title: Analysis of Motor Skills in the Elderly: the Role of Cognitive Abilities for Imagining and Planning Movement.

acronym: Vieillissement

summary: Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. However, the impact of this cognitive decline on motor skills is still poorly understood. The purpose of this research is to study how the changes induced by aging affect motor skills. This would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition

acronym: NUTRIDREP

summary: This study is design to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74. Review.

ReferenceCitation: Weatherall DJ. The inherited diseases of hemoglobin are an emerging global health burden. Blood. 2010 Jun 3;115(22):4331-6. doi: 10.1182/blood-2010-01-251348. Epub 2010 Mar 16. Review.

ReferenceCitation: Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.

ReferenceCitation: Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.

ReferenceCitation: Odièvre MH, Verger E, Silva-Pinto AC, Elion J. Pathophysiological insights in sickle cell disease. Indian J Med Res. 2011 Oct;134:532-7. Review.

ReferenceCitation: Kanter J, Kruse-Jarres R. Management of sickle cell disease from childhood through adulthood. Blood Rev. 2013 Nov;27(6):279-87. doi: 10.1016/j.blre.2013.09.001. Epub 2013 Sep 19. Review.

ReferenceCitation: Quinn CT, Rogers ZR, McCavit TL, Buchanan GR. Improved survival of children and adolescents with sickle cell disease. Blood. 2010 Apr 29;115(17):3447-52. doi: 10.1182/blood-2009-07-233700. Epub 2010 Mar 1.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Ongoing


title: Translation and Transcultural Adaptation of the Arm Activity Measure (ArmA) and Motor Activity Log (MAL) to Assess Perceived Performance of the Upper Limb Use in Adults With Subacute and Chronic Stroke. F-ArmA

acronym: F-ArmA

summary: Upper limb impairment occurs in approximately 70 to 80 per cent of adults post stroke. These impairments will have consequences on functional performance in activities of daily living and hence quality of life. Assessment of upper limb function is a component of rehabilitation that contributes to the selection of optimal interventions according to patient individualized needs. The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance that is only available in it's English version. The aim of this study is to translate and conduct a cross-cultural adaptation of the ArmA is order to investigate its psychometric properties through a validation study among stroke patients.

status: Active, not recruiting

study_type: Observational

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


title: Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients in 2017 and 2018

summary:
Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.

Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.

The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


type: Other Identifier

title: Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor

summary:
The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist.

According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce.

The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device

summary: Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Prospective

lead_sponsor: University Hospital, Lille


title: Use of Discarded Surgery Human Tissue Specimens for Basic Science Research

acronym: HumTisRes

summary: Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.

acronym: DIASEM

summary: The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

lead_sponsor: Nantes University Hospital


title: Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department

acronym: OMA-IA

summary: Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Fondation Lenval

lead_sponsor_type: industriel


title: Assessment of Patient Preoperative Anxiety by Nurse Anesthetist

acronym: EVALANXI

summary: Preoperative anxiety is a major concern for patients who undergo surgery. To accurately identify anxious patient is therefore crucial to improve perioperative patient care. Preoperative anxiety remain highly difficult to quantify in current practice. Many patient fail to express their anxiety and the assessment of the level of anxiety is mainly based on heteroevaluation by caregivers. Nurse anesthetists provide closed support to patient prior to the induction of anesthesia. The aim of the study is to assess whether nurse anesthetist accurately assess patient preoperative anxiety from arrival to the operating room to the induction of anesthesia.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method

summary: Tinnitus and hyperacusis are two hearing disorders that can severely impact the patient and their quality of life, as they may induce sleeping disorders, concentration troubles, social life disturbances. Mayfair Developments has created and developed the innovating ØREBLUE® method in order to relieve, possibly completely, tinnitus and hyperacusis symptoms. The ØREBLUE® method relies on a medical device, CE marked, that consists of an auditory stimulation box associated with five softwares. This medical device diffuses thanks to a headphone a specific and personalized sound therapy treatment for the patient. This retrospective, observational study aims at collecting data about the ØREBLUE® method used in routine care and describing its efficacy on tinnitus and hyperacusis.

lead_sponsor: Mayfair Developments

intervention_type: Device


title: Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years)

summary:
Overall the issue of patients above 65-70 years of age being that it is impossible for most of them to undergo an intensive treatment like autologous stem cell transplant with little prospect of debulking effectively the bone marrow with chemotherapy, and also few possibilities to harass the bone microenvironment in the tumoral niche.

If, advanced age in frail patients is predictive of an increased risk of treatment-related toxicity, there is a growing number of elderly patients in regards to transplantation, but still fit if one considers the objectives of life characterized with prolonged survival. These patients might have the same treatment as to the transplant eligible, but without the transplant procedure. The development of immunotherapy has transformed the treatment landscape of cancer, particularly in MM, increasing the treatment possibilities with possibly fewer adverse events.

The therapeutic strategy and treatment options for NTE patients moved from melphalan-based induction regimens to lenalidomide-based associations, which is now the backbone of most treatment for NTE patients. Even though the latest melphalan, bortezomib and prednisone (MPV) association was considered somewhat effective it was not so well tolerated. Furthermore, MPV hardly prolonged PFS beyond 2 years. It was recently improved with the addition of Daratumumab, first in class anti CD38 Mab in the phase III ALCYONE.

The association lenalidomide and dexamethasone (Rd) has significantly improved the easiness of treating the NTE population and all drugs seem to be possible to combine to Rd. In that extent, proteasome inhibitors have always been one of the most impactful family of agents in MM, and as expected Bortezomib plus Rd has become a very relevant and commonly used regimen in NTE NDMM. These groundbreaking results have favored the development of 2 randomized phase 3 studies for registration of combination of antiCD38Mab (Daratumumab (Cepheus, NCT03652064), Isatuximab (Imroz, NCT03319667) +Rd +Velcade in comparison to VRd. Both studies have used as a comparator the VRd regimen which is today one of the safest, active and popular triplet based Rd regimen, approved, and therefore the best control arm possibly for these studies.

However, as much as there has been no direct head to head comparison of VRd to Dara Rd, when looking at the data from Maia it is anticipated that DRd will become a standard of care, and might challenge strongly VRd. Yet, multiple questions remain still, anticipating the change in backbone from VRd to antiCD38 +Rd becoming the new standard of care for NTE NDMM patients. The investigators have therefore planned to answer the critical question of the role of proteasome inhibitors in NTE non frail NDMM when considering anti CD38 +Rd as the backbone.

lead_sponsor: Poitiers University Hospital

intervention_type: Drug


title: Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

acronym: JAK-SARC

summary: Recent studies suggest that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis. Further investigations are necessary to identify the most suitable patients to receive treatment targeting this pathway, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines.

ReferenceCitation: Rotenberg C, Besnard V, Brillet PY, Giraudier S, Nunes H, Valeyre D. Dramatic response of refractory sarcoidosis under ruxolitinib in a patient with associated JAK2-mutated polycythemia. Eur Respir J. 2018 Dec 20;52(6). pii: 1801482. doi: 10.1183/13993003.01482-2018. Print 2018 Dec.


title: RFID Trial: Breast Localization: RFID Tags vs Wire Localization

acronym: RFID

summary: The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.

lead_sponsor: Centre Jean Perrin


title: Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients

acronym: EPKIVA

summary:
An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency.

