title: PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

acronym: EOS-SPINE

summary:
The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001).

The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.

However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population.

So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

ReferenceCitation: Borenstein D. Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17.

ReferenceCitation: Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

ReferenceCitation: Cats-Baril WL, Frymoyer JW. Identifying patients at risk of becoming disabled because of low-back pain. The Vermont Rehabilitation Engineering Center predictive model. Spine (Phila Pa 1976). 1991 Jun;16(6):605-7. doi: 10.1097/00007632-199106000-00001.

ReferenceCitation: Dubousset J, Charpak G, Dorion I, Skalli W, Lavaste F, Deguise J, Kalifa G, Ferey S. [A new 2D and 3D imaging approach to musculoskeletal physiology and pathology with low-dose radiation and the standing position: the EOS system]. Bull Acad Natl Med. 2005 Feb;189(2):287-97; discussion 297-300. French.

ReferenceCitation: Kalifa G, Charpak Y, Maccia C, Fery-Lemonnier E, Bloch J, Boussard JM, Attal M, Dubousset J, Adamsbaum C. Evaluation of a new low-dose digital x-ray device: first dosimetric and clinical results in children. Pediatr Radiol. 1998 Jul;28(7):557-61. doi: 10.1007/s002470050413.

ReferenceCitation: Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.

ReferenceCitation: Geijer H, Verdonck B, Beckman KW, Andersson T, Persliden J. Digital radiography of scoliosis with a scanning method: radiation dose optimization. Eur Radiol. 2003 Mar;13(3):543-51. doi: 10.1007/s00330-002-1476-1. Epub 2002 Jun 14.

ReferenceCitation: Glassman S, Gornet MF, Branch C, Polly D Jr, Peloza J, Schwender JD, Carreon L. MOS short form 36 and Oswestry Disability Index outcomes in lumbar fusion: a multicenter experience. Spine J. 2006 Jan-Feb;6(1):21-6. doi: 10.1016/j.spinee.2005.09.004.

ReferenceCitation: Hansen J, Jurik AG, Fiirgaard B, Egund N. Optimisation of scoliosis examinations in children. Pediatr Radiol. 2003 Nov;33(11):752-65. doi: 10.1007/s00247-003-1015-5. Epub 2003 Sep 5.

ReferenceCitation: Legaye J, Duval-Beaupere G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103. doi: 10.1007/s005860050038.

ReferenceCitation: Pellise F, Hernandez A, Vidal X, Minguell J, Martinez C, Villanueva C. Radiologic assessment of all unfused lumbar segments 7.5 years after instrumented posterior spinal fusion. Spine (Phila Pa 1976). 2007 Mar 1;32(5):574-9. doi: 10.1097/01.brs.0000256875.17765.e6.

ReferenceCitation: Rossignol M, Suissa S, Abenhaim L. Working disability due to occupational back pain: three-year follow-up of 2,300 compensated workers in Quebec. J Occup Med. 1988 Jun;30(6):502-5.

ReferenceCitation: Roussouly P, Berthonnaud E, Dimnet J. [Geometrical and mechanical analysis of lumbar lordosis in an asymptomatic population: proposed classification]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):632-9. French.

ReferenceCitation: Spengler DM, Bigos SJ, Martin NA, Zeh J, Fisher L, Nachemson A. Back injuries in industry: a retrospective study. I. Overview and cost analysis. Spine (Phila Pa 1976). 1986 Apr;11(3):241-5. doi: 10.1097/00007632-198604000-00010.

ReferenceCitation: Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976). 1987 Sep;12(7 Suppl):S1-59. No abstract available.

ReferenceCitation: Tournier C, Aunoble S, Le Huec JC, Lemaire JP, Tropiano P, Lafage V, Skalli W. Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. Eur Spine J. 2007 Mar;16(3):411-21. doi: 10.1007/s00586-006-0208-7. Epub 2006 Sep 8.


title: Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study

acronym: VVC

summary:
It is an observational, prospective, monocentric study. The purpose of the study is to assess the acute complications rate caused by a central venous catheter placement.

All the patients who require a central venous placement could be enrolled in the study.

The study will not change the usual practice. The placement will be on day 1 and patients will be contacted by phone on day 7 to identify potential complications and to assess pain.

Anaesthesia staff will keep patients under surveillance to control the absence of late complications.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Gambotti L, Perol D, Frering B, Kaemmerlen P, Coronel B, Sebban H, Bulso V, Bachelot V, Chauvin F, Bachmann P. Safety of percutaneous internal jugular catheterization in cancer patients: prospective observational study. J Vasc Access. 2004 Oct-Dec;5(4):161-7. doi: 10.1177/112972980400500405.

ReferenceCitation: Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.

ReferenceCitation: Burns KE, McLaren A. Catheter-related right atrial thrombus and pulmonary embolism: a case report and systematic review of the literature. Can Respir J. 2009 Sep-Oct;16(5):163-5. doi: 10.1155/2009/751507.

ReferenceCitation: Kim HJ, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Park HS, Hong DS. Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study. J Korean Med Sci. 2010 Dec;25(12):1748-53. doi: 10.3346/jkms.2010.25.12.1748. Epub 2010 Nov 24.

ReferenceCitation: Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.

