title: Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation

acronym: STRATIDEP

summary: This study aims to better understand the mechanisms of action of antidepressants, but also the neural correlates of motivation deficits. One hundred patients with a moderate to severe major depressive episode will be enrolled in this prospective multicenter study. The objective will be to predict the therapeutic response to two first-line antidepressants on the basis of an early neurocomputational assessment of motivation. Antidepressant treatment will be administered as monotherapy after randomization between two drugs: escitalopram and vortioxetine. Patients will undergo six visits and follow-up for one year. The investigators will combine computer modeling and functional MRI to identify motivational deficits and elucidate their brain correlates before initiation, after 7 days and after 6 months of treatment. 36 healthy volunteers will also be included to allow comparison with patients with depression. They will not receive any treatment.

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ipd_sharing_description:
The data obtained from medical visits (clinical informations, biological assessments, cognitive data) and brain MRIs will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed. These can be used later for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes.

In case of transfer of the anonymized database resulting from this research abroad (outside the EU), the sponsor undertakes to ensure a level of security equivalent to French or European Union law.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre hospitalier Universitaire de Saint-Etienne

location_facility: Centre hospitalier Universitaire de Lille

location_facility: - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

location_facility: Groupe hospitalo-universitaire de Grenoble Alpes

location_facility: Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université


type: Other Identifier

title: Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance

acronym: JÛVENILE

summary: Immunosenescence is the age-related decline of the immune system, involving a state of chronic inflammation and a decrease in the diversity/adaptability of the lymphocyte repertoire. The consequences of immunosenescence are multiple, including increased susceptibility to infections and poorer vaccine responses.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: EHPAD de la Talaudière, la Rivière, la Croix de l'Horme

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy (ACUPOX)

acronym: ACUPOX

summary: ACUPOX is a multicenter, open label, 2-cohort based phase II clinical study evaluating the interest of a standardized protocol of verum acupuncture in treatment of Oxaliplatin-induced peripheral neuropathy in patients with gastro-intestinal solid tumors who discontinued oxaliplatin-containing chemotherapy.

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Saint Antoine
Hôpital Henri Mondor
Centre intercommunal de Créteil
Hôpital Pitié Salpêtrière
Institu Daniel Hollard

intervention_type: Other

lead_sponsor_type: industriel


title: Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial

acronym: TestICUs

summary:
Critically ill patients experience major insults that lead to increased protein catabolism.

Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage. During acute phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid release. Under stress conditions, protein synthesis cannot match the increased rate of muscle proteolysis because of a state of anabolism resistance, which limits uptake of amino acids into muscles.

Hypermetabolism results in a significant loss of lean body mass with an impact on weaning from the ventilator and muscle recovery. Functional disability can be long term sometimes with no full return to normal.

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

Administration of testosterone induces skeletal muscle fiber hypertrophy and decreases protein breakdown in healthy young men. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in hypogonadal men and women and can improve physical performance. Testosterone administration in burned patients reduces protein breakdown and increases protein synthesis efficiency. Oxandrolone, a synthetic testosterone analogue, reduces body mass and nitrogen loss and accelerates healing in burned patients. Trials in critically ill unburned patients failed to demonstrate any effect on clinical outcome but the studies were underpowered to detect a difference.

Transdermal gel testosterone is the preferred route of administration for achieving steady serum testosterone concentrations as compared to oral and intramuscular formulations.

Intramuscular injection induces strong fluctuations of testosterone plasma concentrations and can cause haematoma in patients with coagulation disorders, a common condition in ICUs. Several studies have raised the concern that testosterone administration could increase the risk of cardiovascular disease events. However, in a recent meta-analysis, no significant effects on cardiovascular risk were observed with either injected or transdermal testosterone supplementation in men, and the French National Agency for Medicines (ANSM) recently reported that drugs containing testosterone were not associated with an increased risk of cardiovascular events.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Service de Médecine Intensive et de Réanimation CHD La Roche sur Yon

location_facility: Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux

location_facility: Service de Médecine Intensive et Réanimation (MIR), CHU Clermont-Ferrand

location_facility: Service d'Anesthésie et Réanimation Centre Jean-Perrin

location_facility: Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin

intervention_type: Drug


title: A Phase I Dose-escalation Trial of TG6050 Administered by Intravenous Infusion in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

summary: This is a phase I, open-label, dose-escalation trial of TG6050 administered by single or repeated IV infusion(s).

