Mexico, D. F., Mexico
- Featured
Caen Cedex 5, Basse-Normandie
Recruiting
Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.
Phase
N/ASpan
283 weeksSponsor
University Hospital, CaenCaen, Normandie
Recruiting
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Phase
N/ASpan
440 weeksSponsor
Biotronik SE & Co. KGCaen
Recruiting
Brain-injured Patients Extubation Readiness Study
Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation failure is very common in this population due to residual neurological impairment with airway control alteration. Guidelines about weaning of mechanical ventilation and extubation exclude brain-injured patients with a residual impaired consciousness. In 2017, a simple and pragmatic extubation readiness clinical score was validated in a prospective observational cohort study of 140 brain injured patients. (Godet et al. Anesthesiology. 2017 Jan;126(1):104-114) In this study, brain injured patients with residual impaired consciousness who succeeded a spontaneous breathing trial were extubated. In multivariate analysis, 4 clinical elements were associated with extubation success. A prediction score was determined using the odds ratio such as followed : 1. Deglutition: 3 points if present 2. Gag reflex: 4 points if present 3. Cough: 4 points if present 4. CRS-R Score, visual item > 2, 3 points if present, 1 point if not For a cut-off value of 9, extubation failure could be predicted with a sensibility of 84%, a specificity of 75%, a positive predictive value of 89% and a negative predictive value of 66%. In order to participate, brain-injured patients will have to succeed a spontaneous breathing trial and meet all inclusion criteria, including not being able to obey to simple orders without sedation. Using a stepped wedge randomisation process with intensive care units as clusters, patients will be weaned and extubated under usual care or using the extubation readiness clinical score. The authors' hypothesis is that this clinical score will allow physicians to extubate patients at the right time interval and prevent extubation failure in this frail population.
Phase
N/ASpan
401 weeksSponsor
University Hospital, Clermont-FerrandCaen
Recruiting
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Phase
N/ASpan
288 weeksSponsor
University Hospital, LilleCaen
Recruiting
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.
Phase
N/ASpan
496 weeksSponsor
Coloplast A/SCaen
Recruiting
Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).
Phase
3Span
154 weeksSponsor
University Hospital, CaenCaen
Recruiting
Effectiveness and Tolerability of Eqwilate in Real-life Conditions
Phase
N/ASpan
97 weeksSponsor
OctapharmaCaen
Recruiting
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
- Patient treated at the first clinical contact - 18 sites (hospitals) in France - Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA < 50 copies/ml) - Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample
Phase
4Span
111 weeksSponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaCaen
Recruiting
Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).
This is a retrospective cohort study conducted at the Universitary hospital of Caen in three surgical departments (gynecology, urology and digestive surgery). Patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (PFDI-20, ICIQ-SF, PFIQ-7) and satisfaction (PGI-I)
Phase
N/ASpan
200 weeksSponsor
University Hospital, CaenCaen, Normandie
Recruiting