title: Impact of Early Diagnosis Algorithm for Early-onset Pneumonia Diagnosis on Prognosis of Patients With Out-of-hospital Cardiac Arrest

acronym: PP-ACR

summary:
Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance.

Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.

lead_sponsor: University Hospital, Brest


type: EudraCT Number

title: Positron Emission Tomography Study of alpha2-adrenergic Receptors With [11C]Yohimbine

summary: The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie C - Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, GHE

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluate the Impact of the "Standing Patient" Pathway on Preoperative Anxiety.

acronym: ANXIPADE

summary:
For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to bring about a global care of the patient by establishing a safe and quality climate. With this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner than he is lying later. "Fast care" is based on the principle that any patient is valid before he / be operated and therefore do not need to come to a bed in the operating room.

The ambulatory surgery department of the CHU of Caen welcomes and supports adults and children over 8 years old. The following specialties are covered: dental surgery and stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery, vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is experimenting with patient support at the operating theater on foot by the service stretcher team since December 2015. It seems that this technique makes it possible to improve the quality of care by respecting the dignity and autonomy; in fact to wander the patient preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and not dependent, he is accompanied and not taken away. The preservation of autonomy improves their feelings, especially in terms of dignity. It also appears to be a technique for participating in the reduction of preoperative anxiety, an important factor for postoperative follow-up.

However, studies reporting the benefit of this technique have rather evaluated the feelings of patients. To the best of our knowledge, there are no studies that have evaluated their benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with appropriate tools seems essential to determine a real impact.

We hypothesize that accompanying the patient to the operating room on foot would reduce preoperative anxiety. We have not yet found any studies showing that the "standing patient" pathway had an impact on preoperative anxiety. We propose to carry out a randomized study comparing the anxiety score using the APAIS scale at the operating room installation between patients benefiting from the "standing patient pathway" versus the patients receiving the care standard, that is to say the stretcher transport to the operating theater.

The duration of this study is evaluated at 2 years.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Caen

intervention_type: Other

status_simplified: Unknown


title: Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery

acronym: FACE-Q

summary: Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Bordeaux


title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom

acronym: STOUT

summary:
The measurement of the transcutaneous oxygen partial pressure (TCPO2) at exercise is, to our knowledge, the only method to estimate during the exercise the importance of ischemia segment of limb by segment of limb bilaterally and carry on. The diagnosis of thoracic outlet syndrome causing remains difficult and dependent operator in ultrasound because of the risk of false positive (loss of signal) or false negative (insufficient effort, inappropriate movement).

Our main hypothesis is the existence of significant measurable ischemia in the forearm by transcutaneous oximetry during the maneuvering of the "candlestick".

In the event of failure of this maneuver, the other maneuvers such as those of Wright, Roos, Tinel and Adson will be realized.

In this study we want to evaluate the possibility of using dynamic transcutaneous Oximetry as a tool for evaluating ischemia in case of suspicion of thoracic outlet syndrome causing.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Hersant J, Ramondou P, Guilleron C, Picquet J, Henni S, Abraham P. A pilot study of forearm microvascular impairment and pain while using a telephone. Microvasc Res. 2020 May;129:103963. doi: 10.1016/j.mvr.2019.103963. Epub 2019 Nov 29.

family: Hersant

full_name: Jeanne Hersant

given: Jeanne

sequence: first

family: Ramondou

full_name: Pierre Ramondou

given: Pierre

sequence: additional

family: Guilleron

full_name: Celine Guilleron

given: Celine

family: Picquet

full_name: Jean Picquet

given: Jean

family: Henni

full_name: Samir Henni

given: Samir

family: Abraham

full_name: Pierre Abraham

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Microvascular Research

oa_host_type: publisher

evidence: open (author manuscript)

host_type: publisher

license_normalized: no license

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Angers

status_simplified: Ongoing


title: Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration

summary: The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction

ipd_sharing: Undecided


title: Efficacy of Long-term Parenteral Nutrition With SmofKabiven® E Concomitant to Chemo- and/or Immunotherapy: A Prospective, Randomised, Controlled, Open, Multicentre, Two-stage, Adaptive Clinical Trial in Metastatic Non-small Cell Lung Cancer

summary: The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Fresenius Kabi

lead_sponsor_type: industriel


title: Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.

summary: Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm

acronym: MilriSpasm

summary: The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the current standard treatment for cerebral vasospasm following subarachnoid hemorrhage. Assessment of IV milrinone safety in this setting is mandatory before the conduction of a large study assessing its effectiveness.

lead_sponsor: Nantes University Hospital


title: Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

acronym: NAUVOLA

summary:
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.

We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor

summary:
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.

A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).

Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.


type: Other Identifier

title: Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life

acronym: NAP-REA

summary: The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.

primary_purpose: Treatment


title: The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory (PedsQLTM) 3.0 Duchenne Muscular Dystrophy Module.

acronym: ValPedsQLDMD

summary: There isn't specific Health related quality of life measure for children with DMD in French. The aim of this study is to validate the French version of the Pediatric Quality of Life Inventory 3.0 Duchenne Muscular Dystrophy module with a multicentric study. The investigators will evaluate the following psychometric properties : convergent validity, internal validity, inter-rater reliability. The investigators would like to be able to use this scientific tool in future clinical trials.

lead_sponsor: University Hospital, Toulouse


title: Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations

acronym: Mutapro

summary:
The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.

This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

acronym: DID&NEPHRO

summary:
A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).

The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).


title: Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients

acronym: DECATRAC

summary:
Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury).

However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily.

This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.

intervention_type: Procedure


title: Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method

acronym: ABIOSCILLO

summary:
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.

We hypothesize that:

- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method.

the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.

lead_sponsor: University Hospital, Limoges

intervention_type: Diagnostic Test


title: Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

acronym: EDILS-AutoAC

summary: This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Rouen


title: Pilot Study Describing the Effect of an Early Nursing Intervention Device on the Anxious Experience of "Third-party" People Who Participate in the First Involuntary Commitment Hospitalization From a Relative

acronym: Vécu/Tiers/Psy

summary:
In a context of first hospitalization under the constraint of a relative in psychiatric emergencies:

effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons
effect of nursing support on family dynamics, on the durability of outpatient care and adherence


title: Sleep Apnea Syndrome in Obese Women During Pregnancy

summary:
Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.

