title: Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy

acronym: FEMINICOL

summary:
Prospective, monocentric study evaluating the impact of a nurse-led sexological follow-up on sexual function in patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy.

The study procedure will consist of nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy.

Evolution of female sexual function and vaginal symptoms will be done through clinical examinations and completion of quality of life and female sexual function questionnaires during radiation oncologist consultation and/or nurse-led sexological consultations until one year after end of brachytherapy.

Study participation of each patient will be 12 months.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study

acronym: TAIA

summary:
The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS).

During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development.

The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility.

Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Institut de Formation et de Recherche en Médecine de Montagne

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer

acronym: IQversusMI

summary:
Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI > 25).

For each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems.

Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.

The study participation of each patient will be a maximum of 24 hours.

status: Completed

primary_purpose: Other

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

status_simplified: Completed


title: Effect of Magnesium Sulfate for Fetal Neuroprotection on Fetal Heart Rate in Case of Prematurity

summary:
Type of study: prospective descriptive monocentric study

Population: 2 groups: -Exposed group: pregnant patient between 24AW+0day and 32AW+0day receiving magnesium sulfate for fetal neuroprotection in the doubt of premature delivery

Control group: pregnant patient between 32AW+1day and 35AW+0day in the same context not requiring magnesium sulfate due to their gestationnal age.

Criterion(s) of judgment: Appearance of a change in short-term variability after injection of magnesium sulfate in the exposed group compared to the control group.

Schedule: Inclusion from February 20 to August 31, 2018

Expected results and prospects:

The general impression during my semester at the Jeanne de Flandre maternity clinic in Lille was the variability improves after injection of the magnesium sulfate used in the premature infant as a neuroprotective. The investigators would like to proove that the use of magnesium sulfate as neuroprotective in premature fetuses would improve the fetal heart rate by increasing variability.

In the literature there are numerous publications on the effects of magnesium sulfate used as tocolytic (higher doses) in the threats of premature labour, generally showing a variability and number accelerations decreases without increase the number of decelerations. Is this effect is the same as the doses used for fetal neuroprotection?

Expected benefits of the research:

Magnesium sulfate used on premature infants for fetal neuroprotection has an impact on fetal heart rate, including variability and number of accelerations.

study_type: Observational

time_perspective: Prospective

lead_sponsor: CHU de Reims

lead_sponsor_type: academique


title: Mitochondrial Dysfunction of Alveolar and Circulating Immune Cells During Acute Respiratory Distress Syndrome: Impact of Infectious Aggression and Alveolar Stretching as a Result of Mechanical Ventilation.

acronym: PNEUMOCHONDRIE

summary:
Sepsis leads to a deregulated host response that can lead to organ failure. During sepsis, experimental and clinical data suggest the occurrence of mitochondrial dysfunctions, particularly in circulating muscle and monocytes, which may contribute to organ failure and death.

Lower respiratory infection is the leading cause of death from infectious causes. Mechanical ventilation (MV) is required in 20% of cases of bacterial pneumopathy with Streptococcus pneumoniae (S.p.) , with mortality reaching 50%. There are then frequently criteria for acute respiratory distress syndrome (ARDS), combining bilateral lung involvement and marked hypoxemia.

Cyclic stretching of lung cells induced by MV causes sterile inflammation and tissue damage (i.e. ventilator-induced lung injury [VILI]), which can cause cellular dysfunction that alter the immune response, particularly during ARDS. This is why the application of a so-called protective MV is then required. However, this does not prevent about one-third of patients from showing signs of alveolar overdistension, as evidenced by an increase in motor pressure (MP) (MP≥ 15 cmH2O), associated with an increase in mortality.

The deleterious effects of MV could be explained by the occurrence of mitochondrial abnormalities. Indeed, the cyclic stretching of lung cells leads to dysfunction in the respiratory chain and the production of free oxygen radicals (FOS), altering membrane permeability. These phenomena could promote VILI, facilitate the translocation of bacteria from the lung to the systemic compartment and lead to alterations in immune response.

In our model of S.p. pneumopathy in rabbits, animals on MV develop more severe lung disorders (lack of pulmonary clearance of bacteria, bacterial translocation in the blood, excess mortality), compared to animals on spontaneous ventilation (SV). Intracellular pulmonary mitochondrial DNA (mtDNA) concentrations, a reflection of the mitochondrial pool, are significantly decreased in ventilated rabbits compared to SV rabbits and in infected rabbits compared to uninfected rabbits. At the same time, the mitochondrial content of circulating cells decreased early (H8) in all infected rabbits, but was only restored in rabbits in SV, those who survived pneumonia (Blot et al, poster ECCMID 2015, submitted article). These data suggest an alteration in the mechanisms that restore mitochondrial homeostasis (mitochondrial biogenesis and mitophagy) during the dual infection/MV agression, which may explain the observed excess mortality. Other work by our team illustrates the importance of these phenomena by showing in a mouse model of polymicrobial infection that inhibition of mitophagia in macrophages promotes survival (Patoli et al, in preparation). Human data on this subject are non-existent.

The phenomena of mitochondrial dysfunction nevertheless deserve to be explored in humans during the combined MV/pneumopathy aggression in order to understand its possible impact on the effectiveness of the host's immune response. In a personalized medicine approach, these data would open up prospects for targeted therapies, capable of activating mitochondrial biogenesis and/or modulating mitophagia, to prevent organ dysfunction and mortality during severe CALs treated with antibiotic therapy.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Blot M, Jacquier M, Aho Glele LS, Beltramo G, Nguyen M, Bonniaud P, Prin S, Andreu P, Bouhemad B, Bour JB, Binquet C, Piroth L, Pais de Barros JP, Masson D, Quenot JP, Charles PE; Pneumochondrie study group. CXCL10 could drive longer duration of mechanical ventilation during COVID-19 ARDS. Crit Care. 2020 Nov 2;24(1):632. doi: 10.1186/s13054-020-03328-0. Erratum in: Crit Care. 2021 Apr 13;25(1):143.

family: Blot

full_name: Mathieu Blot

given: Mathieu

sequence: first

family: Jacquier

full_name: Marine Jacquier

given: Marine

sequence: additional

family: Aho Glele

full_name: Ludwig-Serge Aho Glele

given: Ludwig-Serge

family: Beltramo

full_name: Guillaume Beltramo

given: Guillaume

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Bonniaud

full_name: Philippe Bonniaud

given: Philippe

family: Prin

full_name: Sebastien Prin

given: Sebastien

family: Andreu

full_name: Pascal Andreu

given: Pascal

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Bour

full_name: Jean-Baptiste Bour

given: Jean-Baptiste

family: Binquet

full_name: Christine Binquet

given: Christine

family: Piroth

full_name: Lionel Piroth

given: Lionel

family: Pais de Barros

full_name: Jean-Paul Pais de Barros

given: Jean-Paul

family: Masson

full_name: David Masson

given: David

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Charles

full_name: Pierre-Emmanuel Charles

given: Pierre-Emmanuel

family: Aptel

full_name: François Aptel

given: François

family: Dargent

full_name: Auguste Dargent

given: Auguste

family: Georges

full_name: Marjolaine Georges

given: Marjolaine

family: Labruyère

full_name: Marie Labruyère

given: Marie

family: Lagrost

full_name: Laurent Lagrost

given: Laurent

family: Large

full_name: Audrey Large

given: Audrey

family: Monier

full_name: Serge Monier

given: Serge


title: Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

acronym: prevessure

summary:
Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Phase II Randomized Study in Patients With Upper Aerodigestive Tract Cancer

acronym: ESMULLLAT

summary:
Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy.

Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment.

The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days.

Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Treatment


title: Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced Natural Killer Cells Mediated (NK-mediated) Rejection

acronym: STARR

summary:
Background:

Long-term success of organ transplantation is limited by the inexorable loss of graft function due to rejection. Prevalent dogma defends that allograft rejection is exclusively mediated by the adaptive immune system: T cells are responsible for cellular rejections and B cells producing Donor Specific Antibodies (DSA) are responsible for humoral rejection. Recently, we demonstrated that innate NK cells could be implicated in the generation of chronic vascular rejections lesions by sensing the absence of expression of self Major Histocompatibility Complex (MHC) class I molecules ("missing self") on graft endothelial cells with their Killer cell immunoglobulin-like (KIR) receptors. Using human in vitro and murine in vivo models, we also showed that Mammalian Target Of Rapamycin (mTOR) inhibitors could efficiently prevent this new kind of rejection.

Objective:

The aim of our project is therefore to test in a cohort of kidney transplanted patients the efficiency of mTOR inhibitors to treat this new kind of rejection

Methods:

A cohort of 20 kidney transplant patients with a missing self on their graft responsible for a NK-mediated rejection will be established prospectively. An mTOR inhibitor will be introduced in these patients for 6 months in association with a calcineurin inhibitor and corticosteroids. Graft function, histological lesions and NK activability will be monitored following this modification of treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de transplantation, néphrologie et immunologie clinique, Hôpital Edouard Herriot (HCL)

intervention_type: Drug

status_simplified: Ongoing


title: Needs Assessment of Cancer Patients With Complementary and Alternative Medicines

acronym: MAC'EVAL

summary: The chronic cancer status, multidisciplinary and ambulatory care, as well as the cumbersome effects of the disease and treatments, lead patients to consider other options than those offered by traditional medicine, such as alternative medicine and complementary (CAM)

status: Unknown status

ReferenceType: result

ReferenceCitation: Bernstein BJ, Grasso T. Prevalence of complementary and alternative medicine use in cancer patients. Oncology (Williston Park). 2001 Oct;15(10):1267-72; discussion 1272-8, 1283.

ReferenceCitation: Naja F, Anouti B, Shatila H, Akel R, Haibe Y, Tfayli A. Prevalence and Correlates of Complementary and Alternative Medicine Use among Patients with Lung Cancer: A Cross-Sectional Study in Beirut, Lebanon. Evid Based Complement Alternat Med. 2017;2017:8434697. doi: 10.1155/2017/8434697. Epub 2017 Aug 24.

name: Department of Nutrition and Food Sciences, American University of Beirut, Riad El Solh, Beirut 1107 2020, Lebanon

family: Naja

full_name: Farah Naja

given: Farah

name: Department of Internal Medicine, Division of Hematology/Oncology, American University of Beirut Medical Center, Riad El Solh, Beirut 1107 2020, Lebanon

family: Anouti

full_name: Bilal Anouti

given: Bilal

family: Shatila

full_name: Hibeh Shatila

given: Hibeh

family: Akel

full_name: Reem Akel

given: Reem

family: Haibe

full_name: Yolla Haibe

given: Yolla

family: Tfayli

full_name: Arafat Tfayli

given: Arafat

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Evidence-Based Complementary and Alternative Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

ReferenceCitation: Ernst E, Cassileth BR. The prevalence of complementary/alternative medicine in cancer: a systematic review. Cancer. 1998 Aug 15;83(4):777-82. Review.

ReferenceCitation: Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M. How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther. 2012 Sep;11(3):187-203. doi: 10.1177/1534735411423920. Epub 2011 Oct 21. Review.

apc_source: doaj

family: Horneber

full_name: Markus Horneber

given: Markus

name: Vivantes Klinikum Neukoelln, Berlin, Germany

family: Bueschel

full_name: Gerd Bueschel

given: Gerd

family: Dennert

full_name: Gabriele Dennert

given: Gabriele

family: Less

full_name: Danuta Less

given: Danuta

family: Ritter

full_name: Erik Ritter

given: Erik

family: Zwahlen

full_name: Marcel Zwahlen

given: Marcel

journal_name: Integrative Cancer Therapies

oa_host_type: publisher

title: How Many Cancer Patients Use Complementary and Alternative Medicine

ReferenceCitation: Garland SN, Valentine D, Desai K, Li S, Langer C, Evans T, Mao JJ. Complementary and alternative medicine use and benefit finding among cancer patients. J Altern Complement Med. 2013 Nov;19(11):876-81. doi: 10.1089/acm.2012.0964. Epub 2013 Jun 18.

name: Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

name: Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

name: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

journal_name: The Journal of Alternative and Complementary Medicine

title: Complementary and Alternative Medicine Use and Benefit Finding Among Cancer Patients

ReferenceCitation: Samuels N, Ben-Arye E, Maimon Y, Berger R. Unmonitored use of herbal medicine by patients with breast cancer: reframing expectations. J Cancer Res Clin Oncol. 2017 Nov;143(11):2267-2273. doi: 10.1007/s00432-017-2471-x. Epub 2017 Jun 30.

journal_name: Journal of Cancer Research and Clinical Oncology

ReferenceCitation: Ben-Arye E, Samuels N, Goldstein LH, Mutafoglu K, Omran S, Schiff E, Charalambous H, Dweikat T, Ghrayeb I, Bar-Sela G, Turker I, Hassan A, Hassan E, Saad B, Nimri O, Kebudi R, Silbermann M. Potential risks associated with traditional herbal medicine use in cancer care: A study of Middle Eastern oncology health care professionals. Cancer. 2016 Feb 15;122(4):598-610. doi: 10.1002/cncr.29796. Epub 2015 Nov 24.

name: Integrative Oncology Program, The Oncology Service and Lin Medical Center, Clalit Health Services; Haifa and Western Galilee District Israel

name: Complementary and Traditional Medicine Unit, Department of Family Medicine, Faculty of Medicine, Technion-Israel Institute of Technology; Haifa Israel

name: Tal Center for Integrative Oncology, Institute of Oncology, Sheba Medical Center; Tel Hashomer Israel

name: Clinical Pharmacology Unit, Haemek Medical Center; Afula Israel

name: Center for Palliative Care Research and Education, Dokuz Eylul University; Inciralti Izmir Turkey

name: Faculty of Nursing; Jordan University of Science and Technology; Irbid Jordan

name: Department of Internal Medicine and Integrative Medicine Service; Bnai-Zion Hospital; Haifa Israel

name: Department for Complementary Medicine, Law and Ethics, The International Center for Health, Law and Ethics; Haifa University; Israel

name: Bank of Cyprus Oncology Center; Nicosia Cyprus

name: Sheikh Khalifa Medical City; Abu Dhabi United Arab Emirates

name: Makassed Charitable Hospital; East Jerusalem Israel

name: Division of Oncology, Rambam Health Care Campus; Haifa Israel

name: Dr. A.Y Ankara Oncology Training and Research Hospital; Ankara Turkey

name: National Center for Cancer Care and Research; Doha Qatar

name: Botany Department; National Research Centre; Dokki Giza Egypt

name: Qasemi Research Center, Al-Qasemi Academy; Baqa El-Gharbia Israel

name: Faculty of Arts and Sciences; Arab American University; Jenin Palestinian Authority

name: Department of Cancer Prevention; Ministry of Health; Amman Jordan

name: Cerrahpasa Medical Faculty; Istanbul University; Istanbul Turkey

name: Middle East Cancer Consortium; Haifa Israel

ReferenceCitation: Richardson MA, Sanders T, Palmer JL, Greisinger A, Singletary SE. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000 Jul;18(13):2505-14.

ReferenceCitation: Sparber A, Bauer L, Curt G, Eisenberg D, Levin T, Parks S, Steinberg SM, Wootton J. Use of complementary medicine by adult patients participating in cancer clinical trials. Oncol Nurs Forum. 2000 May;27(4):623-30.

ReferenceCitation: Cassileth BR, Schraub S, Robinson E, Vickers A. Alternative medicine use worldwide: the International Union Against Cancer survey. Cancer. 2001 Apr 1;91(7):1390-3.

ReferenceCitation: Patterson RE, Neuhouser ML, Hedderson MM, Schwartz SM, Standish LJ, Bowen DJ, Marshall LM. Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs. J Altern Complement Med. 2002 Aug;8(4):477-85.

ReferenceCitation: Swisher EM, Cohn DE, Goff BA, Parham J, Herzog TJ, Rader JS, Mutch DG. Use of complementary and alternative medicine among women with gynecologic cancers. Gynecol Oncol. 2002 Mar;84(3):363-7.

ReferenceCitation: Molassiotis A, Panteli V, Patiraki E, Ozden G, Platin N, Madsen E, Browall M, Fernandez-Ortega P, Pud D, Margulies A. Complementary and alternative medicine use in lung cancer patients in eight European countries. Complement Ther Clin Pract. 2006 Feb;12(1):34-9. Epub 2005 Nov 14.

ReferenceCitation: Frenkel M, Cohen L. Effective communication about the use of complementary and integrative medicine in cancer care. J Altern Complement Med. 2014 Jan;20(1):12-8. doi: 10.1089/acm.2012.0533. Epub 2013 Jul 17. Review.

name: Integrative Medicine Program, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

title: Effective Communication About the Use of Complementary and Integrative Medicine in Cancer Care

ReferenceCitation: Blödt S, Mittring N, Schützler L, Fischer F, Holmberg C, Horneber M, Stapf A, Witt CM. A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study. BMC Cancer. 2016 Nov 4;16(1):843.

ReferenceCitation: Fong YK, Marihart S, Harik M, Djavan B. Preventing progression in men with mild symptoms of benign prostatic hyperplasia: a potential role for phytotherapy. Rev Urol. 2004 Fall;6(4):187-92.

ReferenceCitation: Kim SW. Phytotherapy: emerging therapeutic option in urologic disease. Transl Androl Urol. 2012 Sep;1(3):181-91. doi: 10.3978/j.issn.2223-4683.2012.05.10. Review.


title: Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure

acronym: FAIR-PROGRESS

summary: The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients: a Randomized Controlled Study

acronym: PRIMIV

summary: Oocyte vitrification after in vitro maturation (IVM) is one of the main techniques for preserving female fertility before chemotherapy for breast cancer. In this technique, originally developed for patients with ovarian pathology, polycystic ovarian syndrome, induction of an LH peak has been shown to improve outcomes. Young women with breast cancer, who are candidates for urgent fertility preservation, do not have ovarian pathology. The objective of the present study is to assess whether the absence of therapeutic intervention prior to oocyte retrieval for IVM in these patients is at least as effective as the injection of hCG or GnRH agonist used in routine practice.

primary_purpose: Supportive Care

ReferenceCitation: Sonigo C, Le Conte G, Boubaya M, Ohanyan H, Pressé M, El Hachem H, Cedrin-Durnerin I, Benoit A, Sifer C, Sermondade N, Grynberg M. Priming Before In Vitro Maturation Cycles in Cancer Patients Undergoing Urgent Fertility Preservation: a Randomized Controlled Study. Reprod Sci. 2020 Dec;27(12):2247-2256. doi: 10.1007/s43032-020-00244-0. Epub 2020 Jul 2.

family: Sonigo

full_name: Charlotte Sonigo

given: Charlotte

family: Le Conte

full_name: Grégoire Le Conte

given: Grégoire

family: Boubaya

full_name: Marouane Boubaya

given: Marouane

family: Ohanyan

full_name: Haykanush Ohanyan

given: Haykanush

family: Pressé

full_name: Marion Pressé

given: Marion

family: El Hachem

full_name: Hady El Hachem

given: Hady

family: Cedrin-Durnerin

full_name: Isabelle Cedrin-Durnerin

given: Isabelle

family: Benoit

full_name: Alexandra Benoit

given: Alexandra

family: Sifer

full_name: Christophe Sifer

given: Christophe

family: Sermondade

full_name: Nathalie Sermondade

given: Nathalie

family: Grynberg

full_name: Michaël Grynberg

given: Michaël

journal_name: Reproductive Sciences

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hôpital Jean Verdier


title: Platino-resistance in Ovarian Cancer

acronym: PlatinOv

summary:
Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages).

Patients will receive treatment (platinum based-chemotherapy) according to the standard practices.

A prospective database and an associated biological collection will be performed during 5 years:

For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study).

Study participation of each patient will be 5 years.


title: A Randomized Controlled Pilot Study Evaluating the Effect of Dexmedetomidine on Phenylephrine Response During Refractory Septic Shock

acronym: Adress-Pilot

summary:
Septic shock is common in patients admitted to intensive care and hospital mortality occurs in close to 50% of these patients. In half of the cases, death occurs within the first 72 hours in a context of multiple organ failure that does not respond to conventional therapies, particularly circulatory therapies, despite increasing doses of catecholamines. Vasopressor resistance in septic patients defines refractory septic shock. In one study (Conrad et al. 2015), the increase in blood pressure observed with an infusion of increasing doses of phenylephrine (dose-response curve) made it possible to quickly and clearly identify patients resistant to vasopressors at a high risk of death by refractory shock (ROC AUC 0.92). This resistance is due in particular to a downregulation of α1 adrenergic receptors, linked to sympathetic hyper activation associated with septic shock. To date, there is no validated therapy in this situation. However, experimental data have shown that the administration of α2 agonists, usually used for their sedative (dexmedetomidine) or anti-hypertensive (clonidine) effect, normalizes sympathetic activity towards basal values. In animals, α2 agonists restore the sensitivity of alpha1 adrenergic receptors, resulting in improved vasopressor sensitivity and survival. In humans, a beneficial effect on mortality was suggested in the first trial testing dexmedetomidine in septic patients in 2017. This effect was observed especially in the most severe patients, suggesting a restoration of sensitivity to vasopressors.

The hypothesis is that the administration of dexmedetomidine in patients in refractory septic shock may improve response to phenylephrine and decrease resistance to vasopressors. This pilot study could lay the foundation for a randomized controlled trial.

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Other Identifier

title: Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

acronym: COMING

summary:
Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.

The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.


title: Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

acronym: SMD

summary:
Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality.

Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.

lead_sponsor: Hopital Foch


title: Presence and Impact of CD73+ Th1.17 and of the CD39/CD73/Adenosine Cascade in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)

acronym: LAdoRIC

summary: Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX)) and the response to this treatment.

location_facility: Service de Rhumatologie, Centre Hospitalier Lyon-Sud (HCL)


title: Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy

acronym: GIRAFE

summary:
This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer.

Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT.

For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment.

3 recontouring modalities will be evaluated for the study:

Manuel recontouring (standard method)
Precise ART™ deformed contours
Precise RTX™ deformed contours

The total duration of the study for each patient will be 7 weeks.

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)


title: Value of Cardiac Output Monitoring by Supra-sternal Doppler/Echocardiography in Intensive Care Unit

acronym: SSdopler

summary: The aim of this study is to evaluate the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring in intensive care patients already equipped with an invasive monitoring. This invasive monitoring consists of catheters used to measure the cardiac output allowing the supply of organs and is installed when there is need to monitor the blood flow in different hemodynamic reasons. The patient's care will not be modified, the study just requires a supplementary measure in an exam already perform in the standard care. The principal hypothesis is that we can show a concordance between this non-invasive measure and the standard invasive monitoring.


title: Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research

acronym: OrMePro

summary: The aim of the study is the development of the organoid culture technique from metastases from patients with advanced form of prostate cancer. Once the technique is set up, the organoid will serve to test several antitumor molecules.

primary_purpose: Basic Science

lead_sponsor: Centre Antoine Lacassagne


title: Detection by Digital PCR and Next Generation Sequencing of Recurrent Mutations in Waldenström's Disease and Study of Their Distribution in the Different Biological Compartments

acronym: DigiWAL

summary:
Waldenström's disease (WM) is a rare, low-grade lymphoid hematopathy, accounting for 1 to 2% of malignant hematopathies and mainly affecting the elderly. This disease is characterized by lymphoplasmocyte cells infiltration into the bone marrow and by the production of a monoclonal IgM protein in the serum. This disease is accompanied by clinical manifestations of hepato-splenomegaly, signs of hyperviscosity, peripheral neuropathies and biological signs with the presence of cytopenias and cryoglobulinemia. Some forms present node or splenic involvement. While the asymptomatic form maintains overall survival close to that of the healthy subject, the symptomatic form is subject to frequent relapses and remains incurable.

