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NCT ID: NCT06176352 Recruiting - Clinical trials for Choroidal Neovascularization Secondary to Pathologic Myopia

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

POYANG
Start date: March 6, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).

NCT ID: NCT06175611 Recruiting - SARS-CoV2 Infection Clinical Trials

Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

Start date: December 10, 2023
Phase:
Study type: Observational [Patient Registry]

The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: 1. ClariLight Influenza A/B & SARS-CoV-2 test kits and 2. ClariLight Influenza A/B & RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.

NCT ID: NCT06175234 Recruiting - Atrial Fibrillation Clinical Trials

Feasibility Study on the FARAVIEW Technology

NAVIGATE PF
Start date: April 3, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to gather data regarding the utilization of the FARAVIEWâ„¢ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects undergoing catheter-based endocardial mapping and catheter-based ablation treatment of Atrial Fibrillation.

NCT ID: NCT06174987 Recruiting - Metastatic Cancer Clinical Trials

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Start date: January 5, 2024
Phase: Phase 3
Study type: Interventional

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

NCT ID: NCT06174844 Recruiting - Stress Clinical Trials

Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain

HUMANCUIDA
Start date: January 1, 2024
Phase:
Study type: Observational

Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals. Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.

NCT ID: NCT06174649 Recruiting - Clinical trials for Bloodstream Infection

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

FAST
Start date: December 22, 2023
Phase: N/A
Study type: Interventional

This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SOC) antimicrobial susceptibility testing (AST) vs. a rapid AST method known as Revealâ„¢ in addition to SOC AST. The purpose of the FAST trial is to evaluate whether use of a rapid phenotypic AST improves clinical outcomes compared to use of SOC AST methods in clinical settings with high resistance rates.

NCT ID: NCT06173570 Recruiting - Dyslipidemia Clinical Trials

A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

PURSUIT
Start date: January 19, 2024
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

NCT ID: NCT06173518 Recruiting - Clinical trials for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)

Start date: November 16, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase Ib study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL)

NCT ID: NCT06172712 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A

CSA
Start date: May 8, 2024
Phase:
Study type: Observational

This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.

NCT ID: NCT06172647 Recruiting - Colorectal Cancer Clinical Trials

Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer

CMBACT
Start date: June 1, 2022
Phase:
Study type: Observational

Microscopic colitis (MC) is an inflammatory bowel disease characterized by chronic non-bloody watery diarrhoea and a macroscopically normal colonic mucosa upon endoscopic exploration (colonoscopy). The diagnosis is performed by microscopic examination of mucosal biopsies that reveal specific histopathological change. Between 4-20% of patients with chronic non-bloody diarrhoea who undergo colonoscopy with serial biopsies are diagnosed with MC. It has long been hypothesized that the microbiome plays a key role in the pathogenesis of MC. In patients with collagenous colitis, faecal stream diversion results in inflammation and histological remission, followed by disease relapse after intestinal transit is reconstructed. Moreover, studies carried out with faecal samples obtained after colonoscopy have demonstrated microbiome changes (reduced alpha diversity and higher microbial dysbiosis index) in patients with active MC. To avoid potential bias due to the effect of colonic lavage prior to colonoscopy in microbiota composition, the researchers of the present study previously evaluated the microbiome in faecal samples obtained before the diagnostic colonoscopy in patients with active MC. The results confirmed a reduced alpha diversity in diarrhoea groups; however, there were no differences between MC, bile-acid diarrhoea and functional diarrhoea. The microbial dysbiosis index was significantly higher in MC compared to the other diarrheal groups, but no bacterial species showed a significantly different relative abundance. On the other hand, the risk of colorectal cancer (CRC) or adenoma seems to be reduced in MC compared to controls. Growing evidence suggests microbial dysbiosis is a crucial environmental factor in the initiation of precancerous lesions of CRC such as adenomas. The objective of the current multicentric prospective study is to assess the differences in the mucosa adherent intestinal microbiome between patients with MC, non-MC chronic diarrhoea, healthy controls and patients with advanced colon adenomas. In addition to the study of the microbiome, sociodemographic variables, history of drug usage, diets and specific characteristics of diarrhoea will be collected. The hypothesis of the present study is that CM presents a specific mucosa adherent intestinal bacterial profile that may be relevant in the pathogenesis of the disease and that, additionally, may also play a protective role against the development of CRC and adenomas.