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NCT ID: NCT03963102 Suspended - Actinic Keratoses Clinical Trials

Duration of Ameluz Application in Acral Actinic Keratoses Response

Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging.

NCT ID: NCT03854071 Suspended - Clinical trials for Coronary Artery Disease

Development of Novel Physiological CMR Methods in Health and Disease

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

Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.

NCT ID: NCT03756922 Suspended - Cystic Fibrosis Clinical Trials

A DDI Study of FDL169 and FDL176 in Healthy Subjects

Start date: November 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.

NCT ID: NCT03755570 Suspended - Heart Failure Clinical Trials

How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?

COGNI-CRT
Start date: June 21, 2019
Phase:
Study type: Observational

The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or a permanent pacemaker (PPM) with systolic HF (LVEF ≤35%). This clinical investigation is a prospective, single-centre cohort study. Each participant will be followed for 6 months. The study will collect data over 3 years; 2.5 years for enrolment and 6 months until the last participant completes the last 6-month follow-up visit. N.B: COGNI-CRT does NOT affect the patient's care pathway - the patients who will be selected for participation are those who have already been referred for the device implant. The ONLY difference to the patient's care pathway caused by COGNI-CRT is the addition of a battery of cognitive function tests, which involves asking the patient questions and asking them to complete questionnaire-like cognitive tests. NTpro-BNP levels, NYHA classification and LVEF will be measured prior to device implantation and at 6-months post-implant to assess the device's impact on the participant's heart failure (and CRT response). N.B: NT-proBNP, NYHA classification and LVEF are all parts of the patient's standard care pathway, COGNI-CRT is just utilising the data collected as part of the investigation. The main study arm and control group allows COGNI-CRT to assess 3 potential outcomes for patients with severe HF (LVEF <35%): 1. Cognitive function is not improved by CRT, ICDs or PPMs 2. Cognitive function can be improved by the assurance of rate control offered by CRT, ICDs and PPMs 3. Cognitive function can be improved by the assurance of ventricular synchronisation and rate control provided by the additional left ventricular lead in CRT devices.

NCT ID: NCT03711812 Suspended - Anesthesia Clinical Trials

Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department

SABRE
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures. Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days. Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable. The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment. The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.

NCT ID: NCT03679078 Suspended - Malnutrition Clinical Trials

IDDSI Nutritional Drink for Dysphagia Study

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the gastrointestinal (GI) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.

NCT ID: NCT03652987 Suspended - Obesity Clinical Trials

Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)

EMDPCOS
Start date: September 5, 2018
Phase:
Study type: Observational [Patient Registry]

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive age women, which causes disordered follicle growth and ovulation resulting in infertility. In addition women with PCOS have hyperandrogenemia and a dysregulated hormonal profile, resulting in altered feedback on the hypothalamic-pituitary-gonadal (HPG) axis. Obesity, insulin resistance, vitamin D (VD) deficiency and ageing worsen the symptoms. The gonadotrophins - follicle stimulating hormone (FSH) & luteinising hormone (LH), along with the pregnancy hormone human chorionic gonadotrophin (hCG) have structural similarities. The altered levels of FSH and LH in women with PCOS cause production of hCG from the brain leading to false positive pregnancy tests. Part one of this project will involve the investigation of this over-production of hCG in urine and serum of women with PCOS to develop suitable ovulation and pregnancy test kits, in collaboration with Swiss Precision Diagnostics (SPD). In Part two of the project, we would like to see if intervention with VD supplementation and/or using myo-inositol supplement compared with metformin (insulin sensitiser), improves prediabetes, distribution of fat/water content, weight loss and menstrual cyclicity in women with PCOS. We aim to correlate these interventions with particular serum & urine markers to develop better diagnostic tools.

NCT ID: NCT03610100 Suspended - Clinical trials for Pancreatic Neoplasms

Acelarin First Line Randomised Pancreatic Study

ACELARATE
Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to assess whether Acelarin (NUC-1031) is superior to gemcitabine in terms of overall survival for treatment of patients with metastatic pancreatic carcinoma. In addition disease progression, quality of life and comparative safety will be evaluated. Secondary objectives are to compare between the two treatment groups the following: - Progression Free Survival (PFS) - Radiological Response and disease control rate - Toxicity and safety - Quality of Life Additional, exploratory objectives are to discover and validate possible biomarkers to predict additional benefit of Acelarin (NUC-1031) over gemcitabine alone.

NCT ID: NCT03602040 Suspended - Cardiomyopathies Clinical Trials

A Psychoeducational Intervention Supporting Patients With an Inherited Cardiac Condition

PISICC
Start date: June 2022
Phase: N/A
Study type: Interventional

Inherited heart conditions (IHCs) can cause young sudden deaths due to a genetic trait that leads to a thickened heart muscle or abnormal heart rhythms. Relatives of an affected person have a 50% chance of inheriting IHCs and this is determined either through a blood test (predictive genetic test) and/or physical tests such as a heart tracing (electrocardiogram), scan (echocardiogram) and exercise test. When patients find out they are affected or are carriers for an IHC, they have numerous questions about medical management, prognosis, lifestyle; as well as experiencing stress and anxiety because of the impact on their health and risk to their family. Based on published studies and interviews, a psychoeducational intervention underpinned by Self-determination Theory was developed to support these patients An uncontrolled study to determine the feasibility of the intervention and outcome measures will be undertaken. Patients with a new IHC diagnosis or a carrier result aged 16 years and older will be recruited from outpatient clinics in London and will be receive the intervention consisting of a disease-specific information leaflet, a personalised lifestyle consideration guide and participation in a 1-hour group session facilitated by a cardiac genetic nurse. Outcome measures to look at degree of self-determination, autonomy support and competence; and heart-related anxiety will be collected at baseline and at 3 months post intervention. Clinical and socio-demographic data will be obtained from medical notes. The feasibility and acceptability of the intervention will be measured by assessment of the study procedures such as recruitment, retention and any adverse events. It is expected that there will be up to 4 consecutive group sessions and feedback from each session will be used to co-design and refine the intervention model for a definitive clinical trial.

NCT ID: NCT03547063 Suspended - Obesity Clinical Trials

Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour

TASTER
Start date: December 18, 2018
Phase:
Study type: Observational

The aim of this study is to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals, using functional magnetic resonance imaging (fMRI).