Current recommendations for the diagnosis and monitoring of this disease are based on protein electrophoresis from a blood sample to quantify monoclonal IgM production and a myelogram or bone marrow biopsy showing medullary infiltration by lymphoplasmocytic cells. However, protein electrophoresis is an imprecise examination since it does not quantify tumour B lymphocytes and has limitations, particularly in the case of poorly secreting forms.

More than 90% of Waldenström cases have the L265P mutation of the MYD88 gene. Although this mutation is not found only in these diseases, it can help in the diagnosis. Other mutations are also present in this pathology. These mutations can define prognostic factors or possibly make it possible to identify therapeutic targets.

The development of new technologies makes it possible, on the one hand, to follow the L265P mutation of MYD88 over time as a marker of response to treatment and, on the other hand, to define these prognostic markers or therapeutic targets.

This study will first determine the best method for monitoring the mutation of MYD88. In a second step, the investigators will evaluate the best type of sampling and in particular whether this mutation is present in the blood in order to limit the invasive procedures such as bone marrow sampling can be limited. Finally, the investigators will evaluate the prognostic

lead_sponsor: Centre Henri Becquerel


title: Evaluation of Interest of a Systematic Screening for Oncological Supportive Care

acronym: DBSOS

summary: Monocentric, descriptive, cross-sectional, interventional, prospective and non-randomized study.

lead_sponsor: Centre Paul Strauss


title: Clinical and Radiological Impact of Tibial Cutting Int Total Knee Arthroplasty, Accelerated Navigation Versus Extramedullary Targeting : a Randomized Prospective Study

summary:
Type of study :

Superiority study, comparative, randomized, double-blind (patient and evaluator will be blind from the randomization group), multicenter, prospective inclusion. Two groups of patients will be compared: a group of patients whose tibial sections will be performed using extramedullary mechanical sighting and a group whose tibial sections will be performed using gyroscopic and accelerometric navigation (I-Assist) will be randomized. Randomization will be performed with a 1/1 ratio per block.

Population :

Patients requiring 1st line total knee replacement for gonarthrosis with a Hip knee angle (HKA) between 170° and 183° who have agreed to participate in the study. Patients who have already undergone surgery on the same knee (uni-compartmental prosthesis, total knee replacement, tibial or femoral osteotomy for re-alignment, with the exception of arthroscopy) or who have vicious calls will not be included in the study.

The number of subjects required was calculated using NQUERY 4.0 software for the main endpoint data, with the following assumptions: 51% of patients reaching the tibial cut target angles for the "extramedullary mechanical aiming" technique and 68% of patients reaching the tibial cut target angles for the I-Assist gyroscopic and accelerometric navigation technique. With an alpha risk of 5%, a power of 90%, and bilateral test, the number was estimated at 174 per group. Taking into account a percentage of included patients for whom total knee arthroplasty will not be performed of 10%, it is planned to include a total of 382 patients.

Main judgment criteria :

Achievement of the target tibial slope of 3°+/-2° and the target tibial varus/valgus at +/-2°. The tibial slope is defined by the angle (in degrees) between the mechanical axis of the tibia in profile and the tangent to the tibial cut. The varus/valgus tibial is the angle formed between the mechanical axis of the front tibia and the tangent to the tibial cut.

Investigation plan :

Proposal to participate in the research to any eligible patient at the time of a preoperative consultation with the orthopaedic surgeon. If the patient agrees to participate in the research (signature of the informed consent form), a randomization will be performed to determine the group of bone cutting technique. The patient will be blind to the result of randomization.

The clinical follow-up of the patient will not be modified by the study, with as usual:

A 6-week consultation with interrogation, clinical and radiographic examination (Face and profil x-rays, axial patella views)
A 3-month consultation with interrogation, clinical and radiographic examination (Face and profil x-rays, axial patella views, telemetry of the lower limbs in charge and full profile leg x-rays).
Measurements of the radiographic judgement criteria will be performed by two orthopaedic surgeons and a blind radiologist of the cutting technique used. The tibial slope will be analyzed on the entire leg radiograph in profile at 3 months. Coronal alignment will be studied on telemetry of the front lower limbs loaded at 3 months.
Joint amplitudes and patient satisfaction will be assessed at 3 months postoperatively with the New IKS score, by a blind surgeon of the surgical technique used.

Statistical analysis plan :

Comparison of the characteristics of the 2 groups
Analysis of the main endpoint: comparison of the percentage of patients with the target tibial slope achieved in both groups by Chi2 test or an accurate Fisher test, depending on the application conditions.
Analysis of secondary judgment criteria by Student, Wilconxon, Chi2 or exact Fisher tests, depending on the application conditions.

intervention_type: Procedure


title: Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients: Pilot Study (The Water Study)

acronym: WATER

summary:
In ICU and operating theatre, fluid expansion is the main hemodynamic therapeutic. The objective of fluid expansion is to increase cardiac output thus arterial oxygen delivery to match patient's oxygen consumption. To date, it has been shown that all fluid expansion solutions may have side effects (hydro-electrolytic disorder, renal failure, hydro-sodium overload, etc.) that may limit their use.

Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), that of oral water vary in the literature depending on the physiological state of the patient and the clinical state. Oral water can change cardiac output and blood pressure through various physiological effects: increased blood volume, recruitment of splanchnic blood volume, and peripheral vasoconstriction. Usually, ICU patients have feeding through nasogastric tube.

To date, no study has studied the effect of a given amount of enteral cardiovascular system in ICU patients. The objective of this study is to describe the effect of oral water administration on the cardiovascular system of patients during the optimization and/or hemodynamic stabilization phase. The comparison of groups (water/ physiological saline) would allow us: (1) to describe the cardiovascular effects of water in the resuscitation patient, (2) to compare these cardiovascular effects with those of saline solution, (3) to have the data to design further study.

ReferenceCitation: Guinot PG, Nguyen M, Duclos V, Soudry-Faure A, Bouhemad B; Water Study Group. Oral water ingestion in the treatment of shock patients: a prospective randomized study. Intensive Care Med. 2020 Nov;46(11):2111-2112. doi: 10.1007/s00134-020-06215-y. Epub 2020 Aug 26.

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Duclos

full_name: Valerian Duclos

given: Valerian

family: Soudry-Faure

full_name: Agnes Soudry-Faure

given: Agnes

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

journal_name: Intensive Care Medicine


title: Care of AcromioClavicular Arthropathy in Manual Medicine Versus Corticosteroid Infiltration : Non-inferiority Study

summary:
Acromioclavicular pains are one of the etiologies of shoulder pains, the prevalence of which is relatively high, ranging from 5 to 47% in the general population. The cause is usually degenerative, occurring mainly after the age of 40, especially in male manual workers. This pathology is described as the great forger of the shoulder, ignored by clinicians because it is often uninvestigated, whereas an interrogation and a complete clinical examination are sufficient to make the diagnosis.