ReferenceCitation: Yacopetti N, Alexandrou E, Spencer TR, Frost SA, Davidson PM, O'Sullivan G, Hillman KM. Central venous catheter insertion by a clinical nurse consultant or anaesthetic medical staff: a single-centre observational study. Crit Care Resusc. 2010 Jun;12(2):90-5.

lead_sponsor: Centre Leon Berard

lead_sponsor_type: academique

status_simplified: Completed


title: Posttraumatic Stress Disorder (PTSD) Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity: A Cognitive and Neuroanatomical Markers Study Using fMRI,(DTI) and(ASL)

acronym: COPTSD

summary: The goal of this study is to identify the early modifications in fronto-temporal connectivity in female victims who developed PTSD, compared to female victims who did not develop the disorder, and to healthy control females. The investigators will compare between all these groups, structural and functional differences using different techniques (MRI, fMRI, DTI and ASL), and paradigms (cognitive tasks or at rest).

lead_sponsor: University Hospital, Tours

location_facility: Bretonneau Regional Universitary Hospital

intervention_type: Procedure


type: EudraCT Number

title: Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

summary: The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Drug


type: Other Identifier

title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery

summary: Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Vigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23.

lead_sponsor: Tenon Hospital, Paris


title: Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients

summary: The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.

status: Withdrawn

study_completion_date_type: Anticipated

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device

status_simplified: Unknown


title: Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study

acronym: PROSPER

summary: In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Association de Recherche Experimentale et Clinique en Chirurgie Digestive

intervention_type: Behavioral

lead_sponsor_type: industriel


title: Comparison of Dosimetry Following Preparation With Either rhTSH or After Withdrawal of Thyroid Hormone Suppression Therapy in Patients With Metastatic or Locally Advanced Differentiated Thyroid Cancer

acronym: DOSIMETA

summary: Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.

status: Terminated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study

summary: The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.

ReferenceCitation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology


title: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

acronym: OSTEOPATHIE

summary:
This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

ReferenceCitation: Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.

ReferenceCitation: Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.

ReferenceCitation: Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

ReferenceCitation: Labreze L, Dixmerias-Iskandar F, Monnin D, Bussieres E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. French.

ReferenceCitation: Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.

ReferenceCitation: Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.

ReferenceCitation: Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.

ReferenceCitation: Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. doi: 10.7556/jaoa.1996.96.2.113.

ReferenceCitation: Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. doi: 10.5694/j.1326-5377.2002.tb04459.x.

ReferenceCitation: Licht PB, Christensen HW, Hoilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52. doi: 10.1067/mmt.2003.42.

ReferenceCitation: Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. doi: 10.1136/bmj.319.7218.1176. No abstract available.

ReferenceCitation: Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.

ReferenceCitation: Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.

intervention_type: Other


title: Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo

summary:
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).

The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.

lead_sponsor: Pierre Fabre Medicament


title: Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

acronym: DYSEXTRIOSE

summary: The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.


title: Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses

summary: The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.


title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial

acronym: STOB-ACTIV

summary: This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.

ReferenceCitation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

oa_host_type: repository

repository_institution: Coventry University - Pure

repository_normalized: Pure (Denmark)

evidence: oa repository (via OAI-PMH title and last author match)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories:
PubMed Central
Pure (Denmark)
ora.ox.ac.uk

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Bernard P, Ninot G, Cyprien F, Courtet P, Guillaume S, Georgescu V, Picot MC, Taylor A, Quantin X. Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial. J Dual Diagn. 2015;11(3-4):205-16. doi: 10.1080/15504263.2015.1113842.

publisher_dissemination: Informa

lead_sponsor: University Hospital, Montpellier


title: Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis

acronym: Cardioplégie

summary:
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators:
Jazz Pharmaceuticals
Association AIRE (FR)


title: Sleep Apnea in Early to Mid-Stage Alzheimer's Disease: What Impact of Treatment on the Cognitive Functions of Elderly Patients With Memory Loss?

acronym: AZAP

summary:
Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher in patients with dementia such as Alzheimer patients.

Several trials in elderly patients showed modified cognitive functions, particularly executive and attentional functions, in patients with respiratory sleep disorder. However the benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients is still controversial, as there are few studies documenting its effects on dementia patients' cognitive abilities, and clinicians appear reluctant to prescribe this type of treatment.

The investigators must keep in mind that Alzheimer patients suffer significant sleep disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part of the day. In dementia patients, sleep disorder is a major cause of hospitalization and institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any impact on cognitive abilities has yet to be demonstrated.

In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias, and strokes are strongly correlated to OSA. In light of its consequences on morbidity and mortality, OSA should be considered a public health issue.

In this context, the investigators wish to address the impact of CPAP treatment implementation on the cognitive parameters of patients diagnosed with OSA, particularly on their executive functions. This should provide evidence for mid-term assessment of the benefits of CPAP in caring for elderly patients with dementia.

In light of the prevalence of obstructive sleep pathologies in elderly patients reported in various studies and of the potential impact of CPAP treatment on cognitive abilities, the investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer patients' cognitive abilities, particularly on their executive functions.

Executive functions are a rather heterogenous group of high-level cognitive processes which enable individuals to adopt a flexible, context-appropriate behavior. They also include planning abilities, working memory, cognitive control, abstract thought, rule learning, selective attention, motor response selection, etc... Executive functions are mainly associated to the functioning of the brain's frontal lobes, although subcortical structures also play a role. When the executive functions are affected by disease, daily life is significantly impeded as the individual becomes unable to perform complex tasks or regulate his/her behavior. Many tests can help evaluate these functions in dementia patients. A number of "ecological" tests, such as the zoo map test from the Behavioural Assessment of the Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive functions.

This project aims to improve the daily life of Alzheimer patients with sleep apnea by improving their executive cognitive functions through CPAP treatment.

