Ellicott City, Maryland
- Featured
TemPo Studies
**All eligible study participants will receive at no cost:** • Study-related consultation and care • Study visits, tests, assessments, and procedures • Study drugs (investigational drug or placebo)
Phase
N/ASpan
212 weeksSponsor
Cerevel TherapeuticsGrenoble cedex, France
Recruiting
- Featured
La Tronche, Rhone-Alpes
Recruiting
Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer
Phase
N/ASpan
56 weeksSponsor
ARCAGY/ GINECO GROUPGrenoble
Recruiting
Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).
The CELEST double blind RCT demonstrated that 25mmHg elastic compression stockings (ECS) were non inferior to 35mmHg ECS to prevent post thrombotic syndrome (PTS) 2 years after a first proximal deep vein thrombosis (DVT). Likely because of lack of statistical power the investigators were not able to demonstrate that 25mmHg ECS were superior in the overall RCT population and that 35mmHg ECS were superior in patients optimally adherent to ECS. Furthermore, few data are available on the very long term (>5 years). The CELEST Long term is a prospective study, assessing the very long term risk of PTS in patients enrolled in the CELEST RCT. All patients enrolled in CELEST RCT and willing to participate are eligible and will benefit from a 7-year follow-up visit conducted over the phone. Primary objective is to assess the proportion of patients with moderate-severe PTS defined as a patient reported Villalta score (PRVS) ≥10 or a venous leg ulcer ipsilateral to index DVT. Secondary objectives include predictors of moderate to severe PTS, impact of initial ECS strength on the development of moderate-severe PTS, impact of anticoagulant treatment (type and duration) on the development of moderate to severe PTS, proportion of PTS (defined as ≥5 or ipsilateral leg ulcer) and impact of PTS on patient's QOL. Study should last 1 year and up to 288 patients may participate. The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial CE strengths on the risk of PTS.
Phase
N/ASpan
22 weeksSponsor
Laboratoires InnotheraGrenoble
Recruiting
Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
Phase
N/ASpan
114 weeksSponsor
Versailles HospitalGrenoble
Recruiting
A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)
Phase
N/ASpan
406 weeksSponsor
Intergroupe Francophone de Cancerologie ThoraciqueGrenoble
Recruiting
HYPNOSIS DURING PERIOPERATIVE CARDIAC SURGERY
Since 2018, additional care using Ericksonian Medical Hypnosis has been offered to patients undergoing cardiac surgery. Cardiac surgery is one of the most complex and high-risk procedures, requiring a general anaesthetic and a stay in intensive care. Its aim is to reduce pre-operative stress and anxiety, which are always present to varying degrees before this type of treatment. The aim is to put the patient back at the centre of his or her care by making them active and active participants throughout the treatment process. Many studies have demonstrated the benefits of hypnosis in reducing anxiety, depression, pain perception, sedation and comfort during hospitalisation. However, very few studies have looked at the quality of life of these patients for up to a year. Hypnosis support is subject to the number and presence of trained nursing staff. In order to assess the feelings of patients who have benefited from this additional treatment, and to improve our practices, we would like to carry out a satisfaction survey using questionnaires including the EQ5D-5L quality of life questionnaire.
Phase
N/ASpan
135 weeksSponsor
University Hospital, GrenobleGrenoble
Recruiting
Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease
As Parkinson's disease (PD) progresses, the onset of motor and non-motor fluctuations alters patients Quality of Life (QoL). Second-line treatments can then be proposed: either the implantation of deep brain electrodes (Deep Brain Stimulation of the Sub-Thalamic Nuclei (DBS-STN)), or the drug approach (continuous subcutaneous infusion of apomorphine or continuous intrajejunal infusion of levodopa/carbidopa). To date, no randomized double-blind trial has compared the efficacy and adverse effects of these different types of second-line treatments. There is therefore no clearly defined predictive factor that could predict better efficacy of these second-line treatments in patients, or the occurrence of adverse effects leading to discontinuation of these treatments. The choice of treatment must consider patients specific personal needs as well as their clinical phenotype, this constitutes the major challenge of personalized medicine. Thus, personality, which reflects the way a person thinks, reflects, acts and behaves in different situations, appears to be a possible predictive criterion for QoL improvement after second-line treatments. Indeed, using the Temperament and Character Inventory (TCI) self-questionnaire, the investigators have shown that two personality dimensions of the TCI ("Novelty Seeking" and "Cooperativeness") appeared to be predictive of QoL amelioration in PD patients after DBS-STN. Thus, the use of this personality questionnaire, the TCI, enables better prediction of patients therapeutic response after DBS-STN. It could also be useful to predict therapeutic response after other second-line treatments such as continuous subcutaneous infusion of apomorphine. In this study, the investigators therefore propose to evaluate the impact of personality dimensions on therapeutic response after the introduction of this infusion therapy. Investigators carried out a preliminary exploratory study (PSYCHO-PERF study - ClinicalTrials.gov NCT03793491) which showed a significant association between a personality dimension of the TCI ("Reward Dependence") and QoL improvement after six months of continuous subcutaneous infusion of apomorphine in 33 PD patients (article in preparation). This suggests that patients with high Reward Dependence scores may be good candidates for continuous subcutaneous infusion of apomorphine. However, these results need to be confirmed on a larger scale, by means of a multicenter study. Hence, some TCI personality dimensions in PD patients could be predictive of QoL improvement after second-line treatment. Thus, before proposing a second-line treatment, in the context of personalized medicine, personality assessment could be one of the criteria to choose between these different treatments. However, the investigators are aware that PD patients personality can only partly explain the therapeutic response. For this reason, the investigators also wish to include in our study other psycho-bio-social factors (social representations of the disease and treatments, coping strategies and social support perceived by patients) that may influence QoL improvement following treatment. In a more exploratory context, the investigators would also like to assess changes in TCI personality dimensions of PD patients following treatment with continuous subcutaneous infusion of apomorphine, since changes in mood and/or behavior have already been observed. If a change is observed, the investigators will determine whether this change is associated with clinical and demographic data prior to the continuous infusion.
