title: Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers: a Randomized Controlled Trial

summary:
The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. These international phenomena have also been observed in France.

In addition to the constraints of the general population, health care workers have been, and continue to be, subject to other forms of constraints, linked to their professional activity. Indeed, the risk of viral exposure is for them major, the confrontation with the deaths of patients because of their fragility or the weakness of the care structures, are more violent in connection with their immediate reality. In addition, the workload due to health imperatives has also led to physical and psychological exhaustion of the health care teams. In addition to the international evidence, the existence and severity of the psychological consequences for health care workers have recently been documented at the local level in a survey conducted among the staff of the Groupe hospitalier Paris Saint-Joseph (GhPSJ). In this study of more than 780 people, nearly half of whom were in charge of patients infected with SARS-CoV2, 62% reported increased anxiety since the beginning of the epidemic, 41% had symptoms of anxiety, 21% had symptoms of depression and 14% had signs of post-traumatic stress. Approximately 25% of the total population had chosen to make regular use of the "bulle" (a decompression and care platform made available to staff since the first wave within the establishment) with the aim of reducing the anxiety generated by the situation and particularly by their professional activity. Given the importance of anxiety symptoms detected in healthcare professionals during the COVID-19 pandemic, the use of a simple, brief technique, requiring neither trained personnel nor expensive or difficult-to-access devices, aimed at reducing anxious stress could be of significant benefit to the population, especially to caregivers.

The objective of this study is to measure the effect of deep breathing on the anxiety of health professionals in the aftermath of the COVID-19 pandemic, and its effect on their quality of life. In order to measure the quality of the sessions, the breathing movements will be performed using a calibrated program and their immediate effectiveness will be evaluated by the variation of the heart rate, visible just after the program by the user.

The NeurodigitX® system offers to control interactive 3D games on a smartphone application through breath via a sensor connected to the phone by Bluetooth. This tool also allows to measure by plethysmography the heart rate variability in a simple and non-invasive way.

This system has been created as a preventive health solution by allowing everyone to measure, compare and share the activity of their Autonomic Nervous System (ANS) to better predict, understand, prevent and treat certain chronic diseases.

ReferenceCitation: Casagrande M, Favieri F, Tambelli R, Forte G. The enemy who sealed the world: effects quarantine due to the COVID-19 on sleep quality, anxiety, and psychological distress in the Italian population. Sleep Med. 2020 Nov;75:12-20. doi: 10.1016/j.sleep.2020.05.011. Epub 2020 May 12.

ReferenceCitation: Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.

ReferenceCitation: Dutheil F, Mondillon L, Navel V. PTSD as the second tsunami of the SARS-Cov-2 pandemic. Psychol Med. 2021 Jul;51(10):1773-1774. doi: 10.1017/S0033291720001336. Epub 2020 Apr 24.

ReferenceCitation: Ozamiz-Etxebarria N, Dosil-Santamaria M, Picaza-Gorrochategui M, Idoiaga-Mondragon N. Stress, anxiety, and depression levels in the initial stage of the COVID-19 outbreak in a population sample in the northern Spain. Cad Saude Publica. 2020 Apr 30;36(4):e00054020. doi: 10.1590/0102-311X00054020. eCollection 2020. English, Spanish.

ReferenceCitation: Serafini G, Parmigiani B, Amerio A, Aguglia A, Sher L, Amore M. The psychological impact of COVID-19 on the mental health in the general population. QJM. 2020 Jun 22;113(8):531-7. doi: 10.1093/qjmed/hcaa201. Online ahead of print.

ReferenceCitation: d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.

ReferenceCitation: d'Ussel M, Adam F, Fels A, Chatellier G, Philippart F. Characteristics of Hospital Workers Using a Wellbeing Center Implemented During the COVID-19 Pandemic to Prevent the Emotional Impacts of the Crisis. Front Public Health. 2022 Jul 4;10:913126. doi: 10.3389/fpubh.2022.913126. eCollection 2022.

ReferenceCitation: Lefevre H, Stheneur C, Cardin C, Fourcade L, Fourmaux C, Tordjman E, Touati M, Voisard F, Minassian S, Chaste P, Moro MR, Lachal J. The Bulle: Support and Prevention of Psychological Decompensation of Health Care Workers During the Trauma of the COVID-19 Epidemic. J Pain Symptom Manage. 2021 Feb;61(2):416-422. doi: 10.1016/j.jpainsymman.2020.09.023. Epub 2020 Sep 19.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Hôpital Sainte-Marie
Hôpital Marie Lannelongue
Hôpital Paris Saint-Joseph
Hôpital Léopold BELLAN


title: Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

acronym: SCD-TGA

summary:
Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.

The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: BILLOIR

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Multicenter, Prospective, Randomised, Open-label Study, Evaluating the Effect of Two Levels of Haemoglobin on Quality of Life and Speed of Progression of Renal Insufficiency on Renal Transplanted Patients With Chronic Graft Dysfunction (CGD)

summary:
The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect of two levels of haemoglobin on quality of life at 6 months and the speed of progression of renal function degradation at 24 months.

This study will recruit 140 patients in 21 centers in France.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Monpied

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Urinary and Prostate Microbiotes and Prostate Cancer

acronym: MICROPROSTK

summary:
In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.

While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.

The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.

the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.

The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Tours hospital
nice Hospital
marseille Hospital
Cannes hospital

intervention_type: Procedure

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CTRE HOSPITALIER UNIVERSITAIRE DE NICE

type_etablissement: CHUR

acronyme: MICROPROSTK

titre: Microbiotes urinaire et prostatique et cancer de la prostate-MICROPROSTK

discipline_principale: cancer bactériologie

nom_porteur: LOTTE

prenom_porteur: Romain


type: Other Identifier

title: Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice

acronym: ESUB-MG

summary:
In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and methadone. Number of treated patients is around 150,000 with 75% of them treated by buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for initiating methadone, whereas it is recommended for initiating buprenorphine and during follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative analysis of the recent drug consumption, with detection based on designated thresholds, allow a better appraisal of drug exposure, before initiating and during OMT. While intrinsic diagnostic value of these tests is already demonstrated, the consequences of carrying out these tests on OMT have not been clearly established. Some studies suggest that patients exposed to drug tests may have a better OMT retention and in patients treated by methadone, performing urine screening tests has been shown to be associated with a mortality risk reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the recommendations to perform these tests, few GP prescribe tests, and few patients are regularly screened. Availability of commercial kits for urine drug testing in the medical office should improve their utilisation.

The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs working in addictology networks. Despite a global benefit reported in the literature with a better control in prescribing OMT and a better patients' adherence, as far as the investigators know, no study has yet explored the impact of the use of urine drug screening test in decision making in general practice with an intervention study.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: ESUB-MG Study Group. Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients. BMC Fam Pract. 2016 Mar 1;17:24. doi: 10.1186/s12875-016-0413-3.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Toulouse

location_facility: Service de Pharmacologie Médicale et Clinique - Centre d'addictovigilance - CHU de Toulouse

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: ESUB MG

titre: Impact d'une évaluation des consommations de substances au cabinet médical pour la prise en charge des patients initiant un traitement par buprénorphine en médecine générale. Essai clinique randomisé en cluster.

discipline_principale: psychiatrie / addictologie

nom_porteur: LAPEYRE MESTRE

prenom_porteur: Maryse


title: LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study

acronym: LEADH

summary:
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.

Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.

The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_country: Martinique France

location_facility:
CHU Nantes
CHU Martinique
Hôpital Pitié Salpêtrière
CHU Bordeaux
CHU Brest
CHU Amiens-Picardie
CHU Caen
CHU Tours
CHU Nancy

intervention_type: Other


title: Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery

summary:
During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.