As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations.

Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.

summary: Transillumination (TL) is a noninvasive technique that appears to allow preliminary detection of superficial vascular structures of the face to avoid intravascular HA injection. The purpose of our study was to test the efficacy of TL in terms of its sensitivity to locate vessels in the areas undergoing treatment and to reduce post-injection vascular complications.

primary_purpose: Prevention

lead_sponsor: Helynck, Patrick, M.D.


title: Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

acronym: ARTHe 2

summary:
Osteoarthritis is the most common joint disease affecting the joint in a comprehensive and progressive manner. It leads to increasing disability.

The recommendations of recent years favor the non-pharmacological treatment of osteoarthritis including regular physical activity, therapeutic education and weight loss Osteoarthritis population has a low level of physical activity due to a lack of information, motivation and false beliefs related to physical activity and kinesiophobia (fear of movement) A preliminary qualitative study (ARTHe1) evaluating the barriers and levers of the use of an e-health therapeutic education application in patients with osteoarthritis was carried out in order to guide the development of the ARTHe application.

The objective of this study is to have the application tested on a panel of patients in order to assess the benefits of using the application in terms of adherence to the practice of physical activity but also in clinical terms on function and pain, and the satisfaction of the patient

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control

acronym: SPIRALE

summary:
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.

The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.

Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Study of Leukocyte Populations in Patients With Chronic Inflammatory

acronym: LIMA

summary: Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.


title: Management of Constitutional Thinness Through an Adapted Physical Activity Program, Whether or Not Associated With Food Supplementation. Interventional Study Compared to Matched Controls: NUTRILEAN + Study

acronym: NUTRILEAN +

summary: The main aim of the present study is to compare the effect of a 12-week physical activity program on body weight gain and body composition changes between normal weight and constitutionally lean individuals. The second objective will be to question the potential additional effect of a protein supplementation coupled to the physical training intervention on body wright and body composition in constitutionally lean women.


title: Factors Associated With Quality of Life in Patients With Alcohol Use Disorder

acronym: QUALIFACT

summary: The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

lead_sponsor: Hôpital le Vinatier


title: Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility: an Open Label Prospective Randomized Study

acronym: HyperBetashock

summary:
Several data emphasize the relation between tachycardia (>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock.

Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.


title: Access to Kidney Transplant of Obese Patients Beginning Dialysis

acronym: Transplantob

summary: Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.


type: Registry Identifier

title: Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports

acronym: PARAPERF

summary:
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.

The secondary objectives of the study:

quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
quantification and mechanical monitoring by the made-to-measure or usual sportive material.

location_facility: Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP


title: Assessment of Prevalence and Prognostic Value of Acute Myocardial Dysfunction in Severe Trauma Patients With Chest Trauma Using 2D-strain Ultrasound: A Prospective Observational Study

acronym: Strainy trauma

summary:
This study aims to investigate whether the identification of acute myocardial dysfunction by 2D-strain transthoracic sonography in the first week following trauma would allow to better diagnose occult and severe patterns of myocardial contusion, in order to identify a subpopulation at higher risk of complications.

The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.

The investigators strongly suppose that the 2D-strain would allow to better identify subclinical MC in chest trauma, as well as the severe patterns that are associated with more organs dysfunctions and a worst outcome.


title: Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

acronym: COVIPACT 2

summary:
In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.

lead_sponsor: Centre Francois Baclesse


title: Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis Preliminary Study

acronym: CYSTALTERNA

summary:
Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis.

The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem.

several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances.

There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years.

The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities.

Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Combination Product


title: Impact of Exercise and Nutritional Support on the Frailty Syndrome of Eldery Patients in Phase of Post-cancer Treatment

acronym: PANACEE

summary: Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.

lead_sponsor: University Hospital, Grenoble


title: Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

acronym: ReLoT-TCCL

summary:
Mild traumatic brain injury (mTBI) accounts for 70-90% of brain injuries, with 600 cases of mTBI per 100 000 people in the united states, but only 100-300 mTBI patients per 100 000 people receive hospital-based care. Symptoms reported immediately after injury tend to diminish over the following 10 days and are generally resolved by 3 months. However, in 15-25% of cases , problems persist, and may even worsen, at 3 months. Physical, emotional, and behavioral factors can be affected. Physical disorders include pain and fatigue. Sleep disorders are also common. Persistent symptoms can affect patient outcomes (affecting all aspects of life) and increase public healthcare costs .In a previous study (NCT03811626, Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. The investigators were able to demonstrate that early multidisciplinary management improved the outcome and prognosis of patients by statistically significantly reducing the percentage of patients with Post traumatic syndrome distress at six months (6% for the treated group versus 52% for the control group, p < 0.001).

It seems important to verify that if this short-term improvement (6 months after the trauma) persists in the long term, and therefore at a distance from the end of the initially proposed rehabilitation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

acronym: PACHIBA

summary:
The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.

Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.

To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

intervention_type: Radiation


title: Evaluation of the Diagnostic Performances of the TEG 6s® Hemostasis Device and Its Platelet Mapping® Cartridge for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

acronym: TEG-PM

summary: Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

status: Terminated

location_facility: Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière

status_simplified: Unknown


title: Cohort SURVI : Intestinal Ischemia and Vascular Diseases

acronym: Survibase

summary:
The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%.

Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors.

Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient.

The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described.

The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

time_perspective: Other

ipd_sharing: Yes


title: Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study

summary:
Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.

The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.

lead_sponsor: University Hospital, Montpellier


title: Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

acronym: SCLERO-PRL

summary: Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin

lead_sponsor: University Hospital, Lille

intervention_type: Biological


title: First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects

summary: This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

lead_sponsor: Chong Kun Dang Pharmaceutical


title: Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand

acronym: FACEHAND

summary: The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier du Sud - Hôpital Henry Gabrielle

intervention_type: Procedure


title: Acupuncture Effect on the Rate of Maturation in Post Term Pregnancies.

acronym: MATUPUNCTURE

summary:
Brief Summary Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters)

Example: The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED). The first purpose of this randomized study is to determine if five points of acupuncture : 4GI, 6RP, 34VB, 36E, 3F could improve the bishop score for prolonged pregnancies and decrease the rate of maturation.

The protocol of our study consists of proposing to the pregnant women one or two acupuncture sessions the term's day and three days later. Once the consent is signed, women are randomly included in the experimental or placebo arm. In the experimental arm, midwives puncture five points : 4GI, 6 RP, 34VB, 36E, 3F on each side while in the placebo arm, they puncture just one point : 16 HM on each side.

The maturation's rate between the two groups will be compared by a Fisher's exact test and analyzed in function parity (nulliparous or multiparous) and number of sessions (one or two) with a model of univariate and multivariate logistic regression.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19

acronym: Oursyn

summary: Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne

intervention_type: Diagnostic Test


title: Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

acronym: VASC-UC

summary: An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)

acronym: OTEMACS

summary: Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.


title: ARIADE : Augmented Reality for Improving Autonomy in Dementia. Creation, Implementation and Testing of an Augmented Reality Tool to Help People With Alzheimer's Type Dementia in Their Travels.

acronym: ARIADE

summary:
Navigating according to a specific goal is a common activity of everyday life. Spatial navigation requires the implementation of motor and perceptual functions (sight, walking, proprioception), but also various cognitive functions (executive functions, memory, spatial orientation skills). Many people affected by a neurodegenerative disease have topographical difficulties which have a major impact on their autonomy in daily life, by gradually limiting their movements outside their home, then inside their home, and which are the main factor leading to the institutionalization of this population. People with dementia or MCI (Mild Cognitive Impairment) of the Alzheimer type, according to the definition of the NIAA (National Institute on Aging-Alzheimer's Association) have navigation and spatial memory disorders, with difficulty in acquiring mental spatial representations of their environment. These topographical difficulties have been shown to be related to the reduction in volume of the temporal cortex, in particular the hippocampal regions, as well as to atrophy of the retrosplenial cortex.

Augmented Reality (AR), often defined as an intermediary between the totally artificial world of VR and the real world in which we operate, makes it possible in particular to add summary information to the natural environment in which a participant operates. Even if, in particular in outside environment, AR must solve many challenges, such as the integration of the real and virtual worlds in real time, the selection of the modalities of restitution of information, its use is exponential in the medical field, in particular in surgery for the assistance of the practitioner, but also in the field of sensory substitution, in particular to facilitate the movements of people with visual impairment. Other works focused in helping people with dementia of the Alzheimer type, such as those of Quintana and Favela (2012) who proposed preliminary systems of annotations in AR. Hervás et al. were the first in 2014 to test the use of augmented reality to provide navigation assistance to people with dementia. In 2017, Firouzian et al. as well as Sejunaite et al. implemented related systems. Firouzian et al. have developed spectacle frames comprising around ten LED lights in order to provide directional indications to people who moved outdoor. However, the influence of this system on navigation performance has not been tested yet. On the other hand, although simple to develop, this system requires training on the part of the users and only makes it possible to provide directional information, which is not recommended for the implementation of a tool for this population. Finally, Sejunaite et al. used an environmentally tested smart glasses to allow users to display information in the form of a map to help older people navigate independently. However, the literature review indicates that even increased card use does not seem to be suitable for people with dementia or Alzheimer's-type MCI. Finally, these two tools do not allow navigational information to be co-located in the field of vision of people, which represents one of the major advantages of augmented reality. To our knowledge, there is not yet an AR device providing co-located information in the environment dedicated to outdoor navigation of people with dementia or Alzheimer's type MCI.

lead_sponsor: Rennes University Hospital


title: Comparison of the Effects of 2 Therapeutic Plasmapheresis Techniques: Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). A Monocentric Prospective Study With a Single-Case Experimental Design

acronym: LYMPHOARESIS

summary: CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis

acronym: Aticks Live

summary: Anticoagulants influence either coagulation, inflammation and inflammatory processes in deep vein thrombosis (DVT). Acute DVT cause an inflammatory response that may persist for a long period of time. There is a need to describe patterns of change in serum biomarker levels after acute DVT, and explore the association between trajectory biological patterns and clinical evolution in the era of various anticoagulants in the acute phase of treatment in order to be able to further avoid recurrence and late sequelae. It appears that direct oral anticoagulants and heparin alter inflammatory markers in different ways. It is therefore important to study the evolution of markers according to the different treatments used and secondarily to compare them with each other. Tinzaparin is used in the long term in patients with DVT, it is necessary to measure the evolution of inflammatory markers and then in another study to compare with the other molecules.


title: A Randomised, Comparative, Prospective, Multicentre Study of the Efficacy of Nivolumab + Ipilimumab Versus Pazopanib Alone in Patients With Metastatic or Unresectable Advanced Sarcoma of Rare Subtype (RAR-Immune)

acronym: RAR-Immune

summary:
This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator.

In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 12 months, whereas in the control arm, patients will receive Pazopanib alone for 12 months.

The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.

lead_sponsor: Centre Leon Berard


title: Transverse Fractures +/- Posterior Wall of the Acetabulum: Predictors of the Quality of Surgical Reduction and Long-term Outcome

summary:
Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge.

In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. However, this reduction must be a major priority since it is one of the factors conditioning the functional result.

In our study, we wish to analyze a particular type of fracture, less studied, or with small series, that are the transverse fractures (+/- posterior wall), known for their difficulty of reduction. The reduction is even greater as the fracture line often passes through the acetabular bearing zone, compromising the functional prognosis.

The choice of surgical approach for this type of fracture is controversial. More and more, a single approach, usually posterior, without compulsory fixation of the anterior component of the transverse fracture is preferred over the traditional double approach anterior and posterior, and this in particular to reduce the morbidity of this surgery.

But this one-size-fits-all approach does not always achieve a good reduction and it is believed that the time to surgery may play a role.

If it is accepted that the surgical delay before reduction in osteosynthesis of an acetabular fracture is involved in the quality of the reduction and therefore the functional result in these patients, the question asked is whether this delay should condition the choice of a double approach, anterior and posterior, for this type of fracture (transverse +/- posterior wall).

Indeed, with increasing surgical time, the risk of scar tissue formation and early callus increases, making bone fragments less mobile, reduction more difficult and indirect reduction techniques (which are used when single approach is chosen) less efficient.

In addition, most of the studies evaluating the quality of reduction of acetabular fractures use a radiographic score, that of Matta.

However, it has been shown that the CT scan was more efficient than the x-rays in detecting a residual displacement of the fracture. Also, in this study, we want to analyze the quality of reduction thanks to the scanner, which is rarely done in the literature.

This work aims to determine the predictive factors of the quality of reduction of transverse fractures +/- posterior wall of the acetabulum, evaluated on the postoperative CT scan.

ReferenceType: result

ReferenceCitation: Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.

ReferenceCitation: Madhu R, Kotnis R, Al-Mousawi A, Barlow N, Deo S, Worlock P, Willett K. Outcome of surgery for reconstruction of fractures of the acetabulum. The time dependent effect of delay. J Bone Joint Surg Br. 2006 Sep;88(9):1197-203.

ReferenceCitation: Giordano V, do Amaral NP, Pallottino A, Pires e Albuquerque R, Franklin CE, Labronici PJ. Operative treatment of transverse acetabular fractures: is it really necessary to fix both columns? Int J Med Sci. 2009 Jul 12;6(4):192-9.

ReferenceCitation: Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.

family: Verbeek

full_name: Diederik O. Verbeek

given: Diederik O.

sequence: first

family: van der List

full_name: Jelle P. van der List

given: Jelle P.

sequence: additional

family: Villa

full_name: Jordan C. Villa

given: Jordan C.

family: Wellman

full_name: David S. Wellman

given: David S.

family: Helfet

full_name: David L. Helfet

given: David L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Bone and Joint Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN

summary:
Highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on DLM.

Search for a link between asymmetric bending defect and posterior shift in MCA-type DLM.

Analysis of all patients with symptomatic DLM.

location_facility: Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)


title: Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

acronym: EUTACAM

summary:
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.

200 patients will be included in the study.

Each patient will be followed for one day.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Interest of Systematic PPI Therapy After POEM vs Symptomatic Use of PPI Therapy in Prevention of Gastroesophageal Reflux Disease After POEM for Esophageal Achalasia. A Comparative Retrospective Analysis.

acronym: IPPOEM-Retro

summary:
POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD.

The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.

ipd_sharing_description: nc


title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.

summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Therapeutic Benefit of Rehabilitation With Computerized Mirror Therapy for Patients Suffering From Motor Neurological Disorder (FND) of the Upper Limb.

acronym: FND-mirror

summary:
Motor functional neurological disorders (FND) correspond to motor symptoms that are unexplained by an organic lesion but are due to cerebral dysfunction. Patients with these disorders have high rates of disability and health care utilization, and their quality of life is as impaired as that of patients with an "organic" disease. Accompanying these patients in their often-complex health journey represents a socio-economic and human challenge that demands interdisciplinary collaboration. Rehabilitation is seen as an important part of the therapy for motor FND. However, further research is needed to refine appropriate interventions and to create evidence-based recommendations. In this study, patients suffering from a functional neurological motor disorder of the upper limb will be included in a novel rehabilitation protocol that includes computerized mirror therapy. The study will used a multiple baseline, across subjects, single-case experimental design (SCED). In this type of design, each subject is his own control, with individual parameters being repeatedly measured in the presence and absence of the intervention of interest (computerized mirror therapy). Computerized mirror therapy could restore the coherence between the motor program and its execution. The investigators hypothesize that this process could re-normalize upper-limb motor activity and that this will have a beneficial impact on manual dexterity, quality of life, and mental representation capacities of the upper limb.

The objective of this project is to use the single case experimental design method to investigate the efficacy of rehabilitation with computerized mirror therapy for patients suffering from motor neurological disorders (FND) of the upper limb.

location_facility: Hôpital Henry Gabrielle - Hospices Civils de Lyon


title: ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology

acronym: ARTHEMIRS

summary: The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.

ReferenceCitation: Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6.

ReferenceCitation: Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.

ReferenceCitation: Bai Z, Fong KNK, Zhang J, Hu Z. Cortical mapping of mirror visual feedback training for unilateral upper extremity: A functional near-infrared spectroscopy study. Brain Behav. 2020 Jan;10(1):e01489. doi: 10.1002/brb3.1489. Epub 2019 Dec 5.

ReferenceCitation: Brunetti M, Morkisch N, Fritzsch C, Mehnert J, Steinbrink J, Niedeggen M, Dohle C. Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study. Restor Neurol Neurosci. 2015;33(4):421-34. doi: 10.3233/RNN-140421.

ReferenceCitation: Calautti C, Jones PS, Naccarato M, Sharma N, Day DJ, Bullmore ET, Warburton EA, Baron JC. The relationship between motor deficit and primary motor cortex hemispheric activation balance after stroke: longitudinal fMRI study. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):788-92. doi: 10.1136/jnnp.2009.190512. Epub 2010 Apr 14.

ReferenceCitation: Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.

ReferenceCitation: Darbois N, Guillaud A, Pinsault N. Do Robotics and Virtual Reality Add Real Progress to Mirror Therapy Rehabilitation? A Scoping Review. Rehabil Res Pract. 2018 Aug 19;2018:6412318. doi: 10.1155/2018/6412318. eCollection 2018. Review.

ReferenceCitation: Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28. Review.

ReferenceCitation: Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11.

ReferenceCitation: Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.

ReferenceCitation: Inagaki Y, Seki K, Makino H, Matsuo Y, Miyamoto T, Ikoma K. Exploring Hemodynamic Responses Using Mirror Visual Feedback With Electromyogram-Triggered Stimulation and Functional Near-Infrared Spectroscopy. Front Hum Neurosci. 2019 Feb 26;13:60. doi: 10.3389/fnhum.2019.00060. eCollection 2019.

ReferenceCitation: Jihun Kim, Jaehyo Kim. Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:4243-4246. doi: 10.1109/EMBC.2017.8037793.

ReferenceCitation: Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. Epub 2003 Aug 7.

ReferenceCitation: Lee HM, Li PC, Fan SC. Delayed mirror visual feedback presented using a novel mirror therapy system enhances cortical activation in healthy adults. J Neuroeng Rehabil. 2015 Jul 11;12:56. doi: 10.1186/s12984-015-0053-1.

ReferenceCitation: Li YC, Wu CY, Hsieh YW, Lin KC, Yao G, Chen CL, Lee YY. The Priming Effects of Mirror Visual Feedback on Bilateral Task Practice: A Randomized Controlled Study. Occup Ther Int. 2019 Nov 26;2019:3180306. doi: 10.1155/2019/3180306. eCollection 2019.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database : CovPCR

acronym: CovPCR

summary: Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.


title: Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee

acronym: EVAPURGEL

summary: This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).

lead_sponsor: Marco Pacchioni


title: Study of the Influence of Proprioceptive Reweighting Ability on the Lower-extremity Biomechanics During Functional Tasks and Unplanned Sidestep Cutting Manoeuvre

acronym: NEURIBIO

summary:
Anterior cruciate ligament (ACL) injuries are frequent in handball especially among young players. Recent investigations highlighted the implication of the central nervous system as a potential risk factor for ACL rupture.

The ability to dynamically reweight proprioceptive signals according to postural conditions is crucial for balance control.

The aim of this study is therefore to investigate the influence of proprioceptive reweighting on biomechanical determinants of ACL loads during functional tasks and unplanned side cutting manoeuvers.

ReferenceCitation: Strand T, Tvedte R, Engebretsen L, Tegnander A. [Anterior cruciate ligament injuries in handball playing. Mechanisms and incidence of injuries]. Tidsskr Nor Laegeforen. 1990 Jun 30;110(17):2222-5. Norwegian.

ReferenceCitation: Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. Epub 2006 Apr 17.

ReferenceCitation: Giroto N, Hespanhol Junior LC, Gomes MR, Lopes AD. Incidence and risk factors of injuries in Brazilian elite handball players: A prospective cohort study. Scand J Med Sci Sports. 2017 Feb;27(2):195-202. doi: 10.1111/sms.12636. Epub 2015 Dec 10.

ReferenceCitation: Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12.

ReferenceCitation: Petersen W, Braun C, Bock W, Schmidt K, Weimann A, Drescher W, Eiling E, Stange R, Fuchs T, Hedderich J, Zantop T. A controlled prospective case control study of a prevention training program in female team handball players: the German experience. Arch Orthop Trauma Surg. 2005 Nov;125(9):614-21.

ReferenceCitation: Boden BP, Torg JS, Knowles SB, Hewett TE. Video analysis of anterior cruciate ligament injury: abnormalities in hip and ankle kinematics. Am J Sports Med. 2009 Feb;37(2):252-9. doi: 10.1177/0363546508328107.

ReferenceCitation: Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1.

ReferenceCitation: Krosshaug T, Slauterbeck JR, Engebretsen L, Bahr R. Biomechanical analysis of anterior cruciate ligament injury mechanisms: three-dimensional motion reconstruction from video sequences. Scand J Med Sci Sports. 2007 Oct;17(5):508-19. Epub 2006 Dec 20.

ReferenceCitation: Prodromos CC, Han Y, Rogowski J, Joyce B, Shi K. A meta-analysis of the incidence of anterior cruciate ligament tears as a function of gender, sport, and a knee injury-reduction regimen. Arthroscopy. 2007 Dec;23(12):1320-1325.e6. Review.

ReferenceCitation: Rizzo M, Holler SB, Bassett FH 3rd. Comparison of males' and females' ratios of anterior-cruciate-ligament width to femoral-intercondylar-notch width: a cadaveric study. Am J Orthop (Belle Mead NJ). 2001 Aug;30(8):660-4.

