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NCT ID: NCT03891446 Enrolling by invitation - Ocular Hypertension Clinical Trials

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Maia
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

NCT ID: NCT03867513 Enrolling by invitation - Clinical trials for Brain Injuries, Traumatic

The Role of MEG in Assessment and Diagnosis In mTBI

MEGAbIT
Start date: November 6, 2019
Phase:
Study type: Observational

Head injuries are responsible for 1.4 million visits to hospital each year in the United Kingdom (UK). Most patients are allowed home the same day and make a full recovery, but some will have persistent symptoms. The investigators aim to use the latest generation of imaging technology to investigate those with mild traumatic brain injury (mTBI) to better assess them. The investigators will invite patients presenting following trauma to the Emergency Department at Queen's Medical Centre, Nottingham, UK to participate. The investigators will compare those who have a suffered an mTBI to those who have non-head traumatic injuries. The investigators will use two magnetoencephalogram (MEG) systems and ultra-high field magnetic resonance imaging (MRI) to record the functioning and structure of the brain within days of participants' injury. The investigators will test memory and thinking skills, then follow participants for six months, record the severity of participants' symptoms, and find out who does not make a full recovery. Multimodal imaging will consist of a standard MEG device using Superconducting Quantum Interference Device (SQUID) sensors, a novel MEG device using Optically Pumped Magnetometer (OPM) sensors and seven Tesla MRI. The investigators will test whether these innovative imaging techniques are more sensitive to the acute damage that mTBI causes than routine imaging. The investigators will also test whether early imaging can reveal who is most seriously affected, identifying those who will not recover without additional support. It is currently not clear what the predominant mechanism of damage that causes these long-term problems is and the investigators hope this study will address this. The Medical Research Council is funding this work

NCT ID: NCT03859895 Enrolling by invitation - Paget Disease Clinical Trials

Zoledronate In the Prevention of Paget's Disease: Long Term Extension

ZiPP-LTE
Start date: April 5, 2019
Phase:
Study type: Observational

Paget's disease of the bone (PDB) is a metabolic bone disorder which in some individuals can cause pain, bone deformity, arthritis and deafness, although in many patients it does not cause symptoms. Paget's disease has a strong genetic component and SQSTM1 is the most important susceptibility gene. People who inherit mutations in SQSTM1 have a high risk of developing PDB later in life. This study is an extension of the ZiPP (Zoledronate in the Prevention of Paget's) study which was is randomised trial currently in progress to determine if the bisphosphonate zoledronic acid (ZA) can prevent or delay the development of PDB-like bone lesions compared with a dummy treatment (placebo) in people who inherit SQSMT1 gene mutations. Although the ZiPP study will provide information on whether early ZA treatment can favourably influence bone lesion development the significance of this to the patient in terms of symptoms is unclear as yet. The aim of the extension study is to keep these individuals under surveillance for any symptoms or signs of PDB over a further 5 year period and to evaluate if there has been any progression of PDB-like lesions by bone scan at the end of this period.

NCT ID: NCT03837314 Enrolling by invitation - Parkinson's Disease Clinical Trials

Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

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

The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in surgery, complexity, post-surgery complications and cost, and increasing patient satisfaction. To facilitate the shortening and simplifying of the implantation procedure, a miniaturised skull-mounted DBS device (Picostim) has been developed which is optimised to generate waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a unique method of controlling stimulation current. The planned study is a single centre, open label, non-randomised design with the primary objective of showing similarity in control of motor symptoms for the Picostim device compared with previously published data for existing DBS devices.

NCT ID: NCT03802890 Enrolling by invitation - Clinical trials for Rheumatoid Arthritis

Microbial Dysbiosis in Rheumatoid Arthritis

MyRA
Start date: February 1, 2019
Phase:
Study type: Observational

The MyRA study will primarily investigate whether there are associations between the structure and function of the gut microbiome and response to methotrexate in early rheumatoid arthritis patients. The microbiome will be characterised via shotgun metagenomic sequencing of microbial DNA present in stool samples taken during the participant's first 6 months of taking methotrexate.