The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:

CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl
CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl
CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%
CO2 dry and cold with direct intra-abdominal administration of Nacl

The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).

lead_sponsor: University Hospital, Strasbourg, France

location_country: Italy France

location_facility: Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL

intervention_type: Device


title: BeAT1D: Benign Autoimmunity and Type 1 Diabetes

summary: National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes

location_facility: Hôpital Pitié-Salpêtrière - Service de Diabétologie

location_facility: APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie

location_facility: APHP Hôpital Cochin - Service de Chirurgie

location_facility: APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique


title: Assessment of Skin-to-skin Contact During the Transfer of Very Preterm Infants From the Delivery Room to the Neonatal Intensive Care Unit : a Randomised Controlled, Non-inferiority, Open-label Trial, in Comparison With Transfer in Incubator

acronym: TRANSPAPNEO

summary:
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Skin-to-skin contact provides hemodynamic and thermal stability in preterm infants. Regarding parents, skin-to-skin contact sustains the parental bonding, and reduces stress and anxiety related to hospitalization. As a result, early skin-to-skin contact has been associated with an improvement of neurological outcome in very preterm infants.

Thermal stability is crucial during the first hour of life in preterm infants. A temperature at admission in the neonatal intensive care unit below 36.5°C or above 37.2°C has been associated with an increase in neonatal morbidity and mortality.

Early skin-to-skin contact between a newborn and his/her mother in the delivery room significantly decreases the occurrence of hypothermia below 35.5°C.

The practice of skin-to-skin transfer from the delivery room is emerging in France. Pilot studies have been carried out by French neonatal teams that showed the feasibility of this practice in late-preterm, near-term and term infants. Although skin-to-skin contact routinely involves very preterm infants in neonatal intensive care units worldwide, the feasibility and safety of skin-to-skin contact during the transfer from delivery room to the neonatal unit is poorly documented in very preterm infants. Previous data of our team showed that transfer of preterm infants with non-invasive ventilation using skin-to-skin contact was feasible and safe but concerns emerged about the thermal conservation during the procedure.

The main hypothesis of this study is that skin-to skin contact during the transfer from the delivery room to the neonatal intensive care unit could prevent heat losses in preterm infants as well as the transfer in incubator. Another hypothesis is that very early skin-to-skin contact could positively influence the neonatal course and the parental experience in the neonatal care unit.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Tours

location_facility: Neonatology service, University Hospital, Toulouse

location_facility: Neonatal and paediatric service, University Hospital, Tours

location_facility: Neonatal intensive care unit, University Hospital, Saint-Etienne

location_facility: Neonatal medicine and intensive care unit, University Hospital, Orléans


title: A Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy

acronym: IsAMYP

summary: This phase 2 study ain to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy. It will enrolled 46 patients (34 in France and 12 in Australia) through 15 sites (11 in France and 4 in Australia).

lead_sponsor: Intergroupe Francophone du Myelome

collaborators:
Sanofi
Bristol-Myers Squibb

sponsor_collaborators:
Intergroupe Francophone du Myelome
Sanofi
Bristol-Myers Squibb

location_facility: Hôpital Universitaire Necker Enfants Malades

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: CHU Poitiers - Pôle régional de Cancérologie


title: Is Eye-Movement Desensitization and Reprocessing (EMDR) Therapy Effective in Children Aged 3 to 6 Years With Trauma-related Disorders or Stressors and Anxiety? A Double-blinded Randomized Controlled Trial.

acronym: EMDRJEER

summary:
This project aims to answer to the question of EMDR effectiveness in young children and to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. The study requires a total of 60 children, girls and boys, aged 3 to 6 years and presenting disorders related to stressors, anxiety and/or trauma. Participants will be randomly distributed in two groups: "EMDR therapy" (N=30) group or "routine care" (N=30) group. The study will take place in four stages: 1/ Pre-treatment phase : An evaluation of child's various cognitive and executive functions, child's symptomatology and parental distress is planned in a pre-treatment phase. 2/ Treatment phase : An EMDR therapy or a routine care is administered to the child between 6 to 10 weeks. 3/ Post-treatment phase : A reassessment of child's and parent's symptoms is planned at the end of treatment. 4/ Continuation of treatment: Children who have received routine treatment and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment.

A significant reduction in disorders related to trauma or stress and anxiety factors and their symptomatology, as well as comorbid disorders and their symptomatology, is expected in children who received EMDR therapy compared to the group who received a routine care. These results are expected to be robust over a period of at least 3 months. The positive effects of EMDR on child symptomatology are also expected to be more pronounced in children showing higher levels of cognitive functioning

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

intervention_type: Behavioral


type: EudraCT Number

title: Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?

acronym: FLT-THERA

summary:
In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.

This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.

Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.

To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.

The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.

A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.

The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.

status: Unknown status

ReferenceType: background

ReferenceCitation: Vesselle H, Grierson J, Muzi M, Pugsley JM, Schmidt RA, Rabinowitz P, Peterson LM, Vallieres E, Wood DE. In vivo validation of 3'deoxy-3'-[(18)F]fluorothymidine ([(18)F]FLT) as a proliferation imaging tracer in humans: correlation of [(18)F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin Cancer Res. 2002 Nov;8(11):3315-23.

ReferenceCitation: Aouba A, Pequignot F, Le Toullec A, Jougla E. Les causes médicales de décès en France en 2004 et leur évolution 1980-2004. Bul Epidémiol Hebd 2007;35-36:308-14.

ReferenceCitation: Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010 Mar;46(4):765-81. doi: 10.1016/j.ejca.2009.12.014. Epub 2010 Jan 29.

ReferenceCitation: Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

ReferenceCitation: Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

ReferenceCitation: Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

ReferenceCitation: Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.

ReferenceCitation: Chouaid C, Moser A, Coudray-Omnes C, Vergnenegre A. [Economic impact of second- and third-line erlotinib treatment of non small-cell lung cancer]. Rev Mal Respir. 2008 Nov;25(9):1096-103. doi: 10.1016/s0761-8425(08)74979-9. French.

ReferenceCitation: Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207-14. doi: 10.1002/1097-0142(19810101)47:13.0.co;2-6.

ReferenceCitation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Shankar LK, Hoffman JM, Bacharach S, Graham MM, Karp J, Lammertsma AA, Larson S, Mankoff DA, Siegel BA, Van den Abbeele A, Yap J, Sullivan D; National Cancer Institute. Consensus recommendations for the use of 18F-FDG PET as an indicator of therapeutic response in patients in National Cancer Institute Trials. J Nucl Med. 2006 Jun;47(6):1059-66. No abstract available.

ReferenceCitation: Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.

ReferenceCitation: Dittmann H, Dohmen BM, Kehlbach R, Bartusek G, Pritzkow M, Sarbia M, Bares R. Early changes in [18F]FLT uptake after chemotherapy: an experimental study. Eur J Nucl Med Mol Imaging. 2002 Nov;29(11):1462-9. doi: 10.1007/s00259-002-0925-z. Epub 2002 Sep 6.

ReferenceCitation: Barthel H, Perumal M, Latigo J, He Q, Brady F, Luthra SK, Price PM, Aboagye EO. The uptake of 3'-deoxy-3'-[18F]fluorothymidine into L5178Y tumours in vivo is dependent on thymidine kinase 1 protein levels. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):257-63. doi: 10.1007/s00259-004-1611-0. Epub 2004 Sep 4.