According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire department. [27] The study population will therefore be recruited in the "La Charité" center of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from cognitive disorders similar to Alzheimer's disease.

OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will receive CPAP treatment for 4 months, which is the minimum duration required to implement and accept treatment, and to measure its impact on patients' neurocognitive abilities.

ipd_sharing: No

collaborators: Association Lyonnaise de Logistique Posthospitalière

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)

acronym: HER-ception

summary:
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.

The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.

design_allocation: Non-Randomized

lead_sponsor: Centre Francois Baclesse


title: An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up, Followed by a Prolonged Follow up)

acronym: HARMONYIII

summary: This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

lead_sponsor: Bioprojet


title: A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects

summary: This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

lead_sponsor: Hoffmann-La Roche


title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

summary: This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.


title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

summary: Ultra-sound study to assess changes in intragastric volume after bowel preparation.

primary_purpose: Basic Science

ReferenceCitation: Coriat R, Polin V, Oudjit A, Henri F, Dhooge M, Leblanc S, Delchambre C, Esch A, Tabouret T, Barret M, Prat F, Chaussade S. Gastric emptying evaluation by ultrasound prior colonoscopy: an easy tool following bowel preparation. World J Gastroenterol. 2014 Oct 7;20(37):13591-8. doi: 10.3748/wjg.v20.i37.13591.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

publisher_dissemination: Baishideng Publishing Group Inc.

lead_sponsor: Laboratoires Mayoly Spindler


lead_sponsor: University Hospital, Clermont-Ferrand

summary:
Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.

The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.

ReferenceCitation: Moustafa F, Nguyen G, Mathevon T, Baud O, Saint-Denis J, Dublanchet N, Pereira B, Shinjo C, Romaszko JP, Dopeux L, Dutheil F, Schmidt J. Evaluation of the efficacy and tolerance of a short 7 day third-generation cephalosporin treatment in the management of acute pyelonephritis in young women in the emergency department. J Antimicrob Chemother. 2016 Jun;71(6):1660-4. doi: 10.1093/jac/dkw021. Epub 2016 Feb 21.

oa_host_type: publisher

publisher_dissemination: Oxford University Press

title: Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old

source: euctr


type: Registry Identifier

title: Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed.

Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.

primary_purpose: Diagnostic

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Centre Jean Perrin


title: Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain

acronym: EPICORE

summary: Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.

study_start_date_type: Actual


title: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

summary: RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

lead_sponsor: University Hospital, Angers

sponsor_collaborators:
University Hospital, Angers
Fédération Française de Cardiologie
Société Française de Cardiologie


title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

acronym: RIP-Valve

summary: RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

ReferenceCitation: Chao de la Barca JM, Bakhta O, Kalakech H, Simard G, Tamareille S, Catros V, Callebert J, Gadras C, Tessier L, Reynier P, Prunier F, Mirebeau-Prunier D. Metabolic Signature of Remote Ischemic Preconditioning Involving a Cocktail of Amino Acids and Biogenic Amines. J Am Heart Assoc. 2016 Sep 24;5(9):e003891. doi: 10.1161/JAHA.116.003891.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health


title: Validation of the French Version of the Back Belief Questionnaire

acronym: BBQ

summary: The goal of this study is to carry out a transcultural validation of the Back Belief Questionnaire in order to assess its appropriateness for French-speaking populations.


title: Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive

summary:
Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. The investigators suppose that microcirculatory failure develops and results in suffering of non major organs like muscle, skin and digestive tracts. In this study the investigators monitor digestive tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and plasma glycocalyx measurements. The population is composed by patients having coronary artery bypass during cardiopulmonary bypass.

The first aim of this study is to show that digestive tract is suffering with the use of extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will be less than 20 micromol/L.

The second aim is to investigate link between endothelial dysfunction and digestive tract. Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve, resaturation curve and hyperemic response by measurement of area under curve). Endothelial glycocalyx and NO pathway will be investigate (see under)

Our objective is to enroll 100 patients. The same study will be done in a group of patients who benefit from coronary artery bypass without extracorporeal circulation to see the effects of extracorporeal circulation support.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)

summary: This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.


title: Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant

summary:
The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.

Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.

ReferenceType: result

ReferenceCitation: Tron C, Woillard JB, Houssel-Debry P, David V, Jezequel C, Rayar M, Balakirouchenane D, Blanchet B, Debord J, Petitcollin A, Roussel M, Verdier MC, Bellissant E, Lemaitre F. Pharmacogenetic-Whole blood and intracellular pharmacokinetic-Pharmacodynamic (PG-PK2-PD) relationship of tacrolimus in liver transplant recipients. PLoS One. 2020 Mar 12;15(3):e0230195. doi: 10.1371/journal.pone.0230195. eCollection 2020.

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories:
HAL
PubMed Central
figshare.com

repositories_concat: HAL;PubMed Central;figshare.com

publisher_dissemination: Public Library of Science

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies du Foie - Hôpital de Pontchaillou


title: Comparison of Two Strategies of Hypoglycemia Correction in ICU

summary: Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.

study_start_date_type: Anticipated

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Evaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled Trial

acronym: ADJUVITE

summary: The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.

ReferenceCitation: Simonini G, Taddio A, Cattalini M, Caputo R, De Libero C, Naviglio S, Bresci C, Lorusso M, Lepore L, Cimaz R. Prevention of flare recurrences in childhood-refractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab. Arthritis Care Res (Hoboken). 2011 Apr;63(4):612-8. doi: 10.1002/acr.20404.