Acromioclavicular pathologies are better known to orthopaedic surgeons, particularly in traumatic pathologies but also in degenerative pathologies. However, before operating on acromioclavicular osteoarthritis, interventions whose results are sometimes disappointing, a well-managed medical treatment usually helps to relieve pain.

The precise clinical examination and a radiological examination focused on the joint make it possible to diagnose acromioclavicular arthropathy, the key is to think about it and look for it.

Care includes explanation of the diagnosis, drug treatments, physiotherapy techniques and self-exercise as well as osteoarticular manipulations, which are less frequently practiced or performed in isolation outside the medical setting.

The results of the different treatments have been little studied, with studies that don't always allow us to distinguish several etiologies of shoulder pains. Most studies compare surgical techniques with each or with medical techniques. However, there are very few studies comparing traditional medical care with manual medicine.

In order to compare the different non-surgical therapies for the care of acromioclavicular arthropathies of degenerative origin, the investigators propose a dedicated study.

This is a non-inferiority, prospective, open, randomized, two-armed study comparing the efficacy of manipulations by a physician with a training in manual medicine versus cortisone infiltration Under ultrasound control.

After diagnosis of degenerative pathology of the acromioclavicular joint, patients meeting the inclusion criteria will be randomized to the infiltration arm or to the manipulations arm.

The assessment will be based on the pain during and after the procedure.

ReferenceCitation: Michaut A, Planche L, Auzanneau L, Cormier G. Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study. BMJ Open. 2020 Dec 10;10(12):e034439. doi: 10.1136/bmjopen-2019-034439.

family: Michaut

full_name: Alexia Michaut

given: Alexia

family: Planche

full_name: Lucie Planche

given: Lucie

family: Auzanneau

full_name: Lucie Auzanneau

family: Cormier

full_name: Grégoire Cormier

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Impact of a Strategy Dedicated to Low Health Literacy Level Patients to Improve Their Understanding and Ownership of the Discharge Prescription in Cardio-vascular Diseases

acronym: ILIADE

summary:
Health literacy is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. Level of Health Literacy (HL) is low or limited within 47% of interrogated people in Europe, resulting in an inability to understand and/or use written texts and digital concepts about one's health.

There is a demonstrated link between low HL and low therapeutic adherence, an increase in the number of re-admissions, and more generally poor health or survival that is even more limited. An association between low LS and higher health care costs has also been reported in the USA and Switzerland. WHO highlight the central role of LS in health inequalities, regardless of the region of the world.

We chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF), as these patients have cumulative risk factors for misuse and medication errors. They are hospitalized in emergency, for shorter and shorter periods and are discharged with complex drug treatments. The data show that the return home after acute hospitalization for these conditions is a particularly high-risk period for medication errors and misuse, especially with low HL. The proportion of patients with preventable ADR in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months.

Our hypothesis is that in patients hospitalized for AMI or ADHF with low HL levels, information on discharge treatment using appropriate tools and techniques will reduce the risk of patient-related medication errors or misuse within 30 days of discharge.

The purpose of this study is to develop an educational intervention model adapted to low HL levels and routinely feasible, even in case of short stays, in complementarity with traditional therapeutic education programmes that require higher investments and are therefore not accessible to all patients. This innovative approach could then be applied to a large number of chronic diseases.

status: Not yet recruiting

primary_purpose: Health Services Research


title: Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation

summary: The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.


title: FUSION EVALUATION AFTER ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH STAND ALONE LOCKING CAGE WITH BLADE HRCC®

summary: Cervical degenerative disease is an almost universal concomitant of human aging. Over half of the middle aged population has cervical spondylosis. This condition is often asymptomatic, but in 10% to 15% of the cases, it is associated with, or progresses to, neural compression. Cervical spondylotic radiculopathy is a condition due to a root nerve compression while cervical spondylotic myelopathy is a condition due to a medullar cord compression. Root nerve or medullar cord can be compressed either by a soft disc extrusion or by arthrosis due to a degenerative disc. Anterior cervical discectomy and fusion is the standard surgical treatment of the cervical radiculopathy or cervical myelopathy when non-surgical treatment failed. The aim of this surgery is to provide a neurologic decompression associated to spine stabilization. Decompression is achieved by removal the disc and soft disc extrusion if present. Stabilization is supported by implantation of material in the interbody space like bone or cage with bone substitute. This cage provides a bone fusion matrix and an intervertebral height and stability support at the same time. To enforce the stabilization, a plate can be screwed on the anterior cervical vertebral wall. The HRCC® cage is a stand-alone cage with two rotary blades which penetrate into vertebral bone so there is no need to implant plate. One of the reasons why treatment can fail is the pseudarthrosis that is fusion failure. It mays occur as an increase of axial pain or radicular pain. The aim of this study is to demonstrate similar results on bone fusion in the surgical treatment of cervical radiculopathy or myelopathy with HRCC cage used in anterior cervical discectomy and fusion compared with other technics based on a prospective cohort study and a literature review. As secondary outcomes we will search to correlate pseudarthrosis and quality of life impact, to identify complications and to describe the sagittal balance evolution of the cervical spine. To this end, in the context of standard practices, patients who consult the neurosurgical team of the REIMS University Hospital Center with a diagnosis of a cervical radiculopathy or myelopathy with non-surgical treatment failure needing a one level anterior cervical discectomy and fusion will be proposed to be included during this pre-operative consultation. There will be pre-operative collected data about demographic data, pseudarthrosis risk factors, pre-operative symptomatology, quality of life data and pre-operative imagery data. Per-operative and hospitalization data are collected as well with surgery duration, blood lost, surgical technic, pain measurement and hospitalization duration. Next, follow-up starts with consultations at 6 weeks, 6 months and 12 months and pain, quality of life and classic X-Ray data are collected to be compared with pre-operative data. And Imagery data are collected in order to identify presence or absence of pseudarthrosis with dynamic X-Ray and CT-scan at 6 months and 12 months. A statistical analysis of the data is next performed to found significant results.


title: Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors

summary: The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.

intervention_type: Radiation


title: Association Between Presence and Parental Participation in Perinatal Care and Child Psychiatric Profile at 24 Months After Preterm Birth

acronym: parentpart

summary: The aims of the study is to evaluate the association between presence and parental participation in perinatal care and psychic development of the child at 24 months


title: Cutibacterium Acnes in Bone and Joint Infections

acronym: CaBJI

summary: Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.


title: Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.

acronym: CAMIK

summary: Arthrogenic Muscle Inhibition (AMI) is one of the classic complications occurring in the aftermath of knee trauma; AMI is grossly defined as a lack of extension due to quadriceps inhibition and hamstring contracture. However, its origins remains unknown with a strong suspicion for a central brain origin. It could be the missing link explaining this lack of extension following an anterior cruciate ligament (ACL) rupture. The primary hypothesis of this study is that a difference in activation of motor brain areas exists in patients with an ACL rupture, between those with AMI or without. The second hypothesis is that this difference could be seen on brain functional MRI.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

intervention_type: Diagnostic Test


title: Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery

acronym: BDD RAAC

summary: Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).

time_perspective: Cross-Sectional

ReferenceCitation: Lambaudie E, de Nonneville A, Brun C, Laplane C, N'Guyen Duong L, Boher JM, Jauffret C, Blache G, Knight S, Cini E, Houvenaeghel G, Blache JL. Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center. BMC Surg. 2017 Dec 28;17(1):136. doi: 10.1186/s12893-017-0332-9.

family: Lambaudie

full_name: Eric Lambaudie

given: Eric

family: de Nonneville

full_name: Alexandre de Nonneville

given: Alexandre

family: Brun

full_name: Clément Brun

given: Clément

family: Laplane

full_name: Charlotte Laplane

given: Charlotte

family: N’Guyen Duong

full_name: Lam N’Guyen Duong

given: Lam

family: Boher

full_name: Jean-Marie Boher

given: Jean-Marie

family: Jauffret

full_name: Camille Jauffret

given: Camille

family: Blache

full_name: Guillaume Blache

given: Guillaume

family: Knight

full_name: Sophie Knight

given: Sophie

family: Cini

full_name: Eric Cini

family: Houvenaeghel

full_name: Gilles Houvenaeghel

given: Gilles

full_name: Jean-Louis Blache

given: Jean-Louis

journal_name: BMC Surgery

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

lead_sponsor: Institut Paoli-Calmettes


title: Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery

acronym: BS-Women

summary: The aim of the study was to analyse eating rate in comparison to other aspects of eating habits in women suffering from severe/massive obesity.

