title: Study of Electrical Prognostic Factors of Response to Intravenous Immunoglobulin Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

acronym: PRONELEC PIDC

summary:
Chronic inflammatory demyelinating polyradiculoneuropathy (PIDC) is an acquired dysimmune polyneuropathy whose prevalence is estimated to be between 1 to 4 per 100,000 depending on the study, with an incidence of less than 1 per 100,000 per year. The clinical presentation of PIDC is heterogeneous, characterized by a symmetrical lesion predominating generally on large fibers, the most myelinated, responsible for ataxia and a motor deficit in the foreground. In the typical form, patients describe a proximal and distal motor or sensory deficit associated with isflexia that signifies a peripheral neurogenic syndrome.

The physiopathological hypothesis is that of an inflammation responsible for demyelinating nerve fibers, which results in electroneuromyogram (ENMG) by conduction abnormalities and histologically when a neuromuscular biopsy is performed by segmental demyelination.

Given the heterogeneity of the clinical presentation, electrical diagnostic criteria are proposed by the European Federation of Neurological Society in order to classify IPDCs into three categories: certain, probable and possible. In the absence of sufficient criteria to make the diagnosis of IPDC, it is also possible to use criteria of support, using a paraclinical report including the presence of an increase in protein (hyperproteinorachie) without cells for cerebrospinal fluid analysis, visualization of radicular inflammation on imaging (MRI of lumbar and / or brachial plexus), proximal peripheral involvement with somatosensory evoked potentials.

Therapeutically, a joint management between rehabilitation and the introduction of a background treatment allows the clinical improvement of certain patients. To date, the treatments proposed in first intention are corticosteroids, intravenous immunoglobulins (IVIg) and plasma exchanges. In fact, the efficacy of intravenous immunoglobulins has been widely shown by controlled and randomized therapeutic trials. Efficacy studies of IVIg in the literature are most often based on an assessment of clinical response after 24 weeks, but in clinical practice the response to treatment and continuation of treatment is often evaluated after 3 courses of treatment with the help of a clinical evaluation and the realization of an electroneuromyogram. These are administered in day hospitalization or traditional hospitalization, every four weeks, to patients whose diagnosis of PIDC has been established by electroneuromyogram according to the EFNS criteria.

Clinical prognostic factors for good response to IVIG therapy have been described in previous studies, including subacute disease, symmetrical involvement, and absence of amyotrophy.

In order to optimize the management of IPDCs, it is important to identify patients who respond to IVIg. Thus, the objective of our study is to look at the electroneuromyogram, the presence of electrical predictors of good response to treatment with IVIg.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Translation and Validation of the French Quality of Recovery Questionnaire (QoR-15) Postoperative Recovery Assessment Questionnaire

summary:
Surgery (under general anaesthesia or under loco-regional anaesthesia) is an event that causes stress, anxiety, pain and even minor complications such as nausea or vomiting. Peri-operative management and the psychological support allocated to each patient will have an impact on the hospitalization experience. Many studies have focused on reducing peri-operative mortality (decrease in pain intensity as measured by analog visual scale, decrease in nausea/vomiting frequency, decrease in remobilization time, etc.) but few assessed the overall recovery of patients. there is a desire to improve physical and psychological recovery, with particular attention to the patient's own feelings. It is essential to evaluate our peri-operative management practices based on patient-centred criteria. In this context, the development of a scale for measuring the quality of post-operative recovery appears to be necessary. In 2013, a questionnaire was quickly run (about 2-3 min): the QoR-15 was validated. This questionnaire is reliable, sensitive, easily achievable in clinical practice, not onerous for the patient and provides information on the post-operative recovery perceived by the patient himself.

The QoR-15 was validated in English, then in Danish, Chinese, Portuguese and more recently in Swedish. It has not yet been validated in French and therefore cannot be used in studies on francophone patients.

Investigator goal is to validate a French version of the QoR-15, the FQoR-15.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Angers

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 2 Study

summary: The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Fillon A, Beaulieu K, Miguet M, Bailly M, Finlayson G, Julian V, Masurier J, Mathieu ME, Pereira B, Duclos M, Boirie Y, Thivel D. Does exercising before or after a meal affect energy balance in adolescents with obesity? Nutr Metab Cardiovasc Dis. 2020 Jun 25;30(7):1196-1200. doi: 10.1016/j.numecd.2020.04.015. Epub 2020 Apr 23.

family: Fillon

full_name: Alicia Fillon

given: Alicia

sequence: first

family: Beaulieu

full_name: Kristine Beaulieu

given: Kristine

sequence: additional

family: Miguet

full_name: Maud Miguet

given: Maud

family: Bailly

full_name: Mélina Bailly

given: Mélina

family: Finlayson

full_name: Graham Finlayson

given: Graham

family: Julian

full_name: Valérie Julian

given: Valérie

family: Masurier

full_name: Julie Masurier

given: Julie

family: Mathieu

full_name: Marie-Eve Mathieu

given: Marie-Eve

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Duclos

full_name: Martine Duclos

given: Martine

family: Boirie

full_name: Yves Boirie

given: Yves

family: Thivel

full_name: David Thivel

given: David

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

oa_host_type: repository

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

host_type: repository

license_normalized: no license

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Completed


type: EudraCT Number

title: Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

acronym: Oxyeno

summary: This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannulae during airway management for infants general anaesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of theses end-points : desaturation (SPO2 <95%) or Airway management completed.

status: Recruiting

design_allocation: Randomized

primary_purpose: Prevention

intervention_type: Device

status_simplified: Ongoing


title: Study BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects : Monocentric, Prospective, Controlled, Open-label Study Conducted With a Sample of Patients With Behavioural Addiction

summary:
Improving knowledge about behavioural addictions is a real public health issue. The etiopathogenic model of behavioural addictions is multifactorial, with various risk and vulnerability factors, involved in the initiation and maintenance of the disorders. Among these factors, neurocognitive alterations associated with behavioural addictions has recently aroused interest among researchers.

To our knowledge, there is no work wich compared several behavioural addictions with each other on a neurocognitive level. Moreover, neurocognitive data concerning certain behavioural addictions (such as sexual addiction) is almost non-existent. However, understanding the neurocognitive profiles of these patients would allow the investigators, on the one hand, to reinforce the existing literature and improve our understanding of the global process of addiction, and on the other hand, to propose alternative approaches to its management, taking into account the neurocognitive difficulties of the patients.

The investigators therefore propose to explore the neurocognitive alterations of patients suffering from several behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes), by comparing them with each other, to matched healthy control groups and to a recognized behavioural addiction (gambling disorder; data from the BANCO study - NCT03202290).

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Hurel E, Grall-Bronnec M, Thiabaud E, Saillard A, Hardouin JB, Challet-Bouju G. A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. Neuropsychiatr Dis Treat. 2021 Jul 20;17:2369-2386. doi: 10.2147/NDT.S292490. eCollection 2021.

family: Hurel

full_name: Elodie Hurel

given: Elodie

family: Grall-Bronnec

full_name: Marie Grall-Bronnec

given: Marie

family: Thiabaud

full_name: Elsa Thiabaud

given: Elsa

family: Saillard

full_name: Anaïs Saillard

given: Anaïs

family: Hardouin

full_name: Jean-Benoît Hardouin

given: Jean-Benoît

family: Challet-Bouju

full_name: Gaëlle Challet-Bouju

given: Gaëlle

currency_apc_doaj: USD

journal_name: Neuropsychiatric Disease and Treatment

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)

repository_normalized: PubMed Central

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: A Case–Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols

lead_sponsor: Nantes University Hospital


title: Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study

acronym: SyMbOL

summary:
The objective of this pre-clinical study is to demonstrate the robustness of Bone Marrow derived Mesenchymal Stem Cells (BM-MSC) production, to treat patients with severe eye burns.

For bone marrow donors who agree to participate, a 10 ml BM sample will be collected apart the 1 liter BM dedicated to transplantation.

A maximum of three donors of allogeneic BM-MSCs will be included. A ready-to-use BM-MSC suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel


title: Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

acronym: IVOIRE

summary: Over the last few years, dysbiosis has emerged as a possible trigger of gut inflammation in inflammatory bowel disease (IBD) and a promising therapeutic target. The complex diversity of microbiota was initially highlighted by the powerful new tools in genetics, including next-generation sequencing (NGS). NGS permitted to decipher the composition of bacterial intestinal communities, but also that of the gut virome. Since then, the evidence of a dynamic instability of the enteric virome in IBD has grown considerably. IBD patients present an expansion of bacteriophages (Caudovirales) associated with decreased bacterial diversity. Moreover, gut virome richness seems to differ between Crohn's disease (CD) and ulcerative colitis (UC) patients. These insights open the gate of new diagnostic, predictive, and therapeutic approaches. However, little is known about pediatric IBD gut virome in terms of variability and evolution under the influence of different treatments (exclusive enteral nutrition, immunosuppressive therapy and biologics). The aim of this study is to evaluate the gut family viral diversity and relative abundance of eukaryotes and prokaryotes in paediatric IBD patients

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de gastroentérologie nutrition, hépatologie pédiatrique - Hôpital Femme Mère Enfant groupement hospitalier Est - HCL


title: Comparison Between "Conventional Monitoring" Versus "Monitoring Via Vitaphone" in the Detection of Post Ablation Atrial Arrhythmias of Paroxysmal Atrial Fibrillation

acronym: VITAPHONE

summary:
Atrial fibrillation (AF) is the most common atrial arrhythmia. Ablation of AF is a recent technique, nevertheless, the success rates of ablation vary between 50% and 70% depending on the paroxysmal or persistent nature of AF. These rates are difficult to assess in routine practice because they are based on the recurrence of fibrillation.

The Vitaphone is a non-invasive device, with which the patient can record a single-track ECG as his or her symptoms take place. The plot is then transmitted via the internet to the centre, which can thus diagnose a relapse of AF.

The aim of our study is to correlate the rhythm and symptoms of 20 patients with Vitaphone 6 months after AF ablation and to compare them with 20 other patients receiving conventional monitoring.

primary_purpose: Diagnostic

lead_sponsor: Ramsay Générale de Santé

location_facility: CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private Hospital


title: PHASE I Clinical Study: Safety Evaluation of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate for Refractory or Recurrent Metastatic Neuroblastoma Expressing Somatostatin Receptors

acronym: NEUROBLU 02

summary:
This multicentric, prospective study aime to determine the Maximum Tolerated Dose (MTD) of 2 intravenous injections of 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE) administered at 6 weeks apart in children with metastatic progressive neuroblastoma.

The duration of study participation of each patient will be 3 months.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut Claudius Regaud

intervention_type: Drug


title: Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal

acronym: COMPARE

summary:
Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.

Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.

PRP has been injected under ultrasound in tendons or intra-articularly for several years.

This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.

All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.

The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.

time_perspective: Retrospective

location_facility: Department of Radiology, Croix-Rousse Hospital, Hospices Civils de Lyon

intervention_type: Procedure


title: Study and Monitoring of Multiple Endocrine Neoplasia Type 1

acronym: NEM

summary:
Multiple Endocrine Neoplasia Type I (MEN1) is a rare autosomal dominant disorder, predisposing sufferers to the development of endocrine tumors. The three most commont endocrine disorders of MEN1 are the secretory tumours of the parathyroid, pituitary gland and pancreas, in addition to which other tumours may be observed.

The diagnosis of MEN1 is essential for 1) appropriate therapeutic management of proven endocrine disorders, 2) screening for other endocrine and non-endocrine tumours, 3) family screening of affected relatives and 4) monitoring of patients who have been diagnosed. Undiagnosed MEN1 is one of the reasons for therapeutic failure in the management of endocrine damage. Detection is therefore of major importance, and any improvement in early diagnosis can improve management.

The natural history of the disease in all its clinical forms remains poorly understood, with published studies of selected or small populations. There are still clinical forms that are difficult to link to the syndrome. These clinical forms need to be specified in order to ensure optimal management. Only a large cohort will lead to the identification of the various forms of this condition and clarify its prognosis.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Sustainability of a Research Program in Risk Management: Routine Implementation, Appropriation, Effectiveness, Development of the Safety Culture

acronym: SUSTAIN

summary:
Sustainability can be defined by several dimensions: the pursuit of program elements, the maintenance of its effectiveness, its integration into work processes, the adaptation of the program to the local context, its integration into the organizational culture, the dissemination of the program to other centres. Studies show that the continuation of the entire intervention is rare once the research stops.

The PRisM study (Pluriprofessionality and Risk Management through a Multifaceted Program in Primary Care) was a primary care risk management (RM) research project. Its purpose was to develop a safety culture within the participating multi-professional primary care structures. From 2015 to 2017, multi-professional primary care offices participated in the study, half of which implemented a RM program consisting of: 1) Training on RM in the context of primary care; 2) The appointment of a RM referent; 3) The conduct of six meetings of systematic analysis of incidents.

The PRisM study represents a favorable ground for the development of a methodology for evaluating the sustainability of a RM program in primary care.


title: Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study

acronym: Coloqual

summary:
The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.

The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time


title: Individualized Fluid and Vasopressor Administration in Surgical Patients: A Randomized Controlled Trial

acronym: INFIVASP

summary: The purpose of this study is to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis is that the automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Registry Identifier

title: Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis

acronym: SatiSpAction

summary:
The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO.

The secondary objectives of the study are :

to compare the following criteria between 2 groups at 3 and 6 months:

quality of life;
other measures of disease activity ;
sleep quality ;
walking ability
muscle strength of;
professional activity;
cost of cares;
evolution of weight, BMI and waist.
to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.

location_facility: Service de rhumatologie, Hôpital Ambroise Paré


title: A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia

acronym: Ixa-Cyto

summary:
Some patients with antibody-mediated autoimmune hematological diseases (warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (cAIHA) and immune thrombocytopenia (ITP)) shows no or only minor and transient response to therapy despite several treatment-lines. Such patients are more likely to have a severe disease, with a higher morbidity and mortality.

Hypothesis Effective depletion of autoreactive plasma cells might be the key for a curative approach of these diseases. Therefore, there is a rationale for using proteasome inhibitors (PIs) in these refractory patients.

The rationale is that non-tumoral autoreactive plasma cells are rapidly targeted by proteasome inhibitors. It led us to propose a short course of dexamethasone and ixazomib (5 cycles), to evaluate the safety/efficacy of this innovative strategy of treatment.

Method Prospective interventional uncontrolled single arm open study evaluating the rate of patients achieving 5 cycles of ixazomib and dexamethasone without severe toxicity and response on therapy.

status: Withdrawn

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION


title: From the Brain to the Bugs: Evolution of Oropharyngeal and Rectal Microbiota of Patients With Severe Traumatic Brain Injury Admitted in ICU

acronym: BBAX

summary:
Modifications of the human gut microbiota have been associated with different pathological conditions such as obesity, inflammatory bowel diseases and neurodegenerative diseases. Recently the " Brain-Gut Axis ", a bidirectional communication axis between brain and gut, has been described. In recent animal studies, an acute brain injury was associated with rapid modifications of the gut microbiota.

In humans, traumatic brain injury (TBI) is a leading cause of death and disability. The patterns of gut and oropharyngeal microbiota following TBI are unknown. The primary purpose of this study is to characterize gut and oropharyngeal microbiota of patients with severe TBI.

ipd_sharing: Undecided


title: Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

acronym: SIA-CSH

summary: Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation.

lead_sponsor: Institut Paoli-Calmettes


title: Exploratory Study of Oral Therapeutic Education in Stimulated Parkinsonian Patients: Monitoring of Periodontal Status and Microbiota

acronym: BUCCO-PARK

summary: The effect of periodontal disease on the general condition of patients remains today underestimated in Parkinson's disease. The BUCCO-PARK project aims to carry out an exploratory study of oral therapeutic education on the clinical evolution and fate of the microbiota of patients undergoing brain stimulation surgery. During the study, patients will follow the standard care pathway alone or combined with an oral therapeutic education. Biological samples will assess how the microbiota of these patients will be impacted. BUCCO-PARK aims to optimize the care of Parkinson's patients by integrating oral care.

lead_sponsor: Rennes University Hospital


title: FOcUs on Colorectal CAncer oUtcomes: Long-Term Study

acronym: Foucault

summary:
Colorectal cancer (CRC) affects men and women of all racial and ethnic groups and accounts for more than 600,000 deaths per year, globally. Current treatment options may involve surgery, chemotherapy (both adjuvant and neoadjuvant), radiation therapy, and palliative care, each with trade-offs between disease management and patients' quality of life. Unfortunately, significant disparity exists in the quality of care and there is a need for standardization to ensure high-value health care for all patients.

This study evaluates the introduction of a Value-Based Health Care (VBHC) patient-centered framework in CRC treatments. VBHC is an innovative approach that aims to improve health care by identifying and systematically measuring both medical and patient-reported health care outcomes and costs. By applying sets of disease-specific outcomes measurements, health care providers (HCP) can compare care strategies and make informed choices with regard to optimization of care, necessary investments and possible cost reductions.

The adoption of a VBHC patient-centered approach may have a significant impact on therapeutic areas constituting a major disease and cost burden for the global health care, such as CRC. It has the potential to improve cancer care planning, monitoring, and management of patients, by promoting better communication and shared decision making by patients and HCP.

A patient-reported outcome measurement (PROM) is defined as any report about a health condition and its treatment that comes directly from the patient. The use of a tailored pathway including PROMs improve both quality of life (QoL) and survival in cancer patients. Another essential requirement of VBHC approach is the outcome monitoring, to allow HCP accessing to evidence-based, simplified information on the hospital clinical practice and potentially increase health value for both patients and HCP. For patients with CRC, the International Consortium for Health Outcomes Measurement (ICHOM) developed a comprehensive patient-centered outcomes measurement set that could be used in the clinical practice to monitor patients' status.

The purpose of this study is to evaluate the introduction of a VBHC approach in CRC treatments, using a validated VBHC set of clinical outcomes and PROMs, to understand which practice would be most effective in achieving patient-centered care. The underlying hypothesis is that a periodic analysis of these outcomes could increase health value for both patients and HCPs.

time_perspective: Other

ReferenceType: background

ReferenceCitation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

ReferenceCitation: Zerillo JA, Schouwenburg MG, van Bommel ACM, Stowell C, Lippa J, Bauer D, Berger AM, Boland G, Borras JM, Buss MK, Cima R, Van Cutsem E, van Duyn EB, Finlayson SRG, Hung-Chun Cheng S, Langelotz C, Lloyd J, Lynch AC, Mamon HJ, McAllister PK, Minsky BD, Ngeow J, Abu Hassan MR, Ryan K, Shankaran V, Upton MP, Zalcberg J, van de Velde CJ, Tollenaar R; Colorectal Cancer Working Group of the International Consortium for Health Outcomes Measurement (ICHOM). An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017 May 1;3(5):686-694. doi: 10.1001/jamaoncol.2017.0417.

ReferenceCitation: van Zelm R, Coeckelberghs E, Sermeus W, De Buck van Overstraeten A, Weimann A, Seys D, Panella M, Vanhaecht K. Variation in care for surgical patients with colorectal cancer: protocol adherence in 12 European hospitals. Int J Colorectal Dis. 2017 Oct;32(10):1471-1478. doi: 10.1007/s00384-017-2863-z. Epub 2017 Jul 17.

ReferenceCitation: Krell RW, Regenbogen SE, Wong SL. Variation in hospital treatment patterns for metastatic colorectal cancer. Cancer. 2015 Jun 1;121(11):1755-61. doi: 10.1002/cncr.29253. Epub 2015 Jan 29.

ReferenceCitation: Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011 Sep;89(9):46-52, 54, 56-61 passim.

ReferenceCitation: Efficace F, Innominato PF, Bjarnason G, Coens C, Humblet Y, Tumolo S, Genet D, Tampellini M, Bottomley A, Garufi C, Focan C, Giacchetti S, Lévi F; Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. Validation of patient's self-reported social functioning as an independent prognostic factor for survival in metastatic colorectal cancer patients: results of an international study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2008 Apr 20;26(12):2020-6. doi: 10.1200/JCO.2007.12.3117.

ReferenceCitation: Kriza C, Emmert M, Wahlster P, Niederländer C, Kolominsky-Rabas P. Cost of illness in colorectal cancer: an international review. Pharmacoeconomics. 2013 Jul;31(7):577-88. doi: 10.1007/s40273-013-0055-4. Review.

ReferenceCitation: Ekwueme DU, Howard DH, Gelb CA, Rim SH, Cooper CP. Analysis of the benefits and costs of a national campaign to promote colorectal cancer screening: CDC's screen for life-national colorectal cancer action campaign. Health Promot Pract. 2014 Sep;15(5):750-8. doi: 10.1177/1524839913519446. Epub 2014 Feb 6.

ReferenceCitation: Van Cutsem E, Borràs JM, Castells A, Ciardiello F, Ducreux M, Haq A, Schmoll HJ, Tabernero J. Improving outcomes in colorectal cancer: where do we go from here? Eur J Cancer. 2013 Jul;49(11):2476-85. doi: 10.1016/j.ejca.2013.03.026. Epub 2013 Apr 30. Review.

ReferenceCitation: Joranger P, Nesbakken A, Hoff G, Sorbye H, Oshaug A, Aas E. Modeling and validating the cost and clinical pathway of colorectal cancer. Med Decis Making. 2015 Feb;35(2):255-65. doi: 10.1177/0272989X14544749. Epub 2014 Jul 29.

ReferenceCitation: Van Cutsem E, De Gramont A, Henning G, Rougier P, Bonnetain F, Seufferlein T. Improving Outcomes in Patients with CRC: The Role of Patient Reported Outcomes-An ESDO Report. Cancers (Basel). 2017 May 26;9(6). pii: E59. doi: 10.3390/cancers9060059. Review.

ReferenceCitation: Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstädter F, Lorenz W, Steinger B. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:460. doi: 10.1186/s13063-015-0972-y.

ReferenceCitation: Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

ReferenceCitation: Keller DS, Stulberg JJ, Lawrence JK, Samia H, Delaney CP. Initiating statistical process control to improve quality outcomes in colorectal surgery. Surg Endosc. 2015 Dec;29(12):3559-64. doi: 10.1007/s00464-015-4108-y. Epub 2015 Feb 21.

ReferenceCitation: McLean KA, Sheng Z, O'Neill S, Boyce K, Jones C, Wigmore SJ, Harrison EM. The Influence of Clinical and Patient-Reported Outcomes on Post-surgery Satisfaction in Cholecystectomy Patients. World J Surg. 2017 Jul;41(7):1752-1761. doi: 10.1007/s00268-017-3917-7.

ReferenceCitation: Govaert JA, van Dijk WA, Fiocco M, Scheffer AC, Gietelink L, Wouters MW, Tollenaar RA. Nationwide Outcomes Measurement in Colorectal Cancer Surgery: Improving Quality and Reducing Costs. J Am Coll Surg. 2016 Jan;222(1):19-29.e2. doi: 10.1016/j.jamcollsurg.2015.09.020. Epub 2015 Nov 14.

ReferenceCitation: Keel G, Savage C, Rafiq M, Mazzocato P. Time-driven activity-based costing in health care: A systematic review of the literature. Health Policy. 2017 Jul;121(7):755-763. doi: 10.1016/j.healthpol.2017.04.013. Epub 2017 May 10. Review.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients

acronym: RECONNAISSANCE

summary:
Cirrhotic patients have a high risk of bacterial infection. These infections induce systemic inflammation that can lead to acute liver failure or even acute liver failure associated with multi-visceral failure (Acute-to-Chronic Liver Failure, ACLF) associated with an increased risk of short-term mortality in this population.

The most common infections are spontaneous bacterial peritonitis and urinary tract infections, followed by pneumonia, skin and soft tissue infections and spontaneous bacteremia.

In order to cope with the growing risk of resistant bacterial infections, recommendations from the European Association for the Study of the Liver (EASL) were issued in 2014 and are followed by physicians treating cirrhotic patients. These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt. The site of the infection, the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent. However, the ecology of a center varies over time, according to the practices of the hospital center and to the different patients in care. It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients.

The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency.

This descriptive cohort study will determine the local ecology of the center. This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon

intervention_type: Biological


title: Activity Modeling in Birth Room

summary:
At this time, two methods exist to calculate a pregnant woman's presumed delivery date (DPA) : one adds 280 days to last menstruation date (Naegele rule), other estimates early pregnancy's date by imagery and adds 270 days. Unless pathology requires a trigger, this DPA estimated a early pregnancy is not re-estimated. These methods are simple and arbitrary : Mongelli and al. in 1996 found that out of nearly 40 000 unique pregnancies, only 4% give birth at determined DPA by echography and 70% at more or less 5 days. Jukic and al. in 2013 they estimate a natural variation of 37 days between pregnancy durations. Face of these poor performances, the calculating DPA method seems to be open to improvement.

Thus, the DPA calculation formula does not take into account the individual patients characteristics (age, occupation, antecedents ...), nor the follow-up data collected during pregnancy. Jukic and al. in 2013 propose a first model with some individual characteristics and medical measures (period between ovulation and early pregnancy, hormone peak) to refine the estimation. Their study gives promising results but their small patients number (a hundred) does not allow them to detect all interactions. Moreover, their method calculation is not dynamic, i.e it does not refine the DPA as pregnancy progresses. To our knowledge, no studies developing an evolutionary model over time for the DPA exist. However, objectives of a more accurate estimate of expected date are multiple and important. The investigators will mention here the two main ones :

A better understanding of mecanisms leading to early labour or abnormally long gestation in order to anticipate patients at risk
A better material and human needs anticipation, allowing a more efficient organization more adapted to activity and a care of each parturient in optimal conditions.

Our study will focus on predictive model elaboration of pregnancy duration that will evolve as the pregnancy progresses and new data collected. The investigators are considering a machine learning methodology by patient's medical record computerization at the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since early 2016. Thus, for patients who gave birth from end of 2016, the investigators have a large amount of information on their pregnancy and follow-up on hospital servers, which motivates an automatic approach based on massive data analysis.

This study thus intends to implement advanced techniques in Machine Learning (Online Learning, Support Vector Machine ...) to advance a powerful calculation model.

ReferenceType: result

ReferenceCitation: Mongelli M, Wilcox M, Gardosi J. Estimating the date of confinement: ultrasonographic biometry versus certain menstrual dates. Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):278-81.

ReferenceCitation: Jukic AM, Baird DD, Weinberg CR, McConnaughey DR, Wilcox AJ. Length of human pregnancy and contributors to its natural variation. Hum Reprod. 2013 Oct;28(10):2848-55. doi: 10.1093/humrep/det297. Epub 2013 Aug 6.

family: Jukic

full_name: A.M. Jukic

family: Baird

full_name: D.D. Baird

family: Weinberg

full_name: C.R. Weinberg

family: McConnaughey

full_name: D.R. McConnaughey

family: Wilcox

full_name: A.J. Wilcox

bso_classification: Biology (fond.)

journal_name: Human Reproduction

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ipd_sharing: Yes


title: Infliximab Blood Test in Crohn's Disease

summary:
Ano-perineal lesions are the first signs of Crohn's disease in 1/3 to 1/2 of cases. They are most often associated with a poor prognosis of the disease and their management is complex and difficult because of the dilapidated and recurrent nature of lesions with significant repercussions on continence and quality of life.

The treatment of these lesions is most often medical and surgical, consisting of drainage of the suppurative lesions and/or the use of biotherapy +/- combined with an immunosuppressant.

ReferenceCitation: Davidov Y, Ungar B, Bar-Yoseph H, Carter D, Haj-Natour O, Yavzori M, Chowers Y, Eliakim R, Ben-Horin S, Kopylov U. Association of Induction Infliximab Levels With Clinical Response in Perianal Crohn's Disease. J Crohns Colitis. 2017 May 1;11(5):549-555. doi: 10.1093/ecco-jcc/jjw182.

family: Davidov

full_name: Yana Davidov

given: Yana

family: Ungar

full_name: Bella Ungar

given: Bella

family: Bar-Yoseph

full_name: Haggai Bar-Yoseph

given: Haggai

family: Carter

full_name: Dan Carter

given: Dan

family: Haj-Natour

full_name: Ola Haj-Natour

given: Ola

family: Yavzori

full_name: Miri Yavzori

given: Miri

family: Chowers

full_name: Yehuda Chowers

given: Yehuda

family: Eliakim

full_name: Rami Eliakim

given: Rami

family: Ben-Horin

full_name: Shomron Ben-Horin

given: Shomron

family: Kopylov

full_name: Uri Kopylov

given: Uri

journal_name: Journal of Crohn's and Colitis

oa_host_type: publisher

title: Association of Induction Infliximab Levels With Clinical Response in Perianal Crohn’s Disease

ReferenceCitation: Yarur AJ, Kanagala V, Stein DJ, Czul F, Quintero MA, Agrawal D, Patel A, Best K, Fox C, Idstein K, Abreu MT. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn's disease. Aliment Pharmacol Ther. 2017 Apr;45(7):933-940. doi: 10.1111/apt.13970. Epub 2017 Feb 17.

name: Division of Gastroenterology and Hepatology; Department of Medicine; Medical College of Wisconsin; Milwaukee WI USA

family: Yarur

full_name: A. J. Yarur

given: A. J.

family: Kanagala

full_name: V. Kanagala

given: V.

family: Stein

full_name: D. J. Stein

given: D. J.

name: Division of Gastroenterology; Department of Medicine; University of Miami Miller School of Medicine; Miami FL USA

family: Czul

full_name: F. Czul

given: F.

family: Quintero

full_name: M. A. Quintero

given: M. A.

family: Agrawal

full_name: D. Agrawal

given: D.

family: Patel

full_name: A. Patel

given: A.

family: Best

full_name: K. Best

given: K.

family: Fox

full_name: C. Fox

given: C.

family: Idstein

full_name: K. Idstein

ReferenceCitation: Mitrev N, Kariyawasam V, Leong RW. Editorial: infliximab trough cut-off for perianal Crohn's disease - another piece of the therapeutic drug monitoring-guided infliximab dosing puzzle. Aliment Pharmacol Ther. 2017 May;45(9):1279-1280. doi: 10.1111/apt.14020.

name: Concord Hospital IBD Service; Sydney New South Wales Australia


title: Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen

acronym: SCAR

summary: Pressure ulcers associated with osteitis are frequent among patients with spinal cord injury (SCI), and optimal management is not well known. In a French referral center, debridement and flap coverage surgeries performed simultaneously are followed by a short antibiotic treatment targeting the bacteria involved. The aim of the study is to evaluate patient's outcome at Day 45 after surgery, and identify factors associated with failure.

location_facility: Infectious Diseases Department - Raymond Poincaré University Hospital


title: Contraceptive Pills and Retinal Vascularization (Piluret)

acronym: PILURET

summary:
The main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.

Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.

The objective is to find an association between retinal vascular density and combined oral contraceptives intake.

intervention_type: Diagnostic Test


title: Impact of Nicotine on Retinal Vascularization (Tabaret)

acronym: TABARET

summary:
The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization.

Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected.

The objective is to seek an association between retinal vascular density and inhaled nicotine intake.


title: Multimodal Retinal Imaging of Cerebrovascular Stroke

acronym: OCTAV

summary:
The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.

Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.


title: Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia

summary: Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. Distraction would be a more effective strategy to cope with pain. From this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impacts of Remote Digital Support on Adapted Physical Activity for Patients in Pre-bariatric Surgery Care Pathways

acronym: STIMUL

summary: Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Créteil


title: Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis

acronym: EQUODIA

summary:
The objective of the EQUODIA study is to evaluate the hemodynamic stability of hemodialysis with low dialysate flow in patients requiring emergency hemodialysis in the context of acute kidney injury or unscheduled end-stage renal disease, not in intensive care, compared to conventional triweekly high-flow hemodialysis.

Short daily hemodialysis has excellent hemodynamic tolerance, which has already been confirmed by clinical experience. This modality, commonly used in the patient's home through new machines allowing a low dialysate flow purification technique, can prove to be an innovative, effective and safe alternative for patients admitted for hemodialysis in an unscheduled situation (acute kidney injury, unscheduled end-stage renal disease not followed).

Up to now, no studies have evaluated the use of short daily hemodialysis with low dialysate flow in patients with acute kidney injury or unscheduled end-stage renal disease, requiring the initiation of emergency extra-renal purification.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY

acronym: GRAVIDOSE

summary:
Spaceflight induces detrimental changes in most organ systems with both acute changes and chronic adaptations. For example, acute fluid shifts associated with weightlessness (also called - improperly - microgravity) cause initial rapid cardiovascular alterations, whereas the chronic changes are more reflective of cardiovascular deconditioning and cerebrovascular/ocular adaptations (Pavy-Le Traon et al., 2007).

Long-duration stays in weightlessness have resulted in ocular structural and functional adaptations in some astronauts, which has been termed the Spaceflight Associated Neuro-ocular Syndrome (SANS ; see review in Lee et al., 2018). The leading hypothesis is that ocular changes are the consequence of chronic exposure to the weightlessness-induced headward (cephalad) fluid shift experienced by all astronauts. Countermeasures targeted to reverse this fluid shift, including lower body negative pressure and veno-occlusive thigh cuffs, have been proposed and tested in ground-based studies using a head-down tilt model of the cephalad fluid shift. However, the amount of fluid shift reversal required to prevent the development of SANS has not been investigated or determined. Similarly, artificial gravity through centrifugation has been proposed as a SANS countermeasure, given its ability to reverse headward fluid shifts and its efficacy as a countermeasure to long-duration bed rest-induced cardiovascular adaptations (long-duration bed rest is widely employed to simulate the effects of microgravity on various physiological systems). However, the minimum level of artificial gravity required also has not been investigated.

The primary objective of this study is to characterize cardiovascular, cerebrovascular, and ocular changes across a range of gravity levels to identify a threshold of gravitational load that can serve as a countermeasure to SANS during future spaceflight missions.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS)

acronym: GenePNS

summary:
Paraneoplastic neurological syndromes (PNS) are immune-mediated complications of cancer that can affect any part of the central or peripheral nervous system.

PNS occurs at the intersection between immune system and the tumor, where a combination of genetical and environmental factors may play a role.

Mechanisms leading to immune tolerance breakdown and autoimmunity in PNS remain largely unknown, and this reflects in an unsatisfactory repertoire of treatments available. Moreover, a better understanding of the biological mechanisms underlying PNS would allow a more precise identification of the modalities that permit PNS patients to have a better oncological prognosis than cancer patient without PNS, with obvious repercussions in clinical oncology.

To this effect, an extremely innovative approach involves directly exploring the tumoral tissue of patients suffering from specific PNS via genomic and transcriptomic analysis.

The study team hypothesizes that antigen ectopic expression by tumour cells may contribute to the generation of PNS.

In the present study, the investigators will analyze the salient features of tumors associated with PNS, namely the histological and immune cells infiltrate characteristics, their transcriptomic profile, and mutational status of involved antigens.

status: Active, not recruiting

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes


title: Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (GIST) in a Real-life Setting: the METAGIST Observational Study

acronym: METAGIST

summary:
Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases.

There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level.

Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting.

Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of impact of each treatment line on patients outcome in terms of time to next treatment (TNT) and survival

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié, Comprehensive Cancer Center


title: Patterns of Care and Outcomes of Patients With METAstatic BONE Tumors in a Real-life Setting

acronym: METABONE

summary:
Bone tumors make up about 3-5% of childhood cancers and less than 1% of cancers in adults. Of these, osteosarcoma (OSS) is the most commonly diagnosed primary malignant bone tumor. OSS is a primary mesenchymal malignant tumor of bone characterized by the production of osteoid or immature bone by the malignant cells. Despite its rarity, OSS is the most common primary malignancy of bone in children and adolescents, and the fifth most common malignancy among adolescents and young adults aged 15 to 19 years.

Ewing sarcoma (ES) is the second most frequent bone tumors in children and may arise also in soft tissues. This disease encompasses tumors formerly known as Askin's tumor, Peripheral Neuroectodermal Tumor (PNET) and the Ewing Sarcoma Family of Tumors (ESFT).

Chondrosarcoma are rare sarcoma reputed chemorefractory in the non-operable setting and for which little is known in terms of palliative management with systemic treatments.

Despite adequate loco-regional treatment, up to 40% of patients with sarcoma, soft tissue or bone, will develop metastatic disease. When metastases are detected, the standard of care is based on palliative chemotherapy with a median survival in this setting of only 18 months.

A slight improvement has been obtained over years thank to registration of a couple of drugs such as Trabectedin and Pazopanib, the first antiangiogenic registered for soft tissue sarcoma patients. Pazopanib is routinely prescribed worldwide after failure of first line chemotherapy in soft tissue sarcoma. However, bone tumors have not benefited from these small advances yet and treatment still rely on chemotherapy combining doxorubicine cisplatinum and ifosfamide. There is no standard in relapse and palliative settings, and after failure of these agents the survival is very poor. Bone sarcomas are therefore tumors with very little available data and low level of evidence on palliative systemic treatments in clinical trials and in the real life setting.

The primary objective of the METABONE study is to conduct a retrospective descriptive analysis of clinic-biological profiles, patterns of care and modalities of treatment for a set of patients with malignant bone tumors in a real-life national setting.


title: Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials

acronym: SURROGATE-ICI

summary: The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.

ReferenceCitation: Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V. Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review. Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.


title: Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis

summary:
The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution.

This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.


title: STREAM: A Phase 1/2, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Implantation Into One Eye of hESC-derived RPE in Patients With Retinitis Pigmentosa Due to Monogenic Mutation

summary:
Phase I/II open-label, safety, tolerability and preliminary efficacy study of implantation into one eye of hESC-derived RPE (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) in patients with retinitis pigmentosa due to monogenic mutation.

Study non randomized single group assignment consisting in 2 sequential cohorts of patients:

First cohort of 2 patients with very advanced loss of visual acuity (legally blind)
Second cohort of 10 patients with less advanced loss of visual acuity:

lead_sponsor: Centre d'Etude des Cellules Souches

location_facility: •Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts


title: Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis

acronym: ENAPAR

summary:
Prospective multicentric study.

60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow.

Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days.

Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.

lead_sponsor: Puressentiel


title: Prognostic Impact of Non-invasive Imaging Parameters (Cardiac Echocardiography and MRI) in Patients With Primary Mitral Insufficiency (MI) by Prolapse: Observational Cohort, Monocentric (COHORTE-IM)

acronym: COHORTE-IM

summary:
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up).

It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.

A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis.

A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.

lead_sponsor: Lille Catholic University


title: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

acronym: G-EYE-ADR

summary: Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.


title: Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

acronym: RESYSTE

summary: A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.

lead_sponsor: Nantes University Hospital


title: Evaluation of the FOCUS Diffusion's Added Clinical Value Compared to Conventional MRI With Wide Field View Diffusion in Focal Pancreatic Lesions Characterization

summary:
The radiologist plays a key role in the management of pancreatic tumours, which are potentially serious.

While the scanner, with its high spatial resolution, plays a major role in pancreatic pathology, and in particular in the assessment of operability, MRI, with its good contrast resolution, has proven its contribution to the detection and characterization of focal lesions.

Each MRI examination consists of several series of images called sequences, each with its own particularity, to highlight different types of abnormalities such as edema, bleeding, tumor content or vascularization. All the sequences performed constitute a "protocol". The diffusion sequence is a technology that allows the microscopic random movements of water molecules to be translated into images. It thus makes it possible to differentiate between certain aggressive tumours which are characterised by a higher cell density than healthy tissue, in which water molecules do not circulate freely, benign lesions such as cysts in which the circulation of water molecules is not hindered. The calculation of the Apparent Diffusion Coefficient (ADC), an estimate of the diffusion rate of water molecules, is a quantitative diagnostic tool validated in many fields of application and in particular in oncology.

ReferenceCitation: Schima W. MRI of the pancreas: tumours and tumour-simulating processes. Cancer Imaging. 2006 Dec 20;6:199-203. Review.

ReferenceCitation: Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. Review.

ReferenceCitation: Barral M, Taouli B, Guiu B, Koh DM, Luciani A, Manfredi R, Vilgrain V, Hoeffel C, Kanematsu M, Soyer P. Diffusion-weighted MR imaging of the pancreas: current status and recommendations. Radiology. 2015 Jan;274(1):45-63. doi: 10.1148/radiol.14130778. Review.

family: Barral

full_name: Matthias Barral

given: Matthias

family: Taouli

full_name: Bachir Taouli

given: Bachir

family: Guiu

full_name: Boris Guiu

given: Boris

family: Koh

full_name: Doh-Mu Koh

given: Doh-Mu

family: Luciani

full_name: Alain Luciani

given: Alain

family: Manfredi

full_name: Riccardo Manfredi

given: Riccardo

family: Vilgrain

full_name: Valérie Vilgrain

given: Valérie

family: Hoeffel

full_name: Christine Hoeffel

given: Christine

family: Kanematsu

full_name: Masayuki Kanematsu

given: Masayuki

family: Soyer

full_name: Philippe Soyer

given: Philippe

journal_name: Radiology

publisher: Radiological Society of North America (RSNA)

title: Diffusion-weighted MR Imaging of the Pancreas: Current Status and Recommendations

ReferenceCitation: Park MJ, Kim YK, Choi SY, Rhim H, Lee WJ, Choi D. Preoperative detection of small pancreatic carcinoma: value of adding diffusion-weighted imaging to conventional MR imaging for improving confidence level. Radiology. 2014 Nov;273(2):433-43. doi: 10.1148/radiol.14132563. Epub 2014 Jul 4.

family: Park

full_name: Min Jung Park

given: Min Jung

family: Kim

full_name: Young Kon Kim

given: Young Kon

family: Choi

full_name: Seo-youn Choi

given: Seo-youn

family: Rhim

full_name: Hyunchul Rhim

given: Hyunchul

family: Lee

full_name: Won Jae Lee

given: Won Jae

full_name: Dongil Choi

given: Dongil

title: Preoperative Detection of Small Pancreatic Carcinoma: Value of Adding Diffusion-weighted Imaging to Conventional MR Imaging for Improving Confidence Level

ReferenceCitation: d'Assignies G, Fina P, Bruno O, Vullierme MP, Tubach F, Paradis V, Sauvanet A, Ruszniewski P, Vilgrain V. High sensitivity of diffusion-weighted MR imaging for the detection of liver metastases from neuroendocrine tumors: comparison with T2-weighted and dynamic gadolinium-enhanced MR imaging. Radiology. 2013 Aug;268(2):390-9. doi: 10.1148/radiol.13121628. Epub 2013 Mar 26.

family: d’Assignies

full_name: Gaspard d’Assignies

given: Gaspard

family: Fina

full_name: Priscilla Fina

given: Priscilla

family: Bruno

full_name: Onorina Bruno

title: High Sensitivity of Diffusion-weighted MR Imaging for the Detection of Liver Metastases from Neuroendocrine Tumors: Comparison with T2-weighted and Dynamic Gadolinium-enhanced MR Imaging

ReferenceCitation: Motosugi U, Ichikawa T, Morisaka H, Sou H, Muhi A, Kimura K, Sano K, Araki T. Detection of pancreatic carcinoma and liver metastases with gadoxetic acid-enhanced MR imaging: comparison with contrast-enhanced multi-detector row CT. Radiology. 2011 Aug;260(2):446-53. doi: 10.1148/radiol.11103548. Epub 2011 Jun 21.

title: Detection of Pancreatic Carcinoma and Liver Metastases with Gadoxetic Acid–enhanced MR Imaging: Comparison with Contrast-enhanced Multi–Detector Row CT

ReferenceCitation: Kim HW, Lee JC, Paik KH, Kang J, Kim YH, Yoon YS, Han HS, Kim J, Hwang JH. Adjunctive role of preoperative liver magnetic resonance imaging for potentially resectable pancreatic cancer. Surgery. 2017 Jun;161(6):1579-1587. doi: 10.1016/j.surg.2016.12.038. Epub 2017 Feb 23.

ReferenceCitation: Zins M, Matos C, Cassinotto C. Pancreatic Adenocarcinoma Staging in the Era of Preoperative Chemotherapy and Radiation Therapy. Radiology. 2018 May;287(2):374-390. doi: 10.1148/radiol.2018171670. Review.

name: From the Department of Radiology, Groupe Hospitalier Paris Saint-Joseph, 185 rue Raymond Losserand, 75014 Paris, France (M.Z.); Department of Radiology, Champalimaud Clinical Center, Lisbon, Portugal (C.M.); and Department of Radiology, Saint-Éloi University Hospital, Montpellier, France (C.C.).

ReferenceCitation: Klauss M, Lemke A, Grünberg K, Simon D, Re TJ, Wente MN, Laun FB, Kauczor HU, Delorme S, Grenacher L, Stieltjes B. Intravoxel incoherent motion MRI for the differentiation between mass forming chronic pancreatitis and pancreatic carcinoma. Invest Radiol. 2011 Jan;46(1):57-63. doi: 10.1097/RLI.0b013e3181fb3bf2.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Intravoxel Incoherent Motion MRI for the Differentiation Between Mass Forming Chronic Pancreatitis and Pancreatic Carcinoma

ReferenceCitation: Wiggermann P, Grützmann R, Weissenböck A, Kamusella P, Dittert DD, Stroszczynski C. Apparent diffusion coefficient measurements of the pancreas, pancreas carcinoma, and mass-forming focal pancreatitis. Acta Radiol. 2012 Mar 1;53(2):135-9. doi: 10.1258/ar.2011.100252. Epub 2012 Jan 19.

name: University Medical Center Regensburg, Institute of Diagnostic Radiology, Regensburg

name: University Hospital Carl Gustav Carus Dresden, Department of Visceral, Thoracic and Vascular Surgery, Dresden

name: University Hospital Carl Gustav Carus Dresden, Dresden

name: University Hospital Carl Gustav Carus Dresden, Department of Radiology, Dresden

name: University Hospital Carl Gustav Carus Dresden, Department of Pathology, Dresden, Germany

repository_institution: Uni Regensburg - Publikationsserver der Universität Regensburg

ReferenceCitation: Bittencourt LK, Matos C, Coutinho AC Jr. Diffusion-weighted magnetic resonance imaging in the upper abdomen: technical issues and clinical applications. Magn Reson Imaging Clin N Am. 2011 Feb;19(1):111-31. doi: 10.1016/j.mric.2010.09.002. Review.

journal_name: Magnetic Resonance Imaging Clinics of North America

title: Diffusion-Weighted Magnetic Resonance Imaging in the Upper Abdomen: Technical Issues and Clinical Applications

ReferenceCitation: Saritas EU, Cunningham CH, Lee JH, Han ET, Nishimura DG. DWI of the spinal cord with reduced FOV single-shot EPI. Magn Reson Med. 2008 Aug;60(2):468-73. doi: 10.1002/mrm.21640.

ReferenceCitation: Andre JB, Zaharchuk G, Saritas E, Komakula S, Shankaranarayan A, Banerjee S, Rosenberg J, Nishimura DG, Fischbein NJ. Clinical evaluation of reduced field-of-view diffusion-weighted imaging of the cervical and thoracic spine and spinal cord. AJNR Am J Neuroradiol. 2012 Nov;33(10):1860-6. doi: 10.3174/ajnr.A3134. Epub 2012 May 3.

publisher: American Society of Neuroradiology (ASNR)

title: Clinical Evaluation of Reduced Field-of-View Diffusion-Weighted Imaging of the Cervical and Thoracic Spine and Spinal Cord

ReferenceCitation: Reischauer C, Wilm BJ, Froehlich JM, Gutzeit A, Prikler L, Gablinger R, Boesiger P, Wentz KU. High-resolution diffusion tensor imaging of prostate cancer using a reduced FOV technique. Eur J Radiol. 2011 Nov;80(2):e34-41. doi: 10.1016/j.ejrad.2010.06.038. Epub 2010 Jul 16.

ReferenceCitation: Ma C, Li YJ, Pan CS, Wang H, Wang J, Chen SY, Lu JP. High resolution diffusion weighted magnetic resonance imaging of the pancreas using reduced field of view single-shot echo-planar imaging at 3 T. Magn Reson Imaging. 2014 Feb;32(2):125-31. doi: 10.1016/j.mri.2013.10.005. Epub 2013 Oct 18.

ReferenceCitation: Riffel P, Michaely HJ, Morelli JN, Pfeuffer J, Attenberger UI, Schoenberg SO, Haneder S. Zoomed EPI-DWI of the pancreas using two-dimensional spatially-selective radiofrequency excitation pulses. PLoS One. 2014 Mar 3;9(3):e89468. doi: 10.1371/journal.pone.0089468. eCollection 2014.

title: Zoomed EPI-DWI of the Pancreas Using Two-Dimensional Spatially-Selective Radiofrequency Excitation Pulses

ReferenceCitation: Kim H, Lee JM, Yoon JH, Jang JY, Kim SW, Ryu JK, Kannengiesser S, Han JK, Choi BI. Reduced Field-of-View Diffusion-Weighted Magnetic Resonance Imaging of the Pancreas: Comparison with Conventional Single-Shot Echo-Planar Imaging. Korean J Radiol. 2015 Nov-Dec;16(6):1216-25. doi: 10.3348/kjr.2015.16.6.1216. Epub 2015 Oct 26.

name: Department of Radiology, Seoul National University Hospital, Seoul 03080, Korea.

name: Aerospace Medical Group, Air Force Education and Training Command, Jinju 52634, Korea.

name: Institute of Radiation Medicine, Seoul National University College of Medicine, Seoul 03080, Korea.

name: Department of Surgery, Seoul National University Hospital, Seoul 03080, Korea.

name: Division of Gastroenterology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul 03080, Korea.


title: Evaluation of New Hemodynamic Indices to Predict Response to Volemic Expansion in Septic Shock

acronym: EVOLVE

summary: The objective is to determine the sensitivity and specificity via Receiver Operating Characteristic (ROC) curve of Global Longitudinal Strain (GLS) The secondary objectives are the same for the change in the amount of carbon dioxide exhaled (ΔEtCO2) and dynamic arterial elastance (Eadyn). it will also determine the sensitivity and specificity of these indices, either individually or combined to determine persistent responders to volemic expansion.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery: a Randomised Controlled Study

acronym: PTIBOLID

summary:
The main objective of this study is to measure perioperative anxiety in children from 2 to 10 years old in two distinct homogeneous groups before and after the ride in electric cars versus bed travel in the operating room.

The secondary objectives will be to measure the anxiety at the induction, the pain and the agitation of the children in SSPI as well as the satisfaction and the lived experience of the parents during the ambulatory stay of their child in the two groups journey in electric cars versus trip in bed.

It is a prospective, randomized, single-centric observational study (small electric cars versus bed-ridden), focusing on children during their stay in the operating theater at the CHU Nord of Marseille for ENT and ophthalmic surgery.

This study on the use of electric cars as a means of locomotion within the block may lead to other multicenter studies.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Acute Kidney Injury During Daptomycin Versus Vancomycin Treatment in Cardiovascular Critically Ill Patients: a Propensity Score Matched Analysis

acronym: DVN

summary:
Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. AKI compromises seriously short and long-term prognosis of critically ill patients. Several AKI risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. Avoiding nephrotoxic agents is therefore strongly recommended in ICU patients, to reduce the incidence of AKI, or to reduce its severity.

The aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of AKI than vancomycin in cardiovascular ICU patients, with similar efficacy.

This is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care.

Since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. For this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. This propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (AKI within 7 days).

The main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for AKI and with at least a similar efficacy on clinical success rate.

lead_sponsor: University Hospital, Montpellier


title: Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

summary:
Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the population. One of the major complications is the occurrence of thromboembolic events, the thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is therefore almost always indicated, however, in view of the target population, anticoagulant treatment is sometimes contraindicated, justifying the appearance of alternative treatment such as occlusion of the left auricle by surgical or percutaneous means, with the placement of a prosthesis in the left auricle.

Image fusion is a new imaging technique aimed at improving the spatial view of 2D images (made during a catheterization session) by repositioning in real time a 3D model obtained by reconstruction from scanner images of the structure of interest. Once the model has been redesigned, it follows all the consequences that the hemodynamicist wants to take and thus guides the gesture as well as possible.

The purpose of this project is to evaluate the contribution of image fusion to per cutaneous occlusion procedures of the left atrium. This contribution will be evaluated by comparing the procedure time, the irradiation time, the amount of contrast material used between the procedures performed with the image fusion technique and without this new technique.


title: Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.

acronym: PODOMETRE

summary: study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.

ReferenceCitation: Villaron C, Cury F, Eisinger F, Cappiello MA, Marqueste T. Telehealth applied to physical activity during cancer treatment: a feasibility, acceptability, and randomized pilot study. Support Care Cancer. 2018 Oct;26(10):3413-3421. doi: 10.1007/s00520-018-4191-4. Epub 2018 Apr 19.

family: Villaron

full_name: Charlène Villaron

given: Charlène

family: Cury

full_name: François Cury

given: François

family: Eisinger

full_name: François Eisinger

family: Cappiello

full_name: Maria-A Cappiello

given: Maria-A

family: Marqueste

full_name: Tanguy Marqueste

given: Tanguy

journal_name: Supportive Care in Cancer

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care

acronym: EPACAPA

summary: Giant cell arteritis is the leading cause of vasculitis in the elderly. No work evaluates its impact on autonomy. At the diagnosis a gerontological evaluation will be carried out including the scores ADL, iADL, MNA, SF 36, SPPB, FRIED and GDS. A monthly telephone reassessment will collect ADL and iADL. The end-of-study consultation at M12, conducted by a geriatrician, will have the same scores as at M0. This will make it possible to evaluate the difference in the functional autonomy score between M0 and M12 in the elderly with ACG.

lead_sponsor: University Hospital, Limoges


title: Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation With a Duty Factor of 25 % Versus 31.3 % for Advanced Glaucoma

summary: Glaucoma, progressive optical neuropathy, is the leading cause of irreversible blindness in the world. Glaucoma treatment aims to lower intraocular pressure (IOP) by using medication, laser and surgery. Patients suffering from refractory and advanced glaucoma with impaired visual field who are not good candidates for surgery, cadenced subcleral transscleral cyclophotocoagulation (CPCTSI) is commonly used to reduce IOP. The CPCTSI consists in delivering short bursts of energy (in cycle) to the ciliary body, thus reducing production of aqueous humor. The energy gusts develop sequentially to a photocoagulating state in the pigmented epithelium. They are spaced by rest periods that allow surrounding tissue to cool down and remain below photocoagulative threshold, thus avoiding damage to surrounding tissue. Some studies have shown that the risk of complications increases with higher energies. Complications associated with CPCTSI include prolonged intraocular inflammation, pain, intraocular hemorrhage, hypotonia, phthysis, decreased vision and sympathetic ophthalmia. Severity of these complications depends on collateral damage inflicted on surrounding tissues: ciliary muscles, unpigmented epithelium and stroma of ciliary body. Currently, CPCTSI with a cycle ratio of 25% and 31.3% are used in surgical routine in ophthalmology. Cycle ratio is ratio between duration of gusts and total duration of cycle (gusts and rest periods). At St. Joseph's Hospital, both cycle ratios are used and the choice is operator dependent. However, using CPCTSI with a 25% cycle ratio could have fewer complications while maintaining similar efficacy. To our knowledge, there are no studies comparing these two cycle reports, although they are commonly used in practice. Our objective is to compare the CPCTSI with a cycle ratio of 25% and 31.3%.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Automatic Segmentation by a Convolutional Neural Network (Artificial Intelligence - Deep Learning) of Polycystic Livers, as a Model of Multi-lesional Dysmorphic Livers

acronym: ASEPOL

summary:
Assessing the volume of the liver before surgery, predicting the volume of liver remaining after surgery, detecting primary or secondary lesions in the liver parenchyma are common applications that require optimal detection of liver contours, and therefore liver segmentation.

Several manual and laborious, semi-automatic and even automatic techniques exist.

However, severe pathology deforming the contours of the liver (multi-metastatic livers...), the hepatic environment of similar density to the liver or lesions, the CT examination technique are all variables that make it difficult to detect the contours. Current techniques, even automatic ones, are limited in this type of case (not rare) and most often require readjustments that make automatisation lose its value.

All these criteria of segmentation difficulties are gathered in the livers of hepatorenal polycystosis, which therefore constitute an adapted study model for the development of an automatic segmentation tool.

To obtain an automatic segmentation of any lesional liver, by exceeding the criteria of difficulty considered, investigators have developed a convolutional neural network (artificial intelligence - deep learning) useful for clinical practice.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de radiologie - Pavillon B - Cellule Recherche imagerie, Hôpital Edouard Herriot (HCL)


title: Cohort of Patients> 70 Years Old With Cancer and / or Hematological Malignancy Treated With Chemotherapy and / or Immunotherapy and / or Targeted Therapy and / or New Generation Hormone Therapy After Oncogeriatric Evaluation and Therapeutic Revision on Public Assistance -Hospitals From Marseille

acronym: ChimioAge

summary: Follow-up of patients> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions. We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.


title: Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study

acronym: ARFIM

summary: Local percutaneous thermal ablation is frequently proposed in the management of metastatic diseases. Radiofrequency ablation (RFA) has demonstrated good results when the metastatic disease is limited and slowly evolving. The destruction of solid metastasis by RF leads to inflammatory and immunological mechanisms that remain poorly understood. These pathological events may influence the overall and anti-tumor host immune responses. The purpose of the study is to identify and quantify some immune mechanisms triggered by RFA of pulmonary metastases from colorectal cancer origin.

intervention_type: Radiation


title: Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital

acronym: CIVCAP

summary:
More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed.

In 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress.

At the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives.

Morevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature).

Therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Genetic Determinant of Foveolar Hypoplasia in Parents of Albinos Children

acronym: ALAFOR

summary: Fovea plana could be the phenoyipic translation of a genetic anomaly in one of the genes identified in albinisme

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Genetic


title: Long-term Outcomes After Non-invasive Assessment of Acute Cardiac Rejection in Heart Transplantation : the Marie Lannelongue Hospital Experience

summary:
Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. However the sensitivity of endomyocardial biopsy (EMB) is not perfect and can be associated with major complications including fatal tamponade. Moreover, repeated biopsies are associated with reduced quality of life for HTx recipients.

Since almost 20 years, the investigators do not perform routinely EMB for acute rejection screening. Early left ventricular diastolic dysfunction was investigated according to a standardized protocol. The investigators sought to analyze the long-term post-transplant outcomes without systematic EMB. The investigators hypothesize that exclusive echographic screening was not associated with impaired outcomes.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease

acronym: KETO-GUT

summary: Chronic kidney disease (CKD) is associated with accumulation of uremic toxins like p-cresyl sulfate and indoxyl sulfate that are associated of cardiovascular complication and perturbation of glucose metabolism. These toxins are produced by fermentation of protein by intestinal microbiota but the role of low protein diet and ketoanalogue supplementation on uremic toxins production and microbiota composition are unknown. Low protein diet supplemented with ketoanalogues is recommended inCKD patients to prevent progression of renal disease. The aim of this study is to determine the impact of uremic toxins concentration, microbiota composition and gut hormone involved in carbohydrate metabolism ( GLP-1, FGF19, bile acids) with low protein diet supplemented with ketoanalogues.


title: Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases

acronym: ASTERIA

summary:
Patients with acute leukemia or received SCT are hospitalized in protected area, at least for 28 days. In this area, there is some rules like: controlled-visit, protective-clothing….so patient are in social and familial isolation condition.

During their hospitalization, patients are confront to aggressive treatment and psychological distress related to potentially death.

Emergency hospitalization, illness, controlled environment, aggressive treatment and potential complications place patients in a context of anxiety-provoking.

Aesthetic therapy is a new supportive care in cancer therapy access on improving well-being, relaxation and body image.

This supportive care is already used in cancerology department, particularly in breast cancer patients.

In our department, a few patient received aesthetic care during their hospitalization and they appreciated these sessions and impact on well-being was immediately.

Moreover only 6 sessions was proposed and effect on anxiety wasn't measurable Aesthetic care improve well-being but impact on anxiety is unknown. In this study we evaluate the impact off socio aesthetic on the quality off life and anxiety. We evaluate this impact by 3 questionnaires at 3 times during hospitalization.

lead_sponsor: University Hospital, Lille


title: Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET).

acronym: POPINET

summary:
Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA).

Surgery is the only curative treatment. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome.

At the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure.

To correct this absence of radiological standardization, the investigating team has developed a reading grid for Computed Tomography (CT) aimed to facilitate preoperative planning of small bowel NET.

The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status.

The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.


title: Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

acronym: ON RUGBY

summary:
The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres.

In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

location_facility: Fondation Opthalmologique A de Rothschild


title: Development of a Digital Solution for Acute Pain Assessment Using Automartized Facial Expression Analysis

acronym: DEF-I

summary: Managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. Evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. In these cases, pain can only be evaluated by medical staff by the observation of pain-related characteristics like facial expression of pain (FEP). However, recognition of FEP is subjective, time-consuming and subject to multiple biases frequently leading to underestimation of pain and consequently under-treatment. Some of these biases could be solved by the use of facial recognition technology, allowing objective, automated and time-saving pain assessment. DEF-I aims to address technical issues and achieve the development of facial expression recognition digital tool able to evaluate severe acute pain in clinical practice, with high validity and utility by improving the quality of the images to be analyzed, by studying larger samples of patients, data and images, in order to correlate more efficiently the pain intensity felt by a patient with the expression of his face. The main objective of this study is to verify whether it is possible to quantitatively correlate the intensity of acute postoperative pain felt by a patient with his facial expression. The secondary objective is to define a reliable computer algorithm that qualitatively correlates the type of acute postoperative pain experienced by a patient with his facial expression.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Study of Erythropoietin in Newborns and Children

acronym: EPO

summary:
Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney.

Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml.

In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities.

The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device

acronym: PRE-SIMPA

summary:
The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills.

Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE.

To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients.

A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.


title: Evolution of the Physical Condition in Treated Cancer Patients

summary:
Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs.

Descriptive, explorative and prospective study of 3 different populations:

One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.

ReferenceCitation: Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousinière A, Dufour S, Favret F, Pivot X, Hureau TJ, Pagano AF. Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol. Front Oncol. 2020 Aug 7;10:1304. doi: 10.3389/fonc.2020.01304. eCollection 2020.

family: Mallard

full_name: Joris Mallard

given: Joris

family: Hucteau

full_name: Elyse Hucteau

given: Elyse

family: Schott

full_name: Roland Schott

given: Roland

family: Petit

full_name: Thierry Petit

given: Thierry

family: Demarchi

full_name: Martin Demarchi

given: Martin

family: Belletier

full_name: Christine Belletier

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Carinato

full_name: Hélène Carinato

given: Hélène

family: Chiappa

full_name: Pascale Chiappa

given: Pascale

family: Fischbach

full_name: Cathie Fischbach

given: Cathie

family: Kalish-Weindling

full_name: Michal Kalish-Weindling

given: Michal

family: Bousinière

full_name: Audren Bousinière

given: Audren

family: Dufour

full_name: Stéphane Dufour

given: Stéphane

family: Favret

full_name: Fabrice Favret

given: Fabrice

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Hureau

full_name: Thomas J. Hureau

given: Thomas J.

family: Pagano

full_name: Allan F. Pagano

given: Allan F.

journal_name: Frontiers in Oncology

license: cc-by

license_normalized: cc-by

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre Paul Strauss