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NCT ID: NCT03818607 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

DAHLIA
Start date: January 22, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

NCT ID: NCT03818230 Completed - Depression Clinical Trials

An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

EPIC
Start date: August 21, 2018
Phase:
Study type: Observational

This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.

NCT ID: NCT03817983 Completed - Crohn Disease Clinical Trials

MRE as a Screening Tool for axSpA in IBD

ProSpA-CD
Start date: March 4, 2019
Phase:
Study type: Observational

This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.

NCT ID: NCT03817853 Completed - Clinical trials for Advanced Follicular Lymphoma

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma

Start date: February 26, 2019
Phase: Phase 4
Study type: Interventional

This open-label, single arm study will evaluate the safety of obinutuzumab administered as a short duration infusion (SDI; target 90-minute infusion) during cycle 2 and from cycle 2 onwards in combination with chemotherapy in participants with previously untreated advanced follicular lymphoma (FL). The study has two phases: in the first phase, participants will receive the first cycle of obinutuzumab-based chemotherapy (G-chemo) induction therapy as usual with the first three infusions of obinutuzumab (1000 mg) administered at the regular infusion rate on Day 1, 8, and 15 of cycle 1. Phase 2 starts when participants who do not experience any Grade ≥ 3 infusion related reactions during the first cycle receive their first obintuzumab infusion given at the faster infusion rate in Cycle 2. For Cycle 2, Day 1 and all other following infusions (including maintenance), obinutuzumab will be administered at a faster infusion of 90-minute SDI, as long as the participant does not experience any Grade ≥ 3 infusion related reactions. The investigator is free to choose the chemotherapy for each participant (bendamustine, CHOP [cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone/methylprednisolone], or CVP [cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone]). The total number of cycles of G-chemo induction therapy and the cycles length depends on the chemotherapy chosen for each participant.

NCT ID: NCT03817463 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Start date: April 15, 2019
Phase:
Study type: Observational

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

NCT ID: NCT03817294 Completed - COPD Clinical Trials

Personalised Exercise Training in COPD

Start date: October 3, 2018
Phase: N/A
Study type: Interventional

Exercise training as part of Pulmonary Rehabilitation (PR) has been shown conclusively to improve breathlessness,quality of life and exercise capacity for people with COPD. However generally PR is delivered in a 'one size fits all' approach without considering different aspects of an individual's disease. It is hypothesised that a more personalised approach to PR may yield even better results. However to design a personalised programme of PR we need a better understanding of how different people with COPD respond to different possible exercise training modalities. This study will therefore comprehensively characterise a group of patients and then ask them to complete 3 weeks of exercise training in one of four modalities; conventional cycling, eccentric cycling, one-legged cycling and resistance training. The aim is not to prove which type of training is more effective but to develop an idea of which groups of patients would benefit from which type of training. Baseline measures would be designed to fully understand how an individual responds to exercise and would therefore be comprised of a variety of endurance tests, strength tests, questionnaires, and measurements of lung capacity and body composition. This is to give as much information as possible to identify different responses to exercise.

NCT ID: NCT03817138 Completed - Dementia Clinical Trials

Identifying the Course of Dementia Using Medical Records: the CoMed Study

CoMed
Start date: July 9, 2019
Phase:
Study type: Observational

The number of people living with dementia is increasing as the population ages. The UK government has initiated a "Dementia strategy" to respond to this increase, and has set four main goals; 1) to identify those with dementia as early as possible, 2) to prolong their independence, 3) to reduce the need for hospital and nursing home admissions, and 4) to delay the time until death. So far lots of research has looked at what factors might cause or increase the risk of dementia, but less is known about how dementia affects people over time once they have dementia. One of the quickest and efficient ways to identify the actual course of dementia may be to use existing medical records from primary care. Primary care medical records are those kept by the patient's GP. Having the ability to look at the course of dementia over time in these records will help identify people who have a different course (for example a faster and more severe course) and also identify the factors that alter that course. This information would be useful to clinicians and indicate potential targets for treatment in the future to alter the course of someone's disease. To assess whether this is possible, around 1000 patients with dementia who have recently been seen by a dementia service (where patients with a diagnosis of dementia are seen normally every year) will be contacted. Consent to link their primary care medical records (medical records kept by their GP) to their dementia service medical records will be sought. The target for recruitment is 400 patients who will provide consent. Then the assessment of how well the potential markers of disease progression identified from primary care medical records relate to actual changes in disease course from their dementia service medical records can be determined.

NCT ID: NCT03816891 Completed - Prurigo Nodularis Clinical Trials

Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

Start date: March 11, 2019
Phase: Phase 2
Study type: Interventional

Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.

NCT ID: NCT03815396 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

rhAAT-Fc
Start date: July 19, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.

NCT ID: NCT03815188 Completed - Clinical trials for Aortic Valve Surgery

Use of the SonoSite Probe for Measuring Jugular Venous Pressure

PRAGUE
Start date: February 15, 2019
Phase:
Study type: Observational

This prospective study will be performed in the Cardiothoracic (Chesterman) Department at Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients undergoing surgical valvular intervention, breathing both spontaneously and mechanically will be included in the trial. All patients will already have a central venous catheter inserted as part of their ongoing care. Patients will be eligible for the study irrespective of diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following written consent, the day before the trial. The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify if using the angle of Louis to approximate the location of the right atrium produces inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or under positive pressure ventilation will identify if the form of ventilation impacts on JVP and CVP recording. Correlating results between physical JVP examination and ultrasound assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in an era where the physical examination of the cardiovascular system is becoming less valuable.