ReferenceCitation: Zeng C, Gao SG, Wei J, Yang TB, Cheng L, Luo W, Tu M, Xie Q, Hu Z, Liu PF, Li H, Yang T, Zhou B, Lei GH. The influence of the intercondylar notch dimensions on injury of the anterior cruciate ligament: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2013 Apr;21(4):804-15. doi: 10.1007/s00167-012-2166-4. Epub 2012 Aug 15. Review.

ReferenceCitation: Chaudhari AM, Lindenfeld TN, Andriacchi TP, Hewett TE, Riccobene J, Myer GD, Noyes FR. Knee and hip loading patterns at different phases in the menstrual cycle: implications for the gender difference in anterior cruciate ligament injury rates. Am J Sports Med. 2007 May;35(5):793-800. Epub 2007 Feb 16.

ReferenceCitation: Hewett TE, Zazulak BT, Myer GD. Effects of the menstrual cycle on anterior cruciate ligament injury risk: a systematic review. Am J Sports Med. 2007 Apr;35(4):659-68. Epub 2007 Feb 9. Review.

ReferenceCitation: Wojtys EM, Huston LJ, Boynton MD, Spindler KP, Lindenfeld TN. The effect of the menstrual cycle on anterior cruciate ligament injuries in women as determined by hormone levels. Am J Sports Med. 2002 Mar-Apr;30(2):182-8.

ReferenceCitation: Hewett TE, Webster KE, Hurd WJ. Systematic Selection of Key Logistic Regression Variables for Risk Prediction Analyses: A Five-Factor Maximum Model. Clin J Sport Med. 2019 Jan;29(1):78-85. doi: 10.1097/JSM.0000000000000486. Review.

ReferenceCitation: Pappas E, Shiyko MP, Ford KR, Myer GD, Hewett TE. Biomechanical Deficit Profiles Associated with ACL Injury Risk in Female Athletes. Med Sci Sports Exerc. 2016 Jan;48(1):107-13. doi: 10.1249/MSS.0000000000000750.

ReferenceCitation: Arundale AJH, Bizzini M, Giordano A, Hewett TE, Logerstedt DS, Mandelbaum B, Scalzitti DA, Silvers-Granelli H, Snyder-Mackler L. Exercise-Based Knee and Anterior Cruciate Ligament Injury Prevention. J Orthop Sports Phys Ther. 2018 Sep;48(9):A1-A42. doi: 10.2519/jospt.2018.0303.

ReferenceCitation: Taylor JB, Waxman JP, Richter SJ, Shultz SJ. Evaluation of the effectiveness of anterior cruciate ligament injury prevention programme training components: a systematic review and meta-analysis. Br J Sports Med. 2015 Jan;49(2):79-87. doi: 10.1136/bjsports-2013-092358. Epub 2013 Aug 6. Review.

ReferenceCitation: Yoo JH, Lim BO, Ha M, Lee SW, Oh SJ, Lee YS, Kim JG. A meta-analysis of the effect of neuromuscular training on the prevention of the anterior cruciate ligament injury in female athletes. Knee Surg Sports Traumatol Arthrosc. 2010 Jun;18(6):824-30. doi: 10.1007/s00167-009-0901-2. Epub 2009 Sep 4.

ReferenceCitation: Grimm NL, Jacobs JC Jr, Kim J, Denney BS, Shea KG. Anterior Cruciate Ligament and Knee Injury Prevention Programs for Soccer Players: A Systematic Review and Meta-analysis. Am J Sports Med. 2015 Aug;43(8):2049-56. doi: 10.1177/0363546514556737. Epub 2014 Dec 1. Review.

ReferenceCitation: Stevenson JH, Beattie CS, Schwartz JB, Busconi BD. Assessing the effectiveness of neuromuscular training programs in reducing the incidence of anterior cruciate ligament injuries in female athletes: a systematic review. Am J Sports Med. 2015 Feb;43(2):482-90. doi: 10.1177/0363546514523388. Epub 2014 Feb 25. Review.

ReferenceCitation: Taylor JB, Ford KR, Schmitz RJ, Ross SE, Ackerman TA, Shultz SJ. Sport-specific biomechanical responses to an ACL injury prevention programme: A randomised controlled trial. J Sports Sci. 2018 Nov;36(21):2492-2501. doi: 10.1080/02640414.2018.1465723. Epub 2018 Apr 19.

ReferenceCitation: Neto T, Sayer T, Theisen D, Mierau A. Functional Brain Plasticity Associated with ACL Injury: A Scoping Review of Current Evidence. Neural Plast. 2019 Dec 27;2019:3480512. doi: 10.1155/2019/3480512. eCollection 2019. Review.

ReferenceCitation: Shultz SJ, Schmitz RJ, Cameron KL, Ford KR, Grooms DR, Lepley LK, Myer GD, Pietrosimone B. Anterior Cruciate Ligament Research Retreat VIII Summary Statement: An Update on Injury Risk Identification and Prevention Across the Anterior Cruciate Ligament Injury Continuum, March 14-16, 2019, Greensboro, NC. J Athl Train. 2019 Sep;54(9):970-984. doi: 10.4085/1062-6050-54.084. Epub 2019 Aug 28.

ReferenceCitation: Fox AS, Bonacci J, McLean SG, Spittle M, Saunders N. What is normal? Female lower limb kinematic profiles during athletic tasks used to examine anterior cruciate ligament injury risk: a systematic review. Sports Med. 2014 Jun;44(6):815-32. doi: 10.1007/s40279-014-0168-8. Review.

ReferenceCitation: Kristianslund E, Faul O, Bahr R, Myklebust G, Krosshaug T. Sidestep cutting technique and knee abduction loading: implications for ACL prevention exercises. Br J Sports Med. 2014 May;48(9):779-83. doi: 10.1136/bjsports-2012-091370. Epub 2012 Dec 20.

ReferenceCitation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. Epub 2005 Feb 8.

ReferenceCitation: Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337. Review.

ReferenceCitation: Dingenen B, Malfait B, Nijs S, Peers KH, Vereecken S, Verschueren SM, Staes FF. Can two-dimensional video analysis during single-leg drop vertical jumps help identify non-contact knee injury risk? A one-year prospective study. Clin Biomech (Bristol, Avon). 2015 Oct;30(8):781-7. doi: 10.1016/j.clinbiomech.2015.06.013. Epub 2015 Jun 26.

ReferenceCitation: Imwalle LE, Myer GD, Ford KR, Hewett TE. Relationship between hip and knee kinematics in athletic women during cutting maneuvers: a possible link to noncontact anterior cruciate ligament injury and prevention. J Strength Cond Res. 2009 Nov;23(8):2223-30. doi: 10.1519/JSC.0b013e3181bc1a02.

ReferenceCitation: Numata H, Nakase J, Kitaoka K, Shima Y, Oshima T, Takata Y, Shimozaki K, Tsuchiya H. Two-dimensional motion analysis of dynamic knee valgus identifies female high school athletes at risk of non-contact anterior cruciate ligament injury. Knee Surg Sports Traumatol Arthrosc. 2018 Feb;26(2):442-447. doi: 10.1007/s00167-017-4681-9. Epub 2017 Aug 24.