ipd_sharing: Undecided

lead_sponsor: Transgene

location_facility:
Hôpital Européen Georges Pompidou
CHU Rennes - Hôpital Pontchaillou
Institut Bergonié
Hôpital Timone
Institut de Cancérologie de l'Ouest


title: Assessment and Prevention of Caregiver Burden in Oncology

summary:
The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.

Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.

Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.

The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
CH Mémorial de Saint Lo
Centre Antoine Lacassagne
Centre Henri Bequerel
CH Cholet
Institut de Cancérologie de l'Ouest


title: Dynamic Predictions of the Links Between Psychological and Physical Health of Older Patients in Nursing Home Via the Integration of "Multi-omics" Data.

acronym: BioMIND

summary: Taking the older person as a whole is now essential to age well and prevent loss of functional independence. However, the relationship between physical and mental health remains not well understood. Combining the exploration of markers of inflammation, endocrine, nutritional, and metabolic functions, along with long-term monitoring of older persons, could allow for a comprehensive understanding of the biological phenotype, regardless of underlying pathologies. The primary objective will be to simultaneously test the psychosomatic model and the disability model in order to more fully account for the dynamic causal relationships between physical and mental health in older people. The investigators will investigate the mediating role of the biological phenotype on these relationships between mental and physical health. The independent and then combined analysis of specific candidate biomarkers will open up the possibility of identifying a biological mediation between mental and physical health. Furthermore, this will also allow us to deepen our understanding of the evolution of the immune-endocrine-metabolic state and, more broadly, of the biological phenotype of older people during aging.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

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ReferenceCitation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

ReferenceCitation: Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008 Sep;70(7):741-56. doi: 10.1097/PSY.0b013e31818105ba. Epub 2008 Aug 25.

ReferenceCitation: Delphin-Combe F, Dauphinot V, Denormandie P, Sanchez S, Hay PE, Moutet C, Krolak-Salmon P. The Scale of instantaneous wellbeing: validity in a population with major neurocognitive disorders. Geriatr Psychol Neuropsychiatr Vieil. 2018 Sep 1;16(3):329-334. doi: 10.1684/pnv.2018.0745.

ReferenceCitation: Gan Y. Happy People Live Longer and Better: Advances in Research on Subjective Well-Being. Appl Psychol Health Well Being. 2020 Mar;12(1):3-6. doi: 10.1111/aphw.12192. Epub 2020 Jan 29. No abstract available.

ReferenceCitation: Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

ReferenceCitation: Gana K, Bailly N, Saada Y, Joulain M, Trouillet R, Herve C, Alaphilippe D. Relationship between life satisfaction and physical health in older adults: a longitudinal test of cross-lagged and simultaneous effects. Health Psychol. 2013 Aug;32(8):896-904. doi: 10.1037/a0031656. Epub 2013 Mar 11.

ReferenceCitation: Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.

ReferenceCitation: Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

ReferenceCitation: Hernandez R, Bassett SM, Boughton SW, Schuette SA, Shiu EW, Moskowitz JT. Psychological Well-being and Physical Health: Associations, Mechanisms, and Future Directions. Emot Rev. 2018 Jan;10(1):18-29. doi: 10.1177/1754073917697824. Epub 2017 Oct 20.

ReferenceCitation: Katz S, Akpom CA. A measure of primary sociobiological functions. Int J Health Serv. 1976;6(3):493-508. doi: 10.2190/UURL-2RYU-WRYD-EY3K.

ReferenceCitation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

ReferenceCitation: Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995 Feb;43(2):130-7. doi: 10.1111/j.1532-5415.1995.tb06377.x.

lead_sponsor: University Hospital, Tours

collaborators: Research Center for Respiratory Diseases, Inserm U1100

location_facility:
EHPAD Paul Martinais
EHPAD l'Ermitage
EHPAD Le Clos Mignot
EHPAD Les Groussins
EHPAD CHIC Amboise/Chateau-Renault


title: Comparison of the Efficacy and Safety of Idroflog® (Sodium Hyaluronate and Hydrocortisone) and Sodium Hyaluronate for the Treatment of Dry Eye Disease

acronym: IDROFLOG

summary: This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.

ipd_sharing_description: Results information from this trial will be submitted here to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 10 years after the completion of the primary endpoint by contacting the principal investigator, and upon authorization by the Sponsor.

lead_sponsor: Alfa Intes Industria Terapeutica Splendore s.r.l.

location_facility: CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie

intervention_type: Device


title: Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)

acronym: CLODETTE

summary: Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux, Service Hématologie Biologique

location_facility: CHU de Bordeaux, Service Gastro-Entérologie

location_facility: CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire

location_facility: CHU de Bordeaux, Service Médecine Vasculaire

intervention_type: Biological


title: Benefit of Cryopreserved Human Amniotic Membrane (hAM) on Oral Mucosal Healing Among Patients With Stage II Maxillomandibular Osteonecrosis Induced by Antiresorptive and/or Anti-angiogenic Therapies: a Phase II Randomized Trial

acronym: amniOST

summary: This study aims to demonstrate, during the first standard surgical management of patients with stage II MRONJ, the effect of the implantation of a cryopreserved hAM on the maxillomandibular bone, on the healing of the oral mucosa.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Bordeaux Pellegrin
CHU de Reims
CHU de Dijon
CHU de Besancon
CHR Metz Thionville

appel_a_projets: PHRCI

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: AmniOST

titre: Bénéfice de la membrane amniotique humaine (MAH) cryoconservée sur la cicatrisation de la muqueuse buccale de patients atteints d'ostéochimionécrose maxillo-mandibulaire de stade II induite par traitements anti-résorptifs osseux et/ou anti-angiogéniques

discipline_principale: aucune

nom_porteur: MEYER

prenom_porteur: Christophe


title: Very High Definition Cohort: Assessment of New Prognostic Biomarkers of Disability Worsening in a Multicenter Cohort of MS Patients by Imaging, Optical Coherence Tomography and Biology

acronym: VHD cohort

summary:
Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential.

However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers.

In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load.

In particular, the investigators will test:

Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences
Biomarkers extracted from optical coherence tomography (OCT)
Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))

ipd_sharing: Yes

lead_sponsor: EDMUS Foundation

location_facility:
CHU de Nancy
CHU de Lyon
CHU de Nîmes
CHU de Strasbourg
CHU de Rennes


title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest

summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.

ipd_sharing_description: Sharing of IPD will be possible upon request to steering committee of the AfterROSC Network after approval of the project by ethics committee.

lead_sponsor: AfterROSC

location_facility:
CHU Nantes
APHP, Cochin
Clinique Ambroise Paré
Hopital Jacques Cartier
CH Versailles

intervention_type: Diagnostic Test


title: Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery, Compared to the Use of the Combined Fluorescence and Isotopic Method

acronym: FLUORES

summary:
Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node.

Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

intervention_type: Procedure


title: Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of Premature Rupture of Membranes (PROM) at Term in Nulliparous: a Randomized Controlled Trial (RUBAPRO2).

summary:
Premature rupture of membranes (PROM) at term complicates 6 to 22% of singleton pregnancies. Spontaneous labour occurs in 60-67% of these patients within 24h. If no effective uterine contraction occurs, induction of labour (IOL) is the strategy recommended by the French as well as the American College of Obstetricians and Gynecologists. The optimal strategy for IOL in case of PROM with an unfavourable cervix remains unknown and none of the studies conducted in nulliparous women showed the superiority of one induction method over another.

In the current project, we aimed to determine (1) if IOL with association of balloon catheter and oxytocin after 6 hours could increase the rate of delivery < 24h versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of PROM at term in nulliparous women and (2) patient satisfaction using EXIT survey assessed before hospital discharge.

location_facility: Assistance Publique Hôpitaux de Paris- CHU Bicêtre


title: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome

summary:
This study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other.

It will also be possible to assess their comfort and compliance as well as the impact of wearing them on neurological and muscular recovery (functional assessment).

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility: Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon


title: Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care

acronym: VAMOS

summary:
Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%. The general practitioner is the first prescriber of opioid analgesics Our objective was to validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse of AOs.

Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in general practice.

Study design: Psychometric study

Data Collection/Extraction methods: Eligible patients followed in general practice responded to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard used was the DSM-V.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

location_facility: Département de médecine générale, Faculté de médecine, Montpellier

location_facility: CHU Clermont-Ferrand, UMR INSERM 1107, NEURO-DOL

location_facility: Département de médecine Générale, Facultés de Médecine de Clermont-Ferrand

location_facility: Département de médecine générale, Faculté de médecine, Toulouse

status_simplified: Completed


title: Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

acronym: MELpreserv

summary:
Prospective multicentric study including women aged 18 to 35 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2).

Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant settings.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHU Montpellier
Hôpital Saint-Joseph
CHRU de Nîmes
CHU NICE L'archet
AP-HM


title: Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)

acronym: MonSThr

summary: Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. However, their study in MPN and their thrombotic complications has never been performed. In this study, we aim to evaluate the association between monocytes sub-populations and thrombotic risk in MPN patients.

location_facility: CHU de Bordeaux, Hématologie clinique et thérapie cellulaire

location_facility: CHU de Bordeaux, Laboratoire Hématologie

location_facility: CHU de Bordeaux, Médecine Interne et maladies infectieuses

location_facility: CHU de Bordeaux, Médecine interne et immunologie clinique


title: Real-life Data From Diabetic Patients on Closed-loop Pumps

acronym: BLOOM

summary: To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

time_perspective: Retrospective

ipd_sharing_description: The database will be made available on a general-purpose open repository. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. Keyword are type I diabetes, Insulin Infusion Systems, Patient Outcome Assessment

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: CHI Mont de Marsan et du Pays des Sources


title: Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment

acronym: EMILY

summary: Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.

primary_purpose: Prevention

lead_sponsor: Weprom

collaborators:
Resilience Care
Incyte Corporation

sponsor_collaborators:
Weprom
Resilience Care
Incyte Corporation

location_facility: Clinique Victor Hugo/Centre Jean Bernard/ILC


title: Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial

acronym: NO-GARROT

summary: This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

lead_sponsor: Hôpital NOVO

location_facility: Geriatric Department - Intercommunal hospital center - Créteil

location_facility: Geriatric Department - Hospital René Dubos - Pontoise

location_facility: Geriatric Department - Hospital Louis Mourier - Colombes

appel_a_projets: PHRIP

region: Île-de-France

nom_etablissement: HOPITAL NOVO

acronyme: NO-GARROT

titre: Effet de l'abstention de garrot sur la réduction de la douleur lors des prélèvements veineux des personnes âgées : Essai randomisé NO-GARROT

discipline_principale: gériatrie

nom_porteur: QUILLIEN

prenom_porteur: Vella


title: Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

summary:
Inclusion visit (D0):

verification of inclusion and non-inclusion criteria
information and collection of consent
standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial

acronym: E-SEP

summary: The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

lead_sponsor: Lille Catholic University

location_facility:
CH LENS
Saint Vincent hospital
Charles Nicolle Hospital
CH d'Arras
CHRU
Saint-Philibert hospital

region: Hauts-de-France

nom_etablissement: GCS GHICL DES HOPITAUX DE L'ICL

type_etablissement: GCS

acronyme: E-SEP Cognition

titre: Efficacité d'un programme de remédiation via un « serious game » sur les fonctions cognitives des patients atteints de sclérose en plaques : essai contrôlé, randomisé, multicentrique.

discipline_principale: neuropsychologie, neurologie : sclérose en plaques, serious game, remédiation cognitive, troubles cognitivo-émotionnels, participation sociale

nom_porteur: LENNE

prenom_porteur: Bruno


title: Acceptability Assessment of an "Organization of Care Integrating Artificial Intelligence and a Solution of Telemedicine" on Care of the Nursing Home Residents Located in a Medical Desert: Pilot Study INTEL@MED-POC

summary: While depend elderly people needs are important in Nursing Home, the medical resources are weak from both inside and outside residences located in a medical desert. The goal of this project is to measure the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor

lead_sponsor: University Hospital, Limoges

location_facility:
EHPAD Ernest Coulaud
EHPAD La Porte d'Aquitaine
EHPAD Le Bois Joli
EHPAD Le Chant des Rivières
EHPAD J et M Colaud
Ehpad Le Chavanon


title: Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice

acronym: MG HYPNOSIS

summary:
Anxiety is an emotion considered unpleasant but resulting from a normal phenomenon. It corresponds to an adaptive response to events, to stress and helps to ensure our survival.

On the other hand, it becomes embarrassing when it becomes uncontrollable. It can even lead to interfere with activities of daily living. Thus, we can speak of anxiety disorder.

Anxiety disorders are among the most prevalent psychiatric disorders. They are often associated with other comorbidities such as depression, which makes them more difficult to treat and diagnose.

Different treatments are offered to best treat the patient with anxiety : drug treatment (antidepressants, anxiolytics) ; non-drug (psychotherapy, meditation, cognitive behavioral therapies).

The emergence of hypnosis in medical practice in recent years seems to be a technique that can bring benefits to the patient.

A review of clinical studies does not seem to find a benefit to hypnosis in anxiety disorders. In contrast, a study in children with school phobia showed the effectiveness of hypnosis. The limits addressed by this review seem to relate to the number of people included in the studies. Contrariwise, it has been pointed out that hypnosis can have a beneficial effect in the long term.

Thus, it seems interesting to deepen this technique in the practice of a general practitioner exercising the activating consciousness technique in anxiety.

The study will be composed of patients presenting with anxiety and consulting their general practitioner, with: Group 1, patients consulting a doctor not practicing hypnosis Versus Group 2, patients consulting a doctor practicing hypnosis.

During the first consultation and the following 2 consultations scheduled by the general practitioner (spaced 15 days apart), the following data are noted, in addition to the monitoring usually performed by the doctor:

COVI scale
Comfort scale 0 to 10
Management: drugs, TAC, others
Quality of life survey SF36 Patients will be called back at 6 months to reassess quality of life (self-administered survey SF 36) The primary endpoint is to evaluated the change of anxiety from inclusion (J0) to 6 months using COVI scale in the two different groups.

For secondary endpoints, the consumption of drug medicine will be quantified and the quality of life will be measured using Quality of life survey SF36.

status: Unknown status

ReferenceCitation: Pelissolo A. [Hypnosis for anxiety and phobic disorders: A review of clinical studies]. Presse Med. 2016 Mar;45(3):284-90. doi: 10.1016/j.lpm.2015.12.002. Epub 2016 Mar 2. French.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Dr Aurélien BARADEL
Dr Maud BINARD
Dr Matthieu DEMOURGUES
Dr Stéphane FOLACHER
Dr Céline HUMBERT
Dr Christian SAINT-CYR

intervention_type: Behavioral

status_simplified: Unknown


title: PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study

acronym: PETRA

summary:
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials.

Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.

A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.

PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.

location_facility: Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND


title: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers

summary: The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).

ReferenceType: derived

ReferenceCitation: Thery L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Bredart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing_description: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

location_facility:
INSTITUT CURIE Saint-Cloud
Institutcurie Paris
Institut Bergonie
Centre Antoine Lacassagne
Centre Paul Strauss
Institut de Cancerologie de L'Ouest


title: Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder

acronym: SOMMEPT

summary:
Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.

Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.

According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.

In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

acronym: GABRINOX-ART

summary:
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.

The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

ReferenceCitation: Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

ReferenceCitation: Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep-Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repositories_concat: PubMed Central

ReferenceCitation: Suker M, Beumer BR, Sadot E, Marthey L, Faris JE, Mellon EA, El-Rayes BF, Wang-Gillam A, Lacy J, Hosein PJ, Moorcraft SY, Conroy T, Hohla F, Allen P, Taieb J, Hong TS, Shridhar R, Chau I, van Eijck CH, Koerkamp BG. FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. Lancet Oncol. 2016 Jun;17(6):801-810. doi: 10.1016/S1470-2045(16)00172-8. Epub 2016 May 6.

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Kim YJ, Lee WJ, Woo SM, Kim TH, Han SS, Kim BH, Moon SH, Kim SS, Koh YH, Park SJ, Kim JY, Kim DY, Park JW. Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. Radiat Oncol. 2013 Jul 3;8:160. doi: 10.1186/1748-717X-8-160.

ReferenceCitation: Huang J, Robertson JM, Margolis J, Balaraman S, Gustafson G, Khilanani P, Nadeau L, Jury R, McIntosh B. Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer. Radiother Oncol. 2011 May;99(2):114-9. doi: 10.1016/j.radonc.2011.05.038. Epub 2011 May 27.

ReferenceCitation: Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.

ReferenceCitation: Yang YF, Cao XH, Bao CE, Wan X. Concurrent radiotherapy with oral fluoropyrimidine versus gemcitabine in locally advanced pancreatic cancer: a systematic review and meta-analysis. Onco Targets Ther. 2015 Nov 9;8:3315-22. doi: 10.2147/OTT.S91292. eCollection 2015.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Petrelli F, Comito T, Ghidini A, Torri V, Scorsetti M, Barni S. Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):313-322. doi: 10.1016/j.ijrobp.2016.10.030. Epub 2016 Oct 24.

ReferenceCitation: Reyngold M, Parikh P, Crane CH. Ablative radiation therapy for locally advanced pancreatic cancer: techniques and results. Radiat Oncol. 2019 Jun 6;14(1):95. doi: 10.1186/s13014-019-1309-x.

ReferenceCitation: Crane CH, O'Reilly EM. Ablative Radiotherapy Doses for Locally Advanced: Pancreatic Cancer (LAPC). Cancer J. 2017 Nov/Dec;23(6):350-354. doi: 10.1097/PPO.0000000000000292.

ReferenceCitation: Acharya S, Fischer-Valuck BW, Kashani R, Parikh P, Yang D, Zhao T, Green O, Wooten O, Li HH, Hu Y, Rodriguez V, Olsen L, Robinson C, Michalski J, Mutic S, Olsen J. Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):394-403. doi: 10.1016/j.ijrobp.2015.10.015. Epub 2015 Oct 17. Erratum In: Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):243.

ReferenceCitation: Fischer-Valuck BW, Henke L, Green O, Kashani R, Acharya S, Bradley JD, Robinson CG, Thomas M, Zoberi I, Thorstad W, Gay H, Huang J, Roach M, Rodriguez V, Santanam L, Li H, Li H, Contreras J, Mazur T, Hallahan D, Olsen JR, Parikh P, Mutic S, Michalski J. Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. Adv Radiat Oncol. 2017 Jun 1;2(3):485-493. doi: 10.1016/j.adro.2017.05.006. eCollection 2017 Jul-Sep.

ReferenceCitation: Henke LE, Contreras JA, Green OL, Cai B, Kim H, Roach MC, Olsen JR, Fischer-Valuck B, Mullen DF, Kashani R, Thomas MA, Huang J, Zoberi I, Yang D, Rodriguez V, Bradley JD, Robinson CG, Parikh P, Mutic S, Michalski J. Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. Clin Oncol (R Coll Radiol). 2018 Nov;30(11):720-727. doi: 10.1016/j.clon.2018.08.010. Epub 2018 Sep 7.

ReferenceCitation: Henke L, Kashani R, Robinson C, Curcuru A, DeWees T, Bradley J, Green O, Michalski J, Mutic S, Parikh P, Olsen J. Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiother Oncol. 2018 Mar;126(3):519-526. doi: 10.1016/j.radonc.2017.11.032. Epub 2017 Dec 23.

ReferenceCitation: Boldrini L, Cusumano D, Cellini F, Azario L, Mattiucci GC, Valentini V. Online adaptive magnetic resonance guided radiotherapy for pancreatic cancer: state of the art, pearls and pitfalls. Radiat Oncol. 2019 Apr 29;14(1):71. doi: 10.1186/s13014-019-1275-3.

ReferenceCitation: Bohoudi O, Bruynzeel AME, Meijerink MR, Senan S, Slotman BJ, Palacios MA, Lagerwaard FJ. Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. Radiother Oncol. 2019 Mar;132:16-22. doi: 10.1016/j.radonc.2018.11.019. Epub 2018 Dec 20.

ReferenceCitation: El-Bared N, Portelance L, Spieler BO, Kwon D, Padgett KR, Brown KM, Mellon EA. Dosimetric Benefits and Practical Pitfalls of Daily Online Adaptive MRI-Guided Stereotactic Radiation Therapy for Pancreatic Cancer. Pract Radiat Oncol. 2019 Jan;9(1):e46-e54. doi: 10.1016/j.prro.2018.08.010. Epub 2018 Aug 25.

ReferenceCitation: Luterstein E, Cao M, Lamb J, Raldow AC, Low DA, Steinberg ML, Lee P. Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer: A Promising Approach. Cureus. 2018 Mar 14;10(3):e2324. doi: 10.7759/cureus.2324.

ReferenceCitation: Olberg S, Green O, Cai B, Yang D, Rodriguez V, Zhang H, Kim JS, Parikh PJ, Mutic S, Park JC. Optimization of treatment planning workflow and tumor coverage during daily adaptive magnetic resonance image guided radiation therapy (MR-IGRT) of pancreatic cancer. Radiat Oncol. 2018 Mar 24;13(1):51. doi: 10.1186/s13014-018-1000-7.

ReferenceCitation: Tyran M, Jiang N, Cao M, Raldow A, Lamb JM, Low D, Luterstein E, Steinberg ML, Lee P. Retrospective evaluation of decision-making for pancreatic stereotactic MR-guided adaptive radiotherapy. Radiother Oncol. 2018 Nov;129(2):319-325. doi: 10.1016/j.radonc.2018.08.009. Epub 2018 Aug 30.

ReferenceCitation: Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.

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

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Combination Product


title: Evaluation of the Impact of Wearing a Millimetre Wave Bracelet for 3 Months on the Frequency in Number of Days of Migraines in Patients With Episodic Migraines Without Aura

acronym: MISTIC

summary:
Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.

Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.

MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

lead_sponsor: Remedee SA

location_facility:
Cabinet Neuralpes
Cabinet Mornant
Cabinet Saint Ismier
CH Voiron
CHU Grenoble Alpes
CH Fondation Rotschild


title: Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation

acronym: EFICAS

summary: The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

lead_sponsor: Carmat SA

location_facility: Centre Hospitalier Régional Universitaire


title: A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

summary:
As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.

Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.

It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves.

The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising.

The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain.

Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.

ReferenceCitation: Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.

ReferenceCitation: Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS(c)(R) yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.

ReferenceCitation: Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83. doi: 10.1200/JCO.2007.10.7573.

ReferenceCitation: Lyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline. J Clin Oncol. 2018 Sep 1;36(25):2647-2655. doi: 10.1200/JCO.2018.79.2721. Epub 2018 Jun 11.

ReferenceCitation: Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.

ReferenceCitation: Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.

