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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: NCT06174519 Completed - Clinical trials for Bacterial Infections

Evaluation of the Artificial Intelligence-based Prescription Support Software iAST® for the Choice of Empirical and Semi-targeted Antibiotic Treatment

EVIAST
Start date: August 1, 2023
Phase:
Study type: Observational

Inadequate treatment of infections frequently leads to complications that cause new visits to the doctor, lengthen hospital stays and can lead to sepsis, even causing the death of affected patients. Several scientific studies have documented that up to 20%-30% of antibiotic prescriptions are incorrect and do not cover the microorganism causing the infection. iAST® is a simple antibiotic prescribing aid tool that applies complex algorithms based on the latest artificial intelligence technologies to accurately predict the best specific antibiotic for a patient, before knowing the definitive microbiological results (bacterial identification and antibiogram). The objective of the present trial is to demonstrate the non-inferiority of iAST® with respect to physicians for the appropriate choice of empiric and semi-directed therapy of common infectious diseases, including sepsis, urinary tract infections and ventilator-associated pneumonias or tracheobronchitis. The adequacy of the medical prescription and the iAST® prediction will be compared taking the antibiogram report as a reference. The study design is retrospective, so that no intervention will be done on the patients. The investigators will conduct a retrospective search for infection cases and note the antibiotic treatment prescribed by the doctors. In parallel, they will enter basic patient data such as age, sex, service where they were treated, type of infection and microorganism (in the case of semi-directed treatment evaluation) into the iAST® software and will write down the first three treatment options recommended by the tool. The treatments of both arms (medical treatment and iAST® prediction) will be compared with the microbiological results and the success rate of each of them will be calculated.

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.

NCT ID: NCT06170788 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Start date: December 15, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

NCT ID: NCT06169748 Not yet recruiting - Fibromyalgia Clinical Trials

UHCDS a-tDCS + TE in Fibromyalgia Patients

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The present study aims to investigate the effect of a Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise on pain in subjects with FM.

NCT ID: NCT06169423 Completed - Perinatal Death Clinical Trials

Simulation of Perinatal Grief. (SPG)

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals.