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NCT ID: NCT02902094 Recruiting - Stenosis Clinical Trials

Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

DeVA
Start date: January 2016
Phase: N/A
Study type: Interventional

DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.

NCT ID: NCT02898571 Recruiting - Clinical trials for The Impact of Vitamin c and Epicatechin Upon Antioxidant Capactity

Cross-over Double-blind Intervention to Investigate the Effects of Defined Antioxidant-containing Drinks on Time Course of Antioxidant Capacity

Start date: July 2016
Phase: N/A
Study type: Interventional

The aim of this project is to measure the differences in antioxidant capacity at different time points after consuming a single dose of antioxidant-containing drink (vitamin C or epicatechin) compared with a control drink in 10 volunteers, and then match the data with the proposed modelling corresponding to either homeostasis or accumulation. Additionally it will also determine whether the effect on changes of antioxidant capacity in response to epicatechin and vitamin c is equal.

NCT ID: NCT02884453 Recruiting - Clinical trials for Gastrooesophageal Cancer

Proof-of-concept Study of Ibrutinib in c-MYC and HER2 Amplified Oesophagogastric Carcinoma

iMYC
Start date: July 19, 2016
Phase: Phase 2
Study type: Interventional

Some cancers of the oesophagus and stomach express excessive copies of either the cMYC (Myelocytomatosis oncogene) gene, the HER2 (Human epidermal growth factor receptor 2) gene or both. These genes may potentially contribute to the growth and spread of cancer.Ibrutinib is a drug that is already used in the treatment of certain cancers of the immune system. There is preclinical evidence that it shows activity against gastric and stomach cancer cells over-expressing cMYC and HER2 genes. The iMYC study will assess the activity of ibrutinib in cancers of the oesophagus and stomach which over-express these genes and which have previously been treated with standard chemotherapies. Any anti-cancer activity seen will be measured and correlated with metabolic changes on FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) - PET (positron emission tomography) scan, changes in DNA and circulating tumour cells in the blood, and molecular changes in the cancer itself through the use of optional repeat tumour biopsies. If an effect is seen it could provide justification for further research in this group of patients. Patients will be eligible if they have advanced cancer of the oesophagus or stomach and have been treated with at least one line of prior therapy. The study will be conducted at the Royal Marsden Hospital at its Sutton and Chelsea sites. It will involve an initial group of up to 17 patients. Screening, recruitment and follow up will last for 3 years in total. Patients wishing to take part must consent to having their cancer biopsied to test for cMYC and HER2 amplification, as well as a number of imaging and blood tests. There are optional further tumour biopsies whilst on study. Patients will be treated with ibrutinib until progression of their disease or unacceptable toxicity.

NCT ID: NCT02884349 Recruiting - Arthropathy of Hip Clinical Trials

The Relationship Between Component Position and RoM

Start date: October 2016
Phase: N/A
Study type: Interventional

The aim of the study is to determine the influence of the combined anteversion of acetabular cup and the femoral stem used in total hip arthroplasty on the theoretical and actual range of motion of the hip in three dimensional space.

NCT ID: NCT02873403 Recruiting - Clinical trials for Osteoarthritis, Knee

Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis

Start date: March 2017
Phase: N/A
Study type: Interventional

Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to aging and increasing obesity, the prevalence of KOA is expected to increase in the developed country in the next 20 years. KOA decreases quality of life of patients through chronic pain, joint stiffness, and reduced social activity, which influence emotional wellness as well. KOA has also impact on the biomechanics of the lower limbs, leading or amplifying the tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the medial knee joint loading may lead patients into a vicious circle by increasing knee pain, decreasing activities, increasing weight and disease progression. Knee brace is a non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the limb. However, the main issue is the poor compliance because of lack of effectiveness, more drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness, aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in design, 3D printing may resolve most of these complaints. This study aims to compare clinical and biomechanical effectiveness, comfort and patients complaints of a knee brace made by 3D printing to a conventional knee brace. The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead the experimental trial. They will recruit men or women (40 to 70 years old) suffering from medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period, they will wear 2 different knee braces for two weeks each with a 1-week period without knee brace between. Participants will have five visits to GCU: once for leg measurement to make knee braces and four times to fill questionnaires and perform gait analysis. Besides, they will wear activity monitor for 3 non-consecutive weeks.