ReferenceCitation: Sharma M, Lingam VC, Nahar VK. A systematic review of yoga interventions as integrative treatment in breast cancer. J Cancer Res Clin Oncol. 2016 Dec;142(12):2523-2540. doi: 10.1007/s00432-016-2269-2. Epub 2016 Sep 15.

ReferenceCitation: Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10.1002/14651858.CD010802.pub2.

ReferenceCitation: Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.

ReferenceCitation: Chandwani KD, Perkins G, Nagendra HR, Raghuram NV, Spelman A, Nagarathna R, Johnson K, Fortier A, Arun B, Wei Q, Kirschbaum C, Haddad R, Morris GS, Scheetz J, Chaoul A, Cohen L. Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy. J Clin Oncol. 2014 Apr 1;32(10):1058-65. doi: 10.1200/JCO.2012.48.2752. Epub 2014 Mar 3.

ReferenceCitation: Greenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jncimonographs/lgu041. Erratum In: J Natl Cancer Inst Monogr. 2015 May;2015(51):98.

ReferenceCitation: Olsson Moller U, Beck I, Ryden L, Malmstrom M. A comprehensive approach to rehabilitation interventions following breast cancer treatment - a systematic review of systematic reviews. BMC Cancer. 2019 May 20;19(1):472. doi: 10.1186/s12885-019-5648-7.

ReferenceCitation: Felson DT, Cummings SR. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Arthritis Rheum. 2005 Sep;52(9):2594-8. doi: 10.1002/art.21364. No abstract available.

ReferenceCitation: Bower JE, Irwin MR. Mind-body therapies and control of inflammatory biology: A descriptive review. Brain Behav Immun. 2016 Jan;51:1-11. doi: 10.1016/j.bbi.2015.06.012. Epub 2015 Jun 23.

ReferenceCitation: Djalilova DM, Schulz PS, Berger AM, Case AJ, Kupzyk KA, Ross AC. Impact of Yoga on Inflammatory Biomarkers: A Systematic Review. Biol Res Nurs. 2019 Mar;21(2):198-209. doi: 10.1177/1099800418820162. Epub 2018 Dec 20.

ReferenceCitation: Bower JE, Greendale G, Crosswell AD, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Arevalo J, Cole SW. Yoga reduces inflammatory signaling in fatigued breast cancer survivors: a randomized controlled trial. Psychoneuroendocrinology. 2014 May;43:20-9. doi: 10.1016/j.psyneuen.2014.01.019. Epub 2014 Jan 30.

ReferenceCitation: Long Parma D, Hughes DC, Ghosh S, Li R, Trevino-Whitaker RA, Ogden SM, Ramirez AG. Effects of six months of Yoga on inflammatory serum markers prognostic of recurrence risk in breast cancer survivors. Springerplus. 2015 Mar 26;4:143. doi: 10.1186/s40064-015-0912-z. eCollection 2015.

ReferenceCitation: Rao RM, Vadiraja HS, Nagaratna R, Gopinath KS, Patil S, Diwakar RB, Shahsidhara HP, Ajaikumar BS, Nagendra HR. Effect of Yoga on Sleep Quality and Neuroendocrine Immune Response in Metastatic Breast Cancer Patients. Indian J Palliat Care. 2017 Jul-Sep;23(3):253-260. doi: 10.4103/IJPC.IJPC_102_17.

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

location_facility:
Insitut de Cancérologie de Lorraine
CH Libourne
CHU Nîmes
Institut du sein Basque
Icm Val D'Aurelle
Institut de Cancérologie de l'Ouest


title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease

acronym: EFN-VALID

summary: Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Clermont-Ferrand

location_facility:
CHU de Bordeaux-Hôpital Pellegrin
University hospital grenoble
CHU Clermont-Ferrand
CHRU Strasbourg
Hospices Civils Lyon (HCL)
CHU Amiens

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: EFN-VALID

titre: Validation française d'une échelle de fluctuations neuropsychiatriques dans la Maladie de Parkinson

discipline_principale: soins premiers

nom_porteur: MORO

prenom_porteur: Elena