetic resonance imaging (MRI) technique that uses the magnetic properties of tissues and the BOLD (blood oxygen level-dependent) effect. It allows a better visualization of venous structures and hemorrhagic lesions. These sequences are now used in clinical routine.

The extreme sensitivity of these sequences to the oxy/deoxyhemoglobin ratio makes it possible to describe a new MRI semiology, particularly in the context of cerebral ischemia. The interest of the analysis of the venous network signal, which can reflect cerebral perfusion, has been reported.

However, the influence of the hematocrit level on the signal of the venous network in magnetic susceptibility imaging has not been evaluated at present. It seems important to better define the influence of hematocrit level on the signal of the veins with this sequence to avoid potential diagnostic errors.

ReferenceCitation: Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27. Review.

ReferenceCitation: Mittal S, Wu Z, Neelavalli J, Haacke EM. Susceptibility-weighted imaging: technical aspects and clinical applications, part 2. AJNR Am J Neuroradiol. 2009 Feb;30(2):232-52. doi: 10.3174/ajnr.A1461. Epub 2009 Jan 8. Review.

ReferenceCitation: Chalian M, Tekes A, Meoded A, Poretti A, Huisman TA. Susceptibility-weighted imaging (SWI): a potential non-invasive imaging tool for characterizing ischemic brain injury? J Neuroradiol. 2011 Jul;38(3):187-90. doi: 10.1016/j.neurad.2010.12.006. Epub 2011 Feb 26.

ReferenceCitation: Wang Y, Shi T, Chen B, Lin G, Xu Y, Geng Y. Prominent Hypointense Vessel Sign on Susceptibility-Weighted Imaging Is Associated with Clinical Outcome in Acute Ischaemic Stroke. Eur Neurol. 2018;79(5-6):231-239. doi: 10.1159/000488587. Epub 2018 Apr 19.

ReferenceCitation: Horie N, Morikawa M, Nozaki A, Hayashi K, Suyama K, Nagata I. "Brush Sign" on susceptibility-weighted MR imaging indicates the severity of moyamoya disease. AJNR Am J Neuroradiol. 2011 Oct;32(9):1697-702. doi: 10.3174/ajnr.A2568. Epub 2011 Jul 28.

ReferenceCitation: Winchell AM, Taylor BA, Song R, Loeffler RB, Grundlehner P, Hankins JS, Wang WC, Ogg RJ, Hillenbrand CM, Helton KJ. Evaluation of SWI in children with sickle cell disease. AJNR Am J Neuroradiol. 2014 May;35(5):1016-21. doi: 10.3174/ajnr.A3794. Epub 2013 Nov 21.


title: Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery

summary:
The prevalence of hypertension is high, estimated at 80% in patients with cardiovascular (CV) disease. The optimal blood pressure (BP) level for CV prevention remains controversial. Data from the literature highlight that the relationship between BP level and mortality is not linear, but rather J-shaped. In particular, in treated hypertensive patients with stable coronary artery disease, a systolic BP below 120 mm Hg is associated with the risk of recurrent coronary events and CV mortality.

An inverse relationship was recently demonstrated between BP level before revascularization procedure and mortality at 3 months and 1 year after the procedure in patients managed for critical ischemia. These data underline the need for a personalized approach to the management of hypertension, especially in elderly hypertensive patients with comorbidities.

The question of the optimal mean BP value also arises in cardiac surgery, especially during extracorporeal circulation in patients undergoing coronary artery bypass grafting. Hypotension during cardiac surgery appears to be associated with renal failure and perioperative mortality in some patients. Conversely, high blood pressure levels (above the cerebral autoregulatory threshold) may be associated with postoperative cognitive impairment and bleeding risk. In hypertensive patients, the autoregulatory capacity of cerebral and renal perfusion is partly impaired, with a greater susceptibility to ischemia in case of hypotension. Personalized blood pressure targets could be beneficial perioperatively with a lower risk of postoperative complications.

The objective of this protocol is to determine a correlation between perioperative mean arterial pressure level and in-hospital morbidity in a population of patients with ischemic heart disease managed for coronary artery bypass grafting (CABG). The results of this descriptive work would make it possible to introduce the problem of the optimal blood pressure target during extracorporeal circulation according to the existence of peripheral arterial damage and preoperative blood pressure values.

ReferenceCitation: Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Röther J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206.

