title: Interest of DBM Fasciatherapy for Physiotherapy in the Care of Patients Suffering From Non-Specific Chronic Low Back Pain: a Cluster Randomized Multicenter Clinical Trial

summary:
Low back pain (LBP) is pain localized below the costal margin and above the inferior gluteal folds. It may be associated with radiculalgia. Non-specific LBP refers to LBP without specific problems such as infection, inflammation, vertebral fracture or cancer. Chronic LBP is a LBP lasting more than 3 months.

The causes of LBP remain unknown. While there are recommendations for physiotherapy, the protocol of care is not well defined. New therapeutic models centered on neurophysiology are replacing biomechanics-based models. New programs centered on patient education and a biopsychosocial approach are emerging.

Research has shown the possible involvement of fascia in LBP and the interest of manual fascia therapies in the treatment of LBP. To date, there are no studies that have shown the effects of fasciatherapy in the treatment of non-specific LBP.

In France, many physiotherapists use this type of treatment and more specifically fasciatherapy. French physiotherapists say that it may improve their management of LBP. Studies on fasciatherapy have highlighted the effects of fasciatherapy in the management of fibromyalgia pain, the treatment of anxiety, malaise and the improvement of body perception. They show the multidimensional actions of fasciatherapy and support its clinical, functional and psychosocial evaluation for LBP.

Fasciatherapy is part of the manual therapies that target their action on the fascial system. This "patient-centered" technique is a biopsychosocial and humanistic approach to health. The manual and gestural approaches of the fascia are part of the Non-Pharmaceutical Interventions field. Fasciatherapy involves manual and gestural interventions, with the objective of restoring the contractile, elastic and movement properties of the fascia in order to provide relief, improve function and quality of life for patients.

In France, fasciatherapy is not part of recommendations and is not recognized by the Conseil National de l'Ordre des Masseurs-Kinésithérapeutes.

This study aims to assess the effects of fasciatherapy on LBP and to evaluate how it could contribute to its management for physiotherapists. It is a cluster randomized trial conducted on 180 subjects. Intensity of pain (measured with VAS) is the primary outcome. The secondary outcomes are the impact of LBP on daily life (Dallas Pain Questionnaire), on quality of life (SF-12 questionnaire), on anxiety (STAI questionnaire), and the evolution of drug consumption.

The study will take place in France and the treatment structures will be the practitioners' practice.

ReferenceCitation: Bruyère O, Demoulin M, Beaudart C, Hill JC, Maquet D, Genevay S, Mahieu G, Reginster JY, Crielaard JM, Demoulin C. Validity and reliability of the French version of the STarT Back screening tool for patients with low back pain. Spine (Phila Pa 1976). 2014 Jan 15;39(2):E123-8. doi: 10.1097/BRS.0000000000000062.

ReferenceCitation: Marty M, Blotman F, Avouac B, Rozenberg S, Valat J-P. Validation de la version française de l'échelle de Dallas chez les patients lombalgiques chroniques. Revue du rhumatisme (Ed française). 1998;65(2):139-47.

ReferenceCitation: Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23.

ReferenceCitation: Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6.

ReferenceCitation: Ware J, Kolinski M, Keller S. How to score the SF-12 physical and mental health summaries: a user's manual. Boston: The Health Institute, New England Medical Centre, Boston, MA. 1995;

ReferenceCitation: Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

ReferenceCitation: Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.

ReferenceCitation: Wilke J, Schleip R, Klingler W, Stecco C. The Lumbodorsal Fascia as a Potential Source of Low Back Pain: A Narrative Review. Biomed Res Int. 2017;2017:5349620. doi: 10.1155/2017/5349620. Epub 2017 May 11. Review.

ReferenceCitation: Courraud C, Bois D, Lieutaud A. Apports de la pratique de la fasciathérapie à l'exercice de la physiothérapie: le point de vue des praticiens. Mains Libres. 2016;(3):49-58.

ipd_sharing_description: No IPD sharing

lead_sponsor: FasciaFrance


type: Other Grant/Funding Number

title: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study

acronym: OCAPAS

summary:
Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.

