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Found 7 Actively Recruiting clinical trials

C

RECRUITING

Patients recruitment will be curry out in 31 geriatric or cardiologic centres. Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months). The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data. Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre. The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution. Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death

80+ yearsAll Genders
36 locations
E

RECRUITING

ICOPE Trail.Fr is a comparative, multicenter, randomized (1:1), two-arm parallel intervention trial, stratified by center and the number of impairments present at inclusion, open-label, controlled, comparing the effectiveness of the comprehensive ICOPE strategy in preventing functional decline in elderly individuals aged 70 and over living at home, versus the usual care provided by their primary care physician. Participants will be randomized either 1) into the Intervention group, where they will receive the comprehensive ICOPE intervention program, adapted and personalized to their areas of deficit, or 2) into the Control group, where they will be referred to their primary care physician to receive usual care tailored to their health status. Follow-up visits take place at the investigator's center at V2 (12 months), V3 (24 months), V4 (36 months), V5 (48 months), and V6 (60 months). Data related to functional scales are collected by the research nurse, who is blinded to the randomization results. Phone calls will be at 6 (A1), 18 (A2), 30 (A3), 42 (A4), and 54 (A5) months to collect relevant life events. The intervention duration is 36 months, followed by a 24-month extension phase during which all study participants will receive the comprehensive ICOPE intervention.

65+ yearsAll GendersNA
6 locations
E

RECRUITING

This multicentric investigation is planned to include 108 patients in France who will be followed up to 52 weeks. Patients meeting all eligibility criteria will be randomized on a 1: 1 ratio into one of the two following treatment groups: active RGn600 device or sham device (inactivated RGn600). The site investigation teams and patients/caregivers will be blinded. The device will be applied to the patients during 26 weeks through 20-min onsite sessions following the below pattern: * 5 treatment sessions per week from Week 1 (W1) to W8 * 3 treatment sessions per week from W9 to W16 * 2 treatment sessions per week from W17 to W26 Throughout the investigation, patients will be treated per randomization with the device initially allocated by the IWRS. Follow-up will continue up to W52 ± 2 weeks At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, date of AD diagnosis, comorbidities, concomitant medications, sociological data. A blood sample for APOE genotyping will be also performed. Endpoints will be evaluated during 4 onsite visits at Day 0 (Inclusion, randomization to the active or sham group and first treatment session), W8 (last treatment session of), W26 (last treatment session of) and W52 ± 2 weeks. During these visits: * Patient's cognition and autonomy will be assessed through neurological scales and/or neuropsychological tests * Patient's quality of life and medico-economic interest of RGn600 treatment with regards to healthcare consumption will be assessed through questionnaires fulfilled by the patient himself/herself with the help of his/her caregiver * The safety of RGn600 will be assessed : collection of all AEs and device deficiencies, blood samples for safety analysis, clinical exams Within the context of this investigation, a biobank will be created based on blood, fecal and saliva samples of patients included by Toulouse University Hospital Gerontopole site: * Blood samples will be collected for all patients included by this site (at D0, W26 and W52) * Fecal samples will be collected for the first 30 consecutive patients included by this site (at D0, W26 and W52). * Saliva samples will be collected for the patients included by this site after the substantial modification approval (at D0, W26 and W52). The biobank will be located at the site. The objective of this biobank will be to perform subsequent analysis on blood samples of AD blood markers. Other analyses might be conducted on blood, fecal and saliva samples as well such as Inflammatory blood markers (iAGE), fecal microbiota and metabolome and salivary micro RiboNucleic Acid (microRNAs)

55-85 yearsAll GendersNA
6 locations
I

RECRUITING

Double blind controlled study versus placebo. Patients with suppurated CSD's lymphadenitis will receive immediately after the pus aspiration (performed for a diagnostic purpose) an intra-nodal injection of gentamicin or of placebo (NaCl 0,9%) and be treated with oral azithromycin for 5 days.

18+ yearsAll GendersPHASE3
21 locations
P

RECRUITING

PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment) Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders. Secondary Objectives: A- To evaluate the impact of a personalized intervention at 18 months on: For the patient: 1. Unscheduled hospitalizations, 2. Severity of agitation symptoms, 3. The frequency and severity of emerging psycho-behavioral symptoms, other than agitation, 4. Prescription of psychotropic drugs, 5. Quality of life. For the caregiver: 6. Distress related to psycho-behavioral symptoms, 7. All causes hospitalizations, 8. Quality of life. B- Evaluate the medico-economic impact of this personalized intervention, and in particular: 1. Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months, 2. The actual cost of patient's standardized assessment and personalized management 3. The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.

60+ yearsAll GendersNA
16 locations
Q

RECRUITING

Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital. Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient. Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally. Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.

18+ yearsAll GendersNA
6 locations
R

RECRUITING

There is a great heterogeneity in the practice of rapid sequence induction in the operating room in the world. There are no recent data assessing the rate of implementation of the latest French formalized expert recommendations in clinical practice. In addition, the modalities for the management of haemodynamic disorders, particularly hypotensive disorders, during rapid sequence induction are not described in these recommendations, although these are frequent events with a non-zero morbidity mortality potential. The goal of this prospective, observational, multicenter, anesthetic study is to describe the clinical practice of French anesthesiologists regarding the prevention of severe hemodynamic disorders during rapid sequence anesthetic induction in adult patients. The primary outcome measure is the occurrence of a major haemodynamic disorder defined by a MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or the occurrence of sustained arrhythmia not present at induction and/or cardiac arrest within the first 10 minutes after induction of anesthesia. The clinical practices of pre-oxygenation, induction and intubation of French anesthesiologists and compliance with the formalized expert recommendations of 2017 and 2018 will also be studied secondarily. The elements for the prevention of gastric fluid inhalation, the organization and equipment used, the anesthetic and non-anesthetic drugs used, the clinical and paraclinical neurological and cardio-respiratory parameters and the nature of the complications following anaesthetic induction will be collected up to the 10th post-induction minute.

18+ yearsAll Genders
42 locations
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