ReferenceCitation: Bavry AA, Anderson RD, Gong Y, Denardo SJ, Cooper-Dehoff RM, Handberg EM, Pepine CJ. Outcomes Among hypertensive patients with concomitant peripheral and coronary artery disease: findings from the INternational VErapamil-SR/Trandolapril STudy. Hypertension. 2010 Jan;55(1):48-53. doi: 10.1161/HYPERTENSIONAHA.109.142240. Epub 2009 Dec 7.

ReferenceCitation: Vidal-Petiot E, Ford I, Greenlaw N, Ferrari R, Fox KM, Tardif JC, Tendera M, Tavazzi L, Bhatt DL, Steg PG; CLARIFY Investigators. Cardiovascular event rates and mortality according to achieved systolic and diastolic blood pressure in patients with stable coronary artery disease: an international cohort study. Lancet. 2016 Oct 29;388(10056):2142-2152. doi: 10.1016/S0140-6736(16)31326-5. Epub 2016 Aug 30.

ReferenceCitation: Yannoutsos A, Lin F, Billuart O, Buronfosse A, Sacco E, Beaussier H, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Low admission blood pressure as a marker of poor 1-year survival in patients with revascularized critical limb ischemia. J Hypertens. 2021 Aug 1;39(8):1611-1620. doi: 10.1097/HJH.0000000000002821.

ReferenceCitation: Ono M, Arnaoutakis GJ, Fine DM, Brady K, Easley RB, Zheng Y, Brown C, Katz NM, Grams ME, Hogue CW. Blood pressure excursions below the cerebral autoregulation threshold during cardiac surgery are associated with acute kidney injury. Crit Care Med. 2013 Feb;41(2):464-71. doi: 10.1097/CCM.0b013e31826ab3a1.

ReferenceCitation: Ono M, Brady K, Easley RB, Brown C, Kraut M, Gottesman RF, Hogue CW Jr. Duration and magnitude of blood pressure below cerebral autoregulation threshold during cardiopulmonary bypass is associated with major morbidity and operative mortality. J Thorac Cardiovasc Surg. 2014 Jan;147(1):483-9. doi: 10.1016/j.jtcvs.2013.07.069. Epub 2013 Sep 26.

ReferenceCitation: Hori D, Brown C, Ono M, Rappold T, Sieber F, Gottschalk A, Neufeld KJ, Gottesman R, Adachi H, Hogue CW. Arterial pressure above the upper cerebral autoregulation limit during cardiopulmonary bypass is associated with postoperative delirium. Br J Anaesth. 2014 Dec;113(6):1009-17. doi: 10.1093/bja/aeu319. Epub 2014 Sep 25.


type: Registry Identifier

title: Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

summary: The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.

lead_sponsor: TBF Genie Tissulaire

location_facility: Hôpital de la Croix-Rousse, Hospices Civils de Lyon

intervention_type: Biological


title: Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study

summary:
In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.

Analgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.

Cementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).

Fixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prevalence of Dietary Supplement Consumption Among Pregnant Women During the First 20-25 Weeks of Pregnancy: a Cross-sectional Telephone Interview Survey

acronym: PCAFE

summary:
Primary endpoint :

Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy.

Hypothesis of the study :

The sale and consumption of dietary supplements in the general population has increased in recent years. It would be interesting to know if this is also the case for pregnant women or if they are more vigilant about their health during this period. It would also allow to identify factors associated with their consumption if it exists.

The investigators hypothesize that some women may sometimes fail to mention this supplement intake to care givers and they would like to know if these omissions are voluntary or not.

lead_sponsor: University Hospital, Grenoble


title: Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

acronym: IBREED

summary:
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function.

The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.

ReferenceCitation: Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095.

ReferenceCitation: Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. Review.

ReferenceCitation: Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 31;144(9):e171-e191. doi: 10.1161/CIR.0000000000001005. Epub 2021 Jul 28. Review. Erratum in: Circulation. 2021 Aug 31;144(9):e193.

ReferenceCitation: Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849. Review. Erratum in: Circ Res. 2015 Jun 19;117(1):e12.

ReferenceCitation: O'Hare AM, Glidden DV, Fox CS, Hsu CY. High prevalence of peripheral arterial disease in persons with renal insufficiency: results from the National Health and Nutrition Examination Survey 1999-2000. Circulation. 2004 Jan 27;109(3):320-3. Epub 2004 Jan 19.

ReferenceCitation: Ungprasert P, Pornratanarangsi S. Correlation between peripheral arterial disease and stage of chronic kidney disease. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S46-50.