ReferenceCitation: Oyama N, Ponde DE, Dence C, Kim J, Tai YC, Welch MJ. Monitoring of therapy in androgen-dependent prostate tumor model by measuring tumor proliferation. J Nucl Med. 2004 Mar;45(3):519-25.

ReferenceCitation: Sugiyama M, Sakahara H, Sato K, Harada N, Fukumoto D, Kakiuchi T, Hirano T, Kohno E, Tsukada H. Evaluation of 3'-deoxy-3'-18F-fluorothymidine for monitoring tumor response to radiotherapy and photodynamic therapy in mice. J Nucl Med. 2004 Oct;45(10):1754-8.

ReferenceCitation: Graf N, Herrmann K, den Hollander J, Fend F, Schuster T, Wester HJ, Senekowitsch-Schmidtke R, zum Buschenfelde CM, Peschel C, Schwaiger M, Dechow T, Buck AK. Imaging proliferation to monitor early response of lymphoma to cytotoxic treatment. Mol Imaging Biol. 2008 Nov-Dec;10(6):349-55. doi: 10.1007/s11307-008-0162-3. Epub 2008 Aug 14.

ReferenceCitation: Jensen MM, Erichsen KD, Bjorkling F, Madsen J, Jensen PB, Hojgaard L, Sehested M, Kjaer A. Early detection of response to experimental chemotherapeutic Top216 with [18F]FLT and [18F]FDG PET in human ovary cancer xenografts in mice. PLoS One. 2010 Sep 24;5(9):e12965. doi: 10.1371/journal.pone.0012965.

ReferenceCitation: Leyton J, Latigo JR, Perumal M, Dhaliwal H, He Q, Aboagye EO. Early detection of tumor response to chemotherapy by 3'-deoxy-3'-[18F]fluorothymidine positron emission tomography: the effect of cisplatin on a fibrosarcoma tumor model in vivo. Cancer Res. 2005 May 15;65(10):4202-10. doi: 10.1158/0008-5472.CAN-04-4008.

ReferenceCitation: Apisarnthanarax S, Alauddin MM, Mourtada F, Ariga H, Raju U, Mawlawi O, Han D, Bornmann WG, Ajani JA, Milas L, Gelovani JG, Chao KS. Early detection of chemoradioresponse in esophageal carcinoma by 3'-deoxy-3'-3H-fluorothymidine using preclinical tumor models. Clin Cancer Res. 2006 Aug 1;12(15):4590-7. doi: 10.1158/1078-0432.CCR-05-2720.

ReferenceCitation: Molthoff CF, Klabbers BM, Berkhof J, Felten JT, van Gelder M, Windhorst AD, Slotman BJ, Lammertsma AA. Monitoring response to radiotherapy in human squamous cell cancer bearing nude mice: comparison of 2'-deoxy-2'-[18F]fluoro-D-glucose (FDG) and 3'-[18F]fluoro-3'-deoxythymidine (FLT). Mol Imaging Biol. 2007 Nov-Dec;9(6):340-7. doi: 10.1007/s11307-007-0104-5.

ReferenceCitation: Atkinson DM, Clarke MJ, Mladek AC, Carlson BL, Trump DP, Jacobson MS, Kemp BJ, Lowe VJ, Sarkaria JN. Using fluorodeoxythymidine to monitor anti-EGFR inhibitor therapy in squamous cell carcinoma xenografts. Head Neck. 2008 Jun;30(6):790-9. doi: 10.1002/hed.20770.

ReferenceCitation: Ullrich RT, Zander T, Neumaier B, Koker M, Shimamura T, Waerzeggers Y, Borgman CL, Tawadros S, Li H, Sos ML, Backes H, Shapiro GI, Wolf J, Jacobs AH, Thomas RK, Winkeler A. Early detection of erlotinib treatment response in NSCLC by 3'-deoxy-3'-[F]-fluoro-L-thymidine ([F]FLT) positron emission tomography (PET). PLoS One. 2008;3(12):e3908. doi: 10.1371/journal.pone.0003908. Epub 2008 Dec 12.

ReferenceCitation: Wei LH, Su H, Hildebrandt IJ, Phelps ME, Czernin J, Weber WA. Changes in tumor metabolism as readout for Mammalian target of rapamycin kinase inhibition by rapamycin in glioblastoma. Clin Cancer Res. 2008 Jun 1;14(11):3416-26. doi: 10.1158/1078-0432.CCR-07-1824.

ReferenceCitation: Brepoels L, Stroobants S, Verhoef G, De Groot T, Mortelmans L, De Wolf-Peeters C. (18)F-FDG and (18)F-FLT uptake early after cyclophosphamide and mTOR inhibition in an experimental lymphoma model. J Nucl Med. 2009 Jul;50(7):1102-9. doi: 10.2967/jnumed.109.062208. Epub 2009 Jun 12.

ReferenceCitation: Buck AK, Kratochwil C, Glatting G, Juweid M, Bommer M, Tepsic D, Vogg AT, Mattfeldt T, Neumaier B, Moller P, Reske SN. Early assessment of therapy response in malignant lymphoma with the thymidine analogue [18F]FLT. Eur J Nucl Med Mol Imaging. 2007 Nov;34(11):1775-82. doi: 10.1007/s00259-007-0452-z. Epub 2007 May 31.

ReferenceCitation: McKinley ET, Ayers GD, Smith RA, Saleh SA, Zhao P, Washington MK, Coffey RJ, Manning HC. Limits of [18F]-FLT PET as a biomarker of proliferation in oncology. PLoS One. 2013;8(3):e58938. doi: 10.1371/journal.pone.0058938. Epub 2013 Mar 15.

ReferenceCitation: Lawrence J, Vanderhoek M, Barbee D, Jeraj R, Tumas DB, Vail DM. Use of 3'-deoxy-3'-[18F]fluorothymidine PET/CT for evaluating response to cytotoxic chemotherapy in dogs with non-Hodgkin's lymphoma. Vet Radiol Ultrasound. 2009 Nov-Dec;50(6):660-8. doi: 10.1111/j.1740-8261.2009.01612.x.

ReferenceCitation: Sohn HJ, Yang YJ, Ryu JS, Oh SJ, Im KC, Moon DH, Lee DH, Suh C, Lee JS, Kim SW. [18F]Fluorothymidine positron emission tomography before and 7 days after gefitinib treatment predicts response in patients with advanced adenocarcinoma of the lung. Clin Cancer Res. 2008 Nov 15;14(22):7423-9. doi: 10.1158/1078-0432.CCR-08-0312.

ReferenceCitation: Zander T, Scheffler M, Nogova L, Kobe C, Engel-Riedel W, Hellmich M, Papachristou I, Toepelt K, Draube A, Heukamp L, Buettner R, Ko YD, Ullrich RT, Smit E, Boellaard R, Lammertsma AA, Hallek M, Jacobs AH, Schlesinger A, Schulte K, Querings S, Stoelben E, Neumaier B, Thomas RK, Dietlein M, Wolf J. Early prediction of nonprogression in advanced non-small-cell lung cancer treated with erlotinib by using [(18)F]fluorodeoxyglucose and [(18)F]fluorothymidine positron emission tomography. J Clin Oncol. 2011 May 1;29(13):1701-8. doi: 10.1200/JCO.2010.32.4939. Epub 2011 Mar 21.

ReferenceCitation: Mileshkin L, Hicks RJ, Hughes BG, Mitchell PL, Charu V, Gitlitz BJ, Macfarlane D, Solomon B, Amler LC, Yu W, Pirzkall A, Fine BM. Changes in 18F-fluorodeoxyglucose and 18F-fluorodeoxythymidine positron emission tomography imaging in patients with non-small cell lung cancer treated with erlotinib. Clin Cancer Res. 2011 May 15;17(10):3304-15. doi: 10.1158/1078-0432.CCR-10-2763. Epub 2011 Mar 1.