ReferenceType: background

ReferenceCitation: Canterini CC, Gaubil-Kaladjian I, Vatin S, Viard A, Wolak-Thierry A, Bertin E. Rapid Eating is Linked to Emotional Eating in Obese Women Relieving from Bariatric Surgery. Obes Surg. 2018 Feb;28(2):526-531. doi: 10.1007/s11695-017-2890-4.


title: Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students

acronym: InforMed

summary: Two programmes have been built to prevent suicidal ideation; one focuses on stress management based on cognitive and behavioural principles and the other on health promotion.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer

acronym: APACO

summary: Various recent scientific data testify to the cognitive deficiencies of cancer patients, called Cancer-Related Cognitive Impairments (CRCI) (Noal, Daireaux & Joly, 2010). At the same time, regular physical activity (aerobic, muscle building, and yoga) has been shown to decrease CRCIs, although commonly used cognitive measures are self-reported (Zimmer et al., 2016). The investigators will develop an interventional study using objective measures of cognition to confirm the cause-and-effect relationship, and specify the orientation of the cognitive effects of the adapted physical activities. The main and original objective will be to determine if the cognitive functions most affected by CRCI (episodic memory, inhibition, treatment speed) can be optimized in patients undergoing treatment.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Behavioral


title: Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences

acronym: NETMRI

summary:
The aim of our study is to assess variability of measurements of liver metastases from neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.

In this institutional review board-approved retrospective study from January 2011 to December 2012, all liver MRIs performed at our department in patients with proven liver metastases from NETs and with at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST 1.1) were included.

ReferenceCitation: Lestra T, Kanagaratnam L, Mulé S, Janvier A, Brixi H, Cadiot G, Dohan A, Hoeffel C. Measurement variability of liver metastases from neuroendocrine tumors on different magnetic resonance imaging sequences. Diagn Interv Imaging. 2018 Feb;99(2):73-81. doi: 10.1016/j.diii.2017.12.009. Epub 2018 Jan 12.


title: Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients

acronym: COPILOT

summary: Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

location_facility: Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)


title: Non-invasive Assessment of Ventriculo Arterial Coupling Among Cirrhotics in Intensive Care Unit

acronym: VACCI

summary:
Cirrhotic in intensive care unit have a very specific haemodynamic status. Cardiovascular abnormalities in advanced liver cirrhosis are characterized by a hyperdynamic circulation featuring increased heart rate and high cardiac output, concomitant with decreased systemic vascular resistance. As liver cirrhosis progresses, cardiac dysfunction, known as cirrhotic cardiomyopathy, is associated with prognosis of these patients.

Specifically, diastolic dysfunction has been more emphasized for estimating clinical outcome in cirrhotic patients, whereas systolic dysfunction has limited prognostic implications in hepatorenal syndrome patients.

However, in most cirrhotic patients, cardiac dysfunction is latent and only manifests under stressful conditions because reduced ventricular contractility in these patients is masked by pronounced arterial vasodilation and increased arterial compliance. Therefore, a load-dependent index such as left ventricular ejection fraction is insensitive to detect systolic cardiac impairment in the resting state in cirrhotic patients. Hence, a more appropriate index is required to evaluate the integration of the ventricular and arterial systems in cirrhotic cardiovascular disorders.

Interaction between the left ventricle and the arterial system has been explained on the basis of end-systolic pressure-volume relation. Left ventricular end-systolic elastance (Ees), as quantified by the ratio of end-systolic pressure to end-systolic volume, is an index of the load-independent ventricular contractile state. Given this pressure-volume relationship, effective arterial elastance (Ea) can be calculated by the ratio of end-systolic pressure to stroke volume, indicating a net measure of arterial load. The ratio of these values (Ea/Ees), designated ventriculo-arterial coupling (VAC), represents the integrated interaction of the ventricular and arterial systems.

We can evaluate it with non-invasive echocardiographic method.

We analyse VAC among cirrhotic patients admitted in intensive care unit, with non-invasive echographic method thanks to records made from August 2018 to April 2019.

Hypothesis: VAC decrease from the baseline value when mean arterial pressure is improved.


lead_sponsor: University Hospital, Lille

acronym: REGALIA

type: EudraCT Number

source: euctr

title: RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation: a Prospective, Phase II Study by the SFGM-TC

summary:
Poor graft function (PGF) after allogeneic hematopoietic cell transplantation (allo-HCT) is a misunderstood complication associated with poor outcome and limited therapeutic options. Despite the lack of standardized diagnostic criteria, PGF is commonly defined as follows: one or several significant cytopenias after allo-HCT persisting or developing after allo-HCT despite full donor chimerism and in the absence of relapse or other causes. Not only PGF can alter patients' quality of life by leading to recurrent transfusions, bleeding events and infections, but it is also associated with poor survival after allo-HCT.

Although PGF is relatively frequent, there is no well-codified behavior in the literature or in the recommendations issued by the various learned societies of transplantation.

The aim objective of the investigator's study is to demonstrate that eltrombopag improve PGF after allo-HCT


title: Alteration of the Immune Response in Bacterial Infection

acronym: ARIIBACT

summary:
The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.

In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.

It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"

lead_sponsor: Versailles Hospital

intervention_type: Biological


title: Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).

acronym: ADPKDPD

summary: Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD.

ReferenceCitation: Sigogne M, Kanagaratnam L, Dupont V, Couchoud C, Verger C, Maheut H, Hazzan M, Halimi JM, Barbe C, Canivet E, Petrache A, Dramé M, Rieu P, Touré F. Outcome of autosomal dominant polycystic kidney disease patients on peritoneal dialysis: a national retrospective study based on two French registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Nephrol Dial Transplant. 2018 Nov 1;33(11):2020-2026. doi: 10.1093/ndt/gfx364.

ipd_sharing: Undecided

lead_sponsor: CHU de Reims


title: Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity.

acronym: ORNICA

summary:
Squamous cell carcinoma of the VADS represents the majority of cancers in ENT. Metastatic lymph node involvement is an important prognostic factor. In N0 patients clinically and scanographically, the prevalence of cervical lymph node metastasis remains important. Only the anatomopathological analysis of cervical lymph node dissection confirms the presence of a micro-metastasis. However, new criteria of interpretation in nuclear medicine seem promising in the detection of lymph node lesions not detectable in traditional imaging.

The main objective of this study is to study the positive predictive value (PPV) of CT scans in the anatomo-pathological analysis of N0 clinical and radiological or N + unilateral neck ganglia in patients with squamous cell carcinoma of the oral cavity.

ReferenceCitation: Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

ReferenceCitation: Arya S, Rane P, Deshmukh A. Oral cavity squamous cell carcinoma: role of pretreatment imaging and its influence on management. Clin Radiol. 2014 Sep;69(9):916-30. doi: 10.1016/j.crad.2014.04.013. Epub 2014 Jun 5.

ReferenceCitation: Schöder H, Carlson DL, Kraus DH, Stambuk HE, Gönen M, Erdi YE, Yeung HW, Huvos AG, Shah JP, Larson SM, Wong RJ. 18F-FDG PET/CT for detecting nodal metastases in patients with oral cancer staged N0 by clinical examination and CT/MRI. J Nucl Med. 2006 May;47(5):755-62.