The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.

One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.

This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Hayotte M, Iannelli A, Nègre V, Pradier C, Thérouanne P, Fuch A, Diagana O, Garbarino JM, Vuillemin A, Colson SS, Chevalier N, d'Arripe-Longueville F. Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. BMJ Open. 2021 Jul 30;11(7):e046184. doi: 10.1136/bmjopen-2020-046184.

family: Hayotte

full_name: Meggy Hayotte

given: Meggy

sequence: first

family: Iannelli

full_name: Antonio Iannelli

given: Antonio

sequence: additional

family: Nègre

full_name: Véronique Nègre

given: Véronique

family: Pradier

full_name: Christian Pradier

given: Christian

family: Thérouanne

full_name: Pierre Thérouanne

given: Pierre

family: Fuch

full_name: Alain Fuch

given: Alain

family: Diagana

full_name: Odile Diagana

given: Odile

family: Garbarino

full_name: Jean-Marie Garbarino

given: Jean-Marie

family: Vuillemin

full_name: Anne Vuillemin

given: Anne

family: Colson

full_name: Serge S Colson

given: Serge S

family: Chevalier

full_name: Nicolas Chevalier

given: Nicolas

family: d'Arripe-Longueville

full_name: Fabienne d'Arripe-Longueville

given: Fabienne

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: No

lead_sponsor: Pr Fabienne d'Arripe-Longueville

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy - SATISFY: a Cross-sectional Study

acronym: SATISFY

summary:
The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management. Thus, the satisfaction of an individual in their interview with the pharmacist is a very important element.

The pharmacist in his professional activity may have to manage patients with opioid related disorders. Pharmacist activity will result in the dispensing of opioid replacement therapy (ORT), single-use syringes, harm reduction kits and prevention advices for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of ORT has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients undergoing ORT is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed ORT in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with patient suffering of opioid related disorders, which can have an impact on patient's satisfaction.

The objective of this study will be to assess the satisfaction of patients undergoing ORT regarding their management by community pharmacists.

status: Unknown status

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Generalized Training Program for Caregivers on the ESDM

acronym: PEGASE

summary:
The main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.

This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in Marseille's university Department of Child Psychiatry.

This center is a regional expert center in diagnostic and research missions in the field of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD) The center receives requests for diagnostic assessment from all the region. Autism is to date a major public health problem, current prevalence rates are 1 child / 88 in the United States. This prevalence continues to increase.

Autism is a severe neurodevelopment disorder with significant functional impact.

An essential axis in the field of health is to develop new treatment strategy including low costs and family impact particularly in quality of life.

In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum Disorders (ASD) people and interventions were edited.

Support for grade recommendations have been issued. In this research, the investigators focus on a global, early and coordinated management method: the Early Start Denver Model. This intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver Model (ESDM) is scientifically proven by a lots of studies.

Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P (parents ESDM). Even if in both ways of care, the parent is put in a central position around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento Davis University.

P ESDM is not yet developed in France and has not been the subject of any French-language publication to date.

This program is dedicated to young parents of children with autism spectrum disorders aged between 2 and 4 years old.

This is a 7-month program (with a duration of inclusion of 3 year). The program is based on ESDM techniques, it meets both the need to include parents in care and the idea of reducing the cost of these care (need fewer hours of care by professionals).

This program is offered to all parents of autism spectrum disorders children between the ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.

The aim of this study is to objectify the effectiveness of this parental intervention in a French population.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de pédopsychiatrie Sainte-Marguerite


title: Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults

acronym: EMPIRE

summary: A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk older patients using a 6-month pre-post intervention analysis.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Completed


title: Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice

acronym: TELEDERMATO

summary:
In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.

Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology.

