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NCT ID: NCT04796116 Not yet recruiting - Suicide, Attempted Clinical Trials

Male Suicide and Metacognition

MSM
Start date: April 1, 2021
Phase:
Study type: Observational

Suicide is the act of killing oneself and accounts for one death every 40 seconds around the world. In the UK, over 75% of suicides are completed by men. Suicidal ideation is a symptom of depression and is assessed when diagnosing depressive disorder. Men are three times more likely to complete suicide than women but half as likely to be diagnosed with depression, and therefore risk missing out on potentially lifesaving treatments. Men experiencing depression and associated suicidality are less likely to demonstrate traditional symptoms such as hopelessness and sadness, and more likely to engage in unhelpful coping strategies such as avoidance through over-working, substance misuse, or risk-taking behaviours, and may feel that they have lost control. Previous research has shown a link between rumination and increased suicidal intent. Unhelpful coping strategies, distorted beliefs about uncontrollability, and thinking processes such as rumination, are central to the metacognitive model of psychological distress and are targeted in Metacognitive Therapy (MCT). The aim of this project is to identify if any aspects of the thinking styles described above are present in a sample of men who are suicidal. The project will also explore beliefs about masculinity and how these beliefs might impact help-seeking. In order to achieve these aims, 15 male service-users without a severe and enduring mental illness, who are receiving care from the Home Based Treatment Team following suicidal thoughts or actions, will be invited to take complete some questionnaires and partake in an interview.

NCT ID: NCT04794712 Not yet recruiting - Clinical trials for Chronic Venous Insufficiency

Evaluation of Pain Associated With Chronic Venous Insufficiency

Start date: May 15, 2021
Phase:
Study type: Observational [Patient Registry]

Chronic venous insufficiency occurs when your leg veins don't allow blood to flow back up to your heart. Normally, the valves in your veins make sure that blood flows toward your heart. But when these valves don't work well, blood can also flow backwards. This can cause blood to collect (pool) in the legs. Chronic venous disease is a highly prevalent condition in the general population, and it has a significant impact on quality of life. While it is usually manifested by obvious signs, such as varicose veins and venous ulcers, other symptoms of the disease are less specific. Among the other symptoms, which include heaviness, swelling, muscle cramps and restless legs, pain is the symptom that most frequently compels CVeD patients to seek medical aid. However, there is a substantial discrepancy between pain severity and clinically detectable signs of CVeD, questioned by several opposing studies. Further evaluation is needed to clarify this subject, and to analyse whether pain development predicts objective tool to evaluate pain by dosflexin exercise pre surgery and post and measure the severity of pain by heat stimulation . General management of CVeD starts with advising lifestyle . pain in chronic venous insufficiency it will measure before and after treatment by using contact heat evoked potential (CHEPS) and visual dialog scale ( VAS ) to estimate the pain intensity the severity of the pain before the patient do exercise before three moths of leaser endovenous ablation procedure . 2-photo-plethysomography Non invasive technique , pp sensor emit infrared light detects changes in reflection from epiderma layer . Vessels full of blood reflect 10 times less than without blood . On dorsiflexion - pressure drops, increasing reflection in the measuring window Venous assessment the venous refill time, is shorter and typically less than 20 s

NCT ID: NCT04791631 Not yet recruiting - Quality of Life Clinical Trials

'Distortion as a Predictor of ERM Surgery Outcome'

Start date: April 1, 2021
Phase:
Study type: Observational

Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Management options include observation if asymptomatic, or surgery to peel the membrane if symptomatic. Limited data exists regarding how to identify patients who are most likely to benefit from surgery. We propose to measure the effects on distortion (using D chart), visual acuity and vision-related quality of life (using a validated vision-related quality of life questionnaire) of ERM surgery. This will allow us to investigate whether pre-operative D chart score can predict subsequent improvement in quality of life following surgery. We hope the results will help patients and VR surgeons decide whether or not to proceed with ERM surgery. The study will be a prospective case series consisting of patients with symptomatic epiretinal membranes who choose to have epiretinal membrane surgery. The study participants will get standard care with the additional administration of a quality of life questionnaire and measurement of distortion (using a D-chart) at 3 different time points (pre-op, and post-op at 26 and 52 weeks). Recruitment will be in Glasgow, with a possibility of other sites being added on at a later stage.

