title: Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk

summary:
Joiner's interpersonal theory of suicide postulates that the wish of death comes from feelings of perceived burdensomeness and thwarted belongingness. But, only people who have acquired the capability to kill themselves will attempt suicide. The acquired capability refers to a reduction of fear to death, and a higher pain tolerance. Indeed, to commit suicide involves to endure pain during the act. Thus, higher pain tolerance seems to be a necessary feature for suicidal act.

Past studies have shown higher pain threshold and tolerance in suicidal patients, whatever the stimulus was (electric, thermic or mechanical), compared to patients without suicide history. Moreover, Caceda and colleagues demonstrated higher pain threshold in recent suicide attempters (suicidal act within 72h) compared with depressed patients. Five days after the initial evaluation, pain threshold of recent suicide attempters decreased to be similar to depressed patients with suicidal ideation. Therefore, it may exist a specific state during which the pain tolerance is increased. During this "hypoalgesic state" patients with suicidal ideation could attempt suicide to get relief from suffering.

However, little is known about the specific mechanisms that are responsible for the higher pain threshold and tolerance in suicide attempters. Pain is a dynamic system that results from excitatory and inhibitory messages. The modification of one of these mechanisms could explain the higher tolerance in recent suicide attempters. Three of them are of particular interest:

The conditioned pain modulation (CPM) is a modulatory pain mechanism. CPM works through descending pathway that reaches the spinal cord and modulates pain processing from the first nociceptive synapse.In recent suicidal patients, an increase of the CPM could explain higher pain tolerance.
The "wind-up" mechanism is defined as the highest excitability of the second order nerve. Even if the stimulus remains stable, pain continuously raises. In recent suicide attempters, a reduction of this mechanism could explain higher pain tolerance.
The threshold of Aδ and C nociceptors. If a nociceptive fiber is less excitable than the other, it would explain higher pain threshold.

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital of Montpellier
Clinic La Lironde

intervention_type: Biological


type: Registry Identifier

title: Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease (AETIONOMY)

acronym: AETIONOMY

summary: The AETIONOMY project will generate a refined taxonomy and testable mechanisms underlying the derived stratification of patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Germany France Spain Sweden

location_facility: Karolinska Institutet (KI), Karolinska University Hospital S3:01

location_facility: Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Rossello 149- 153

location_facility: Universitaetsklinikum Bonn (UKB), Sigmund-Freud 25 Strasse

location_facility: CIC Neurosciences - ICM - Hôpital Pitié-Salpêtrière, 47-83 Bd de l'Hôpital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline

acronym: SCD-WELL

summary:
The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition.

It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD.

The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Whitfield T, Demnitz-King H, Schlosser M, Barnhofer T, Frison E, Coll-Padros N, Dautricourt S, Requier F, Delarue M, Gonneaud J, Klimecki OM, Lutz A, Paly L, Salmon E, Schild AK, Walker Z, Jessen F, Chetelat G, Collette F, Wirth M, Marchant NL; Medit-Ageing Research Group. Effects of a mindfulness-based versus a health self-management intervention on objective cognitive performance in older adults with subjective cognitive decline (SCD): a secondary analysis of the SCD-Well randomized controlled trial. Alzheimers Res Ther. 2022 Sep 6;14(1):125. doi: 10.1186/s13195-022-01057-w.

ReferenceCitation: Demnitz-King H, Gonneaud J, Klimecki OM, Chocat A, Collette F, Dautricourt S, Jessen F, Krolak-Salmon P, Lutz A, Morse RM, Molinuevo JL, Poisnel G, Touron E, Wirth M, Walker Z, Chételat G, Marchant NL; Medit-Ageing Research Group. Association of Self-reflection With Cognition and Brain Health in Cognitively Unimpaired Older Adults. Neurology. 2022 Sep 27;99(13):e1422-e1431. doi: 10.1212/WNL.0000000000200951. Epub 2022 Jul 19.

ReferenceCitation: Marchant NL, Barnhofer T, Coueron R, Wirth M, Lutz A, Arenaza-Urquijo EM, Collette F, Poisnel G, Demnitz-King H, Schild AK, Coll-Padros N, Delphin-Combe F, Whitfield T, Schlosser M, Gonneaud J, Asselineau J, Walker Z, Krolak-Salmon P, Molinuevo JL, Frison E, Chételat G, Jessen F, Klimecki OM; The Medit-Ageing Research Group. Effects of a Mindfulness-Based Intervention versus Health Self-Management on Subclinical Anxiety in Older Adults with Subjective Cognitive Decline: The SCD-Well Randomized Superiority Trial. Psychother Psychosom. 2021;90(5):341-350. doi: 10.1159/000515669. Epub 2021 Apr 19.

ipd_sharing: No

location_country:
Germany
France
Spain
United Kingdom

location_facility: The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)

location_facility: The Division of Psychiatry at University College London (UCL).

location_facility: The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)

location_facility: The Department of Psychiatry at University of Cologne (UKK)

intervention_type: Behavioral


title: EURopean Study on Encephalitis in Intensive CAre

acronym: EURECA

summary: Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

time_perspective: Prospective

lead_sponsor: ICUREsearch

location_country: Spain Italy Austria India France Netherlands

location_facility: Institute Of Medical Sciences Banaras Hindu University

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Fondation Opthalmologique Adolphe de Rothschild

location_facility: Sri Ramachandra Institute of Higher Education and Research

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Hôpitaux universitaires Est Parisien, Tenon

location_facility: Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

location_facility: Centre Hospitalier Intercommunal de Poissy

lead_sponsor_type: industriel


type: EudraCT Number

title: A Dose-Escalation Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP 1 and PARP 2 Inhibitor) in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma

summary: The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma.

primary_purpose: Treatment

lead_sponsor: Cephalon

location_country: France Belgium

location_facility:
Teva Investigational Site 2
Teva Investigational Site 3
Teva Investigational Site 1

intervention_type: Drug


title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

acronym: EuroECMO-COVID

summary:
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.

ReferenceCitation: Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Mølbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26. Erratum in: Lancet Infect Dis. 2012 Sep;12(9):655.

ReferenceCitation: Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.

ReferenceCitation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

ReferenceCitation: Drosten C, Günther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguière AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Müller S, Rickerts V, Stürmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. Epub 2003 Apr 10.

ReferenceCitation: Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. Epub 2003 Apr 10.

ReferenceCitation: Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394.

ReferenceCitation: de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15.

ReferenceCitation: Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28.

ReferenceCitation: Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27.

ReferenceCitation: Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

ReferenceCitation: Lorusso R, De Piero ME, Mariani S, Di Mauro M, Folliguet T, Taccone FS, Camporota L, Swol J, Wiedemann D, Belliato M, Broman LM, Vuylsteke A, Kassif Y, Scandroglio AM, Fanelli V, Gaudard P, Ledot S, Barker J, Boeken U, Maier S, Kersten A, Meyns B, Pozzi M, Pedersen FM, Schellongowski P, Kirali K, Barrett N, Riera J, Mueller T, Belohlavek J; EuroECMO-COVID Study Group. In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study. Lancet Respir Med. 2022 Nov 16. pii: S2213-2600(22)00403-9. doi: 10.1016/S2213-2600(22)00403-9. [Epub ahead of print]

lead_sponsor: Maastricht University Medical Center

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Italy
Netherlands
Lithuania
Russian Federation
Switzerland
United Kingdom
Sweden
Hungary
France
Israel
Belgium
Germany
Czechia

location_facility: Heart Center Leipzig - University Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: University Heart Center Freiburg - Bad Krozingen

location_facility: Bambino Gesù Hospital and Research Institute

location_facility: Copenhagen University Hospital at Herlev

location_facility: City Hospital No 40, Saint Petersburg, Russia

location_facility: City Clinical Hospital No. 67, Moscow, Russia

location_facility: A.O.U. Città della Salute e della Scienza - Molinette Hospital

location_facility: Children's Medical Hospital, University of Essen, Essen, Germany

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: City Hospital No 41, Ekaterinburg, Russia

location_facility: Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash

location_facility: Vilnius University Hospital Santaros Klinikos

status_simplified: Ongoing


title: Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics

summary:
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers are increasing due to our ageing population. Bone grafting intends to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage, but this is only attained presently by including cells capable of forming bone into the augmentation.

Bone autograft is the safest and most effective grafting procedure, since it contains patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with frequent consequent pain and complications.

We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically implanted with synthetic bone substitutes contribute to the resolution of the health and socioeconomic complications of delayed union or non-union after diaphyseal and metaphyseal-diaphyseal fractures with safety and efficacy.

location_country: Germany France Spain Italy

location_facility: Department of Orthopaedic Trauma, University of Ulm

location_facility: Depatment of Orthopaedic Surgery, Hôpital Henri Mondor

location_facility: Department of Orthopaedic Surgery, CHRU Tours

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

intervention_type: Procedure


title: Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

acronym: SEPSISEO

summary:
Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse

status: Unknown status

ipd_sharing: Undecided

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg

status_simplified: Unknown


title: Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke

acronym: CANNASTROKE

summary:
Incidence of strokes has increased these last 20 years in young population. This rise could be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been descripted as a potential factor of reversible vasoconstriction. The main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects.

There's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.

primary_purpose: Prevention


title: Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

acronym: ILEHOS

summary:
Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

status: Terminated

location_facility: Hôpital Jean Minjoz - Service de Chirurgie Digestive

location_facility: CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne

location_facility: Hôpital de Hautepierre-Service de Chirurgie Digestive

location_facility: Hôpital Emile MULLER - Service de Chirurgie Digestive

location_facility: Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive

location_facility: Hôpitaux Civils de Colmar - Service de Chirurgie Digestive


title: Detect, Monitor and Prevent Vascular Abnormalities Associated With Turner Syndrome

acronym: AVAST

summary:
Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and ovarian failure with infertility.

Other anomalies are inconstant: morphological characteristics of varying intensity, associated malformations, and increased risk of acquired diseases ...

The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular complications (congenital heart disease, dilatation of the ascending aorta with risk of dissection or rupture of aneurysm), causing early mortality with reduction of life expectancy of at least 10 years.

For these reasons, screening for heart disease and dilatation of the ascending aorta is established and is intended to prevent the complications associated with medical treatment and / or surgery to increase life expectancy and reduce the co-morbidities.

On the vascular level, the recommendations other than those relating to the monitoring of the diameter of the ascending aorta include research of renal artery stenosis by doppler ultrasound if the patient is hypertensive and looking for lymphedema.

However, other arterial lesions were described in the literature, outside of the aneurysm of the ascending aorta. These peripheral arterial lesions can also be life and / or functional prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner syndrome.

In addition, specific vascular lesions outside the affected artery are described: hepatic cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or lymphatic disease is unknown.

A single-center review of 9 cases of patients followed at the University Hospital of Strasbourg showed the presence of vascular lesions discovered incidentally during assessments performed for reasons other than cardiovascular screening: cystic lymphangioma, internal carotid aneurysm, agenesis of the inferior vena cava, early varicose veins, embryonic cerebral artery, etc ... None of these patients showed any dilatation of the ascending aorta or heart disease. Peripheral vascular abnormalities in this patient group are exclusive.

In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the entire arterial territory and is not confined to the ascending aorta. Screening for arterial lesions should be performed on the entire arterial vascular tree and regularly in the course of time, especially as the presence of cardiovascular risk factors increases with the age of these patients.

The venous and lymphatic vascular damage in the literature and in our series of cases in University Hospital of Strasbourg description should also lead to the detection of these lesions.

These vascular complications can be alone responsible for the reduction in life expectancy or responsible for serious morbidity. Improved screening of associated vascular lesions is necessary to enable the best prevention of cardiovascular complications.