We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.

primary_purpose: Diagnostic

ReferenceCitation: Piette E, Nougairède M, Vuong V, Crickx B, Tran VT. Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care. J Telemed Telecare. 2017 Sep;23(8):725-732. doi: 10.1177/1357633X16663328. Epub 2016 Aug 5.

name: Department of General Medicine, Paris Diderot University, Paris, France

name: Sorbonne Paris Cité University, Paris, France

family: Piette

full_name: Edouard Piette

given: Edouard

family: Nougairède

full_name: Michel Nougairède

given: Michel

name: Department of Dermatology, Hospital Bichat, Assistance Publique-Hôpitaux de Paris, Paris France

family: Vuong

full_name: Valerie Vuong

given: Valerie

family: Crickx

full_name: Beatrice Crickx

given: Beatrice

name: Centre de recherche en Epidémiologie et Statistiques, INSERM U1153, Paris, France

family: Tran

full_name: Viet-Thi Tran

given: Viet-Thi

journal_name: Journal of Telemedicine and Telecare

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Paris 7 - Denis Diderot


type: Other Identifier

title: Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes

acronym: EVIDENCE

summary: This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.

ReferenceType: result

ReferenceCitation: Gautier JF, Martinez L, Penfornis A, Eschwège E, Charpentier G, Huret B, Madani S, Gourdy P. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study. Adv Ther. 2015 Sep;32(9):838-53. doi: 10.1007/s12325-015-0245-x. Epub 2015 Sep 30.

family: Gautier

full_name: Jean-Francois Gautier

given: Jean-Francois

family: Martinez

full_name: Luc Martinez

given: Luc

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Eschwège

full_name: Eveline Eschwège

given: Eveline

family: Charpentier

full_name: Guillaume Charpentier

given: Guillaume

family: Huret

full_name: Benoît Huret

given: Benoît

family: Madani

full_name: Suliya Madani

given: Suliya

family: Gourdy

full_name: Pierre Gourdy

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via page says license)

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

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study

ReferenceCitation: Martinez L, Penfornis A, Gautier JF, Eschwège E, Charpentier G, Bouzidi A, Gourdy P. Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study. Adv Ther. 2017 Mar;34(3):674-685. doi: 10.1007/s12325-017-0476-0. Epub 2017 Jan 30.

family: Bouzidi

full_name: Amira Bouzidi

given: Amira


title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

summary:
This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

lead_sponsor: Nordic Pharma SAS


title: Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals

acronym: PsyCOVID All P

summary: SARS-COV-2 has created an unprecedented health crisis, resulting in unprecedented mobilization of all hospital professionals. The massive influx of patients overwhelmed the human, therapeutic and material resources available, and teams were confronted with an unusually heavy workload in a highly stressful emergency context. These professionals were thus exposed to a risk of over-investment in a context of acute and repetitive stress over an indefinite period of time, combining a heavy workload, emotional challenges and specific ethical issues. These factors simultaneously affected the professional sphere but also the personal and family spheres (lockdown, risk of contamination). In this context, the mental health of hospital staff is considered to be more important than ever, as emphasized on numerous occasions by the Director General of Health and the French Minister for Health and Solidarity. Mental health involves the way in which individuals respond specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the question of the mental health of hospital professionals cannot be considered without taking into account the strategies implmented to combat stress, and the factors that contribute or not to the construction and stabilization of the work environment (collaboration, support).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Vaccination Coverage in People Linving With Diabetes

acronym: VacDiab

summary:
For several years, the prevalence of people living with diabetes (pDT) has been steadily increasing. It was estimated by the health insurance in 2016 at 5 %, or more than 3.3 million people in France. By different physiological mechanisms, diabetes is associated with immunodeficiency. As a result, several vaccines are recommended in pDT.

The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. This vaccine is especially indicated for this segment of the population because diabetes is a risk factor for tetanus. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for pDT according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious for these patients compared to the general population. Influenza vaccine has to be done annually in the early winter period. The vaccine coverage for winter 2018/2019 was estimated at 46.8 % of the target population. The vaccination scheme for pneumococcal vaccine is more complex: it involves a primary vaccination with a vaccine with 13 valences followed by another with 23 valences at least eight weeks later. Thereafter, a recall is to be carried out every five years with the 23 valences vaccine. Vaccination coverage was estimated in France in 2011 at 8.1 % in the population at risk.