ReferenceCitation: Benz MR, Herrmann K, Walter F, Garon EB, Reckamp KL, Figlin R, Phelps ME, Weber WA, Czernin J, Allen-Auerbach MS. (18)F-FDG PET/CT for monitoring treatment responses to the epidermal growth factor receptor inhibitor erlotinib. J Nucl Med. 2011 Nov;52(11):1684-1689. doi: 10.2967/jnumed.111.095257.

ReferenceCitation: Girard N, Sima CS, Jackman DM, Sequist LV, Chen H, Yang JC, Ji H, Waltman B, Rosell R, Taron M, Zakowski MF, Ladanyi M, Riely G, Pao W. Nomogram to predict the presence of EGFR activating mutation in lung adenocarcinoma. Eur Respir J. 2012 Feb;39(2):366-72. doi: 10.1183/09031936.00010111. Epub 2011 Jul 20.

ReferenceCitation: Garassino MC, Martelli O, Broggini M, Farina G, Veronese S, Rulli E, Bianchi F, Bettini A, Longo F, Moscetti L, Tomirotti M, Marabese M, Ganzinelli M, Lauricella C, Labianca R, Floriani I, Giaccone G, Torri V, Scanni A, Marsoni S; TAILOR trialists. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol. 2013 Sep;14(10):981-8. doi: 10.1016/S1470-2045(13)70310-3. Epub 2013 Jul 22.

ReferenceCitation: Bouchet F, Geworski L, Knoop BO, Ferrer L, Barriolo-Riedinger A, Millardet C, Fourcade M, Martineau A, Belly-Poinsignon A, Djoumessi F, Tendero K, Keros L, Montoya F, Mesleard C, Martin AL, Lacoeuille F, Couturier O. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT. PLoS One. 2013;8(3):e58152. doi: 10.1371/journal.pone.0058152. Epub 2013 Mar 13.

ReferenceCitation: Laffon E, Bardies M, Barbet J, Marthan R. Calculating an estimate of tissue integrated activity in 18F-FDG PET imaging using one SUV value. EJNMMI Res. 2013 Apr 5;3(1):26. doi: 10.1186/2191-219X-3-26.

ReferenceCitation: Kahraman D, Scheffler M, Zander T, Nogova L, Lammertsma AA, Boellaard R, Neumaier B, Ullrich RT, Holstein A, Dietlein M, Wolf J, Kobe C. Quantitative analysis of response to treatment with erlotinib in advanced non-small cell lung cancer using 18F-FDG and 3'-deoxy-3'-18F-fluorothymidine PET. J Nucl Med. 2011 Dec;52(12):1871-7. doi: 10.2967/jnumed.111.094458. Epub 2011 Nov 7.

lead_sponsor: University Hospital, Angers

sponsor_collaborators:
University Hospital, Angers
University Hospital, Tours
Army Hospital, Percy
Créteil Hospital
University Hospital, Rouen
Central Hospital, Nancy, France
University Hospital, Toulouse
University Hospital, Bordeaux

location_facility:
University Hospital, Nancy
Hospital, Créteil
University Hospital, Bordeaux
University Hospital, Angers
University Hospital, Rouen
Army Hospital, Percy
University Hospital, Tours
University Hospital, Toulouse

intervention_type: Radiation

status_simplified: Unknown


title: Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts

summary: Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.

lead_sponsor: University Hospital, Caen


title: Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery

acronym: PoLyDOL

summary: After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Ministry of Health, France
Insurance CNP foundation

location_facility: APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation

location_facility: département d'anesthésie-réanimation 3, hôpital Pellegrin

location_facility: CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne


title: Impact of a Transitional Care Program Involving an Advanced Practice Nurse on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward (PROUST Study)

acronym: PROUST

summary: In France, it has be estimated that the hospital readmission rate within 30 days of patients aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is evidence that interventions "bridging" the transition from hospital to home involving a dedicated professional (usually nurses) would be most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a program of transitional care from hospital to home for people of 75 years old or more admitted to acute care.

primary_purpose: Health Services Research

ReferenceCitation: Occelli P, Touzet S, Rabilloud M, Ganne C, Poupon Bourdy S, Galamand B, Debray M, Dartiguepeyrou A, Chuzeville M, Comte B, Turkie B, Tardy M, Luiggi JS, Jacquet-Francillon T, Gilbert T, Bonnefoy M. Impact of a transition nurse program on the prevention of thirty-day hospital readmissions of elderly patients discharged from short-stay units: study protocol of the PROUST stepped-wedge cluster randomised trial. BMC Geriatr. 2016 Mar 3;16:57. doi: 10.1186/s12877-016-0233-2.

repositories_concat: PubMed Central

lead_sponsor: Hospices Civils de Lyon

location_facility:
CH Bourg-en-Bresse
Hôpital Édouard Herriot
Clinique des portes du sud
CH Saint-Chamond
CH Villefranche
Centre Hospitalier Alpes Léman
CH Gériatrique des Monts d'Or
CHG Annecy
Centre Hospitalier Lyon Sud


title: Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection

acronym: SEVASAR

summary: The COVID-19 epidemic has now raged for more than a year with more than 100 million identified cases and nearly 2.5 million deaths worldwide. Since November 2020, we have been witnessing the emergence of viral variants in different regions of the world. This expected genetic drift of the virus, but somewhat abrupt since November, raises questions concerning the characteristics of transmissibility, pathogenicity, sensitivity to possible treatments, and escape from natural or vaccine immunity. The objective of this study is to find out whether the new variants of SARS-CoV-2 are associated with particular clinical forms. The results of this research will provide elements to determine whether the new variants of SARS-CoV-2 are associated with more severe clinical forms.

time_perspective: Other

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre Hospitalier Châteaubriant Nozay Pouancé


title: Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice

acronym: YuChooSeR

summary:
The TRANSLUMINA GmbH YuChooSeR Observatory is a prospective, multicentric post-marketing observatory designed to evaluate large scale safety and reliability of the Yukon Choice PC and the Yukon Chrome PC stents systems use in routine, clinical practice.

This based observatory will enroll 3000 patients to 30 sites in France.

lead_sponsor: Translumina GmbH

sponsor_collaborators:
Translumina GmbH
EVAMED

location_facility:
Centre Hospitalier de Soissons
Centre Hospitalier de Quimper
Centre Hospitalier de Compiègnes
Polyclinique Saint-Laurent
Centre Hospitalier de Périgueux
Centre Hospitalier de Bigorre
Centre Hospitalier de Vannes
Clinique Axium
Clinique Saint Hilaire
Hopital Privé du Confluent
Clinique Pasteur
Centre Hospitalier Sud Francilien
Hopital A. Schweitzer - Ghca
Centre Hospitalier Haguenau
GHM Grenoble
Clinique Pont de Chaume
Hopital privé Beauregard
Clinique Louis Pasteur
Centre Hospitalier de Saint Malo


title: Peer-supporting for Teenagers With Cystic Fibrosis in a Process of Transition of Care From Paediatric to Adult Services : a Mixed-method Pilot Study to Assess the Feasibility of the Peer-support Intervention

