title: Assessment of Fatigue in Psoriatic Arthritis and Cutaneous Psoriasis Patients

acronym: RPso-Fatigue

summary:
Psoriatic arthritis is characterized with pain, swelling and joint stiffness. These are inflammatory reactions against tendons, ligaments and joints associated with fatigue. In France, almost 93.000 people are affected by psoriatic arthritis and the main symptoms appear between 30 and 50 years old. Psoriatic arthritis may be due to a genetic predisposition involving the HLA B27 gene, or to environmental factors such as stress, physical or psychological trauma, or infection. Obesity, type 2 diabetes and hypertension can also be factors associated with the onset of psoriatic arthritis.

Cutaneous psoriasis is a non-contagious chronic inflammatory skin disease, where the skin renews itself at an abnormally rapid rate. In France, between 2 and 3 million people are affected by cutaneous psoriasis, approximately 60.000 new cases every year. The disease begin in adolescence or young adulthood. There are multiples forms of cutaneous psoriasis (plaque, guttate, pustular, erythrodermic, inverse, facial, scalp, nail and mucous membranes). The main symptom is the appearance of thick red patches of varying size, covered with white dead skin. These lesions are most often found on the hands, elbows, knees, lower back, face or scalp. There is little to no itching. During periods of remission, lesions can disappear completely or partially, then reappear during a new attack, called a "flare-up". A familial genetic predisposition is present in 1/3 of psoriasis patients. Other immune and environmental factors, such as medication, irritations, sun exposure or psychological state, can influence psoriasis flare-ups. Psoriasis has no serious health consequences, but it can be aesthetically unpleasant, affect relationships and psychological well-being.

Fatigue is a common symptom in psoriatic arthritis patients, and can significantly affect quality of life and work capacity. Fatigue, which affects over 50% of psoriatic arthritis patients, is a major component of the disease's impact. Fatigue in psoriatic arthritis is a much-discussed topic in the current scientific literature. Although less well documented, patients with cutaneous psoriasis also experience fatigue. Several clinical trials show that, once the disease has been treated, fatigue tends to diminish, but in some cases, the treatment itself may play a role in the vicious fatigue circle. The risk of suffering other skin manifestations despite being under treatment can often be misunderstood by the patient, leading to increased depression and fatigue. Overall, treatments are more likely to play an important role in the variability of fatigue. Ultimately, fatigue is a multifactorial symptom that can be linked either to the disease itself, or to the therapies used. It therefore appears to be the most difficult symptom to treat with commercially available therapies.

As fatigue is a major symptom of psoriatic arthritis and cutaneous psoriasis, it is essential to know how the therapies offered influence this symptom, and to study whether certain therapies are more likely to increase it, despite their efficacy on joint and skin symptoms. It is also relevant to determine whether fatigue is correlated with disease severity, duration and even more so with the therapy used, to better understand the psychological impact of patients with psoriatic arthritis or cutaneous psoriasis.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon


title: Comparison of the Non-invasive Approach and Fetal Exome Sequencing in Prenatal Diagnosis When Fetal Ultrasound Signs Are Discovered

acronym: DPNI-Exome

summary:
The discovery of congenital malformations and/or non-specific signs by ultrasound (5% of pregnancies) represents a real medical challenge. Their prognosis is variable depending on the underlying etiology, ranging from acquired fetopathies to rare genetic diseases. In France, the diagnostic approach is currently based on imaging examinations (ultrasound, brain MRI, 3D bone scans, etc.) and/or biological examinations, generally on invasive sampling (trophoblast biopsy, amniocentesis or fetal blood puncture) with infectious (CMV, toxoplasmosis, parvovirus B19, etc.), metabolic (enzymes in the bloodstream, etc.), and genetic (standard karyotype, FISH, array CGH and targeted gene sequencing) investigations. The yield of this strategy is about 30%, leaving 70% of couples without a possible prognosis.

Over the last decade, medical genetics has undergone a technological revolution with the development of high-throughput DNA sequencing (HTS) allowing the analysis of targeted genes (panel) or the exome (ES). International studies published on the use of ES in prenatal diagnosis (PND) have become more common, with variable inclusion criteria, resulting in diagnostic rates between 15 and 36%, higher than those of array CGH (8-15%). In France, FHU TRANSLAD coordinates the national pilot study AnDDI-PRENATOME, which has made it possible to remove the technological barriers for PND ES and to obtain a diagnostic yield of 39% in 33 days on average.

In parallel, the recent development of NIPD (Non-invasive prenatal screening) on free fetal DNA circulating in maternal blood has made it possible to propose a non-invasive strategy. However, this technique is currently used in prenatal care only in a few indications: determination of the fetal sex, search for aneuploidies, analysis of the fetal rhesus status or, more rarely, the targeted diagnosis of monogenic diseases. The team in Strasbourg has recently conducted a pilot study using an NIPD-panel in couples with a history of neomutation in a gene responsible for intellectual disability, which has demonstrated the feasibility of capturing and then sequencing a panel of 500 genes on free fetal DNA circulating in maternal blood.

As high-depth exome sequencing from small amounts of DNA is now affordable and feasible, the investigators wish to compare invasive and non-invasive approaches for the discovery of fetal malformations on ultrasound: a trio exome analysis will be performed in parallel to circulating fetal DNA and fetal DNA extracted after an invasive puncture in order to compare the diagnostic performance of these two approaches.

The investigators propose a pilot study in order to prepare an organizational evaluation including an evaluation of the stakes for coordination and interactions between professionals, the relevance of the system (acceptability, expectations, satisfaction of couples and professionals...), its effectiveness and efficiency. The aim of this pilot project will be to observe the organizational impact on the Plurldisciplinary Centers for Prenatal Disagnostics and the genetic laboratories, and to refine the indicators necessary for monitoring the system; it will also involve conducting exploratory interviews with professionals and couples in order to prepare the qualitative study that will subsequently make it possible to evaluate the relevance of the organization.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCI

region: Bourgogne-Franche-Comté

nom_etablissement: CHU DIJON BOURGOGNE

type_etablissement: CH

acronyme: DPNI-Exome

titre: Comparaison de l'approche non invasive et du séquençage d'exome foetal en diagnostic prénatal lors de ladécouverte de signes échographiques ftaux

discipline_principale: aucune

nom_porteur: NAMBOT

prenom_porteur: Sophie


acronym: MEGACEP

intervention_type: Drug

lead_sponsor: UNICANCER

summary:
Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival are influenced by metastatic lymph node involvement. Its frequency in France is estimated at less than 1% of human cancers. This spread follows a sequential process via the superficial and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic dissemination.

The management of inguinal areas is the cornerstone of penile cancer. It is curative in about 80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85% for pN0 patients and 40% for pN+ patients. For pN+ patients, 5-year overall survival was 70 to 80% for pN1 (only 1 lymph node invasion), 30 to 40% for pN2, and 0 to 10% for pN3.

The risk of local recurrence is 5-10% for pN0 and 20-30% for pN+ after local treatment by lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months. Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN+. Its indication depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of nodal disease (≥pT1bG2).

Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple, low risk, and possible in consultation. When the result is positive, it allows an early dissection. Single or double fine needle biopsy will be used in cN+ patients. For patients at risk of lymp nodes involvement (cN0 and ≥pT1B or G2), the sentinel node diagnosis may be followed by modified or bilateral lymphadenectomy.

Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in patients with metastatic lymph node involvement. Therefore it seems important to develop a multimodal approach in the management of these patients in order to increase the response rate to treatment and survival.

From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide, and cisplatin) appears to have an efficacy / toxicity acceptable.

The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant treatment in patients with high risk of lymph nodes involvement (cN0 and ≥pT1B or G2), and with inguinal mobile palpated lymph nodes (cN+) respectively, after lymph nodes involvement proven (pN+).

sponsor_collaborators:
UNICANCER
National Cancer Institute, France

location_facility: Institut de Cancerologie Du Gard - Centre Oncogard

title: Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

ipd_sharing: No

lead_sponsor_type: industriel


title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

acronym: SME

summary:
Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: MedtronicNeuro

sponsor_collaborators:
MedtronicNeuro
Medtronic Bakken Research Center

status_simplified: Completed


title: Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).

acronym: STRATEGE

summary:
This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors.

The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.

ReferenceType: derived

ReferenceCitation: Gaujoux-Viala C, Hudry C, Zinovieva E, Herman-Demars H, Flipo RM. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE. Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

lead_sponsor: Nordic Pharma SAS


title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa. SPICES Study Implementation Phase

summary:
Cardiovascular disease (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Three quarters of CVD deaths occur in developing countries (LDCs). According to estimates in 2030, CVD will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries. The lack of an adequate primary care network in developing countries limits the screening and treatment of people with CVRF. As a result, these people do not benefit from appropriate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Cardiovascular risk factor prevention measures (CVRF) have been shown to be effective. Interventions are possible on a large scale (policies against smoking and unfavorable eating habits, promoting physical activity, etc.). Actions are possible at the individual level, both in primary prevention (fight against the FDRCV) and secondary, where many treatments have proven their effectiveness. These interventions are effective and profitable from a macroeconomic point of view. It has been estimated that the cost for such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization (WHO) stresses the importance of the triad composed by the patient and his family, the community and health professionals. Results are possible only when these three components work together for the same purpose. Many studies show the benefit of people's involvement in care in rich and developing countries.

SPICES project builds on progress in HIV / AIDS treatment in sub-Saharan Africa (SSA) and chronic disease management through the Innovative Care for Chronic Conditions (ICCC Framework), WHO plan. With regard to HIV treatment, these interventions have proven to be effective and cost-effective in many SSA countries, both in terms of disease control and adherence. These data on communicable and infectious diseases seem to be transferable to non-communicable diseases.

These projects were born from the observation that the model of care of the rich countries (individual approach of the patient, centered on the hospital and the specialist with a regular clinical and paraclinical follow-up) could not be transposed to the developing countries, because the limitation of human, technical and financial resources. But also that this model was becoming more and more difficult to maintain in developed countries or resources become limited. New approaches need to be developed to increase the effectiveness of health systems.

A paradigm shift is needed to improve the control of CVD with greater cost-effectiveness.

The SPICES project incorporates the most up-to-date knowledge to improve the prevention and control of CVD in high-, middle- and low-income countries.

Rich countries and developing countries are therefore involved in the study. The selected sites are France, United Kingdom, Belgium, South Africa and Uganda.

Some main axes of the ICCC Framework will be developed in SPICES:

improve the efficiency of health professionals through the delegation of skills and appropriate training,
center care around the patient and his family and more generally his caregivers,
simplify the monitoring and treatment protocols,
support patients in their community and emphasize prevention, information and patient education.

A first step of observation in the various countries made it possible to make an inventory of fixtures and to target the most adapted interventions.

The following steps are the implementation of these interventions (delegation of skills, information campaign and screening, improve the availability of treatments, measure of strengthening of compliance, etc. ..) and their evaluation.

This study, carried out in France and integrated into the SPICES project, will test the best non-pharmacological interventions selected in the community and by the community.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Le Goff D, Barais M, Perraud G, Derriennic J, Aujoulat P, Guillou-Landreat M, Le Reste JY. Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa). BMC Public Health. 2021 Jul 19;21(1):1422. doi: 10.1186/s12889-021-11443-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
ERCR SPURBO

location_facility:
LE GOFF
LE RESTE

intervention_type: Other


title: Study of the Motivations and Psychological Aspects of Gamete Donation Candidates Following the Change in the Law on Anonymity: a National Multicenter Study

summary: The objective of this project is to describe the motivations, the representation of donation and sterility, to evaluate the psychological aspects of the new male and female candidates to gamete donation and then to compare the results obtained from this population (post anonymity) with the previous population (anonymity).

lead_sponsor: University Hospital, Toulouse


title: Screening for Excessive Gambling Behaviors on the Internet (EDEIN Study). Study of the Database of French Online Gambling Sites.

acronym: EDEIN

summary:
The Internet medium is particularly vector for gambling problems. Since the opening of the online gambling sector in France, no screening for excessive gambling behaviours is provided for by the law, although it is known that preventive actions are more effective if they are implemented early in the gambler's career.

The investigators propose to develop a model for screening excessive gambling practices based on the gambling behaviours observed on French gambling websites, coupled to a clinical validation. The objective is to lead to early preventive measures directed towards the more vulnerable gamblers and adapted for each type of gambling.

This study will therefore contribute to setting up an innovative measure of prevention, to inform and protect gamblers as early as possible.

time_perspective: Other

ReferenceCitation: Balem M, Perrot B, Hardouin JB, Thiabaud E, Saillard A, Grall-Bronnec M, Challet-Bouju G. Impact of wagering inducements on the gambling behaviors of on-line gamblers: A longitudinal study based on gambling tracking data. Addiction. 2022 Apr;117(4):1020-1034. doi: 10.1111/add.15665. Epub 2021 Sep 23.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Perrot B, Hardouin JB, Costes JM, Caillon J, Grall-Bronnec M, Challet-Bouju G. Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites. BMJ Open. 2017 May 17;7(5):e014600. doi: 10.1136/bmjopen-2016-014600.

lead_sponsor: Nantes University Hospital

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

collaborators: MILDECA (Mission Interministérielle de Lutte contre les Drogues Et les Conduites Addictives)

collaborators: Institut de Recherche en Santé Publique, France


title: Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU)

acronym: PS-ICU

summary: This study aims to construct and validate an international professional perceived stress scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive Care Units).

status: Unknown status

time_perspective: Retrospective

ipd_sharing_description: eCRF

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: Laboratoire de psychologie université de franche Comté

collaborators: Unité de méthodologie et de qualité de vie en cancérologie CHU de besançon

collaborators: Hospital de Sabadell Department of Critical Care Spain

collaborators: Policlinico A. Gemelli Department of Critical Care Italy

collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

collaborators: Alfred Hospital Intensive Care Unit Australia

status_simplified: Unknown


title: Hospital Cohort Survey of Public Health Post-attack of July 14, 2016

acronym: ECHOS

summary:
The terrorist attack on the ram truck, which occurred on 14 July 2016 on the Promenade des Anglais in Nice, involved a significant number of casualties in the civilian population: 86 dead including 10 children and adolescents, and 434 wounded. The attack harmed families gathered for a festive event, the national holiday fireworks, and affected both adults and children of all ages. The people directly involved in the attack number in the thousands: wounded, threatened with death, bereaved, direct witnesses, workers - including firefighters and health personnel (in situations of prolonged extreme tension or insecurity).

Following the attacks in Ile-de-France in January and November 2015, Public Health France conducted in 2015 and 2016 two large-scale studies to estimate the psycho-traumatic impact for those involved in the attack, to know the use of care devices to provide useful information, and ultimately provide information to improve the management devices in place. IMPACTS carried out following the attacks of January, ESPA 13 November carried out following the attacks of 13 November 2015, relate to two main types of population:

Non-responders (civilian population) present on or near scenes of crime or their relatives.
Persons intervened to secure the premises or provide assistance, or provide psychological support the same day or within 3 weeks.