According to several studies, the shingles virus has a greater impact and is more aggressive in pDT than in the general population. Similarly, the virus would tend to unbalance diabetes. There is currently a vaccine against shingles that is recommended and reimbursed in the population aged 65 to 74 years.

In our practice, a pharmaceutical team has been carrying out medication reconciliation for several years at the hospital admission and discharge of the patient in the endocrinology-nutrition department of the university hospital of Montpellier.

During this medication reconciliation, a pharmaceutical interview on the management of drug treatments is carried out . Since May 2019, we added to this interview an assessment of the vaccination coverage and feelings of people regarding vaccination. Following this assessment, a report is made during an interview with the doctor responsible for the patient. During this interview, the update of mandatory and recommended vaccinations are discussed between the doctor and the pharmacist.

In this context, it seems interesting to us to make an assessment of our practices and the investigator make the following assumptions:

There is a defect in the mandatory and recommended process of vaccination for pDT
A synthesis of pDT vaccine status between the physician and the pharmacist at the time of hospitalization would allow optimization of vaccine management in accordance with current recommendations and practices.

The main objective of the study is to assess vaccine coverage for mandatory and recommended pDT vaccines at hospital admission.

The secondary objectives are:

Description of pDT experience with vaccination;
Description of the management of vaccination within the Department of Endocrinology-Nutrition-Diabetes during and after the patient's hospitalization in terms of (intra-hospital vaccination, hospital prescriptions of a vaccine after hospitalization and number of vaccination recommendations in the hospitalization report).
Description of transmission of vaccination status of patients to their treating physician


title: Relationship Between Adverse Drug Reactions and Unlicensed/ Off-label Drug Use in Hospitalized Children: an Observational Multicenter Prospective Study

acronym: EREMI

summary:
Medications are the most commonly used clinical intervention and complications associated with their use are one of the most common causes of adverse events in health care. Adverse Drug Reactions (ADR) are a major cause of morbidity and pose a substantial burden on limited health care resources.

Many drugs used to treat children in hospitals are either not licensed for use in children or are prescribed outside the terms of their product license (off-label prescribing). This is mainly due to the lack of clinical trials in this vulnerable population, and both practical difficulties and ethical considerations arising from involving children in clinical research.

Drugs used within the specifications of the product license might be less likely to cause ADR compared to drugs that are either unlicensed or off-label for use in children. Few studies have shown a significant association between pediatric off-label drug use and ADR.

To compare the probability of ADR after a licensed drug prescription versus the probability of ADR after prescribing a drug off-label in children, we are conducting a multi-center prospective observational study in different pediatric hospital wards in France.

The availability of electronic health records made this study feasible. An automatic data extraction from hospital information systems has been implemented. A computer algorithm for determining pediatric drug labelling (i.e. off-label or unlicensed use) using the French summaries of product characteristics available in Thériaque® database has been developed. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients' electronic health records. The causality between ADRs and suspected medications is evaluated using the Naranjo and the French methods by regional pharmacovigilance centers. An independent pharmacovigilance board validates ADR evaluations, assesses both of their severity and avoidability, and indicates therapeutic alternatives to suspected medications.

This is, to our knowledge, the first large multi-center and prospective study in France that evaluates the relationship between adverse drug reactions and unlicensed/ off-label drugs use in hospitalized children. The results of this study will provide more information on the prescription practice and the amplitude, nature and consequences of unlicensed/off-label drug use in hospitalized children. It will also help identify the risk factors of ADR that could be used to implement preventive actions, and guide future research in the field. An indirect benefit is represented by the increase of physicians' awareness in detecting and declaring ADRs and by communicating the results to the health professionals and to the public. This study is funded by ANSM (the French Medicine Agency).

