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NCT ID: NCT04670289 Completed - Tennis Elbow Clinical Trials

Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

Start date: August 14, 2020
Phase: Phase 1
Study type: Interventional

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible.

NCT ID: NCT04670198 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)

YES
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. The investigators have co-designed with young people a psychologically modelled educational programme - Youth Empowerment Skills (YES), which aims to facilitate a positive adaption to living with diabetes while improving knowledge and self-management behaviours. Integrated programme components include social and peer-based learning, immersive simulations, and an outreach youth worker. The aim of this study is to test the feasibility of the YES programme (acceptance, implementability, recruitment and completion), and estimate its efficacy in relation to metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1 diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.

NCT ID: NCT04669600 Completed - Clinical trials for Immune Thrombocytopenia (ITP)

A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

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

Primary Objective: - To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: - To assess the safety and tolerability of BIVV020 - To assess the pharmacokinetics of BIVV020 - To assess the response rate of treatment with BIVV020 - To assess the time to response - To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy - To assess the immunogenicity of BIVV020

NCT ID: NCT04669002 Completed - Ovarian Cancer Clinical Trials

EP0057 in Combination With Olaparib in Advanced Ovarian Cancer

Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

NCT ID: NCT04667858 Completed - Pregnancy Clinical Trials

Home Ovulation Test One Cycle at Home Study

Start date: December 22, 2020
Phase:
Study type: Observational

This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.

NCT ID: NCT04667845 Completed - Pregnancy Clinical Trials

Digital Home Ovulation Test One Cycle at Home Study

Start date: December 22, 2020
Phase:
Study type: Observational

This study will assess the usability of a Digital Home Ovulation Test when used at home by lay-users seeking to conceive.

NCT ID: NCT04667377 Completed - Obesity Clinical Trials

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

NCT ID: NCT04667312 Completed - Clinical trials for Non-Small Cell Lung Cancer NSCLC

Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom

CODAK
Start date: June 24, 2021
Phase:
Study type: Observational

This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with locally advanced, unresectable Stage III non-small cell lung cancer receiving durvalumab in the United Kingdom (the CODAK study). Physicians who have treated patients who have locally advanced, unresectable Stage III NSCLC with durvalumab will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients receiving durvalumab through the Early Access Programme (EAP) or post-reimbursement.

NCT ID: NCT04666597 Completed - Clinical trials for Dental Caries in Children

Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Start date: November 15, 2020
Phase:
Study type: Observational

The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients. The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS. The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of: - Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children. - Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire. - Costs of CCI adapted for caries management, in economic terms, number and appointment time.

NCT ID: NCT04666285 Completed - Clinical trials for Mental Health Wellness 1

Southampton Women's Survey COVID-19 Study

SWS_COVID-19
Start date: February 15, 2021
Phase:
Study type: Observational

The current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study.