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NCT ID: NCT04873557 Completed - Clinical trials for Healthcare Associated Infection

Copper Use as Protection Against Antimicrobial Resistance in the ICU

CUPRIC
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

CUPRIC is an investigator initiated and conducted, prospective, quasi-experimental study to determine whether the combined use of copper-alloyed objects plus copper-enriched textiles reduce the burden of MDRO colonization and HAIs incidence in the critically ill population.

NCT ID: NCT04867135 Completed - Clinical trials for Neonatal Sepsis, Late-Onset

Population Pharmacokinetics of Amikacin in Neonates

Start date: December 1, 2019
Phase:
Study type: Observational

Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. Despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population. In addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis. Due to the lack of pharmacokinetic and pharmacodynamic (PK / PD) studies of Amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.

NCT ID: NCT04863170 Completed - Clinical trials for Health-related Quality of Life

Cross Cultural Adaptation and Validation of Orthognathic Quality of Life Questionnaire (OQLQ)

Start date: November 21, 2018
Phase:
Study type: Observational

The aim of this study was to develop a Spanish version of the Orthognathic Quality of Life Questionnaire (OQLQ) that is conceptually equivalent to the original questionnaire, as well as acceptable, reliable, valid, and responsive for use in Chilean patients with dentofacial deformities.The cross cultural adaptation process was carried out according to the recommended standard methodology with direct and back-translation.

NCT ID: NCT04823533 Completed - Healthy Lifestyle Clinical Trials

Improving Wellbeing Through the Brain-Gut-Microbiota Axis

IBMA
Start date: March 30, 2021
Phase: N/A
Study type: Interventional

Well-being is a state defined as the optimal psychological functioning and the experience associated with it, integrating physical and subjective factors. It has been suggested that the bidirectional interaction between the brain and the rest of the body is fundamental in the regulation of wellbeing levels. In particular, the gastrointestinal system (modulated by the microbiota) sends information that is integrated by the brain, affecting its functioning and mental processes. However, the mechanism of such communication is still unknown. The aim of this proposal is to study the different ways in which psychological processes can influence gut signals and vice versa, and how this relationship might be trained or modified in order to improve wellbeing.

NCT ID: NCT04809701 Completed - Clinical trials for Ventricular Arrythmia

Non-vascular ICD Electrode Configuration Feasibility Study

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.

NCT ID: NCT04799041 Completed - Acute Pain Clinical Trials

Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study

Start date: October 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial. The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.

NCT ID: NCT04786275 Completed - Pain Clinical Trials

Evaluation of the Nociception Guided by NoL Index and PK of Fentanyl in Pediatric Patients Under General Anesthesia

NoLPedFenta
Start date: December 1, 2020
Phase:
Study type: Observational

Fentanyl is one of the most common used opioids for analgesia during general anesthesia, however there are few studies that describe the relationship between its pharmacokinetics and pharmacodynamics, especially in the pediatric population. The monitoring of the analgesia component during general anesthesia has been traditionally by changes in patient's vital signs, with new devices that measure nociceptive indexes like the Nociception level (NoL) index currently being validated for adults. There is still lacking evidence with nociceptive indexes in the pediatric population. Insufficient dose of opioids may cause sympathetic response, respiratory complications, development of persistent post-surgical pain and even prolonged hospitalization. In the other hand, and overdose of opioids may cause over sedation, postoperatory nausea and vomiting, respiratory depression, hyperalgesia and tolerance. Given the lack of evidence on the Pharmacokinetic and pharmacodynamic (PK/PD) of fentanyl in this group of patients, has led to raise the development of this observational prospective study; which is to describe a PK/PD model of fentanyl in pediatric population, through evaluation of the NoL index, in patients submitted to elective general non-cardiac surgery.

NCT ID: NCT04783662 Completed - Frailty Clinical Trials

Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients

Start date: May 13, 2021
Phase:
Study type: Observational

Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. It has been associated with worse results in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. Currently, there are several instruments for diagnosis and screening of frailty. All of them require time for their execution, an experienced evaluator and an adequate validation in the population in which they are intended to be used. The use of frontal electroencephalography during the intraoperative period has become increasingly popular. It allows the monitoring of brain activity during the administration of anesthetics. Various intraoperative electroencephalographic markers, such as alpha spectral power or total spectrum power, have been associated with factors such as preoperative physical activity, preoperative cognitive level, comorbidities, and postoperative delirium. The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in ≥ 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery.

NCT ID: NCT04781816 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

CLEan
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: - Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) - Assess the effect of SAR443122 on CLE induced itch and overall pain - Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo - Assess the effect of SAR443122 on the CLASI components score - Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) - Assess oral cavities for patients with oral lesions - Assess the disease specific quality of life (QoL) - Assess the safety and tolerability of SAR443122 in patients with CLE - Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

NCT ID: NCT04779567 Completed - Acute Pain Clinical Trials

Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients

Start date: June 10, 2019
Phase: Phase 4
Study type: Interventional

Cancer pain is one of the most frequent and relevant symptoms in cancer patients and has a great impact on a patient's quality of life. International and local standards recommend as an initial strategy, the use of an analgesic scheme composed of strong opioids (morphine, methadone or fentanyl) associated with adjuvants such as paracetamol, based upon the assumption that the use of combined analgesics could have a better analgesic effect, could allow the use of lower dose of opioids and that also could prevent the occurrence of adverse effects of opioids. However, there is uncertainty about the impact of paracetamol as an adjuvant in patients who use strong opioids for pain management in cancer patients with moderate to severe pain. To clarify this question, this study aims to evaluate the efficacy and safety of intravenous paracetamol associated with strong opioids in hospitalized cancer patients who have pain associated with cancer of moderate to severe intensity, (4 or more), older than 18 years. Randomized double-blinded controlled study comparing intravenous acetaminophen 1 gr 4 times a day versus placebo for 48 hours as an adjuvant to strong opioids. We will assess pain intensity as a primary outcome validated assessments that estimate Verbal Numerical Rating Scale (VNRS) analogous verbal pain from 0 to 10, and de visual Analog Scale (VAS). We estimated that a decrease of 1 point on the verbal numerical scale would be statistically significant. In addition, the investigators will calculate the amount of total opioid dose in 24 hours and then perform the intervention. As a secondary outcome, adverse effects such as drowsiness, constipation, nausea and vomiting would be evaluated