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NCT ID: NCT06189261 Completed - Melanoma Clinical Trials

Holistic Needs Assessments in Patients With Melanoma

Start date: February 2016
Phase:
Study type: Observational

This study will assess whether a needs assessment/management intervention for patients with malignant melanoma is achievable, reasonable, realistic and of value to patients with malignant melanoma and health professionals involved in their care. The study will also explore what the levels of patients' unmet needs are, whether unmet needs change over time, and what the potential effects of the intervention may be on patients' unmet needs, symptom severity, self-confidence in dealing with the illness, wellbeing, and satisfaction with the care received. In this study, the investigators will involve skin cancer nurse specialists, who will be asked to use an 'intervention questionnaire' to offer a needs assessment/management intervention to 30 people newly diagnosed with malignant melanoma. The investigators have used information from the literature to select the most appropriate 'intervention questionnaire' for this patient population. Each consenting patient (i.e. participant) will be expected to participate in the study over 4 months. During the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. At the start of each intervention consultation, participants will be asked to complete the intervention questionnaire. The recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs. Throughout the study, participants will also be asked to complete a set of questionnaires in the clinic (months 1 and 3) or at home (months 2 and 4) to explore potential effects of the intervention. A study evaluation form will be used at month 4 to collect participants' and health professionals' views on the intervention and how it was delivered. Face-to-face interviews will take place at the end of the study to explore participants' (a subset of 10 people) and health professionals' experiences with the intervention.

NCT ID: NCT06189131 Recruiting - Surgery Clinical Trials

The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting

LESS
Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.

NCT ID: NCT06188962 Recruiting - Depression Clinical Trials

Evaluating Knowledge Insight Tools (KIT) for Reducing Anxiety and Low Mood in UK Secondary School Students

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

Background and Study Aims: Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support. Who can participate? Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services. What does the study involve? The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment. What are the possible benefits and risks of participating? The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time. Where is the study run from? The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be. When is the study starting and how long is it expected to run for? The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed. Who is funding the study? The study is funded by Place2Be and Anna Freud, both UK-based charities. Who is the main contact? The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).

NCT ID: NCT06188936 Recruiting - Male Infertility Clinical Trials

Home Semen Analysis Tests as a Screening Tool for Fertility Patients

Start date: November 8, 2023
Phase: N/A
Study type: Interventional

Infertility, defined as the inability to conceive after 12 months of regular unprotected intercourse, is estimated to affect 1 in 7 heterosexual couples. Semen analysis, carried out as per the detailed World Health Organisation (WHO) standards in an andrology laboratory, is the primary investigation for the male partner presenting to the fertility clinic and reports on multiple semen parameters. Hospital clinic attendance is required, which could be at a significant distance from the patient's home, to produce a sample at a given appointment time that is then analysed by the laboratory without delay, as the results are time sensitive. A formal report is produced after several weeks. This process was not sustainable during the Covid pandemic and these methods would be threatened by similar situations in the future. Despite semen analysis being an essential component of fertility work-up the WHO themselves state that the test does not distinguish between fertile and infertile men. In addition, it involves a significant cost to the national healthcare system. Therefore, a more efficient initial test of male fertility warrants consideration. Home semen analysis tests are a screening tool that provide a simplified, initial assessment. They are widely available to purchase in the UK, but are not currently issued to patients seen in NHS clinics. They have the potential to reduce time to diagnosis and reduce the cost to the healthcare provider. To investigate the clinical and cost effectiveness of using home semen analysis tests a randomised controlled trial (RCT) is needed comparing them to laboratory semen analysis (standard care). Before a fully-fledged national trial is planned in a UK setting, the investigators would like to undertake a feasibility study to answer, "Is it feasible to conduct a trial comparing home semen analysis tests with current standard practice for the initial assessment of men referred to the fertility clinic?"

NCT ID: NCT06188689 Recruiting - Clinical trials for Calcium Release Deficiency Syndrome (CRDS)

Evaluation of A Clinical Diagnostic Test for CRDS

DIAGNOSE CRDS
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.

NCT ID: NCT06188520 Recruiting - Clinical trials for ER+ HER2- Advanced Breast Cancer

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

CYCAD-1
Start date: December 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

NCT ID: NCT06188507 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants

Start date: January 11, 2024
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.

NCT ID: NCT06188065 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Eosinopenia in Severe COPD Exacerbation

A-TREC
Start date: January 22, 2024
Phase:
Study type: Observational

The goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted to hospital with a severe exacerbation of COPD and associated eosinopenia. The main aims of the study are to: 1. Identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD 2. Assess the time to recovery from eosinopenia to stable BEC following a severe exacerbation of COPD

NCT ID: NCT06187012 Recruiting - Hypertension Clinical Trials

Hypertension Explored in Long-term Postpartum Follow-up in Later Life

HELPFUL
Start date: March 23, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.

NCT ID: NCT06186544 Not yet recruiting - Clinical trials for Chronic Limb-Threatening Ischemia

Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients

PROMOTEGLASS
Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs. It is typically caused by the narrowing or blockage of an artery and can result in severe pain, tissue gangrene, and the potential loss of a limb (Amputation). This condition requires medical intervention and will not improve on its own. To diagnose leg ischemia, the doctor will conduct a thorough vascular clinical examination. Depending on the findings, further imaging tests such as duplex ultrasound, magnetic resonance arteriography (MRA), or computed tomography (CT) may be conducted. In some cases, an arteriogram may be necessary which is an x-ray of the arteries while the dye is injected into the blood vessels. Following the diagnosis, the best management course is recommended by a multidisciplinary team (MDT), considering each patient's disease pattern and overall health. Treatment options include performing a key-hole procedure, called an endovascular procedure (EVT) within the artery, where the vascular surgeon will be using a balloon to widen the artery, and/or a wire-reinforced stent which remains inside the artery serving as a scaffolding to keep it open. The primary aim of the PROMOTE GLASS study is to investigate if the Global Anatomical Staging System (GLASS) score, which is a summation of points given according to the disease pattern as seen on assessment images (Duplex Ultrasound, MRA, and CT scans) can accurately tell if the treatment using catheters and stents inside blood vessels will work well for people with ischemia in their legs. The researchers also want to see if the GLASS score can predict how well patients with ischemia will heal and if they will need further treatments in the long term after having treatment with catheters and stents inside their blood vessels. A prospective, observational study will be delivered by Cardiff and Vale University Health Board (CAVUHB). The vascular team will prospectively collect data over a 12-month period. This will be in patients undergoing elective and/or emergency primary EVT procedure, with follow-up 4-6 weeks after the procedure and at 12 months.