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Filter by:UROGEN WELL D-ONE Principal research question: Can the UROGEN WELL D-ONE assay detect urinary tract infections and urethritis in clinical samples from patients attending Genitourinary Medicine outpatient clinics as accurately as standard laboratory microscopy and culture methodologies, while simultaneously identifying antimicrobial resistance? The primary aim of this study is to evaluate the rapid diagnostic assay UROGEN WELL D-ONE and determine if it can accurately detect infectious organisms causing UTI's and urethritis. Secondary research question: Is the antimicrobial resistance identified by the UROGEN WELL D-ONE assay accurate as compared to determination by the Clinical and Laboratory Standards Institute international guidelines? The secondary research objective will be to assess the accuracy of the breakpoint antimicrobial susceptibility measurement by the assay. This is particularly important with the global increase in antibiotic resistance, when the acquisition of mobile resistance genes to the remaining effective therapeutics is rising internationally.
In German cardiac rehabilitation clinics the number of patients with reduced ejection fraction is continuously increasing since years. Approximately 2,000 patients with cardiac diseases were treated per year per clinic and LVEF < 40% was often found in patients. The mean length of stay in the rehabilitation clinics is 21 days, which gives the chance and the necessity to optimize not only medical therapy. Here, all relevant baseline parameters (indication for rehabilitation, all clinical diagnoses, age, sex, BMI, echocardiographic parameters such as LVEF or diastolic dysfunction, laboratory parameters corresponding to the recording standard of the clinic, etc.) will be recorded in an electronic CRF. Medical treatment is recorded at the drug class level and enquires about the use of the following drug classes: betablockers (BB) (yes/no), angiotensin converting enzyme inhibitors (ACEI) (yes/no), angiotensin receptor blockers (ARB) (yes/no), aldosterone receptor antagonist (yes/no) and diuretics (yes/no). Furthermore, treatment according Guideline ESC 2016 (yes/no) will be recorded in all patients at initial presentation and follow-up as well as if recommended target dose was reached (yes/no). New York Heart Association (NYHA) quantification of heart failure symptoms will be noted. Furthermore, NT-proBNP at baseline and, if available, at discharge, Quality of Life (SF-12), anxiety and depression (HADS-D) will be determined and non-drug therapy including nutrition (minimal nutrition assessment = MNA) (5) and exercise (patient exercise diary) will be investigated during inpatient rehabilitation and follow-up period. After discharge, patients will be contacted by mail after three and twelve months. Here, general questions about drug therapy and dosages, re-hospitalizations especially in connection with HFrEF are recorded in a standardized questionnaire. If postal response cannot be achieved, a telephone contact will be carried out. Drug therapy with special regards to HFrEF will be documented by comparing drug lists at demission to the patient reported drugs, which are taken at time of follow-up. The patient will be asked whether medication has been changed and if so, why, and who changed it. The observational design of the project allows no exact calculation of sample size, however, inclusion of 500 patients is aimed (50 patients per site). Continuous variables will be described using summary statistics: mean, standard deviation, median, 25% and 75% percentiles, and minimum and maximum values. Categorical variables will be described using number and percent per category. For comparison of change from clinic entry endpoints, which are normally distributed variables, the paired sample t-test will be used. The Wilcoxon signed rank test will be used to assess skewed change variables, which do not meet the normality assumption. For categorical variables, the chi-square test will be employed. Statistical analyses were performed using SPSS® software, V24 (SPSS Inc., Chicago, Illinois).
The microbiome can affect skin health from the gut-skin axis, from environmental exposure, and topical treatments. Decreasing biodiversity of skin microbiota has been linked to inflammatory conditions, allergies, and skin health. This cross sectional study will be used to survey healthy volunteers and measure the density and diversity of skin flora of varying skin types. The aim of this study is to identify associations between the skin flora and characteristics of healthy skin types.
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study. The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB). The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group. The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.
The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.
Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.
Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI
Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment, yet hospital caregivers (HCGs) are ill-prepared to manage patients with ADRD with less than 5% reporting mandatory dementia care training. Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological Symptoms of Dementia (BPSD) associated with functional and cognitive decline, increased resource consumption, institutionalization, premature death, and caregiver burden. The overall objective is to test the preliminary efficacy of an innovative model of care, PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (PES) to deliver dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants with training in crisis-prevention techniques provide care to psychiatric patients. On the intervention unit, these mental health assistants, as PES, purposefully engage patients with BPSD. In the pilot study, investigators found patients with cognitive impairment admitted to the PES unit were significantly less likely to require constant observation, chemical and physical restraints, suggesting improved management of BPSD. The central hypothesis is that PES-4-BPSD will improve the ability of PES to create an "enabling" milieu that addresses factors leading to BPSD and improves the experience of hospital caregivers. Guided by a social-ecological framework, PES-4-BPSD incorporates dementia education and training, environmental modifications-cohorting, increased staffing-PES, and staff support. The investigators' multidisciplinary research team is well-positioned to accomplish the following: Aim 1) Determine the preliminary efficacy of PES-4-BPSD for reducing BPSD during hospitalization (please refer to NCT# 04481568 for more details on this aim), and Aim 2) Evaluate whether dementia care training improves the perceived ability of PES staff (intervention) and nurse assistant staff (control) to care for hospitalized persons with ADRD. For Aim 1, investigators will conduct a non-randomized preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79 control, 79 intervention). The primary outcome will be presence of BPSD during hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2, investigators will use survey methodology in a repeated measures design to evaluate within and between-group differences in attitudes, experience, and satisfaction toward managing patients with ADRD. Measures will be completed at baseline (T1), immediately following training (T2), and at the end of the intervention period (T3). This proposal will be the first to study an innovative model of care utilizing PES as specialized hospital caregivers for reducing BPSD in the hospital setting. The investigators' findings will lay the essential groundwork for a multi-site trial of PES-4-BPSD and inform the development of a program that can be easily implemented in other hospitals.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with Metastatic Castration Resistant Prostate Cancer