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NCT ID: NCT05344066 Active, not recruiting - Diabetes Clinical Trials

Manchester Intermittent Diet in Gestational Diabetes Acceptability Study

MIDDAS-GDM
Start date: November 24, 2022
Phase: N/A
Study type: Interventional

A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.

NCT ID: NCT05338970 Active, not recruiting - Clinical trials for Nonsquamous Non-small Cell Lung Cancer

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Start date: July 8, 2022
Phase: Phase 3
Study type: Interventional

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

NCT ID: NCT05337553 Active, not recruiting - Clinical trials for Neuromuscular Diseases

A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy

RESILIENT
Start date: July 6, 2022
Phase: Phase 3
Study type: Interventional

This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen or risdiplam or have a history of onasemnogene abeparvovec-xioi, compared to placebo.

NCT ID: NCT05331040 Active, not recruiting - Rectal Cancer Clinical Trials

Radiomics in Rectal Cancer

Start date: May 1, 2020
Phase:
Study type: Observational

This retrospective study aims to investigate whether initial imaging characteristics of rectal cancer on Magnetic Resonance Imaging (MRI) correlate with the underlying tumour pathology and oncological outcomes such as response to treatment. Using radiomic features, calculated using new high throughput analysis of previously acquired imaging, a statistically robust prognostic model will be created with the overall aim of developing imaging biomarkers.

NCT ID: NCT05330481 Active, not recruiting - Exercise Metabolism Clinical Trials

Body Weight and Carb Metabolism

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

Whilst theoretically, body size should influence the capacity for intestinal carbohydrate absorption and thus exogenous oxidation rates during exercise, there is currently little empirical evidence to support this hypothesis. Accordingly, current nutrition guidelines for carbohydrate intake during exercise do not take body mass into account. Therefore, there is a need to establish whether body mass is related to exogenous carbohydrate oxidation rates during exercise. If such a relationship is established, this would lay the foundation to revise the current sports nutrition guidelines regarding carbohydrate intake during exercise. The aims of this study are, therefore, to: 1) establish whether larger individuals display higher rates of exogenous carbohydrate oxidation than smaller individuals; and 2) establish if such a difference can be explained by the higher absolute exercise intensity, and thus the energy demand of exercise. It is hypothesised that larger individuals will demonstrate higher exogenous carbohydrate oxidation rates than smaller individuals, and that this difference will be partly (but not completely) diminished when the absolute intensity of exercise is matched.

NCT ID: NCT05329896 Active, not recruiting - Psoriatic Arthritis Clinical Trials

Ticopa Serum Analysis: an Analysis of Blood Samples From the TICOPA Study

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

A range of different drugs are available to treat psoriatic arthritis (PsA) inflammation. However, clinicians are unable to predict who will respond well to a given drug, who will fail to respond and who will develop side effects. Responder/non-responder effects may also differ for the skin and joint domains of PsA. Patients currently undergo a trial and error phase of treatment, sometimes withstanding a period of nonresponse, and thus pain and discomfort, for a period of time. Treatment failures also waste resources and undermine patient confidence. There is a pressing need to identify predictors for response / non response and side effects, and this study will utilise novel bioinformatics approaches to address this need. The samples and clinical information collected from participants in the TICOPA (Effect of tight control of inflammation in early psoriatic arthritis) study (1) are a valuable resource. The investigators aim to use these existing serum samples to determine the potential of molecular markers to predict patients' response to treatment both with regard to effects and side effects. This analysis could potentially lead to the identification of serum and clinical parameters which when measured in a defined combination would be predictive of patients' response to treatment. 1 https://doi.org/10.1016/S0140-6736(15)00347-5

NCT ID: NCT05329415 Active, not recruiting - Diabetes Mellitus Clinical Trials

Tuberculosis Drug Levels and Continuous Glucose Monitoring in Diabetic Patients

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

Diabetes significantly increases the risk of developing active tuberculosis (TB). Diabetic patients who do develop TB have worse treatment outcomes and overall mortality. TB also worsens blood glucose control in diabetics, the mechanism of which is not well understood. The incidence of type 2 diabetes is rising globally, and consequently diabetes and TB co-infection is increasingly common, and improving outcomes in this cohort is of growing importance. Low TB drug levels in diabetic patients have been postulated as a reason for these worse outcomes. There is however contradictory evidence in the literature that TB drug levels really are consistently and significantly lower in diabetics compared with non-diabetics. If this were shown to be the case, performing therapeutic drug monitoring in diabetic patients may be a straightforward way to improve outcomes. Improving blood glucose control may also lead to improved outcomes, however there is nothing previously in the literature looking at detailed blood glucose monitoring in diabetic patients being treated for TB. This study is planned as a case control study comparing 24 non-diabetic patients commencing TB treatment with 24 cases who have both TB and diabetes. Samples for post-dose TB drug levels will be taken at 2 time points at weeks 2, 8 and 16. These will be analysed via population pharmacokinetics to compare pharmacokinetic profiles between the 2 groups, with the hypothesis that the diabetic group will have a significantly lower exposure to TB drugs than the non-diabetic group. The diabetic group will also be asked to wear a continuous glucose monitor (blinded Dexcom) for 10 days at baseline and week 16, with data compared between the 2 time points.

NCT ID: NCT05323734 Active, not recruiting - Clinical trials for Tuberous Sclerosis Complex

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).

NCT ID: NCT05323656 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Start date: April 6, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

NCT ID: NCT05323045 Active, not recruiting - Solid Tumor Clinical Trials

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

Start date: March 21, 2022
Phase: Phase 1
Study type: Interventional

This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.