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NCT ID: NCT05923944 Not yet recruiting - Anxiety Clinical Trials

Video Game Play to Alleviate Adolescent Anxiety

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

Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. At least two lines of research have been explored in the past years in this area. First, studies have tested the anxiolytic effects of casual video games, hypothesizing that, through the induction of flow, these games can effectively distract individuals from anxiety-related thoughts and feelings. Second, the bidirectional link between poor attentional control and higher anxiety has led to the design of novel interventions aiming to improve attentional control such as working memory training studies. Importantly, action video games, classified as a distinct gaming genre, have been shown to enhance attentional control. In this study, we aim to compare the effects of action video game play and casual game play to a no-training group, assessing their potential to alleviate anxiety when delivered entirely online. The goal of this three- arms randomized controlled trial is to evaluate the feasibility of a 6-week video game training intervention to reduce adolescent anxiety-related symptoms. We will also examine the efficacy of the proposed treatment when entirely deployed at adolescents' home.

NCT ID: NCT05880563 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)

18F-RoSMALS
Start date: August 2023
Phase: Phase 1
Study type: Interventional

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance [18F]-RoSMA-18-d6 are being carried out for the first time. This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals. The following questions will be answered by this clinical trial. 1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ? 2. Does the amount of this protein change during the course of the disease? 3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?

NCT ID: NCT05830513 Not yet recruiting - Pain, Postoperative Clinical Trials

OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up

OPU-LUX
Start date: May 2023
Phase: N/A
Study type: Interventional

In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.

NCT ID: NCT05819307 Not yet recruiting - Retinal Disease Clinical Trials

Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)

STARFLI
Start date: May 1, 2023
Phase:
Study type: Observational

To investigate the feasibility of a combined OCT/FLIM device

NCT ID: NCT05813210 Not yet recruiting - Clinical trials for Myocardial Ischemia Demand

Myocardial Ischemia Detection With a Combined Cardiovascular Magnetic Resonance and Biomarker Protocol

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

Background: Early detection and treatment of coronary artery disease (CAD) can help curb the high incidence of cardiovascular disease, which is the leading cause of death worldwide. Today, we have sophisticated imaging techniques available to diagnose CAD, including cardiovascular magnetic resonance (CMR). CMR is able to detect relevant myocardial ischemia and guide treatment options. Therefore, it is recommended by the current guidelines for patients at intermediate risk. In clinical practice, we often encounter two main issues: first, because of their availability and increasing uncertainty in the population, imaging techniques are increasingly used, even in patients with a low pretest probability for the presence of CAD. Second, the diagnostic accuracy of the techniques is not perfect, and false-negative stress CMR perfusion studies are an important limitation of the method, especially in patients with advanced CAD and balanced ischemia. In addition, the standard method with pharmacologic testing carries an inherent risk. Aim: The aim of our project is to review the clinical pretest probability to reduce unnecessary imaging studies and to evaluate the improvement of diagnostic accuracy of CMR stress testing by adding exercise test and reviewing biomarkers, which could reduce the number of false-negative results, especially in patients with balanced ischemia, who usually suffer from severe CAD. Methodology: This is a prospective, randomized, two-arm, controlled, monocentric, national study performed in collaboration by two centers (Solothurner Spitäler AG and CRIB). Included are consecutive patients with suspected inducible myocardial ischemia who are examined by CMR at the Kantonsspital Olten and during the course also at the Bürgerspital Solothurn. Since all patients from the Kanton Solothurn are referred to us for CMR diagnosis, this represents an ideal referral pattern of unselected patients with a wide range of pretest probability for myocardial ischemia (interquartile range of pretest probability 20-60%). Patients able to exercise will randomized to either standard CMR stress protocol with regadenoson or to the combined CMR stress protocol, which includes additional exercise testing and measurement of hs-cTn, a biomarker for detecting myocardial damage. Patients with positive CMR results will be received to coronary angiogram. Potential Significance: This project has the potential to reduce the residual risk and thereby reduce cardiovascular mortality in patients with false-negative test result, especially those with balanced ischemia or inadequate response to vasodilatation drugs. In addition, the investigator will be able to make a statement about the additional use of biomarkers for the diagnosis of CAD in patients with stable condition. Thereby, the integrated use of biomarkers may improve the diagnostic accuracy and this might prevent unnecessary further strategies, which will reduce high-cost in health care systems. Furthermore, the investigator hopse for better patient selection in order to avoid unnecessary examinations in the future.

NCT ID: NCT05785897 Not yet recruiting - Clinical trials for ST Elevation Myocardial Infarction

STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT

STARS DAPT
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Primary percutaneous coronary intervention (PCI) is the preferred revascularization strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Compared with bare-metal stents (BMS) and early-generation thick-strut polymer-based drug-eluting stents (DES), newer-generation DES with thinner strut stent platforms and durable or biodegradable polymers have been shown to improve long-term safety and efficacy outcomes among patients with STEMI. Accordingly, the use of newer-generation DES over BMS is currently recommended by the most recent guidelines. Vessel healing at the culprit site after DES implantation is however substantially delayed in patients with acute STEMI as compared to those with chronic coronary syndromes and is associated with a long-term risk for recurrent stent-related adverse clinical outcomes. These findings highlight the need for future iterations in modern DES technology to further improve clinical outcomes following PCI in this highest-risk patient subset. Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a potent P2Y12 receptor inhibitor for 12 months after primary PCI for STEMI, unless there are contraindications such as excessive risk of bleeding. A recent meta-analysis of five large-scale randomized clinical trials including a total of 32'145 patients, of whom 4,070 (12.7%) patients were treated for STEMI, indicated that 1-3 months of DAPT followed by P2Y12 inhibitor-based single antiplatelet therapy (SAPT) after second-generation DES implantation in patients with chronic and acute coronary syndromes was associated with lower risk for major bleeding and similar risk for stent thrombosis, all-cause death, myocardial infarction, and stroke compared with conventional DAPT. These findings suggest that a potent P2Y12 inhibitor-based SAPT following a short DAPT course (1-3 months) may represent a preferable treatment option, which is associated with similar ischemic, but lower bleeding risk, for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT. The question of whether SAPT using a potent oral P2Y12 inhibitor (ticagrelor or prasugrel) without aspirin (aspirin-free strategy) after primary PCI with a newest-generation thin-strut polymer-free drug-eluting stent is safe and effective compared to a conventional guideline-recommended 6- to 12-month DAPT course among patients with STEMI remains uncertain.

NCT ID: NCT05765058 Not yet recruiting - Root Caries Clinical Trials

The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial

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

The aim of this study is to summarize the current level of evidence on the prevalence of root caries in elderly population, evaluate the prevalence of root caries in elderly patients living in Canton Bern, Switzerland and to analyze the association between the data collected with demographic and relevant socioeconomic factors, provide relevant long-term clinical, radiographic and oral health related outcomes and to establish a pivotal reference in treatment of elderly patients by means of non-operative root caries treatment.

NCT ID: NCT05726825 Not yet recruiting - Septic Shock Clinical Trials

Efficacy of add-on Plasma Exchange as an Adjunctive Strategy Against Septic Shock

EXCHANGE-2
Start date: November 28, 2023
Phase: N/A
Study type: Interventional

Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.

NCT ID: NCT05715190 Not yet recruiting - Behavior Clinical Trials

Development and Feasibility of a Nurse-led Person-centered Education Program

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

Background Psoriasis is a chronic inflammatory skin disease causing reduced quality of life. Psoriasis patients are often insufficiently informed about their disease with its treatment possibilities leading to non-adherence of treatment resulting in unsatisfactory patient outcomes. We therefore propose to develop an educational intervention for psoriasis patients; evaluate the feasibility of implementing it in a nurse-led psoriasis-outpatient clinic and compare the psoriasis percentage reduction, quality of life, health literacy and patient benefit, between patients receiving this educational intervention and those receiving standard care. Method/Design We first will develop an evidence-based educational intervention in collaboration with an expert panel and second will conduct a randomized controlled feasibility study in a psoriasis outpatient clinic in Western Switzerland. Twenty eligible patients with psoriasis will be randomized to receive either a multidisciplinary education and usual care or only usual care, for 6 weeks. Data will be analyzed using R conducting linear models allowing us to assess the impact of the intervention on psoriasis reduction and other secondary outcomes of interest, once controlled for reliable socio-economic cofounding factors. Discussion This trial will investigate the feasibility of the elaborated nurse-led education and the planed randomized controlled trial. In this study, we will elaborate and provide an informational brochure with information concerning psoriasis in addition to a nurse-led oral educational program in addition to medical standard care. We expect that this nurse-led person-centered intervention will contribute to enhanced education with a higher functioning, better self-efficacy and improved quality of life, better disease knowledge with a better adherence to the medication protocol. The results will further inform the final design of a subsequent large-scale randomized controlled trial, which will examine the effectiveness of this educational intervention. Additionally, through this study the role of the nursing profession and its research will be strengthened in assuring that the voice of individuals, families and communities are incorporated into design and operations of clinical health systems by eliminating gaps and disparities in health care.

NCT ID: NCT05709717 Not yet recruiting - Perianal Fistula Clinical Trials

Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Start date: January 25, 2023
Phase:
Study type: Observational [Patient Registry]

Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)