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NCT ID: NCT04736628 Completed - Clinical trials for Chronic Kidney Disease

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.

NCT ID: NCT04735822 Completed - Healthy Volunteers Clinical Trials

A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability

Start date: October 26, 2020
Phase: Early Phase 1
Study type: Interventional

This is a single-center, randomized, open-label, 2-part study in healthy male subjects to evaluate the taste profile of different belumosudil oral suspensions and the relative bioavailability of those chosen oral suspensions of belumosudil compared to oral tablets of belumosudil. Part 1 is an open-label, randomized single-period study of oral suspensions of belumosudil 40 mg/mL delivered in 6 different vehicles. Approximately 12 healthy male subjects, 2 subjects in each of 6 groups, will be administered a single dose of belumosudil 40 mg/mL in 6 different vehicles (Vehicles 1, 2, 3, 4, 5, and 6) in corresponding Regimens A, B, C, D, E, and F in different sequences of the 6 vehicles. All subjects will receive 1 dose of all belumosudil in all 6 vehicles which are as follows: ABFCED; BCADFE; CDBEAF; DECFBA; EFDACB; and FAEBDC. Part 2 is a single-center, open-label, randomized, 3-period design to assess the relative bioavailability of a selected belumosudil suspension formulation compared to the oral belumosudil. Tablet reference and the effect of food on the selected belumosudil suspension formulation in 18 healthy male subjects. Subjects will be randomized prior to the administration of the first dose of IMP to 1 of 6 treatment sequences (GHI, HIG, IGH, IHG, GIH and HGI), with 3 subjects assigned to each treatment sequence where: Regimen G--oral belumosudil 200 mg tablet (reference) with the subject fed; Regimen H--belumosudil powder 200 mg for oral suspension or belumosudil 200 mg oral suspension with the subject fasting; and Regimen I--belumosudil 200 mg powder for oral suspension or belumosudil 200 mg oral suspension with the subject fed.

NCT ID: NCT04735783 Completed - Obesity Clinical Trials

Placebo Breakfast Consumption, Appetite and Food Intake

Start date: January 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study was to examine the effects of a very low-energy, viscous placebo breakfast meal on subjective appetite sensations during the morning, and food intake at lunch, compared to a typical whole-food breakfast meal and a water-only control. Participants will not be told that the placebo breakfast contains nearly no energy until the end of the study. The breakfasts will be provided in a randomised order, with a period of at least four days separating the trials. Blood samples will be taken before and after the breakfast is eaten to see how appetite-regulating proteins and blood sugars respond during the morning. Appetite questionnaires will also be completed throughout the morning, and a pasta-based lunch meal will be provided so that voluntary food intake can be measured.

NCT ID: NCT04734938 Completed - Micronutrients Clinical Trials

The Effect on Micronutrient Status of a Diet of 100% Huel

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

This project will assess the effect of Huel Food replacement on the micronutrient status of healthy volunteers over a 4-week period. To achieve this, 30 (non-smoking) generally healthy volunteers will be recruited to attend the study centre on three separate occasions. Volunteers will be asked to consume their normal diet for one week whilst recording what they eat. They will then be asked to only consume Huel Powder and water for 4 weeks.

NCT ID: NCT04734509 Completed - Clinical trials for Nitrous Oxide Inhalation Sedation

Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation

Start date: February 21, 2019
Phase: N/A
Study type: Interventional

This is a randomised non-blinded controlled clinical trial, which involves the measurement of efficiency and acceptability of the Silhouette Mask system and compares it with the Porter Brown Mask system used for Inhalation Sedation in children having dental treatment at the Leeds Dental Institute. All eligible participants will be introduced to both masks (Porter Brown and Silhouette) in the assessment session prior to their first treatment session. Then participants will be randomly allocated to undergo treatment under nitrous oxide-oxygen inhalation sedation using either the Porter Brown or the Silhouette System. The efficiency and acceptability will be measured by a feedback questionnaire at the end of the treatment session and the scavenging efficiency will be measured by a diffusion pen which will measure the levels of nitrous oxide in the dentist's environment

NCT ID: NCT04734275 Completed - Clinical trials for Chronic Kidney Disease

Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers

Start date: February 1, 2021
Phase: Phase 1
Study type: Interventional

This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.

NCT ID: NCT04733040 Completed - Glomerulonephritis Clinical Trials

Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE)

NewPLACE
Start date: January 20, 2021
Phase: Phase 2
Study type: Interventional

This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy

NCT ID: NCT04732949 Completed - COVID-19 Clinical Trials

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

SPRINTER
Start date: January 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

NCT ID: NCT04732780 Completed - Clinical trials for Diabetes Mellitus, Type 1

Avoidance of Hyperglycaemia in People With Type 1 Diabetes

HYPE
Start date: March 2, 2021
Phase:
Study type: Observational

This study aims to learn more about avoidance of hyperglycaemia in adults with type 1 diabetes. People who attend a type 1 diabetes clinic will be invited to complete a number of self-report questionnaires and a survey. A subsection of people who experience avoidance of hyperglycaemia will be invited to take part in an interview in order to gain a more in-depth understanding of this issue.

NCT ID: NCT04732208 Completed - Clinical trials for Diabetic Retinopathy

Automated Screening of Diabetic Retinopathy Using a Smartphone-based Camera

Start date: April 20, 2022
Phase:
Study type: Observational

The prevalence of diabetic retinopathy (DR) in the UK is on the rise. Within 20 years of diabetes diagnosis, nearly all people with type 1 and almost two thirds of people with type 2 diabetes (60%) have some degree of DR. NHS guidelines mandate annual DR screening in all patients aged 12 and above to prevent complications of DR. Screening for DR in England involves labour-intensive manual grading of retinal images through the teleophthalmology platform. Automated retinal image analysis systems with the use of artificial intelligence (AI) may offer an alternative to manual grading. The purpose of this study is to evaluate the performance of a portable, hand-held fundus camera with integrated artificial intelligence for diabetic retinopathy screening by comparing it against the current standard i.e diagnosis provided by trained human graders evaluating the standard photographs/ophthalmologists.