NCT ID: NCT03802799 Enrolling by invitation - Fragile X Syndrome Clinical Trials

Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

Start date: November 9, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

NCT ID: NCT03789825 Enrolling by invitation - Liver Diseases Clinical Trials

Population-based Study in Screening for Liver Fibrosis

LiverScreen
Start date: May 1, 2018
Phase:
Study type: Observational

Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

NCT ID: NCT03773016 Enrolling by invitation - Mild Dementia Clinical Trials

Touchscreen Technology and Art for People With Dementia in Care Homes

Start date: February 20, 2019
Phase: N/A
Study type: Interventional

The prevalence of dementia is rapidly growing worldwide, affecting 46.8 million people in 2015. The 2014 Alzheimer's Society report estimated that 311,730 people with dementia were living in care homes in the United Kingdom (UK). In care homes, people are more likely to be socially isolated and experience a lack of stimulation. It has been argued that access to meaningful activities is of high importance. One strategy that may engage older people in enjoyable leisure activities is the use of touchscreen technology. Previous research has indicated that people with dementia and care staff reported positive experiences when using touchscreen technology, showing improvements in quality of life, relationships and interpersonal interaction. A possible way to engage people with dementia with touchscreen technology could be through the use of the visual arts. Preliminary evidence shows the use of arts with this population to be beneficial in reducing behavioural symptoms, depression and isolation and make people with dementia more able to express feelings. The use of visual art activities in touchscreen technology is a promising idea, as positive results from interventions using these activities independently can be found in scientific literature. This intervention will consist of the use of two different visual art apps on touchscreen tablets with people with dementia living in care homes. Study data collection will take 8 weeks; four weeks will involve the execution of the intervention and four weeks for measurements. Participants will be supported to use the app twice-weekly, with a maximum of 8 individual sessions. So far, very little research on the benefits of visual art interventions on touchscreen devices has been made. Thus, there is a need to have more research on this topic. This study will add to research on this field, and its results could be valuable to care staff and people with dementia.

NCT ID: NCT03768804 Enrolling by invitation - Clinical trials for Heart Failure, Systolic

SyncAV Study: Investigation of the Efficacy of the SyncAV Fusion Pacing Algorithm on Exercise

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

In patients with weak pumping function of the heart, uncoordinated contraction of the chambers can be corrected using a cardiac resynchronization therapy ("CRT") pacemaker. These devices make patients live longer by improving how the heart pumps and reducing symptoms such as breathlessness. However, not all patients benefit from CRT and programming devices optimally can greatly influence success. Predicting the correct timings of contraction between the atria (top chambers of the heart) and the ventricles (bottom chambers), as well as between the left and right ventricles, especially when heart rate increases during exercises, is challenging. A new approach to optimizing CRT programming has been proposed known as 'fusion-pacing'. This allows the electrical wave from the heart's own conduction system to merge or fuse with the impulse from the pacemaker in the left ventricle. The timing of the pacemaker's impulse is continuously adjusted to measurements the device makes of the hearts natural conduction. What is not clear is how effective 'fusion-pacing' is during exercise when the hearts natural conduction changes rapidly and unpredictably. We plan to investigate this by monitoring the electrocardiogram ("ECG") whilst accurately measuring exercise performance and ability during a cardiopulmonary exercise test ("CPET") on an exercise bike. We will also ask participants to rate their perceived exercise intensity to see whether fusion pacing improves ECG resynchronization, exercise performance, and patients' symptoms compared to standard programming.

NCT ID: NCT03763786 Enrolling by invitation - Infertility Clinical Trials

Frozen Embryo Transfer With GnRH-antagonist Trial

Start date: December 13, 2018
Phase: Phase 4
Study type: Interventional

The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET). There are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. However, there is some suspicion that this drug (GnRH antagonist) may not be required and that women are using this drug unnecessarily. Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result. This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone, either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. The study is an open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is provided by Oxford Fertility.