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NCT ID: NCT04640922 Completed - Bacterial Vaginosis Clinical Trials

Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis

Nefertiti
Start date: January 27, 2020
Phase: N/A
Study type: Interventional

This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV. The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning). Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study. On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate. Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days. Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study. Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence. Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence). Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.

NCT ID: NCT04637204 Completed - Clinical trials for Renal Cell Carcinoma

Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England

Start date: November 24, 2020
Phase:
Study type: Observational

The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).

NCT ID: NCT04636944 Completed - Depression Clinical Trials

Management of Depression and Anxiety in HF

Start date: October 2, 2020
Phase:
Study type: Observational

Heart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Many studies reported that depression is prevalent among HF patients and it is being associated with high morbidity, mortality and costs. The European Society of Cardiology guidelines stresses the importance of routine depression screening with a validated questionnaire and initiating treatment for depression for all depressed HF patients and their access to psychological treatment. The community heart failure nurses provide the integrated heart failure service in the local area of Southwark and Lambeth in South London. The aim of the integrated heart failure team in the community is to provide the HF treatment effectively, help patients understand and manage their symptoms and support with lifestyle changes. Even though, the community HF nurses have extensive role in managing HF patients in the community, their role in assessing anxiety and depressionÍž and providing psychological treatment needs to be further explored. Therefore, there is a need to assess the process by which community HF nurses assess and manage anxiety and depression. This current study builds on our recent systematic review which illustrated how cognitive behaviour therapy is effective at improving depressive symptoms in HF, but more studies are needed to build on these findings. The findings from this review will be used to examine the perspectives on assessing, managing and treating depression and anxiety in HF patients. In this current study, an online focus group with community heart failure nurses and qualitative telephone/online interviews with community-based HF patients will be undertaken to explore their views and experiences in managing depression and anxiety; and to assess whether COMPASS a web-based intervention would be useful. Also, this study will explore the impact of COVID-19 on the psychological wellbeing of community-based HF patients.

NCT ID: NCT04634864 Completed - Stroke Clinical Trials

Transcranial Direct Current Stimulation in Post-stroke Fatigue

TIPS
Start date: January 10, 2018
Phase: N/A
Study type: Interventional

This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.

NCT ID: NCT04634253 Completed - Clinical trials for Rheumatoid Arthritis

A Study of LY3462817 in Participants With Rheumatoid Arthritis

Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).

NCT ID: NCT04633538 Completed - Clinical trials for Pulmonary Hypertension

Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension

6-APP
Start date: January 15, 2018
Phase:
Study type: Observational

Comparison of standard 6 minute walk test with 6 minute walk test smartphone app.

NCT ID: NCT04632706 Completed - Covid19 Clinical Trials

Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19

Start date: September 22, 2020
Phase: Phase 1
Study type: Interventional

An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.

NCT ID: NCT04631562 Completed - Healthy Clinical Trials

Study of ALXN1820 in Healthy Adult Participants

Start date: January 8, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

NCT ID: NCT04631354 Completed - Healthy Volunteer Clinical Trials

Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device

Start date: November 9, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the total lung deposition of radiolabelled S-770108 inhalation powder formulation after each of two separate single inhaled doses in healthy adult participants at two different target peak inspiratory flow rates (PIFRs)

NCT ID: NCT04631302 Completed - Exercise Clinical Trials

The Work Engagement and Wellbeing Study

SWELL
Start date: February 23, 2021
Phase: N/A
Study type: Interventional

Mindfulness and exercise are both widely used to improve mental health and well-being. Some people find that these activities also improve their ability to focus. This study aims to find out whether mindfulness and light exercise could be similarly effective in improving mental wellbeing and engagement at work. The study further investigates the cognitive processes (e.g., memory and attention skills) that might improve as a result of mindfulness and exercise.