Clinical Trials Logo

Filter by:
NCT ID: NCT05471986 Not yet recruiting - Clinical trials for Diabetic Retinopathy

Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

Start date: August 1, 2024
Phase:
Study type: Observational

This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.

NCT ID: NCT05488080 Not yet recruiting - Pain Clinical Trials

PAINED: Project Addressing INequities in the Emergency Department

PAINED
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.

NCT ID: NCT05491382 Not yet recruiting - Blood Pressure Clinical Trials

Muscle and Body Temperature Responses During Uphill and Downhill Running

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

In animal models of thermoregulation (how the body regulates heat), heat-sensitive nerve cells that help regulate body temperature have been identified throughout the body (e.g. in muscles, viscera, and blood vessels, among others); however, in human thermoregulation models, only two locations are generally recognized: the core (brain) and the skin. The limited number of recognized locations in humans are likely due to the difficulty in testing these locations in humans, as these locations are typically identified in animals by sedating them, surgically opening them up, stimulating the area of interest with a hot or cold probe, and then measure thermoregulatory responses. Based on the literature, the researchers believe that by having participants run at the same energy expenditure but at three different inclines (uphill, downhill and flat) on a treadmill, the researchers can independently alter muscle temperature, while keeping core and skin temperature the same. Additionally, recent studies have suggested that temperature has a greater role at regulating blood flow through muscle tissue than previously recognized. Because of this, the researchers aim to have a second arm of the study to see whether these differences in muscle temperature result in differences in post-exercise blood flow to the muscle. Finally, downhill running is often used to study exercise-induced muscle damage, due to the greater breaking forces compared to flat land running. Because of this, a third study aim will be to examine the association between fitness level, body morphology and sex on exercise-induced muscle damage.

NCT ID: NCT05526196 Not yet recruiting - Clinical trials for Driving Under the Influence

Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes

CASE-CT
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Co-administration of cannabis and tobacco is a common practice, but there is little experimental evidence aimed at understanding the reasons for this prevalence. Some preliminary evidence suggests that tobacco may actually counteract the cognitive-impairing effects of cannabis, and may also increase the subjective ('liking') effects of cannabis, but results are inconclusive. Further, there are no studies into the effects of tobacco on other cannabis-related harms such as driving, or on the ability of tobacco to alter the blood levels of THC, the chemical responsible for the psychoactive properties of cannabis. The purpose of the present study will be to evaluate the effects of tobacco, cannabis or combinations of tobacco and cannabis on driving, cognition, subjective effects and blood THC. Driving will be assessed using a state-of-the-art driving simulator that allows for the safe and objective measurement of the effects of intoxicating substances on driving. Participants will be regular users of cannabis and will be invited to the lab for four counterbalanced test sessions. In these test sessions they will drive the simulator and undergo cognitive tests before and after smoking: 1) cannabis; 2) tobacco; 3) cannabis + tobacco; or 4) placebo. Outcomes will be measured at several time points after smoking the product. Participants will also give blood for determination of levels of THC, and will complete subjective effects questionnaires both before and after smoking the cigarette. This study will be one of the first experimental laboratory studies of the reasons behind co-administration of tobacco and cannabis.

NCT ID: NCT05548205 Not yet recruiting - Diabetes Clinical Trials

Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.

NCT ID: NCT05633550 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

SPSI Validity and Test-Retest Reliability Study

Start date: August 1, 2024
Phase:
Study type: Observational

Orthopaedic surgeons are often faced with the clinical dilemma of whether or not to add fusion to a decompression procedure. To decide between these two surgical options, surgeons rely mostly on their experience to conclude if a level is unstable preoperatively or if a specific decompression procedure is likely to destabilize the spine. Recently, the Sagittal Plain Shear Index (SPSI) has been developed as a valid test for determining the degree of spinal (in)stability. The SPSI metric, which can be calculated using flexion-extension radiographs of the lumbar spine, informs the orthopaedic surgeon about whether the spine is stable in and of itself (necessitating decompression surgery only) or whether there is spinal instability (necessitating decompression and additional fusion surgery). The SPSI metric can be calculated using both the validated semi-automated QMA® and more recently developed fully automated Spine CAMP software platforms. The concurrent validity between these two software platforms, as well as the reliability of both of these objective diagnostic indicator for spinal instability have not yet been evaluated. This study will investigate if SPSI-metrics/values obtained with Spine CAMP are equivalent to measurements from QMA®, and will also investigate the repeatability of two measurements of the SPSI taken one hour apart ('test-retest reliability').

NCT ID: NCT05641766 Not yet recruiting - THC Clinical Trials

Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

THC-MEG
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.

NCT ID: NCT05647096 Not yet recruiting - Sepsis Clinical Trials

Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating cfDNA/NETs in Subjects With Sepsis

NUC-CAP
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in sepsis patients.

NCT ID: NCT05682664 Not yet recruiting - Telemedicine Clinical Trials

Luchtbrug Junior: the Next Step

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Rationale: The introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, "Luchtbrug", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age). Objective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50% Study design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care. Follow-up: 12 months. Study population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea). Intervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135) Main study parameters/endpoints: Primary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months). Secondary objectives: Healthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents/caregivers. Usual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire. Online care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents/caregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents/caregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.

NCT ID: NCT05759663 Not yet recruiting - Muscle Diastasis Clinical Trials

MIRRAD Versus Plication of Entire Diastasis Trial

MIRRADRCT
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Background Postpartum diastasis of the rectus abdominis muscles (DRAM) has gained increasing attention as a condition that may affect abdominal trunk function but that may be alleviated by surgery. Most techniques for surgical reconstruction of DRAM are, however, associated with high costs, postoperative pain and risk of surgical complications. The aim of the present study is to evaluate a Minimal Incision Repair of Rectus Abdominis Diastasis (MIRRAD) in a randomized controlled open label trial. Altogether 120 women will be included. Population Postpartum women with DRAM of at least 2 cm. Intervention Plication of Linea alba through a 3-5 centimeter long incision at the level of the umbilicus Control Plication of the entire Linea alba through a low transverse incision. Outcome Primary outcome: Abdominal function rated with the Disability Rating Index Secondary outcomes: Operative time, postoperative stay, surgical complications, sick leave, persisting pain orated with the Ventral Pain Hernia Questionnaire, cosmetic outcome rated with BODY-Q Follow-up Follow-up one month and one year after surgery Significance If the study shows that MIRRAD is equally effective as plication of the entire Linea alba one year after surgery, it may be introduced as a standard technique for DRAM. If it is not as effective, it may still be an alternative with advantages in terms of cost benefit and the possibility to perform it as a daycare procedure.