It is also to establish the prevalence of vascular anomalies, whether arterial, venous or lymphatic, to better understand the disease and its management. By collecting systematically karyotype leading to diagnosis, it may be possible to make a link between the genetic defect and heart or vascular disease.

status: Active, not recruiting

location_facility: Service HTA, maladies vasculaires et pharmacologie clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service d'explorations fonctionnelles non invasives cardio-vasculaires, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service d'endocrinologie, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires

location_facility: Service de Chirurgie et Médecine Vasculaire, CHU Jean Minjoz


summary: The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).

ReferenceCitation: Pérez Martínez C, Grollemund B, Gavelle P, Viaux-Savelon S, Guedeney A. The Prevalence of Social Withdrawal in Infants With Cleft Lip and Palate: The Feasibility of the Full and the Modified Versions of the Alarm Distress Baby Scale. Front Pediatr. 2022 Jul 7;10:804802. doi: 10.3389/fped.2022.804802. eCollection 2022.

ReferenceCitation: Grollemund B, Dissaux C, Gavelle P, Martínez CP, Mullaert J, Alfaiate T, Guedeney A; CLIP team (Cleft Lip & palate Infant Parent). The impact of having a baby with cleft lip and palate on parents and on parent-baby relationship: the first French prospective multicentre study. BMC Pediatr. 2020 May 18;20(1):230. doi: 10.1186/s12887-020-02118-5.

ReferenceCitation: Grollemund B, Guedeney A, Vazquez MP, Picard A, Soupre V, Pellerin P, Simon E, Velten M, Dissaux C, Kauffmann I, Bruant-Rodier C, Danion-Grilliat A. Relational development in children with cleft lip and palate: influence of the waiting period prior to the first surgical intervention and parental psychological perceptions of the abnormality. BMC Pediatr. 2012 Jun 8;12:65. doi: 10.1186/1471-2431-12-65.

location_facility: CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central

location_facility: CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro

location_facility: APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale

location_facility: CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1


title: A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.

acronym: LI-AMB

summary: We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.

location_facility: Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest

location_facility: Service d'Anestésie et Réanimation - Hôpital Beaujon

location_facility: Service d'Anesthésie et Réanimation - Hôpital de Hautepierre

location_facility: Service d'Anesthésie et Réanimation - Hôpital Pasteur


title: Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

acronym: API-CAT

summary: The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country:
Poland
Spain
Italy
Austria
Greece
United Kingdom
Switzerland
France
Belgium
Netherlands

location_facility: Parc Santari Sant Joan de Deu - Hospital general

location_facility: Istituto Oncologico della svizzera Italiana

location_facility: Hospital general Universitario Santa Lucia

location_facility: Hospital universitari Germans trias i Pujol

location_facility: Hôpital d'Instruction des Armées Clermont Tonnerre

location_facility: Centre of postgraduate medical education at the european health centre Otwock

location_facility: HÔPITAL PRIVÉ ARRAS LES BONNETTES - Espace Artois Santé

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: CHU DIJON BOURGOGNE - Hôpital François Mitterrand

location_facility: National and Kapodistrian University of Athens ALEXANDRA Hospital

location_facility: Hospital general universitario de ciudad real


title: Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain

summary:
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.

The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.

lead_sponsor: Decathlon SE

location_facility: Centre Hospitalier Universitaire de Lille

intervention_type: Device


title: Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

acronym: ConFIRM

summary: The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation

ReferenceCitation: Delbos L, Parot-Schinkel E, El Hachem H, Legendre G, Descamps P, Boucret L, Ferré-L'Hotellier V, Jeanneteau P, Dreux C, Morinière C, May-Panloup P, Bouet PE. ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial. Trials. 2018 Oct 17;19(1):565. doi: 10.1186/s13063-018-2936-5.

lead_sponsor: University Hospital, Angers

location_country: France Guadeloupe

location_facility:
IHC Créteil
UH Rennes
UH Grenoble
UH Angers
Cholet Hospital
UH Nîmes
Clinique Léonard de Vinci
UHR Tours
UH Lille
UH Pointe-à-Pitre
UH Caen
Polyclinique Jean Villar
UH Potiers
Clinique Mutualiste de la Sagesse
Lorient Hospital
UH Besançon
Antoine Béclère Hospital AP-HP
Jean Verdier Hospital, APHP
Victor Pauchet Clinic
UH Toulouse
UH Strasbourg
Sud Francilien Hospital
Clinique Pierre Cherest
Tertre Rouge Clinic
Clinique Jules Verne
Hospital of Orléans
Cochin Hospital, APHP
Polyclinique de L'Atlantique
Poissy Saint Germain en Laye Hospital
UH Rouen
UH La conception AP-HM
UH Nantes


title: Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow

acronym: MatriBone

summary: The main objective of this clinical study is the estimation of the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\or spondylolisthesis.

ReferenceCitation: Anand N, Hamilton JF, Perri B, Miraliakbar H, Goldstein T. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine (Phila Pa 1976). 2006 Sep 15;31(20):E748-53.

ReferenceCitation: Battié MC, Videman T, Levälahti E, Gill K, Kaprio J. Genetic and environmental effects on disc degeneration by phenotype and spinal level: a multivariate twin study. Spine (Phila Pa 1976). 2008 Dec 1;33(25):2801-8. doi: 10.1097/BRS.0b013e31818043b7.

ReferenceCitation: Battié MC, Videman T, Kaprio J, Gibbons LE, Gill K, Manninen H, Saarela J, Peltonen L. The Twin Spine Study: contributions to a changing view of disc degeneration. Spine J. 2009 Jan-Feb;9(1):47-59. doi: 10.1016/j.spinee.2008.11.011.

ReferenceCitation: Carter JD, Swearingen AB, Chaput CD, Rahm MD. Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. Spine J. 2009 Jun;9(6):434-8. doi: 10.1016/j.spinee.2008.11.004. Epub 2008 Dec 25.

ReferenceCitation: Chen Z, Zhao J, Liu A, Yuan J, Li Z. Surgical treatment of recurrent lumbar disc herniation by transforaminal lumbar interbody fusion. Int Orthop. 2009 Feb;33(1):197-201. doi: 10.1007/s00264-008-0531-1. Epub 2008 Mar 21.

ReferenceCitation: el-Masry MA, Khayal H, Salah H. Unilateral transforaminal lumbar interbody fusion (TLIF) using a single cage for treatment of low grade lytic spondylolisthesis. Acta Orthop Belg. 2008 Oct;74(5):667-71.

ReferenceCitation: Goyal N, Wimberley DW, Hyatt A, Zeiller S, Vaccaro AR, Hilibrand AS, Albert TJ. Radiographic and clinical outcomes after instrumented reduction and transforaminal lumbar interbody fusion of mid and high-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Jul;22(5):321-7. doi: 10.1097/BSD.0b013e318182cdab.

ReferenceCitation: Houten JK, Post NH, Dryer JW, Errico TJ. Clinical and radiographically/neuroimaging documented outcome in transforaminal lumbar interbody fusion. Neurosurg Focus. 2006 Mar 15;20(3):E8.

ReferenceCitation: Jagannathan J, Sansur CA, Oskouian RJ Jr, Fu KM, Shaffrey CI. Radiographic restoration of lumbar alignment after transforaminal lumbar interbody fusion. Neurosurgery. 2009 May;64(5):955-63; discussion 963-4. doi: 10.1227/01.NEU.0000343544.77456.46.

ReferenceCitation: Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L. Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1693-8.

ReferenceCitation: Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, Hilibrand AS, Albert TJ. Complications associated with single-level transforaminal lumbar interbody fusion. Spine J. 2009 Aug;9(8):623-9. doi: 10.1016/j.spinee.2009.04.004. Epub 2009 May 30.

ReferenceCitation: Rihn JA, Makda J, Hong J, Patel R, Hilibrand AS, Anderson DG, Vaccaro AR, Albert TJ. The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Eur Spine J. 2009 Nov;18(11):1629-36. doi: 10.1007/s00586-009-1046-1. Epub 2009 May 28.

ReferenceCitation: Sasso RC, LeHuec JC, Shaffrey C; Spine Interbody Research Group. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech. 2005 Feb;18 Suppl:S77-81.

ReferenceCitation: Schleicher P, Beth P, Ottenbacher A, Pflugmacher R, Scholz M, Schnake KJ, Haas NP, Kandziora F. Biomechanical evaluation of different asymmetrical posterior stabilization methods for minimally invasive transforaminal lumbar interbody fusion. J Neurosurg Spine. 2008 Oct;9(4):363-71. doi: 10.3171/SPI.2008.9.10.363.

ReferenceCitation: Xiao Y, Li F, Chen Q. Transforaminal lumbar interbody fusion with one cage and excised local bone. Arch Orthop Trauma Surg. 2010 May;130(5):591-7. doi: 10.1007/s00402-009-0917-6. Epub 2009 Jun 30.

ReferenceCitation: Xiao YX, Chen QX, Li FC. Unilateral transforaminal lumbar interbody fusion: a review of the technique, indications and graft materials. J Int Med Res. 2009 May-Jun;37(3):908-17. Review.

ReferenceCitation: Yan DL, Pei FX, Li J, Soo CL. Comparative study of PILF and TLIF treatment in adult degenerative spondylolisthesis. Eur Spine J. 2008 Oct;17(10):1311-6. doi: 10.1007/s00586-008-0739-1. Epub 2008 Aug 7.

lead_sponsor: University Hospital, Bordeaux

location_facility: Unité d'Orthopédie-Traumatologie rachis II, Pellegrin


title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

ReferenceType: result

ReferenceCitation: Ray-Coquard I, Pautier P, Pignata S, Pérol D, González-Martín A, Berger R, Fujiwara K, Vergote I, Colombo N, Mäenpää J, Selle F, Sehouli J, Lorusso D, Guerra Alía EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marmé F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.

ReferenceCitation: González-Martín A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levaché CB, Marmé F, Bazan F, de Gregorio N, Dohollou N, Fasching PA, Scambia G, Rubio-Pérez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I; PAOLA1/ENGOT-ov25 investigators. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2022 Oct;174:221-231. doi: 10.1016/j.ejca.2022.07.022. Epub 2022 Sep 5.

ReferenceCitation: Fujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.

lead_sponsor: Arcagy Research

location_country: Denmark Spain Italy Austria Finland Monaco Sweden France Belgium Japan Germany

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Saitama Medical University International Medical Center

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Catherine de Sienne - Group confluent

location_facility: Istituto Nazionale Tumori - IRCCS Pascale

location_facility: Charité - Universitätsmedizin Berlin (CVK)

location_facility: Institut Curie - Hopital Claudius Régaud


acronym:
HyQvia

 HyQvia

title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia

lead_sponsor: University Hospital, Lille

source: euctr

location_facility:
Hôpital Haut Lévèque
CHRU, Hôpital Claude Huriez
CHU de Strasbourg
CHU de Nantes - Hôtel Dieu
Hôpital Necker
Hôpital de la Conception
Hôpital St Louis

summary: Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks


title: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19

acronym: REMPAR-EHPAD

summary: REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

time_perspective: Retrospective

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study

acronym: AFP

summary: Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.

ReferenceCitation: Bénet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glélé LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.

lead_sponsor: Hospices Civils de Lyon

location_facility: Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health


title: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

acronym: VIDMED

summary:
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Rouen
University Hospital


title: Randomized Trial Comparing Digestive and Urinary Dysfunction Secondary to 2 Surgical Techniques Used in the Management of Deep Endometriosis Infiltrating the Rectum: Colorectal Resection and Rectal Nodules Excision (ENDORE)

acronym: ENDORE

summary: The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

ReferenceCitation: Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217. Erratum in: Hum Reprod. 2020 Mar 27;35(3):736.

ReferenceCitation: Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.

location_facility: Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6

location_facility: Service de Gynécologie et Obstétrique, CHU Jean de Flandre


type: Other Identifier

title: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?

acronym: ETPARK-REMED

summary: Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.

study_start_date_type: Anticipated

ReferenceCitation: Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, Bérard E, Bourrel R, Molinier L, Brefel-Courbon C. Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial. PLoS One. 2016 Sep 29;11(9):e0162646. doi: 10.1371/journal.pone.0162646. eCollection 2016.

ReferenceCitation: Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.

lead_sponsor: University Hospital, Toulouse


title: Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease

acronym: Prodygi-II

summary:
Pilot study:

Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations


title: High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714

acronym: INFLAPARK

summary:
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however hard to evidence microglial activation in vivo, especially in the substantia nigra: first, the investigators need very high resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.

18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the topography and intensity of microglial activation in several different groups of PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients ("honeymoon") (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a new generation tomography having a very high resolution.

This study might reveal significant neuroinflammatory process in the midbrain of PD patients and will determine if such process is present in both sporadic and genetic forms of PD. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.

primary_purpose: Basic Science

ReferenceCitation: Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6). pii: e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.

ReferenceCitation: Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.

intervention_type: Radiation


title: POLYGEN DEFI-ALPHA : Genetic Polymorphisms Study in Children With Alpha-1 Antitrypsin Deficiency, Included in the DEFI-ALPHA Cohort

acronym: Polygen

summary:
The deficiency of alpha-1 antitrypsin (DA1AT) is a genetic disorder of variable clinical expression, initially described in adults with pulmonary emphysema patients. In children, it is the second cause of neonatal cholestasis after biliary atresia and is a common indication for liver transplantation.

Several genotypes for SERPINA1 gene coding for alpha-1 anti-trypsin were identified. The main ones are M / M, M / Z, M / S and Z / Z and each genotype is closely correlated with the concentration of blood A1AT. The estimate for France suggests a prevalence of genotype deficit Z / Z of the order of 1/6054, (9982 patients), which in 11% of cases, have liver disease (prolonged neonatal jaundice). Half of them will move towards the development of cirrhosis with portal hypertension, at worst liver transplantation.

Currently, we do not know what are the clinical and genetic factors that predispose a patient A1AT deficiency develop liver damage. Recent studies have led us to think that polymorphisms in the gene SERPINA1, as well as that of the alpha-mannosidase 1 endoplasmic reticulum (Erman gene) could be a predictive marker of liver complications. Another possible candidate gene is one of the importin beta (KPNB1), a protein involved in the elimination of misfolded proteins. These data lead us to propose the study of genetic polymorphisms.

The main objective of the study is to compare the allele frequencies of these polymorphisms between (i) a cohort of A1AT deficient patients and with hepatic symptoms (portal hypertension and its complications, severe liver failure leading to transplant or not, or an indication for liver transplantation) and (ii) a cohort of A1AT deficient patients without signs of hepatic call. To build this last cohort, we will include in the genetic study the family members of deficient patients, some of whom probably carrying a deficit genotype Z / Z but without any associated clinical manifestations. This will allow us to facilitate the establishment of genotype profiles / phenotype clearly identified, which then allow a more appropriate care for children who may have such a development, we will strive to achieve a haplotype interpretation of polymorphisms found.

This study will be conducted in association with the DEFI-ALPHA study to identify clinical and biological prognostic factors such as age at diagnosis, the diagnostic mode, the results of liver biopsy (when available), the clinical course, family history, the existence of IUGR and long-term treatment.

The secondary objectives of the study are :

The measurement and interpretation of serum IL-8 in A1AT-deficient patients. Indeed, one study showed a higher IL-8 in patients with ulcerative colitis compared with healthy patients' serum. These considerations led us to hypothesize that IL-8 may be a marker of liver disease in A1AT deficiency.
Preservation of blood samples for further study of other genes, which may be in the future suspected to be associated with the occurrence of liver complications. To this end, a DNA bank will be created. It will involve the children with a deficiency of alpha-1 antitrypsin and their family of 1st and 2nd degree in civil law (parents and siblings).

This study is a continuation of the cohort DEFI-ALPHA (descriptive study of a cohort of children with DA1AT) and sought to identify the clinical and biological factors such as age at diagnosis, diagnosis mode, the result sets of the liver biopsy (when available), clinical course, family history, the presence of IUGR and long-term treatment.

The only criterion for not-inclusion is, according to the subject, the lack of consent of the child and his parents, the lack of consent of the adult patient, or the lack of consent of the witness. Demographic and clinical history data (for parents and brothers/sisters showing no DA1AT) will be collected.

Currently, the cohort of patients with DA1AT is being set up in the framework of the "Cohort DEFI-ALPHA." This multicenter project is realized with the help of french pediatric hepatology centers that regularly follow patients DA1AT. Today, over 100 patients DA1AT have already been identified, and the collection of historical data has already begun on several centers since September 2009. This study is therefore a continuation of this work.

Over a period of 30 months, the total number of potentially includable subjects is estimated at about 400 in this study (100 patients and 300 related to the first degree such as parents, brothers and sisters).

This study will be promoted by the Hospices Civils de Lyon. Authorization of the competent authority and the ethical committee will be obtained as well as informed consent from families before blood sampling.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Joly P, Ruiz M, Garin R, Karatas E, Lachaux A, Restier L, Belmalih A, Renoux C, Lombard C, Dechomet M, Bouchecareilh M. A Particular SORL1 Micro-haplotype May Prevent Severe Liver Disease in a French Cohort of Alpha 1-Antitrypsin-deficient Children. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):e68-e72. doi: 10.1097/MPG.0000000000003125.

ReferenceCitation: Ruiz M, Lacaille F, Berthiller J, Joly P, Dumortier J, Aumar M, Bridoux-Henno L, Jacquemin E, Lamireau T, Broué P, Rivet C, Belmalih A, Restier L, Chapuis-Cellier C, Bouchecareilh M, Lachaux A; Groupe Francophone d'Hépatologie Gastroentérologie et Nutrition Pédiatriques. Liver disease related to alpha1-antitrypsin deficiency in French children: The DEFI-ALPHA cohort. Liver Int. 2019 Jun;39(6):1136-1146. doi: 10.1111/liv.14035. Epub 2019 Feb 1.

location_facility: Centre de Pédiatrie Gatien de Clocheville


title: Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

acronym: HARMONIC-RT

summary: The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of modern external beam radiotherapy techniques in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

time_perspective: Other

location_country: Denmark France Germany Belgium

location_facility: University Hospital Essen, The West German Proton Therapy Centre Essen


title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients

summary:
Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation.

Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.

ReferenceCitation: Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41.

ReferenceCitation: American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

ReferenceCitation: Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19. Review.

ReferenceCitation: Guérin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.

ReferenceCitation: Gómez-Merino E, Sancho J, Marín J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83.

ReferenceCitation: Martínez-Alejos R, Martí JD, Li Bassi G, Gonzalez-Anton D, Pilar-Diaz X, Reginault T, Wibart P, Ntoumenopoulos G, Tronstad O, Gabarrus A, Quinart A, Torres A. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects. Respir Care. 2021 Sep;66(9):1371-1379. doi: 10.4187/respcare.08641. Epub 2021 Jun 8.

location_facility: Polyvalent ICU. Centre medico-chirurgicale Magellan 2.


title: Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

summary: This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).

lead_sponsor: Poitiers University Hospital

location_facility:
Pascal DERKINDEREN
Chu de Poitiers
Marc VERIN


title: Transplantation of Ex-vivo Expanded Human Cord Blood Hematopoietic Stem Cells Expanded: Evaluation of Hematopoietic and Immunologic Reconstitution After a Reduced-intensity Conditioning Regimen

acronym: GRAPA

summary:
This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor.

An economy of means in that this method could serve as an alternative to 2 units of placental blood transplantation. The current cost of disposal of a unit of placental blood from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is more economical. Moreover, the availability of placental blood is not infinite, and the use of one unit per patient will also save resources that can be valuable for certain groups of patients.

In the longer term, methods of amplification of specific immunocompetent cells (from the fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to consider a faster recovery, better and more targeted, including cells against the disease for which transplantation is performed.

ReferenceCitation: Petersdorf EW. Risk assessment in haematopoietic stem cell transplantation: histocompatibility. Best Pract Res Clin Haematol. 2007 Jun;20(2):155-70. Review.

ReferenceCitation: Koh LP, Chao NJ. Umbilical cord blood transplantation in adults using myeloablative and nonmyeloablative preparative regimens. Biol Blood Marrow Transplant. 2004 Jan;10(1):1-22. Review.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. Epub 2004 Oct 5.

ReferenceCitation: Castello S, Podestà M, Menditto VG, Ibatici A, Pitto A, Figari O, Scarpati D, Magrassi L, Bacigalupo A, Piaggio G, Frassoni F. Intra-bone marrow injection of bone marrow and cord blood cells: an alternative way of transplantation associated with a higher seeding efficiency. Exp Hematol. 2004 Aug;32(8):782-7.

ReferenceCitation: Shpall EJ, Quinones R, Giller R, Zeng C, Baron AE, Jones RB, Bearman SI, Nieto Y, Freed B, Madinger N, Hogan CJ, Slat-Vasquez V, Russell P, Blunk B, Schissel D, Hild E, Malcolm J, Ward W, McNiece IK. Transplantation of ex vivo expanded cord blood. Biol Blood Marrow Transplant. 2002;8(7):368-76.

ReferenceCitation: Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M, Demirer T, Dini G, Einsele H, Gratwohl A, Madrigal A, Niederwieser D, Passweg J, Rocha V, Saccardi R, Schouten H, Schmitz N, Socie G, Sureda A, Apperley J; European Group for Blood and Marrow. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone Marrow Transplant. 2006 Mar;37(5):439-49.

ReferenceCitation: Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. Epub 2007 Jun 14.

ReferenceCitation: Gluckman E, Rocha V. Donor selection for unrelated cord blood transplants. Curr Opin Immunol. 2006 Oct;18(5):565-70. Epub 2006 Aug 8. Review.

ReferenceCitation: Takahashi S. Leukemia: cord blood for allogeneic stem cell transplantation. Curr Opin Oncol. 2007 Nov;19(6):667-72. Review.

ReferenceCitation: Kobari L, Pflumio F, Giarratana M, Li X, Titeux M, Izac B, Leteurtre F, Coulombel L, Douay L. In vitro and in vivo evidence for the long-term multilineage (myeloid, B, NK, and T) reconstitution capacity of ex vivo expanded human CD34(+) cord blood cells. Exp Hematol. 2000 Dec;28(12):1470-80.

ReferenceCitation: Duchez P, Dazey B, Douay L, Vezon G, Ivanovic Z. An efficient large-scale thawing procedure for cord blood cells destined for selection and ex vivo expansion of CD34+ cells. J Hematother Stem Cell Res. 2003 Oct;12(5):587-9.

ReferenceCitation: Dazey B, Duchez P, Letellier C, Vezon G, Ivanovic Z; French Cord Blood Network. Cord blood processing by using a standard manual technique and automated closed system "Sepax" (Kit CS-530). Stem Cells Dev. 2005 Feb;14(1):6-10.

ReferenceCitation: Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. Epub 2003 May 8.

ReferenceCitation: Ljungman P, Bregni M, Brune M, Cornelissen J, de Witte T, Dini G, Einsele H, Gaspar HB, Gratwohl A, Passweg J, Peters C, Rocha V, Saccardi R, Schouten H, Sureda A, Tichelli A, Velardi A, Niederwieser D; European Group for Blood and Marrow Transplantation. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009. Bone Marrow Transplant. 2010 Feb;45(2):219-34. doi: 10.1038/bmt.2009.141. Epub 2009 Jul 6.