The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.

the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.

lead_sponsor: University Hospital, Lille


title: EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer

acronym: TWISTlung

summary: The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.

time_perspective: Other

lead_sponsor: European Georges Pompidou Hospital


title: Phase I Multicenter Trial Combining Nivolumab, Alone or With Ipilimumab, Plus Hypo-fractionated Radiotherapy for Pretreated Advanced Stage Non-small Cell Lung Cancer Patients

summary:
Nivolumab is superior to docetaxel monotherapy as second line treatment in advanced stage non-small cell lung cancer (NSCLC) patients. However, the long term survival advantage seems to be limited to a 20% proportion of treated patients. To date, no definitive biomarker, including tumor cells or infiltrative cells PD-L1 expression, has been demonstrated to predict nivolumab (or other PD1 or PD-L1 inhibitors) efficacy. Ipilimumab has also suggested efficacy in the same patient population. Finally, the addition of ipilimumab to nivolumab has a suggested better efficacy over nivolumab alone in advanced stage NSCLC patients with an acceptable safety profile.

In parallel, hypo-fractionated radiotherapy alone has been suggested to elicit the immune system activity as demonstrated by the occurrence of an abscopal effect. Some case reports in melanoma but also lung cancer patients reinforced this hypothesis.

Furthermore, preclinical and clinical data suggest that radiation may have a synergistic effect with antibodies targeting the immune checkpoints (PD1, PD-L1, CTLA4) and improve antitumor efficacy. Moreover, it has been shown that fractionated radiotherapy delivered in combination with aPD-1 or aPD-L1 mAbs is able to generate efficacious CD8þ T-cell responses that will in turn improve local tumor control, long-term survival, and protection against tumor rechallenge.

Therefore, the combination of single fraction or hypo-fractionated radiotherapy with the anti PD1 nivolumab and/or the anti CTLA4 ipilimumab warrants further investigation. However, a large number of doses, sequences and schedules remain possible. In order to select the best combination, a mathematical modeling of immunotherapy in cancer and its synergy with radiotherapy has been set up. This work provides with mathematical formulas to link the drug serum concentrations of nivolumab and ipilimumab, and the dose of radiation therapy, to the immune response. In silico, the single and three fractions schedule have been found to have the same efficacy while activation of the immune response seems to be better using a hypo-fractionated (less than 6 fractions) radiotherapy in vivo.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Radiation


title: Study of Addiction Criteria in the Elderly

acronym: CAPA

summary:
Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.

The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.


title: Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation

acronym: MENINGREF

summary:
Allogeneic hematopoietic stem cell transplant (HSCT) recipients are at risk of various bacterial infections, especially due to a progressive decrease of specific antibodies. Around 90% of HSCT recipients have unprotective titers of specific antibodies to serogroups A and C meningogocci (Parkkali 2001; Mahler 2012).

Some small studies suggest that the response to meningococcal A and C vaccines is close to 100% after 3 doses given 18 months after transplant. Although the response to 2 doses of 4CMenB is over 75% in other immunocompromised patients (Feavers, 2017), studies with 4CMenB are lacking after HSCT. Nevertheless, as serogroup B caused 74% of IMD in Europe between 2004-2014 (Whittaker, 2017), the meningococcal B vaccination is recommended by the more recent guidelines from 6 months after transplant. There are, however, no data on the safety and efficacy of this vaccine after hematopoietic stem cell allograft (HSCT).

The objective of this study is to assess the response to 2 doses of a multicomponent meningococcal B vaccine (4CMenB) given at 2 months interval in adult allogeneic HSCT recipients transplanted at least 6 months ago.

The response will be assessed 1 month and 10 months after the second dose of vaccine by measuring bactericidal antibodies against NadA, fHbp, NHBA and PorAP1 vaccinal antigens according to methods previously reported (Caron Lancet Infect Dis 2011). The response rate will be correlated to pre- and post-transplant factors.

The hypothesis of this study is that 80% of the patients should have protective titers one month after the 2nd dose.

ReferenceType: background

ReferenceCitation: Caron F, du Châtelet IP, Leroy JP, Ruckly C, Blanchard M, Bohic N, Massy N, Morer I, Floret D, Delbos V, Hong E, Révillion M, Berthelot G, Lemée L, Deghmane AE, Bénichou J, Lévy-Bruhl D, Taha MK. From tailor-made to ready-to-wear meningococcal B vaccines: longitudinal study of a clonal meningococcal B outbreak. Lancet Infect Dis. 2011 Jun;11(6):455-63. doi: 10.1016/S1473-3099(11)70027-5. Epub 2011 Apr 12. Erratum in: Lancet Infect Dis. 2011 Jul;11(7):495.

ReferenceCitation: Mahler MB, Taur Y, Jean R, Kernan NA, Prockop SE, Small TN. Safety and immunogenicity of the tetravalent protein-conjugated meningococcal vaccine (MCV4) in recipients of related and unrelated allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Jan;18(1):145-9. doi: 10.1016/j.bbmt.2011.07.027. Epub 2011 Aug 4.

ReferenceCitation: Parkkali T, Käyhty H, Lehtonen H, Ruutu T, Volin L, Eskola J, Ruutu P. Tetravalent meningococcal polysaccharide vaccine is immunogenic in adult allogeneic BMT recipients. Bone Marrow Transplant. 2001 Jan;27(1):79-84.

ReferenceCitation: Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. Erratum in: Clin Infect Dis. 2014 Jul 1;59(1):144.