ReferenceCitation: Callejas-Rubio JL, Sanchez-Cano D, Serrano JL, Ortego-Centeno N. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008 Dec;24(6):613-4; author reply 614. doi: 10.1089/jop.2008.0073. No abstract available.

ReferenceCitation: Tynjala P, Kotaniemi K, Lindahl P, Latva K, Aalto K, Honkanen V, Lahdenne P. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford). 2008 Mar;47(3):339-44. doi: 10.1093/rheumatology/kem356. Epub 2008 Jan 31.

ReferenceCitation: Biester S, Deuter C, Michels H, Haefner R, Kuemmerle-Deschner J, Doycheva D, Zierhut M. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):319-24. doi: 10.1136/bjo.2006.103721. Epub 2006 Oct 11.

ReferenceCitation: Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.

ReferenceCitation: Quartier P, Baptiste A, Despert V, Allain-Launay E, Kone-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136/annrheumdis-2017-212089. Epub 2017 Dec 23.

publisher_dissemination: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Abbott


title: Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin

acronym: IMAGINE

summary: Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation and the treatment of venous thromboembolism. It is administered with fixed dose and does not require laboratory monitoring because of the low inter and intra individual pharmacokinetic (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic polymorphism. The inhibition of this protein can cause a significant increase in intestinal absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major drug interactions have been identified : quinidine (cons-indication) and amiodarone (precautions). It is likely that other interactions exist and can be clinically significant in patients not selected such as testing. The development of tools to study the influence of P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic polymorphism, the study of the latter is an important element in the detection of drug interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to evaluate the primary mechanism of drug interaction of dabigatran and optimize the experimental design of studies to be conducted.


title: Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist

acronym: IDILIC

summary: This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.

ReferenceCitation: Sens F, Viprey M, Piriou V, Peix JL, Herquelot E, Occelli P, Bourdy S, Gawande AA, Carty Mj MJ, Michel P, Lifante JC, Colin C, Duclos A; IDILIC Study Group. Safety Attitude of Operating Room Personnel Associated With Accurate Completion of a Surgical Checklist: A Cross-sectional Observational Study. J Patient Saf. 2022 Aug 1;18(5):449-456. doi: 10.1097/PTS.0000000000000954. Epub 2021 Dec 17.

ReferenceCitation: Duclos A, Peix JL, Piriou V, Occelli P, Denis A, Bourdy S, Carty MJ, Gawande AA, Debouck F, Vacca C, Lifante JC, Colin C; IDILIC Study Group. Cluster randomized trial to evaluate the impact of team training on surgical outcomes. Br J Surg. 2016 Dec;103(13):1804-1814. doi: 10.1002/bjs.10295. Epub 2016 Sep 19.

lead_sponsor: Hospices Civils de Lyon


title: Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy

summary:
Cognitive and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. These symptoms are noticed before the diagnostic of dementia, their prevalence and their intensity increase with the evolution of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of cognition and behaviour to "go in goal". Assessment of psychological and behavioural symptoms is realised principally with neuropsychiatric scales. These contribute to obtain particular informations about health of patient allowing by patient and caregiver discussions and impressions of clinician. These scales are simples but loss of subjectivity. An alternative of this method is the use of gerontechnology as actigraphy (system out-patient which records locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video recording which is associated to an informatic treatment of signal in order event recognition.

The aim of study is to realise an objective assessment of activities "go in goal" during experimental sequence which has well-characterized acts, using at the same time an actigraphic record of activity "motive" (system of assessment indirect of apathy fit) and a video records which uses an informatic event recognition system. The assessment will realise with participants controls (n=30) and Alzheimer disease patients with (n=20) or without (n=20) apathy, during well-characterized records. The final aim is to obtain a particular assessment of some disorders behaviours, as apathy, which is principally characterize by a decrease of behaviours "to go in goal".

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

acronym: IBISD

summary: The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.

lead_sponsor: Genethon

sponsor_collaborators:
Genethon
Institute of Myology


title: Early Prediction of Chronic Allograft Nephropathy by Non Invasive Monitoring of Urinary Cell mRNAs

acronym: Prefigur

summary:
The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in early protocol biopsies of the renal allograft predicts the progression of fibrosis during the first year post-transplantation.

The investigators will develop a non-invasive approach for predicting fibrosis as a substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary cells from kidney transplant recipients during the first year post-transplantation.

time_perspective: Other

collaborators:
Fondation Centaure
ROTRF

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation Centaure
ROTRF

intervention_type: Genetic


title: Biological Study of Feasibility Concerning the Research for Mutation of the Gene of EGFR and for K-Ras in Circulating Tumoral Cells(CTCs) of the Patients Carriers of Metastatic Non Small Cells Bronchial Carcinomas

acronym: CTC-Poumon

summary:
The knowledge concerning the biology of the human tumors do not stop widening, in particular concerning the molecular mechanisms at the origin of the process of carcinogenesis and its ability to become perpetual. The identification and the increasing knowledge of these abnormalities allowed during these last years the development of therapeutic strategies targeting specifically the molecular pathways involved in the carcinogenesis. It quickly lead to numerous therapeutic successes in association with conventional chemotherapy, allowing a better individualization of the treatment according to the biological characteristics of the tumor of the patient.

However such therapeutics are effective only if the patients carries specific genomic mutations making necessary the systematic research for one kind of mutation.

The problem is that currently the mutational status is frequently made on the tissue resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the biology of the metastasis reports a different genomic status, the only theoretical solution is then to make biopsy systematically on metastasis, what is not always technically possible. The problem still complicates when the investigators know that the biology of the tumor may evolve in time, particularly under treatment, with appearance of chemotherapy resistant clones. The monitoring of the genomic status of the tumor thus appears to be a crucial stake in the next years in cancer research as far as the efficiency of numerous therapeutic targeted put at the disposal of the clinician, depends on it largely. The repeated access to tumor tissue, during the follow-up of the patient in treatment, seems from then on indispensable to guide prematurely the therapeutics, in particular by stopping a targeted therapeutics which the investigators know that it is not any more going to be effective, and so avoiding exposing the patient to useless toxicity of a treatment often extremely expensive, and of which usage should have to be reserved to patient who could respond to it.

The access to the circulating tumor cells in the blood of patients is a repeatable, not invasive technique (blood test) and henceforth accessible thanks to a technique using a magnetic sorting of the tumor cells selected by an antibody directed against the tumor antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and automated, allows from a total sample of blood of the patient, to determine the quantity of circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a powerful prognosis tool at the moment diagnosis, but also during treatment, according to its decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA) recently approved the use of this system for the quantification of the CTCs in the care of the patients affected by breast, colon, and prostate cancer. The CellSearch system will probably become in the future years an indispensable tool to help the clinicians to encircle better the prognosis of their patient. This technology already allows to realize besides a quantification, the isolation of viable CTCs, from which the genetic material can be extracted, amplified thus potentially analyzed. The investigators thus see all the interest which such a device can represent in the non invasive monitoring of the patients under treatment targeting molecular abnormality susceptible to evolve in time. The investigators thus propose to study thanks to the system CellSearch the feasibility of the research for the mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small cells bronchial carcinoma.

Secondly, the investigators research will be interested in the possible conflicts existing between the primitive tumor and the CTCs for the various popular mutations. In case of feasibility of the method, and the good initial concordance between the genomic status of the CTCs and that of the tumor, the investigators shall describe the genomic evolution under treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators shall describe then if the premature observation of modification precedes the appearance of an effective resistance in treatments.

primary_purpose: Screening

lead_sponsor: Centre Georges Francois Leclerc

sponsor_collaborators:
Centre Georges Francois Leclerc
AstraZeneca

intervention_type: Biological


title: Pulmonary Hypertension: Impact of the Evolution of a Rare Disease on the Quality of Life and Role of Variables Psychosocial as Predictive of the Current and Later Quality of Life

acronym: HyPsy

summary:
The investigators aim to :

describe and analyse psychological characteristics, cognitive factors and representations in patients with Pulmonary Hypertension, a rare disease.
assess the psychological characteristics impact on quality of life, check the association between disease and QoL evolution, and the variability of QoL parameters over severity class changes and follow-up

ReferenceCitation: Halimi L, Suehs CM, Marin G, Boissin C, Gamez AS, Vachier I, Molinari N, Bourdin A. Health-related quality of life and disease progression in pulmonary arterial hypertension patients: a 3-year study. ERJ Open Res. 2021 Aug 23;7(3):00617-2020. doi: 10.1183/23120541.00617-2020. eCollection 2021 Jul.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: European Respiratory Society

ReferenceCitation: Halimi L, Marin G, Molinari N, Gamez AS, Boissin C, Suehs CM, Vachier I, Bourdin A. Impact of psychological factors on the health-related quality of life of patients treated for pulmonary arterial hypertension. J Psychosom Res. 2018 Feb;105:45-51. doi: 10.1016/j.jpsychores.2017.12.003. Epub 2017 Dec 6.

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

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

repositories_concat: HAL

publisher_dissemination: Elsevier

sponsor_collaborators:
University Hospital, Montpellier
GlaxoSmithKline


title: Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array

acronym: CYTOSEP

summary: Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).


title: Early Detection and Diagnostic Performance of Bio-markers During Bacterial Sepsis: Multicentre Cohort Study in Intensive Care

acronym: Captain

summary:
Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes.

Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.

ReferenceCitation: Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.

ReferenceCitation: Adib-Conquy M, Monchi M, Goulenok C, Laurent I, Thuong M, Cavaillon JM, Adrie C. Increased plasma levels of soluble triggering receptor expressed on myeloid cells 1 and procalcitonin after cardiac surgery and cardiac arrest without infection. Shock. 2007 Oct;28(4):406-10. doi: 10.1097/shk.0b013e3180488154.

ReferenceCitation: Cavaillon JM, Adib-Conquy M, Fitting C, Adrie C, Payen D. Cytokine cascade in sepsis. Scand J Infect Dis. 2003;35(9):535-44. doi: 10.1080/00365540310015935.

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.

ReferenceCitation: Monneret G, Lepape A, Voirin N, Bohe J, Venet F, Debard AL, Thizy H, Bienvenu J, Gueyffier F, Vanhems P. Persisting low monocyte human leukocyte antigen-DR expression predicts mortality in septic shock. Intensive Care Med. 2006 Aug;32(8):1175-83. doi: 10.1007/s00134-006-0204-8. Epub 2006 Jun 2.

ReferenceCitation: Munoz C, Carlet J, Fitting C, Misset B, Bleriot JP, Cavaillon JM. Dysregulation of in vitro cytokine production by monocytes during sepsis. J Clin Invest. 1991 Nov;88(5):1747-54. doi: 10.1172/JCI115493.

