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NCT ID: NCT04766372 Active, not recruiting - Exercise Clinical Trials

A Multi-component Physical Activity Intervention for Adolescent Girls

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

A four-arm randomised pilot trial involving: 1. Physical activity programme only - live exercise sessions, social support, standardised text messages 2. Individual behaviour change support only - regular one-to-one video calls with an activity mentor 3. Combined - Physical activity provision and individual behaviour change support 4. Usual care control All groups will be provided with a menu of physical activities. Objectives. To conduct a RE-AIM evaluation of a 6-month multi-component PA intervention for adolescent girls, through investigating: - Who the intervention reaches, how representative they are for the population (Reach, Adoption) and who is most likely to benefit from the intervention (Reach); - The extent to which the intervention is delivered as intended (Implementation), and factors that affect this (Adoption); - Preliminary impact on participants' PA, sedentary behaviour, cardiovascular fitness and psychological wellbeing at 3, 6 and 12 months (Effectiveness, Maintenance); - The qualitatively examine the acceptability of the intervention for adolescent girls, and identify necessary refinements; - To gather data to inform a sample size calculation for a main trail

NCT ID: NCT04764448 Active, not recruiting - Clinical trials for Alpha 1-Antitrypsin Deficiency

A Study of Belcesiran in Patients With AATLD

ESTRELLA
Start date: February 12, 2021
Phase: Phase 2
Study type: Interventional

This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD). The study will be conducted in 3 separate cohorts. A total of up to 16 participants may be enrolled in Cohort 1 and 2. A total number of 30 subjects will be enrolled in cohort 3. The 3 cohorts are differentiated by the duration of the treatment period, the number of doses administered, and the timing of the second liver biopsy.

NCT ID: NCT04763408 Active, not recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

STELLAR
Start date: April 9, 2021
Phase:
Study type: Observational

The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events [SAEs], grade 3 to 5 adverse events [AEs], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

NCT ID: NCT04762108 Active, not recruiting - Clinical trials for Sjogren's Syndrome Childhood-onset

Paediatric Sjögren Syndrome Cohort Study and Repository (PaedSSCoRe)

PaedSSCoRe
Start date: January 11, 2020
Phase:
Study type: Observational [Patient Registry]

Sjögren syndrome (SS) in adults is characterised by inflammation of the exocrine glands, principally the salivary and lacrimal glands resulting in xerostomia (dry mouth) and xerophthalmia (dry eyes).It can also present with more extensive exocrinopathy as well as extra-glandular, systemic features. SS is defined as primary SS (pSS) when it occurs in isolation, and as secondary SS, if associated with other autoimmune conditions. The incidence and prevalence rates of SS vary depending on the population. To date, there have been no studies reporting accurate incidence or prevalence of SS in childhood. Childhood onset SS defined as disease diagnosed before 18 years of age is believed to be rare; however, it is likely it is under-recognised and therefore under-diagnosed. The overarching aim of this study is to identify epidemiological, clinical and laboratory characteristics of paediatric SS in a United Kingdom (UK) multi-centre cohort of patients. Using this data our goal is to develop universally accepted classification criteria that could be validated for use in a paediatric population. Inclusion criterion for the study and repository is a diagnosis of SS made before 18 years by the referring physician. A data collection pack will be sent to authors willing to participate. Information collected will include but not exclusive to: demographic, clinical and laboratory/histological data at diagnosis and subsequent follow-up appointments. Biological samples including blood, tears, saliva, urine and glandular and extra-glandular (e.g. renal) tissue will be collected prospectively if available. Outcome measures related to disease activity and damage, as well as patient reported outcomes will also be collected at set time points (every 6 months) and during flares. PaedSSCoRe will capture data on a significant cohort of children with SS providing a powerful resource to help improve our understanding of the pathogenesis and natural course of this disease. Prospective data collection will allow a fuller analysis of poor prognostic features, impact of therapy and damage accrual, and variable outcome of childhood SS.

NCT ID: NCT04758767 Active, not recruiting - Multiple Myeloma Clinical Trials

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

NCT ID: NCT04757636 Active, not recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

COAST
Start date: March 12, 2021
Phase: Phase 3
Study type: Interventional

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

NCT ID: NCT04754919 Active, not recruiting - Clinical trials for Type 1 Diabetes Mellitus

The Diabetes Transition Study for Young People Aged Between 16-20 Years of Age.

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Study into the use of a diabetes specialist transition nurse in the care of young people aged 16-20 years, with type 1 diabetes; undergoing transition from the paediatric to the adult diabetes services at the Northampton General Hospital

NCT ID: NCT04753697 Active, not recruiting - Clinical trials for Eosinophilic Esophagitis

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: - Placebo for Induction and Maintenance - CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance - CC-93538 360 mg SC once weekly for Induction and Maintenance

NCT ID: NCT04752332 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

eMonarcHER
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

NCT ID: NCT04750109 Active, not recruiting - Clinical trials for Cancer of Unknown Primary Site

Carcinoma of Unknown Primary (CUP): A Comparison Across Tissue and Liquid Biomarkers

CUP-COMP
Start date: June 9, 2021
Phase:
Study type: Observational

Patients with Carcinoma of Unknown Primary (CUP) have widespread cancer at diagnosis however the specific site of origin cannot be found, despite significant testing, making it difficult to treat. CUP has a poor prognosis; it is the 6th most common cause of cancer death in the UK. To date there have been limited studies investigating molecular genomics in CUP patients, resulting in limited evidence to evaluate whether genomic profiling has added value over and above the standard diagnostics provided in the NHS. As a result, our project will aim to; - Assess genomic sequencing (both in tissue and blood) for the diagnosis and treatment guidance in CUP patients including a comparison of the effectiveness of tissue and blood based biomarkers - Collect evidence to further develop technology that predicts an individual's response to a treatment - Develop innovative systems of clinical data capture in patients with CUP - Investigate novel biomarkers to determine the primary tumour location Approximately 120-140 CUP patients will be recruited across 7 UK NHS sites. Tumour samples will be collected from patients undergoing a standard of care procedure OR medically fit patients with accessible tumour. Archival tumour may also be obtained. Some samples will be stored for future translational research. Sequencing results alongside clinical data will be discussed by a multi-disciplinary CUP Molecular Tumour Board. They will provide oversight on the nature, clinical significance and relevance of the results. They will inform the local CUP team of any "actionable" genetic changes, which could potentially direct selection of a targeted therapy trial for that patient. Sequential blood samples will be collected to investigate genetic characteristics that may be able to predict response to therapy. The aggregated anonymised data will be made publicly available following completion of this trial.