lead_sponsor: Hospices Civils de Lyon

location_facility: Pediatric Clinical Research and Investigation Centre CIC 1407 Inserm-UMR 5558 CNRS Lyon University & Hospices Civils de Lyon


type: EudraCT Number

title: A Randomized Non-Inferiority Clinical Trial of Doxycyline Vs BPG for Early Syphilis

acronym: SY-DOXY

summary:
According to European and US Centers for Disease Control and Prevention (CDC) guidelines, the recommended treatment for uncomplicated early syphilis in adults (i.e. primary, secondary and early latent) is a single intramuscular injection of 2.4 million units of benzathine benzylpenicillin G (BPG). Recent reviews have also recommended BPG as the first-line treatment of early syphilis, reporting a success rate of more than 90% over a large panel of studies. This form of the drug provides weeks of treponemicidal levels of penicillin in the blood, but does not efficiently cross the blood-brain barrier.

However, despite the use of BPG for almost 70 years and its status as the gold standard treatment for early syphilis, the need to administer this antibiotic parenterally has led to the use of second-line oral antibiotics, including firstgeneration macrolides, and then second-generation macrolides, such as azithromycin. Several African studies have shown 1 g azithromycin bid treatment for one day to be effective against early syphilis, but most authors agree that azithromycin should not generally be used as resistance to this macrolide is highly prevalent in Western countries. Moreover, a recent study by our group showed that more than 80% of the treponemal strains isolated in France harbor the mutation conferring resistance to azithromycin. The use of this alternative would, therefore, be highly unlikely to be effective in France. Tetracycline antibiotics have also been proposed as an alternative in patients with a contraindication for BPG or other forms of penicillin. Doxycycline, at a dose of 100 mg orally twice daily for 14 days, has been endorsed as a preferred alternative treatment, but few data are available concerning its efficacy. This issue is crucial, for two main reasons: there has been a recrudescence of early syphilis in most western countries over the last 20 years, increasing the need for BPG, and two periods of BPG shortage were experienced in 2013 and 2017, leading to the use of alternative treatments due to the temporary unavailability of BPG or its limitation to cases in which no other treatment was possible. Data for the manufacturing and distribution of antibiotics are not publicly available, but reports of limited availability, shortages, and price increases for old antibiotics suggest that the current system is too fragile to provide what should be a given in modern medicine: access to effective treatment for common and potentially severe bacterial infections. The recurrence of BPG shortages over the last five years has created an urgent need to demonstrate that doxycycline is safe, or at least as safe as BPG, for treating early syphilis. The investigators hypothesize that the recommended doxycycline regimen is not inferior to BPG and plan to test this hypothesis in a randomized clinical trial.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study

summary:
The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients under OST is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed OST in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with opioid-dependent patients, even though these pharmacists have received education in the management of addictions during their studies. Indeed, it can consider that these courses should help to better understand the addictive disease both in its nosological / semiological and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction education on pharmacists' perception of opioid dependence. In this perspective, it would be interesting to focus on pharmacy students.

The objective of this study will be to evaluate the perception by pharmacy students of opioid dependent patients. Investigator would like to know if pharmacy students consider opioid addiction to be an illness and whether having taken education on drug use and addictions changes this perception.


title: Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population

acronym: ALEX

summary: Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


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.

lead_sponsor: MedtronicNeuro


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.


title: Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial

acronym: EDPT-ADOS

summary:
The symptomatic and clinical expression of psychiatric disorders in children and adolescents is strongly influenced by the cultural setting they are growing up in. These cultural variations complicate psychiatric care, especially for migrant children, for whom appropriate care must be designed.

Transcultural psychotherapy is an original psychotherapeutic technique developed to meet these specific requirements in France and in different European and American countries. Its theoretical and methodological foundations rest on the works of George Devereux in ethnopsychiatry (1970). A psychotherapeutic technique intended for first-generation migrants was developed by Tobie Nathan and coll (1986). Marie-Rose Moro and colleagues (1990) have adapted this technique to second-generation migrants.

Indicated as a second-line treatment after the failure of standard management, this technique is fully formalized today. It comprises group consultations for the child and the family as a one-hour session each month, directed by a principal therapist, assisted by a group of co-therapists (of diverse cultural origins and occupations) and an interpreter in the family's mother tongue. The concept of culture is used to establish the therapeutic alliance, decode the symptoms, and propose treatment.

The children and adolescents receiving this treatment have varied psychopathological profiles, mostly involving depressive and/or anxiety disorders. Specifically, migrants' children are especially vulnerable to depression, their psychiatric care is generally longer and less effective than in the general population, and their rate of treatment failure higher.

Transcultural psychotherapy has demonstrated its value in these situations in numerous qualitative studies, but its efficacy has not yet been assessed by a method providing a high level of evidence, such as randomized controlled trials.

location_facility: Service de médecine interne, unité de consultation transculturelle, CHRU Saint-André (CHU Bordeaux)

location_facility: Secteur 75G23, Centre Médico-psychologique (CMP), GHU PARIS, Maison blanche

location_facility: Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse

location_facility: Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne

location_facility: Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied


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: 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


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.

lead_sponsor: UNICANCER

acronym: MEGACEP

location_facility: Institut de Cancerologie Du Gard - Centre Oncogard

source: euctr

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

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+).


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


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.

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux


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: 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.


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: 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.

primary_purpose: Prevention


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.

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.

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

family: Chaplais

full_name: Elodie Chaplais

given: Elodie

family: Vilmant

full_name: Audrey Vilmant

given: Audrey

family: Courteix

full_name: Daniel Courteix

given: Daniel

family: Duche

full_name: Pascale Duche

given: Pascale

family: Abergel

full_name: Armand Abergel

given: Armand

family: Pfabigan

full_name: Daniela M Pfabigan

given: Daniela M

family: Han

full_name: Shihui Han

given: Shihui

family: Mobdillon

full_name: Laurie Mobdillon

given: Laurie

family: Vallet

full_name: Guillaume T Vallet

given: Guillaume T

family: Mermillod

full_name: Martial Mermillod

given: Martial

family: Boudet

full_name: Gil Boudet

given: Gil

family: Obert

full_name: Philippe Obert

given: Philippe

family: Izem

full_name: Omar Izem

given: Omar

family: Miolanne-Debouit

full_name: Magalie Miolanne-Debouit

given: Magalie

family: Farigon

full_name: Nicolas Farigon

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Boirie

full_name: Yves Boirie

given: Yves


title: Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

acronym: POSEIDON

summary: Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.


title: Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis

acronym: SPAXIM

summary:
There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.

ReferenceCitation: Mulleman D, Lauféron F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350.

family: Mulleman

full_name: Denis Mulleman

given: Denis

family: Lauféron

full_name: Francine Lauféron

given: Francine

family: Wendling

full_name: Daniel Wendling

family: Ternant

full_name: David Ternant

given: David

family: Ducourau

full_name: Emilie Ducourau

given: Emilie

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Goupille

full_name: Philippe Goupille

journal_name: Arthritis Research & Therapy

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Tours

location_facility: University Hospital Jean MINJOZ -Besançon


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: Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital.

summary: The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.

ReferenceType: background

ReferenceCitation: Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.

lead_sponsor: University Hospital, Grenoble


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.

lead_sponsor: University Hospital, Clermont-Ferrand


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.

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. Review.

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.

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

family: De Jonghe

full_name: Bernard De Jonghe

given: Bernard

family: Guezennec

full_name: Pierre Guezennec

given: Pierre

family: Debbat

full_name: Karim Debbat

given: Karim

family: Hayon

full_name: Jan Hayon

given: Jan

family: Monsel

full_name: Antoine Monsel

given: Antoine

family: Fangio

full_name: Pascal Fangio

given: Pascal

family: Appere de Vecchi

full_name: Corinne Appere de Vecchi

given: Corinne

family: Ramaut

full_name: Cédric Ramaut

given: Cédric

family: Outin

full_name: Hervé Outin

given: Hervé

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Intermittent Subglottic Secretion Drainage and Ventilator-associated Pneumonia

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.