ReferenceCitation: Misset B, Philippart F, Fitting C, Bedos JP, Diehl JL, Hamzaoui O, Annane D, Journois D, Parlato M, Moucadel V, Cavaillon JM, Coste J; CAPTAIN Study Group. Clustering ICU patients with sepsis based on the patterns of their circulating biomarkers: A secondary analysis of the CAPTAIN prospective multicenter cohort study. PLoS One. 2022 Oct 27;17(10):e0267517. doi: 10.1371/journal.pone.0267517. eCollection 2022.

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv
orbi.ulg.ac.be

repositories_concat: PubMed Central;medRxiv;orbi.ulg.ac.be

lead_sponsor: Fondation Hôpital Saint-Joseph

sponsor_collaborators:
Fondation Hôpital Saint-Joseph
BioMérieux
Institut Pasteur
Assistance Publique - Hôpitaux de Paris


title: Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques

acronym: LCA IRM

summary: The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: A Randomized Phase II Study of PEP02 or Irinotecan in Combination With Leucovorin and 5-Fluorouracil in Second Line Therapy of Metastatic Colorectal Cancer

acronym: PEPCOL

summary:
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride PEP02 together with leucovorin calcium and fluorouracil is more effective than giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well it works compared with giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


title: Screening Project for a Detection of Fabry Disease in Chronic Renal Failure Patients in Area PACA

summary:
Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function properly. As a result, the lipid accumulates in the body, this leads to multisystem impairment, including progressive renal failure.

Several studies have focused on the detection of this disease in end-stage renal failure patients, transplant or hemodialysis.

This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine level greater than 0,5 g/l.

This screening will be conducted by a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper. If this assay was positive, confirmation of diagnosis of Fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase A activity.

This multicenter prospective study, openly contacted in medical practice, with patient follow-up corresponding to the management of renal insufficiency, will be offered to all departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.

The objective of this study is to assess the prevalence of Fabry disease in the target population and to identify previously undiagnosed patients, enabling them to benefit from appropriate management of their disease, including whether need enzyme replacement therapy.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Service de Néphrologie - Hôpital Pasteur


title: Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

summary: The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

ReferenceCitation: Pannier D, Adenis A, Bogart E, Dansin E, Clisant-Delaine S, Decoupigny E, Lesoin A, Amela E, Ducornet S, Meurant JP, Le Deley MC, Penel N. Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial. BMC Cancer. 2018 Jul 31;18(1):775. doi: 10.1186/s12885-018-4678-x.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

lead_sponsor: Centre Oscar Lambret


title: Impact of c242T Polymorphism of p22phox in the Development of Diabetic Nephropathy,in Caucasian Diabetic Type 1 Patient.

acronym: NEPHRODIANOX

summary:
The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely.

The aim of the study is to look about the association of the C282T polymorphism of P22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX 12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last polymorphism is correlated to albuminuria in diabetic patients.

lead_sponsor: University Hospital, Grenoble


title: Study Searching for Hypoxemic Sleep Breathing Disorders in a Cohort of Patients With Idiopathic Pulmonary Arterial Hypertension (IPAH) and Chronic Post-embolic Pulmonary Hypertension (CPEPH)

summary: In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.

ReferenceCitation: Jilwan FN, Escourrou P, Garcia G, Jais X, Humbert M, Roisman G. High occurrence of hypoxemic sleep respiratory disorders in precapillary pulmonary hypertension and mechanisms. Chest. 2013 Jan;143(1):47-55. doi: 10.1378/chest.11-3124.

location_facility: Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital


title: Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the Unit for Prevention, Monitoring and Analysis of Aging (UPSAV).

acronym: GEROPASS

summary:
Background :

The evolving concept of frailty was born in the United States under the term of " frail elderly ". It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. It is about an effective concept, especially in the field of the prevention where it determines strategies of specific care. The ageing, changing according to individuals, is characterized by a decrease of the physiological reserves leading to a precarious balance and to a destabilization.

Epidemiological studies show a very uneven distribution of three categories of old persons according to their health status. Every year, approximately, 12 % of the independent population of 75 years of age and older and living at home, lose their autonomy for one of the activities of the daily life and turn into frailty.

Identifying frailty of old subjects is interesting in order to apply preventive and specific care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA) is the gold standard to detect frailty in this population. The beneficial effects of the GGA during the hospitalization have been recognized in international literature.

The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a difficult approach for the nurses or family practioners in taking care of old persons at home.

To balance these difficulties and to optimize prevention of dependence in the elderly, an experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University of Limoges. It is an innovative organizational structure because, for the first time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA to detect the risks of loss of autonomy and to propose a coordination of preventive actions.

Purpose :

UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This action is led in partnership with all the professionals working around old persons.

The randomized study endpoint is to evaluate elderly from 75 years of age and older at home and to select two homogeneous groups: "reference" and " specific intervention ".

lead_sponsor: University Hospital, Limoges

location_facility: Pôle Personnes âgées et soins à domicile - Limoges UH


title: PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY

summary:
In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial.

Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day).

The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping).

The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors.

Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points.

In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.

lead_sponsor: L'Oreal

sponsor_collaborators:
L'Oreal
Société des Produits Nestlé (SPN)

intervention_type: Dietary Supplement


title: A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers

summary: This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.

lead_sponsor: Hoffmann-La Roche


title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS

summary: This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.


title: Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit

acronym: FAMILLE

summary:
Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses.

Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality.

In the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on Anxiety developed by relatives and family of ICU patients.

The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side.

During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". The information process will be as usual in the other unit : "control arm". During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over).

For each included patient, one relative or family member is pointed to be the referring family member or "referent". This "referent" receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the "referent" and the living patient at day 30. The day 30 questionnaires are send by mail at the "referent" address.