ReferenceCitation: Ng SH, Yen TC, Chang JT, Chan SC, Ko SF, Wang HM, Lee LY, Kang CJ, Wong AM, Liao CT. Prospective study of [18F]fluorodeoxyglucose positron emission tomography and computed tomography and magnetic resonance imaging in oral cavity squamous cell carcinoma with palpably negative neck. J Clin Oncol. 2006 Sep 20;24(27):4371-6.

ReferenceCitation: Stoeckli SJ, Steinert H, Pfaltz M, Schmid S. Is there a role for positron emission tomography with 18F-fluorodeoxyglucose in the initial staging of nodal negative oral and oropharyngeal squamous cell carcinoma. Head Neck. 2002 Apr;24(4):345-9.

ReferenceCitation: Lee SJ, Choi JY, Lee HJ, Baek CH, Son YI, Hyun SH, Moon SH, Kim BT. Prognostic value of volume-based (18)F-fluorodeoxyglucose PET/CT parameters in patients with clinically node-negative oral tongue squamous cell carcinoma. Korean J Radiol. 2012 Nov-Dec;13(6):752-9. doi: 10.3348/kjr.2012.13.6.752. Epub 2012 Oct 12.

ReferenceCitation: Ryu IS, Kim JS, Roh JL, Cho KJ, Choi SH, Nam SY, Kim SY. Prognostic significance of preoperative metabolic tumour volume and total lesion glycolysis measured by (18)F-FDG PET/CT in squamous cell carcinoma of the oral cavity. Eur J Nucl Med Mol Imaging. 2014 Mar;41(3):452-61. doi: 10.1007/s00259-013-2571-z. Epub 2013 Oct 1.

ReferenceCitation: Chung MK, Jeong HS, Son YI, So YK, Park GY, Choi JY, Hyun SH, Kim HJ, Ko YH, Baek CH. Metabolic tumor volumes by [18F]-fluorodeoxyglucose PET/CT correlate with occult metastasis in oral squamous cell carcinoma of the tongue. Ann Surg Oncol. 2009 Nov;16(11):3111-7. doi: 10.1245/s10434-009-0621-3. Epub 2009 Jul 16.

lead_sponsor: University Hospital, Grenoble


type: Registry Identifier

title: iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic

acronym: iMEA

summary:
Pelvic organ prolapse (POP) is defined by the International Continence Society (ICS) as a downward displacement of one or several of the followings: "the anterior wall of the vagina", "the posterior wall of the vagina" or "the cervix".

Principal risk factor of the POP is the muscular trauma of the Levator Ani Muscle (LAM) or pelvic nerve injury during vaginal delivery and pregnancy. The POP is a real public health problem. Nearly a quarter of the female population will be affected by this pathology during their lifetime. Also, the POP is responsible for impaired quality of life. POP management is mainly surgical. The LAM is classically described as a striated muscle. In an anatomic study based on female human fetuses, it has been described a new representation of nerve supplying LAM innervation with both autonomic and somatic participation. In a second study, it has been observed within the LAM, a visceral medial area (interface with the pelvic viscera) composed of smooth muscle cells under autonomic nervous control and a lateral parietal area (interface with the bone basin) composed of striated muscle cells under somatic control. Because of the medial localization of these smooth muscle areas, it is hypothesed that the visceral medial zone within the LAM plays a major role in pelvic status maintaining.

The main goal is to compare the proportion of smooth muscle cells within the MEA in patients with urogenital prolapse and in asymptomatic ones.

The secondary objectives are:

To compare the expression of neurotransmitters within smooth muscle cell areas in patients with POPs and asymptomatic patients.
To compare the proportion of striated muscle cells in MEA in patients with POPs and asymptomatic patients.

lead_sponsor: Rennes University Hospital


title: Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining FSH and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer

acronym: DEGASTIM

summary:
The present investigation aims to evaluate the efficacy of an innovative protocol of controlled ovarian stimulation for breast cancer patients, who are candidates for fertility preservation.

Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation. However, this stimulation induces an increase in serum estrogen levels, which is theoretically problematic in case of hormone-sensitive tumors such as breast cancer. The majority of oncology teams accept, in very specific situations (particularly when the tumor has been surgically removed), this ovarian stimulation, because the expected benefits of fertility preservation far outweigh the risks. However, everyone agrees that it would be more comfortable to be able to offer vitrification of oocytes and/or embryos using ovarian stimulation without increasing estrogen levels.

In this research, investigators will evaluate the efficacy of degarelix (Firmagon®), currently indicated for the treatment of prostate cancer, as an innovative ovarian stimulation procedure. Administered at the beginning of ovarian stimulation, they believe it should maintain serum estradiol levels at physiological values at the end of stimulation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

acronym: AmmoTOX

summary: Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

acronym: CRA-MD

summary: The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research

ReferenceCitation: Ghenim S, Féron T, Barbe C, Wolak-Thierry A, Jolly D. [Clinical research and data collection during the investigation: Influence of a dedicated staff]. Therapie. 2018 May - Jun;73(3):267-272. doi: 10.1016/j.therap.2017.10.003. Epub 2017 Nov 11. French.


title: Impact of Multisensory Hand Massage on the Well-being of Cancer Patients

acronym: ONCOTACT

summary: The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Discrepancy Between Factor IX Level and Bleeding Phenotype

acronym: Hémophilie B

summary: It appears that the mutation p.Ile112Thr in the factor IX gene confers a discrepancy between mild factor IX level and severe bleeding phenotype. Databases and litterature analysis are poor on this matter. The goal of this study is to compile bleeding phenotype in patients with this specific mutation to prove the clinico-biological discordance in order to improve patient care and follow-up.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients

acronym: SEGEX

summary: This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.

acronym: PAMAL

summary: Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography

acronym: RINOCERAUS

summary:
Botulinum toxin injections are the treatment of choice for cervical dystonia. Even if this treatment is successful for most of the patients, partials or completes failures still remained.

Usually, botulinum toxin injections are realized by clinical localization techniques (observation and palpation of target muscles). The use of Ultrasonography to guide injections of Botulinum toxin has theoretical benefits (as an improved precision, an improved reproducibility, the targeting of deep-seated muscles, and a lower risk of adverse events) but its interest has never been demonstrated.

location_facility: Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A


title: A Double-blind Placebo-controlled Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects

acronym: TURBIO-GOLD

summary: The aim of this study is to evaluate the safety and tolerance of Turmipure Gold™ product during a chronic consumption of 5 weeks in healthy subjects. The hypothesis of this study is that there are no alterations of the gastrointestinal tolerance, of the haematological and biochemical profiles due to Turmipure Gold™ consumption compared to placebo.

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.

summary: Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.

lead_sponsor: University Hospital, Bordeaux


title: The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance

acronym: HARMONY

summary: Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all Authorized Research Centers (ARC) conducting phase I/II clinical trials of experimental drugs.


title: Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention

acronym: CAT

summary:
This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neurosciences de Lyon, INSERM U1028


title: BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

acronym: BLUE

summary: Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.


title: Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.

acronym: Penicillin

summary: Penicillin is one of the earliest discovered antibiotics and a drug of choice for several infections. Up to 10 to 20% of all patients in clinical trial are labeled as penicillin allergic. Most of these patients do not have a true allergy but few have had it verified. Approximately 80% of patients with IgE-mediated penicillin allergy lose their sensitivity after 10 years. Several studies have been conducted denying the risk of sensitization following negative testing of penicillin allergy. Investigators have not had the same experience and have therefore decided to conduct a retrospective study review of 83 adult outpatients with a distant penicillin allergy label and evaluate outcomes of skin retesting six weeks following Drug Provocation Test and challenge.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome

acronym: EvoHSD

summary: A prospective, mono-center, interventional study evaluating the effect of one year initial care by hygieno-dietary advices with or without Phlebotomy on glycemia after at least 5 years in Patients with dysmetabolic iron overload syndrome


title: Investigating the Noradrenergic System in the Living Human Brain With Hybrid Molecular Functional Imaging

summary: The main goal of this research proposal is to provide, for the first time in humans, a wider understanding of the role of the noradrenergic system both in health and illness (Parkinson's disease) through the use of a newly developed radiotracer (11Carbon [11C]Yohimbine) visualizing alpha-2 (α2) adrenergic receptors (AR) combined with cutting-edge technology, the hybrid positron emission tomography (PET)/magnetic resonance imaging (MRI) scanner. The secondary aim of this study will be to determine whether the expected age- and Parkinson's disease (PD)-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (such as cognitive, motor and/or olfactory abilities).

location_facility: Hôpital Neurologique Pierre Wertheimer, Groupement Hospitalier Est


title: Impact of 50% Nitrous Oxide Inhalation on Pain Induced by Lumbar Puncture in Emergency: a Double-blind Randomized Controlled Trial.

acronym: LENOX

summary: Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.

ReferenceCitation: Herres J, Chudnofsky CR, Manur R, Damiron K, Deitch K. The use of inhaled nitrous oxide for analgesia in adult ED patients: a pilot study. Am J Emerg Med. 2016 Feb;34(2):269-73. doi: 10.1016/j.ajem.2015.10.038. Epub 2015 Oct 24.

ReferenceCitation: Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56.

ReferenceCitation: Koscielniak-Nielsen Z, Hesselbjerg L, Brushøj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22.

ReferenceCitation: Lavi R, Yarnitsky D, Rowe JM, Weissman A, Segal D, Avivi I. Standard vs atraumatic Whitacre needle for diagnostic lumbar puncture: a randomized trial. Neurology. 2006 Oct 24;67(8):1492-4. Erratum in: Neurology. 2007 Feb 27;68(9):711. Yernitzky, D [corrected to Yarnitsky, D].

ReferenceCitation: Lukas A, Niederecker T, Günther I, Mayer B, Nikolaus T. Self- and proxy report for the assessment of pain in patients with and without cognitive impairment: experiences gained in a geriatric hospital. Z Gerontol Geriatr. 2013 Apr;46(3):214-21. doi: 10.1007/s00391-013-0475-y.

ReferenceCitation: Moisset X, Ruet A, Brochet B, Planche V, Jaffeux P, Gilleron V, Ong N, Clavelou P. Who Performs Lumbar Puncture, How Many Do They Perform, How and Why? A Retrospective Study of 6,594 Cases. Eur Neurol. 2016;76(1-2):8-11. doi: 10.1159/000447452. Epub 2016 Jun 24.

ReferenceCitation: Moisset X, Sia MA, Pereira B, Taithe F, Dumont E, Bernard L, Clavelou P. Fixed 50:50 mixture of nitrous oxide and oxygen to reduce lumbar-puncture-induced pain: a randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):46-52. doi: 10.1111/ene.13127. Epub 2016 Sep 25.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Musinduc : Impact of Music During the Period of Anaesthetic Induction - a Randomized Controlled Clinical Trial

acronym: MUSINDUC

summary:
Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.

Objective :

We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.

Materials and methods :

Randomized, prospective, monocentric study

2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.

The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.

This study should include 104 subjects (52 in each group) requiring general anesthesia.

Hypothesis tested:

Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.

lead_sponsor: University Hospital, Caen


title: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study

acronym: Vitisod

summary:
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.

Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.

The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women

acronym: PACWOMan

summary:
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Moreover, abdominal fat mass accumulation is associated with an increase of cardiovascular disease risks.

Recent studies suggest that physical activity may positively alter gut microbiota composition. Accumulating evidence suggests that high intensity interval training (HIIT) is an effective strategy for reducing body fat of overweight individuals, especially at the abdominal level. Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscle groups. Thus, RT is also an interesting modality to fight against deconditioning and autonomy loss with age.

The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.

It is hypothesized that HIIT +RT will improve gut microbiota and body composition (including whole body and (intra)-abdominal fat mass) in a concomitant and parallel way.

lead_sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques


title: Innovative Biomarkers in de Novo Parkinson's Disease

acronym: INNOBIOPARK

summary: This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.


title: Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique

acronym: SEPT-LEG

summary: The aim of the study was to assess clinical and radiological results with the "induces membrane" technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

ReferenceCitation: Siboni R, Joseph E, Blasco L, Barbe C, Bajolet O, Diallo S, Ohl X. Management of septic non-union of the tibia by the induced membrane technique. What factors could improve results? Orthop Traumatol Surg Res. 2018 Oct;104(6):911-915. doi: 10.1016/j.otsr.2018.04.013. Epub 2018 Jun 7.

family: Siboni

full_name: Renaud Siboni

given: Renaud

family: Joseph

full_name: Etienne Joseph

given: Etienne

family: Blasco

full_name: Laurent Blasco

given: Laurent

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Bajolet

full_name: Odile Bajolet

given: Odile

family: Diallo

full_name: Saïdou Diallo

given: Saïdou

family: Ohl

full_name: Xavier Ohl

given: Xavier

journal_name: Orthopaedics & Traumatology: Surgery & Research

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: CHU de Reims


title: Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment

summary: The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.


title: Multimodal Imaging Analysis, OCT-angiography (Optical Coherence Tomography) and SD-OCT (Spectral Domain Optical Coherence Tomography), of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery

acronym: CAROCT-A

summary: The purpose of this study is to describe the changes in morphology and Retinal vascularization after revascularization of the internal carotid artery. Indeed, the stenosis of the internal carotid artery can lead to ophthalmological charts. The underlying hypothesis is that revascularization of the internal carotid artery would improve ipsilateral and retinal homolateral perfusion in the short term. The OCT-angiography technique accurately studies the retinal vasculature and also assesses the risk of retinal and choroidal embolism, which is recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.

acronym: PAPS

summary: Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.


title: Genetical Characterization of Patients Presenting With Dyslipidemia

acronym: GENELIP

summary:
The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia.

In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients.

The goal of this project is to gain new insight into genotype/phenotype correlation.

location_facility: Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est, Département de biochimie et biologie moléculaire Grand Est


title: Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique

acronym: GAIT-TOX

summary:
Efficient gait requires effective postural control, both static and dynamic. Hence, postural disorders may affect gait. Yet, very little is known about the specific effects of focal postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients' mobility.

The present research therefore aims at analyzing gait characteristics in patients presenting with these conditions in order to document possible gait alterations.

In addition, the investigators will explore the effect of botulinum toxin treatment, which the most frequently used therapeutic option, on the patients' gait characteristics. Indeed, while the treatment improves both dystonia and pain, and therefore quality of life, its influence on gait is presently unknown. the investigators aim at filling this knowledge gap

ReferenceCitation: Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. Review.

ReferenceCitation: Barr C, Barnard R, Edwards L, Lennon S, Bradnam L. Impairments of balance, stepping reactions and gait in people with cervical dystonia. Gait Posture. 2017 Jun;55:55-61. doi: 10.1016/j.gaitpost.2017.04.004. Epub 2017 Apr 4.

ReferenceCitation: Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6. Review.

lead_sponsor: University Hospital, Grenoble


title: Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography

acronym: Reacshock

summary: Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Very little work has been published in intensive care unit (ICU) and no studies have been done on hemodynamically unstable patients. The aim of this work is to compare the cardiac output measured by Physioflow® to the transthoracic echocardiography (TTE) in ventilated, sedated patients hospitalized in ICU receiving catecholamines and for whom the attending physician wants to evaluate the fluid responsiveness using the TTE and a passive leg raising maneuver (PLR).


title: Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram

acronym: ADCACO

summary: Observational study.

lead_sponsor: Rennes University Hospital