acronym: MUKADO

summary:
In patients with cystic fibrosis, a deterioration in lung function around age 18, the age of transfer from pediatrics to adult care services, has been observed. Transfer is only one step in a transition process from pediatric to adult care taking place from age 12 to 24. Adolescence is a period of identity construction during which the disease alters self-image and self-esteem, and a period of empowerment in the management of the disease involving a re-appropriation of it. During this period, coping strategies and psychosocial skills are important to face all the issues that the adolescent encounters. Interventions for youth with chronic illnesses rarely incorporate this dimension. Peer support or peer-mentoring is one avenue for developing these coping skills. Peer support encompasses mutual support between people who are coping or have coped with similar challenging life experiences. Individuals with similar experiences would represent more credible role models to stimulate positive change in their peers. The function of peer support are to provide emotional, experiential, informational support.The effect of peer support improves social integration, coping skills, sense of self-efficacy of the peers being helped. Promotion of healthy youth behaviors by youth is the most widely evaluated youth engagement strategy in the community health sector. Peer-assisted devices have been tested to improve medication adherence and health status with youth with juvenile arthritis, asthma, and liver transplant recipients. By sharing their experience of a successful transition, young adults with cystic fibrosis may be able to help their adolescent peers better understand this transition. Our hypothesis is that implementing peer support with adolescents with cystic fibrosis improves their sense of self-efficacy, a dimension of coping skills.To our knowledge, there are no research studies on peer support in cystic fibrosis in France or abroad. Patients are recognized as partners capable of sharing their experiential knowledge with patients with a similar disease.

But this raises questions about the recruitment, supervision, preparation for peer-help and the role of these patients; about the effects of their involvement for themselves (valorization, anxiety) and for their peers (re-assurance, feeling of personal effectiveness). This justifies conducting an exploratory study to assess the feasibility of a peer-support intervention for youth with cystic fibrosis.

location_facility: CRCM Grenoble pédiatrie - Hôpital Albert Michallon

location_facility: CRCM Lyon pédiatrie - Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: CRCM Lyon adulte - Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: CRCM Grenoble adulte - Hôpital Albert Michallon


title: Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients

acronym: CORRESPAGE

summary: In France, hospitalised elderly patients (EP) aged >75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Dependence related to hospitalisation, partly avoidable, occurs in 30 to 60% of patients aged over 70. Faced with this situation Geriatric Mobile Teams (GMT) were created in 2002 to meet the need for geriatric expertise in hospitals and in the community by making punctual evaluations. Expert and multidisciplinary, the GMTs are a referring team for "advice, information and training for health care teams" for the care of vulnerable EPs. The GMTs are dependent on an exclusively medical demand system. The lack of knowledge of a specific care for EPs by nurses and nursing assistants and the occasional contribution of GMTs prevents a systematic targeted a for EP. Over the past 30 years, an American nursing programme (NICHE) aimed at improving the overall care of EPs in hospitals has shown that the training of geriatric resource nurses in speciality wards brought about a significant change in hospital geriatric culture. The training is based on evidence based practice including the HELP programme targeting confusion. The HELP programme has shown that nurses and nursing assistants play a pivotal role in reducing the incidence of hospital confusion. In the USA, the implementation of NICHE begins with the creation of a team of nursing leaders (geriatric/education/clinical care experts), dedicated to the coordination of the training and the companionship of geriatric resource nurses. Within the framework of the targets of the Ségur de la santé 2020 and Ma Santé 2022, our hypothesis is that an adaptation of NICHE to the French health context could improve specific care for EP in specialist wards, reduce the occurrence of complications and reduce the length of stay. Indeed, the GMT would ensure this coordination role in the training and support of a nurse and nursing assistant duo, based on the model of hygiene correspondents, in order to disseminate good geriatric practices.

time_perspective: Retrospective

location_facility: service de court séjour gériatrique, Hôpital Lyon Sud


title: Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management

acronym: PSYDEV

summary: Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU de Rouvray
CHU de Nice
Pitié Salpétrière
CHRU de Lille
CHU de Rouen
Fondation Vallée, Gentilly

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: PSYDEV

titre: Abord dimensionnel et développemental des épisodes psychotiques de l'enfant et de l'adolescent :  impact dans leurs prises en charge

discipline_principale: autre

nom_porteur: LAURENT-LEVINSON

prenom_porteur: Claudine


title: A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor

acronym: ReLUTH

summary: In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.

ReferenceCitation: Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.

ReferenceCitation: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of Kentucky - UKnowledge

repository_institution: King's College London - Research Portal

version: acceptedVersion

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

oa_host_type: repository

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Rudisile S, Gosewisch A, Wenter V, Unterrainer M, Boning G, Gildehaus FJ, Fendler WP, Auernhammer CJ, Spitzweg C, Bartenstein P, Todica A, Ilhan H. Salvage PRRT with 177Lu-DOTA-octreotate in extensively pretreated patients with metastatic neuroendocrine tumor (NET): dosimetry, toxicity, efficacy, and survival. BMC Cancer. 2019 Aug 8;19(1):788. doi: 10.1186/s12885-019-6000-y.

ReferenceCitation: Vaughan E, Machta J, Walker M, Toumpanakis C, Caplin M, Navalkissoor S. Retreatment with peptide receptor radionuclide therapy in patients with progressing neuroendocrine tumours: efficacy and prognostic factors for response. Br J Radiol. 2018 Nov;91(1091):20180041. doi: 10.1259/bjr.20180041. Epub 2018 Mar 20.

ReferenceCitation: Yordanova A, Mayer K, Brossart P, Gonzalez-Carmona MA, Strassburg CP, Essler M, Ahmadzadehfar H. Safety of multiple repeated cycles of 177Lu-octreotate in patients with recurrent neuroendocrine tumour. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1207-1214. doi: 10.1007/s00259-017-3652-1. Epub 2017 Mar 1.

ReferenceCitation: Sabet A, Haslerud T, Pape UF, Sabet A, Ahmadzadehfar H, Grunwald F, Guhlke S, Biersack HJ, Ezziddin S. Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2014 Feb;41(2):205-10. doi: 10.1007/s00259-013-2547-z. Epub 2013 Sep 13.

ReferenceCitation: van Essen M, Krenning EP, Kam BL, de Herder WW, Feelders RA, Kwekkeboom DJ. Salvage therapy with (177)Lu-octreotate in patients with bronchial and gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2010 Mar;51(3):383-90. doi: 10.2967/jnumed.109.068957. Epub 2010 Feb 11.

ReferenceCitation: Gleisner KS, Brolin G, Sundlov A, Mjekiqi E, Ostlund K, Tennvall J, Larsson E. Long-Term Retention of 177Lu/177mLu-DOTATATE in Patients Investigated by gamma-Spectrometry and gamma-Camera Imaging. J Nucl Med. 2015 Jul;56(7):976-84. doi: 10.2967/jnumed.115.155390. Epub 2015 May 21.

ReferenceCitation: Sundlov A, Sjogreen-Gleisner K, Svensson J, Ljungberg M, Olsson T, Bernhardt P, Tennvall J. Individualised 177Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry. Eur J Nucl Med Mol Imaging. 2017 Aug;44(9):1480-1489. doi: 10.1007/s00259-017-3678-4. Epub 2017 Mar 22.