ReferenceCitation: Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.

ReferenceCitation: Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34. doi: 10.1097/01.CCM.0000059996.30263.94.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere


title: Effects of an In-Patient Individualized Rehabilitation Program on Severity and Symptoms of Obstructive Sleep Apnea Syndrome (OSAS):Results of a Randomized Controlled Pilot Study

acronym: Rehsolvas

summary:
The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of traffic accidents but also other cognitive disorders with significant impact on quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and other systemic metabolic dysregulation of many whose levels are correlated with the severity of the disease.

Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept and/or poorly tolerated, limiting its effectiveness.

Weight loss and regular physical activity are clearly recommended but rarely done in clinical practice. A few studies have applied to study the effects of rehabilitation training (REE) on the sleep apnea patients and have shown an improvement in sleep quality, reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their methodology was questionable, and the number of patients included was too low.

The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program comprising educational activities, dietary management and individualized exercise training (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL). This IET program (24 sessions during 4 weeks) could also help to improve many metabolic dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk). Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may play a role in enabling a better control of ventilation in these patients.

ReferenceCitation: Desplan M, Mercier J, Sabate M, Ninot G, Prefaut C, Dauvilliers Y. A comprehensive rehabilitation program improves disease severity in patients with obstructive sleep apnea syndrome: a pilot randomized controlled study. Sleep Med. 2014 Aug;15(8):906-12. doi: 10.1016/j.sleep.2013.09.023. Epub 2014 Apr 1.

lead_sponsor: 5 Santé

collaborators: INSERM U1046 Physiologie et médecine expérimentale du cœur et des muscles


title: Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

acronym: RF-DBG

summary: Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

ReferenceCitation: Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.

location_facility: Gastroenterology and Endoscopy department, Cochin Hospital


title: Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study

acronym: HYBERNATUS

summary: Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall morbidity and mortality associated with convulsive SE (CSE) is 60% at three months. The alteration of functional prognosis of these patients is more conventionally attributed to the cause than to CSE itself. Longer seizure duration, progression to refractory status EPILEPTICUS and presence of cerebral insult are strong factors independently associated with a poor functional outcome. These three factors offer may be amenable to improvement and hope for preventive strategies. Current guidelines recommend the use of anticonvulsant treatment whose goal is prompt cessation of clinical and electrical seizures. None of these treatments has demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and 34 ° C) showed interest in neuroprotection of post anoxic coma patients after a cardiovascular arrest on ventricular fibrillation by reducing morbidity and mortality in about 20% without major side effects. This technique has been used successfully in various pathologies such as stroke or traumatic brain injury. Pathophysiological mechanisms involved in epileptogenesis and neurotoxicity induced by persistence of seizures can be blocked by therapeutic hypothermia. Recent work on experimental models of SE demonstrated neuroprotective and anticonvulsant interest of therapeutic hypothermia. Therapeutic hypothermia has also been successfully used in some cases of particularly refractory CSE. Its early use in patients with SE would have a double interest: neuroprotective and anticonvulsant. There is currently no published studies or ongoing to determine the interest of its early use in patients with CSE.

ReferenceCitation: Fontaine C, Lemiale V, Resche-Rigon M, Schenck M, Chelly J, Geeraerts T, Hamdi A, Guitton C, Meziani F, Lefrant JY, Megarbane B, Mentec H, Chaffaut C, Cariou A, Legriel S; HYBERNATUS Study Group. Association of systemic secondary brain insults and outcome in patients with convulsive status epilepticus: A post hoc study of a randomized controlled trial. Neurology. 2020 Nov 3;95(18):e2529-e2541. doi: 10.1212/WNL.0000000000010726. Epub 2020 Sep 10.

ReferenceCitation: Legriel S, Lemiale V, Schenck M, Chelly J, Laurent V, Daviaud F, Srairi M, Hamdi A, Geri G, Rossignol T, Hilly-Ginoux J, Boisrame-Helms J, Louart B, Malissin I, Mongardon N, Planquette B, Thirion M, Merceron S, Canet E, Pico F, Tran-Dinh YR, Bedos JP, Azoulay E, Resche-Rigon M, Cariou A; HYBERNATUS Study Group. Hypothermia for Neuroprotection in Convulsive Status Epilepticus. N Engl J Med. 2016 Dec 22;375(25):2457-2467. doi: 10.1056/NEJMoa1608193.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Legriel S, Pico F, Tran-Dinh YR, Lemiale V, Bedos JP, Resche-Rigon M, Cariou A. Neuroprotective effect of therapeutic hypothermia versus standard care alone after convulsive status epilepticus: protocol of the multicentre randomised controlled trial HYBERNATUS. Ann Intensive Care. 2016 Dec;6(1):54. doi: 10.1186/s13613-016-0159-z. Epub 2016 Jun 21.

location_facility: Hôpital André MIGNOT- Service de réanimation médico-chirurgical


title: Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage

acronym: ABCSAH

summary:
The goal of this observational study is to develop and validate a predictive score of 1-year outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.

Using our database filled up prospectively, the investigators plan to collect clinical, biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score in a validation cohort (from 2008 to 2009).

time_perspective: Retrospective

ReferenceCitation: Degos V, Apfel CC, Sanchez P, Colonne C, Renuit I, Clarencon F, Nouet A, Boch AL, Pourmohamad T, Kim H, Gourraud PA, Young WL, Puybasset L. An admission bioclinical score to predict 1-year outcomes in patients undergoing aneurysm coiling. Stroke. 2012 May;43(5):1253-9. doi: 10.1161/STROKEAHA.111.638197. Epub 2012 Feb 23.

location_facility: Neuro-réanimation Chirurgicale Babinski - Hopital Pitié Salpetriere


title: Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain: a Randomized Double-blind Study

acronym: MEOPA

summary: Less than 10% of patients with a traumatic pain have been managed by a physician before to be admitted in an emergency service. 50 % of those patients have been carried by paramedics. Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.

