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NCT ID: NCT05304715 Completed - Mortality Clinical Trials

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

BEYOND
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) who are at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND randomized clinical trial (RCT) is to investigate if adjunctive bezlotoxumab treatment to the current standard-of-care may decrease the likelihood of unfavorable outcome for patients who score positive by the BEYOND score.

NCT ID: NCT05304520 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis (RRMS)

A Study for Tysabri Participant Preference

Start date: October 12, 2021
Phase:
Study type: Observational

The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

NCT ID: NCT05303623 Completed - Clinical trials for Intensive Care Unit Acquired Weakness

The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients.

NCT ID: NCT05303025 Completed - Clinical trials for Artificial Intelligence

Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a CDSS Based on AI in the ICU

KATRINA
Start date: April 13, 2022
Phase:
Study type: Observational

The goal of this study is to explore the different attitudes and preconditions of potential end-users (doctors & physicians in training) required to achieve successful clinical implementation of models based on artificial intelligence (i.e. both machine learning and knowledge-driven techniques) as clinical decision support software.

NCT ID: NCT05302011 Completed - Clinical trials for Esophageal Squamous Cell Carcinoma

Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients

NCT ID: NCT05300802 Completed - Clinical trials for Cardiopulmonary Bypass

The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study

Start date: December 16, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, the prevalence is 43.200 out of 4.8 million births annually. The morbidity and mortality of cyanotic CHDs in the National Cardiovascular Center Harapan Kita (NCCHK) are higher than acyanotic CHDs. Open-heart surgery using a cardiopulmonary bypass (CPB) machine temporarily takes over the function of the heart and lung during surgery. However, the use of CPB has several negative effects such myocardial injury, systemic inflammation, and reperfusion injury. Preoperative hypoxia in cyanotic CHD tends to be associated with a higher risk of myocardial injury. Myocardial protection has an important role in attenuating those effects. Generally, we use a cardioplegia solution as myocardial protection, but there are several non-cardioplegia techniques that can be used to enhance myocardial protection during cardiac bypass, such as adding an anesthetic agent. Dexmedetomidine (DEX) is the active dextroisomer of medetomidine, a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of proinflammatory cytokines released. Research related to the priming and infusion of DEX during CPB in patients with cyanotic CHDs who are undergoing open-heart surgery is less reported. The aims of this study are to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study is pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score.

NCT ID: NCT05300633 Completed - Clinical trials for Substance Use Disorders

Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention

CRAFT-EPI
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

The goal of this pilot feasibility and proof of concept study is to evaluate whether Community Reinforcement and Family Training (CRAFT) as adapted for group delivery in an early psychosis intervention (EPI) program has a clinically significant impact on the concerned significant other (CSO) and Identified patient (IP), and whether a larger, definitive trial is feasible. The intervention aims to improve treatment engagement and reduce distress, as reported by the CSO. To assess feasibility of the intervention for a definitive trial of CRAFT-EPI, the investigators will evaluate recruitment, retention, and assessment completion rates.

NCT ID: NCT05298540 Completed - Clinical trials for Postoperative Cognitive Dysfunction

Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery

FACCT
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aims of this study are to (1) evaluate the feasibility and acceptability of a home-based computerised cognitive training programme in the postoperative cardiac surgical population, and (2) estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.

NCT ID: NCT05297188 Completed - Sleep Clinical Trials

The Effect of Ergonomic Sleep Mask Usage on Patients' Sleep Quality and Comfort

Start date: September 1, 2020
Phase:
Study type: Observational

In intensive care units, the sleep quality of patients decreases considerably due to reasons such as alarm sounds of some special devices, the number of healthcare professionals working in comparison to other clinics, their circulation is high, and the lights are constantly on.Studies conducted in intensive care units to facilitate the transition of patients to sleep and to improve sleep quality;has revealed that non-pharmacological applications increase sleep time and quality, reduce sleep disturbance,delirium,post-traumatic stress disorder and duration of stay in the intensive care unit.Although wearing earplugs and eye masks is a cost-effective and safe method and can improve perceived sleep quality in patients,eye masks and ear plugs are sometimes not comfortable.While the ear plugs dislocate during night sleep may cause the patients to wake up again,there are also situations such as the eye masks not being sized properly for the patients' eyes,and the part of the mask surrounding the head is thin and tense, disturbing the patient.By eliminating this situation that disturbs the patients, other solutions are needed to increase the quality of sleep without being affected by intensive care light and noise. The project was planned to determine the effect of the ergonomic sleep mask on the sleep quality and comfort of patients in surgical patients whose treatment and care continues in intensive care units.The sample of the project consists of 128 patients by performing power analysis.Patients will be divided into two groups as 64 randomized patients in the control and experimental groups by applying block randomization.While there is no application to the experimental and control groups on the first night, an ergonomic sleep mask will be worn to the experimental group,and an ear plug and eye mask will be worn to the control group.At the end of the first night and the second night, the sleep quality of the patients will be evaluated with the 'Richard Campell Sleep Scale' and their comfort levels with the 'Visual Analogue Scale'.The data of the project will be collected using the Patient Information Form prepared in accordance with the literature. In the analysis of the data,Mann-Whitney U test, t test in independent groups, one-way ANOVA test and correlation analysis will be done.

NCT ID: NCT05295836 Completed - Clinical trials for Antioxidative Stress

Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

This clinical study evaluates the acute effect of glycerol ingestion on performance (power output), weight, urine specific gravity, biochemical (antioxidants and lactate) and metabolic (indirect calorimetry) markers in international athletes in hot conditions. The investigators hypothesized that acute glycerol ingestion can prevent performance loss (power generated at submaximal intensity) in hot conditions. To justify this hypothesis, the investigators will measure the aforementioned markers, which could establish a cause-effect relationship between acute glycerol intake and decreased performance loss in hot conditions.