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.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_country: Réunion Belgium France Guadeloupe

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

location_facility: CHU de Strasbourg Hôpital de Hautepierre

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

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise


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. Epub 2007 Feb 20.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


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: 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: Study of Klotho Gene Polymorphisms in the Regulation of Serum Phosphate Levels in Hemodialysis Patients

summary: Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.

ReferenceCitation: Prié D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. Review.

location_facility: Clinique de l'Orangerie - Service de Néphrologie et Dialyse


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.

family: Quartier

full_name: P. Quartier

given: P.

family: Allantaz

full_name: F. Allantaz

given: F.

family: Cimaz

full_name: R. Cimaz

given: R.

family: Pillet

full_name: P. Pillet

family: Messiaen

full_name: C. Messiaen

given: C.

family: Bardin

full_name: C. Bardin

family: Bossuyt

full_name: X. Bossuyt

given: X.

family: Boutten

full_name: A. Boutten

given: A.

family: Bienvenu

full_name: J. Bienvenu

given: J.

family: Duquesne

full_name: A. Duquesne

family: Richer

full_name: O. Richer

given: O.

family: Chaussabel

full_name: D. Chaussabel

given: D.

family: Mogenet

full_name: A. Mogenet

family: Banchereau

full_name: J. Banchereau

family: Treluyer

full_name: J.-M. Treluyer

family: Landais

full_name: P. Landais

family: Pascual

full_name: V. Pascual

given: V.

journal_name: Annals of the Rheumatic Diseases

evidence: open (via free pdf)

repository_institution: KU Leuven - Lirias

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories:
LIRIAS (KU Leuven)
PubMed Central
open-archive.highwire.org

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: 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: 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: Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate

acronym: AGADIR

summary:
Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD) was frequent among patients with alcohol-dependence. However, no investigation has ever addressed whether ADHD may impact the drinking outcome.

Moreover, most of the different aforementioned studies assessed ADHD using the ADHD self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness.

The study aims to evaluate "ADHD: Gaps between patients with Alcohol Dependence and Impact on early Relapse" (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. They are assessed for ADHD using the ASRS, but also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. ASRS is re-performed at the end of the follow-up.

lead_sponsor: University Hospital, Lille


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.

primary_purpose: Other

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

location_facility: Etablissement Public de Santé Mentale (EPSM)

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


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

location_facility: CF Center - Fondation Ildys Site de Perharidy

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


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


title: Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia

summary: Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.

primary_purpose: Basic Science

ReferenceCitation: Blanchard V, Ramin-Mangata S, Billon-Crossouard S, Aguesse A, Durand M, Chemello K, Nativel B, Flet L, Chétiveaux M, Jacobi D, Bard JM, Ouguerram K, Lambert G, Krempf M, Croyal M. Kinetics of plasma apolipoprotein E isoforms by LC-MS/MS: a pilot study. J Lipid Res. 2018 May;59(5):892-900. doi: 10.1194/jlr.P083576. Epub 2018 Mar 14.

apc_source: openAPC

family: Blanchard

full_name: Valentin Blanchard

given: Valentin

family: Ramin-Mangata

full_name: Stéphane Ramin-Mangata

given: Stéphane

family: Billon-Crossouard

full_name: Stéphanie Billon-Crossouard

given: Stéphanie

family: Aguesse

full_name: Audrey Aguesse

given: Audrey

family: Durand

full_name: Manon Durand

given: Manon

family: Chemello

full_name: Kevin Chemello

given: Kevin

family: Nativel

full_name: Brice Nativel

given: Brice

family: Flet

full_name: Laurent Flet

given: Laurent

family: Chétiveaux

full_name: Maud Chétiveaux

given: Maud

family: Jacobi

full_name: David Jacobi

given: David

family: Bard

full_name: Jean-Marie Bard

given: Jean-Marie

family: Ouguerram

full_name: Khadija Ouguerram

given: Khadija

family: Lambert

full_name: Gilles Lambert

given: Gilles

family: Krempf

full_name: Michel Krempf

given: Michel

family: Croyal

full_name: Mikaël Croyal

given: Mikaël

currency_apc_doaj: USD

journal_name: Journal of Lipid Research

evidence: open (via crossref license)

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

version: submittedVersion

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

ReferenceCitation: Ferchaud-Roucher V, Croyal M, Moyon T, Zair Y, Krempf M, Ouguerram K. Plasma Lipidome Analysis by Liquid Chromatography-High Resolution Mass Spectrometry and Ion Mobility of Hypertriglyceridemic Patients on Extended-Release Nicotinic Acid: a Pilot Study. Cardiovasc Drugs Ther. 2017 Jun;31(3):269-279. doi: 10.1007/s10557-017-6737-y.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe


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.

status: Active, not recruiting

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. Review.

ReferenceCitation: Saltz LB, Kelsen DP. Adjuvant treatment of colorectal cancer. Annu Rev Med. 1997;48:191-202. Review.

ReferenceCitation: Pagès 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.

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

ReferenceCitation: Pagès 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.

name: From the AVENIR L'Institut National de la Santé et de la Recherche Médicale (INSERM) Integrative Cancer Immunology Team, INSERM U872; Université Paris-Descartes; Cordeliers Research Center; Université Pierre et Marie Curie Paris 6; Departments of Immunology, Pathology, and General and Digestive Surgery of the Georges Pompidou European Hospital, Assistance Publique Hôpitaux de Paris, Paris; Departments of General and Digestive Surgery, and Pathology, Avicenne Hospital, Bobigny, France; Institute for...

family: Pagès

full_name: Franck Pagès

given: Franck

family: Kirilovsky

full_name: Amos Kirilovsky

given: Amos

family: Mlecnik

full_name: Bernhard Mlecnik

given: Bernhard

family: Asslaber

full_name: Martin Asslaber

given: Martin

family: Tosolini

full_name: Marie Tosolini

given: Marie

family: Bindea

full_name: Gabriela Bindea

given: Gabriela

family: Lagorce

full_name: Christine Lagorce

given: Christine

family: Wind

full_name: Philippe Wind

given: Philippe

family: Marliot

full_name: Florence Marliot

given: Florence

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

family: Zatloukal

full_name: Kurt Zatloukal

given: Kurt

family: Trajanoski

full_name: Zlatko Trajanoski

given: Zlatko

family: Berger

full_name: Anne Berger

given: Anne

family: Fridman

full_name: Wolf-Herman Fridman

given: Wolf-Herman

family: Galon

full_name: Jérôme Galon

given: Jérôme

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: In Situ Cytotoxic and Memory T Cells Predict Outcome in Patients With Early-Stage Colorectal Cancer

ReferenceCitation: Mlecnik B, Tosolini M, Kirilovsky A, Berger A, Bindea G, Meatchi T, Bruneval P, Trajanoski Z, Fridman WH, Pagès 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.

name: From the Institut National de la Santé et de la Recherche Médicale, Integrative Cancer Immunology Team and Team 13 (INSERM U872); Université Paris Descartes; Cordeliers Research Center, Université Pierre et Marie Curie Paris 6; Hôpital Européen Georges Pompidou, Paris, France; and Biocenter, Section for Bioinformatics, Innsbruck Medical University, Innsbruck, Austria.

family: Meatchi

full_name: Tchao Meatchi

given: Tchao

title: Histopathologic-Based Prognostic Factors of Colorectal Cancers Are Associated With the State of the Local Immune Reaction

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, Pagès 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. Review.

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.

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. Review.

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

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.

ReferenceCitation: Pagès F, Galon J, Dieu-Nosjean MC, Tartour E, Sautès-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. Review.

ReferenceCitation: Fridman WH, Pagès F, Sautès-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. Review.

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, Pagès 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.

location_facility: Hopital Europeen Georges Pompidou (HEGP)


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).

ipd_sharing: Yes

ipd_sharing_description: eCRF