IMPACTS was conducted face-to-face with investigators and concerned 232 participants, 45 people of the medico-psychological relief (Samu, Cump, Hôtel Dieu) between 6 and 10 months after the events. A second wave of interviews took place from 16 to 20 months after the events.

ESPA 13th November took place via a web-based questionnaire and 800 participants took part, including 67 CUMPs, 121 hospital staff and 26 people from Samu between 9 and 12 months after the events.

Based on the expertise of Public Health France and the model developed for the ESPA study on November 13th, the Public Health Department of the University Hospital of Nice wished to carry out a specific study among the health professionals of the University Hospital of Nice and the Hospitals pediatrics of Nice CHU-Lenval, as well as students of the Faculty of Medicine of Nice Sophia-Antipolis.

Many professionals of all categories were directly impacted: either at the scene of the attack as a civilian population or as professionals, or in the care services that received the victims and families (including services of the Pasteur2 hospital, Lenval Hospital on the Promenade des Anglais).

The population of medical students is also included in the study, and external students in particular have made a significant contribution to the Institut Médico-Légal.

This involvement could be done directly (presence as hospital staff at the scene of the attack, care of the victims or their relatives, in the emergency and care services), but also indirect (close and knowledge affected by the attack, specific repercussions in the local context, forced changes in the organization of work). It is therefore all hospital professionals, medical students (external, internal) and paramedical students who will be involved in the study.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral


title: Budget Impact Analysis of Discontinuing Tyrosin Kinase Inhibitors in Patients With Chronic Myeloid Leukemia Achieving a Complete Molecular Response by Using Probabilistic Markov Approach

acronym: ECOSTIM

summary:
Chronic myeloid leukemia (CML) is a model of targeted therapy for human malignancies. Over the past decade, a broad array of drugs designed to selectively inhibit protein tyrosine kinases (PTK) [i.e., tyrosine kinase inhibitors, (TKI)] have emerged as novel therapies for cancer patients. Hence, CML is an hematopoietic stem cell disorder in which a t(9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated PTK. TKIs, such as imatinib by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival. CML patients treated with TKI are monitored by quantitative RT-PCR to detect leukemic BCR-ABL1 transcript performed from peripheral blood samples (1).

Since TKI treated CML patients have a near-normal life expectancy two important issues must be considered in the future:

the quality of life and ethical aspects of a lifetime treatment,
the budget impact for healthcare providers of treating patients during lifetime.

One of the best ways to consider these two points is to ask the question about stopping TKI in good responder patients. We first reported a pilot study where imatinib was withdrawn in 12 CML patients treated and maintained in complete molecular remission (CMR), defined by undetectable residual disease (with sensitivity of 4.5 log) on quantitative RT-PCR, for at least two years. Then, we demonstrated in a multicenter study entitled STIM trial that imatinib could be safely discontinued in patients with CMR for at least 2 years (2). All molecular relapsing patients were sensitive when imatinib was re-challenged (3). Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation (4). Taking into account the cost of imatinib and the number of months without treatment in STIM trial, the savings in France were estimated to be 9 million €. However, since only 40 % of patients are in treatment free remission, a study, assessing the real budget impact of stopping TKI in the eligible population seems necessary as no published study has ever addressed this question in France.

Our aim is to assess the budget impact of discontinuing TKI treatment in patients with CML in deep molecular response since at least two years, compared with treatment during lifetime, from the French healthcare system point of view. This budget impact will be expressed as a "net benefit" and will be based on the difference between total costs incurred by this strategy and total costs avoided also.

One of the originality of our study is to raise the issue of treatment cessation in the context of a chronic disease from an economic point of view.

The other originality of this study is to use a decision model to perform this French budget impact analysis of TKI discontinuation, without setting up another trial. Besides the literature review and meta-analysis; the proposed probabilistic Markov model will use direct costs (including treatment costs and all health care related costs as well as costs related to relapse) extracted mainly from the French Health Insurance Databases.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Bordeaux PharmacoEpi

appel_a_projets: PRMEK

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: ECOSTIM

titre: ECOSTIM- Probabilistic Markov model to assess the budget impact of tyrosine kinase inhibitors (TKI) discontinuation in chronic myeloid leukemia (CML) patients with deep molecular response

discipline_principale: hématologie

nom_porteur: MAHON

prenom_porteur: François-Xavier


title: Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

acronym: ENDHY

summary:
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.

The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.

intervention_type: Device


title: Stress Management in Obesity During a Thermal Spa Residential Program: a Randomized Controlled Trial

acronym: ObesiStress

summary:
Stress can lead to obesity via inappropriate eating. In addition, obesity is a major stress factor. Furthermore, stressed people are also those who have the greatest difficulties to lose weight. The relationships between obesity and stress are biological via the action of stress on the major hormones regulating appetite (leptin, ghrelin). International recommendation proposals suggest to implement stress management programs in obesity for a sustainable weight loss. Moreover, stress and obesity are two public health issues. Among the multiple physical and psychological consequences of stress and obesity, increased mortality and cardiovascular morbidity seem the main concern. Many spa resorts are specialized in the treatment of obesity in France but actually no thermal spa proposes a specific program to manage stress in obesity.

The main hypothesis is that a thermal spa residential program (21 days) of stress management in obesity will exhibit its efficacy through objective measures of well-being and cardiovascular morbidity.

study_start_date_type: Anticipated

ReferenceCitation: Dutheil F, Chaplais E, Vilmant A, Courteix D, Duche P, Abergel A, Pfabigan DM, Han S, Mobdillon L, Vallet GT, Mermillod M, Boudet G, Obert P, Izem O, Miolanne-Debouit M, Farigon N, Pereira B, Boirie Y. Stress management in obesity during a thermal spa residential programme (ObesiStress): protocol for a randomised controlled trial study. BMJ Open. 2019 Dec 23;9(12):e027058. doi: 10.1136/bmjopen-2018-027058.

repository_institution: PubMed Central - Europe PMC

repository_institution: Université du Québec à Trois-Rivières - Le dépôt institutionnel

repositories_concat: PubMed Central;depot-e.uqtr.ca

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Regional Council of Auvergne-Rhône-Alpes

collaborators: Spa resort of Vichy, Compagnie de Vichy, 1 et 3 avenue Eisenhower, 03200 Vichy, France

collaborators: Hospital of Vichy, Boulevard Denière, 03200 Vichy, France

collaborators: LaPEC laboratory (EA 4278), Avignon University, Avignon, France

collaborators: Center of Auvergne for Obesity and its health-related risks (CALORIS), Auvergne, France


title: Feasibility to Achieve, Before One Month of Age, the Diagnosis of Congenital CMV Diagnosis and the Formal Audiologic Assessment in Newborns Who Failed Newborn Hearing Screening

acronym: CymeAudit

summary: Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

ReferenceCitation: Fourgeaud J, Boithias C, Walter-Nicolet E, Kermorvant E, Couderc S, Parat S, Pol C, Mousset C, Bussieres L, Guilleminot T, Ville Y, Nkam L, Grimaldi L, Parodi M, Leruez-Ville M. Performance of Targeted Congenital Cytomegalovirus Screening in Newborns Failing Universal Hearing Screening: A Multicenter Study. Pediatr Infect Dis J. 2022 Jun 1;41(6):478-481. doi: 10.1097/INF.0000000000003474. Epub 2022 Jan 27.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion

summary:
This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.

The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.


title: Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH

acronym: SGA

summary: Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.

status: Terminated


title: Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

acronym: Conta-Lait

summary: Recent international data have shown that the levels of chemical substances found in human milk could be at risk for breastfed infants. New data are necessary to assess this risk among French newborns.


title: Combined Incentive Actions, Focusing on Primary Care, to Improve Cervical Cancer Screening in Women Residing in Socio-economically Disadvantaged and Untracked Geographical Areas: a Hybrid Efficacy and Implementation Trial

acronym: RESISTE

summary:
Though potentially eradicable, cervical cancer is the 3rd most prevalent gynecological cancer, and the 2nd most prevalent before the age of 45. In France, approximately 1100 women die from cervical cancer each year, with 5-year survival strongly linked to the stage at diagnosis (93%, 63%, 35% and 16% for stages IA, IIA, IIIA and IVA). The prevention of cervical cancer is currently based on the combination of the vaccination of adolescent girls against the most common high-risk oncogenic human papilloma virus types and routine Papanicolaou cytology (Pap smears) every three years in women aged 25 to 65 years. The Health and Social Protection Survey conducted by the Institute for Research and Documentation in Health Economics in 2012 showed that young women who are not vaccinated have a socio-economic profile similar to that of women who do not attend cervical cancer screening, mainly: (i) the least screened women and least vaccinated young women live in low-income families; (ii) a low level of education is associated with fewer Pap smears; (iii) an absence of pap smears in mothers in the last three years is associated with less human papillomavirus vaccination in their daughters. Cervical cancer is the female cancer which, in France, has the highest proportion attributable to precariousness (21.1%), and for which there are strong territorial disparities in incidence.

Several factors may explain the difficulties in obtaining satisfactory rates of screening, such as geographical remoteness, the disengagement of general practitioners, economic constraints, or the geographical origin of women. Several countries such as the Netherlands have started routinely screening for cervical cancer by testing for human papillomavirus. This approach appears to be as beneficial as a screening campaign based on the Pap smear.

This approach has also just been validated by the French Health Authority which, in its public health recommendation dated 11 July 2019, states that "From the age of 30, the High Authority for Health recommends that the human papillomavirus test replace the cytological examination in primary screening for cervical cancer." In addition, this recommendation states that "Vaginal self-sampling is an alternative to cervical sampling by a health professional to detect the human papillomavirus test for undetected or under-detected women. This makes it easier to screen women who never get tested or who do not get tested as recommended." Moreover, the French Authority for Health specifies "In addition, complementary studies should be carried out to evaluate the feasibility and effectiveness of the different modalities for making these vaginal self-samples available, depending on the specific populations concerned (French Guyana, Mayotte, women living on the street, in shantytowns, migrant women, with limited access to health services, etc.)".

Two French trials show that when women ignored a letter sent to the home to invite them to receive a Pap smear, only 16 to 18% of women performed vaginal self-sampling when a kit was subsequently sent to their home. The delivery of a vaginal swab by a health professional does not increase adherence to screening compared to a reminder letter for a Pap smear (12% vs. 11.9%). Economic incentives may increase adherence to prevention policies, including those against human papillomavirus infections. They are often used to combat "present bias", i.e. the tendency to seek immediate, even limited, satisfaction rather than greater future satisfaction. A factorial design will be used to analyze the respective contribution of the delivery of the vaginal swab to a healthcare professional and an economic incentive of 20€. The hypothesis is that the the fact of returning the vaginal self-sampling to a health professional or an economic incentive will increase the participation of socially disadvantaged women in cervical cancer screening compared to simply returning it by mail without an incentive. It also postulate that health professionals will encourage women to perform a vaginal swab and adhere to the recommendations of the French Health Authority in case of a positive human papillomavirus test and that socially disadvantaged women will accept vaginal swabbing as a method of cervical cancer screening. Factors such as precariousness, life and migration paths, the socio-sanitary context, and the provision of primary care all play a role in prevention behaviors and may explain the heterogeneity of the observed effects.


title: The Brest Registry of Stroke

acronym: BREST

summary: The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.

collaborators: Santé publique France-InVS (Institut National de Veille sanitaire)

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


title: Effects of a Thermal Spa Short Residential Program for Prevention of Work-related Stress / Burn-out on Biomarkers of Stress - A Proof of Concept Study

acronym: ThermStress

summary:
Work-related stress is a public health issue. Among the multiple physical and psychological consequences of stress, increased mortality and cardiovascular morbidity seem the main concern. The thermal spa resort of Néris-Les-Bains is one of the five spa resorts in France specialized in the treatment of psychosomatic disorders. Among all these resorts proposing a thermal residential program of three weeks, only one thermal spa resort (Saujon) has a program for occupational burn-out. However, a shorter thermal spa residential program seems more compatible with professional context (availability of individuals), and focusing on work-related stress prevention (before the state of burn-out).

The main hypothesis is that a short thermal spa residential program (6 days) of work-related stress prevention will exhibit its efficacy through objective measures of well-being and cardiovascular morbidity.

collaborators: Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France

sponsor_collaborators: Regional Council of Auvergne-Rhône-Alpes

sponsor_collaborators: LaPEC laboratory (EA 4278), Avignon University, Avignon, France


title: Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study

acronym: DEMETER

summary: In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.

ReferenceType: background

ReferenceCitation: Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.

ReferenceCitation: Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.

ReferenceCitation: Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.

ReferenceCitation: Branch-Elliman W, Wright SB, Howell MD. Determining the Ideal Strategy for Ventilator-associated Pneumonia Prevention. Cost-Benefit Analysis. Am J Respir Crit Care Med. 2015 Jul 1;192(1):57-63. doi: 10.1164/rccm.201412-2316OC.

ReferenceCitation: Loupec T, Petitpas F, Kalfon P, Mimoz O. Subglottic secretion drainage in prevention of ventilator-associated pneumonia: mind the gap between studies and reality. Crit Care. 2013 Dec 9;17(6):R286. doi: 10.1186/cc13149. No abstract available.

lead_sponsor: Centre Hospitalier Departemental Vendee

sponsor_collaborators:
Centre Hospitalier Departemental Vendee
Ministry of Health, France
URC Eco Ile de France
University Hospital, Tours

location_country: Réunion Guadeloupe Belgium France

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise

location_facility: CHU de Strasbourg Hôpital de Hautepierre

location_facility: CHU La Réunion, site de Saint Pierre de la Réunion

location_facility: CHU La Réunion, site de Saint Denis de la Réunion

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: CHD VENDEE

type_etablissement: EPSM

acronyme: DEMETER

titre: Drainage des sécrétions sous-glottiques et prévention des pneumonies acquises sous ventilation mécanique en réanimation, Etude Médico-Economique multicentrique randomisée,en clusTer, en crossovER: étude DEMETER

discipline_principale: economie de la santé

nom_porteur: Lacherade

prenom_porteur: Jean-Claude


title: Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

acronym: VIBR-AVC

summary:
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.

The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.

This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
École Normale Supérieure de Cachan


title: Clinical and Biological Efficacy of Hazelnut Oral Immunotherapy

summary: This study is retrospective. It focuses on hazelnut allergic patients with a clinical history and a positive specific immunoglobulin E (sIgE) against hazelnut and its recombinants that have followed a hazelnut oral tolerance induction at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2011.

lead_sponsor: Lille Catholic University


title: Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft

acronym: PERIDATOR

summary:
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009.

This clinical trial aims to build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.

ReferenceCitation: Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.

