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NCT ID: NCT02717975 Recruiting - Urinary Retention Clinical Trials

The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients

Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient get the urge to pass urine and empty the bladder. The main objective of this study is to see the effect of catheter valve on the length of clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed. In this study after randomization, patients in Group A (catheter valve group) will be given a catheter valve before they are sent home with the catheter.They will be asked to close the valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250 mls in bladder with natural filling) before their appointment. It is very likely that by the time these patients are seen in the TWOC clinic their bladder is already full and they will void soon after removal of catheter.The patients in Group B (control) will go home with free drainage catheter and urine bag (standard catheter removal). These patients on arrival, in the TWOC clinic will have an empty bladder when their catheter is removed, they will then drink plenty of fluids in the clinic and wait for their bladder to be full before they void spontaneously. This study will last for one year after approval by ethical committee. The time saved in this process would lessen patient anxiety, lead to more patients being reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.

NCT ID: NCT02717845 Recruiting - Bone Malalignment Clinical Trials

CT Imaging Study for Knee Osteotomy (CISKO)

CISKO
Start date: March 2016
Phase: N/A
Study type: Interventional

Malalignment of the knee joint causes arthritis in later life. Currently there are three surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and high tibial osteotomy (HTO). The former two very much focus on treating the effect of malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the arthritis, namely the joint malalignment. This preserves the patient's joint and it means that a patient will start using the unaffected part of the knee joint more. HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the knee joint, to redistribute load from the affected medial part to lateral part. To keep the tibia in the new position, a medical nail device is attached to keep it in place and allow new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at surgery and therefore the change in bone angle cannot be changed afterwards. It does mean that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new CE-marked device is being tested in an interventional trial; it is produced by Ellipse Technologies. This device is an extendable nail and inserted intramedullary; following surgery the nail is tend slowly extended over a period of time until the bone correction is satisfactory. The CISKO imaging study will assess whether there is a difference between the TomoFix and Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6 months post-operatively. This will be quantified by two independent radiological reports. A secondary objective is to investigate patient satisfaction and also patient pain levels at these time intervals. The degree of bone healing is usually the main factor holding clinicians back when it comes to advising patients on what activities they can return to post-operatively. A difference in bone healing between the two systems may impact on the advice clinicians can give patients regarding recommencing more intense activities such as recreational sports, which ultimately could positively impact patients' health and well-being.

NCT ID: NCT02715284 Recruiting - Neoplasms Clinical Trials

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

GARNET
Start date: March 7, 2016
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.

NCT ID: NCT02712684 Recruiting - Prostate Cancer Clinical Trials

Cancer Diagnosis by Multiparametric UltraSound of the Prostate

CADMUS
Start date: July 2015
Phase: N/A
Study type: Observational

In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

NCT ID: NCT02708134 Recruiting - Cardiac Arrest Clinical Trials

Quality of Pediatric Resuscitation in a Multicenter Collaborative

pediRES-Q
Start date: May 2, 2016
Phase:
Study type: Observational

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.

NCT ID: NCT02705846 Recruiting - Prostate Cancer Clinical Trials

Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations

GENPROS
Start date: September 2014
Phase:
Study type: Observational

GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers with PCa matched with a control group of men with PCa who are known not to carry a mutation in the same gene. Clinical data regarding treatment and patient outcome will be collected retrospectively and prospectively. Archived tumour samples will also be collected for tumour profiling. A blood or saliva sample will be taken, if the participant consents to this part of the study, for genetic profiling to investigate any association of other inherited factors with PCa outcomes. Information obtained from this study will be of critical importance to support clinical trials investigating the most appropriate management of PCa in this group of patients at increased risk of prostate cancer.

NCT ID: NCT02704520 Recruiting - Rectal Cancer Clinical Trials

Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial

TRIGGER
Start date: March 2016
Phase: N/A
Study type: Interventional

Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post treatment MRI scans routinely performed, no change from the MERCURY trials high resolution MRI protocol is required. Patients will be randomised to either the control arm for management according to national guidelines - conventional MDT, clinical assessment post-treatment planning using the baseline MRI. Patients in the interventional arm will have their post treatment MRI scans read by a radiologist trained and supported to reliably report the mrTRG grade and have their management directed accordingly - 'Good response' (mrTRG 1&2) - watch and wait (avoidance of surgery) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next steps in treatment and surveillance. Patients are followed up for five years with QoL questionnaires completed at registration, 3 and 5 years.

NCT ID: NCT02703155 Recruiting - Cystic Fibrosis Clinical Trials

The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes

HomeOGTT
Start date: October 2015
Phase: N/A
Study type: Interventional

The aim of this study is to establish if the self-administered electronic Oral Glucose Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are between 10 and 17 years of age with CF.

NCT ID: NCT02699645 Recruiting - Hypertension Clinical Trials

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

TRIDENT
Start date: September 28, 2017
Phase: Phase 3
Study type: Interventional

An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, on time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.

NCT ID: NCT02696746 Recruiting - Chronic Pain Clinical Trials

Painful Channelopathies Study

PCS
Start date: February 2012
Phase:
Study type: Observational

To understand the pathophysiological basis of heritable pain syndromes. This will consist of a number of components: - Determine the genetic basis for heritable pain syndromes. - Investigate the pain symptoms, psychological co-morbidity and quality of life in patients with heritable pain syndromes. - Use quantitative sensory testing to investigate abnormalities in sensory processing. - Use imaging modalities to investigate the neural correlates of pain perception in heritable channelopathies. - In select patients to perform skin biopsy to determine if there has been any damage to C-fibres. - To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for future studies into the molecular basis of altered pain perception. - To use neurophysiological tests, the axon reflex, and conditioning challenges to determine how peripheral nerves, in heritable channelopathies and unusual pain syndromes, have been altered. - Microneurographic recordings for directly detecting the function of pain fibres in peripheral nerves. Knowledge gained from the study will be used to aid the further development of genetic testing and specific pain questionnaires for the diagnosis of heritable pain syndromes secondary to channelopathies. - Ultimately better knowledge of underlying pathophysiology in these heritable pain conditions may inform the development of novel treatments.