ReferenceCitation: Amighi J, Schlager O, Haumer M, Dick P, Mlekusch W, Loewe C, Böhmig G, Koppensteiner R, Minar E, Schillinger M. Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease. Eur J Clin Invest. 2009 Sep;39(9):784-92. doi: 10.1111/j.1365-2362.2009.02180.x. Epub 2009 Jun 12.

ReferenceCitation: Andreucci M, Faga T, Serra R, De Sarro G, Michael A. Update on the renal toxicity of iodinated contrast drugs used in clinical medicine. Drug Healthc Patient Saf. 2017 May 22;9:25-37. doi: 10.2147/DHPS.S122207. eCollection 2017. Review.


title: Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

acronym: SOPHNEURO

summary:
Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders.

In addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate.

After having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy.

Our hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy.

primary_purpose: Supportive Care

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Behavioral


title: Fitness Assessment in Young Adults Recovered From Lymphoma or Hodgkin's Disease

acronym: CUPCAKE

summary:
Regular physical activity (PA) is associated with maintaining body composition, increased cardiorespiratory capacity, muscle mass and bone mineral density. In the event of a cancer, the development of physical capacities and metabolism may therefore be disturbed by cancer, these associated treatments (chemotherapy, radiotherapy and hematopoietic stem cell transplantation) but also undernutrition and the reduction in physical activity or even a sedentary lifestyle.

Although the benefits of PA in oncology are now well identified for adult populations, studies are still rare in the population of children, adolescents and young adults, and the results are still difficult to generalize. As a result, there is no recommendation on the practice of physical activity in pediatric oncology or adolescents and young adults and the levels of physical activity of cured patients remain lower than those of the general population.

Fitness is a marker of health in adults as well as in adolescents. Physical condition is a set of components such as cardiorespiratory capacity (transport and use of O2), body composition (distribution of bone, muscle and fat masses) and muscle function (strength, power, fatigue, energy metabolism) .

The investigators hypothesize that, compared to young adults, recovered from lymphoma are expected to exhibit impaired physical condition, due to physical deconditioning.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pre-clinical Models for Mesenchymal Stem Cell Therapy in Hemophilic Arthropathy

summary: Hemophilia is a constitutional coagulation disorder responsible for a hemorrhagic phenotype in patients from an early age. Hemarthrosis is one of the most frequent complications in hemophiliacs and leads to the development of severe and early arthropathy, sometimes as early as childhood. To date, there is no curative treatment for these joint disorders and preventive treatments are insufficient to completely prevent joint degradation. Mesenchymal stem cells have been shown to be of therapeutic interest in the management of pathologies such as osteoarthritis and inflammatory arthritis through their anti-inflammatory, regenerative and anti-apoptotic effects. Hemophilic arthropathy is a separate condition at the border of these two diseases Our study aim to show pre-clinical interest of mesenchymal stem cell therapy in hemophilic arthropathy

ipd_sharing_description: NC


title: Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies : an Interventional, Prospective, Single-center Study

acronym: FRACPED

summary:
Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery.

X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by emergency pediatricians before being reviewed by radiologists (most often the day after).

Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5% to 15%.

A tool to investigate in diagnosing limb fractures could be helpful for any emergency physicians exposed to this condition

lead_sponsor: Fondation Lenval

location_facility: Hopitaux Pediatriques de Nice Chu-Lenval


title: Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates : a Case Series

summary: The aim of this study was to assess the accuracy of computer-aided orthognathic surgery and patient specific titanium plates for maxillar osteotomy with bi or tripartite disjonction in 22 patients who underwent bimaxillar osteotomy for occlusal trouble.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Interest of the Ultrasound Follow-up of Lymphedema by Elastography Assessment and Cutaneous and Subcutaneous Thickness Measurement During Intensive Treatment of Lymphedema.

acronym: ELASTOLYMPH

summary:
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema

Hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression.

Patients who are undergoing intensive decongestive treatment for four or five days in the department perform an ultrasound check/examiantion on the first day.

During this echography, in 5 usual measurement points are made an ultrasound image recording (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an instantaneous measurement).

The study hypothesis is to note that intensive decongestive treatment has an impact on tissues flexibility and cutaneous and subcutaneous thickness.

