title: Macrophage Phenotype in Type 2 Diabetics After Myocardial Infarction and the Potential Role of miRNAs Secreted

summary:
The prevalence of type 2 diabetes is growing steadily. Patients with diabetes, cardiovascular complications (such as myocardial infarction (MI)) are more frequent and severe than in non-diabetic subjects. The anti-diabetic therapies available have little or no effect on the incidence of cardiovascular events. It is therefore urgent in diabetics develop new therapeutic strategies to reduce the occurrence of MI or limit the consequences.

In the two weeks following MI, monocytes / macrophages are the most represented in the ischemic heart tissue cells. The infiltration by monocytes / macrophages after infarction MI is a two-phase process. In the first phase, monocytes / macrophages M1 promote digestion injured areas, and monocytes / macrophages M2 intervene to promote angiogenesis, collagen deposition and contribute to tissue repair. The optimal repair after myocardial infarction depends on effective recruitment of monocytes and macrophages M1 transition needed to digest the damaged tissue and M2 macrophages necessary for tissue repair. The balance between these two phenotypes M1 and M2 is controlled by different modulators, such as transcription factors, cellular miRNA and miRNA extracellular contained in the microvesicles (MVs). Interestingly, plasma MVs circulating essentially derived monocytes and platelets contain miRNA and are impaired by inflammation or during various pathological situations (such as IDM). Furthermore, metabolic disorders such as hypercholesterolemia (often associated with diabetes) affect the transition from M1 to M2 response and response delay cardiac repair. To date, the mechanisms that control the M1 / M2 transition at heart level are not elucidated. Moreover, the impact of diabetes, which leads to chronic low-grade inflammation, is not explored. Targeting the immune response by promoting the transition M1 / M2 after MI could be an innovative therapeutic approach. However, better characterization of the response of M1 and M2 macrophages after MI and the mechanisms by which they contribute to tissue remodeling and the effect of diabetes are needed. The goal is to study how the phenotypes / macrophage functions after MI are changed by diabetes and to determine the potential role of miRNAs contained in secreted MVs in the transition M1 / M2 after MI.

Monocytes / macrophages from subjects with normal blood sugar or diabetes who underwent an IDM (10 per group) will be characterized phenotypically. Their ability to produce MVs will be analyzed. These MVs will be tested functionally for their ability to orient the polarization of healthy recipients monocytes. The content of these MVs in terms of miRNAs will be analyzed in detail. By bioinformatics analysis, some miRNAs of interest (based on their abundance and target genes) will be selected. These miRNAs are over-expressed in macrophages and MVs produced by these cells will be analyzed for their ability to modulate differentiation of monocytes recipients. Finally, the circulating levels of these miRNAs of interest will be measured after 1 year of IDM and will be correlated to the clinical phenotype of patients (recurrence, arrhythmias, heart failure). Ultimately, the goal is to identify VMs that can promote the differentiation of monocytes to an alternative phenotype and identify miRNAs responsible for this effect. This could help in the future, in a subject with impaired ability of monocytes to differentiate alternatively, can change by introducing the miRNA of interest to re-inject or inject MVs macrophage containing the miRNA of interest and thus correct the defect of differentiation.


title: Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers

acronym: ATIASP

summary: Clarify the determinants of the construction of a Therapeutic Alliance (AT) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric Whether the quality of Therapeutic Alliance influences the continued support outpatient , after completion of full-time hospitalization.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description:
At the end of the study, patient could be informed of result of the study if they wish.

No individual result will be communicate.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique

status_simplified: Completed


title: Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.

acronym: ERGONOMIE

summary:
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:

60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.

The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.

study_type: Interventional

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other


type: Other Identifier

title: Research of Biomarkers of Air Pollutants Exposure

summary:
Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been reported in part due to the rising in life expectancy. For instance, exposure to air pollution, and in particularly to fine particles has been classified by the International Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly population particularly sensitive. However, no validated biomarkers have been identified to assess the exposure to fine particles maybe correlated to cancerogenesis.

AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses of fine particles.

Secondly, the study aims to analyze, according to age, the leukocytes response to the urban pollution exposure.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Lille Catholic University

intervention_type: Procedure


title: CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

acronym: CANPOS

summary: CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon / Hôpital Neurologique Pierre Wertheimer

intervention_type: Biological

status_simplified: Ongoing


title: Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea

summary: Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.

status: Terminated

primary_purpose: Treatment

lead_sponsor: Hopital Foch

intervention_type: Device

status_simplified: Unknown


title: Neural Development of Deductive Reasoning: an fMRI Study of Relational and Categorical Reasoning in Children

acronym: NEUREAS

summary: Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships is critical for the acquisition of deductive reasoning, that is, the ability to reach logically valid conclusions from given premises. Behavioral and neuroimaging studies in adults suggest processing differences between these relations: While arguments that involve linear-orders may be preferentially associated with spatial processing, arguments that involve set-inclusions may be preferentially associated with verbal processing. In this study, we use functional magnetic resonance imaging to investigate how and when these processing differences appear in children from 8 to 14.

status: Unknown status


title: Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery

acronym: LiNe

summary: The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery.

ReferenceType: derived

ReferenceCitation: Pickering G, Voute M, Macian N, Ganry H, Pereira B. Effectiveness and safety of 5% lidocaine-medicated plaster on localized neuropathic pain after knee surgery: a randomized, double-blind controlled trial. Pain. 2019 May;160(5):1186-1195. doi: 10.1097/j.pain.0000000000001502.

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

sequence: first

family: Voute

full_name: Marion Voute

given: Marion

sequence: additional

family: Macian

full_name: Nicolas Macian

given: Nicolas

family: Ganry

full_name: Hervé Ganry

given: Hervé

family: Pereira

full_name: Bruno Pereira

given: Bruno

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Pain

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of the Composition of the Packed Red Blood Cell Supernatant on Renal Dysfunction and Post-transfusion Immunomodulation

acronym: TRANSNEPHRON

summary:
Safety during transfusions is a major issue in medical economics. Despite drastic quality control measures, transfusion is still a source of short, mid and long-term morbi-mortality. This can be explained to some extent by changes in the composition of the packed red blood cell (PRBC) supernatant during storage essentially with the appearance of immunologically active compounds possibly involved in organ dysfunction on the one hand and post-transfusion immunomodulation on the other hand. These phenomena impact upon outcomes for cardiac surgery patients.

In terms of organ dysfunction, kidney failure due to acute tubular necrosis and pulmonary failure are the 2 main issues. Following cardiac surgery, 11% of patients will present with transient renal dysfunction characterised by a 25% increase in serum creatinine levels and 3.5% require dialysis. The intensity of acute renal failure (ARF) is correlated to resuscitation : a 20% increase in serum creatinine levels 2 to 3 days after surgery significantly raises morbidity rates and a 50% increase raises the mortality rate to 10%.

The precise mechanisms governing post-transfusion immunomodulation have not yet to be defined. The appearance of soluble type I Human leukocytes Antigen (HLA) molecules (sHLA-I), the FAS ligand (FAS-L) or cluster designation 40 (CD40-L) in the supernatant of PRBCs along the storage of blood products may be involved in such phenomena. These molecules are capable of activating or triggering the death of innate or adaptive immunity cells, especially the Natural Killer (NK) cells.

Consequently the investigators propose to focus specifically on the detailed composition of transfused PRBC supernatants in order to identify the candidate molecules responsible for organ dysfunction or post-transfusion immunoparalysis. The investigators will combine a clinical approach based on the transcriptional analysis of renal tubular cells in transfused patients and an ex-vivo approach investigating the effect of the supernatant on immune cells and the Natural Killer cells of healthy volunteers

lead_sponsor: Nantes University Hospital


title: Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup

acronym: HOLISTER

summary: In acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. Because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux


title: Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.

acronym: PASI-PAC

summary: This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.


title: Restrictive Transfusion Strategy Early After Cardiac Surgery

acronym: ReTSEACS

summary:
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.

This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.

Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).

Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.

Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


title: Assessment of the Interests of Mesure of Ultrasound Engagement on the Cesarean Rate :Study Eng - Echo Randomized Comparative Prospective Study Multicenter Center Open

acronym: eng - echo

summary:
The reduction in the rate of caesarean section is a major public health issue, it has reached 21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth increase doubles the risk of fetal morbidity, néonatal and maternal history of when césareinne. recommendations for clinical practice (RPC) to "scarred uterus" are being drafted under the auspices of the National College of obstetrics and gynecology (CNGOF) well highlighting the health problem public this represents. During 2011, 15% of the 2,700 patients who have recently given birth to the north of Marseille Hospital were carriers of a scarred uterus (internal data).The objective of the obstetrician is to ensure the welfare mother and fetus at the end of pregnancy and childbirth. To do this, the realization of a work being cesarean allows in some cases to reduce neonatal morbidity related to workflow especially in case of abnormal fetal pericardial pace that suggest fetal hypoxia. However, a significant number of caesarean section is performed by the side of caution during the second part of the work to a suspicion of non-engagement of the fetal presentation. These caesareans are indicated, rightly, before a clinical doubt about the height of the engagement of the fetal presentation in order to avoid making a difficult instrumental delivery, potentially harmful to the mother (perineal tear 3rd and 4th degree) and fetus (head injury, intracranial hemorrhage, cephalohematoma). A prospective study published in the Lancet estimated 37% error percentage attributable to the clinical examination in case of doubt on the commitment of presenatation fœtale. The CNGOF held through PRC publication what to do in case of obstetric clinical doubt about the commitment of the fetal presentation and "not recommended" no show against an instrumental extraction in this situation (RPC 2008).

Ultrasound has revolutionized pregnancy monitoring. Its routine use has in other prenatal diagnosis of fetal pathologies, it is the other reference screening tool of the most common obstetric pathology, preterm labor. Its use became widespread in the delivery room, the presence of an ultrasound machine is recommended by the decrees of perinatal care in maternity hospitals performing more than 1,500 deliveries per year. It is natural for conducting ultrasound during labor has emerged, first to help identify the variety of the presentation of the fetal head and then more recently in aid to instrumental delivery. Several studies have shown that ultrasound had a sensitivity of commitment over 90% for predicting the success of instrumental extraction and a vaginal delivery.

To our knowledge, to date, there is no study that investigated the benefit of ultrasound commitment to reduce the rate of cesarean section during labor. To answer this question, we want to show that making a commitment in case of diagnostic ultrasound of doubt about the level of engagement of the fetal head (4% of births) reduces by 30% the rate of caesarean section fully dilated.

primary_purpose: Prevention

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient

acronym: CAM-ICU

summary: Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi

intervention_type: Behavioral


title: Preoperative Localization of Infraclinical Breast Tumors: Isotopic Localization by iodine125 Seed Versus Standard Localization Using a Metal Wire: A Randomized Prospective Trial

acronym: IodineBreast

summary:
This is a monocentric, non-inferiority, randomized cohort study with an open 1:1 ratio comparing the impact of iodine seed tumor localization (arm B) vs. standard localization using a metal guide (arm A) on the quality of the surgical resection margins in parallel groups with an interim analysis in patients with breast cancer.

Randomization will be performed using histologic status stratification: in situ ductal /invasive lobular +/- an in situ component / invasive ductal +/- an in situ component.

lead_sponsor: Centre Antoine Lacassagne

lead_sponsor_type: industriel


title: Beneficial Effects of Preference on Behavior

acronym: COGNICOMA

summary:
Preferred music improves cognitive function in patients with disorders of consciousness (DOC). However, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents).

The aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised

location_facility: Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique


title: Conciliating Mastery Learning and Time Constraints on High-fidelity Simulators: Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.

summary: The objective of this study is to compare two forms of pre-training (an online narrative presentation and a serious game) to prepare 2nd year medical students for a hands-on training with physical simulators about out-of-hospital cardiac arrest management.

ReferenceType: background

ReferenceCitation: Mundell WC, Kennedy CC, Szostek JH, Cook DA. Simulation technology for resuscitation training: a systematic review and meta-analysis. Resuscitation. 2013 Sep;84(9):1174-83. doi: 10.1016/j.resuscitation.2013.04.016. Epub 2013 Apr 23. Review.

ReferenceCitation: Wayne DB, Butter J, Siddall VJ, Fudala MJ, Wade LD, Feinglass J, McGaghie WC. Mastery learning of advanced cardiac life support skills by internal medicine residents using simulation technology and deliberate practice. J Gen Intern Med. 2006 Mar;21(3):251-6.

ReferenceCitation: Cook DA, Brydges R, Zendejas B, Hamstra SJ, Hatala R. Mastery learning for health professionals using technology-enhanced simulation: a systematic review and meta-analysis. Acad Med. 2013 Aug;88(8):1178-86. doi: 10.1097/ACM.0b013e31829a365d. Review.

ReferenceCitation: Creutzfeldt J, Hedman L, Felländer-Tsai L. Effects of pre-training using serious game technology on CPR performance--an exploratory quasi-experimental transfer study. Scand J Trauma Resusc Emerg Med. 2012 Dec 6;20:79. doi: 10.1186/1757-7241-20-79.

ReferenceCitation: Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesnière A. Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study. Eur J Anaesthesiol. 2017 Dec;34(12):836-844. doi: 10.1097/EJA.0000000000000675.

family: Drummond

full_name: David Drummond

given: David

family: Delval

full_name: Paul Delval

given: Paul

family: Abdenouri

full_name: Sonia Abdenouri

given: Sonia

family: Truchot

full_name: Jennifer Truchot

given: Jennifer

family: Ceccaldi

full_name: Pierre-François Ceccaldi

given: Pierre-François

family: Plaisance

full_name: Patrick Plaisance

given: Patrick

family: Hadchouel

full_name: Alice Hadchouel

given: Alice

family: Tesnière

full_name: Antoine Tesnière

given: Antoine

journal_name: European Journal of Anaesthesiology

lead_sponsor: Ilumens

location_facility: Département de Simulation iLumens, Université Paris Descartes


title: A Phase I/II, Non Randomized, Monocentric Open-label Study of Autologous CD34+ Cells Transduced With the G1XCGD Lentiviral Vector in Patients With X-Linked Chronic Granulomatous Disease

summary:
X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects boys. It is a primary immunodeficiency disorder which results from an inability of the white blood cells called phagocytic cells (or phagocytes) to kill invading bacteria and fungi. These cells have difficulty forming the free radicals (most importantly the superoxide radical due to defective phagocyte NADPH oxidase complex) which are important in the killing of ingested pathogens. In X-CGD (which accounts for two thirds of CGD patients), the defect lies in a gene which makes up a critical part of the NADPH-oxidase complex (the catalytic subunit; gp91-phox protein). Therefore they kill bacteria and fungi poorly, and the patients suffer from severe and recurrent infections. This also results in inflammation which can damage parts of the body such as the lung and gut.

In many cases, patients can be adequately protected from infection by constant intake of antibiotics. However, in others, severe life-threatening infections break through. In some cases, inflammation in the bowel or urinary systems results in blockages which cannot be treated with antibiotics, and which may require the use of other drugs such as steroids. Development of curative treatments for CGD is therefore of great importance.

status: Active, not recruiting

lead_sponsor: Genethon

intervention_type: Genetic


summary:
Introduction:

The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.

Objectives:

To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes

Methods :

It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.

Expected results :

The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.


summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact on the general morbidity and risk of stroke, AF is a great concern for public health. Several mechanisms, including endothelial dysfunction and inflammatory processes, have been postulated as predisposing factors for AF, as well as for stroke.

Both clinical and experimental studies highlight inflammation as a predisposing factor for AF and its complications. Nevertheless, the source of high inflammatory proteins in patients with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation in AF patients.

The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also help to define the site of endothelial dysfunction and of production of this thrombogenic factor.

Although AF is associated with an increased risk of stroke, the risk is not homogeneous. Permanent and persistent AF are associated with similar thromboembolic risk to that of paroxysmal AF.


title: T Cell Phenotypes in ALS, Influence of Vitamin D

acronym: VITALS

summary: ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is 3 years after onset, but may vary from a few months to more than 30 years. Various factors have been suspected to play a role in such a variation, but recently, it has been described that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D is an hormone know to regulated T reg function in vivo and in vitro. It have recently demonstrated that vitamin D (VD) levels correlated with ALS prognosis. The investigator want to go further in the study of the immune processes that could modulate prognosis in ALS. This could allow proposing VD as a potential treatment of ALS in a future trial. More largely, this could reinforce arguments in favor of an immune intervention to attenuate the severity of this devastating disorder.

ipd_sharing: Yes

ipd_sharing_description: The investigator communicate the global results on demand


title: Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M Cad Cam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea Syndrome (OSA) Therapy: ESTAMPS Study

acronym: ESTAMPS

summary:
ESTAMPS is a randomized clinical trial with a crossover design:

Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume

secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning

lead_sponsor: ResMed


title: Claudication et Fatigue Musculaire de l'artériopathe

acronym: CLAUSEL

summary: Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication

lead_sponsor: University Hospital, Angers


title: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation: A Randomized Controlled Study

acronym: REVAR

summary: Repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. The objective of this study is to compare the use of repeated versus varied simulation cases for teaching the management of pediatric asthma exacerbation to 3rd year medical students.

ReferenceCitation: Tofil NM, Peterson DT, Wheeler JT, Youngblood A, Zinkan JL, Lara D, Jakaitis B, Niebauer J, White ML. Repeated versus varied case selection in pediatric resident simulation. J Grad Med Educ. 2014 Jun;6(2):275-9. doi: 10.4300/JGME-D-13-00099.1.

ReferenceCitation: Cook DA, Hamstra SJ, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hatala R. Comparative effectiveness of instructional design features in simulation-based education: systematic review and meta-analysis. Med Teach. 2013;35(1):e867-98. doi: 10.3109/0142159X.2012.714886. Epub 2012 Sep 3. Review.


title: Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula

acronym: ABISS

summary:
The primary objective of this double-blind study is to compare the frequency of primary patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with paclitaxel).

The other objectives of the study are:

To compare the frequency of primary patency at 3 months and 12 months.
To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12 months.
To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow rate).
To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml / min.
To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.
To compare, at 3, 6 and 12 months, the medical costs related to direct medical care, initial treatments, monitoring, diagnosis and treatments of complications.

location_facility: Service chirurgie vasculaire, Hôpital Ambroise Paré

intervention_type: Combination Product


title: Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer

acronym: ORAL-ISO

summary:
Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue.

The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.

lead_sponsor: Rennes University Hospital


title: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study

acronym: SAPAAD

summary:
Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea.

The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.

ReferenceCitation: Champ-Rigot L, Ferchaud V, Prévost JN, Moirot P, Pellissier A, Legallois D, Alexandre J, Scanu P, Morello R, Saloux E, Milliez PU. Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). Clin Med Insights Cardiol. 2018 Jan 8;12:1179546817751628. doi: 10.1177/1179546817751628. eCollection 2018.

name: Department of Cardiology, CHU de Caen, Caen, France

name: EA4650, Université Caen Normandie, Caen, France

family: Champ-Rigot

full_name: Laure Champ-Rigot

given: Laure

family: Ferchaud

full_name: Virginie Ferchaud

given: Virginie

name: Department of Pneumology, CHU de Caen, Caen, France

family: Prévost

full_name: Jean-Noël Prévost

given: Jean-Noël

family: Moirot

full_name: Pierre Moirot

given: Pierre

family: Pellissier

full_name: Arnaud Pellissier

given: Arnaud

family: Legallois

full_name: Damien Legallois

given: Damien

name: Department of Pharmacology, CHU de Caen, Caen, France

family: Alexandre

full_name: Joachim Alexandre

given: Joachim

family: Scanu

full_name: Patrice Scanu

given: Patrice

name: Department of Biostatistics and Clinical Research, CHU de Caen, Caen, France

family: Morello

full_name: Remy Morello

given: Remy

family: Saloux

full_name: Eric Saloux

given: Eric

family: Milliez

full_name: Paul Ursmar Milliez

given: Paul Ursmar

currency_apc_doaj: USD

journal_name: Clinical Medicine Insights: Cardiology

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 OAI-PMH doi match)

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Hospital, Caen


title: Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?

summary:
Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence. In fact, there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention. In addition, the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition, the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention.

