A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing...
Chronic SinusitisThe goal of this clinical trial is to learn about the safety and effectiveness of Novabel bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to answer are: The safety of this device for the chronic sinusitis The effectiveness of this device for the chronic sinusitis Participants will be implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure. Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.
Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico
Heart DiseasesType2 Diabetes13 moreThe overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.
Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments
Chronic DiseaseThe presence of a clinical pharmacist (for their pharmacological expertise) and a general practitioner (for their somatic expertise) in surgery departments would contribute to improve the management of medications in elderly patients.
Adapted Physical Activity Centre (in the) CITY for Elders Aged 70 and Over With at Least One Long...
Chronic DiseaseElders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
Older AdultChronic Disease3 moreThe hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization. The main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay. The secondary objectives are to measure the impacts of EOPC's intervention on: unexpected readmissions, emergency use, medical complications and adverse drug reactions; patient and health professional satisfactions (community pharmacists and physicians); the costs of drug treatments in ambulatory care.
RIVER At Home Ketamine Protocols
Chronic ConditionChronic Pain4 moreMultiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).
Evaluate the Effectiveness of a Virtual Community of Practice
Chronic DiseasesObjective: To evaluate and compare the effectiveness and cost-effectiveness of a Virtual Community of Practice (VCoP) via a web-based application versus individual and self-administered online education to improve the activation of middle-aged people with multimorbidity. Design: Randomized controlled pragmatic clinical trial with two parallel arms and 18 months follow-up. Setting: Primary health centres and hospitals (Catalonia, Madrid, and the Canary Islands). Population: Middleaged people (30-60 years old) with multimorbidity (≥=2 chronic diseases). Sample size: 240 patients. Randomization: all participants will be randomly assigned to the intervention (VCoP) or the active control group. Data analysis will be blinded to intervention allocation. Intervention: The intervention group will be offered participation for 12 months in a VCoP based on a gamified web-based application. The control group will receive individual, content-focused education through a web platform that will cover the same topics as the VCoP but will be self-administered and without social interaction within the platform. Measurements: The main variable will be measured using the Patient Activation Measure (PAM) questionnaire at baseline, 6, 12 and 18 months. Secondary variables: participant sociodemographics, depression (PHQ-9), anxiety (HADS-A), treatment burden (TBQ), quality of life (EQ-5D-5L), variables related to the use of health resources and to the use of the VCoP. Analysis: Mixed-effects linear regression will be used to determine the effects of the VCoP on the changes in patient activation. Scores at baseline, 6, 12 and 18 months will be included as a fixed effect variable, and the patient and health professional as random effect variables. Analyses will be performed on an intention-to-treat basis. An economic evaluation will be carried out to analyze the cost-effectiveness of the VCoP compared to active control, from the National Health System and social perspectives.
Ketamine Treatment Plans for Chronic Conditions
Chronic PainDepressive Disorder2 moreA study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.
Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study
Cardiometabolic SyndromeThis is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.
Viral and Epigenetic Influences in CRSwNP
Chronic Rhinosinusitis (Diagnosis)Background/rationale While multiple disorders feature a Type 2 (T2) inflammation, triggers for T2 remains unknown. In Chronic Rhinosinusitis with Nasal Polyposis CRSwNP), a classic Type 2 disorder, dysfunction of the epithelial barrier is suggested by loss of epithelial cell differentiation, impaired response to wounding, and impairment of innate defense mechanisms. After unsuccessful attempts to describe T2 disorders solely by host genetic or environmental factors, the role of epigenetics in the modification of innate immune response and epithelial integrity appears an important unexplored mechanism for a novel appreciation of T2 disease. In addition, the investigators explore the possibility that these changes may be induced by viral pathogens. This concept has been supported by the recent observation that SARS-CoV-2 viral reduction measures resulted in a reduction of the frequency of respiratory viruses and a concomitant reduction in chronic airway disease, suggesting a role for viruses in T2 disease. Hypothesis The investigators believe T2 chronic rhinosinusitis (CRSwNP) involves epigenetic mechanisms where external factors, possibly viruses, contribute to disease via epigenetic manipulation and/or chronic viral infection. Objectives The investigators aim to identify epigenetic signatures associated with T2 CRS and explore the contribution of viruses. Method A robust methylation profiling with extensive coverage will be used for epigenome-wide association studies in T2 CRS patients assessing healthy subjects, CRS patients in remission, and diseased patients undergoing surgery. Moreover, advanced transcriptomic and metagenomic methods will identify gene expression profiles and viruses. This proposal also includes a cross-sectional study of patients undergoing surgery to assess transcriptomic patterns and epigenetics at the single-cell level. Expected outcome The investigators expect to identify epigenetic biomarkers and implicate several pathogenic viruses to open new targets for novel therapies.