No many authors discussed this suject, hence the interest of this study. All the data collected and the results obtained will serve for further studies.


title: Qualitative Analysis of Patients' Medical Records, to Understand the Reasons of the Difficulty in Controlling Asthma, in Difficult Forms

acronym: DIFFAsthme

summary:
Asthma is a chronic inflammatory disease, resulting from environmental, genetic and immunological factors. This is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their management. Our environment has not stopped changing over the past 30 years, so has our way of life and our way of working. The early detection of asthma and the initiation of an adequate therapy are most often carried out by primary care physicians, such as the general practitioner and the general pediatrician. These practitioners find themselves confronted with the medical complexity of asthma which essentially resides in the management of severe forms of asthma, defined by the high therapeutic charge needed to obtain a good control of the disease and, sometimes, in the management of difficult asthma which is an uncontrolled asthma independently of the patients' compliance and of the prescribed therapies. While general practitioners refer many cases of asthma to hospital experts, the investigators wanted to address the issue of difficult asthma, the management of which is less codified.

The main objective of this work is to identify, by a qualitative analysis of medical records, the profiles of patients referred for difficult asthma in a tertiary hospital in order, secondly, to target individual characteristics or subgroups on which therapeutic actions could be implemented, and to provide educational support for doctors.


title: Retrospective Study on Pecan Nut Allergy Epidemiology

acronym: PEC-ALL

summary:
IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. The gold standard remains the oral provocation test, which is performed in a hospital environment. Once the diagnosis is made, an elimination diet is still considered as the cornerstone of treatment for most food allergies.

While some allergies, such as cow's milk or egg, tend to resolve spontaneously, others, such as allergy to pecan nuts, show a tendency to be persistent. In addition, pecan allergy is often characterized by potentially serious clinical reactions, compared to other foods, which can even be life threatening. In our clinical practice, the investigators found that patients with allergies to pecan nuts often present with severe hypersensitivity reactions when challenged orally to this food. Beyond this information, there are few studies regarding pecans. The investigators decided to retrospectively evaluate the results of oral food challenge and of the allergy work-up in our patients sensitized and allergic to pecan nuts, to better understand the current epidemiology of such food allergy.


title: Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry

summary: This study aims at exploring qualitatively experiences and perceived needs among parents of children exposed to potentially traumatic events, including their attitudes and understanding of trauma and resilience, their perceptions of their parental role in the peri-traumatic period, and their expectations of a family intervention for post-traumatic stress. This will ultimately guide future research to develop and design and intervention that would be tailored to their needs and expectations


title: Evaluation of the Effectiveness of Osteopathic Treatment on the Mother-newborn Dyad in the Event of Painful Breastfeeding in the Maternity Hospital Despite the Application of All Usual Aids: Randomized Interventional Study in Clusters in Two Parallel Arms Without Blinding. AMATOSTEO

acronym: AMATOSTEO

summary: Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth


title: Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study

acronym: TOP-ANK

summary: Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

lead_sponsor: Nantes University Hospital


title: Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.

summary: This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions.


title: Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness

summary: Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.


title: Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19

acronym: ELDERCOV

summary:
SARS-COV-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the ICU in 5-20% of affected patients. Age is a major risk factor for developing a severe form and for death. ARDS related to SARS-COV-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. These specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). To investigator's knowledge, no study has evaluated the prognosis in the ICU and the long-term functional outcome of elderly people admitted for a severe or critical form of COVID-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...).

Investigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of COVID-19. The objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe COVID-19.

lead_sponsor: Centre Hospitalier le Mans


title: Medullary Colonic Carcinoma

acronym: MEDCCR

summary: Retrospective cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. Collection of relevant data for this rare entity. Subgroup analysis in search of prognostic factors. Comparison of the data from our cohort with those from the literature.

lead_sponsor: University Hospital, Limoges

location_facility: Service de Chirurgie Digestive et Endocrinienne du CHU de Limoges


title: Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia

acronym: BIOSOM

summary:
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).

To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.

Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.

The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.

The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.

location_facility: Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant


title: Evaluation of Frail Elderly in Ambulatory Primary Care

acronym: EPAFRA

summary: Evaluate the sensitivity of the GERONTOPOLE scale, used by general practitioners in primary care outpatients for the diagnosis of frailty in non-dependent people more than 65 years old, using as reference the "évaluation gériatrique standardisée clinique" (EGS)

lead_sponsor: University Hospital, Lille


title: Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

acronym: TSC-URO

summary: Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results [Cozzi et al., 2008; Draper et al., 2009]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia [Hambraeus et al., 2018] and rise concerned about long-term renal function [Khanna et al., 2019; Rehfuss et al., 2020] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.

lead_sponsor: University Hospital, Montpellier


title: Interest of Plasma Exchange in Patients With Anti-interferon Type 1 Autoantibodies With Severe COVID-19 -

acronym: EPIC

summary:
COVID-19 associated mortality remains high despite the advances in therapeutics such as dexamethasone. The severity of COVID-19 results from direct viral cytotoxicity, and the inflammatory response, which is associated with a hypercoagulable state, contribute to lethal hypoxemic pneumonia. During the SARS-CoV-2 replication phase, infected cells secrete chemokines and die by activating the immune system locally. A local inflammatory loop induces tissue destruction, which activates the immune system's circulating cells, leading to another amplifying loop called the cytokine storm. In these phenomena, the integrity of the interferon pathway plays a significant role.