Phase
N/ASpan
111 weeksSponsor
University Hospital, ToulouseGrenoble
Recruiting
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
Multicentre randomized open-label controlled trial. Patients admitted to visceral surgery for aSBO are screened and the study is offered for patients who do not meet the criteria for emergency surgery. If they accept the study, a randomization is carried out by stratification according to (i) the sex, (ii) the center (University hospital/ Peripheral center), (iii) the number of previous episodes of aSBO (0 or ≥1 ) and the value of the radiological score (< or ≥5). Patients are cared for according to the strategy defined by randomisation (standard procedure vs early surgery proposed according to the radiological score). Demographic information, medical and surgical history, and treatments are collected on the day of admission. A visit is made each day (from admission to discharge) to collect information on the surgery (if performed), on the medical management and its success or failure (if applicable), on the recovery of functions gastrointestinal, on perioperative management, on morbidity and mortality. Patients have a follow-up consultation on D30 and D90 postoperative. Any morbidity, mortality or recurrence that occurred during this period is collected. Patients are contacted by telephone after 12 months to ensure that no recurrence of aSBO has occurred.
Phase
N/ASpan
209 weeksSponsor
University Hospital, AngersGrenoble
Recruiting
Predictive Study on Hearing Rehabilitation After Cochlear Implant
Cochlear implants are indicated in France in cases of severe to profound bilateral sensorineural hearing loss with an audiometric threshold of less than or equal to 50% speech discrimination in silence in the Fournier list (or equivalent) at 60 dB, in the free field, with well-fitted hearing aids. Cochlear implant represents a major advance in the management of severe to profoundly deaf patients and has also shown a benefit in the prevention of neurodegenerative diseases. An average of 1800 cochlear implants are placed in France per year, 58% of which are placed in patients over 18 years of age. The results of cochlear implants are in favour of a benefit in speech comprehension compared to hearing aids in cases of severe to profound deafness. However, there is a strong disparity in hearing performance after cochlear implantation from one patient to another, whether in silence or in noise. Several factors influencing the results of the implant have been identified. Some of them are linked to the patient: etiology of the deafness, duration of auditory deprivation, age at implantation, residual hearing, pre- or post-lingual status of the deafness, some others are related to implant surgery (insertion of the electrode in the tympanic ramp, complete insertion, presence of a translocation, depth of electrode insertion). Finally, there are factors related to the quality of the settings of the implant and to the brain plasticity of the patients.The 4 main factors seem to be the duration of the deafness, the age of onset of the deafness, its etiology and the duration of the patient's experience with the implant. It is assumed that the performance of cochlear implantation is strongly related to the individual's auditory processing abilities and the integrity of the central nervous system from the auditory nerve to the cortex. At present, it is very difficult to predict the outcome of cochlear implants in deaf patients with a cochlear implant indication prior to implantation. The results remain variable from one patient to another and, to date, both the etiology and the state of the central auditory pathways are not taken into account in the indication for cochlear implantation. Animal studies have demonstrated anterograde degenerative neural damage in cochlear deafness (presbycusis, endolymphatic hydrops) and such damage is likely to explain the functional variability observed in humans in the case of neural stimulation with cochlear implants. Multiple integration of clinical data to propose a predictive model can now be done using both supervised (Deep Learning) and unsupervised (Manifold Learning) Machine Learning techniques, including for predicting auditory recovery. It is now possible to extend machine learning models to include quantitative data from diffusion MRI with the goal of providing an objective functional parameter from the central auditory pathways, then combined with clinical parameters and genetic to obtain a predictive model of hearing recovery after cochlear implantation. This study will allow us, through the study of brain tractography, to specify the role of the central auditory pathways in the results of cochlear implantation, a role that has not been determined to date, and to evaluate their correlation with clinical and genetic in order to create a predictive model of good auditory rehabilitation in artificial intelligence. The objective is to better select patients who can benefit from a cochlear implant in order to implant them in an optimal timing and to improve indications for cochlear implant.
Phase
N/ASpan
159 weeksSponsor
University Hospital, GrenobleGrenoble
Recruiting