ReferenceCitation: Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut de Cancérologie de l'Ouest Site d'Angers

appel_a_projets: PHRCK

nom_etablissement: ICM MONTPELLIER

type_etablissement: CLCC

acronyme: RELUTH

titre: RELUTH-Étude prospective de phase 2 randomisée évaluant les schémas de retraitement par LUTATHERA® (177Lu-DOTATATE) chez les patients présentant une nouvelle progression de leur tumeur neuroendocrine intestinale bien différenciée.

discipline_principale: cancer

nom_porteur: DESHAYES

prenom_porteur: Emmanuel


title: Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults: the EXSPRAY Trial

acronym: EXSPRAY

summary: The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day, versus placebo on nasal congestion in subject with common cold.

ipd_sharing_description: IPD won't be shared

lead_sponsor: Larena SAS

sponsor_collaborators:
Larena SAS
BioFortis

location_facility: Biofortis - Unité d'investigation clinique


title: Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study

acronym: TOSCANA

summary: There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.

lead_sponsor: French Cardiology Society

collaborators:
Novo Nordisk A/S
CEBIMER

sponsor_collaborators:
French Cardiology Society
Novo Nordisk A/S
CEBIMER

location_facility:
CHU de Poitiers
CHU de Nice
CHU de Limoges
CHU de Tours
Hôpital Lariboisière, APHP
CHU de la Réunion
Hopital Saint Antoine
Centre de Cardiologie de Thionville
CHU de Bordeaux

intervention_type: Diagnostic Test


title: High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study

acronym: preopticap

summary: High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

ReferenceCitation: Marjanovic N, Flacher A, Drouet L, Gouhinec AL, Said H, Vigneau JF, Chollet B, Lefebvre S, Sebbane M. High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Respir Care. 2020 Sep;65(9):1241-1249. doi: 10.4187/respcare.07278. Epub 2020 Apr 14.

evidence: open (via free pdf)

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

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

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

repositories_concat: HAL

publisher_dissemination: Daedalus Enterprises

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Fisher and Paykel Healthcare


title: Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units

acronym: SPCMD-REA

summary: This research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in France. All data collected is part of the patient record. The main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation

location_facility: CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation

location_facility: Hôpital Pitié-Salpêtrière - Réanimation Polyvalente

location_facility: CHU MONTPELLIER - Hôpital Arnaud de Villeneuve

location_facility: CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale

location_facility: Hôpital Privé Gériatrique Les Sources- Nice

location_facility: Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse

location_facility: CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir

location_facility: Centre Hospitalier Bretagne Atlantique de Vannes

location_facility: CHU de Rennes - Réanimation chirurgicale

location_facility: Centre Hospitalier de Laon - Réanimation Polyvalente

location_facility: Hôpital d'Instruction des Armées Sainte Anne

location_facility: CHRU de Lille - service de déchocage et de soins intensifs - Urgence

location_facility: Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: CHU Rouen - Réanimation cardiaque chirurgicale

location_facility: Hôpital Pitié-Salpêtrière - Réa neuro chir


title: Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting

acronym: TENOR

summary: The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease [CD] and Ulcerative Colitis [UC]).

lead_sponsor: Janssen Cilag S.A.S.


title: Prospective, Multicenter, Non-interventional Study to Characterize Profile of Patient With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab

summary: The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.


title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age

summary:
Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.

ReferenceCitation: Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16. doi: 10.1186/1741-7015-7-16.

lead_sponsor: Merck Sharp & Dohme LLC

location_country: Germany France


title: Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding and Platelets Functions in Coronary Surgical Patients Treated Prophylactically With Tranexamic Acid: the ICARE Study.

acronym: ICARE

summary:
Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary syndromes. Although the maintenance of aspirin until surgery does not affect postoperative bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and results: This prospective observational study will include 136 consecutive patients scheduled for first-time CABG. Postoperative bleeding and blood transfusion requirements will be compared (non inferiority)between patients pretreated during a period of 5 days prior surgery by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically used in all these patients considered as high risk for bleeding.

In concusion, this study has to to test the hypothesis that with tranexamic acid also, bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin alone group after CABG surgery, according to the previous study using aprotinin.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

acronym: PROBIOCOL

summary:
In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

status: Active, not recruiting

ReferenceCitation: Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.

ReferenceCitation: Lee L, Saleem A, Landry T, Latimer E, Chaudhury P, Feldman LS. Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. J Am Coll Surg. 2014 Jan;218(1):82-91. doi: 10.1016/j.jamcollsurg.2013.09.015. Epub 2013 Sep 29.

ReferenceCitation: Swann JM, Turek FW. Transfer from long to short days reduces the frequency of pulsatile luteinizing hormone release in intact but not in castrated male golden hamsters. Neuroendocrinology. 1988 Apr;47(4):343-9. doi: 10.1159/000124935.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Claude Huriet Hospital
Beauvais hospital
Charles Nicolle Hospital
Lariboisiere Hospital
Caen hospital
Amiens Universitary Hospital
Amiens university hospital


title: Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life

acronym: HYPOAGE

summary:
Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.

Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized

status: Terminated

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Sud Francilien
CH d'Ancenis
CHU de Poitiers
CHU de Toulouse
CHRU de Lille
CHU d'Angers
CHU de Nantes


title: Stereotactic Prostate Radiotherapy With Dose Escalation Focused on the "Dominant Intra-prostatic Lesion" (DIPL) Delineated by Multi-parametric MRI and 68Ga-PSMA PET (Prostate-SIB-PSMA)

acronym: Prostate-SIB

summary:
In localized intermediate- and high-risk prostate cancers (according to the NCCN classification), external radiotherapy delivering a "high" dose (dose equivalent 78-80Gy EQD2, α/ß=1.5) to the entire prostate volume combined with hormonal treatment, if necessary, has shown its benefit in terms of recurrence-free survival and is considered a standard treatment for this indication.

Two fractionation modalities (number of sessions) are considered as therapeutic standards, conventional fractionation (39 to 40 sessions of 2 Gy in 8 weeks) and moderate hypo-fractionation (20 sessions of 3 Gy). More recently, phase II and two phase III studies have shown equivalence in terms of safety and efficacy of "extreme hypofractionation" (5 or 6 sessions) for these localized cancers, using stereotactic-type techniques. In view of the current data, this fractionation is considered a therapeutic standard in some countries (notably the USA) and an option in France.

Delivering higher doses, beyond 80 GyEQD2 would improve tumor control, as demonstrated by randomized studies using brachytherapy, but at the cost of an increased risk of urinary toxicity.

As an alternative to this combination of external radiotherapy and brachytherapy, an innovative approach of external radiotherapy has been developed to increase the therapeutic ratio of patients with localized prostate cancer, based on an escalation of the radiation dose (> 95 GyEQD2) focused on the macroscopic tumor or "dominant intra-prostatic lesion" (DIPL), the area most at risk of local recurrence after conventional dose radiotherapy (3). This external radiotherapy technique consists in performing a conventional dose irradiation on the whole prostate, with at the same time (at each session) a higher dose ("Boost") on the DIPL. This is a modality known as "simultaneous integrated boost" (SIB).

The feasibility of simultaneous integrated boost (SIB) on the DIPL has been proven in external radiotherapy using conventional fractionation in the phase III FLAME study and the results in terms of long-term tumor control of this study showed a benefit in terms of biological recurrence-free survival.

Feasibility in terms of tolerance has also been established for very hypofractionated regimens (5 sessions), in particular in the HypoFLAME study that followed the above-mentioned study .

Multiparametric MRI (mpMRI) is used to identify and delineate the "dominant intra-prostatic lesion" (DIPL), and is the most commonly used modality in clinical studies that have evaluated SIB techniques.

However, several studies show that PET imaging, particularly 68Ga-PSMA PET, significantly improves the correlation between the image-defined DIPL and histological data and may improve the likelihood of tumor control. A dosimetric simulation study also showed that dose escalation based on 68Ga-PSMA PET could improve local tumor control with an acceptable level of toxicity .

Moreover, 68Ga-PSMA PET could be used to select the patients who could benefit most from this dose escalation, by excluding patients with lymph node or distant metastases.

lead_sponsor: Centre Leon Berard

location_facility: CAC-Clermont-Ferrand - Centre Jean Perrin

location_facility: Hospices Civils de Lyon (Hôpital Edouard Herriot)


title: Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study

acronym: SEPAGE

summary: This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.

lead_sponsor: Merck KGaA, Darmstadt, Germany

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France


title: Innate Immunity During Community Acquired Pneumonia: A Translational Approach

acronym: ImPACT

summary:
Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with 40% hospital mortality.

Dysregulation of immune response is thought to be largely implicated in severe pneumonia progressing to ARDS. Notably, experimental studies have recently suggested the implication of non-conventional T lymphocytes and innate cells in this immunopathology. However, no data are available in Humans in clinical settings.

This study aims to explore the role of non-conventional T cells in pneumonia and ARDS, in participants. For this purpose, 100 participants admitted to Intensive Care Unit (ICU) with a diagnosis of CAP will be included, and 50 "control" participants with no pneumonia nor shock. Presence and functionality of non-conventional T cells and innate cells will be explored using flow-cytometry and ex-vivo stimulation, alongside with cytokines productions. These analyses are conducted in the blood, and, for invasively ventilated participants, in tracheal aspirates or broncho-alveolar fluids if available. For each participants included, the analyses are conducted at different time-points during ICU stay: inclusion, day 3, day 8 and day 15. Moreover, participants with ARDS, for whom a post-ICU follow-up program is normally established after discharge, will have blood analysis from blood samples taken during the follow-up visit up to 8 months after inclusion.

Immunophenotypage and functionality of non-conventional T cells and innate cells will be compared to clinical parameters and their evolution, between "CAP" participants and "Control" participants", and for each participants, according to the different time-point of analysis, in order to better understand dynamic of innate immunity during pneumonia and ARDS.

lead_sponsor: University Hospital, Tours

location_facility: University Hospital -Bretonneau - Intensive Care

location_facility: University Hospitakl of TOURS Département of Pneumonia

location_facility: University Hospital of Tours; INSERM CIC 1415


title: Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer

acronym: CALMETTE

summary:
Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.

Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.

Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.

Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.

The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.

However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.

It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.

The final aim is to optimize survival by an adapted metabolic imaging guided therapy.

lead_sponsor: Centre Henri Becquerel

location_facility: Centre hospitalier intercommunal Elbeuf Louviers


lead_sponsor: LEO Pharma

summary: An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas

title: Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

source: euctr


title: Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. Multicenter Randomized Therapeutic Trial

summary:
Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia due to deficiency in either insulin secretion, insulin action, or both. There are different types of diabetes. The most common nowadays is type 2 diabetes, characterized by insulin resistance and a relative deficiency of insulin secretion, either of which may dominate to a varying degree. This form of diabetes occurs mainly in mature adults but can also occur at a younger age, or even during adolescence.

According to estimates, the number of diabetic subjects in the world increased from 153 million in 1980 to 347 million in 2008. In France, the prevalence of diabetes treated increased from 2.6% to 4.4% between 2000 and 2009, reaching nearly 3 million people. Type 2 diabetes accounts for 92% of cases of diabetes treated, and its share continues to increase due to a relative stability of type 1 diabetes and a steady increase in type 2 diabetes (5.4% per year). The aging of the population, the increase in obesity and the lack of physical activity contribute to the development of type 2 diabetes. According to the Entred study conducted in France between 2001 and 2007, four out of five type 2 diabetic patients were either overweight (39%) or obese (41%).

In the long term, unbalanced diabetes exposes to macro-vascular complications such as myocardial infarction and stroke, and microvascular complications affecting the peripheral nervous system, kidneys, retina may result in amputation of the lower limb, renal failure and blindness, respectively. As a result, the risk of death for diabetics is at least twice as high as for non-diabetics.

However, a good control of the disease by a lifestyle adaptation (lifestyle and dietary measures, physical activity) with good medical care, and possibly pharmacological, can avoid or significantly reduce the risk of complications. The purpose of dietary and lifestyle measures is to reduce hyperglycaemia and to control the weight of the patient. The implementation of effective dietary measures is a necessary prerequisite for the medication treatment of glycemic control and their application should be continued throughout the course of treatment. The treatment of other cardiovascular risk factors and complications of diabetes is also essential for the management of the diabetic patient.

The HAS (Haute Autorité de Santé : High Authority of Health) in its latest recommendations for a drug strategy for glycemic control of type 2 diabetes emphasizes that the short-term goal of decreasing hyperglycemia is the improvement of symptoms (thirst, polyuria, asthenia, weight loss and fuzziness visual) and the prevention of acute complications (infectious and hyperosmolar coma). The longer-term goal is the prevention of chronic microvascular complications (retinopathy, nephropathy and neuropathy), macrovascular (myocardial infarction, stroke, and peripheral arterial occlusive disease) and decreased mortality. The HAS notes, however, that HbA1c as a criterion for substituting morbidity and mortality endpoints in type 2 diabetes is not sufficiently supported in the scientific literature.

Be that as it may, HAS recommends individualizing the goal of glycemic control according to the profile of the patient and in particular to mobilize the recommended therapeutic means to reach the HbA1c target, in particular the dietary and hygiene measures. The data in the literature do not allow to define a lower limit for the HbA1c target. For most type 2 diabetic patients, an HbA1c target of less than or equal to 7% is recommended.

A target of 6.5% is recommended for newly diagnosed patients with no history of cardiovascular disease and a life expectancy of more than 15 years, as well as for women during pregnancy. An HbA1c target of 8% or less is recommended for patients with proven severe comorbidity and / or limited life expectancy (<5 years), or with advanced or long-lasting macrovascular complications diabetes (> 10 years) and for whom the target of 7% is difficult to achieve because drug intensification causes severe hypoglycaemia, or with a history of macrovascular complication considered as advanced, or with severe chronic renal insufficiency or (stages 4 and 5), as well as for the so-called frail elderly. For elderly people who are "sick", the priority is to avoid acute complications due to diabetes (dehydration, hyperosmolar coma) and hypoglycaemia; Pre-meal capillary glucose values of between 1 and 2 g / l and / or an HbA1c level of less than 9% are recommended. There are many molecules available on the pharmaceutical market to treat this disease (biguanides, hypoglycemic sulfonamides, DPP-4 inhibitors, GLP-1 analogues, alpha-glucosidase inhibitors, insulin, etc.). It is important to choose, depending on the clinical profile of the patient, the molecule (s) to be combined in order to achieve the glycated hemoglobin targets set by health organizations.

ReferenceCitation: Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, Lin JK, Farzadfar F, Khang YH, Stevens GA, Rao M, Ali MK, Riley LM, Robinson CA, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. Lancet. 2011 Jul 2;378(9785):31-40. doi: 10.1016/S0140-6736(11)60679-X. Epub 2011 Jun 24.

ReferenceCitation: Ampudia-Blasco FJ, Benhamou PY, Charpentier G, Consoli A, Diamant M, Gallwitz B, Khunti K, Mathieu C, Ridderstrale M, Seufert J, Tack C, Vilsboll T, Phan TM, Stoevelaar H. A decision support tool for appropriate glucose-lowering therapy in patients with type 2 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):194-202. doi: 10.1089/dia.2014.0260. Epub 2014 Oct 27.

ReferenceCitation: Debaty I, Halimi S, Quesada JL, Baudrant M, Allenet B, Benhamou PY. A prospective study of quality of life in 77 type 1 diabetic patients 12 months after a hospital therapeutic educational programme. Diabetes Metab. 2008 Nov;34(5):507-13. doi: 10.1016/j.diabet.2008.03.007. Epub 2008 Sep 30.

ReferenceCitation: Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91. doi: 10.1023/a:1026485130100.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

ReferenceCitation: Hanh T, Serog P, Fauconnier J, Batailler P, Mercier F, Roques CF, Blin P. One-year effectiveness of a 3-week balneotherapy program for the treatment of overweight or obesity. Evid Based Complement Alternat Med. 2012;2012:150839. doi: 10.1155/2012/150839. Epub 2012 Dec 24.

ReferenceCitation: Gin H, Demeaux JL, Grelaud A, Grolleau A, Droz-Perroteau C, Robinson P, Lassalle R, Abouelfath A, Boisseau M, Toussaint C, Moore N. Observation of the long-term effects of lifestyle intervention during balneotherapy in metabolic syndrome. Therapie. 2013 May-Jun;68(3):163-7. doi: 10.2515/therapie/2013025. Epub 2013 Jul 26.

lead_sponsor: Association Francaise pour la Recherche Thermale

collaborators: TIMC-IMAG Floralis

location_facility:
DAOUDI
WATERLOT
ROUSSEL Ludivine
ODDOU Christel
CLERGEOT Annie
PENFORNIS Alfred
SOUDET Simon
PARADIS Sabrina
BETRY Cécile


title: Evaluation of Informal Opinions of the Infectious Disease Specialist Referent for the Good Use of AnTiBiotics in General Medicine

acronym: AIRBUS-ATB

summary:
The increase in bacterial resistance and the overuse of antibiotics have led health authorities to propose incentives for the proper use of antibiotics. Among these measures, the introduction of referring physicians for antibiotic therapy and tele-advisory devices for infectious diseases have shown positive effects on antibiotic prescriptions in hospitals. Today, an increase is observed in the consumption of antibiotics linked to ambulatory prescriptions.

The objective of the project is to deploy tele-advice devices for general practitioners and to evaluate the effects on ambulatory antibiotic dispensing.

AIRBUS-ATB is a prospective, multi-center, population-based, interrupted time-series observational study with a control group with 12 points before and 24 points after the deployment of the intervention in voluntary territories.

ReferenceCitation: Gennai S, Francois P, Sellier E, Vittoz JP, Hincky-Vitrat V, Pavese P. Prospective study of telephone calls to a hotline for infectious disease consultation: analysis of 7,863 solicited consultations over a 1-year period. Eur J Clin Microbiol Infect Dis. 2011 Apr;30(4):509-14. doi: 10.1007/s10096-010-1111-z. Epub 2010 Nov 11.

ReferenceCitation: Sellier E, Labarere J, Gennai S, Bal G, Francois P, Pavese P. Compliance with recommendations and clinical outcomes for formal and informal infectious disease specialist consultations. Eur J Clin Microbiol Infect Dis. 2011 Jul;30(7):887-94. doi: 10.1007/s10096-011-1172-7. Epub 2011 Feb 11.

ReferenceCitation: Bal G, Sellier E, Gennai S, Caillis M, Francois P, Pavese P. Infectious disease specialist telephone consultations requested by general practitioners. Scand J Infect Dis. 2011 Dec;43(11-12):912-7. doi: 10.3109/00365548.2011.598874. Epub 2011 Aug 26.

ReferenceCitation: Lesprit P, Landelle C, Brun-Buisson C. Unsolicited post-prescription antibiotic review in surgical and medical wards: factors associated with counselling and physicians' compliance. Eur J Clin Microbiol Infect Dis. 2013 Feb;32(2):227-35. doi: 10.1007/s10096-012-1734-3. Epub 2012 Aug 24.

ReferenceCitation: Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

ReferenceCitation: Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017 Feb 1;46(1):348-355. doi: 10.1093/ije/dyw098. Erratum In: Int J Epidemiol. 2020 Aug 1;49(4):1414.

ReferenceCitation: Pavese P, Sellier E, Laborde L, Gennai S, Stahl JP, Francois P. Requesting physicians' experiences regarding infectious disease consultations. BMC Infect Dis. 2011 Mar 14;11:62. doi: 10.1186/1471-2334-11-62.

ReferenceCitation: Borowsky SJ. What do we really need to know about consultation and referral? J Gen Intern Med. 1998 Jul;13(7):497-8. doi: 10.1046/j.1525-1497.1998.00150.x. No abstract available.

ReferenceCitation: Keating NL, Zaslavsky AM, Ayanian JZ. Physicians' experiences and beliefs regarding informal consultation. JAMA. 1998 Sep 9;280(10):900-4. doi: 10.1001/jama.280.10.900.

lead_sponsor: University Hospital, Grenoble

location_facility:
CH Notre Dame de la Miséricorde
Cochin, APHP
CH de Melun
CHU de Nice
CH Métropole Savoie
Hospices civils de Lyon
CHU Clermont-Ferrand
CHU Rennes
CHU Saint Etienne
Chu de Grenoble Alpes
Olivier.rogeaux@ch-metropole_savoie.fr
MIIT Lyon
CH Annecy Genevois

appel_a_projets: PREPS

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: AIRBUS-ATB

titre: Impact des avis informels des infectiologues référents sur le bon usage des antibiotiques en médecine générale. AIRBUS-ATB/étude des Avis des Infectiologues Référents pour le Bon USage des ATB

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: Pavese

prenom_porteur: Patricia


title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study

summary: Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

lead_sponsor: Physio-Assist

sponsor_collaborators: Physio-Assist Icadom

location_facility: Grenoble University Hospital : pneumo-pediatric department

location_facility: Grenoble University-Affiliated Hospital : Pneumology department

location_facility: Nice University-Affiliated Hospital : Pneumo-pediatric department

location_facility: Nice University-Affiliated Hospital : Pneumology department


title: Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress: Non-interventional Study

summary:
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department.

Patients are followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

lead_sponsor: Wellell France

sponsor_collaborators:
Wellell France
Clin-Experts

location_facility:
Ehpad Duc de Lorge
Ehpad Villa Du Tertre
Ehpad Esbv
Ehpad Du Parc Chateau D'Abondant
Ehpad Residence Le Parc


title: Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care

acronym: FIBRO-COPD

summary: This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (FEV1), in patients with Chronic obstructive pulmonary disease (COPD) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

lead_sponsor: University Hospital, Bordeaux

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Cabinet médical
Cabinet Médical

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: FIBRO-BPCO

titre: Impact du taux de FIBROcytes sanguins circulants sur le déclin de la fonction respiratoire chez des patients en phase précoce de Broncho-Pneumopathie Chronique Obstructive en soins primaires

discipline_principale: bpco, exacerbations, fibrocytes, fonction respiratoire, soins primaires

nom_porteur: PROTHON


title: Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study

acronym: COVIDOCRECHE

summary: According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

primary_purpose: Diagnostic

ReferenceCitation: Lachassinne E, de Pontual L, Caseris M, Lorrot M, Guilluy C, Naud A, Dommergues MA, Pinquier D, Wannepain E, Hausherr E, Jung C, Gajdos V, Cohen R, Zahar JR, Brichler S, Basmaci R, Boelle PY, Bloch-Queyrat C, Aupiais C; COVIDOCRECHE collaborators. SARS-CoV-2 transmission among children and staff in daycare centres during a nationwide lockdown in France: a cross-sectional, multicentre, seroprevalence study. Lancet Child Adolesc Health. 2021 Apr;5(4):256-264. doi: 10.1016/S2352-4642(21)00024-9. Epub 2021 Feb 8.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Jean Verdier - Service de Pédiatrie