NCT ID: NCT04779619 Not yet recruiting - Clinical trials for Emotional Instability

Exploring a New Measure of Emotion Regulation

EMER
Start date: March 1, 2021
Phase:
Study type: Observational

Background: Emotion regulation has been established as an important concept in mental health research across a range of different diagnoses. There are numerous questionnaires used to measure emotion regulation but only one (the Perth Emotion Regulation Competency Inventory - PERCI) is based on the most recent and widely accepted model of emotion regulation (Gross' extended process model of emotion regulation). This recently developed measure has not yet been extensively used or psychometrically tested in clinical populations. However, it may be more theoretically and psychometrically sound than other measures widely used in the research literature to date. Methods/Design: An online survey including this new measure with other relevant questionnaires will sample non-clinical and two specific clinical populations in order to explore the reliability, validity and utility of this measure. Discussion: This will inform the ways in which emotion regulation competency is measured in future research and clinical practice.

NCT ID: NCT04755829 Not yet recruiting - Breast Cancer Clinical Trials

Breath Test to Predict Breast Cancer and Outcome of Mammography

Start date: March 2021
Phase:
Study type: Observational

To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

NCT ID: NCT04755582 Not yet recruiting - Clinical trials for Cardiovascular Diseases

SMARTHEART Validation Study

Start date: July 1, 2021
Phase:
Study type: Observational

To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

NCT ID: NCT04725604 Not yet recruiting - Clinical trials for Acute Compartment Syndrome

Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System

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

Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crush injuries. If ACS is not diagnosed early enough, it can result in muscle and other tissues dying off because of the lack of blood supply. Diagnosing ACS remains a challenge for doctors - currently clinical assessment and pressure probes are used to assess patients at risk of ACS. Previous research has shown that measuring pH in injured muscles is promising in diagnosing ACS and may help doctors diagnose ACS earlier than they can using current methods. In this study, the investigators will use a pH probe to measure muscle pH, and in particular, any build-up of acid caused by reduced blood flow in the injured limb. The investigators will compare the pH probe values with the existing methods for diagnosing ACS. Patients with a fracture or crush injury who are risk of developing ACS will be recruited into the study. Participants will have a pH probe inserted into tissue close to their injury and pH data will be logged for up to 72 hours. Diagnosis and any treatment decisions for participants in the study will be made using the existing methods and not based on information from the pH probe (the team treating the patient will not have access to the pH data). Data on diagnosis and any treatment given for ACS will be collected from participant's medical notes. The Soft pH trial team will compare how well the pH probe performs in diagnosing ACS compared to the existing methods. The investigators will follow participants up at 6 months after their initial injury to identify missed ACS cases based on clinical findings. Diagnosing ACS earlier may reduce the likelihood of long-term symptoms and loss of function that is often seen in cases of ACS.

NCT ID: NCT04705389 Not yet recruiting - Clinical trials for Merkel Cell Carcinoma

SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

SUMMERTIME
Start date: September 2021
Phase: N/A
Study type: Interventional

Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

NCT ID: NCT04695821 Not yet recruiting - Covid19 Clinical Trials

Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology in Covid-19

REMAP-WEST-COV
Start date: January 2021
Phase: N/A
Study type: Interventional

The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device? The investigators will also consider: Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)? These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.

NCT ID: NCT04693091 Not yet recruiting - Respiratory Disease Clinical Trials

Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology

REMAP-WEST-FEA
Start date: February 2021
Phase: N/A
Study type: Interventional

The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the care of the community respiratory team. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: 1. What is the feasibility of the Senti data-capture device? 2. Is this device usable in clinical practice? 3. What are the requirements to train patients to use the device? The investigators will also consider: 4. Does the device function technically and practically, in real-world clinical scenarios? 5. What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores). These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals.