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NCT ID: NCT06346132 Not yet recruiting - Pain Clinical Trials

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

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

The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.

NCT ID: NCT06346457 Not yet recruiting - Menopause Clinical Trials

Breast Cancer & Antiestrogenic Therapy & Brain

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

The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health.

NCT ID: NCT06346626 Not yet recruiting - Optometry Clinical Trials

To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children

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

Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded. Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features. This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S.

NCT ID: NCT06346977 Not yet recruiting - Diagnosis Clinical Trials

Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC

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

Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases. Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques. To address these pressing diagnostic and monitoring needs in NSCLC-LM management, the investigator proposes a forward-looking, non-interventional clinical study harnessing the power of cutting-edge proteomic technologies. These platforms, characterized by their high throughput, exquisite sensitivity, and minimal sample volume requirements, offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy. The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy, ultimately contributing to enhanced patient care and personalized therapeutic strategies.

NCT ID: NCT06347380 Not yet recruiting - Overactive Bladder Clinical Trials

Usability Study of the FemPulse System

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

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.

NCT ID: NCT06348238 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Strategies to Improve Well-Being and Diabetes Management

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

This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are: - Will self-affirmation reduce feelings of stigmatization? - Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors. - Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it. After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention.

NCT ID: NCT06348290 Not yet recruiting - Solid Tumor, Adult Clinical Trials

Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.

NCT ID: NCT06348745 Not yet recruiting - Diaphragm Clinical Trials

Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.

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

- Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients. - Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function. - Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

NCT ID: NCT06349863 Not yet recruiting - Cholecystitis Clinical Trials

Dutch CHolEcystitis Snapshot Study

Dutch-CHESS
Start date: April 1, 2024
Phase:
Study type: Observational

Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes. Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome. Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a >7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded. Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.

NCT ID: NCT06349928 Not yet recruiting - Clinical trials for Stress, Psychological

"The Show Must go on" : The Experience of Injuries Among Dancers: Fears, Thoughts, and Beliefs. A Qualitative Study

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

This qualitative, cross-sectional study aims at describing the experience of Italian dancers with injury. Dancers face a high risk of sustaining one or more injuries during their career (87-94%), which may lead to physical, psychological, and socioeconomic consequences affecting dancer's lives and careers both short and long-term. Dancers report fearing injury and its consequences and believing in the existence of a stigma around injury and injured colleagues; many of them also try to self-manage pain and delay reporting injuries to healthcare professionals, possibly making its outcomes worse. This study will collect data from dancers via focus groups and individual interviews, investigating dancers' experiences, thoughts, and beliefs about injury. Records from the interviews will be transcribed ad verbatim and analyzed using the framework method to synthetize the data and highlight the most meaningful content. Understanding dancers' thoughts and behaviors regarding past or possible future injuries may be beneficial in improving treatment efficacy and designing adequate education and prevention strategies. It may also help raise awareness of dancers' complex and unique needs, and the importance of having accessible, specialized professionals around dance companies and schools.