ReferenceCitation: Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

ReferenceCitation: Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.

collaborators:
CHU de Reims
University Hospital, Marseille
University Hospital, Lille
Central Hospital, Nancy, France
University Hospital, Grenoble
CMCO SIHCUS, Schiltingheim
University Hospital, Bordeaux
Nantes University Hospital
University Hospital, Limoges

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)

summary:
Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA)
Design: Double blind, randomized trial testing the efficacy of one month Anakinra treatment versus placebo (2 groups of 12 patients each). All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered (= descriptive part of the trial to assess the tolerance and efficacy over 12 months).
Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.
Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria), age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease, no previous IL-1ra treatment.

ReferenceCitation: Quartier P, Allantaz F, Cimaz R, Pillet P, Messiaen C, Bardin C, Bossuyt X, Boutten A, Bienvenu J, Duquesne A, Richer O, Chaussabel D, Mogenet A, Banchereau J, Treluyer JM, Landais P, Pascual V. A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011 May;70(5):747-54. doi: 10.1136/ard.2010.134254. Epub 2010 Dec 20.

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

location_facility: Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevres


title: Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System

acronym: CCENDO

summary: The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

ReferenceCitation: Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.

ReferenceCitation: Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17. doi: 10.1002/dmrr.764.

ReferenceCitation: Engeli S, Bohnke J, Feldpausch M, Gorzelniak K, Janke J, Batkai S, Pacher P, Harvey-White J, Luft FC, Sharma AM, Jordan J. Activation of the peripheral endocannabinoid system in human obesity. Diabetes. 2005 Oct;54(10):2838-43. doi: 10.2337/diabetes.54.10.2838.

ReferenceCitation: Bluher M, Engeli S, Kloting N, Berndt J, Fasshauer M, Batkai S, Pacher P, Schon MR, Jordan J, Stumvoll M. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes. 2006 Nov;55(11):3053-60. doi: 10.2337/db06-0812.

ReferenceCitation: Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

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

location_facility: Haut Lévêque Hospital, Endocrine department

intervention_type: Procedure


title: Investigation of Cross-allergies Between Cefazolin and Amoxicillin With Skin Tests and Provocation Test

acronym: CEFAZOPE

summary:
Antibiotic prophylaxis in the operating room reduces the frequency of occurrence of surgical site infections (SSI) by preventing bacterial proliferation.

The main antibiotic used in all surgery is CEFAZOLINE. This antibiotic of the Beta-lactam family, and more precisely of the 1st generation cephalosporins, is active on a specific bacterial target, which is often the cause of surgical site infections. Patients known to be allergic to penicillin have a 50% higher risk of surgical site infection. The choice of antibiotic prophylaxis often comes up against the risk of allergy in anesthesia. In France in 2004, according to the INSERM database, 100 IgE-mediated immediate hypersensitivity reactions (IHR) were observed out of 1 million anesthesias. The attributable allergens in descending order were curares (60.6%), latex (5.2%) then antibiotics (18.2%), followed by dyes (3.5%), hypnotics, opioids, gelatins and local anesthetics were rarely found. Regarding allergy to antibiotics, the leading antibiotic for allergy in France is AMOXICILLIN, which accounts for 29% of drug-induced anaphylaxis. In view of the risk of cross-allergy, a history of allergy to AMOXICILLIN in the operating room is a contraindication to all beta-lactam antibiotics and therefore leads to an alternative choice to CEFAZOLINE when the latter was indicated for first-line antibiotic prophylaxis.

However, this choice of alternative antibiotic to CEFAZOLINE is not without consequences. First of all, the alternative antibiotics Vancomycin and Clindamycin have a narrower spectrum and therefore may not cover all germs found in SSI. They do not cover Gram-negative organisms for Vancomycin and Gram-negative aerobes for Clindamycin. Moreover, the use of these antibiotics exposes to undesirable effects. They can promote the occurrence of nosocomial infections such as Clostridium difficile colitis, infections with resistant germs such as methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant Enterococcus (VRE). Other adverse effects may occur such as Nephrotoxicity and Red Man Syndrome with Vancomycin. In addition, these antibiotics may be more difficult to handle, not allowing for the optimization of recommended delivery conditions. Secondly, the notion of the cost of these antibiotics must be taken into account.

Two elements could encourage investigators to use CEFAZOLINE despite a history of allergy to AMOXICILLIN.

1. Allergy declarations such as can be obtained in consultation correspond mainly to false positives. In fact, out of 10% of the world's population reporting an allergy to penicillins, only 1 to 2% of subjects have a proven allergy. In GHPSJ, among the patients consulting for a suspected allergy, the reintroduction test confirmed it in only 5.6% of them.
From a molecular point of view, there is a low rate of similarity between these two molecules. Contrary to popular belief, cephalosporin allergy is not mediated by the β-lactam core. The cross-allergy between cephalosporins and penicillin comes from the similarities of the R1 chain which is attached to the β-lactam nucleus at position 7 for cephalosporins, at position 6 for penicillins. This may therefore explain the lack of clinical cross-reactivity.

The primary objective is to evaluate the proportion of patients of allergies between CEFAZOLINE and AMOXICILLINE.

The secondary objectives are to evaluate the diagnostic value of skin tests to CEFAZOLINE and to describe the safety of protocol of reintroduction of CEFAZOLINE and AMOXICILLINE in the context of IgE-mediated cross-reactivity.

status: Active, not recruiting

time_perspective: Cross-Sectional

ReferenceCitation: Blumenthal KG, Ryan EE, Li Y, Lee H, Kuhlen JL, Shenoy ES. The Impact of a Reported Penicillin Allergy on Surgical Site Infection Risk. Clin Infect Dis. 2018 Jan 18;66(3):329-336. doi: 10.1093/cid/cix794.

ReferenceCitation: Tacquard C, Collange O, Gomis P, Malinovsky JM, Petitpain N, Demoly P, Nicoll S, Mertes PM. Anaesthetic hypersensitivity reactions in France between 2011 and 2012: the 10th GERAP epidemiologic survey. Acta Anaesthesiol Scand. 2017 Mar;61(3):290-299. doi: 10.1111/aas.12855.

ReferenceCitation: Blanca M, Torres MJ, Garcia JJ, Romano A, Mayorga C, de Ramon E, Vega JM, Miranda A, Juarez C. Natural evolution of skin test sensitivity in patients allergic to beta-lactam antibiotics. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):918-24. doi: 10.1016/s0091-6749(99)70439-2.

ReferenceCitation: Vorobeichik L, Weber EA, Tarshis J. Misconceptions Surrounding Penicillin Allergy: Implications for Anesthesiologists. Anesth Analg. 2018 Sep;127(3):642-649. doi: 10.1213/ANE.0000000000003419.

ReferenceCitation: Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.