ReferenceCitation: Whittaker R, Dias JG, Ramliden M, Ködmön C, Economopoulou A, Beer N, Pastore Celentano L; ECDC network members for invasive meningococcal disease. The epidemiology of invasive meningococcal disease in EU/EEA countries, 2004-2014. Vaccine. 2017 Apr 11;35(16):2034-2041. doi: 10.1016/j.vaccine.2017.03.007. Epub 2017 Mar 14.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Urodynamic Evaluation of Incontinent Obese Women Before and After Weight Reduction by Bariatric Surgery : What Urodynamic Healing Factors? BUDI (Bariatric UroDynamic Improvement)

acronym: BUDI

summary:
In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%. It was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the IU. However, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated.

The main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.

ReferenceCitation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78.

ReferenceCitation: Legendre G, Fritel X, Capmas P, Pourcelot AG, Fernandez H. [Urinary incontinence and obesity]. J Gynecol Obstet Biol Reprod (Paris). 2012 Jun;41(4):318-23. doi: 10.1016/j.jgyn.2012.02.007. Epub 2012 Apr 17. Review. French.

ReferenceCitation: Sandvik H, Hunskaar S, Seim A, Hermstad R, Vanvik A, Bratt H. Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health. 1993 Dec;47(6):497-9.

ReferenceCitation: Subak LL, Richter HE, Hunskaar S. Obesity and urinary incontinence: epidemiology and clinical research update. J Urol. 2009 Dec;182(6 Suppl):S2-7. doi: 10.1016/j.juro.2009.08.071. Review.

ReferenceCitation: Elia G, Dye TD, Scariati PD. Body mass index and urinary symptoms in women. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):366-9.

ReferenceCitation: Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S3-9.

ReferenceCitation: Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5.

ReferenceCitation: Agur W, Rizk DE. Obesity and urinary incontinence in women: is the black box becoming grayer? Int Urogynecol J. 2011 Mar;22(3):257-8. doi: 10.1007/s00192-010-1293-z. Epub 2010 Oct 6.

ReferenceCitation: Lose G, Tanko A, Colstrup H, Andersen JT. Urethral sphincter electromyography with vaginal surface electrodes: a comparison with sphincter electromyography recorded via periurethral coaxial, anal sphincter needle and perianal surface electrodes. J Urol. 1985 May;133(5):815-8.

ReferenceCitation: Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8.

ReferenceCitation: Banerjea R, Findley PA, Sambamoorthi U. Disparities in preventive care by body mass index categories among women. Women Health. 2008;47(4):1-17. doi: 10.1080/03630240802099261.

ReferenceCitation: Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.

ReferenceType: result

ReferenceCitation: Chen CC, Gatmaitan P, Koepp S, Barber MD, Chand B, Schauer PR, Brethauer SA. Obesity is associated with increased prevalence and severity of pelvic floor disorders in women considering bariatric surgery. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):411-5. doi: 10.1016/j.soard.2008.10.006. Epub 2008 Oct 29.

family: Chen

full_name: Chi Chiung Grace Chen

given: Chi Chiung Grace

family: Gatmaitan

full_name: Patrick Gatmaitan

given: Patrick

family: Koepp

full_name: Sidney Koepp

given: Sidney

family: Barber

full_name: Matthew D. Barber

given: Matthew D.

family: Chand

full_name: Bipan Chand

given: Bipan

family: Schauer

full_name: Philip R. Schauer

given: Philip R.

family: Brethauer

full_name: Stacy A. Brethauer

given: Stacy A.

journal_name: Surgery for Obesity and Related Diseases

ReferenceCitation: Knepfler T, Valero E, Triki E, Chilintseva N, Koensgen S, Rohr S. Bariatric surgery improves female pelvic floor disorders. J Visc Surg. 2016 Apr;153(2):95-9. doi: 10.1016/j.jviscsurg.2015.11.011. Epub 2015 Dec 8.

family: Knepfler

full_name: T. Knepfler

given: T.

family: Valero

full_name: E. Valero

given: E.

family: Triki

full_name: E. Triki

family: Chilintseva

full_name: N. Chilintseva

given: N.

family: Koensgen

full_name: S. Koensgen

given: S.

family: Rohr

full_name: S. Rohr

journal_name: Journal of Visceral Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

ReferenceCitation: Kuruba R, Almahmeed T, Martinez F, Torrella TA, Haines K, Nelson LG, Gallagher SF, Murr MM. Bariatric surgery improves urinary incontinence in morbidly obese individuals. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):586-90; discussion 590-1. Epub 2007 Oct 18.

ReferenceCitation: Burgio KL, Richter HE, Clements RH, Redden DT, Goode PS. Changes in urinary and fecal incontinence symptoms with weight loss surgery in morbidly obese women. Obstet Gynecol. 2007 Nov;110(5):1034-40.

ReferenceCitation: Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai TC, Lemack G, Sirls L, Dandreo KJ, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life. J Urol. 2010 Feb;183(2):622-8. doi: 10.1016/j.juro.2009.09.083. Epub 2009 Dec 16.

name: University of Alabama at Birmingham, Birmingham, Alabama

family: Richter

name: New England Research Institutes, Watertown, Massachusetts

name: University of Texas Health Science Center at San Antonio, San Antonio

name: University of California at San Diego, San Diego, California

name: University of Maryland, Baltimore, Maryland

name: University of Texas Southwestern, Dallas, Texas

name: William Beaumont Hospital, Royal Oak, Michigan

publisher: Ovid Technologies (Wolters Kluwer Health)

title: The Impact of Obesity on Urinary Incontinence Symptoms, Severity, Urodynamic Characteristics and Quality of Life

ReferenceCitation: Richter HE, Creasman JM, Myers DL, Wheeler TL, Burgio KL, Subak LL; Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group. Urodynamic characterization of obese women with urinary incontinence undergoing a weight loss program: the Program to Reduce Incontinence by Diet and Exercise (PRIDE) trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1653-8. doi: 10.1007/s00192-008-0694-8. Epub 2008 Aug 5.

name: for the Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group

ReferenceCitation: Nathan PA, Keniston RC, Myers LD, Meadows KD. Obesity as a risk factor for slowing of sensory conduction of the median nerve in industry. A cross-sectional and longitudinal study involving 429 workers. J Occup Med. 1992 Apr;34(4):379-83.

ReferenceCitation: Bump RC, Sugerman HJ, Fantl JA, McClish DK. Obesity and lower urinary tract function in women: effect of surgically induced weight loss. Am J Obstet Gynecol. 1992 Aug;167(2):392-7; discussion 397-9.

ReferenceCitation: Romero-Talamás H, Unger CA, Aminian A, Schauer PR, Barber M, Brethauer S. Comprehensive evaluation of the effect of bariatric surgery on pelvic floor disorders. Surg Obes Relat Dis. 2016 Jan;12(1):138-43. doi: 10.1016/j.soard.2015.08.499. Epub 2015 Aug 13.

ReferenceCitation: Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52.

ReferenceCitation: Townsend MK, Curhan GC, Resnick NM, Grodstein F. BMI, waist circumference, and incident urinary incontinence in older women. Obesity (Silver Spring). 2008 Apr;16(4):881-6. doi: 10.1038/oby.2008.14. Epub 2008 Feb 14.

title: BMI, Waist Circumference, and Incident Urinary Incontinence in Older Women

ReferenceCitation: Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8.

ipd_sharing_description: study protocol statistical analysis plan informed consent form analytic code clinical study report


title: Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study

acronym: PROLIV

summary: Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.


title: Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis

acronym: SCLEROLUNG

summary:
Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects 75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic biomarkers of SSc-associated ILD have been validated to date. The search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management.

We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease.

Objectives and means: We aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / SSc without ILD (control group in the context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF) (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.

location_facility: Assistance Publique Hopitaux de Marseille


type: Registry Identifier

title: Neurobiological Substrate of Social Context on Cognitive Control in Drug Users

acronym: STNdrugaddict

summary:
The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts.

This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play a critical role in these processes. Addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. These disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex.

For the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ".

This task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. In this task associated with fMRI, it was previously shown that the STN is involved in the control of inhibition. These results confirm our data in the rat, and especially those showing that STN lesions block the ability to stop. The stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users.

In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. Since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure.

There will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). The "stop-signal" task should induce increased activity of the STN that should be modulated by the cocaine-associated cues and by the presence of a peer.

intervention_type: Device


title: Impact of Cytomegalovirus (CMV) Status Prior Antiretroviral Therapy on HIV Viral Load Decay

summary:
Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV infection. No study to date has investigated the impact of CMV infection on HIV viral load decay during antiretroviral therapy.

Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were enrolled. Clinical, biological and virological data were collected from HIV antiretroviral therapy initiation to the day of HIV viral load undetectability if any.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Description and Evaluation of Care Practices Amongst Geriatric Oncology Unit in the Alpine Valley, in the Follow-up of Cancer Patients.

acronym: SONGAlp

summary:
As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects.

As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp) has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric evaluation and trying to establish adapted cares.

In order to evaluate the impact of those evaluation on patients' health, the investigators have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).

The investigators want to develop a common data base to these centres, in order to evaluate the care practices that were developped, and demonstrate the benefit for the patient on the dependence level and the overall survival.

lead_sponsor: University Hospital, Grenoble


title: Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)

acronym: THERMO-HTA

summary:
Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.

In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.

For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.

Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.

Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of the Child's Traumatic Ankle Injuries

acronym: ANKLE

summary: Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)

location_facility: Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro


title: Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series

acronym: SVN

summary:
Villo-nodular synovitis can affect the joints, bursae or tendon sheaths. This condition is rare, with 1.8 cases per million inhabitants. The hip is affected in 3.6 to 18.1% of cases. The age of predilection is between 30 and 50 years old and this condition is rarely described in children.

Two articles report a case of villous-nodular synovitis of the child's hip. Surgical treatment by resection seems to be consensus but various adjuvant treatments are also proposed. A case of villous-nodular synovitis of the hip in children was treated without surgical intervention. The main objective of this study was to evaluate the efficacy of surgical treatment of villous nodular synovitis of the hip in children.

lead_sponsor: Lille Catholic University


title: Evaluation of a Treadmill Workstation in an Emergency Dispatch Center. A Randomized Controlled Trial.

summary:
The principal objective of this study is to determine if the provision of a treadmill workstation in an emergency medical services (EMS) dispatch center increases the number of steps that participants make daily within 6 months compared to the usual working conditions.

The investigators hypothesized that the provision of a treadmill workstation with a slow walking could increase the number of daily steps and decrease days of leave, musculoskeletal disorders without decreasing the dispatch quality.


title: Study and Follow-up of Multiple Endocrine Neoplasia Type 1

acronym: GENEM

summary:
Multiple Endocrine Neoplasia type I (MEN1) or Wermer syndrome is an autosomal dominant disease that predisposes patients to the development of endocrine tumours, principally parathyroid, pituitary or duodenal-pancreatic tumours. It is due to mutations that abolish the function of the MEN1 gene, which contributes to tumour regulation. It is a rare disease, with an estimated prevalence in the general population of 1/30,000. Penetrance of the disease is late but very high (almost 100% at 50 years of age). The first clinical manifestations usually appear after the age of 30 or 40 years.

The three cardinal endocrine characteristics of MEN1 are secreting tumours of the parathyroid, the pituitary gland and the pancreas. Tumours of the adrenal glands, bronchial or thymic endocrine tumours, ependymoma and meningioma of the central nervous system, visceral leiomyomas, and certain cutaneous tumours can also be found as well as these cardinal tumours.

The diagnosis of MEN1 is essential to ensure 1) appropriate therapeutic management of the proven endocrine manifestations 2) screening for other endocrine and non-endocrine tumours (lesions), 3) family screening of affected relatives whether they are symptomatic or not 4) the surveillance of thus diagnosed patients. Studies on mortality in MEN1 have shown that the causes of death are mainly due to the disease. The non-diagnosis of MEN1 is a cause of therapeutic failure in the management of the endocrine lesions. For the success of the surgical treatment of an isolated endocrine lesion it is important for patients to be oriented towards a diagnosis of MEN1 as the management is different from that in usual situations. Detection is thus of major importance, as early diagnosis can improve the management.

Even though the syndrome was discovered in 1903 by Erdheim and correctly documented in 1954 by Wermer, it was only in the 1970s that we became aware of the variety of clinical forms and attempted to codify its treatment. Nonetheless, published studies are fragmented and concern selected populations of few patients. They only partially answer questions arising in clinical practice concerning the prognosis and optimal management of patients. The natural history of the disease in all of its clinical forms is still poorly understood. Although advances in genetics have helped in the diagnosis of MEN1, some clinical forms are still difficult to associate with the syndrome: atypical forms, forms with hardly any symptoms and no genetic diagnosis (10%). These clinical forms need to be clarified to ensure optimal care. Only a large cohort will make it possible to describe the different forms of this disease and to clarify its prognosis


title: The Pancreas and the Bilio-pancreatic Junction: Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?

summary: Limited pancreatic resections are increasingly performed, but the rate of postoperative fistula is higher than after classical resections. Pancreatic segmentation, anatomically and radiologically identifiable, may theoretically help the surgeon removing selected anatomical portions with their own segmental pancreatic duct and thus might decrease the postoperative fistula rate. Current pancreatic segmentation theories do not enable defining anatomical-surgical pancreatic segments. To our knowledge, no study has tried to describe pancreatic segmentation from the divisions of the pancreatic ducts to date. Hence, we hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts, using extensive reconstructions of pancreatic duct using micro-scanner on injected human pancreas.

lead_sponsor: CHU de Reims


title: Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

acronym: PERIFLOW

summary:
Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases.

The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

status: Withdrawn

location_facility: University Hospital Toulouse (Faculty of Dental Surgery)


title: Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy

summary: The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment


title: A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®

acronym: NEFI

summary:
Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one patient to another, with great heterogeneity in clinical, physical, social, psychological and therapeutic responses. . A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients; a collective expertise is led by INSERM to help in patient care. Faced with the heterogeneity of FM, several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which suggested four groups, but with methodological limitations, not taking into account the new criteria10 for evaluating FM.

Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of the autonomous system. Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN much simpler, faster and less invasive than the technique of ophthalmology or biopsy. Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19, no study has been used to assess the presence of SFN in FM.

The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this new non-invasive device, in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age, sex, BMI and by menopausal status for women.

ReferenceCitation: Perrot S, Choy E, Petersel D, Ginovker A, Kramer E. Survey of physician experiences and perceptions about the diagnosis and treatment of fibromyalgia. BMC Health Serv Res. 2012 Oct 10;12:356. doi: 10.1186/1472-6963-12-356.

ReferenceCitation: Tagami J, Tao L, Pashley DH. Correlation among dentin depth, permeability, and bond strength of adhesive resins. Dent Mater. 1990 Jan;6(1):45-50.

ReferenceCitation: Aktas A, Walsh D, Rybicki L. Symptom clusters: myth or reality? Palliat Med. 2010 Jun;24(4):373-85. doi: 10.1177/0269216310367842. Review.

ReferenceCitation: Flor H, Turk DC. Psychophysiology of chronic pain: do chronic pain patients exhibit symptom-specific psychophysiological responses? Psychol Bull. 1989 Mar;105(2):215-59. Review.

ReferenceCitation: Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthritis Rheum. 2003 Oct;48(10):2916-22.

ReferenceCitation: Wilson HD, Robinson JP, Turk DC. Toward the identification of symptom patterns in people with fibromyalgia. Arthritis Rheum. 2009 Apr 15;61(4):527-34. doi: 10.1002/art.24163.

ReferenceCitation: de Souza JB, Goffaux P, Julien N, Potvin S, Charest J, Marchand S. Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study. Rheumatol Int. 2009 Mar;29(5):509-15. doi: 10.1007/s00296-008-0722-5. Epub 2008 Sep 27.

ReferenceCitation: Bergman S. Psychosocial aspects of chronic widespread pain and fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):675-83.

ReferenceCitation: Salaffi F, Mozzani F, Draghessi A, Atzeni F, Catellani R, Ciapetti A, Di Carlo M, Sarzi-Puttini P. Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res. 2016 May 13;9:279-86. doi: 10.2147/JPR.S100829. eCollection 2016.

ReferenceCitation: Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4. Review.

ReferenceCitation: Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: clinical and immunologic implications. Arthritis Rheumatol. 2014 Jul;66(7):1945-54. doi: 10.1002/art.38662.

ReferenceCitation: Doppler K, Rittner HL, Deckart M, Sommer C. Reduced dermal nerve fiber diameter in skin biopsies of patients with fibromyalgia. Pain. 2015 Nov;156(11):2319-2325. doi: 10.1097/j.pain.0000000000000285.

ReferenceCitation: Oaklander AL, Herzog ZD, Downs HM, Klein MM. Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. Pain. 2013 Nov;154(11):2310-2316. doi: 10.1016/j.pain.2013.06.001. Epub 2013 Jun 5.

ReferenceCitation: Üçeyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, Casanova-Molla J, Reiners K, Sommer C. Small fibre pathology in patients with fibromyalgia syndrome. Brain. 2013 Jun;136(Pt 6):1857-67. doi: 10.1093/brain/awt053. Epub 2013 Mar 9.

ReferenceCitation: Ramírez M, Martínez-Martínez LA, Hernández-Quintela E, Velazco-Casapía J, Vargas A, Martínez-Lavín M. Small fiber neuropathy in women with fibromyalgia. An in vivo assessment using corneal confocal bio-microscopy. Semin Arthritis Rheum. 2015 Oct;45(2):214-9. doi: 10.1016/j.semarthrit.2015.03.003. Epub 2015 Mar 19.

ReferenceCitation: Karnaukhov VK. [Significance of dyskinesia of the large intestine in the diagnosis of nonspecific ulcerative colitis]. Sov Med. 1973 Apr;36(4):97-100. Russian.

ReferenceCitation: Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224. doi: 10.1371/journal.pone.0138224. eCollection 2015.

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ReferenceCitation: Mao F, Liu S, Qiao X, Zheng H, Xiong Q, Wen J, Liu L, Tang M, Zhang S, Zhang Z, Ye H, Lu B, Li Y. Sudoscan is an effective screening method for asymptomatic diabetic neuropathy in Chinese type 2 diabetes mellitus patients. J Diabetes Investig. 2017 May;8(3):363-368. doi: 10.1111/jdi.12575. Epub 2016 Oct 5.

ReferenceCitation: Pickering G, Achard A, Corriger A, Sickout-Arondo S, Macian N, Leray V, Lucchini C, Cardot JM, Pereira B. Electrochemical Skin Conductance and Quantitative Sensory Testing on Fibromyalgia. Pain Pract. 2020 Apr;20(4):348-356. doi: 10.1111/papr.12857. Epub 2019 Dec 24.

name: Neuro‐Dol Laboratory Inserm 1107 Clermont Auvergne University Clermont‐Ferrand France

name: Clinical Pharmacology Department CPC/CIC Inserm 1405 Clermont‐Ferrand University Hospital Clermont‐Ferrand France

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

family: Achard

full_name: Alexanne Achard

given: Alexanne

family: Corriger

full_name: Alexandrine Corriger

given: Alexandrine

family: Sickout‐Arondo

full_name: Sophia Sickout‐Arondo

given: Sophia

family: Macian

full_name: Nicolas Macian

given: Nicolas

family: Leray

full_name: Vincent Leray

given: Vincent

family: Lucchini

full_name: Camille Lucchini

given: Camille

name: CIC Inserm 1405 Clermont‐Ferrand University Hospital Clermont Auvergne University MEDIS Clermont‐Ferrand France

family: Cardot

full_name: Jean‐Michel Cardot

given: Jean‐Michel

name: Biostatistics Unit (DRCI) Clermont‐Ferrand University Hospital Clermont‐Ferrand France

family: Pereira

full_name: Bruno Pereira

given: Bruno

journal_name: Pain Practice

oa_host_type: repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Clermont-Ferrand


acronym: ATRIL

source: euctr

title: Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2

summary:
ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42 SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be included.

Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months.

Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected patients and may increase survival.

Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To assess primary criterion, the percentage of patients with a decrease of at least 1 point of the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.


title: First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging

summary: This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.


title: Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis

acronym: CALIMERO 2

summary:
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

intervention_type: Behavioral


title: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

acronym: IMPEC

summary:
Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods.

Hypothesis of our study is that [11C] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma

location_facility: Service de Médecine Nucléaire - Hospices Civils de Lyon


title: Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.

acronym: EFINO-C

summary: The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.


title: Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly

summary: The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.


title: Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects

summary: Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and long-term cardiovascular and metabolic tolerance associated with these drugs The primary objective of this study is to analyze the impact of anti-TNF treatment during the first year of administration on the energy metabolism of patients suffering from RA, assessed as an absolute value (before-after) and in comparison with a standard measured in healthy matched subjects.


title: Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study

summary: This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.

lead_sponsor: Bristol-Myers Squibb


title: Emotional Reactions of Mothers Facing Premature Births

acronym: mother's traum

summary:
Our intervention in the maternity and neonatal wards helped our sensibility to the immediate parental reaction to the premature birth. Among these reactions, what is called "stress" by the parents occurs most often and is at the origin of trauma. The investigators can cite the unexpected confrontation with a baby is far from corresponding to what the parents had anticipated; the stunned feeling while experiencing a chain of events rapidly taking place, an experience of emptiness when the baby is placed in the intensive care unit, the feeling of powerlessness when facing the real risk of the infant's death, the striking spectacle of invasive treatments, etc. The parents worry about the viability and future of their premature infant. Their parental impressions and more specifically those of the mother facing the premature birth could in and of themselves have repercussions on the development of the infant, by betting on a complex meeting and atypical interactions.

These observations have driven us to elaborate on a hypothesis that finds itself separate from the lesion model commonly applied to premature infants, and shifts the psychopathological approach to the post-traumatic reaction of the mother following the premature birth and repositions the question of behavioral disorders of the child in the interaction mother-infant field. The investigators think that the premature birth can bring about in a second phase and notably in the mother, post-traumatic symptoms as described in the post-traumatic stress state, and that this reaction could have effects on the mother-infant interactions. The investigators have carried out the current study to clarify the relationship between the mother's post-traumatic reaction triggered by the premature birth and the mother-infant interactions.


title: Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation

acronym: Ventiphono

summary: Ventilation is a major treatment of respiratory failure due to neuromuscular disorders. First line treatment is noninvasive ventilation (NIV) but in some situations, especially in case of NIV inefficiency, invasive ventilation with tracheostomy (IVT) may be required. In both situations, patients may become dependent on ventilatory support with the disease evolution. Ventilation then can interfere speech and the quality of communication of the patients. Modification of the ventilation parameters may result in improved speech quality (for example, positive expiratory pressure (PEP) while not necessary for ventilation quality can dramatically improve speech in tracheostomized patients). Therefore, it would be of interest to allow patients to benefit from these specific parameters when they need to speak without maintaining them when patients are not speaking. We want to evaluate a specific ventilator feature which can detect speech and switch to specific ventilation parameters adapted for speech We believe that this feature will improve significantly speech quality in patients dependant either on NIV or IVT.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)

acronym: ORFALU

summary: The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans

acronym: OHTICKS

summary:
Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic animals in Europe, and currently, the incidence of tick-borne disease is rising. The most common European human tick-borne disease is Lyme borreliosis, with an estimated 90 000 new cases every year (compared to 300 000 new cases in the United States annually). This disease is initially clinically diagnosed by the presence of migrating erythema following a tick bite, which is then subsequently confirmed by serological tests. In parallel with classic Lyme borreliosis cases, tick-bitten patients can also present with polymorphic and on-specific clinical symptoms (asthenia, fever, myalgia, etc. …) for which there is no known etiological diagnosis. It is extremely difficult to determine the proportion of tick-bitten patients with these symptoms compared to patients which have actually contracted Lyme disease, although it is estimated that 50% of fevers following a tick bite have an unknown infectious origin.

Typical tick habitats are woodlands, prairies, pastures, and gardens. Ticks are extremely sensitive to environmental fluctuations, which are often brought about by human socio-economic changes, thus tick-borne diseases are excellent candidates for emergence. Consequently, it is incontestable that tickborne diseases pose a significant threat to our society. In addition to improving diagnostic techniques, one of the major hurdles relates to improving public and health professional knowledge about tick disease risk. The battle against tick-borne diseases is based on relatively simple prevention measures, and their effectiveness is immeasurably improved when citizens are more informed and involved.Therefore, a multidisciplinary project, bringing together veterinarians, doctors, scientists, and consultant sociologists has been designed to create a global "One Health" approach to tick-borne diseases. Specific scientific project objectives are to (1) detect, identify, and isolate new microorganisms-both unknown or unexpected-from patients or animals suffering from unexplainable symptoms following tick bites; (2) to demonstrate tick competence in their ability to transmit these agents; and (3) to generate concrete recommendations to improve tick-borne disease management.

lead_sponsor: Institut Pasteur


title: Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.

acronym: OFraDDom

summary:
In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional Supplement (ONS) recommended in case of malnutrition once daily during the study period.

Three visits will be planned for each patient enrolled in the study (baseline visit, visits of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one month or three months according to the duration of supplementation.

The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by the patient of the physician's prescription) at the end of the first month.

Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly population, are very limited. The study could complete knowledge about oral nutritional supplementation in the undernourished frail elderly people and help to demonstrate that oral nutritional supplements have benefits on nutritional status and physical performances in frail elderly people.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Dietary Supplement


title: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep

acronym: VISA

summary:
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.

lead_sponsor: Poitiers University Hospital


title: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice

acronym: Cuff-Bercy

summary:
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

ReferenceCitation: Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.

family: Karsenti

full_name: David Karsenti

given: David

family: Tharsis

full_name: Gaelle Tharsis

given: Gaelle

family: Perrot

full_name: Bastien Perrot

given: Bastien

family: Cattan

full_name: Philippe Cattan

given: Philippe

family: Tordjman

full_name: Gilles Tordjman

given: Gilles

family: Venezia

full_name: Franck Venezia

given: Franck

family: Zrihen

full_name: Elie Zrihen

given: Elie

family: Gillot

full_name: Dominique Gillot

given: Dominique

family: Gillet

full_name: Agnes Gillet

given: Agnes

family: Hagege

full_name: Charles Hagege

given: Charles

family: Samama

full_name: Joelle Samama

given: Joelle

family: Etienney

full_name: Isabelle Etienney

given: Isabelle

family: Lab

full_name: Jean-Philippe Lab

given: Jean-Philippe

family: Guigui

full_name: Bernard Guigui

given: Bernard

family: Zago

full_name: Jacqueline Zago

given: Jacqueline

family: Benkessou

full_name: Bouchra Benkessou

given: Bouchra

family: Burtin

full_name: Pascal Burtin

given: Pascal

family: Cavicchi

full_name: Maryan Cavicchi

given: Maryan

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Société Française d'Endoscopie Digestive


title: Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors Carcinoid Heart Disease (CHD): An Observational French Multi-Centre Cohort Study CRUSOE - NETs (CaRdiac UltraSonic OutcomEs - NETs)

acronym: CRUSOE-NETs

summary:
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.

This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.

status: Not yet recruiting

location_facility: Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon


title: Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients

acronym: COCON

summary:
This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.

The effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.


title: Diurnal Variations of Cerebral Metabolite Concentrations in Proton Magnetic Resonance Spectroscopy

summary:
Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. However, it is not possible to say if the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy subjects.

Moreover, the investigators also want to investigate the association between choline concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the white matter of the centrum ovale. The results obtained from this objective will allow to obtain reference values of an estimate of the association between Cho concentrations and AF values in healthy subjects. These data are intended to improve the diagnostic and therapeutic management of patients with neurological pathologies.


title: Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.

acronym: CHA

summary: The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.

ipd_sharing_description: no plan

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Comparison of Image Quality Between New Collimator LEHRS (General Electric - GE Healthcare) vs Siemens LEHR on Bone Scintigraphy

acronym: LEHRS

summary: Comparison of quality image with a new LEHRS GE collimator vs standard LEHR Siemens collimator on bone scintigraphy.

ReferenceCitation: Gilland DR, Welch BL, Lee S, Kross B, Weisenberger AG. Evaluation of a novel collimator for molecular breast tomosynthesis. Med Phys. 2017 Nov;44(11):5740-5748. doi: 10.1002/mp.12564. Epub 2017 Oct 13.

ReferenceCitation: Songy B, Lussato D, Guernou M, Queneau M, Geronazzo R. Comparison of myocardial perfusion imaging using thallium-201 between a new cadmium-zinc-telluride cardiac camera and a conventional SPECT camera. Clin Nucl Med. 2011 Sep;36(9):776-80. doi: 10.1097/RLU.0b013e31821a294e.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders

acronym: CONNECT

summary: Severe mental illnesses have a significant social cost, as much by their impact on the sick as on their entourage. The Deinstitutionalization and care in the community of patients with severe mental illness result in increased families and loved ones (also known as "informal caregivers" or "informal caregivers") If psychoeducation programs have been developed to help caregivers better manage and cope with the illness of the person being helped (optimize the quality of care, manage anxiety and isolation, these initiatives appear minimal in view of the magnitude of the burden (notion of burden: "burden") and the suffering of caregivers. Quality of life levels remain extremely low compared to the general population, nearly 4 out of 10 caregivers show a sense of inability to cope with the "permanent anxiety" of this load, 1/3 feels depressed and over 1/10 feels isolated on a personal and professional level


title: Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.

acronym: AwARD

summary: The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Multimodal MRI Study of Accumbofrontal Tract in Anorexia Nervosa and Obessional Compulsive Disorder : Search for Structural and Functional Changes Between Orbito-frontal Cortex and Accumbens Nucleus Subdivisions

acronym: ACCUMBENS

summary: Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have structural and functional changes in the accumbofrontal tract. The main objective of this study will be to compare the structure and the connectivity of this tract in MRI with diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of anorexic patients, patients with OCD and healthy patients. The role of the accumbo-frontal tract in the cortico-striato-hypothalamo-cortical circuit seems to be established. DTI tractography will allow the measurement of functional anisotropy (FA), a parameter that evaluates the diffusion of water molecules along the white matter fibers, and therefore the potential alteration of the studied tract. Resting state sequences will allow to estimate the BOLD signal and the functionality of the tract.


title: Soluble CD146 and Proteinuria in Chronic Renal Disease

acronym: CPinMRC

summary:
Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as cardiovascular risk factors in both diabetic and non-diabetic populations, independently of GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146 (CD146) is an endothelial adhesion molecule with preferential localization in the junction. Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to assay. The increase in CD146 levels was described during the MRC, especially in diabetic patients with significant proteinuria. In two independent cohorts of patients with CDR, CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria.

The aim of our study is to determine whether the blood concentration of CD146s is correlated with proteinuria independently of GFR. For this purpose, we propose this study in the kidney nephrology and transplantation center of Conception Hospital, with the objective of highlighting the link between proteinuria and serum CD146 levels in patients with CKD, whatever their renal function and / or underlying pathology. 205 patients will be included over two years with dosing of CD146s and proteinuria at the same time. These 205 patients will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker predicting the risk of renal function impairment or cardiovascular risk independent of renal function.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Predictive Factors of Violence in Prison, Retrospective Study in an French Incarcerated Male Population

summary:
Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.

That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.

lead_sponsor: University Hospital, Montpellier


title: Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin

acronym: SALTORL

summary: This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility: Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan


title: Evaluation of the Use of an Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity After a Stay for Effort Retraining in Rehabilitation and Recuperative Care Facilities for Oncology Patients

summary: The purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (VELIS)

ReferenceCitation: Phillips SM, Alfano CM, Perna FM, Glasgow RE. Accelerating translation of physical activity and cancer survivorship research into practice: recommendations for a more integrated and collaborative approach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):687-99. doi: 10.1158/1055-9965.EPI-13-1355. Epub 2014 Mar 5.

ReferenceCitation: Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. Epub 2007 Aug 1.

ReferenceCitation: Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. Review.

ReferenceCitation: Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Ávila JM, Aranceta-Batrina J, Gil Á, Ortega RM, Serra-Majem L, Varela-Moreiras G, González-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.

ReferenceCitation: Pavey TG, Anokye N, Taylor AH, Trueman P, Moxham T, Fox KR, Hillsdon M, Green C, Campbell JL, Foster C, Mutrie N, Searle J, Taylor RS. The clinical effectiveness and cost-effectiveness of exercise referral schemes: a systematic review and economic evaluation. Health Technol Assess. 2011 Dec;15(44):i-xii, 1-254. doi: 10.3310/hta15440. Review.

ReferenceCitation: Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.

ReferenceCitation: Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.

ReferenceCitation: Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.

ReferenceCitation: Simons M, Van Es E, Hendriksen I. Electrically assisted cycling: a new mode for meeting physical activity guidelines? Med Sci Sports Exerc. 2009 Nov;41(11):2097-102. doi: 10.1249/MSS.0b013e3181a6aaa4.

ReferenceCitation: Falzon C, Sabiston C, Bergamaschi A, Corrion K, Chalabaev A, D'Arripe-Longueville F. Development and validation of the Cancer Exercise Stereotypes Scale. J Psychosoc Oncol. 2014;32(6):708-26. doi: 10.1080/07347332.2014.955237.

ReferenceCitation: Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.

lead_sponsor: Fondation Audavie


title: Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma

acronym: PharmacoCHC

summary:
To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription.

Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug.

Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.

Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.

This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.

lead_sponsor: University Hospital, Caen


title: Evaluation of Calcinosis Prevalence in Systemic Sclerosis : a Cross Sectional Study Evaluating Calcinosis Cutis Prevalence by Hand and Feet Radiographic Assessment in Systemic Sclerosis Patients and Study Their Correlation With Organ Injury

acronym: CALCIDERMIS

summary: Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.

lead_sponsor: University Hospital, Lille


title: Role of Senescence in the Development of Endometrial Cancer

summary:
Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).

A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

lead_sponsor: CHU de Reims

intervention_type: Genetic


title: Evaluation of Metamemory in Patients With Schizophrenia

summary:
The purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a generation strategy. 4 groups will be necessary to comparison:

Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 59.5 years) Aged controls (≥ 59.5 years)

The effects of age and the disease could lead to interaction in regulating metamemory. The effect of age would be aggravated by the disease.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.

summary: The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.


title: Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients

acronym: ACQUAVIP

summary: Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.

acronym: MUCO-OS

summary:
The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.

Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.

Finally the action of CFTR modulators on these bone cells will be tested.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Iron Metabolism After Out of Hospital Cardiac Arrest

acronym: DESFER

summary: Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease

acronym: CORANAE

summary: Recommendations for cardiovascular rehabilitation (CVR) encourage exercise training, primarily involving the aerobic system, to allow patients to regain independence in daily activities. However, the lactic anaerobic process is also involved during these activities (stair climbing, carrying loads, etc.). Hence there is a major interest in accurately assessing patients' anaerobic capacities in order to tailor suitable exercise programs. However, there are no functional tests specifically dedicated to the evaluation of lactic anaerobic metabolism and adapted to people with coronary disease. The investigators offer a dedicated test, the short and fast test (SFST), which can be applied in current clinical practice and has already been evaluated in a population of healthy subjects. The purpose of this project is to evaluate the safety, feasibility and validity of SFST in a population of patients with coronary artery disease.