ReferenceCitation: Ducasse JL, Siksik G, Durand-Bechu M, Couarraze S, Valle B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous oxide for early analgesia in the emergency setting: a randomized, double-blind multicenter prehospital trial. Acad Emerg Med. 2013 Feb;20(2):178-84. doi: 10.1111/acem.12072.

lead_sponsor: University Hospital, Toulouse


title: Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.

acronym: REANURSUF

summary:
Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients.

Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included.

During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.

ReferenceCitation: Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.


title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques

summary: The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

primary_purpose: Supportive Care

lead_sponsor: Lescuyer Laboratory

collaborators: Association Nationale de Prévention Médicale.

location_facility: Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion


title: Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients

acronym: RIT 90YEpra

summary: The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.

ReferenceCitation: Chevallier P, Eugene T, Robillard N, Isnard F, Nicolini F, Escoffre-Barbe M, Huguet F, Hunault M, Marcais A, Gaschet J, Cherel M, Guillaume T, Delaunay J, Peterlin P, Eveillard M, Thomas X, Ifrah N, Lapusan S, Bodet-Milin C, Barbet J, Faivre-Chauvet A, Ferrer L, Bene MC, Le Houerou C, Goldenberg DM, Wegener WA, Kraeber-Bodere F. (90)Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study. Lancet Haematol. 2015 Mar;2(3):e108-17. doi: 10.1016/S2352-3026(15)00020-4. Epub 2015 Feb 25.

lead_sponsor: Nantes University Hospital


title: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

summary: The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.

ReferenceCitation: Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.

sponsor_collaborators:
Lescuyer Laboratory
BioFortis


title: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

summary: The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.

collaborators: CIC Hôpital de la Conception - Marseille


title: Therapeutic Education in Very Young Children With Diabetes Mellitus. Evaluation of the Impact of a Specific Tool for Parents on Glycemic Control and Prevention of Acute Events (Hypoglycemia and Ketosis)

acronym: DIAB-EDUC

summary: DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effects of Ingestion of Different Sports Drinks on Fatigue During Playing Tennis

summary: The main objective of this study is to investigate the effects of ingestion of different sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis tournament simulation.

ReferenceCitation: Brink-Elfegoun T, Ratel S, Lepretre PM, Metz L, Ennequin G, Dore E, Martin V, Bishop D, Aubineau N, Lescuyer JF, Duclos M, Sirvent P, Peltier SL. Effects of sports drinks on the maintenance of physical performance during 3 tennis matches: a randomized controlled study. J Int Soc Sports Nutr. 2014 Sep 2;11:46. doi: 10.1186/s12970-014-0046-7. eCollection 2014.

version: acceptedVersion

repositories:
HAL
PubMed Central
eprints.vu.edu.au

repositories_concat: HAL;PubMed Central;eprints.vu.edu.au

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

collaborators: Service de Médecine du Sport et des Explorations Fonctionnelles - CHU G Montpied - Clermont-Ferrand

collaborators: Université Blaise Pascal, Clermont-Ferrand


title: Dose-effect Relationship of Repeated Administration of Low-dose IL-2 Versus Placebo on the Kinetic of Regulatory T Cells in Patients With Type 1 Diabetes

summary: IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The investigators recently showed that low dose IL-2 is well tolerated in patients with an autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg induction, the investigators aim to protect the remaining/regenerating β-cells from autoimmune destruction, thus improving or even curing T1D.

ReferenceCitation: Hartemann A, Bensimon G, Payan CA, Jacqueminet S, Bourron O, Nicolas N, Fonfrede M, Rosenzwajg M, Bernard C, Klatzmann D. Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):295-305. doi: 10.1016/S2213-8587(13)70113-X. Epub 2013 Oct 8.


title: Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?

acronym: ColoBioParker

summary: The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.


title: A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

summary: This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.

ReferenceCitation: Goschzik T, Schwalbe EC, Hicks D, Smith A, Zur Muehlen A, Figarella-Branger D, Doz F, Rutkowski S, Lannering B, Pietsch T, Clifford SC. Prognostic effect of whole chromosomal aberration signatures in standard-risk, non-WNT/non-SHH medulloblastoma: a retrospective, molecular analysis of the HIT-SIOP PNET 4 trial. Lancet Oncol. 2018 Dec;19(12):1602-1616. doi: 10.1016/S1470-2045(18)30532-1. Epub 2018 Nov 1.

evidence: open (via crossref license)

repository_institution: no - no

repositories_concat: PubMed Central;nrl.northumbria.ac.uk

repositories_institution:
PubMed Central - Europe PMC
no - no

lead_sponsor: Institut Curie

intervention_type: Radiation


title: Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

acronym: Nosten

summary: Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

ReferenceCitation: Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: Springer

lead_sponsor: University Hospital, Lille


title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

summary: Circulating tumor DNA detection and quantification in patients with ovarian cancer.

primary_purpose: Other


title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

acronym: TETRADIA-UNI

summary: This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

lead_sponsor: University Hospital, Rouen


title: Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing Whose Maturation Depends on the Protein HuR, Including Gene Encoding Insulin Receptor

acronym: METFORGENE

summary:
Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète