title: Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study

acronym: EMERALD

summary: Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.

ReferenceCitation: Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27.

lead_sponsor: University Hospital, Grenoble

collaborators: Clinical Investigation Centre for Innovative Technology Network

location_facility: University Hospital Grenoble-Alps (CHU-GA)


title: Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?

acronym: Cinescan

summary:
For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 :

Study of clinically unsuspected injuries discovered on WBCT
Description
Predictive factors
Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes

lead_sponsor_type: academique

status_simplified: Completed


title: "Follow Up-Intergroupe Francophone du Myélome 2009" Database Post IFM/DFCI 2009 Study

summary: Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Toulouse

status_simplified: Unknown


title: Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer

acronym: RFA-BILIAIRE

summary:
90 % of the patients with bile duct cancer are not justifiable of a surgical resection with curative aim for oncologic reasons ( metastatic extensions), for reasons of resectability (canalar extension, vascular) or still for surgically reasons (age, comorbidity).

The palliative care of these patients consists at first in assuring an effective biliary drainage, infectious complications being one of the main causes of death. The biliary drainage allows to improve the survival of these patients. It bases by the implementation, by the endoscopic or percutaneous way of biliary, generally metallic prosthesis the duration of average permeability of which is of approximately 6 months.

The standard oncologic treatment is the administration of a chemotherapy exclusive or associated with a radiotherapy. The radiotherapy and the radio chemotherapy did not show efficiency on the survival superior to the exclusive biliary drainage. The first-line exclusive chemotherapy bases on the gemcitabine-cisplatin association with a median survival of 11,6 months. No study allows to justify the administration of a chemotherapy of the second line.

Thus the preservation of the permeability of the biliary ways is today, the most important factor to improve the survival of these patients. Therefore, the addition of a treatment allowing to obtain a local tumoral response to the insertion of biliary prosthesis would allow to increase the duration of permeability of the biliary prosthesis and would limit the local evolution.

Endoductal destruction tumoral technics were thus developed in this indication:

Dynamic phototherapy which demonstrated, during preliminary studies, a certain efficiency both on the tumoral response estimated on the improvement of the tumoral stenosis as on the survival in case of cholangiocarcinoma bile ducts not resectables. However, the improvement of the survival was not confirmed by wider randomized studies. A study randomized of phase III was interrupted prematurely because of a survival decreased in the experimental arm.
The radium therapy and the brachytherapy were estimated in this indication with results interesting on series limited in size, but is not used in routine because of its cost and of technics difficulties.

Ablation therapy technics (radio frequency, microwaves, radium therapy) percutaneous by radiological or surgical way proved their efficiency for the treatment of hepatocarcinoma and liver metastasis.

The hepatic radio frequency was estimated, during trials of phases II, for peripheral cholangiocarcinoma intra hepatic (developed at a distance main bile ducts) with interesting tumoral rates of necrosis.

However, the direct percutaneous access of the cholangiocarcinoma of the biliary ways is not practicable because of the risk of iatrogenic biliary fistula.

Therefore, systems allowing to realize ablation therapy by endoductal radio frequency are from now on available. It is miniaturized bipolar probes which are inserted into bile ducts by reactionary way (retrograde cholangiography), or anterograde percutaneous.

Two systems (Habib ®, ELLRA ®) are at present available and were estimated during in vitro and in vivo studies, to the animal and in man.

The purposes of this study are to estimate the feasibility, the efficiency and the morbidity of the biliary radio frequency for the treatment of the extra hepatic cholangiocarcinoma non resectable (resection or transplantation).

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Device


title: Randomized Controlled Trial for the Evaluation of Complete Microscopic Resection Margin (R0) and Lymph Node Involvement After Standard Pancreatosplenectomy (SPS) Versus Radical Anterograde Modular Pancreatosplenectomy (RAMPS)

summary:
Resection with negative margins (R0) followed by adjuvant chemotherapy is today the standard of care and the only chance of cure for patients with pancreatic ductal adenocarcinoma (PDA). Incomplete microscopic resection margin (R1) after pancreatic resection has been reported to occur in 17 to >80% of cases depending on the nonconsensual definition of R1 status. This discrepancy is reflected in conflicting reports regarding the prognostic relevance of R1 resection. Currently, neither the definition of the margin involvement nor the surgical technique to clear the margins is consistently applied, resulting in conflicting data in the literature. The Radical Antegrade Modular Pancreatosplenectomy (RAMPS) was described by Strasberg et al. in 2003 to increase the rate of R0 resection for left PDA. However, there is no grade A recommendation and surgical practices still remain heterogeneous as many surgeons still consider the "retrograde" technique as the standard procedure. The invasion of the resection margins is often poorly evaluated, including in large clinical trials. The surgical specimens are not systematically inked and the microscopic invasion of the splenic vessels is underreported, leading to inaccurate pathologic evaluation.

A French prospective multicenter study (Delpero JR et al; ClinicalTrials.gov: NCT00918853) was previously conducted for pancreaticoduodenectomy specimens. A recent update (Ann Surg 2017, in press) has emphasized the value of a standardized pathology protocol to accurately assess the impact of R0 resection and improve patient's stratification.

Today, no recommendations are available regarding the surgical procedure and histological analysis for DP specimen handling.

The primary endpoint of this multicenter randomized control trial (RCT) is to investigate the benefit of the RAMPS procedure in comparison to standard distal pancreatosplenectomy (SDPS) on the R0-resection rate using a high-quality pathology protocol. To date, there are no prospective data assessing the superiority of the RAMPS technique over standard resection. This study will be the first RCT on the subject.

This study could improve the surgical practices and define a surgical standard of care. The pathology protocol used for the study could help to standardize histopathology report on margin status. It could also provide a better evaluation of the impact of adjuvant and neoadjuvant therapies on local control. This study should lead to improved selection of patients for upfront surgery and give appropriate perioperative treatment tailored to a well-defined disease stage. Furthermore, guidelines for surgical practices and standardization of histological examination may represent a significant step forward in the design of future trials to assess perioperative strategies.

status: Recruiting

design_allocation: Randomized

intervention_type: Procedure

status_simplified: Ongoing


type: Other Identifier

title: Characterization of Bone Marrow Adipocytes in Osteoarthritic and Post-menopausal Patients: a Comparative Study With Adipocytes From Subcutaneous Adipose Tissue

acronym: MEDADIPO

summary:
Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage.

The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.

time_perspective: Prospective

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
MSDAVENIR Foundation


title: Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.

acronym: TaiChiRA

summary: The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.

study_start_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Erratum In: Ann Intern Med. 2015 Sep 1;163(5):400.

ReferenceCitation: Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.

ReferenceCitation: Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, Bauman A, Lee IM; Lancet Physical Activity Series 2 Executive Committe; Lancet Sedentary Behaviour Working Group. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016 Sep 24;388(10051):1302-10. doi: 10.1016/S0140-6736(16)30370-1. Epub 2016 Jul 28. Erratum In: Lancet. 2016 Sep 24;388(10051):e6.

ReferenceCitation: Gossec L, Paternotte S, Aanerud GJ, Balanescu A, Boumpas DT, Carmona L, de Wit M, Dijkmans BA, Dougados M, Englbrecht M, Gogus F, Heiberg T, Hernandez C, Kirwan JR, Mola EM, Cerinic MM, Otsa K, Schett G, Scholte-Voshaar M, Sokka T, von Krause G, Wells GA, Kvien TK. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis. 2011 Jun;70(6):935-42. doi: 10.1136/ard.2010.142901.

ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.

ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Saboul D, Ren L, Rousset S. The eMouveRecherche application competes with research devices to evaluate energy expenditure, physical activity and still time in free-living conditions. J Biomed Inform. 2017 May;69:128-134. doi: 10.1016/j.jbi.2017.04.005. Epub 2017 Apr 9.

ReferenceCitation: Jones SD, Porter J, Garrett SL, Kennedy LG, Whitelock H, Calin A. A new scoring system for the Bath Ankylosing Spondylitis Metrology Index (BASMI). J Rheumatol. 1995 Aug;22(8):1609. No abstract available.

ReferenceCitation: Uhlig T. Tai Chi and yoga as complementary therapies in rheumatologic conditions. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):387-98. doi: 10.1016/j.berh.2012.05.006.

ReferenceCitation: Veldhuijzen van Zanten JJ, Rouse PC, Hale ED, Ntoumanis N, Metsios GS, Duda JL, Kitas GD. Perceived Barriers, Facilitators and Benefits for Regular Physical Activity and Exercise in Patients with Rheumatoid Arthritis: A Review of the Literature. Sports Med. 2015 Oct;45(10):1401-12. doi: 10.1007/s40279-015-0363-2.

ReferenceCitation: Waite-Jones JM, Hale CA, Lee HY. Psychosocial effects of Tai Chi exercise on people with rheumatoid arthritis. J Clin Nurs. 2013 Nov;22(21-22):3053-61. doi: 10.1111/jocn.12327. Epub 2013 Sep 13.

ReferenceCitation: Wang C. Role of Tai Chi in the treatment of rheumatologic diseases. Curr Rheumatol Rep. 2012 Dec;14(6):598-603. doi: 10.1007/s11926-012-0294-y.

ReferenceCitation: Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other


title: Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort

acronym: PICARO

summary:
Recently, the medical management of cancer patients has considerably improved the prognosis of these patients and today some cancers are becoming "chronic diseases". As a result, new adverse effects (AEs) are observed, particularly cardiac.

These "new" cardiac AEs are the consequence of a significant increase in patients life expectancy (delayed AEs not previously seen) but also the use of new pharmacological classes of anticancer drugs such as kinase inhibitors. The incidence of these cardiac AEs varies according to the patient profile and the anticancer molecules used, but their impact on the morbidity and mortality of the patients is significant.

In this context, we started at the University Hospital of Caen Normandy in September 2017 a cardio-oncology program entitled "prevention and pharmacological management of cardiac adverse effects induced by drugs used in Oncology" (PICARO program). This program involves the pharmacology department (opening of a dedicated consultation), the cardiology department (opening of a dedicated ultrasound consultation), vascular medicine departement (opening of a dedicated consultation) and the oncology federation. This program aims to be regional in the future. We therefore propose to build a cohort backed up to the PICARO program to assess the regional impact of cardiac AEs of anticancer drugs and thus to be better able to specify the number of AEs, the incidence and regional prevalence of these drugs. .

The constitution of this cohort is only the first step towards the constitution in the near future (2 years) of an observatory and then a regional registry of cardiac AEs induced by anticancer drugs. The objectives associated with the establishment of such a registry would be to reduce the number of cardiac AEs, the hospitalizations caused by these AEs, a better information of health professionals and patients, an improvement in the screening of patients at risk, all coming back in the context of health, clinical, epidemiological and pharmacological surveillance.

ReferenceType: derived

ReferenceCitation: Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Caen


title: Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients

acronym: TestICUs

summary:
Critically ill patients experience major insults that lead to increased protein catabolism. Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage. During acute phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid release. Under stress conditions, protein synthesis cannot match the increased rate of muscle proteolysis because of a state of anabolism resistance, which limits uptake of amino acids into muscles. Hypermetabolism results in a significant loss of lean body mass with an impact on weaning from the ventilator and muscle recovery. Functional disability may be long term sometimes with no full return to normal.

In critically ill patients, severe and persistent testosterone deficiency is very common and is observed early after ICU admission. This acquired hypogonadism promotes the persistent loss of skeletal muscle protein and is related to poor outcome.

Administration of testosterone induces skeletal muscle fiber hypertrophy, decreases protein breakdown in healthy young men and burned patients. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in young and older hypogonadal men and women and can improve physical performance.

ReferenceCitation: Plank LD, Connolly AB, Hill GL. Sequential changes in the metabolic response in severely septic patients during the first 23 days after the onset of peritonitis. Ann Surg. 1998 Aug;228(2):146-58. doi: 10.1097/00000658-199808000-00002.

ReferenceCitation: Hussain SN, Mofarrahi M, Sigala I, Kim HC, Vassilakopoulos T, Maltais F, Bellenis I, Chaturvedi R, Gottfried SB, Metrakos P, Danialou G, Matecki S, Jaber S, Petrof BJ, Goldberg P. Mechanical ventilation-induced diaphragm disuse in humans triggers autophagy. Am J Respir Crit Care Med. 2010 Dec 1;182(11):1377-86. doi: 10.1164/rccm.201002-0234OC. Epub 2010 Jul 16.

ReferenceCitation: Vanhorebeek I, Gunst J, Derde S, Derese I, Boussemaere M, Guiza F, Martinet W, Timmermans JP, D'Hoore A, Wouters PJ, Van den Berghe G. Insufficient activation of autophagy allows cellular damage to accumulate in critically ill patients. J Clin Endocrinol Metab. 2011 Apr;96(4):E633-45. doi: 10.1210/jc.2010-2563. Epub 2011 Jan 26.

ReferenceCitation: Weijs PJ, Cynober L, DeLegge M, Kreymann G, Wernerman J, Wolfe RR. Proteins and amino acids are fundamental to optimal nutrition support in critically ill patients. Crit Care. 2014 Nov 17;18(6):591. doi: 10.1186/s13054-014-0591-0.

ReferenceCitation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].

ReferenceCitation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

ReferenceCitation: Dos Santos C, Hussain SN, Mathur S, Picard M, Herridge M, Correa J, Bain A, Guo Y, Advani A, Advani SL, Tomlinson G, Katzberg H, Streutker CJ, Cameron JI, Schols A, Gosker HR, Batt J; MEND ICU Group; RECOVER Program Investigators; Canadian Critical Care Translational Biology Group. Mechanisms of Chronic Muscle Wasting and Dysfunction after an Intensive Care Unit Stay. A Pilot Study. Am J Respir Crit Care Med. 2016 Oct 1;194(7):821-830. doi: 10.1164/rccm.201512-2344OC.

ReferenceCitation: Stevens RD, Marshall SA, Cornblath DR, Hoke A, Needham DM, de Jonghe B, Ali NA, Sharshar T. A framework for diagnosing and classifying intensive care unit-acquired weakness. Crit Care Med. 2009 Oct;37(10 Suppl):S299-308. doi: 10.1097/CCM.0b013e3181b6ef67.

ReferenceCitation: De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

ReferenceCitation: Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

ReferenceCitation: Fletcher SN, Kennedy DD, Ghosh IR, Misra VP, Kiff K, Coakley JH, Hinds CJ. Persistent neuromuscular and neurophysiologic abnormalities in long-term survivors of prolonged critical illness. Crit Care Med. 2003 Apr;31(4):1012-6. doi: 10.1097/01.CCM.0000053651.38421.D9.

ReferenceCitation: Solverson KJ, Grant C, Doig CJ. Assessment and predictors of physical functioning post-hospital discharge in survivors of critical illness. Ann Intensive Care. 2016 Dec;6(1):92. doi: 10.1186/s13613-016-0187-8. Epub 2016 Sep 20.

ReferenceCitation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

ReferenceCitation: Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

ReferenceCitation: Ma L, Shen C, Chai J, Yin H, Deng H, Feng R. Extracellular signal-regulated kinase-mammalian target of rapamycin signaling and forkhead-box transcription factor 3a phosphorylation are involved in testosterone's effect on severe burn injury in a rat model. Shock. 2015 Jan;43(1):85-91. doi: 10.1097/SHK.0000000000000244.

ReferenceCitation: Ferrando AA, Sheffield-Moore M, Yeckel CW, Gilkison C, Jiang J, Achacosa A, Lieberman SA, Tipton K, Wolfe RR, Urban RJ. Testosterone administration to older men improves muscle function: molecular and physiological mechanisms. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E601-7. doi: 10.1152/ajpendo.00362.2001.

ReferenceCitation: Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Lenrow DA, Holmes JH, Dlewati A, Santanna J, Rosen CJ, Strom BL. Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age. J Clin Endocrinol Metab. 1999 Aug;84(8):2647-53. doi: 10.1210/jcem.84.8.5885.

ReferenceCitation: Diaz EC, Herndon DN, Porter C, Sidossis LS, Suman OE, Borsheim E. Effects of pharmacological interventions on muscle protein synthesis and breakdown in recovery from burns. Burns. 2015 Jun;41(4):649-57. doi: 10.1016/j.burns.2014.10.010. Epub 2014 Nov 16.

ReferenceCitation: Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.

ReferenceCitation: Sinha-Hikim I, Artaza J, Woodhouse L, Gonzalez-Cadavid N, Singh AB, Lee MI, Storer TW, Casaburi R, Shen R, Bhasin S. Testosterone-induced increase in muscle size in healthy young men is associated with muscle fiber hypertrophy. Am J Physiol Endocrinol Metab. 2002 Jul;283(1):E154-64. doi: 10.1152/ajpendo.00502.2001.

ReferenceCitation: Sinha-Hikim I, Roth SM, Lee MI, Bhasin S. Testosterone-induced muscle hypertrophy is associated with an increase in satellite cell number in healthy, young men. Am J Physiol Endocrinol Metab. 2003 Jul;285(1):E197-205. doi: 10.1152/ajpendo.00370.2002. Epub 2003 Apr 1.

ReferenceCitation: Brodsky IG, Balagopal P, Nair KS. Effects of testosterone replacement on muscle mass and muscle protein synthesis in hypogonadal men--a clinical research center study. J Clin Endocrinol Metab. 1996 Oct;81(10):3469-75. doi: 10.1210/jcem.81.10.8855787.

ReferenceCitation: Urban RJ, Bodenburg YH, Gilkison C, Foxworth J, Coggan AR, Wolfe RR, Ferrando A. Testosterone administration to elderly men increases skeletal muscle strength and protein synthesis. Am J Physiol. 1995 Nov;269(5 Pt 1):E820-6. doi: 10.1152/ajpendo.1995.269.5.E820.

ReferenceCitation: Ferrando AA, Sheffield-Moore M, Wolf SE, Herndon DN, Wolfe RR. Testosterone administration in severe burns ameliorates muscle catabolism. Crit Care Med. 2001 Oct;29(10):1936-42. doi: 10.1097/00003246-200110000-00015.

ReferenceCitation: Liva SM, Voskuhl RR. Testosterone acts directly on CD4+ T lymphocytes to increase IL-10 production. J Immunol. 2001 Aug 15;167(4):2060-7. doi: 10.4049/jimmunol.167.4.2060.

ReferenceCitation: Khosla S, Atkinson EJ, Dunstan CR, O'Fallon WM. Effect of estrogen versus testosterone on circulating osteoprotegerin and other cytokine levels in normal elderly men. J Clin Endocrinol Metab. 2002 Apr;87(4):1550-4. doi: 10.1210/jcem.87.4.8397.

ReferenceCitation: Malkin CJ, Pugh PJ, Jones RD, Kapoor D, Channer KS, Jones TH. The effect of testosterone replacement on endogenous inflammatory cytokines and lipid profiles in hypogonadal men. J Clin Endocrinol Metab. 2004 Jul;89(7):3313-8. doi: 10.1210/jc.2003-031069.

ReferenceCitation: Tsilidis KK, Rohrmann S, McGlynn KA, Nyante SJ, Lopez DS, Bradwin G, Feinleib M, Joshu CE, Kanarek N, Nelson WG, Selvin E, Platz EA. Association between endogenous sex steroid hormones and inflammatory biomarkers in US men. Andrology. 2013 Nov;1(6):919-28. doi: 10.1111/j.2047-2927.2013.00129.x. Epub 2013 Sep 30.

ReferenceCitation: Zhang Y, Gao Y, Tan A, Yang X, Zhang H, Zhang S, Wu C, Lu Z, Wang M, Liao M, Qin X, Li L, Hu Y, Mo Z. Endogenous sex hormones and C-reactive protein in healthy Chinese men. Clin Endocrinol (Oxf). 2013 Jan;78(1):60-6. doi: 10.1111/j.1365-2265.2012.04359.x.

ReferenceCitation: Sharshar T, Bastuji-Garin S, De Jonghe B, Stevens RD, Polito A, Maxime V, Rodriguez P, Cerf C, Outin H, Touraine P, Laborde K. Hormonal status and ICU-acquired paresis in critically ill patients. Intensive Care Med. 2010 Aug;36(8):1318-26. doi: 10.1007/s00134-010-1840-6. Epub 2010 Mar 24.

ReferenceCitation: Vogel AV, Peake GT, Rada RT. Pituitary-testicular axis dysfunction in burned men. J Clin Endocrinol Metab. 1985 Apr;60(4):658-65. doi: 10.1210/jcem-60-4-658.

ReferenceCitation: Wang C, Chan V, Yeung RT. Effect of surgical stress on pituitary-testicular function. Clin Endocrinol (Oxf). 1978 Sep;9(3):255-66. doi: 10.1111/j.1365-2265.1978.tb02208.x.

ReferenceCitation: Van den Berghe G, de Zegher F, Lauwers P, Veldhuis JD. Luteinizing hormone secretion and hypoandrogenaemia in critically ill men: effect of dopamine. Clin Endocrinol (Oxf). 1994 Nov;41(5):563-9. doi: 10.1111/j.1365-2265.1994.tb01819.x.

ReferenceCitation: Nierman DM, Mechanick JI. Hypotestosteronemia in chronically critically ill men. Crit Care Med. 1999 Nov;27(11):2418-21. doi: 10.1097/00003246-199911000-00016.

ReferenceCitation: Kim JJ, Oh SJ, Shin JH, Hwang SY, Hyun SY, Yang HJ, Lee G. Testosterone related good neurologic outcome on the patients with return of spontaneous circulation after cardiac arrest: a prospective cohort study. Resuscitation. 2013 May;84(5):645-50. doi: 10.1016/j.resuscitation.2012.10.022. Epub 2012 Nov 7.

ReferenceCitation: Bhasin S, Storer TW, Berman N, Yarasheski KE, Clevenger B, Phillips J, Lee WP, Bunnell TJ, Casaburi R. Testosterone replacement increases fat-free mass and muscle size in hypogonadal men. J Clin Endocrinol Metab. 1997 Feb;82(2):407-13. doi: 10.1210/jcem.82.2.3733.

ReferenceCitation: Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N; Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2839-53. doi: 10.1210/jcem.85.8.6747.

ReferenceCitation: Bhasin S, Woodhouse L, Casaburi R, Singh AB, Mac RP, Lee M, Yarasheski KE, Sinha-Hikim I, Dzekov C, Dzekov J, Magliano L, Storer TW. Older men are as responsive as young men to the anabolic effects of graded doses of testosterone on the skeletal muscle. J Clin Endocrinol Metab. 2005 Feb;90(2):678-88. doi: 10.1210/jc.2004-1184. Epub 2004 Nov 23.

ReferenceCitation: Storer TW, Basaria S, Traustadottir T, Harman SM, Pencina K, Li Z, Travison TG, Miciek R, Tsitouras P, Hally K, Huang G, Bhasin S. Effects of Testosterone Supplementation for 3 Years on Muscle Performance and Physical Function in Older Men. J Clin Endocrinol Metab. 2017 Feb 1;102(2):583-593. doi: 10.1210/jc.2016-2771.

ReferenceCitation: Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731.

ReferenceCitation: Sheffield-Moore M, Paddon-Jones D, Casperson SL, Gilkison C, Volpi E, Wolf SE, Jiang J, Rosenblatt JI, Urban RJ. Androgen therapy induces muscle protein anabolism in older women. J Clin Endocrinol Metab. 2006 Oct;91(10):3844-9. doi: 10.1210/jc.2006-0588. Epub 2006 Aug 8.

ReferenceCitation: Miller KK, Biller BM, Beauregard C, Lipman JG, Jones J, Schoenfeld D, Sherman JC, Swearingen B, Loeffler J, Klibanski A. Effects of testosterone replacement in androgen-deficient women with hypopituitarism: a randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2006 May;91(5):1683-90. doi: 10.1210/jc.2005-2596. Epub 2006 Feb 14.

ReferenceCitation: Miller BE, De Souza MJ, Slade K, Luciano AA. Sublingual administration of micronized estradiol and progesterone, with and without micronized testosterone: effect on biochemical markers of bone metabolism and bone mineral density. Menopause. 2000 Sep-Oct;7(5):318-26. doi: 10.1097/00042192-200007050-00006.

ReferenceCitation: Davis SR, McCloud P, Strauss BJ, Burger H. Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality. Maturitas. 1995 Apr;21(3):227-36. doi: 10.1016/0378-5122(94)00898-h.

ReferenceCitation: Chapman IM, Visvanathan R, Hammond AJ, Morley JE, Field JB, Tai K, Belobrajdic DP, Chen RY, Horowitz M. Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women. Am J Clin Nutr. 2009 Mar;89(3):880-9. doi: 10.3945/ajcn.2008.26538. Epub 2009 Jan 14.

ReferenceCitation: White HD, Brown LA, Gyurik RJ, Manganiello PD, Robinson TD, Hallock LS, Lewis LD, Yeo KT. Treatment of pain in fibromyalgia patients with testosterone gel: Pharmacokinetics and clinical response. Int Immunopharmacol. 2015 Aug;27(2):249-56. doi: 10.1016/j.intimp.2015.05.016. Epub 2015 May 21.

ReferenceCitation: Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G. Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA. 2000 Feb 9;283(6):763-70. doi: 10.1001/jama.283.6.763.

ReferenceCitation: Bhasin S, Storer TW, Asbel-Sethi N, Kilbourne A, Hays R, Sinha-Hikim I, Shen R, Arver S, Beall G. Effects of testosterone replacement with a nongenital, transdermal system, Androderm, in human immunodeficiency virus-infected men with low testosterone levels. J Clin Endocrinol Metab. 1998 Sep;83(9):3155-62. doi: 10.1210/jcem.83.9.5079.

ReferenceCitation: Johansen KL, Mulligan K, Schambelan M. Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. JAMA. 1999 Apr 14;281(14):1275-81. doi: 10.1001/jama.281.14.1275.

ReferenceCitation: Schols AM, Soeters PB, Mostert R, Pluymers RJ, Wouters EF. Physiologic effects of nutritional support and anabolic steroids in patients with chronic obstructive pulmonary disease. A placebo-controlled randomized trial. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1268-74. doi: 10.1164/ajrccm.152.4.7551381.

ReferenceCitation: Casaburi R, Bhasin S, Cosentino L, Porszasz J, Somfay A, Lewis MI, Fournier M, Storer TW. Effects of testosterone and resistance training in men with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Oct 15;170(8):870-8. doi: 10.1164/rccm.200305-617OC. Epub 2004 Jul 21.

ReferenceCitation: Li H, Guo Y, Yang Z, Roy M, Guo Q. The efficacy and safety of oxandrolone treatment for patients with severe burns: A systematic review and meta-analysis. Burns. 2016 Jun;42(4):717-27. doi: 10.1016/j.burns.2015.08.023. Epub 2015 Oct 9.

ReferenceCitation: Gervasio JM, Dickerson RN, Swearingen J, Yates ME, Yuen C, Fabian TC, Croce MA, Brown RO. Oxandrolone in trauma patients. Pharmacotherapy. 2000 Nov;20(11):1328-34. doi: 10.1592/phco.20.17.1328.34889.

ReferenceCitation: Bulger EM, Jurkovich GJ, Farver CL, Klotz P, Maier RV. Oxandrolone does not improve outcome of ventilator dependent surgical patients. Ann Surg. 2004 Sep;240(3):472-8; discussion 478-80. doi: 10.1097/01.sla.0000137131.22608.e2.

ReferenceCitation: Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Transl Androl Urol. 2016 Dec;5(6):834-843. doi: 10.21037/tau.2016.07.10.

ReferenceCitation: Yoshida EM, Erb SR, Scudamore CH, Owen DA. Severe cholestasis and jaundice secondary to an esterified testosterone, a non-C17 alkylated anabolic steroid. J Clin Gastroenterol. 1994 Apr;18(3):268-70. doi: 10.1097/00004836-199404000-00036. No abstract available.

ReferenceCitation: Jeschke MG, Finnerty CC, Suman OE, Kulp G, Mlcak RP, Herndon DN. The effect of oxandrolone on the endocrinologic, inflammatory, and hypermetabolic responses during the acute phase postburn. Ann Surg. 2007 Sep;246(3):351-60; discussion 360-2. doi: 10.1097/SLA.0b013e318146980e.

ReferenceCitation: Dobs AS, Meikle AW, Arver S, Sanders SW, Caramelli KE, Mazer NA. Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men. J Clin Endocrinol Metab. 1999 Oct;84(10):3469-78. doi: 10.1210/jcem.84.10.6078.

ReferenceCitation: Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014.

ReferenceCitation: Dillon EL, Durham WJ, Urban RJ, Sheffield-Moore M. Hormone treatment and muscle anabolism during aging: androgens. Clin Nutr. 2010 Dec;29(6):697-700. doi: 10.1016/j.clnu.2010.03.010. Epub 2010 May 7.

ReferenceCitation: Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.

ReferenceCitation: Vigen R, O'Donnell CI, Baron AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013 Nov 6;310(17):1829-36. doi: 10.1001/jama.2013.280386. Erratum In: JAMA. 2014 Mar 5;311(9):967.

ReferenceCitation: Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni JF Jr, Hoover RN. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014 Jan 29;9(1):e85805. doi: 10.1371/journal.pone.0085805. eCollection 2014.

ReferenceCitation: Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119.

ReferenceCitation: Basaria S, Harman SM, Travison TG, Hodis H, Tsitouras P, Budoff M, Pencina KM, Vita J, Dzekov C, Mazer NA, Coviello AD, Knapp PE, Hally K, Pinjic E, Yan M, Storer TW, Bhasin S. Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial. JAMA. 2015 Aug 11;314(6):570-81. doi: 10.1001/jama.2015.8881.

ReferenceCitation: English KM, Steeds RP, Jones TH, Diver MJ, Channer KS. Low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina: A randomized, double-blind, placebo-controlled study. Circulation. 2000 Oct 17;102(16):1906-11. doi: 10.1161/01.cir.102.16.1906.

ReferenceCitation: Baillargeon J, Urban RJ, Kuo YF, Ottenbacher KJ, Raji MA, Du F, Lin YL, Goodwin JS. Risk of Myocardial Infarction in Older Men Receiving Testosterone Therapy. Ann Pharmacother. 2014 Sep;48(9):1138-1144. doi: 10.1177/1060028014539918. Epub 2014 Jul 2.

ReferenceCitation: Corona G, Maseroli E, Rastrelli G, Isidori AM, Sforza A, Mannucci E, Maggi M. Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf. 2014 Oct;13(10):1327-51. doi: 10.1517/14740338.2014.950653. Epub 2014 Aug 19.

ReferenceCitation: Borst SE, Shuster JJ, Zou B, Ye F, Jia H, Wokhlu A, Yarrow JF. Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis. BMC Med. 2014 Nov 27;12:211. doi: 10.1186/s12916-014-0211-5.

ReferenceCitation: Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.

ReferenceCitation: Singh AB, Lee ML, Sinha-Hikim I, Kushnir M, Meikle W, Rockwood A, Afework S, Bhasin S. Pharmacokinetics of a testosterone gel in healthy postmenopausal women. J Clin Endocrinol Metab. 2006 Jan;91(1):136-44. doi: 10.1210/jc.2005-1640. Epub 2005 Nov 1.

ReferenceCitation: Mackenzie TA, Clark NG, Bistrian BR, Flatt JP, Hallowell EM, Blackburn GL. A simple method for estimating nitrogen balance in hospitalized patients: a review and supporting data for a previously proposed technique. J Am Coll Nutr. 1985;4(5):575-81. doi: 10.1080/07315724.1985.10720100.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086. Erratum In: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393.

ReferenceCitation: Muscular weakness assessment: use of normal isometric strength data. The National Isometric Muscle Strength (NIMS) Database Consortium. Arch Phys Med Rehabil. 1996 Dec;77(12):1251-5. doi: 10.1016/s0003-9993(96)90188-4.

ReferenceCitation: Dyer C. US authorities face legal challenges over anaesthetics used in executions. BMJ. 2011 Mar 24;342:d1925. doi: 10.1136/bmj.d1925. No abstract available.

ReferenceCitation: Ryan TE, Brophy P, Lin CT, Hickner RC, Neufer PD. Assessment of in vivo skeletal muscle mitochondrial respiratory capacity in humans by near-infrared spectroscopy: a comparison with in situ measurements. J Physiol. 2014 Aug 1;592(15):3231-41. doi: 10.1113/jphysiol.2014.274456. Epub 2014 Jun 20.

ReferenceCitation: Adami A, Cao R, Porszasz J, Casaburi R, Rossiter HB. Reproducibility of NIRS assessment of muscle oxidative capacity in smokers with and without COPD. Respir Physiol Neurobiol. 2017 Jan;235:18-26. doi: 10.1016/j.resp.2016.09.008. Epub 2016 Sep 19.

ReferenceCitation: Mourtzakis M, Prado CM, Lieffers JR, Reiman T, McCargar LJ, Baracos VE. A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab. 2008 Oct;33(5):997-1006. doi: 10.1139/H08-075.

ReferenceCitation: Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.

ReferenceCitation: Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.

intervention_type: Drug

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: TestICUs

titre: Evaluation de l'efficacité de la testostérone en gel administrée précocement en réanimation sur la performance physique : étude multicentrique randomisée contrôlée en double aveugle

discipline_principale: anesthesiology / resuscitation


title: Treating Depression on a Day-to-day Basis: Development of a Novel Clinical Tool for Physicians Based on a Smartphone Application, the SMART Project (Smartphones and Mood Disorders, an Application for Research and Treatment)

acronym: SMART

summary: Testing and validating an e-health (smartphone application) approach to better understand the determinants of day-to-day symptomatology in depression, medication adherence, and treatment efficacy in the goal of maximizing patient care.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

region: Nouvelle-Aquitaine

nom_etablissement: CH CHARLES PERRENS

type_etablissement: EPSM

acronyme: SMART

titre: La prise en charge de la dépression au quotidien: développement d'un outil clinique novateur destiné aux médecins basé sur une application smartphone, le projet SMART (Smartphones and Mood disorders, an Application for Research and Treatment).

discipline_principale: psychiatrie / addictologie

nom_porteur: MISDRAHI

prenom_porteur: David


title: Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.

summary:
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing).

Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Hospital of Aurillac


title: Determinants of the Recovery of Diaphragm Dysfunction in Patients With Prolonged Mechanical Ventilation

acronym: DD-SRPR

summary: The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.

status: Active, not recruiting

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations

acronym: BioMAV

summary:
The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.

The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.

The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel


title: Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli

acronym: Absence SLI

summary: Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.

status: Terminated

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


acronym: Phase 1

summary: Overview of response rate published in recent oncology phase I trials

ReferenceType: result

ReferenceCitation: Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Institut Bergonié


title: International Consensus Process to Provide Guidelines for the Definition of Efficacy Endpoints to Assess Treatment Efficacy in Randomized Controlled Trials in Elderly Cancer Patients

acronym: DATECANelderly

summary:
Context and hypothesis: In cancer randomized controlled trials (RCT), the validated and most objective criterion to assess treatment efficacy is overall survival (OS). In the elderly population, OS presents limitations as it can be affected by factors other than treatment such as comorbidity or severe toxicity. Although mortality reduction is important for patients of all ages, alternative outcomes such as the ability to live independently or with a better quality of life, may be more important for older patients.

Reviews of RCT have highlighted (i) the heterogeneity of such alternative efficacy outcomes and (ii) an absence of standardized definitions for these endpoints. As a result, this may limit the quality of RCT as well as the comparison of results across trials. Our objective is to provide guidelines for standardized definitions of such alternative endpoints to assess treatment efficacy in cancer RCT in elderly populations.

The development of guidelines will follow a formal consensus method (questionnaires + in-person meetings). A large panel of international experts will participate.

Guidelines are awaited due to the heterogeneity of endpoints and absence of standardized definitions. Standardizing definitions will improve the quality and design of future trials and enhance comparison between trials.

collaborators: European Organisation for Research and Treatment of Cancer - EORTC

collaborators: International Society of Geriatric Oncology


title: GRAFted Patients' anxieTY Report (GRAFTY)

acronym: GRAFTY

summary: Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers

acronym: EFRADO

summary:
In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.

We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Midline Catheter and Its Impact on Central Lines Removal in ICU

acronym: MIDREA

summary: The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Status of Superficial Esophageal Cancers Treated by Endoscopy

acronym: OESOFARE

summary:
In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

lead_sponsor: Nantes University Hospital


title: Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

acronym: SEQ-IRM

summary: Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux

collaborators: L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)


title: Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas

acronym: AQUARIUM

summary: The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

lead_sponsor: Hôpital NOVO

intervention_type: Behavioral


title: Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

acronym: HYP-ANGE

summary:
This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

appel_a_projets: PHRIP

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: HYP-ANGE

titre: Efficacité de l'hypnoanalgésie réalisée par un manipulateur en radiologie chez des enfants ayant un angiome cutané traité par sclérose en radiologie interventionnelle.

discipline_principale: radiologie interventionnelle

nom_porteur: Benoit-Ruby

prenom_porteur: Claire


title: Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

acronym: PRURI-C

summary: The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

lead_sponsor: University Hospital, Brest


title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers

acronym: TRAIN-ONLINE

summary: An online single blinding, randomized, comparative therapeutic web-based, controlled trial. The main objective of the study is to assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks, as compared to a control program with a similar setting.

ReferenceCitation: Santiago A, Carre A, Miranda R, Lemogne C, LeStrat Y, Benyamina A, Perney P, Luquiens A. Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial. BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641.

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

collaborators: ARJEL (Autorité de Régulation des Jeux En Ligne)


title: Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension

acronym: HPepic

summary: Monocentric cohort study, prospective, evaluating the variability of cardiac output measurement by resting and stress impedancemetry as a prognostic factor for Pulmonary Hypertension

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Oxygenation Methods and Non-invasive Ventilatory Support in Patients With Acute Respiratory Failure for Whom a Do-not Intubate Order Was Taken: Prospective Observational Study

acronym: OXYPAL

summary: ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

ReferenceCitation: Robert R, Frasca D, Badin J, Girault C, Guitton C, Djibre M, Beuret P, Reignier J, Benzekri-Llefevre D, Demiri S, Rahmani H, Argaud LA, I'her E, Ehrmann S, Lesieur O, Kuteifan K, Thouy F, Federici L, Thevenin D, Contou D, Terzi N, Nseir S, Thyrault M, Vinsonneau C, Audibert J, Masse J, Boyer A, Guidet B, Chelha R, Quenot JP, Piton G, Aissaoui N, Thille AW, Frat JP. Comparison of high-flow nasal oxygen therapy and non-invasive ventilation in ICU patients with acute respiratory failure and a do-not-intubate orders: a multicentre prospective study OXYPAL. BMJ Open. 2021 Feb 12;11(2):e045659. doi: 10.1136/bmjopen-2020-045659.

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

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

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

lead_sponsor: Poitiers University Hospital


title: Sensors for HEalth Recording and Physical Activity Monitoring

acronym: SHERPAM

summary: The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.

design_allocation: Non-Randomized

primary_purpose: Device Feasibility

ReferenceCitation: Houssein A, Ge D, Gastinger S, Dumond R, Prioux J. Estimation of respiratory variables from thoracoabdominal breathing distance: a review of different techniques and calibration methods. Physiol Meas. 2019 Apr 3;40(3):03TR01. doi: 10.1088/1361-6579/ab0b63.

publisher_dissemination: IOP Publishing

ReferenceCitation: Dumond R, Gastinger S, Rahman HA, Le Faucheur A, Quinton P, Kang H, Prioux J. Estimation of respiratory volume from thoracoabdominal breathing distances: comparison of two models of machine learning. Eur J Appl Physiol. 2017 Aug;117(8):1533-1555. doi: 10.1007/s00421-017-3630-0. Epub 2017 Jun 13.

publisher_dissemination: Springer-Nature

ReferenceCitation: Khreis S, Ge D, Rahman HA, Carrault G. Breathing Rate Estimation Using Kalman Smoother With Electrocardiogram and Photoplethysmogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):893-904. doi: 10.1109/TBME.2019.2923448. Epub 2019 Jun 17.

publisher_dissemination: IEEE

lead_sponsor: Rennes University Hospital

collaborators:
LTSI-INSERM U1099
CIC-IT 14-14

sponsor_collaborators:
Rennes University Hospital
LTSI-INSERM U1099
CIC-IT 14-14


title: Peri-gravidic Exposure to Endocrine Disrupting Persistent Organic Pollutants Dioxins and Dioxin-like Dioxins and the Development of Breast Cancer Within 15 Years: Prospective Longitudinal Case-control Study

acronym: SEINPOL

summary:
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and unequal distribution of its prevalence throughout the world, regardless of age and genetic factors (< 10% of cases), observations in migrant women and the increased risk in women who have been exposed in utero to diethylstilbestrol, suggest the involvement of environmental factors that can act very early in development, such as persistent chemical pollutants (POPs) that are endocrine disrupting (EP) acting via nuclear receptors. But the demonstration of the deleterious role of such exposure to chemical pollutants is confronted epidemiologically with methodological difficulties: the correlation is most often sought at the time of cancer discovery when the critical windows of exposure are for the breast, fetus, perinatal, peri-advertising or pregnant and a single pollutant is usually measured, whereas they can be potentiated ("cocktail effect").

The objective of this project is therefore to assess the risk related to pre- and per-gravidic exposure to a range of POPs families (dioxins, dioxin-like, PolyChlorinated Bysphenyls PCBs, flame-retardant polybrominated compounds, waterproofing perfluorinated compounds and several organochlorine pesticides), to develop breast cancer within 15 years of delivery, taking into account the conventional risk factors for breast cancer.

This project benefits from a historical bio-bank of 6242 cord blood, an indirect reflection of the pre and per-gravidic maternal exposure, a bank set up between 2002 and 2005, during a PHRC at the Nice University Hospital, frozen and stored under strict and regulatory conditions, declared to the CNIL, and the Cancer Observatory / CRISAP of the PACA-Corsica region, with an exhaustive register of over 92% since 2005, and containing the main characteristics of cancer. The cross-referencing of these two registers (biobanks and CRISAP), supported by the preliminary feasibility study (155 cases of cancer expected, 35% of controls lost to follow-up or opposed to participation), makes it possible to consider a prospective case-control study nested in the cohort of mothers included in the bio-bank.

It will therefore be investigated whether women parturient women of this period who had the highest levels of POPs cord blood between 2002 and 2005 had a higher risk of developing breast cancer than those who had the lowest levels, taking into account other known risk factors.

The assays will be carried out by LABERCA in Nantes, the national reference laboratory, using gas chromatography/high-resolution mass spectrometry coupling. Blood lipid concentrations will be described in quartile and analyzed in continuous values, alone or in combination with a cumulative score, in N=140 cases and 2N=280 controls, matched for age and parity at birth by random drawing, sample required for 80% power, risk 5% OR at 2, frequency of exposure>70%.

The investigators propose to develop a predictive model of breast cancer occurrence based on exposure to endocrine disrupters measured during pregnancy by adjusting for known breast cancer risk factors.

These conditions should provide information on the possible association of exposure to POPs present in the domestic environment during critical pre- and per-gravidic periods and the risk of breast cancer and reinforce the relevance of preventive measures recently recommended during pre-conceptional and/or pre-natal consultations.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: SMOLY : Phenotype and Functions of Monocyte Subtypes in High Grade B Lymphoma: Towards New Biomarkers?

acronym: SMOLY

summary:
Large-cell B-cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma and accounts for about 40% of new cases. Although the DLBCL is a single entity in the WHO classification, several subgroups with different prognoses are recognized. These subgroups take into account the tumor localization (primitive cerebral lymphoma, serous lymphoma, intravascular or exclusive lymph node) or a particular molecular signature (GCB profile, germline center B cell or ABC, activated B cell). Despite the introduction of immunotherapy, treatment failures are common. Overall survival at 5 years is estimated to be between 26 and 73%. This highlights the important heterogeneity of this pathology and therefore the need for biomarkers prognosis. Recently, an increase in monocytes in the blood of DLBCL patients has been proposed as a prognostic factor for independent survival. This marker of poor prognosis is also found in many solid.

Monocytes are effectors of the inflammatory response. They have different functional profiles depending on the level of expression of CD14 and CD16. Four subtypes of monocytes are distinguished: classical (CD14posCD16neg), intermediate (CD14posCD16pos) and non-classical (CD14lowCD16pos); the latter population is divided into two sub-groups depending on the expression of the SLAN protein. The different monocytic subpopulations have very diverse functions ranging from an immunosuppressive profile to an activation of the immune system. CD14posCD16neg monocytes are specialized in phagocytosis, production of oxygen derivatives (ROS) and pro-inflammatory cytokine secretion in response to microbial infection. CD14dimCD16pos monocytes are specialized in immune surveillance and produce proinflammatory cytokines such as TNFα and IL-1β in response to LPS stimulation.7 The Slanpos subpopulation produces IL-12 and thus has pro-inflammatory properties. Finally, CD14posCD16pos monocytes have controversial functions. For some authors, they produce the immunomodulatory cytokine IL-10, inhibit the proliferation of CD4 T lymphocytes and induce the recruitment of regulatory T lymphocytes, while for others they produce TNF-α, a pro- inflammatory.From a practical point of view CD14 and CD16 expression forms a continuum, which translates into complexity in the phenotypic definition of these cells and explains the contradictory data on their functionalities. Interestingly, in a laboratory work and in the course of publication, this fraction is increased in the blood of DLBCL patients compared to healthy donors (manuscript in preparation), on the contrary the monocytic fraction CD14dimCD16 pos is decreased in these patients.

In the end, if the increase in monocytes is known to be poor prognosis in patients with DLBCL, the monocyte fraction involved and the monocytic functions involved in this phenomenon are not known.

Since 2011, the Clinical and Biological Hematology Services have a database from a research protocol (BMS_LyTrans). This protocol includes patients with DLBCL as well as healthy patients, in order to allow the biological characterization of biomarkers in this pathology. Thus, we have blood samples and analysis of certain monocyte subtypes by flow cytometry at diagnosis, in more than 100 patients with DLBCL.

sponsor_collaborators:
Rennes University Hospital
Vanderbilt University


title: Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children

acronym: COMPUFLO

summary: A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


title: Pilot Study Evaluating the Safety and Efficacy of a Photobiomodulation Prototype, REGEnLIFE RGn530 Device, on Cognitive Performances Evolution From Mild-to-moderate Alzheimer's Disease Patients

summary:
REGEnLIFE RGn530 is a photobiomodulation medical device, consisting in a modular helmet and abdominal panel, composed of near-infrared low-level lasers (LLLT), near-infrared and red LEDs as well as a static magnetic field. RGn device application on both head and abdomen have demonstrated striking efficacy in preclinical studies. The investigator's results clearly indicated that RGn treatment produces a normalization of all parameters that are strongly modified in the model, including memory performances associated to oxidative stress, neuroinflammation or apoptosis markers, microbiota composition and specific markers related to the amyloid or tau processes (Blivet et al., Alzheimers Dement (NY), 2018).

Following such promising results, this pilot clinical study will evaluate the safety and efficacy of REGEnLIFE RGn530 device on cognitive performances evolution from mild-to-moderate Alzheimer's disease patients. The double-blind, randomized, monocentric sham-controlled clinical trial will be performed at the CHU de Montpellier. 64 patients will be enrolled: 32 in photobiomodulation group and 32 in sham group. Each patient will follow 8 weeks of treatment with 5 sessions of 25min per week (total of 40 sessions) and will undergo, for a total period of three months, series of clinical examinations including cognitive evaluation, biological and electrophysiological analyses, sleep recordings, and imaging assessments.

REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective. In the light of anti-amyloid therapeutic approaches lack of success, RGn530 dual treatment is hoped to be particularly valuable as an innovative and extensive treatment strategy for AD.

location_facility: Montpellier University Hospital, Gui de Chauliac


title: Study of Circulating Glicentin Levels in Patients With Intestinal Ischemia

acronym: GLICENTINEDIGE

summary:
Hormones derived from proglucagon represent a family of peptides produced by the alpha cells of the pancreas and by the intestinal L cells. In the pancreas, the maturation of proglucagon mainly leads to the synthesis of glucagon, while in the intestine, the cleavage of proglucagon allows the synthesis of different peptides including glicentine, oxyntomodulin, Glucagon Like Peptide-1 (GLP-1) and Glucagon Like Peptide-2 (GLP-2).

Glicentin is produced by L cells throughout the digestive tract, from the small intestine to the rectum, with a majority secretion in the colon. Studies in humans and animals have shown its role in the intestinal mucosa. It has a stimulating effect on the proliferation of the intestinal mucosa as well as an effect on smooth muscle cells and regulates trophicity and intestinal motility. Its circulating rate could be modified in case of intestinal ischemia. Mesenteric ischemia is a major diagnostic problem with high morbidity and mortality, particularly in the event of delayed treatment.

The sensitivity and specificity of current markers are low. The identification of new biomarkers of the disease would improve the diagnosis and management of patients with the disease.

The objective of the project is to determine a difference in circulating glicentin levels in patients with intestinal ischemia versus a control group.

On this prospective monocentric study, 40 patients with digestive ischemia will be included in the Emergency Department of the University Hospital of Nice. A control group of 40 patients with abdominal pain will be formed. The circulating glicentin levels will be measured on serum by Elisa technique at the Biochemistry Laboratory of the University Hospital of Nice, work that has been published in 3 scientific journals allowing us to develop and validate the technique.The staff will determine whether patients with digestive ischemia have impaired serum glicentin levels.

The evaluation of the interest of new biological markers of mesenteric ischemia such as glicentine would constitute a definite diagnostic advance. This project could eventually offer new diagnostic and/or therapeutic perspectives in the management of these patients.

primary_purpose: Basic Science

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

acronym: CBCF

summary:
Clubfoot is one of the most common birth defects, with a prevalence in Europe estimated between 1 and 4.5 for 1000 live birth.

It is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). For the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality.

In those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself.

In case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with CGH array is a consensual attitude.

What the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. Thus, the management of these patients may vary from one CPDP to another.

This study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.

ipd_sharing_description: NC


title: Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements

acronym: FREESTYLE

summary: Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

ReferenceCitation: Halbron M, Bourron O, Andreelli F, Ciangura C, Jacqueminet S, Popelier M, Bosquet F, Rouanet S, Amouyal C, Hartemann A. Insulin Pump Combined with Flash Glucose Monitoring: A Therapeutic Option to Improve Glycemic Control in Severely Nonadherent Patients with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jul;21(7):409-412. doi: 10.1089/dia.2019.0041.

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia

acronym: THERMOLIB

summary:
Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia .

In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.


title: Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection

acronym: EVTSVCGEC

summary:
Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection.

Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma.

In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).

ReferenceCitation: Carlson ML, Tveiten OV, Driscoll CL, Neff BA, Shepard NT, Eggers SD, Staab JP, Tombers NM, Goplen FK, Lund-Johansen M, Link MJ. Long-term dizziness handicap in patients with vestibular schwannoma: a multicenter cross-sectional study. Otolaryngol Head Neck Surg. 2014 Dec;151(6):1028-37. doi: 10.1177/0194599814551132. Epub 2014 Oct 1.

ReferenceCitation: Park CE, Park BJ, Lim YJ, Yeo SG. Functional outcomes in retrosigmoid approach microsurgery and gamma knife stereotactic radiosurgery in vestibular schwannoma. Eur Arch Otorhinolaryngol. 2011 Jul;268(7):955-9. doi: 10.1007/s00405-011-1596-9. Epub 2011 Apr 11.

ReferenceCitation: Pollock BE, Driscoll CL, Foote RL, Link MJ, Gorman DA, Bauch CD, Mandrekar JN, Krecke KN, Johnson CH. Patient outcomes after vestibular schwannoma management: a prospective comparison of microsurgical resection and stereotactic radiosurgery. Neurosurgery. 2006 Jul;59(1):77-85; discussion 77-85. doi: 10.1227/01.NEU.0000219217.14930.14.

ReferenceCitation: Coelho DH, Roland JT Jr, Rush SA, Narayana A, St Clair E, Chung W, Golfinos JG. Small vestibular schwannomas with no hearing: comparison of functional outcomes in stereotactic radiosurgery and microsurgery. Laryngoscope. 2008 Nov;118(11):1909-16. doi: 10.1097/MLG.0b013e31818226cb.

lead_sponsor: University Hospital, Grenoble


title: Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital

acronym: CONTEMPS

summary: Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.


title: Impact of Personalized SMS in Relay of Therapeutic Education Programs to Improve the Physical Activity of Patients in Rheumatology

summary: Therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. The practice of physical activity is one of the goals of TPE in rheumatology and new technologies, such as SMS messages represent a possible complementary tool to amplify behavioral changes The study primary objective is to evaluate the impact of individualized SMS compared to standard SMS messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. Our hypothesis is that individualized SMS has a higher efficiency compared to standard SMS messages to increase the practice of physical activity in these patients.

lead_sponsor: Hôpital Cochin


title: Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

acronym: PANORAMIC

summary: Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.


title: Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?

acronym: COVAP

summary:
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%).

Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.

The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.

lead_sponsor: University Hospital, Tours

location_facility: Adult Emergency Department, University Hospital, Tours


title: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.

acronym: FATSCAR

summary:
Autografting of fat cells is widely used in plastic surgery in breast reconstruction, burn scars, unsightly scars etc. It is known that the autografting of fat cells not only makes it possible to bring adipocytes, and thus to create a volume, but also promotes neo-angiogenesis by providing the growth factors which allows an improvement of the local cutaneous tissue.

Currently the investigators perform this action in their service on healed eschars, by analogy with burn scars that are also dystrophic, so as to improve cutaneous trophicity, and reduce the recurrence of eschars on these scars. However, the literature on the autografting of fat cells on eschars is limited.


title: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital

summary:
The effectiveness of the analgesic and anti-nausea prevention techniques of the investigators justifies being evaluated regularly in order to adapt the management strategy to the specificities of each surgical act.

A first evaluation took place in June 2016 and allowed to identify a category of patients (partial breast surgery with or without axillary gesture) not benefiting from an ideal algological management because justifying in 30% of the cases of a level 3 analgesic remedy in the postoperative recovery room. This use of morphine results in a significant incidence of postoperative nausea and prolonged recovery time before return home harmful to the patient.

With their experience in locoregional anesthesia technique in complete breast surgery (total mastectomy) and aware of the effectiveness of this type of anesthesia on the management of immediate and chronic pain, the investigators have extended their indications of ALR to partial breast surgery in ambulatory.

ReferenceCitation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.

ReferenceCitation: Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

ReferenceCitation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

ReferenceCitation: Kumar SP. Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.

lead_sponsor: Institut Claudius Regaud


title: Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection

summary:
Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.

CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.

Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.

In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.


title: Association Between Hidradenitis Suppurativa and Spondyloarthritis

acronym: VESPA

summary:
Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands.

The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. The most frequently cited rheumatismal disease thought to be associated with Hidradenitis suppurativa is spondyloarthritis.

Taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. Indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (MRI) or the recent classification of spondyloarthritis.

ReferenceCitation: Fauconier M, Reguiai Z, Barbe C, Colosio A, Eschard JP, Salmon JH, Direz G. Association between hidradenitis suppurativa and spondyloarthritis. Joint Bone Spine. 2018 Oct;85(5):593-597. doi: 10.1016/j.jbspin.2017.09.005. Epub 2017 Sep 28.

lead_sponsor: CHU de Reims

intervention_type: Radiation


title: Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement.

acronym: ICTUS

summary: Management of NSTEMI in emergency departements represent 10% of the global activity. Since the the last European Society of Cardiology recommendation the use of an 1 hour rule-in and rule-out protocol is recommended combined with high-sensitivity troponin. But studies show 3% of the patients are false negative using this protocol. This study aims at analysing the feasibility of this protocol in an Emergency Departement and the security of this protocol if combined with a pre-troponin probability score.


title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

acronym: CALIGALOC

summary: To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.

lead_sponsor: University Hospital, Lille


title: Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)

acronym: IIAPEDIA

summary: The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.

intervention_type: Biological


title: Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People.

acronym: PREPA

summary:
According to several reports, the percentage of persons aged of more than 80 years is going to be doubled for the 25 years, to reach 10 % of the population. This implies an adaptation of practices of taken care for elderly people. Furthermore, the expectancy of life without any disability at 65 years old is 10.4 years and remains much lower than the general expectancy of life, which is of 24.4 years for women and 19.1 years for men.

Among predictive factors of loss of autonomy, the loss of mobility and muscular weakness are major components (OR=3.28 up to 3 years). These two factors are the origins for disabilities being responsible of falls, fractures, which lead to quality of life diminution, and increase of mortality.

The only components easily employed in a preventive manner and which have proved their efficacy are physical exercise and nutrition. But programs nowadays are still not implemented into primary taken care.

A multimodal program including these two components for patients at risk of loss of mobility is an imperative of public health.

location_facility: Service de Médecine Gériatrique Groupement Hospitalier Sud


title: Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device Coupled With a Tele-reeducative Follow-up in Patients With Parkinson's Disease on a Defined Health Area (TELE-PARK)

acronym: TELE-PARK

summary: Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).

lead_sponsor: Pôle Saint Hélier

sponsor_collaborators:
Pôle Saint Hélier
Réseau Parkinson Bretagne
Rennes University Hospital