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NCT ID: NCT05344027 Completed - Clinical trials for Adrenocortical Carcinoma

The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

MitoS-FP
Start date: April 11, 2022
Phase:
Study type: Observational

This work will evaluate the effects of mitotane treatment on serum protein concentrations in patients treated for ACC with mitotane therapy and compare them to patients with an adrenal neoplasm and pregnant cohort. All of the individuals were treated at King's Hospital between April 2019 and June 2020. Proteins which will be evaluated during this study, include CBG and TBG.

NCT ID: NCT05342012 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect of Nitrate on Brown Fat

Start date: June 30, 2022
Phase: N/A
Study type: Interventional

Type 2 diabetes mellitus (T2DM) is a metabolic condition characterized by chronic hyperglycemia and progressive insulin resistance, which progressively lead to macro- and microvascular damage. With the number of people with T2DM continuing to rise, this pandemic is expected to reach 700 million people by 2045, such that the costs associated with its clinical management are likely to become unsustainable. Therefore, identifying cost effective alternative interventions is imperative. Diets rich in fruits and vegetables are well known to have cardiovascular benefits and reduce the risk of getting T2DM. The beneficial effects of vegetables on cardiovascular outcomes are particularly effective in green leafy vegetables and beetroot. This may in part be due to a high concentration of inorganic nitrate, and its beneficial effects on cardiovascular health due to its effect on nitric oxide (NO•). Increased dietary nitrate intake elevates cyclic guanosine monophosphate [(cGMP)]. Importantly, cGMP has also been shown to increase brown fat expression by 'beiging' WAT in mice through an NO• dependent process. Recent developments in the ability to non-invasively measure BAT activation using magnetic resonance imaging (MRI) and infrared thermography (ITR) has opened the possibility to study the effects of nitrate on BAT activation in man. BAT depots in humans with T2DM have been identified using MRI but not yet with the more easily accessible technique of IRT. It is hypothesised that nitrate can increase BAT activation and quantity in people with T2DM.

NCT ID: NCT05339191 Completed - Clinical trials for Intellectual Disability

Compassionate Imagery for People With An Intellectual Disability

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The current study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging in the workshop. It is an early exploratory study in what is hoped will be a longer process consisting of future feasibility and piloting work. Between 6-10 participants who are attending the National Health Service (NHS) NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.

NCT ID: NCT05339100 Completed - Clinical trials for Healthy Participants Study

Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

Start date: March 22, 2022
Phase: Phase 1
Study type: Interventional

This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.

NCT ID: NCT05338892 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ORCHID
Start date: June 22, 2022
Phase:
Study type: Observational

Primary Objective: To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting: 1. ORR according to Lugano classification and as assessed by treating physician evaluation 2. Complete Response (CR) rate according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 3. Progression Free Survival (PFS) according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 4. Overall Survival (OS) 5. Duration of response (DOR) according to Lugano classification and as assessed by - Independent central review and - Treating physician evaluation 6. Disease control rate (DCR) according to Lugano classification and as assessed by: - Independent central reviewed - Treating physician evaluation 7. Time to next treatment (TTNT)

NCT ID: NCT05338879 Completed - Clinical trials for Relapsed/Refractory Follicular Lymphoma

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma

FLORA
Start date: June 22, 2022
Phase:
Study type: Observational

Primary Objective: To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review. Secondary Objectives: To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting: 1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation 2. Complete response (CR) rate according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 3. Progression-free survival (PFS) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 4. Overall survival (OS) 5. Duration of response (DOR) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 6. Disease control rate (DCR) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 7. Time to next treatment (TTNT) 8. Histological transformation (HT)

NCT ID: NCT05335447 Completed - Healthy Clinical Trials

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

Start date: April 19, 2022
Phase: Phase 1
Study type: Interventional

This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.

NCT ID: NCT05330273 Completed - Malaria Clinical Trials

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz

Start date: April 28, 2022
Phase: Phase 1
Study type: Interventional

This study assessed the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination. Results from this study will provide guidance on prescribing ganaplacide and lumefantrine combination when co-administered with moderate inducers of CYP3A4.

NCT ID: NCT05330234 Completed - Clinical trials for Research With Clinical Staff in Stroke Rehabilitation

Usability Study of OnTrack Tools

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

Aims: Assess the usability of OnTrack Tools, a clinician facing interface to manage stroke survivors using the OnTrack rehabilitation system. Background: Arm disability is a common problem after stroke that can lead to loss of independence, it affects ~450,000 people in the UK. Repetitive activity is critical for recovery but research shows people can struggle with intensity and keeping track of progress. The OnTrack system being developed at Imperial College London is a potential solution to this problem. Intervention: The OnTrack system consists of two software applications, OnTrack App - used by patients, and OnTrack Tools - used by clinicians. OnTrack Tools pulls data generated by the OnTrack App and enables the monitoring of clients' arm activity, and management of goals and educational content. The software is used to inform selfmanagement coaching by helping therapists understand more about how and when patients use their affected arm between treatment sessions. Design and methods: This study will assess the usability of the OnTrack Tools component of the system. The study will recruit stroke therapists from Imperial College Healthcare NHS Trust to provide feedback on the experience and usability of OnTrack Tools' graphical user interface (GUI). The study will be divided into three progressive cycles of testing, feedback and iteration. Each cycle will see participants individually completing specific tasks related to system navigation and the management of patients under simulation. Participants will complete outcome measures and take part in focus groups. Researchers will analyse and use the feedback to improve the GUI ready for the next testing cycle. Patient and public involvement: The project team includes a PPIE group of stroke survivors who oversee the project and help us with public facing documentation. They are members of the research team and are reimbursed for their time and travel, according to INVOLVE guidance. Dissemination: Results of the study will be written-up for technical reporting and publication. Participants will be provided with a summary of results at the end of the study. The study team will be providing general updates on the progress of the study via their social media channels (e.g. Twitter @OnTrackRehab @ImperialIGHI @HelixCentre).

NCT ID: NCT05329610 Completed - Prediabetes Clinical Trials

β-alanine Supplementation in Adults With Overweight/Obesity

BASA-O
Start date: April 5, 2022
Phase: N/A
Study type: Interventional

The study will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with overweight or obesity. Beta-alanine is a widely used dietary supplement that can increase the amount of carnosine in skeletal muscle. Both carnosine and beta-alanine occur naturally in animal food products and previous research shows that supplementation with beta-alanine leads to an improvement in exercise performance; more recently, the present investigators have shown that increasing carnosine can also help to improve cardiometabolic health, detoxify skeletal muscle, and improve glucose (sugar) uptake into muscle cells. The investigators will recruit 30 participants (15 per arm) with overweight or obesity who meet the study criteria (this accounts for up to 20% attrition - a minimum of 12 participants per arm). Those who are eligible will be required to receive three short telephone calls and attend three laboratory sessions. Participants will be randomised to receive either beta-alanine or placebo (an inactive sugar pill) for the 3-month study period. To see whether beta-alanine supplementation is feasible in this population the investigators will measure recruitment, adherence (how well people can stick to the supplement regime), the number and nature of side effects, and blinding to the intervention. Markers of cardiac function, glycaemic control, and metabolic health will also be explored. All measurements will take place before and after a 3-month supplementation period. This will provide us with novel information of the role of beta-alanine and carnosine in cardiometabolic health; and will aid in the planning of a larger randomised controlled trial to assess the efficacy of beta-alanine supplementation as a therapeutic strategy.