ReferenceCitation: Dempsey AR, Lloyd DG, Elliott BC, Steele JR, Munro BJ, Russo KA. The effect of technique change on knee loads during sidestep cutting. Med Sci Sports Exerc. 2007 Oct;39(10):1765-73.

ReferenceCitation: Sigward SM, Powers CM. Loading characteristics of females exhibiting excessive valgus moments during cutting. Clin Biomech (Bristol, Avon). 2007 Aug;22(7):827-33. Epub 2007 May 24.

ReferenceCitation: Hewett TE, Myer GD. The mechanistic connection between the trunk, hip, knee, and anterior cruciate ligament injury. Exerc Sport Sci Rev. 2011 Oct;39(4):161-6. doi: 10.1097/JES.0b013e3182297439.

ReferenceCitation: Ford KR, Shapiro R, Myer GD, Van Den Bogert AJ, Hewett TE. Longitudinal sex differences during landing in knee abduction in young athletes. Med Sci Sports Exerc. 2010 Oct;42(10):1923-31. doi: 10.1249/MSS.0b013e3181dc99b1.

ReferenceCitation: Pollard CD, Sigward SM, Powers CM. Limited hip and knee flexion during landing is associated with increased frontal plane knee motion and moments. Clin Biomech (Bristol, Avon). 2010 Feb;25(2):142-6. doi: 10.1016/j.clinbiomech.2009.10.005. Epub 2009 Nov 13.

ReferenceCitation: Lawrence RK 3rd, Kernozek TW, Miller EJ, Torry MR, Reuteman P. Influences of hip external rotation strength on knee mechanics during single-leg drop landings in females. Clin Biomech (Bristol, Avon). 2008 Jul;23(6):806-13. doi: 10.1016/j.clinbiomech.2008.02.009. Epub 2008 Apr 18.

ReferenceCitation: Nguyen AD, Taylor JB, Wimbish TG, Keith JL, Ford KR. Preferred Hip Strategy During Landing Reduces Knee Abduction Moment in Collegiate Female Soccer Players. J Sport Rehabil. 2018 May 1;27(3):213-217. doi: 10.1123/jsr.2016-0026. Epub 2018 Apr 23.

ReferenceCitation: Sigward SM, Pollard CD, Havens KL, Powers CM. Influence of sex and maturation on knee mechanics during side-step cutting. Med Sci Sports Exerc. 2012 Aug;44(8):1497-503. doi: 10.1249/MSS.0b013e31824e8813.

ReferenceCitation: Stearns KM, Keim RG, Powers CM. Influence of relative hip and knee extensor muscle strength on landing biomechanics. Med Sci Sports Exerc. 2013 May;45(5):935-41. doi: 10.1249/MSS.0b013e31827c0b94.

ReferenceCitation: Zazulak BT, Hewett TE, Reeves NP, Goldberg B, Cholewicki J. Deficits in neuromuscular control of the trunk predict knee injury risk: a prospective biomechanical-epidemiologic study. Am J Sports Med. 2007 Jul;35(7):1123-30. Epub 2007 Apr 27.

ReferenceCitation: Zazulak BT, Hewett TE, Reeves NP, Goldberg B, Cholewicki J. The effects of core proprioception on knee injury: a prospective biomechanical-epidemiological study. Am J Sports Med. 2007 Mar;35(3):368-73. Epub 2007 Jan 31.

ReferenceCitation: Decker MJ, Torry MR, Wyland DJ, Sterett WI, Richard Steadman J. Gender differences in lower extremity kinematics, kinetics and energy absorption during landing. Clin Biomech (Bristol, Avon). 2003 Aug;18(7):662-9.

ReferenceCitation: Hewett TE, Ford KR, Xu YY, Khoury J, Myer GD. Utilization of ACL Injury Biomechanical and Neuromuscular Risk Profile Analysis to Determine the Effectiveness of Neuromuscular Training. Am J Sports Med. 2016 Dec;44(12):3146-3151. Epub 2016 Jul 29.

ReferenceCitation: Griffin LY, Agel J, Albohm MJ, Arendt EA, Dick RW, Garrett WE, Garrick JG, Hewett TE, Huston L, Ireland ML, Johnson RJ, Kibler WB, Lephart S, Lewis JL, Lindenfeld TN, Mandelbaum BR, Marchak P, Teitz CC, Wojtys EM. Noncontact anterior cruciate ligament injuries: risk factors and prevention strategies. J Am Acad Orthop Surg. 2000 May-Jun;8(3):141-50. Review.

ReferenceCitation: Mendiguchia J, Ford KR, Quatman CE, Alentorn-Geli E, Hewett TE. Sex differences in proximal control of the knee joint. Sports Med. 2011 Jul 1;41(7):541-57. doi: 10.2165/11589140-000000000-00000. Review.

ReferenceCitation: Myer GD, Brent JL, Ford KR, Hewett TE. A pilot study to determine the effect of trunk and hip focused neuromuscular training on hip and knee isokinetic strength. Br J Sports Med. 2008 Jul;42(7):614-9. doi: 10.1136/bjsm.2007.046086. Epub 2008 Feb 28.

ReferenceCitation: Bonnette S, Diekfuss JA, Grooms DR, Kiefer AW, Riley MA, Riehm C, Moore C, Barber Foss KD, DiCesare CA, Baumeister J, Myer GD. Electrocortical dynamics differentiate athletes exhibiting low- and high- ACL injury risk biomechanics. Psychophysiology. 2020 Apr;57(4):e13530. doi: 10.1111/psyp.13530. Epub 2020 Jan 20.

ReferenceCitation: Swanik CB. Brains and Sprains: The Brain's Role in Noncontact Anterior Cruciate Ligament Injuries. J Athl Train. 2015 Oct;50(10):1100-2. doi: 10.4085/1062-6050-50.10.08. Epub 2015 Sep 4. Review.

ReferenceCitation: Grooms DR, Page SJ, Nichols-Larsen DS, Chaudhari AM, White SE, Onate JA. Neuroplasticity Associated With Anterior Cruciate Ligament Reconstruction. J Orthop Sports Phys Ther. 2017 Mar;47(3):180-189. doi: 10.2519/jospt.2017.7003. Epub 2016 Nov 5.

ReferenceCitation: Needle AR, Lepley AS, Grooms DR. Central Nervous System Adaptation After Ligamentous Injury: a Summary of Theories, Evidence, and Clinical Interpretation. Sports Med. 2017 Jul;47(7):1271-1288. doi: 10.1007/s40279-016-0666-y. Review.

ReferenceCitation: Swanik CB, Covassin T, Stearne DJ, Schatz P. The relationship between neurocognitive function and noncontact anterior cruciate ligament injuries. Am J Sports Med. 2007 Jun;35(6):943-8. Epub 2007 Mar 16.

ReferenceCitation: Grindstaff TL, Jackson KR, Garrison JC, Diduch DR, Ingersoll CD. Decreased quadriceps activation measured hours prior to a noncontact anterior cruciate ligament tear. J Orthop Sports Phys Ther. 2008 Aug;38(8):508-16. doi: 10.2519/jospt.2008.2761. Epub 2008 Aug 1.

ReferenceCitation: Diekfuss JA, Grooms DR, Yuan W, Dudley J, Barber Foss KD, Thomas S, Ellis JD, Schneider DK, Leach J, Bonnette S, Myer GD. Does brain functional connectivity contribute to musculoskeletal injury? A preliminary prospective analysis of a neural biomarker of ACL injury risk. J Sci Med Sport. 2019 Feb;22(2):169-174. doi: 10.1016/j.jsams.2018.07.004. Epub 2018 Jul 10.