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau

location_facility: Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan


title: A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants

summary: The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

lead_sponsor: Corin

location_facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

acronym: CORIMUNO-SARI

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

ReferenceCitation: CORIMUNO-19 Collaborative group. Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial. Lancet Rheumatol. 2022 Jan;4(1):e24-e32. doi: 10.1016/S2665-9913(21)00315-5. Epub 2021 Nov 17.

ipd_sharing: Yes

location_facility:
NECKER Hospital
HEGP
Cochin Aphp
Kremlin Bicetre hospital APHP


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy and Other CentroNuclear Myopathies

acronym: NatHis-CNM

summary: This is the 2 years extension of the prospective and longitudinal study of the natural history and functional status of patients with myotubular myopathy and other centronuclear (CNM) sponsored by Dynacure including ten additional pediatric patients with mutation in MTM1 or DNM2 genes). the patients are planned to be enrolled in one year leading to an expected total number of 70 patients followed at least over 1 year period. Data from the study will be used to characterize the disease course of CNM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

lead_sponsor: Institut de Myologie, France

location_country: Spain Italy France Belgium Germany

location_facility: Centre de référence neuromusculaire, CHR La Citadelle

location_facility: Hôpital Femme Mère Enfant, CHU Lyon L'Escale


title: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities

acronym: Explor-AVD

summary: The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.

lead_sponsor: Hopital Foch


title: Towards an Early Integration of Palliative Care in Oncology: Descriptive Study of Needs for Patients With Metastatic Cancer and the Adequacy of These Needs With Healthcare Facilities

acronym: BESACE

summary:
The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death.

As secondary objectives, the study aims:

to determinate the proportion of patients with an indication for palliative care according to Hui et al., and to describe the adequation of health needs and the services for them;
to study the association between clinical pathway and the indication of targeted palliative care;
to study the association between the integration of palliative care service and the adequation of health needs service of patients;
to study the factors such as the disease, the practice and the care, contribute to the patient's survivor of 1 year.

status: Not yet recruiting

ReferenceCitation: Hui D, Mori M, Watanabe SM, Caraceni A, Strasser F, Saarto T, Cherny N, Glare P, Kaasa S, Bruera E. Referral criteria for outpatient specialty palliative cancer care: an international consensus. Lancet Oncol. 2016 Dec;17(12):e552-e559. doi: 10.1016/S1470-2045(16)30577-0. Review.

location_facility: Mobile palliative care and support team, Ambroise Paré hospital, APHP


title: The Fami-Life Study: Protocol of a Prospective Multicenter Observational Mixed Study of Psychological Consequences of Grieving Families in French Palliative Care Units on the Behalf of the F.R.I.P.C Research Network

acronym: FAMI-LIFE

summary: The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

ReferenceCitation: Fasse L, Flahault C, Brédart A, Dolbeault S, Sultan S. Describing and understanding depression in spouses of cancer patients in palliative phase. Psychooncology. 2015 Sep;24(9):1131-7. doi: 10.1002/pon.3777. Epub 2015 Feb 24.

ReferenceCitation: Kentish-Barnes N, Chaize M, Seegers V, Legriel S, Cariou A, Jaber S, Lefrant JY, Floccard B, Renault A, Vinatier I, Mathonnet A, Reuter D, Guisset O, Cohen-Solal Z, Cracco C, Seguin A, Durand-Gasselin J, Éon B, Thirion M, Rigaud JP, Philippon-Jouve B, Argaud L, Chouquer R, Adda M, Dedrie C, Georges H, Lebas E, Rolin N, Bollaert PE, Lecuyer L, Viquesnel G, Léone M, Chalumeau-Lemoine L, Garrouste M, Schlemmer B, Chevret S, Falissard B, Azoulay É. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015 May;45(5):1341-52. doi: 10.1183/09031936.00160014. Epub 2015 Jan 22.

ReferenceCitation: Flahault C, Dolbeault S, Sankey C, Fasse L. Understanding grief in children who have lost a parent with cancer: How do they give meaning to this experience? Results of an interpretative phenomenological analysis. Death Stud. 2018 Sep;42(8):483-490. doi: 10.1080/07481187.2017.1383951. Epub 2018 Jan 24.

ReferenceCitation: Fasse L, Sultan S, Flahault C, Mackinnon CJ, Dolbeault S, Brédart A. How do researchers conceive of spousal grief after cancer? A systematic review of models used by researchers to study spousal grief in the cancer context. Psychooncology. 2014 Feb;23(2):131-42. doi: 10.1002/pon.3412. Epub 2013 Sep 30. Review.

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Poulain E, Evin A, Guirimand F, Fossez-Diaz V, Perruchio S, Verlaine C, Vanbésien A, Kaczmarek W, Birkui de Francqueville L, De Larivière E, Bouquet G, Copel L, Verliac V, Marché V, Mathias C, Gracia D, Mhalla A, Michonneau-Gandon V, Poupardin C, Touzet L, Ranchou G, Guastella V, Richard B, Bienfait F, Sonrier M, Michel D, Ruckly S, Bailly S, Timsit JF. The Fami-life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the family research in palliative care (F.R.I.P.C research network). BMC Palliat Care. 2019 Dec 9;18(1):111. doi: 10.1186/s12904-019-0496-4.

lead_sponsor: GCS IHFB Cognacq-Jay


title: Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease

summary:
Parkinson's disease is characterized not only by motor symptoms but also by psycho-behavioral symptoms including Visual Hallucinations (VH) and illusions (I), that are generally associated with a severe functional impairment and a bad prognosis for patients. Visual Hallucinations are defined by a visual perception without any real objet to perceive, whereas illusions are defined by a wrong perceptions of an object that is really present. In most of studies investigating the pathophysiology of VH in PD, no difference is made between VH and I, however different mechanisms could lead to the emergence of these two phenomenon, with different prognosis.

Investigator hypothesize that illusions could be related to a visual impairment, maybe at the retinal level, known to be impaired in PD, whereas Visual hallucinations would be due to a more widespread impairment affecting higher levels visuo-perceptive and cognitive functions.