Based on these evidences, we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.

ReferenceCitation: Lemesle G, Laine M, Pankert M, Boueri Z, Motreff P, Paganelli F, Baumstarck K, Roch A, Kerbaul F, Puymirat E, Bonello L. Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial. JACC Cardiovasc Interv. 2020 Apr 27;13(8):907-917. doi: 10.1016/j.jcin.2020.01.231.

family: Lemesle

full_name: Gilles Lemesle

given: Gilles

family: Laine

full_name: Marc Laine

given: Marc

family: Pankert

full_name: Mathieu Pankert

given: Mathieu

family: Boueri

full_name: Ziad Boueri

given: Ziad

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Paganelli

full_name: Franck Paganelli

given: Franck

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Roch

full_name: Antoine Roch

family: Kerbaul

full_name: François Kerbaul

given: François

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Bonello

full_name: Laurent Bonello

given: Laurent

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Lemesle G, Laine M, Pankert M, Puymirat E, Bonello L. Great expectations. Lancet. 2018 Jan 27;391(10118):306. doi: 10.1016/S0140-6736(18)30096-5. Epub 2018 Jan 31.

bso_classification: Chemistry

journal_name: The Lancet

evidence: open (via free pdf)

title: Great expectations


title: Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

acronym: ISOMAB

summary:
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.

However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.

ReferenceCitation: Nadel L, Moscovitch M. Memory consolidation, retrograde amnesia and the hippocampal complex. Curr Opin Neurobiol. 1997 Apr;7(2):217-27. Review.

ReferenceCitation: Cabeza R, St Jacques P. Functional neuroimaging of autobiographical memory. Trends Cogn Sci. 2007 May;11(5):219-27. Epub 2007 Mar 26.

ReferenceCitation: Mizumatsu S, Monje ML, Morhardt DR, Rola R, Palmer TD, Fike JR. Extreme sensitivity of adult neurogenesis to low doses of X-irradiation. Cancer Res. 2003 Jul 15;63(14):4021-7.

ipd_sharing_description: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).


title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

acronym: TrauCC

summary: Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.

lead_sponsor: University Hospital, Lille

intervention_type: Drug


title: Health Care Courses of Elderly Hospitalized Patients for Inappropriate Reasons: Qualitative and Economic Analyzes

acronym: PAGE

summary:
For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the emergency unit. They are described as inappropriate hospitalization because they don't require the use of technical platform or diagnostic neither therapeutic procedures under medical supervision. Those are inappropriate because the patient could have a paramedical and social care at home or in more efficient structures. The hospital remains the place of remedy for social and health situations whose resolution was not possible because of a lack of infrastructure available, of patient or his relative information, or a lack of coordination in medico-social establishment.

These inappropriate hospitalizations involve an increase of length of stay that enhancing the fragility and vulnerability of the elderly. They have deleterious effects as decompensation, comorbidities and loss of autonomy.

Moreover, the suffering of natural or informal caregivers is also an important public health question; Caregivers may have a serious disease resulting from caring their relative. That leads to increase their consumption of health care and medical goods.

This comprehensive study will highlight the deficiencies of the actual health care through the analysis of the speech of the different parts involved (main study). Simultaneously, a comparative analysis of the costs of health care will be conducted (economic combined study).

lead_sponsor: Régis AUBRY


title: Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking

acronym: StiVeN

summary:
The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.

Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection.

They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last.

A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s.

No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking.

We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required.

lead_sponsor: Fondation Lenval


title: Estimation of Perceptual Levels Used in Cochlear Implant Fitting Based on Electrophysiological Measures

acronym: ENPICME

summary:
The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis.

The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Service ORL Pavillon U


type: Registry Identifier

title: Evaluation of the Effectiveness of an Aldehyde Inhibitor Dehydrogenases (DIMATE) on the Cell Population Leukemic or Normal Stem

acronym: DIMATE

summary:
Aldehyde dehydrogenases (ALDHs) are cellular enzymes responsible for detoxifying aldehyde resulting from the metabolism of endogenous and exogenous xenobiotic cellular constituents. Although ALDHs are considered to play an important role in tumorigenesis, the role of ALDH activity in cancer stem cells, and more particularly that of the acute leukemia must be specified.

Several studies have shown that ALDHs are potent apoptogenic compounds on normal or cancer cells. Therefore, the cells that were damaged and their increased ALDH activity does not die by apoptosis but become highly proliferating. This result is a plausible mechanism for the "evasion of apoptosis", a characteristic shared by many cancer cells.

On this basis, it is proposed an innovative approach to cancer chemotherapy through inhibition of one of the protective mechanisms against apoptosis, ie the increase in ALDH activity than cancer cells put involved in overcoming the lethal effects of damaged roads. ALDHs of inhibitors they may have immediate application as anti -cancer in vivo? The limited experimental data obtained so far on human tumor xenografts in immunodeficient mice and the absence of data on the in vivo toxicology do not allow direct passage to clinical trials. Indeed, some members of the ALDH superfamily are expressed constitutively in some vital organs they protect against the deleterious effects of xenobiotics and adverse endogenous metabolites. Consequently, if ALDHs should be inhibited, of the collateral damages for the normal cells could occur. However, when normal cells have not undergone deleterious exposure, these harmful metabolites are not or in very small quantities, which do not require high levels of ALDH activity, and therefore without harm to the inhibition of cell of these enzymes.

From a hematological point of view, it seems essential to test the therapeutic index of the inhibitor of ALDH DIMATE between normal hematopoietic cells and leukemic stem. Indeed, in the pathophysiology of acute leukemia, the leukemia stem cells are of major importance because they are much more resistant to chemotherapy than more differentiated cells and thus causing the high rate of relapse observed in acute leukemia despite the high rate of complete remission often obtained. In this study, it will be tested in vitro sensitivity of the cluster of differentiation 4 and cluster of differentiation 38 (CD4/CD38) highly purified of leukemic origin or normal to the DIMATE compound. The objective will be to analyze the effects of DIMATE on the parameters of the proliferation, the apoptose, the cytokinins of secretions and the changes transcriptomic in general, in order to better define the therapeutic index of this compound and to determine all the precursory hematopoietic normals and leukaemic cellular effects. The reversible cytostatic of DIMATE effect on normal cells but its irreversible apoptotic effect on cancer cells is an advantage to try to eliminate.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis

acronym: PRIMICISTIM

summary: Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.


acronym: PROFES

summary:
With aging of the persons living with HIV, cardiovascular diseases now account for substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age.

The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance.

It would also be important to know whether HIV patients need specific protocols for stroke emergency management.

The study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by HIV.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases " The DIFFUsE Study "

acronym: DIFFUsE

summary:
New strategies are needed to early detect myocardial involvement in these diseases. Histological studies showed that diffuse fibrosis and cardiomyocyte hypertrophy precede the LV remodelling (dilatation) observed by cardiac imaging. Quantification of LV diffuse myocardial fibrosis using magnetic resonance imaging (MRI) could reach this goal. Recently, contrast enhanced cardiac MRI has been used to measure the extracellular volume fraction (ECV) of the myocardium, and it has been able to detect diffuse myocardial fibrosis. In diseases in which increased collagen deposition enlarges the extra-cellular space, the ECV can act as a fibrosis index. ECV is correlated with the amount of fibrosis measured by histology. Left ventricular overloads induced by regurgitant VHD result in cardiomyocyte hypertrophy and diffuse fibrosis. Other methods can be used to estimate the degree of myocardial fibrosis such as the serum level of galectine-3 or ST2. Moreover, although the pathophysiological mechanisms leading to the occurrence of myocardial fibrosis differ in patients with various cardiac diseases, the cellular effectors of fibrotic remodelling are common and involve similar signalling pathways. At the cellular level, key progression of ventricular hypertrophy is associated with increased cardiomyocytes apoptosis and fibrosis, suggesting that these two processes are responsible for the transition.

To our knowledge, no study has analysed the impact of the rate of myocardial diffuse fibrosis, non-invasively estimated by ECV, in the risk of LV dysfunction during MR and AR, especially after surgery. The measurement of ECV could become an important tool for risk stratification in left-sided regurgitant VHD. Thus, it would provide an early marker of LV myocardial involvement before the occurrence of global remodeling, might help physicians in surgical decision, and would improve prognosis. This is an innovative original project because it uses modern imaging modalities to answer to a crucial question. The clinical implications would be important because this work would modify the international surgical indications of MR and AR in order to finally improve the prognosis of patients with this frequent heart disease. Moreover, investigators will analyze the genetic factors that can influence the myocardial reaction resulting from these regurgitations, which will improve the quality of this work and offer new future perspectives.

Investigators hypothesize that the ECV measurement could be used as an early predictor of LV dysfunction in the left-sided valve regurgitations.


title: Validation of a Clinical Screening Grid for Syndromic Schizophrenia

acronym: Schizo-CGH-EXM

summary:
Background:

Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red flags for syndromic forms of schizophrenia remain poorly documented.

lead_sponsor: Hôpital le Vinatier


title: Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study

acronym: ProstaChoc 1

summary: The primary objective of this study is to evaluate changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores.

study_start_date_type: Anticipated

status: Withdrawn

ReferenceCitation: Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)

acronym: PONVACS

summary: To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.

ipd_sharing_description: On demand

lead_sponsor: Hôpital Privé de Parly II - Le Chesnay


lead_sponsor: University Hospital, Limoges

acronym: PTH

source: euctr

title: Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo

summary:
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.

The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.

Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.

Evaluations are planned evry 6 months.


acronym: ROBOPHYSE

summary:
Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology.

Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective.

A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome.

The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).

In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Validation of PINI Score in ICU

summary: Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU

lead_sponsor: University Hospital, Clermont-Ferrand


title: Beneficial Effects of Music on Cognition and Consciousness Level

acronym: MUSICOREVEIL

summary:
Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged patients. However, it is still difficult to understand what precisely in music causes a positive effect : are they emotional components, familiarity or preference which improve cognition or is there any specific effect of music? Moreover, it is not yet possible to characterize the neural and functional links between the brain systems solicited by music and those associated with other cognitive functions enhanced by music.

Finally, researches on brain-damaged patients have not exploited the potential effect of music on the level of alert and perceptual awareness, while this type of stimulation could be a valuable tool to improve cognition in patients with a disturbance of consciousness and alertness.

The main objective is to describe the impact of music on the brain's response to self-referential or neutral stimuli in brain-damaged patients with persistent consciousness disorder after a coma and in healthy participants.

location_facility: Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation


title: Phase 1/2 Randomized Trial Combination of Ruxolitinib and Peg-interferon Alpha-2a in Patients With Primary Myelofibrosis Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis

acronym: RUXOPeg

summary: Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose combination that also satisfies certain safety requirements. It consists in a dose finding study to assess the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients.

ipd_sharing_description: e crf

lead_sponsor: French Innovative Leukemia Organisation

location_facility: FILO French Innovative Leukemia Organization


title: Evaluation of the Effect of an Educational and Explanatory Program for a Surgical Act Provided to the Patient Prior to Said Act on Preoperative Anxiety - a Pilot Study at the Nîmes University Hospital on Elective Coronary Angiography

acronym: HEART-LINK

summary: The main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the Nîmes University Hospital.

primary_purpose: Supportive Care


title: Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer

acronym: REVIS

summary: The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.


title: Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture

acronym: LIGAMYS

summary:
The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.


title: Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.

summary:
Introduction

Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL).

Materiel and Methods

We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain.

We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study.

Expected results

We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.

ReferenceCitation: Schmitt A, Crochet P, Baumstark K, Tourette C, Poizac S, Pivano A, Boubli L, Cravello L, Agostini A. Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):38. doi: 10.1186/s13063-017-2429-y.

family: Schmitt

full_name: Andy Schmitt

given: Andy

family: Crochet

full_name: Patrice Crochet

family: Baumstark

full_name: Karine Baumstark

family: Tourette

full_name: Claire Tourette

given: Claire

family: Poizac

full_name: Sabine Poizac

given: Sabine

family: Pivano

full_name: Audrey Pivano

given: Audrey

family: Boubli

full_name: Léon Boubli

given: Léon

family: Cravello

full_name: Ludovic Cravello

given: Ludovic

family: Agostini

full_name: Aubert Agostini

given: Aubert

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique Hopitaux De Marseille


acronym: DIABOLOPIG

summary: Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or gastric) has become a standard technique validated. The rate of high technical and clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains that validation. However this treatment is done at the cost of a higher median number of treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see the advent of metal prosthesis completely covered by a membrane allowing them endoscopic extraction with ease. It has thus been recently developed short prostheses, of large diameter (up to 15/16 mm), with broad flange (or stent "diabolo") to be considered for use in the drainage of digestive peri collections. Few studies respectively determined the effectiveness of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate multicenter prospective clinical and technical efficiency of laying completely covered stent "diabolo" in echo endoscopy for the treatment of necrosis of pancreatic origin.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study

acronym: BELACOR

summary:
BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal transplant recipient with immunological risk factors such as pre transplant donor-specific anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not well defined and improving both short and long-term graft outcome remains a challenging question. Recent experimental data suggest that Belatacept could induce B cell anergy , induce regulatory B cell and decrease Ig production. These findings are strengthened by the results of both phase II and III clinical studies, showing a significant lower incidence of DSA in patients treated with Belatacept compared to recipients receiving a conventional immunosuppressive regimen with calcineurin inhibitors (CNI).

Primary objective will be the incidence of clinical and subclinical humoral rejection (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12), level of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12). Inclusion period will be of two years. DSA identification and quantitative analysis before and after transplantation will be centralized in only one HLA laboratory Unit (Hospital Saint Louis) for providing results homogeneity.

According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral Rejection is close to 20% in patients with mild immunological risk defined by the presence of DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and 3000 (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR incidence, 91 patients will be included in this study. Results will be compared to a cohort matched for age, sex, immunological risk factor (DSA), time of transplant, transplant center and grafted with a similar immunosuppressive regimen including CNI instead of Belatacept

ReferenceCitation: Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.

ReferenceCitation: Lefaucheur C, Loupy A, Hill GS, Andrade J, Nochy D, Antoine C, Gautreau C, Charron D, Glotz D, Suberbielle-Boissel C. Preexisting donor-specific HLA antibodies predict outcome in kidney transplantation. J Am Soc Nephrol. 2010 Aug;21(8):1398-406. doi: 10.1681/ASN.2009101065. Epub 2010 Jul 15.

ReferenceCitation: Gaston RS, Cecka JM, Kasiske BL, Fieberg AM, Leduc R, Cosio FC, Gourishankar S, Grande J, Halloran P, Hunsicker L, Mannon R, Rush D, Matas AJ. Evidence for antibody-mediated injury as a major determinant of late kidney allograft failure. Transplantation. 2010 Jul 15;90(1):68-74. doi: 10.1097/TP.0b013e3181e065de.

ReferenceCitation: Loupy A, Suberbielle-Boissel C, Hill GS, Lefaucheur C, Anglicheau D, Zuber J, Martinez F, Thervet E, Méjean A, Charron D, Duong van Huyen JP, Bruneval P, Legendre C, Nochy D. Outcome of subclinical antibody-mediated rejection in kidney transplant recipients with preformed donor-specific antibodies. Am J Transplant. 2009 Nov;9(11):2561-70. doi: 10.1111/j.1600-6143.2009.02813.x. Epub 2009 Sep 22.

ReferenceCitation: Haas M, Montgomery RA, Segev DL, Rahman MH, Racusen LC, Bagnasco SM, Simpkins CE, Warren DS, Lepley D, Zachary AA, Kraus ES. Subclinical acute antibody-mediated rejection in positive crossmatch renal allografts. Am J Transplant. 2007 Mar;7(3):576-85. Epub 2007 Jan 4.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares

acronym: ADC

summary: Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Randomized Study Comparing Two Strategies Carboplatin and Etoposide Topotecan in Patients With SCLC on the Second Row With Relapsed at Least Three Months After Initial Response to Chemotherapy With Platinum-etoposide 6 Cycles

acronym: CBPC

summary: The purpose of this study was to determine prospectively in all patients with SCLC in second line therapy that progression-free survival with the expected reintroduction of platinum / etoposide is greater progression-free survival in the standard arm (topotecan ) in patients who have relapsed at least three months after initial chemotherapy with platinum-etoposide

ReferenceCitation: Baize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, Vergnenegre A, Crequit J, Lamy R, Auliac JB, Letreut J, Le Caer H, Gervais R, Dansin E, Madroszyk A, Renault PA, Le Garff G, Falchero L, Berard H, Schott R, Saulnier P, Chouaid C; Groupe Français de Pneumo-Cancérologie 01-13 investigators. Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1224-1233. doi: 10.1016/S1470-2045(20)30461-7.

family: Baize

full_name: Nathalie Baize

given: Nathalie

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Greillier

full_name: Laurent Greillier

family: Geier

full_name: Margaux Geier

given: Margaux

family: Lena

full_name: Hervé Lena

given: Hervé

family: Janicot

full_name: Henri Janicot

given: Henri

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

family: Crequit

full_name: Jacky Crequit

given: Jacky

family: Lamy

full_name: Regine Lamy

given: Regine

family: Auliac

full_name: Jean-Bernard Auliac

given: Jean-Bernard

family: Letreut

full_name: Jacques Letreut

given: Jacques

family: Le Caer

full_name: Hervé Le Caer

family: Gervais

full_name: Radj Gervais

given: Radj

family: Dansin

full_name: Eric Dansin

given: Eric

family: Madroszyk

full_name: Anne Madroszyk

given: Anne

family: Renault

full_name: Patrick-Aldo Renault

given: Patrick-Aldo

family: Le Garff

full_name: Gwenaëlle Le Garff

given: Gwenaëlle

family: Falchero

full_name: Lionel Falchero

given: Lionel

family: Berard

full_name: Henri Berard

family: Schott

full_name: Roland Schott

given: Roland

family: Saulnier

full_name: Patrick Saulnier

given: Patrick

family: Chouaid

full_name: Christos Chouaid

given: Christos


title: Hematopoietic Stem Cells Transplantation in Children With Combined Immunodeficiency (CID): Selective Depletion of Naive Cells From the Graft

summary: The purpose of this study is to evaluate selective depletion of naïve CD45RA+ T cells from allogenic peripheral blood stem cell graft in children transplanted for combined immune deficiency. The aims of this procedure are to prevent graft versus host disease (GVHD) while preserving anti-infectious response from donor memory T lymphocytes.

ReferenceCitation: Touzot F, Neven B, Dal-Cortivo L, Gabrion A, Moshous D, Cros G, Chomton M, Luby JM, Terniaux B, Magalon J, Picard C, Blanche S, Fischer A, Cavazzana M. CD45RA depletion in HLA-mismatched allogeneic hematopoietic stem cell transplantation for primary combined immunodeficiency: A preliminary study. J Allergy Clin Immunol. 2015 May;135(5):1303-9.e1-3. doi: 10.1016/j.jaci.2014.08.019. Epub 2014 Oct 3.


title: Ridge Preservation With a Low Resorption Xenograft in Posterior Mandible Postextraction Sockets

acronym: Flapless

summary: The aim of this study is to evaluate the volume of madibular bone after placement of a xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 35 patients.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks

acronym: DACODEC

summary: Diving disorders and particularly Decompression sickness (DCS) represent a major concern in recreational and occupational pressure-related activities. As a result of decompression from higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues take part in embolism then resulting in DCS. Individual factors such as vascular or respiratory defects are now considered to increase the risk of this dysbarism disease.

lead_sponsor: University Hospital, Brest


title: Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors

summary:
The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin.

This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology.

The aim of the study is to describe the characteristics reproducibly for confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.

The patients seen in consultation with vulvar lesions suspicious looking will be included.

The results will be compared systematically to the histological results of biopsies of lesions (gold standard).

primary_purpose: Screening


title: Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer

acronym: OSAGE

summary:
Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.

Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.

ReferenceCitation: Servagi-Vernat S, Créhange G, Bonnetain F, Mertens C, Brain E, Bosset JF. Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE). BMC Cancer. 2017 Jul 13;17(1):483. doi: 10.1186/s12885-017-3465-4.

family: Servagi-Vernat

full_name: Stéphanie Servagi-Vernat

given: Stéphanie

family: Créhange

full_name: Gilles Créhange

given: Gilles

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Mertens

full_name: Cécile Mertens

given: Cécile

family: Brain

full_name: Etienne Brain

given: Etienne

family: Bosset

full_name: Jean François Bosset

given: Jean François

journal_name: BMC Cancer

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Motivation and Executive Control in Schizophrenia

summary:
In order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. This control is required in unusual situation. Appropriate actions are selected and coordinated according to context and aim.

Several studies try to draw a model of executive function. Recently, Koechlin has suggested a three levelled organisation to explain how the prefrontal cortex controls actions.

Contextual control is useful to answer appropriately with the immediate context. Episodic control allows selecting the action according to specific information given before. Sensorial control is the automatic response when a stimulus is presented.

Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal cortex. Chambon and al (2008) have identified a dysfunction of contextual control in schizophrenia.

As the prefrontal cortex is involved in motivational process, it seems interesting to study potential links between executive function and motivation. A study from Kouneiher shows contextual and episodic activation of motivation in healthy population.

Investigators aim to study the way motivational process are recruited in schizophrenia.


title: Measuring the Effect of a Program of 20 Sessions of Transcranial Direct Current Stimulation With 2 Milli-ampere Targeting the Dorsolateral Prefrontal Cortex on the Symptoms of Anorexia Nervosa: An Open Label Uncontrolled Pilots Study

acronym: STAR

summary:
Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss. The result is a massive weight loss and / or pathological thinness. The care of anorexia is difficult and few treatments have proved to be effective in adults.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an electrical current of low intensity. It allows to modulate the corticospinal excitability: two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull according to the region which is desired to influence the operation.

Although tDCS was shown to no noticeable side effects, it is first necessary to assess the feasibility and safety of this technique in these physically frail patients. A recent pilot study suggests the acceptability, safety and efficacy of tDCS program in patients with anorexia nervosa.

Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa. The current data are too preliminary to consider a randomized controlled trial, the investigators hope, initially, replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology .

ReferenceCitation: Strumila R, Thiebaut S, Jaussent I, Seneque M, Attal J, Courtet P, Guillaume S. Safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of Anorexia Nervosa. The open-label STAR study. Brain Stimul. 2019 Sep - Oct;12(5):1325-1327. doi: 10.1016/j.brs.2019.06.017. Epub 2019 Jun 19.


title: Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial

acronym: ConcReHosp

summary:
The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:

group receiving a pharmacist-led standardized medication review (experimental group); and
group not receiving the medication review (control group).

The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.

Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.

ReferenceCitation: Renaudin P, Baumstarck K, Daumas A, Esteve MA, Gayet S, Auquier P, Tsimaratos M, Villani P, Honore S. Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial. Trials. 2017 Feb 9;18(1):65. doi: 10.1186/s13063-017-1798-6.

family: Renaudin

full_name: Pierre Renaudin

given: Pierre

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Daumas

full_name: Aurélie Daumas

given: Aurélie

family: Esteve

full_name: Marie-Anne Esteve

given: Marie-Anne

family: Gayet

full_name: Stéphane Gayet

given: Stéphane

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Tsimaratos

full_name: Michel Tsimaratos

given: Michel

family: Villani

full_name: Patrick Villani

family: Honore

full_name: Stéphane Honore

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Impact of Clinical Pharmacy Consultations in Patients With Cancer Treated With Oral Anti-cancer Therapies on the Rate of Serious Adverse Events

acronym: PharmaOnco

summary:
The improvement of the care pathway of oncology patients through Clinical Pharmacy activities for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.

In order to improve the care pathway of patients on anticancer oral therapies, The investigators suggest in this research project to integrate into the medical care a "Clinical Pharmacy follow-up" for the patient at the hospital in the form of "pharmaceutical consultations". These pharmaceutical consultations carried out in coordination with the hospital clinical teams also aim to make the link between the hospital and community pharmacists.


acronym: APADIAB-ESPOIR

summary:
The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity.

It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.

lead_sponsor: University Hospital, Angers


title: Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

acronym: Mask

summary:
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.

This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.


acronym: PROPAN

summary: Adrenergic processes stimulated by epinephrine and norepinephrine drive to the development of tumor growth and metastasis. Beta-adrenergic receptor (BAR) antagonists have shown efficacy against melanoma, breast cancer and prostate cancer. The non-specific BAR inhibitor propranolol has been used as the gold standard treatment in pediatric patients with benign infantile hemangioma which express high levels of beta adrenergic receptors potentially explaining their sensitively to propranolol. BAR have been shown to be expressed across a diverse panel of vascular tumors, with the highest expression in malignant vascular tumors including angiosarcoma. Several reports indicate positive results from beta-blockade in patients with moderately threatening vascular tumors. It remains to be determined if more malignant vascular tumor such as the angiosarcomas are susceptible to propranolol. Besides, due to the lack of adequate therapies for angiosarcoma (doxorubicin or paclitaxel and finally cyclophosphamide in third line) and to the poor prognosis of this rare and aggressive tumor, there is a strong need for the development of treatments against this tumor type. Recently using a panel of angiosarcoma cell lines. demonstrate that beta-adrenergic inhibition blocks cell proliferation and induces apoptosis in a dose dependent manner. Moreover, using in vivo tumor models they demonstrate that propanolol shows remarkable efficacy in reducing the growth of angiosarcoma tumors. Based on these proofs of mechanisms in vitro and in vivo and due to the well established safety propranolol in humans, investigators propose to determine among a wide range of propranolol dose (80 mg/d ; 120 mg/d and 160 mg/d) the optimal one based on bivariate efficacy-toxicity outcome in patients with angiosarcoma treated by cyclophosphamide. Because these two drugs have different pharmacological mechanisms, the aim is to determine the optimal dose of propranolol having the best systemic cardiovascular tolerability and the best potential antiangiogenic effect in addition with cyclophosphamide.


title: Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination

summary:
Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.

Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.

lead_sponsor: Fondation Lenval


title: Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer

acronym: SENTINELLE

summary: The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.


title: Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia

acronym: QUALITY

summary:
Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.

The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.

To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.

ReferenceCitation: Frederic D, Corinne R, Matthieu R, Francesca SP, Stephanie TJ, Nathalie R. The Schizophrenia Oral Health Profile: Development and Feasibility. Transl Neurosci. 2018 Sep 22;9:123-131. doi: 10.1515/tnsci-2018-0019. eCollection 2018.

family: Frederic

full_name: Denis Frederic

given: Denis

family: Corinne

full_name: Rat Corinne

given: Rat

family: Matthieu

full_name: Reynaud Matthieu

given: Reynaud

family: Francesca

full_name: Siu-Paredes Francesca

given: Siu-Paredes

family: Stephanie

full_name: Tubert-Jeannin Stephanie

given: Tubert-Jeannin

family: Nathalie

full_name: Rude Nathalie

given: Rude

currency_apc_doaj: EUR

journal_name: Translational Neuroscience

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Walter de Gruyter GmbH

publisher_dissemination: De Gruyter

publisher_group: De Gruyter

publisher_normalized: De Gruyter

title: The schizophrenia oral health profile: Development and feasibility

ReferenceCitation: Siu-Paredes F, Rude N, Rat C, Reynaud M, Hamad M, Moussa-Badran S, Denis F. The Schizophrenia Coping Oral Health Profile. Development and Feasibility. Transl Neurosci. 2018 Jun 20;9:78-87. doi: 10.1515/tnsci-2018-0014. eCollection 2018.

family: Siu-Paredes

full_name: Francesca Siu-Paredes

given: Francesca

family: Rude

full_name: Nathalie Rude

given: Nathalie

family: Rat

full_name: Corinne Rat

given: Corinne

family: Reynaud

full_name: Matthieu Reynaud

given: Matthieu

family: Hamad

full_name: Mohamad Hamad

given: Mohamad

family: Moussa-Badran

full_name: Sahar Moussa-Badran

given: Sahar

family: Denis

full_name: Frederic Denis

given: Frederic

title: The schizophrenia coping oral health profile. Development and feasibility


type: EudraCT Number

title: Study Evaluating the Optimal Dosage for Equivalence Between a Tablet and Capsule Dosage Form of an Intravaginal Treatment With Total Freeze-dried Culture of Lcr Regenerans® (Lactobacillus Rhamnosus Lcr35®) on Vaginal Flora Colonisation in Healthy Women.

acronym: COMPRIGEL

summary: The primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.

lead_sponsor: Biose


title: A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

acronym: VICTORIANE

summary: This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer without resistance to Aromatase Inhibitors (AI).


title: Implantation of the Transcatheter Aortic Prosthesis SAPIEN 3 With or Without Prior Balloon Predilatation

acronym: DIRECTAVI

summary: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

ReferenceCitation: Akodad M, Roubille F, Marin G, Lattuca B, Macia JC, Delseny D, Gandet T, Robert P, Schmutz L, Piot C, Maupas E, Robert G, Targosz F, Albat B, Cayla G, Leclercq F. Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial. J Am Heart Assoc. 2020 Dec 15;9(24):e018405. doi: 10.1161/JAHA.120.018405. Epub 2020 Dec 10.

name: Department of Cardiology Montpellier University Hospital Montpellier France

name: PhyMedExp INSERM U1046CNRS UMR 9214 Montpellier France

family: Akodad

full_name: Mariama Akodad

given: Mariama

family: Roubille

full_name: François Roubille

given: François

name: Department of Medical Information Montpellier University Hospital Montpellier France

family: Marin

full_name: Gregory Marin

given: Gregory

name: Department of Cardiology CHU NimesMontpellier University Nimes France

family: Lattuca

full_name: Benoit Lattuca

given: Benoit

family: Macia

full_name: Jean‐Christophe Macia

given: Jean‐Christophe

family: Delseny

full_name: Delphine Delseny

given: Delphine

name: Department of Cardiovascular Surgery University Hospital of Montpellier France

family: Gandet

full_name: Thomas Gandet

given: Thomas

family: Robert

full_name: Pierre Robert

given: Pierre

family: Schmutz

full_name: Laurent Schmutz

given: Laurent

family: Piot

full_name: Christophe Piot

given: Christophe

family: Maupas

full_name: Eric Maupas

given: Eric

full_name: Gabriel Robert

given: Gabriel

family: Targosz

full_name: Frederic Targosz

family: Albat

full_name: Bernard Albat

given: Bernard

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Leclercq

full_name: Florence Leclercq

given: Florence

journal_name: Journal of the American Heart Association

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

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

ReferenceCitation: Leclercq F, Robert P, Akodad M, Macia JC, Gandet T, Delseny D, Chettouh M, Schmutz L, Robert G, Levy G, Targosz F, Maupas E, Roubille F, Marin G, Nagot N, Albat B, Lattuca B, Cayla G. Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial. JACC Cardiovasc Interv. 2020 Mar 9;13(5):594-602. doi: 10.1016/j.jcin.2019.12.006.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

ReferenceCitation: Leclercq F, Robert P, Labour J, Lattuca B, Akodad M, Macia JC, Gervasoni R, Roubille F, Gandet T, Schmutz L, Nogue E, Nagot N, Albat B, Cayla G. Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial. Trials. 2017 Jul 4;18(1):303. doi: 10.1186/s13063-017-2036-y.


title: Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems

acronym: EPIC

summary: The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.

primary_purpose: Health Services Research


title: Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial

acronym: RADAR

summary:
The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the construction of hemodialysis arteriovenous fistula. In this technique, the radial artery pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of this study is to compare the safety and efficacy of this technique with the traditional end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular access in hemodialysis patients.

The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of maturation and patency.

location_facility: CHU de Nice - Service de chirurgie vasculaire


title: Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.

acronym: CONDUCT

summary: Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

location_facility: CHRU BREST, Hôpital de la Cavale Blanche