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NCT ID: NCT04008732 Completed - Clinical trials for Erectile Dysfunction

Evaluating MED2005 & Nitrostat Bioavailability

FM58
Start date: November 15, 2017
Phase: Phase 1
Study type: Interventional

Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology. Treatment requires the application of a small quantity of gel (approx 300 mg), containing a fixed dose of GTN, to the glans of the penis. Pharmacokinetic studies in healthy volunteers indicate rapid absorption of the drug and low systemic exposure, reducing the risk of adverse events (such as headache) commonly associated with GTN therapy. The purpose of this study is to demonstrate similar or lower bioavailability of GTN from MED2005 (test IMP) with that from Nitrostat (reference IMP). The study will be conducted in two parts (Part 1 and 2). Part 1 will be conducted in 30 subjects and Part 2 will be conducted in 10 subjects. Part 1 will compose of a pre-study screen, followed by six treatment periods and a post-study follow-up. Part 2 will compose of a pre-study screen, followed by two treatment periods and a post-study follow-up. Subjects can only participate in either Part 1 or 2 of the study (not both).

NCT ID: NCT04008498 Completed - Preterm Infant Clinical Trials

AEEG in Pre-term Infants

AEEG
Start date: May 30, 2018
Phase: N/A
Study type: Interventional

Amplitude integrated encephalography (aEEG) is a monitor that measures brain activity by attaching leads to a baby's head, and is used routinely in term babies who have brain injury because of a difficult birth. There is little information on how useful aEEG is in premature babies, and most studies only look at small numbers of babies. However, these studies suggest that the aEEG is different in premature babies with brain injury, infections / meningitis, and in those receiving certain drugs. It is also affected by changes in blood pressure and blood acid levels. It is theoretically possible that, if the investigators can detect changes using aEEG early on, the investigators will be able adjust treatment to make a baby better.

NCT ID: NCT04008485 Completed - Preterm Birth Clinical Trials

Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

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

Every year, globally, about 15 million babies are born preterm (before 37 weeks). This number is rising. Preterm birth (PTB) complications are the leading cause of death among children under 5 years of age, responsible for nearly 1 million deaths annually. PTB poses a strain on scarce health resources: each very premature baby costs tens of thousands of pounds in newborn care. One in 4 babies born before 28 weeks develop neurological impairment, a parent often having to give up work to care for an affected child. The prediction and prevention of PTB remain challenging because current methods, such as measuring the cervix by ultrasound, have limited accuracy. If a technique that reliably predicts PTB could be developed, there are care measures that can be employed to delay birth to reduce long-term disability/impairment. The Investigators have been studying whether they can detect the changes in cervical tissue structure and composition that precede PTB by using very low current Electrical Impedance Spectroscopy (EIS). Evidence recently showed that women at high risk of PTB (history of previous PTB), who deliver preterm, including delivery before 28 weeks gestation, have lower cervical "resistance" in mid-pregnancy than those who deliver at term. With NIHR funding, the investigators have developed a new device, based on a technique called magnetic impedance spectroscopy (MIS) that should address limitations of the EIS device for assessing PTB risk. The investigators now want to refine the new MIS device by minimising the signals it receives from other tissues around the cervix and making its measurements at internal body temperature more stable. The researchers also conduct clinical experiments to test whether it predicts PTB better than the previous EIS device, and check whether pregnant women find its use acceptable. This information will allow them to obtain UK regulatory approval to test the device in larger trials.

NCT ID: NCT04008277 Completed - Ovulation Clinical Trials

Investigation of Heart Rate Variability During the Menstrual Cycle

Start date: July 19, 2019
Phase:
Study type: Observational

In this study, women will be required to wear a heart rate monitor continuously and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

NCT ID: NCT04007536 Completed - Clinical trials for Mucopolysaccharidosis II

A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome

Start date: October 23, 2019
Phase:
Study type: Observational

This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity and/or treatment response and prospectively assess the progression of disease in participants with MPS II who are aged ≤30 years at the time of enrollment.

NCT ID: NCT04006873 Completed - Cystic Fibrosis Clinical Trials

Gut Imaging for Function & Transit in Cystic Fibrosis Study 2

GIFT-CF2
Start date: September 3, 2019
Phase: Phase 2
Study type: Interventional

People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur. Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function. The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.

NCT ID: NCT04006132 Completed - Clinical trials for Bilateral Hearing Loss

Evaluation of the Benefits of Bilateral Fitting in BAHS Users

Start date: July 4, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

NCT ID: NCT04005885 Completed - Myopia Clinical Trials

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

NCT ID: NCT04005742 Completed - Colorectal Cancer Clinical Trials

The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study

BFU
Start date: March 13, 2017
Phase:
Study type: Observational

Worldwide, colorectal cancer is the 3rd most common cancer; risk increases with age and is modified by lifestyle factors notably diet, physical activity and obesity. The BORICC Follow-Up (BFU) Study is a 12+ year follow-up of participants recruited to the Biomarkers of Risk of Colon Cancer (BORICC) Study. This longitudinal study will investigate associations between ageing and lifestyle factors and a panel of molecular biomarkers linked with colorectal cancer risk.

NCT ID: NCT04005352 Completed - Clinical trials for Age-related Macular Degeneration

Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

TALON
Start date: September 25, 2019
Phase: Phase 3
Study type: Interventional

This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.