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NCT ID: NCT04921124 Completed - Stress Fracture Clinical Trials

Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide (PTH 1-34) Between Sexes

PHAB
Start date: May 24, 2021
Phase: Phase 3
Study type: Interventional

To test for a difference in the pharmacokinetics (PK) and pharmacodynamics (PD) of teriparatide (PTH 1-34), between healthy male and female volunteers matched to military recruits in training.

NCT ID: NCT04920370 Completed - Healthy Clinical Trials

Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

Start date: September 4, 2019
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

NCT ID: NCT04920071 Completed - Clinical trials for Age Related Macular Degeneration

Optimising Visual Acuity Measurement in Macular Degeneration

OPTIMISE
Start date: July 25, 2019
Phase:
Study type: Observational

Age-related macular degeneration (AMD) is the leading cause of visual impairment in the UK. The condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. The ability to accurately measure vision is central to the detection and management of AMD. The most common test (visual acuity) typically requires patients to identify black letters of varying size on a white background, with the smallest letter read representing the limit of vision. Conventional tests are however known to be variable, making it difficult to determine if a true change in vision has occurred. Previous work has found the Moorfields Acuity Chart, which contains specially constructed letters composed of a black core and white border, to be more sensitive to early AMD compared to standard charts. Despite this advantage, it is unclear if there is an associated increase in measurement variability with the Moorfields Acuity Chart and if this changes with the severity of disease. In this study, the relationship between vision test sensitivity and measurement variability will be quantified with both conventional visual acuity tests and the new Moorfields Acuity Chart to identify the optimal vision test to detect and monitor AMD in the clinic.

NCT ID: NCT04919863 Completed - Healthy Clinical Trials

Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Start date: May 24, 2021
Phase: Phase 1
Study type: Interventional

A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.

NCT ID: NCT04919499 Completed - Clinical trials for Diabetic Retinopathy

A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment

PARTRIDGE
Start date: July 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128. In this study, BI 765128 is given to people for the first time. The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B. In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. In this part, participants receive study treatment once every month for 3 months. Participants in part A are in the study for about 4 months and visit the study site about 8 times. Participants in part B are in the study for about 5 months and visit the study site about 7 times. The doctors regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT04916470 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

STEP HFpEF DM
Start date: June 15, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. - At 6 of the visits participants will have blood samples taken. - At 5 of the visits participants will be asked to fill in a questionnaire - At 4 of the visits participants will have to do a 6-minute walking test - At 3 of the visits participants will have a test to check the heart. - participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04914754 Completed - COVID-19 Clinical Trials

Mechanisms Underlying Long-term Fatigue and Exercise Intolerance Following COVID-19

MEXICO
Start date: May 7, 2021
Phase:
Study type: Observational

The MEXICO study is an observational study that aims to identify underlying mechanisms contributing to exercise intolerance in the presence of persistent COVID-19 symptoms (Long COVID).

NCT ID: NCT04911972 Completed - Sarcoma Clinical Trials

Functional Muscle Transfers in Lower Limb Sarcoma: 3D Gait Analysis and Environmental Simulation

Start date: January 1, 2016
Phase:
Study type: Observational

The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. This study will use 3D Gait Analysis, Environmental simulation and Patient Reported Outcome Measures to compare patients with function restoring surgery against patients without function restoring surgery.

NCT ID: NCT04908800 Completed - Healthy Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects

Start date: May 27, 2021
Phase: Phase 1
Study type: Interventional

This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with itraconazole will be evaluated.

NCT ID: NCT04908683 Completed - Clinical trials for Respiratory Syncytial Viruses

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

EVERGREEN
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.