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NCT ID: NCT03099096 Completed - Asthma Clinical Trials

Study of Mepolizumab Autoinjector in Asthmatics

Start date: May 4, 2017
Phase: Phase 3
Study type: Interventional

This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves or via caregivers. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in autoinjector (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 158 subjects will be enrolled in the study.

NCT ID: NCT03098030 Completed - Clinical trials for Small Cell Lung Cancer

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Start date: June 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).

NCT ID: NCT03097172 Completed - Clinical trials for Coronary Artery Disease

The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention

GRAVITY
Start date: June 1, 2017
Phase:
Study type: Observational

This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries. When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down. The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.

NCT ID: NCT03096834 Completed - Episodic Migraine Clinical Trials

A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

Start date: March 20, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

NCT ID: NCT03096795 Completed - Clinical trials for Part II (MAD) - Chronic Obstructive Pulmonary Disease

Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants

Start date: May 15, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.

NCT ID: NCT03096509 Completed - Asthma Clinical Trials

Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes

Start date: January 19, 2017
Phase:
Study type: Observational

Innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs. The investigators will assess whether the implementation of the service is effective, and how it can be adjusted, in addition to introducing innovations to assess whether the expected benefits for patients are realised.

NCT ID: NCT03094962 Completed - Clinical trials for Patient Specific Computational Modeling

Development of a Musculoskeletal Model of the PIP Joint

Start date: January 21, 2015
Phase: N/A
Study type: Interventional

The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In order to improve these outcomes, it would be helpful to understand the geometry of the joint, how it moves and the forces that are involved. This can be achieved using computer models that model the bones and the soft tissues - musculoskeletal models. In order to make these models as representative as possible, they should be generated using anatomical data. Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and computed tomography (CT) scans. This will enable the computer model to begin being constructed. In parallel to the model initialisation, anatomical and motion data of the PIP joint of healthy volunteers will be collected. The necessary data will be collected using CT and MRI scans, as well as optical motion tracking methods. These data will then be used to populate the musculoskeletal model. Once the model is constructed, it will be used to simulate the motion of the joint and look at the effect of a simulated PIP joint replacement. This information should then provide insight as to how PIP joint replacements might be improved in future.

NCT ID: NCT03094507 Completed - HIV Clinical Trials

The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers

SSAT073
Start date: April 19, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to look at the levels of three HIV medications: dolutegravir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 14 days. There will be two groups. Participants in Group 1 will take dolutegravir everyday for 14 days, then nothing for 7 days, then dolutegravir and darunavir/cobicistat together for 14 days, nothing for 7 days, and then darunavir/cobicistat alone for 14 days. If participants go into Group 2 they will begin with darunavir/cobicistat everyday for 14 days, then nothing for 7 days, then dolutegravir and darunavir/cobicistat together for 14 days, nothing for 7 days, and then dolutegravir alone for 14 days. Drug levels for both groups will be measured on days 14, 35 and 56. If the participants decide to take part, the duration of the study will be up to 57 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 15 to 22 days after the last dose of study medication. Eligible participants will be randomized (1:1 ratio) to group 1 or group 2. Participants and the study doctor will know which study medications the participant is taking at all times during the study.

NCT ID: NCT03093974 Completed - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)

PROMIS-I
Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

The objective of the trial was to investigate the effect of the use of inhaled CMS, administered b.i.d. via a specific nebuliser for 12 months, compared to placebo in subjects with NCFB chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

NCT ID: NCT03093818 Completed - Clinical trials for Adverse Drug Reaction

PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

PREPARE
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.