Specific impairment of the interferon pathway has been identified in a subset of patients and is associated with high Covid-19 severity. This subset of patients presents preexisting autoimmune disease mediated by autoantibodies directed against IFN. It represents 10.2% (101/987) of patients admitted in ICU with COVID-19 pneumonia, and the observed mortality in this subgroup is 40%.

The investigators hypothesized that plasma exchanges (PE) would eliminate these autoantibodies while acting on other mechanisms of the pathogenesis of severe COVID-19, such as cytokine storm or hypercoagulability(7).

The EPIC trial aims to demonstrate the efficacy of plasma exchange in the subpopulation of patients with anti-interferon autoantibodies and severe COVID-19 hospitalized in intensive care and on oxygen therapy, high flow or not, receiving non-ventilation or invasive ventilation, on D28 survival.

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ReferenceCitation: Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28. Review.

ReferenceCitation: Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.

ReferenceCitation: Bastard P, Rosen LB, Zhang Q, Michailidis E, Hoffmann HH, Zhang Y, Dorgham K, Philippot Q, Rosain J, Béziat V, Manry J, Shaw E, Haljasmägi L, Peterson P, Lorenzo L, Bizien L, Trouillet-Assant S, Dobbs K, de Jesus AA, Belot A, Kallaste A, Catherinot E, Tandjaoui-Lambiotte Y, Le Pen J, Kerner G, Bigio B, Seeleuthner Y, Yang R, Bolze A, Spaan AN, Delmonte OM, Abers MS, Aiuti A, Casari G, Lampasona V, Piemonti L, Ciceri F, Bilguvar K, Lifton RP, Vasse M, Smadja DM, Migaud M, Hadjadj J, Terrier B, Duffy D, Quintana-Murci L, van de Beek D, Roussel L, Vinh DC, Tangye SG, Haerynck F, Dalmau D, Martinez-Picado J, Brodin P, Nussenzweig MC, Boisson-Dupuis S, Rodríguez-Gallego C, Vogt G, Mogensen TH, Oler AJ, Gu J, Burbelo PD, Cohen JI, Biondi A, Bettini LR, D'Angio M, Bonfanti P, Rossignol P, Mayaux J, Rieux-Laucat F, Husebye ES, Fusco F, Ursini MV, Imberti L, Sottini A, Paghera S, Quiros-Roldan E, Rossi C, Castagnoli R, Montagna D, Licari A, Marseglia GL, Duval X, Ghosn J; HGID Lab; NIAID-USUHS Immune Response to COVID Group; COVID Clinicians; COVID-STORM Clinicians; Imagine COVID Group; French COVID Cohort Study Group; Milieu Intérieur Consortium; CoV-Contact Cohort; Amsterdam UMC Covid-19 Biobank; COVID Human Genetic Effort, Tsang JS, Goldbach-Mansky R, Kisand K, Lionakis MS, Puel A, Zhang SY, Holland SM, Gorochov G, Jouanguy E, Rice CM, Cobat A, Notarangelo LD, Abel L, Su HC, Casanova JL. Autoantibodies against type I IFNs in patients with life-threatening COVID-19. Science. 2020 Oct 23;370(6515). pii: eabd4585. doi: 10.1126/science.abd4585. Epub 2020 Sep 24.

ReferenceCitation: Zhang Q, Bastard P, Liu Z, Le Pen J, Moncada-Velez M, Chen J, Ogishi M, Sabli IKD, Hodeib S, Korol C, Rosain J, Bilguvar K, Ye J, Bolze A, Bigio B, Yang R, Arias AA, Zhou Q, Zhang Y, Onodi F, Korniotis S, Karpf L, Philippot Q, Chbihi M, Bonnet-Madin L, Dorgham K, Smith N, Schneider WM, Razooky BS, Hoffmann HH, Michailidis E, Moens L, Han JE, Lorenzo L, Bizien L, Meade P, Neehus AL, Ugurbil AC, Corneau A, Kerner G, Zhang P, Rapaport F, Seeleuthner Y, Manry J, Masson C, Schmitt Y, Schlüter A, Le Voyer T, Khan T, Li J, Fellay J, Roussel L, Shahrooei M, Alosaimi MF, Mansouri D, Al-Saud H, Al-Mulla F, Almourfi F, Al-Muhsen SZ, Alsohime F, Al Turki S, Hasanato R, van de Beek D, Biondi A, Bettini LR, D'Angio' M, Bonfanti P, Imberti L, Sottini A, Paghera S, Quiros-Roldan E, Rossi C, Oler AJ, Tompkins MF, Alba C, Vandernoot I, Goffard JC, Smits G, Migeotte I, Haerynck F, Soler-Palacin P, Martin-Nalda A, Colobran R, Morange PE, Keles S, Çölkesen F, Ozcelik T, Yasar KK, Senoglu S, Karabela ŞN, Rodríguez-Gallego C, Novelli G, Hraiech S, Tandjaoui-Lambiotte Y, Duval X, Laouénan C; COVID-STORM Clinicians; COVID Clinicians; Imagine COVID Group; French COVID Cohort Study Group; CoV-Contact Cohort; Amsterdam UMC Covid-19 Biobank; COVID Human Genetic Effort; NIAID-USUHS/TAGC COVID Immunity Group, Snow AL, Dalgard CL, Milner JD, Vinh DC, Mogensen TH, Marr N, Spaan AN, Boisson B, Boisson-Dupuis S, Bustamante J, Puel A, Ciancanelli MJ, Meyts I, Maniatis T, Soumelis V, Amara A, Nussenzweig M, García-Sastre A, Krammer F, Pujol A, Duffy D, Lifton RP, Zhang SY, Gorochov G, Béziat V, Jouanguy E, Sancho-Shimizu V, Rice CM, Abel L, Notarangelo LD, Cobat A, Su HC, Casanova JL. Inborn errors of type I IFN immunity in patients with life-threatening COVID-19. Science. 2020 Oct 23;370(6515). pii: eabd4570. doi: 10.1126/science.abd4570. Epub 2020 Sep 24.

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ReferenceCitation: Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barré syndrome. Cochrane Database Syst Rev. 2017 Feb 27;2:CD001798. doi: 10.1002/14651858.CD001798.pub3. Review.

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ipd_sharing_description: These documents are shared upon request to the sponsor

lead_sponsor: Centre Hospitalier St Anne


title: Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis

acronym: RMN-SARCURINES

summary:
"Sarcoidosis is a systemic granulomatous disease of unknown cause(s).Determining disease activity is a major element in the treatment decision.

1H- Nuclear magnetic resonance (NMR) spectroscopy allows the identification of biomarkers in different pathologies and in particular in a pilot study of saliva of patients with sarcoidosis. Applications to sarcoidosis are still rare, having concerned only serum and saliva. In this context we hypothesize the existence of a difference in the metabolic products found in the urine of sarcoidosis patients with different degrees of activity and/or disease severity.

We designed an analysis of urinary metabolomics in sarcoidosis patient using NMR spectroscopy with multivariate statistical analysis, followed by metabolite identification and pathway analysis. "

ReferenceCitation: Duchemann B, Triba MN, Guez D, Rzeznik M, Savarin P, Nunes H, Valeyre D, Bernaudin JF, Le Moyec L. Nuclear magnetic resonance spectroscopic analysis of salivary metabolome in sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):10-6.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

acronym: GastrExtub

summary:
Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.

When an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.

Gastric ultrasounding monitoring may help assessing gastric content prior to extubation.

Investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.

location_facility: Paediatric intensive care Unit - Hopital Femme Mère Enfant - Hospices Civils de Lyon


title: Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure

acronym: ChaSPerf

summary:
Many people are required to work in stressful situations combining sleep debt and hot environmental conditions. If the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. These alterations may favour the occurrence of accidents.

The changes in cognitive performance induced by hyperthermia are also poorly characterised and often not dissociated from the effects of dehydration. Little is known about the effects of the combination of sleep debt and heat exposure on mental performance. Describing and understanding the alterations induced by this combined situation could provide a better understanding of the mechanisms explaining the deterioration of performance in hot conditions and promote the development of appropriate countermeasures.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Exploratory Feasibility Study for the Development of Mindfulness-based Stress Reduction Program (MBSR )in Parkinsonian Patients - MPARK

acronym: M-PARK

summary: Non-pharmacological therapies become more important in the management of Parkinson's disease (PD). Among these, mindfulness meditation is the subject of high expectations. This intervention, such as the Mindfulness-Based Stress Reduction-based (MBSR) stress reduction program, have shown effects on psychological distress, motor and non-motor disorders, and quality of life. However, the data is still very frail and the conditions for practical use are still very uncertain. The objective of the study is to determine the feasibility of a standardized MBSR program in Parkinsonians patients.

lead_sponsor: University Hospital, Bordeaux


title: Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy

acronym: BIS-Program

summary:
The aim of this study is to determine, using immunohistochemistry (IHC) on biopsies and surgically removed tumor if short-treatment immunotherapy with atezolizumab monotherapy or in combination with other biologic agents (ipatasertib / Bevacizumab / Trastuzumab / Pertuzumab) is associated with increased levels of activated GzmB+ CD8+ T cells from baseline to post treatment sample.

Moreover, from baseline to post treatment sample, evolution of others biomarkers will be studied : GzmB/CD8, CD8/FoxP3, CD8/CD68 in IHC, cell proliferation, PD-L1, MHC-I, change in gene expression (RNA-Seq). Tjis study aim also to assess the safety and tolerability of study treatments in this population and to determine the effect of short-term immunotherapy treatment in pCR at surgery.

Patients will undergo tumor biopsies at screening and 15 days after the beginning of treatment (if they start neoadujavant chemotherapy) / at surgery, in order to evaluate in IHC evolution of activated GzmB+ CD8+ T cells and evaluate other markers

It targets 2 different cohorts: newly diagnosed, non-metastatic early-stage triple-negative (TNBC) or HER2+ breast cancer. TNBC cohort is composed of 4 open-label, randomized arms, HER2+ of 2 arms.

A maximum of 210 patients will be included in the trial (147 in TNBC cohort and 63 in HER2+ cohort).

Tumor evaluation will be performed by clinical examination and Breast echography at baseline and end of treatment visit.

The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests and through the collection of ongoing toxicities or adverse events.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Predictive Properties of Myocardial Fibrosis Biomarkers on the Outcome of Atrial Fibrillation Ablation

acronym: PROFIB-AF

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia. As an independent predictor of cardiovascular mortality, particularly for stroke, its management is a real public health issue. AF is associated with diabetes, obesity, hypertension, heart failure and, occasionally, hyperthyroidism. Atrial fibrosis is one of the major players in the genesis and maintenance of AF. It has a strong impact on rhythmic prognosis and treatment success.

Currently the AF ablation is the treatment recommended by the European Society of Cardiology (ESC) and by the American Society of Cardiology. The rate of AF recurrence is variable according to the patient characteristics and remains unfortunately today difficult to predict.

Abnormal concentrations of circulating biomarkers reflecting the underlying pathophysiologic mechanisms of myocardial fibrosis could help to identify patients at higher risk of developing AF and/or AF recurrence after ablation. Thus, the development of simple, reliable and valid biological tests of atrial fibrosis would allow the clinicians i) to estimate the potential success of AF ablation; ii) to predict AF recurrence; iv) and to propose a AF personalized therapeutic approach.

The main objective of PROFIB-AF study is to identify, among biological markers (ICTP, PICP, PIIINP, sRAGE, AGE, Galectin 3, sSt2, microRNAs) of myocardial fibrosis, those which can predict the recurrence risk after AF ablation.


title: Description of the Evolution of Functional Dysphonia Managed by Hypnotherapy

acronym: HYPNODYS

summary: HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers

acronym: BP ONEDAY

summary: Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.


title: Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

acronym: DECISIONING

summary:
The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial revascularization, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD.

The aim of the study is to to demonstrate a positive effect of personalized medicine on angina in patients with epicardial revascularization by PCI and with significant CMVD assessed by IMR.


title: Impact of the Combination of Music and Relaxing Light on the Patient's Anxiety Postoperatively After Cardiac Surgery in the Intensive Care Unit: Randomized Pilot Study.

acronym: RéaRelax

summary:
Cardiac surgery is not trivial. It requires opening the thorax in certain indications: coronary artery bypass grafting, valve replacements or plasties, aortic dissection, etc. These different procedures, both pre- and post-op, generate anxiety in the patient, the effects of which can be harmful to the recovery process and general well-being. It can be increased by the resuscitation environment during the immediate postoperative management. This environment also favors the development of delirium. It is possible to improve this environment by using non-drug and inexpensive techniques. Indeed, making the stay in the ICU better while respecting the safety of the patient and the efficiency of the care, could reduce anxiety as well as the appearance of delirium. Studies have been carried out on the effectiveness of music in health care with a positive impact on anxiety and pain.