NCT ID: NCT02872883 Recruiting - Clinical trials for Prelabour Rupture of Membranes at Term

A Pilot RCT on the Management of Term Prelabour Rupture of Membranes

Start date: November 2016
Phase: N/A
Study type: Interventional

This is a pilot study that will eventually result in a main randomised controlled trial that will look at what management is associated with a higher rate of normal birth and a lower rate of chorioamnionitis (maternal infection) when women break their waters but labour does not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks gestation) is a physiological event that happens during labour. However, according to Gunn et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time between the rupture and the onset of labour is called latent phase and time wise is variable. Studies have showed no statistically significant differences in terms of neonatal infection or chorioamnionitis when the investigators induce labour with prostaglandins compared to when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of confounding factors that might relate to the incidence of chorioamnionitis (maternal infection), the strongest predictor was having more than 8 vaginal examinations since the rupture of membranes and before delivery which was a stronger predictor than the duration of the latent phase. It is thought that by reducing the number of internal examinations, chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main RCT will compare clinical outcomes and maternal satisfaction when women consent to be randomized to four groups: (1) Active management and routine internal examinations during labour, (2) Active management and reduced internal examinations, (3) Expectant management and routine internal examinations, (4) Expectant management and reduced internal examinations. This application seeks ethics approval for the pilot phase to ensure that a definitive study can be undertaken appropriately. It is important to test that all the components work well individually and as a whole, to estimate sample size and ultimately to test the integrity of the research protocol before embarking on the main trial.

NCT ID: NCT02870426 Recruiting - Spinal Cord Injury Clinical Trials

Collection and Characterisation of Human Olfactory Ensheathing Cells

Start date: April 9, 2018
Phase:
Study type: Observational

We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two groups who will qualify: Group 1 - Deceased Donors: 1A: Donors after brainstem death (DBDs) undergoing solid organ donation 1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation Group 2 - Living Donors: Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON) is cut as part of the surgical procedure. The OB of the concomitant severed ON would be donated. We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We will study the effects of patient diagnosis, age, cause of death (if applicable), co-morbidities and warm ischaemic time on cell survival and regenerative function. In future studies we aim to store OECs in a GMP facility and transplant OECs into patients with spinal cord injuries.

NCT ID: NCT02867410 Recruiting - Clinical trials for Infants Admitted to Neonatal Units

Which Infants in a Neonatal Unit Are at Most Risk of Feeding Difficulties?

Start date: November 2016
Phase: N/A
Study type: Observational

Feeding problems are common among babies who are born preterm or who have medical conditions. It is not yet known which babies admitted to neonatal units are most at risk of feeding problems. Studies have shown that the degree of prematurity and the presence of additional health problems make feeding difficulties more likely. However, research does not always agree on which health problems are most associated with feeding problems and many studies on prematurity exclude babies with the most complex health problems. Additionally, not all babies with complex health problems and feeding problems are premature. This study aims to answer the question 'Is gestational age or medical status the better indicator of risk for feeding difficulties?' This research will study babies admitted to the Royal Preston Hospital Neonatal Unit in 2015 using routinely collected data about stored on BadgerNet, a patient data management system. Coded data will be collected for the following variables: gestational age category (extremely preterm, very preterm, moderate-late preterm, term), medical status by number and type of bodily systems with health issues, and feeding outcome (full oral feeding by 37 weeks, 40 weeks, before discharge, or discharged home with tube feeding). Appropriate statistical tests will be used to determine the presence or absence of correlation between gestation age and medical variables and feeding outcome. Information from this study will be used to inform neonatal service delivery (including Speech and Language Therapy referral criteria and caseload prioritization) and areas in need of further research.

NCT ID: NCT02866370 Recruiting - Clinical trials for Ovarian Clear Cell Carcinoma

Study Of Nintedanib Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium

NiCCC
Start date: April 2015
Phase: Phase 2
Study type: Interventional

The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30 with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation

NCT ID: NCT02861573 Recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Start date: November 17, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.