ReferenceCitation: Marques A, Beze S, Lambert C, Bonamy L, de Chazeron I, Rieu I, Chiambaretta F, Durif F. Psycho-sensory modalities of visual hallucinations and illusions in Parkinson's disease. Rev Neurol (Paris). 2021 Dec;177(10):1228-1236. doi: 10.1016/j.neurol.2021.04.007. Epub 2021 Jul 5.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Post Operative Analgesia After Wrist Fracture Surgery Under Regional Anesthesia: Randomized Trial, Open Study, With Evaluation of the Endpoint and Patient Blind (PROBE Design), Evaluating the Equivalence Between Ultrasound-guided Nerve Bloc and Local Infiltration

acronym: BNINF

summary:
Distal radial fracture reparations by volar plating are often managed under regional anaesthesia, but are associated with severe pain when the block ends. Acute post-operative pain may delay rehabilitation, and even be a risk factor for the development of chronic pain. The use of opioids and the inevitable opioid-related side effects further decrease patient satisfaction. A multimodal approach to pain management should include local or regional analgesia technique when possible. In the case of wrist fractures, two methods are available: peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly used for the management of postoperative pain after diverse orthopaedic surgeries.

The purpose of this study was to determine the equivalence between ultrasound-guided peripheral nerve block and local infiltration by the surgeon for short-term postoperative analgesia after surgical reparation of isolated closed wrist fractures by volar plating under regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse events were recorded for the first 48 hours following surgery.


title: Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI) Is Nintendo Wii an Effective Intervention for Children With Osteogenesis Imperfecta

summary:
Children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. The physical rehabilitation of these children is a fundamental aspect of treatment.

It has been shown that playing Wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. This type of physical exercise with this type of fun game console might have a role in the treatment of OI children on the physical side but also on the psychological side.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation

acronym: ICU-diary

summary: The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.

ReferenceCitation: Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022.

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonnière C, Lautrette A, Badié J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonnière C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Medical and surgical Intensive Care unit


title: Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

acronym: MUCO-SOPHRO

summary: The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

acronym: MSA-DOUL

summary:
Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it ended with the patient's death few years later. No neuroprotective treatment has shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication of dopamine neuromediator pathway in integration and modulation of pain. Several studies suggest the existence of various influences with dopamine implication in the appearance of painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to a lost of control of sensitizes centres, to Parkinson control.

It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold and to characterise the levodopa effect on the patient's pain threshold. Better physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care. Because the efficacy of others treatments is low, it's important to improve the research for a better comfort of patients with a better understanding, analysing and treating of the pain.


title: Use of MEOPA for Elderly With Dementia.

summary:
Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring.

MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers.

In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Gerontology department, Nice University Hospital


title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

acronym: Aquavip

summary: Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group


title: Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man

summary: This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

ReferenceCitation: Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagège AA, Marijon E, Tanter M, Bertrand B, Rémond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25.

lead_sponsor: Cardiawave SA

location_country: Netherlands France

location_facility:
Amphia Hospital
Hôpital Européen Georges Pompidou


title: Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers

summary: This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D. Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a, the cohort will be further expanded by up to 19 more patients to a total of 29 patients to confirm the efficacy and safety profile of onapristone in this selected patient population (Stage 2b).

ReferenceCitation: Cottu PH, Bonneterre J, Varga A, Campone M, Leary A, Floquet A, Berton-Rigaud D, Sablin MP, Lesoin A, Rezai K, Lokiec FM, Lhomme C, Bosq J, Bexon AS, Gilles EM, Proniuk S, Dieras V, Jackson DM, Zukiwski A, Italiano A. Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. PLoS One. 2018 Oct 10;13(10):e0204973. doi: 10.1371/journal.pone.0204973. eCollection 2018.

lead_sponsor: Arno Therapeutics

location_facility:
Centre Oscar Lambret
Institut Curie Oncologie Medicale
Institut Gustave Roussy


title: Prospective Study of the Natural History of Patients With Type 2 and 3 Spinal Muscular Atrophy

acronym: NatHis-SMA

summary: NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to characterize the disease course over 2 years and identify prognostic variables of the disease and biomarkers of SMA progression, as well as determine the best outcome measures for further therapeutics approaches.

ReferenceCitation: Chabanon A, Seferian AM, Daron A, Péréon Y, Cances C, Vuillerot C, De Waele L, Cuisset JM, Laugel V, Schara U, Gidaro T, Gilabert S, Hogrel JY, Baudin PY, Carlier P, Fournier E, Lowes LP, Hellbach N, Seabrook T, Toledano E, Annoussamy M, Servais L; NatHis-SMA study group. Prospective and longitudinal natural history study of patients with Type 2 and 3 spinal muscular atrophy: Baseline data NatHis-SMA study. PLoS One. 2018 Jul 26;13(7):e0201004. doi: 10.1371/journal.pone.0201004. eCollection 2018.

location_country: Germany France Belgium

location_facility: Maladie Neuromusculaire de l'enfant - Service Maladies infectieuses et neurologie infantile - Hôpital Roger Salengro

location_facility: Service de Rééducation Pédiatrique Infantile " L'Escale " - Hôpital Femme Mère Enfant

location_facility: Reference centre for neuromuscular diseases - UZ Leuven - Department of Pediatrics - University Hospitals Leuven

location_facility: Unité de neurologie pédiatrique - Hôpital des enfants

location_facility: Centre de Référence neuromusculaire - CHR La Citadelle

location_facility: Neuropédiatrie - Service de Pédiatrie 1 - CHU Hautepierre

location_facility: Universitätsklinikum Essen (AöR) - Klinik für Kinderheilkunde I - Sozialpädiatrisches Zentrum

location_facility: Centre de référence Maladies Neuromusculaires Nantes-Angers - Hôtel Dieu


title: Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study

acronym: SEROTAMS

summary: Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Limoges
CHU de Toulouse
CHU de Bordeaux


title: Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients

acronym: NEPHROTRAUMA

summary: Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test >0.3


title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

acronym: VHLSUT

summary:
VHL patients may benefit from sunitinib. This study will investigate the following objectives :

PRIMARY OBJECTIVE

To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.

SECONDARY OBJECTIVES

To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
To evaluate quality of life in VHL patients receiving sunitinib.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Hospital Saint André - Service de cancérologie

location_facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale


title: Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers

acronym: PREFAC-CRT

summary: Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.