The proposed study aims to evaluate the implementation of relaxation moments adapted to the resuscitation sector from the day after surgery. They target the senses available and accessible at that moment, such as hearing (relaxing music chosen by the patient will be played) and sight (a multi-effect light projector and a bubble column will be deployed). Environmental stressors will be minimized, while maintaining an optimal level of safety.

The primary objective is to compare anxiety before and after the first session in cardiac surgery patients in the cardiothoracic and vascular surgery (CCTV) resuscitation unit between the group with the usual rest session and the group with the rest session combining soft music and light.

The secondary objectives are based on an evaluation of anxiety over different time periods, patient comfort, occurrence of postoperative delirium, patient pain, average length of stay (LOS).

This is a pilot, comparative, monocentric, randomized, interventional research with minimal risks and constraints in 2 parallel groups. 110 patients will be included over a period of 12 months In the experimental group, once a day, a relaxation session with the association of soft music and light will be proposed by adapting the environment of the patient's resuscitation room. The control group will have the usual rest session.

lead_sponsor: Poitiers University Hospital


title: Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

summary:
Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

lead_sponsor: University Hospital, Caen


title: Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

acronym: MICRODIGCOV

summary: The study investigators hypothesize that SARS-Cov2 infection alters the composition of the digestive microbiota and its functionality, resulting in changes in intestinal permeability and consequently in microbial digestive translocation. These changes may correlate with the magnitude of the SARS-CoV-2 viral load in the gastrointestinal tract and may have an impact on the clinical manifestations and evolvability of COVID-19.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

acronym: PréPaLim

summary: The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Anterior Tibial Translation of the Knee in Healthy Women, at Two Times of the Menstrual Cycle, on Hormonal Contraceptives or Not (FLEX)

acronym: FLEX

summary: Women's participation in sports at all levels has been increasing in recent decades. Many individual and team sports are at risk of anterior cruciate ligament (ACL) injury. This injury leads to a permanent or long-lasting interruption of sports practice and to significant medical and economic expenses. Women are recognized as being more at risk of anterior cruciate ligament injury with a risk 6 times higher than men. Hyperlaxity is a risk factor for anterior cruciate ligament injury, but the pathophysiological bases are little studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for anterior cruciate ligament injury. It therefore seems interesting to investigators to study the influence of hormonal impregnation on ligament laxity. To date no study has investigated such a relationship.


title: In Vivo Study of the Dual Mobility Cup Stability and Mobility Using Ultrasound Imaging

acronym: USDMC

summary:
The concept of dual mobility cup (DMC), developed in the 1970s by Gilles Bousquet, allows a greater motion and a better stability of the implants, reducing the prosthetic dislocations frequency in at-risk populations. This type of prosthesis has a small-diameter head that ensures a low wear rate and a large-diameter head, with a polyethylene liner, to increase prosthetic stability. This prosthesis has survival rates comparable to those found with conventional prostheses. However, actually, its in vivo behaviour has not yet been established, leading orthopaedic surgeons to keep this concept for patients with a high risk of dislocation (elderly subjects, neurological pathologies, spinal pathologies, falls, etc.). To date, no in vivo studies have been carried out - non-invasively and dynamically - to understand the biomechanical behaviour and the stability properties of the dual mobility cup implanted in patients.

The objective of this study is to visualize and quantify the in vivo movement of the polyethylene liner using 3D ultrasound imaging. The second objective is to obtain in vivo data (using the motion analysis system and the force platform) allowing the use of a musculoskeletal model to improve the understanding of the prosthetic dislocation phenomenon.

Participants will carry out daily life activities (walk, chair up, etc.). During this study, liner ultrasound acquisitions and motion analysis of the lower limb will be performed, thanks to a movement analysis system composed of cameras coupled to a force platform.

Hip kinematics will be obtained from the motion analysis data and will be based on the model of Leardini et al. 2007. The position of the liner and liner plane will be determined using 3D ultrasound data. The abduction and anteversion motion of the liner plane will be measured relative to the pelvic landmark.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital Lyon Sud - Service de Chirurgie Orthopédique