ReferenceCitation: Diekfuss JA, Grooms DR, Nissen KS, Schneider DK, Foss KDB, Thomas S, Bonnette S, Dudley JA, Yuan W, Reddington DL, Ellis JD, Leach J, Gordon M, Lindsey C, Rushford K, Shafer C, Myer GD. Alterations in knee sensorimotor brain functional connectivity contributes to ACL injury in male high-school football players: a prospective neuroimaging analysis. Braz J Phys Ther. 2020 Sep - Oct;24(5):415-423. doi: 10.1016/j.bjpt.2019.07.004. Epub 2019 Jul 17.

ReferenceCitation: Grooms DR, Page S, Onate JA. Brain Activation for Knee Movement Measured Days Before Second Anterior Cruciate Ligament Injury: Neuroimaging in Musculoskeletal Medicine. J Athl Train. 2015 Sep 29. [Epub ahead of print]

ReferenceCitation: Goossens N, Janssens L, Caeyenberghs K, Albouy G, Brumagne S. Differences in brain processing of proprioception related to postural control in patients with recurrent non-specific low back pain and healthy controls. Neuroimage Clin. 2019;23:101881. doi: 10.1016/j.nicl.2019.101881. Epub 2019 May 28.

ReferenceCitation: Monjo F, Forestier N. Movement unpredictability and temporal constraints affect the integration of muscle fatigue information into forward models. Neuroscience. 2014 Sep 26;277:584-94. doi: 10.1016/j.neuroscience.2014.07.055. Epub 2014 Jul 30.

ReferenceCitation: Peterka RJ. Sensory integration for human balance control. Handb Clin Neurol. 2018;159:27-42. doi: 10.1016/B978-0-444-63916-5.00002-1. Review.

ReferenceCitation: Vuillerme N, Danion F, Marin L, Boyadjian A, Prieur JM, Weise I, Nougier V. The effect of expertise in gymnastics on postural control. Neurosci Lett. 2001 May 4;303(2):83-6.

ReferenceCitation: Grooms DR, Onate JA. Neuroscience Application to Noncontact Anterior Cruciate Ligament Injury Prevention. Sports Health. 2016 Mar-Apr;8(2):149-52. Review.

ReferenceCitation: Koga H, Nakamae A, Shima Y, Bahr R, Krosshaug T. Hip and Ankle Kinematics in Noncontact Anterior Cruciate Ligament Injury Situations: Video Analysis Using Model-Based Image Matching. Am J Sports Med. 2018 Feb;46(2):333-340. doi: 10.1177/0363546517732750. Epub 2017 Oct 12.

ReferenceCitation: Kiers H, Brumagne S, van Dieën J, Vanhees L. Test-retest reliability of muscle vibration effects on postural sway. Gait Posture. 2014;40(1):166-71. doi: 10.1016/j.gaitpost.2014.03.184. Epub 2014 Apr 3.

ReferenceCitation: Eklund G. General features of vibration-induced effects on balance. Ups J Med Sci. 1972;77(2):112-24.

ReferenceCitation: Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90.

ReferenceCitation: Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.

ReferenceCitation: Forestier N, Terrier R, Teasdale N. Ankle muscular proprioceptive signals' relevance for balance control on various support surfaces: an exploratory study. Am J Phys Med Rehabil. 2015 Jan;94(1):20-7. doi: 10.1097/PHM.0000000000000137.

ReferenceCitation: Ivanenko YP, Talis VL, Kazennikov OV. Support stability influences postural responses to muscle vibration in humans. Eur J Neurosci. 1999 Feb;11(2):647-54.

ReferenceCitation: Brumagne S, Cordo P, Verschueren S. Proprioceptive weighting changes in persons with low back pain and elderly persons during upright standing. Neurosci Lett. 2004 Aug 5;366(1):63-6.

ReferenceCitation: Kiers H, Brumagne S, van Dieën J, van der Wees P, Vanhees L. Ankle proprioception is not targeted by exercises on an unstable surface. Eur J Appl Physiol. 2012 Apr;112(4):1577-85. doi: 10.1007/s00421-011-2124-8. Epub 2011 Aug 21.

ReferenceCitation: Brumagne S, Diers M, Danneels L, Moseley GL, Hodges PW. Neuroplasticity of Sensorimotor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):402-414. doi: 10.2519/jospt.2019.8489.

ReferenceCitation: Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.

ReferenceCitation: Lubetzky AV, McCoy SW, Price R, Kartin D. Response to Tendon Vibration Questions the Underlying Rationale of Proprioceptive Training. J Athl Train. 2017 Feb;52(2):97-107. doi: 10.4085/1062-6050-52.1.06. Epub 2017 Jan 26.

ReferenceCitation: Claeys K, Dankaerts W, Janssens L, Pijnenburg M, Goossens N, Brumagne S. Young individuals with a more ankle-steered proprioceptive control strategy may develop mild non-specific low back pain. J Electromyogr Kinesiol. 2015 Apr;25(2):329-38. doi: 10.1016/j.jelekin.2014.10.013. Epub 2014 Oct 31.

ReferenceCitation: Bonnet CT, Lepeut M. Proximal postural control mechanisms may be exaggeratedly adopted by individuals with peripheral deficiencies: a review. J Mot Behav. 2011;43(4):319-28. doi: 10.1080/00222895.2011.589415. Epub 2011 Jul 6. Review.

ReferenceCitation: van den Hoorn W, Kerr GK, van Dieën JH, Hodges PW. Center of Pressure Motion After Calf Vibration Is More Random in Fallers Than Non-fallers: Prospective Study of Older Individuals. Front Physiol. 2018 Mar 26;9:273. doi: 10.3389/fphys.2018.00273. eCollection 2018.

ReferenceCitation: Peterka RJ. Sensorimotor integration in human postural control. J Neurophysiol. 2002 Sep;88(3):1097-118.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

acronym: SPutOM-CF

summary:
The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy.

All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up


title: Prospective Study on the Contribution of Fluorescence in the Guidance of Lymphadenectomy and in Peroperative Evaluation of Pre-anastomotic Tissue Perfusion in Laparoscopic Esogastric Oncologic Resections

acronym: FOREGUT

summary: A high number of resected lymph nodes is an independent prognostic factor for improved survival after esophagectomy or gastrectomy for cancer. The quality of the lymphadenectomy is operator-dependent, as is the evaluation of the vascularization of the digestive structures that are anastomosed to restore digestive continuity after esophago-gastric resection. The aim of the study is to evaluate the impact of Indocyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.

ReferenceCitation: Rosenthal EL, Warram JM, Bland KI, Zinn KR. The status of contemporary image-guided modalities in oncologic surgery. Ann Surg. 2015 Jan;261(1):46-55. doi: 10.1097/SLA.0000000000000622. Review.

ReferenceCitation: van der Werf LR, Dikken JL, van Berge Henegouwen MI, Lemmens VEPP, Nieuwenhuijzen GAP, Wijnhoven BPL; Dutch Upper GI Cancer Audit group. A Population-based Study on Lymph Node Retrieval in Patients with Esophageal Cancer: Results from the Dutch Upper Gastrointestinal Cancer Audit. Ann Surg Oncol. 2018 May;25(5):1211-1220. doi: 10.1245/s10434-018-6396-7. Epub 2018 Mar 9.

ReferenceCitation: Tachimori Y. Pattern of lymph node metastases of squamous cell esophageal cancer based on the anatomical lymphatic drainage system: efficacy of lymph node dissection according to tumor location. J Thorac Dis. 2017 Jul;9(Suppl 8):S724-S730. doi: 10.21037/jtd.2017.06.19. Review.

ReferenceCitation: Nafteux P, Depypere L, Van Veer H, Coosemans W, Lerut T. Principles of esophageal cancer surgery, including surgical approaches and optimal node dissection (2- vs. 3-field). Ann Cardiothorac Surg. 2017 Mar;6(2):152-158. doi: 10.21037/acs.2017.03.04.

ReferenceCitation: Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.

ReferenceCitation: Woo Y, Goldner B, Ituarte P, Lee B, Melstrom L, Son T, Noh SH, Fong Y, Hyung WJ. Lymphadenectomy with Optimum of 29 Lymph Nodes Retrieved Associated with Improved Survival in Advanced Gastric Cancer: A 25,000-Patient International Database Study. J Am Coll Surg. 2017 Apr;224(4):546-555. doi: 10.1016/j.jamcollsurg.2016.12.015. Epub 2016 Dec 23.

ReferenceCitation: Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23. Review.

ReferenceCitation: Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.

ReferenceCitation: Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.

ReferenceCitation: Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28.

ReferenceCitation: Turner SR, Molena DR. The Role of Intraoperative Fluorescence Imaging During Esophagectomy. Thorac Surg Clin. 2018 Nov;28(4):567-571. doi: 10.1016/j.thorsurg.2018.07.009. Review.

ReferenceCitation: Hachey KJ, Gilmore DM, Armstrong KW, Harris SE, Hornick JL, Colson YL, Wee JO. Safety and feasibility of near-infrared image-guided lymphatic mapping of regional lymph nodes in esophageal cancer. J Thorac Cardiovasc Surg. 2016 Aug;152(2):546-54. doi: 10.1016/j.jtcvs.2016.04.025. Epub 2016 Apr 11.

ReferenceCitation: Park SY, Suh JW, Kim DJ, Park JC, Kim EH, Lee CY, Lee JG, Paik HC, Chung KY. Near-Infrared Lymphatic Mapping of the Recurrent Laryngeal Nerve Nodes in T1 Esophageal Cancer. Ann Thorac Surg. 2018 Jun;105(6):1613-1620. doi: 10.1016/j.athoracsur.2018.01.083. Epub 2018 Mar 5.

ReferenceCitation: Kaburagi T, Takeuchi H, Oyama T, Nakamura R, Takahashi T, Wada N, Saikawa Y, Kamiya S, Tanaka M, Wada T, Kitagawa Y. Intraoperative fluorescence lymphography using indocyanine green in a patient with chylothorax after esophagectomy: report of a case. Surg Today. 2013 Feb;43(2):206-10. doi: 10.1007/s00595-012-0391-6. Epub 2012 Oct 30.

ReferenceCitation: Kim M, Son SY, Cui LH, Shin HJ, Hur H, Han SU. Real-time Vessel Navigation Using Indocyanine Green Fluorescence during Robotic or Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Jun;17(2):145-153. doi: 10.5230/jgc.2017.17.e17. Epub 2017 Jun 9.

ReferenceCitation: Zehetner J, DeMeester SR, Alicuben ET, Oh DS, Lipham JC, Hagen JA, DeMeester TR. Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy. Ann Surg. 2015 Jul;262(1):74-8. doi: 10.1097/SLA.0000000000000811.

ReferenceCitation: Campbell C, Reames MK, Robinson M, Symanowski J, Salo JC. Conduit Vascular Evaluation is Associated with Reduction in Anastomotic Leak After Esophagectomy. J Gastrointest Surg. 2015 May;19(5):806-12. doi: 10.1007/s11605-015-2794-3. Epub 2015 Mar 20.

ReferenceCitation: Agzarian J, Visscher SL, Knight AW, Allen MS, Cassivi SD, Nichols FC 3rd, Shen KR, Wigle D, Blackmon SH. The cost burden of clinically significant esophageal anastomotic leaks-a steep price to pay. J Thorac Cardiovasc Surg. 2019 May;157(5):2086-2092. doi: 10.1016/j.jtcvs.2018.10.137. Epub 2018 Nov 15.

ReferenceCitation: Carrott PW, Markar SR, Kuppusamy MK, Traverso LW, Low DE. Accordion severity grading system: assessment of relationship between costs, length of hospital stay, and survival in patients with complications after esophagectomy for cancer. J Am Coll Surg. 2012 Sep;215(3):331-6. doi: 10.1016/j.jamcollsurg.2012.04.030. Epub 2012 Jun 8.

ReferenceCitation: Wang S, Xu L, Wang Q, Li J, Bai B, Li Z, Wu X, Yu P, Li X, Yin J. Postoperative complications and prognosis after radical gastrectomy for gastric cancer: a systematic review and meta-analysis of observational studies. World J Surg Oncol. 2019 Mar 18;17(1):52. doi: 10.1186/s12957-019-1593-9.

ReferenceCitation: Carus T, Dammer R. Laparoscop fluorescence angiography with indocyanine green to control the perfusion of gastrointestinal anastomoses intraoperatively. Surg Technol Int. 2012 Dec;22:27-32.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.


title: Persistent Eosinopenia is Associated With In-hospital Mortality Among Elderly Patients : Revisiting and Old Forgotten Marker of Infection

summary:
No biological marker is highly specific of infection and currently available, especially for bacterial infection. The ideal marker would be easy to perform, rapidly, inexpensive, and correlated with the severity and prognosis of the infection.

decreased in eosinophil count (EC) is unspecific of a particular clinical picture and may support a systemic inflammation, whereas the deeper the eosinopenia is, the darker is the prognosis in ICU.

The duration of eosinopenia is not clearly documented, but it has been recently shown that EC tends to normalization, rapidly after appropriate and effective antimicrobial therapy in case of bacterial infection among adults patients hospitalized in a medicine ward. In the light of this findings, Terradas et al. described that EC returned back to normal between the day 2 or day 3 in survivors, indicating a potential interest as a predictive marker of the evolution among hospitalized patients.

To the best of our knowledge, no work has studied eosinopenia as a prognostic marker of mortality during bacterial infections in the elderly patients in a hospital setting. Our study aims to evaluate the prognosis value of the EC in a geriatric unit of tertiary care hospital.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Corneal Wounds Repair Emergencies During COVID-19 : 10/0 Absorbable Polyglactin Sutures as a Valuable Strategy

summary:
Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of Delayed Growth on the Quality of Life of Children Treated for a Chronic Disease and Quality of Life Study of Their Parents and Siblings

acronym: CROQUIE

summary:
Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease

acronym: CINC

summary: We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study

acronym: ANTICOV

summary:
Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load.

The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

type: EudraCT Number

source: euctr

title: Prospective Study of the Safety and Efficacy of the Use of a Lipiodol Emulsion for the Embolization of Inflammatory Hypervascularizations Observed in Patients With Joint or Abarticular Knee Pain

summary: Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.