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NCT ID: NCT05603260 Completed - Psychosis Clinical Trials

Imagery Interventions for Auditory Vocal Hallucinations

Start date: April 7, 2022
Phase: N/A
Study type: Interventional

This study explores the feasibility, acceptability, and effectiveness of four imagery intervention techniques (metacognitive imagery intervention, imagery rescripting, promoting positive imagery and competing imagery task) for auditory vocal hallucinations using four single case series with an A-B-A within subject design.

NCT ID: NCT05598905 Completed - Clinical trials for Opioid-induced Respiratory Depression

Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing

POLO
Start date: October 10, 2022
Phase: Phase 4
Study type: Interventional

Opioids are commonly prescribed for moderate to severe pain. While initially intended for moderate to severe acute and cancer pain, opioids are currently frequently considered and prescribed in chronic noncancer pain. Due to the large increase in opioid prescription rate, the number of unintentional drug overdoses is rapidly increasing, not only in the Unites States but also in the Netherlands. A potential lethal consequence of an opioid overdose is opioid-induced respiratory depression. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example alcohol, benzodiazepines, cannabis, neuropathic pain medication including the anticonvulsant pregabaline. There are no high-quality data on the interaction between oxycodone and (neuropathic pain) medication on the ventilatory control system. Case reports and randomized studies show that pregabalin induces respiratory depression when combined with opioids. Some alternatives to pregabalin may have a better safety profile. One such alternative is lacosamide, an antiepileptic with a different mode of action than pregabalin, and effective in the treatment of neuropathic pain. The hypothesis is that in contrast to lacosamide, pregabalin will increase the respiratory depressant effect of low-dose oxycodone. The objective of the study is to quantify the effect of pregabalin and lacosamide on oxycodone-induced respiratory depression. 24 participants will be screened beforehand if subjects meet the inclusion and exclusion criteria. If so, the subjects will visit the hospital twice. On both occasions, participants will take a 10 mg oxycodone tablet and 90 minutes after a capsule of pregabalin or lacosamide. The order of visits will be randomized. During the visits, at set time points the hypercapnic ventilatory response will be measured, relief of nociception, pupil diameter and several side effects other than respiratory depression. There will be a washout period of 7 days between study visits with the study ending after 2 visits. Amendment: In order to get an impression of the effect of 10 mg oxycodone per se, one open label arm of just 10 mg oxycodone was added as a visit 3. Since the procedures in this third arm will be identical to the two blinded arms, no changes will be made to any of the procedures apart from not administering any lacosamide or pregabalin.

NCT ID: NCT05590403 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Start date: October 28, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA

NCT ID: NCT05589428 Completed - Clinical trials for Heart Failure, Systolic

Low-salt Bread in Heart Failure, Pilot Study

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

SUMMARY Rationale Patients with heart failure may suffer from a poor quality of life (QoL) due to frequent hospital admittance, medication intake, and symptoms as a result of progression of their disease. The general salt intake in the Dutch population is too high, leading indirectly to hypertension resulting in worsening of cardiovascular disease such as heart failure. Patients with heart failure are highly salt sensitive. A quarter of the daily salt intake originates from bread. Salt restriction is difficult to maintain. The aim of this study is to lower the daily salt intake by providing a palatable low salt bread to patients with heart failure. This may lead to a stable disease and therefore an improvement in quality of life. Objective The aim of this study is to investigate whether substitution of normal bread by a new palatable form of low salt bread is effective in reducing salt intake in patients with chronic heart failure. The investigators will evaluate the effectiveness, the compliance and the outcome of the presumed salt reduction. Study design This is a single center, randomized, double blinded, cross-over trial with a follow-up period of twelve weeks performed in VieCuri, Medical Centre in Venlo. Study population In this study, 20 patients visiting the outpatient clinic with heart failure NYHA class 3-4 will be included. All patients are 18 years or older. Intervention Given the study design all 20 patients receive a low salt bread (0.05 gram sodium per slice) for one period and received bread with a normal amount of sodium (0.35 gram sodium per slice) in the other period. After six weeks follow up, the groups change the intervention. Main study parameters/endpoints The investigators expect a reduction of daily salt intake of 1.5 gram sodium by an average of 5 slices bread a day. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patients should visit the hospital three times. Prior the hospital visit they have to collect 24- hour urine. During all visits blood samples will be taken and a physical exam is performed. Also blood pressure will be measured. Most of these parameters are also collected for clinical purposes. Patients should at the same time report their daily intake in a personal food diary and fill in questionnaires about their opinion of the bread and quality of life.

NCT ID: NCT05581342 Completed - Clinical trials for Basal Cell Carcinoma

Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment

TOBI
Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.

NCT ID: NCT05581238 Completed - Blood Transfusion Clinical Trials

Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.

TRACK-TCT
Start date: November 1, 2022
Phase:
Study type: Observational

The transfusion risk and clinical knowledge (TRACK) allogeneic blood transfusion prediction model was developed more than ten years ago and demonstrated good discriminative ability in patients with increased risk for allogeneic blood transfusion in an all Italian population. At the time of derivation, dual anti-platelet medication was suggested in the treatment of acute coronary syndrome, but not yet fully implemented. The aim of this study is to externally validate the TRACK blood transfusion prediction model in the cardiac surgery population of Medisch Spectrum Twente Thoraxcentrum Twente. Additionally, the impact of adding the preoperative use of dual anti-platelet medication, as additional predictive factor, to the TRACK blood transfusion prediction model will be investigated.

NCT ID: NCT05579106 Completed - Nociceptive Pain Clinical Trials

Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit

NEMO
Start date: November 8, 2022
Phase:
Study type: Observational

Pain (nociception), stress and discomfort are difficult to detect in sedated and intubated patients during mechanical ventilation. In order to improve this several nociception level monitors (NOL) were developed that objectively track nociception in sedated or anesthetized patients. Earlier studies showed that for sedated and intubated patients in the operating room, using such monitors is beneficial in reducing stress hormones and post operative pain scores. In this study the investigators aim to observe whether the NOL could be equally beneficial in managing nociception in sedated and intubated ICU patients.

NCT ID: NCT05578755 Completed - Clinical trials for Future Self-identification

Evaluation of a Novel Intervention Aimed at Instilling Future-oriented Mindsets and Behaviors Using a Smartphone Application and Immersive Virtual Reality

Start date: October 19, 2022
Phase: N/A
Study type: Interventional

Short-term thinking, or the inability to make informed tradeoffs between immediate benefits and longer-term costs, has been related to a variety of negative or self-defeating behaviors, such as substance use, impulsive decision making, and delinquency, whereas future-oriented thinking tends to be positively associated with positive behaviors, such as self-esteem, planning, and goal-directed behaviors. To bolster people's psychosocial development, the investigators are developing an intervention, FutureU, aimed at instilling future-oriented mindsets and behaviors by strengthening people's identification with who they may be in the future, i.e., their 'future self'. Through the use of a smartphone application (app) and immersive virtual reality (VR), participants interact with a visual representation of their future self. In the present study, the investigators will evaluate the current iteration of this intervention and compare the FutureU app and FutureU VR with each other and with a goal-setting control group. Knowledge and insights gained from this study will be used to further develop the FutureU intervention program and can provide insights for intervention theory building and implementation strategies.

NCT ID: NCT05576883 Completed - Anxiety Clinical Trials

Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students

Start date: February 10, 2023
Phase: N/A
Study type: Interventional

This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.

NCT ID: NCT05576805 Completed - Clinical trials for Cytomegalovirus (CMV)

A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

Start date: June 19, 2023
Phase:
Study type: Observational

The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts. No study medicines will be provided to participants in this study.