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NCT ID: NCT05533190 Recruiting - Anxiety Clinical Trials

Clinical Investigation of Wysa

Start date: December 13, 2022
Phase: N/A
Study type: Interventional

Mental health concerns are a large burden for individuals, healthcare systems, and the economy. Over a million people are referred to UK mental health services each year, but more than half only receive one session of workbook-based support. Many others have to wait over 12 weeks for assessment and treatment. Wysa is a digital health app with over 3 million users that uses an artificial intelligence (AI) chatbot and a series of self-care exercises to provide mental health support and to help people develop strategies to manage their mental health and improve their resilience. This project aims to examine the impact of using Wysa on patients' symptoms of anxiety and depression during the referral process for standard UK mental health services. Patients will be given access to Wysa at the point of referral to the Improving Access to Psychological Therapies (IAPT) programme and can begin to explore the self-support tools, while they are on the waitlist for assessment and treatment. The investigators will gather a group of patients and members of the public to contribute to the recruitment of patients for the study, the methods we use to evaluate Wysa, and to provide insights on how best to share the results of our study with the general public. The investigators will use the standard IAPT measures of anxiety and depression to look at the effect of using Wysa patients' mental well-being. These questionnaires will be provided through the app and the results will be compared with a waitlist control group. The investigators will examine whether Wysa can identify people who are experiencing severe mental health difficulties so that they can be provided with additional support. Users' levels of engagement with Wysa will be assessed and some participants will be randomly selected to do an interview so the investigators can get a better understanding of what people liked and disliked about using the app and why. Finally, the investigators will be evaluating the cost-effectiveness of Wysa compared with usual care. The investigators expect that the study will show that Wysa helps reduce symptoms of anxiety and depression in people who are on the waiting list for IAPT. If the study shows this positive impact, this will provide evidence to support the use of Wysa to improve the accessibility of mental health support in clinical pathways. The investigators will be publishing the results of our study in academic journals as well as in more generally accessible platforms.

NCT ID: NCT05532930 Recruiting - Cervical Cancer Clinical Trials

An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer (EMPIRIC Study)

EMPIRIC
Start date: August 5, 2022
Phase:
Study type: Observational

Patients with cervical cancer that has not spread to other parts of the body can be cured with radiotherapy. One of the reasons radiotherapy can fail is because there are areas within the tumour that have a poor oxygen supply which makes them resistant to radiotherapy. This study aims to assess if it is feasible using special types of magnetic resonance imaging (MRI) - multi-parametric (MP) MRI to identify areas of low oxygen within the tumour so a higher dose of radiation can be given specifically to these areas to overcome the resistance and potentially improve cure rates without increasing side effects.

NCT ID: NCT05531773 Recruiting - COVID-19 Clinical Trials

Post COVID-19 Condition

Start date: July 1, 2022
Phase:
Study type: Observational

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.

NCT ID: NCT05531565 Recruiting - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST
Start date: September 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

NCT ID: NCT05531526 Recruiting - Alzheimer Disease Clinical Trials

Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)

Start date: December 23, 2022
Phase: Phase 3
Study type: Interventional

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

NCT ID: NCT05531253 Recruiting - Cardiac Disease Clinical Trials

Respired Gases in Patients Post Cardiac Surgery

REGAPS
Start date: October 30, 2022
Phase:
Study type: Observational

Certain diseases relating to the heart can only be definitively treated with surgery. When untreated, these can lead to heart failure with a lack of supply of oxygen-rich blood to the tissues, leading to damage to other organs. Adults who undergo heart surgery vary greatly in terms of age and relative health. This has significant implications when predicting outcomes in the aftermath of surgery. For example, a 90-year-old man with a variety of comorbidities such as diabetes and high cholesterol who requires a heart valve replacement may have an unfavourable chance of surviving the postoperative period when compared to an 18-year-old woman with no significant medical history undergoing the same procedure. Almost invariably, patients are admitted to an Intensive Care Unit (ICU) following heart surgery. This is done to facilitate close monitoring of the patients' vital organ functions and to also provide organ support if needed. For the heart, this can include the administration of drugs to help a heart pump forcibly, cause blood vessels to contract and increase blood pressure. Patients who have undergone heart surgery have been placed on a mechanical ventilator, following a tube placed in their windpipe. This form of ventilation often continues in ICU for a period of time, depending on the patient's condition. One specific type of ICU level monitoring that occurs in patients who have undergone heart surgery is cardiac output monitoring. This involves a thin tube, called a pulmonary artery catheter, that extends from the skin to the heart, via large blood vessels. Cardiac output monitoring is essential in this patient group to guide organ support and to provide information of how well the heart is functioning. In this observational study, the investigators wish to study patients who have undergone cardiac surgery, are receiving mechanical ventilation and have pulmonary artery catheters inserted. The investigators will collect cardiopulmonary data in these patients and compare these data with values of exhaled and inhaled gases (oxygen and carbon dioxide) over the same time period. This will enable the investigators to investigate the link between cardiopulmonary data and respired gas values. A better understanding of this link between cardiopulmonary function and oxygen/carbon dioxide values will then inform future studies aiming to determine the effect of various interventions in similar patient groups.

NCT ID: NCT05527262 Recruiting - Stroke Clinical Trials

Intensive Upper Limb Training in Chronic Stroke

INTENSIVE
Start date: July 4, 2022
Phase: Phase 2
Study type: Interventional

The evidence supporting routine provision of high-dose, high-intensity upper limb neurorehabilitation treatment for stroke survivors beyond the first few months after stroke is limited. The Queen Square Upper Limb (QSUL) programme provides 90 hours of upper limb neurorehabilitation over 3-weeks to chronic stroke survivors. The recently published service evaluation demonstrated encouragingly large, clinically meaningful effects at the level of activity and body function. An alternative way to deliver high doses of effective therapy is through technological developments, e.g. immersive interactive gaming environments such as the MindPod Dolphin programme. The intention of this study is to provide stronger level evidence for intensive upper limb rehabilitation by conducting a randomised controlled trial of two different types of upper limb training compared to usual care. Patients considered suitable for the QSUL programme will be randomised to either: Group 1- intensive upper limb rehabilitation programme (QSUL); Group 2- MindPod programme; Group 3-wait-list control (who will be offered the treatment after the waiting list is complete). The first aim of the study is to compare the effect of each type of high-dose, high-intensity upper limb training to usual care using measures of upper limb impairment and activity levels 3 months after treatment is complete. The secondary aims are to comply with recent recommended by the Stroke Recovery and Rehabilitation Roundtable, and (i) investigate the effects of upper limb neurorehabilitation on kinematics of upper limb movement (using a KINARM exoskeleton), and (ii) use neuroimaging (MRI and EEG) and neurophysiological (TMS) measures to determine the characteristics of stroke survivors who are most likely to benefit from this treatment approach. The results from this work will (i) help determine the impact of two methods of high dose, high intensity upper limb training in chronic stroke patients; (ii) identify whether there are any predictors of treatment response that will help stratify patients in future clinical trials of upper limb neurorehabilitation.

NCT ID: NCT05526755 Recruiting - Clinical trials for Stage II-IIIB Non-small Cell Lung Carcinoma

A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

TARGET
Start date: March 6, 2023
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.

NCT ID: NCT05526508 Recruiting - Clinical trials for Neurological Diseases or Conditions

Rebound Exercise in Neurological Disorders

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.

NCT ID: NCT05526391 Recruiting - Clinical trials for Multiple System Atrophy

A Study of TAK-341 in Treatment of Multiple System Atrophy

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.