ReferenceCitation: Pool C, Kass J, Spivack J, Nahumi N, Khan M, Babus L, Teng MS, Genden EM, Miles BA. Increased Surgical Site Infection Rates following Clindamycin Use in Head and Neck Free Tissue Transfer. Otolaryngol Head Neck Surg. 2016 Feb;154(2):272-8. doi: 10.1177/0194599815617129. Epub 2015 Nov 16.

lead_sponsor: Fondation Hôpital Saint-Joseph


acronym: BADGE-PD

summary: The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD (n=200) and 200 matched PD patients without ICD (n=200).

intervention_type: Genetic


title: Antioxidant Signature in Adult Patients With Phenylketonuria (PKU) and Healthy Volunteers : Relationship With Metabolic Disturbances

acronym: StressOX-PCU

summary: To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim of the present study is to investigate oxidative stress in PKU with more comprehensive methods.The relationship between oxidative stress and metabolic disturbances (hyperPhenylalaninemia) will also be studied.

lead_sponsor: University Hospital, Tours


title: Atrioventricular Block and Cluster Headache

acronym: SEVA

summary: Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.

primary_purpose: Other

ipd_sharing_description: No data sharing plan ahs been established

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
AP-HP Hôpital la Timone


title: Criterion and Convergent Validity of Activity Monitors to Study Walking Activity

acronym: VAMOS

summary: Wearable activity monitors represent a real opportunity to assess people' daily walking activity, however their level of validity remains poorly understood in the assessment of intermittent walking activity, i.e. as it occurs in everyday life conditions. Indeed, the available validation studies mainly focused on steps count accuracy of wearable activity monitors, but their validity to detect and quantify bouts of intermittent walking in daily life conditions remains insufficiently studied. It is important not only to determine which indicators would be the most accurate but also which methods would be the most suitable for detecting intermittent walking bouts, and then estimating energy expenditure. The main objective of the VAMOS project is to study the criterion and convergent validity of consumer-level and research-grade wearable activity monitors in assessing daily life intermittent walking in healthy subjects.

lead_sponsor: University of Rennes 2

collaborators: Ecole normale supérieure de Rennes (FRANCE)

location_facility: Health, Sport and Movement Laboratory (M2S)


title: Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital

acronym: ILYAD

summary:
Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse - Department of Pneumology


title: Testing the Effect of Raltegravir on Persistent de Novo HIV Infection in Virologic Responders to Antiretroviral Therapy ( RALNOVO )

acronym: RALNOVO

summary:
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients.

Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir.

Secondary objectives

To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood
Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART
Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels
Identify virological responders may benefit from treatment intensification

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Institute of Human Genetics, France


title: Personalizing Colorectal Cancer Medicine: an Integrative Approach for the Identification of Prognostic Parameter Combinations at the Time of Surgery and During the Follow-up

summary:
Colorectal cancers are the leading cancers for both sexes combined. They represent 15-20% of all cancers. This cancer has a severe prognosis, the survival rate at 5 years is around 55% and in France it is estimated, all colorectal cancers are responsible for an annual mortality of 15,000 patients. The prognosis of colon cancer knows no significant improvement.

The treatment of colon cancer is surgical. It is intended for removal of colonic segment bearing the tumor with margins of healthy colon. The therapeutic attitude following the surgery is essentially driven by histopathology of the tumor. Adjuvant chemotherapy for all patients with localized stage II provides no benefit because the effectiveness of chemotherapy is limited and vulnerable to systemic toxicity. However, nearly 30% of patients with stage II disease will have a recurrence / metastasis. These patients could benefit from adjuvant chemotherapy.

Intense research efforts have been made to identify markers predictive of relapse. Over thirty biological markers (eg. Mutations, deletions, chromosomal instability, ...) were highlighted. None of them has so far sufficient prognostic value (independent of TNM) to justify routine application in clinical practice in order to adapt the treatment of patients.

The identification of new prognostic markers is a major issue for colorectal cancer. We showed that the intratumoral density memory T lymphocytes (CD45RO) and cytotoxic (CD8) strongly influenced the clinical outcome of patients. We have developed and validated a "immunoscore" technique intratumoral immune quantification and creates a platform to facilitate the clinical immuno transfer.

We are currently conducting a large international retrospective study (22 centers,> 9000 patients) with promotion of cancer immunotherapy Company (SITC) to validate the method "immunoscore." At the same time, we are conducting a prospective multicenter study "ImmuCol" (National PHRC) to validate the prognostic value of "immunoscore" in colorectal cancer stage I-IV. The goal of inclusion has been achieved, as 420 patients were included for 18 months. Clinical follow-up will be 3 years after surgery.

The program ImmuCol2 research takes advantage of the ImmuCol study to extend the investigation beyond the immunoscore to define the combination of interest, prognostic and theranostic parameters at diagnosis and during the clinical course patients with an objective of personalized medicine.

ReferenceCitation: Dunn GP, Bruce AT, Ikeda H, Old LJ, Schreiber RD. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol. 2002 Nov;3(11):991-8. doi: 10.1038/ni1102-991.

ReferenceCitation: Saltz LB, Kelsen DP. Adjuvant treatment of colorectal cancer. Annu Rev Med. 1997;48:191-202. doi: 10.1146/annurev.med.48.1.191.

ReferenceCitation: Pages F, Berger A, Camus M, Sanchez-Cabo F, Costes A, Molidor R, Mlecnik B, Kirilovsky A, Nilsson M, Damotte D, Meatchi T, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Galon J. Effector memory T cells, early metastasis, and survival in colorectal cancer. N Engl J Med. 2005 Dec 22;353(25):2654-66. doi: 10.1056/NEJMoa051424.

ReferenceCitation: Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pages C, Tosolini M, Camus M, Berger A, Wind P, Zinzindohoue F, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Pages F. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006 Sep 29;313(5795):1960-4. doi: 10.1126/science.1129139.

ReferenceCitation: Pages F, Kirilovsky A, Mlecnik B, Asslaber M, Tosolini M, Bindea G, Lagorce C, Wind P, Marliot F, Bruneval P, Zatloukal K, Trajanoski Z, Berger A, Fridman WH, Galon J. In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer. J Clin Oncol. 2009 Dec 10;27(35):5944-51. doi: 10.1200/JCO.2008.19.6147. Epub 2009 Oct 26.

ReferenceCitation: Mlecnik B, Tosolini M, Kirilovsky A, Berger A, Bindea G, Meatchi T, Bruneval P, Trajanoski Z, Fridman WH, Pages F, Galon J. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol. 2011 Feb 20;29(6):610-8. doi: 10.1200/JCO.2010.30.5425. Epub 2011 Jan 18.

ReferenceCitation: Galon J, Mlecnik B, Bindea G, Angell HK, Berger A, Lagorce C, Lugli A, Zlobec I, Hartmann A, Bifulco C, Nagtegaal ID, Palmqvist R, Masucci GV, Botti G, Tatangelo F, Delrio P, Maio M, Laghi L, Grizzi F, Asslaber M, D'Arrigo C, Vidal-Vanaclocha F, Zavadova E, Chouchane L, Ohashi PS, Hafezi-Bakhtiari S, Wouters BG, Roehrl M, Nguyen L, Kawakami Y, Hazama S, Okuno K, Ogino S, Gibbs P, Waring P, Sato N, Torigoe T, Itoh K, Patel PS, Shukla SN, Wang Y, Kopetz S, Sinicrope FA, Scripcariu V, Ascierto PA, Marincola FM, Fox BA, Pages F. Towards the introduction of the 'Immunoscore' in the classification of malignant tumours. J Pathol. 2014 Jan;232(2):199-209. doi: 10.1002/path.4287.

ReferenceCitation: Myron Kauffman H, McBride MA, Cherikh WS, Spain PC, Marks WH, Roza AM. Transplant tumor registry: donor related malignancies. Transplantation. 2002 Aug 15;74(3):358-62. doi: 10.1097/00007890-200208150-00011.

ReferenceCitation: Dalerba P, Maccalli C, Casati C, Castelli C, Parmiani G. Immunology and immunotherapy of colorectal cancer. Crit Rev Oncol Hematol. 2003 Apr;46(1):33-57. doi: 10.1016/s1040-8428(02)00159-2.

ReferenceCitation: Jass JR. Lymphocytic infiltration and survival in rectal cancer. J Clin Pathol. 1986 Jun;39(6):585-9. doi: 10.1136/jcp.39.6.585.

ReferenceCitation: Phillips SM, Banerjea A, Feakins R, Li SR, Bustin SA, Dorudi S. Tumour-infiltrating lymphocytes in colorectal cancer with microsatellite instability are activated and cytotoxic. Br J Surg. 2004 Apr;91(4):469-75. doi: 10.1002/bjs.4472.

ReferenceCitation: Pages F, Galon J, Dieu-Nosjean MC, Tartour E, Sautes-Fridman C, Fridman WH. Immune infiltration in human tumors: a prognostic factor that should not be ignored. Oncogene. 2010 Feb 25;29(8):1093-102. doi: 10.1038/onc.2009.416. Epub 2009 Nov 30.

ReferenceCitation: Fridman WH, Pages F, Sautes-Fridman C, Galon J. The immune contexture in human tumours: impact on clinical outcome. Nat Rev Cancer. 2012 Mar 15;12(4):298-306. doi: 10.1038/nrc3245.

ReferenceCitation: Bindea G, Mlecnik B, Tosolini M, Kirilovsky A, Waldner M, Obenauf AC, Angell H, Fredriksen T, Lafontaine L, Berger A, Bruneval P, Fridman WH, Becker C, Pages F, Speicher MR, Trajanoski Z, Galon J. Spatiotemporal dynamics of intratumoral immune cells reveal the immune landscape in human cancer. Immunity. 2013 Oct 17;39(4):782-95. doi: 10.1016/j.immuni.2013.10.003.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Hopital Europeen Georges Pompidou (HEGP)

appel_a_projets: PRTK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

titre: Médecine personnalisée et cancers colorectaux : approche intégrative pour l'identification de combinaisons de paramètres pronostiques initiaux et au cours du suivi clinique.

discipline_principale: cancer

nom_porteur: PAGES

prenom_porteur: Franck


title: Coronavirus Disease 2019 (Covid-19) at the Regional Hospital Center Metz-Thionville: a Descriptive Study

summary:
France and especially the region "Grand Est" have been damaged by the COVID-19 pandemic. This pandemic resulted in a reorganization of the hospitalization sectors.

In order to better understand the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient data. This study would notably allow us to identify some prognostic factors.

The main objective of this study is to identify individual factors that are associated with a poor prognosis (with ICU admission or death).

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Evaluation of a Parathyroid Hormone Suppression Test With Cinacalcet. Comparison: 1- With the Results of the Intravenous Calcium Suppression Test in Healthy Controls; 2- Between Healthy Controls and Patients With Primary Hyperparathyroidism.

summary: The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.

lead_sponsor: University Hospital, Rouen


title: Phone-based Safety Monitoring of the First Year of Baclofen Treatment for Alcohol Use Disorder: the BACLOPHONE Cohort Study

acronym: BACLOPHONE

summary:
BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of 792 patients during their first year of baclofen prescription for alcohol use disorder.

The main objective of the study is to determine the rate of patients who stop baclofen due to an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to determine which types of AEs and serious AEs are actually liable to baclofen, and which other types are more likely the consequence of confounding factors, e.g., concomitant alcohol, psychotropic medications or substance uses, and comorbidities.

lead_sponsor: University Hospital, Lille

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility: Etablissement Public de Santé Mentale (EPSM)

location_facility: Centres de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA) Le Cèdre Bleu

location_facility: Service d'Aide aux Toxicomanes (SATO-Picardie)

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: BACLOPHONE

titre: Suivi téléphonique de pharmacovigilance des prescriptions hors-AMM de baclofène

discipline_principale: autre

nom_porteur: JARDRI

prenom_porteur: Renaud


title: Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management

acronym: MEDECO-AIT

summary:
The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.

Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.

lead_sponsor: University Hospital, Toulouse


title: Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters

acronym: GPs

summary:
Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.

The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).

primary_purpose: Screening

location_facility: Centre de Coordination des Dépistages des Cancers (CCDC)


title: Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study

acronym: ITHI

summary:
This study compare an usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, in France. The aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:

patients divided according to the severity of their FEV1 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.

lead_sponsor: Fondation Ildys

sponsor_collaborators:
Fondation Ildys
Lille Catholic University

location_facility: CF Center - Fondation Ildys Site de Perharidy

location_facility: CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran


title: Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes

acronym: CERADIAB

summary: Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Relationship Between Hidradenitis Suppurativa and Periodontal Diseases

acronym: HSPDA

summary:
Hidradenitis suppurativa or Verneuil's disease (HS) is a neglected and often overlooked chronic inflammatory skin disease. Nevertheless, it is frequent (1% of the general population) and deeply affects quality of life in patients with moderate and severe forms of HS. This disease is characterized by the occurrence of deep, recurrent and painful nodules, progressing to abscess formation and suppuration. It is usually localized in the axillary, inguinal and anogenital areas. The pathogenesis of HS remains partly unknown but is probably multifactorial (inflammatory, genetic, infectious, etc.) and related to many risk factors (mostly smoking and obesity). An association can be found with other inflammatory diseases such as gastrointestinal and rheumatic diseases like Crohn's disease and spondylo-arthritis respectively.

Periodontal diseases are a heterogeneous group of infectious diseases with an inflammatory component. Their clinical expression results in more or less rapid destruction of tooth supporting tissues. Without treatment, these lesions may progress ultimately to tooth exfoliation, the rate of disease progression being unevenly distributed in the population. Various epidemiological studies in France indicate that 12 to 13% of middle-aged adults have severe periodontal damage. In addition, a recent study shows that while 50% of adults in France are suffering from severe attachment loss, generalized forms are rare and about 10% of individuals seem to require special care. The bacterial factor is the main etiological factor of these diseases but their progression depends primarily on the host immune response and on modifying factors (genetic, systemic, environmental and behavioural). Some of these factors are identified such as uncontrolled diabetes, smoking, stress, etc.. Finally, it is well established that periodontal disease may also trigger the development of some systemic diseases such as diabetes.

Thus, many common etiopathogenic factors between HS and periodontal diseases such as inflammatory components and tobacco are found. This is corroborated by observations collected from some patients with HS complaining of oral pain exacerbated during acute flares of HS. Hence the aim of this project is to clarify existing potential association between Hidradenitis suppurativa and periodontal diseases using a multicenter cross-sectional descriptive clinical approach.

One hundred patients with HS will be included in the departments of dermatology at the University Hospital in Reims and at the Pasteur Institute in Paris. They will be compared with one hundred patients without HS recruited from "general practice" consultations in the departments of Odontology at the University Hospital in Reims and at Bretonneau Hospital in Paris.

The severity of HS will be assessed with Hurley's score by the dermatologist. The periodontal status will be evaluated with clinical indices and radiographical parameters by a periodontist according to the "Armitage" classification of periodontal disease and to CDC-AA case definitions updated in 2012. Meanwhile, human saliva is a biological fluid taken to reflect the health status of an individual and is or may be used for diagnosis and prognosis of some oral cancers, some systemic diseases (type 2 diabetes, sarcoidosis, etc.) or periodontal diseases. The saliva will be collected and analysed by proteomics and metabolomics techniques in order to identify biomarkers for diagnosis and prognostic of HS associated or not to periodontal diseases.

These unpublished works could demonstrate a predisposition to develop periodontal disease in a subgroup of HS patients and help to unravel new etiopathogenic mechanisms common to both diseases as well as ultimately lead to early periodontal management in order to avoid disease progression and tooth losses.

lead_sponsor: CHU de Reims

collaborators: Association Française pour la Recherche sur l'Hidrosadénite (Financial sponsor)

collaborators: Association Française d'épargne et de retraite (Financial sponsor)


type: Other Grant/Funding Number

title: The Prevention of Post Operative Cognitive Dysfunction by Ketamine: a Prospective Multicenter Randomized Blinded Placebo-controlled Trial in Elderly Patients Undergoing Elective Orthopaedic Surgery

acronym: POCK

summary:
Over 30 million patients require a major surgery annually in the US alone and more than half of them are performed in patients over 60 years of age. Post-operative cognitive dysfunction (POCD) is a keystone complication of these surgeries and affects up to 40% of surgical patients aged over 60 years on discharge from the hospital. Despite controlled longitudinal studies have shown that POCD is transient, it is associated with delirium, higher mortality, earlier retirement, and greater utilization of social financial assistance The pathophysiology of persistent postoperative cognitive dysfunction and causal relationship between POCD and delirium remain incompletely understood. Identified clinical risk factors for both include advanced age, type of surgery, preexisting cognitive impairment, and drug addiction. We and others have provided evidence that the inflammatory response triggered by surgical trauma and pain may contribute to the development of delirium and cognitive impairment after surgery.

Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia and postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on neuronal and microglial brain cells, it contributes to tone down the neuroinflammatory process associated with surgery. A recent body of evidence has shown that ketamine reduces the depressive-like behavior induced by inflammatory or stress-induced stimuli in mice. Ketamine was also found to reduce levels of inflammatory biomarkers in cardiac surgical patients.

Orthopaedic surgery is a high-risk situation for developing postoperative cognitive dysfunction. In patients undergoing non-cardiac surgery, the prevalence of POCD is 26% one week after surgery and decreased to 10% at 3 months postoperatively, and a similar prevalence is found 12 months after the operation. Postoperative delirium is associated with an increased risk of POCD. Hundred thousands of patients > 60 years undergo elective orthopaedic procedures per year around the world.

ReferenceCitation: Kurdi MS, Theerth KA, Deva RS. Ketamine: Current applications in anesthesia, pain, and critical care. Anesth Essays Res. 2014 Sep-Dec;8(3):283-90. doi: 10.4103/0259-1162.143110.

ReferenceCitation: Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

ReferenceCitation: Riou B, Lecarpentier Y, Viars P. Inotropic effect of ketamine on rat cardiac papillary muscle. Anesthesiology. 1989 Jul;71(1):116-25. doi: 10.1097/00000542-198907000-00020.

ReferenceCitation: Riou B, Viars P, Lecarpentier Y. Effects of ketamine on the cardiac papillary muscle of normal hamsters and those with cardiomyopathy. Anesthesiology. 1990 Nov;73(5):910-8. doi: 10.1097/00000542-199011000-00019.

ReferenceCitation: Zanos P, Moaddel R, Morris PJ, Georgiou P, Fischell J, Elmer GI, Alkondon M, Yuan P, Pribut HJ, Singh NS, Dossou KS, Fang Y, Huang XP, Mayo CL, Wainer IW, Albuquerque EX, Thompson SM, Thomas CJ, Zarate CA Jr, Gould TD. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016 May 26;533(7604):481-6. doi: 10.1038/nature17998. Epub 2016 May 4.

ReferenceCitation: Harraz MM, Tyagi R, Cortes P, Snyder SH. Antidepressant action of ketamine via mTOR is mediated by inhibition of nitrergic Rheb degradation. Mol Psychiatry. 2016 Mar;21(3):313-9. doi: 10.1038/mp.2015.211. Epub 2016 Jan 19.

ReferenceCitation: Zorumski CF, Nagele P, Mennerick S, Conway CR. Treatment-Resistant Major Depression: Rationale for NMDA Receptors as Targets and Nitrous Oxide as Therapy. Front Psychiatry. 2015 Dec 9;6:172. doi: 10.3389/fpsyt.2015.00172. eCollection 2015.

ReferenceCitation: Hudetz JA, Patterson KM, Iqbal Z, Gandhi SD, Byrne AJ, Hudetz AG, Warltier DC, Pagel PS. Ketamine attenuates delirium after cardiac surgery with cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):651-7. doi: 10.1053/j.jvca.2008.12.021. Epub 2009 Feb 23.

ReferenceCitation: Arrowsmith JE, Harrison MJ, Newman SP, Stygall J, Timberlake N, Pugsley WB. Neuroprotection of the brain during cardiopulmonary bypass: a randomized trial of remacemide during coronary artery bypass in 171 patients. Stroke. 1998 Nov;29(11):2357-62. doi: 10.1161/01.str.29.11.2357.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRCN

acronyme: POCK

titre: Prévention des troubles cognitifs post-opératoires par la Ketamine: un essai prospectif multicentrique randomisé en double aveugle contre placebo

discipline_principale: anesthésiologie / réanimation

nom_porteur: MANTZ

prenom_porteur: Jean


title: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up

acronym: COVIDothèque

summary:
SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.

The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.

ipd_sharing_description: NC


title: Qualitative Study on the Perception of Changes in the Psychotherapy of Traumatized Young People

acronym: TRAUMADOPSY

summary:
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents.

Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.

location_facility: University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France


title: Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

acronym: ENMG-DIAPH

summary:
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

location_facility: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France


title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

summary: Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

ReferenceCitation: Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: French Database of Left Atrial Appendage Closure

acronym: FLAAC

summary:
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.

This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.

This database is strictly observational.

Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.

ReferenceCitation: Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Spaulding C, Armero S, Champagnac D, Bhugaloo H, Ternacle J, Lellouche N, Audureau E, Le Corvoisier P; French national Left Atrial Appendage Closure registry (FLAAC) investigators. Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry. Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.

ReferenceCitation: Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Pasquie JL, Rioufol G, Lepillier A, Elbaz M, Horvilleur J, Brenot P, Pierre B, Le Corvoisier P; French National Left Atrial Appendage Closure Registry (FLAAC) Investigators. Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events. Circ Cardiovasc Interv. 2018 Mar;11(3):e005841. doi: 10.1161/CIRCINTERVENTIONS.117.005841.

oa_colors: green other

evidence: open (via free pdf)

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

version: submittedVersion

repositories_concat: HAL

unpaywall_oa_status: bronze

lead_sponsor: Henri Mondor University Hospital

collaborators: French association for research in cardiology (ARCARD)


title: Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial

acronym: ELUMEN

summary:
Meningioma, the most common intracranial primary tumor of the central nervous system predominantly affects people in their fifties. Meningiomas are generally subdivided into two entities: a priori non-aggressive meningiomas (grade 1), and meningiomas at high risk of aggressive behavior (grade 2/atypical and 3/anaplastic). The current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory irrespectively of grade, and in these rare entities, the therapeutic arsenal is reduced to the few treatments that have shown limited efficacy. Refractory, and particularly grades 2 and 3 meningiomas, have very poor prognoses with a progression-free survival at 6 months (PFS-6) of 26%. The European Response Assessment in Neuro-Oncology group (RANO) recommends that in any new, grades 2 and 3 meningioma, therapy that achieves a PFS-6 >30% in phase II trials be considered promising.

In Nuclear Medicine, Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE, currently used on a compassionate basis in refractory meningioma, deploys an octreotide-like effect, and appears very promising, with preliminary PFS-6 of 94% and an overall survival at 12 months (OS-12) of 88% in grade 1 meningioma. However, its PFS-6 is reduced to 28% with an OS-12 of 65% in WHO grades 2 and 3 meningioma. Recently the non-radiolabeled octreotide and everolimus combination however achieved a PFS-6 of 55% and an OS-12 of 75% in a population of 90% WHO grades 2 and 3 meningioma.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHRU of Nancy
Nancy Hospital