Clinical Trials Logo

Filter by:
NCT ID: NCT03421743 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Pilot Trial of Inhaled Molgramostim in Nontuberculous Mycobacterial (NTM) Infection

OPTIMA
Start date: March 1, 2018
Phase: Phase 2
Study type: Interventional

The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; rhGM-CSF) in subjects with persistent pulmonary Nontuberculous Mycobacterial (NTM) infection. Subject will be treated for 24-weeks with inhaled molgramostim and will be followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.

NCT ID: NCT03421431 Completed - Clinical trials for Non-Alcoholic Steatohepatitis

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

Start date: April 25, 2018
Phase: Phase 2
Study type: Interventional

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis

NCT ID: NCT03420729 Completed - Dyspepsia Clinical Trials

Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

Start date: March 7, 2017
Phase: N/A
Study type: Interventional

Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures. The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo MACE prior to OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.

NCT ID: NCT03420352 Completed - Clinical trials for Post-Dural Puncture Headache

Non-Luer Butterfly Needle With One-way Valve for the Epidural Blood Patch: Does it Alter Blood Clotting?

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. The one-way valve and length of tubing has the potential to activate the clotting cascade. This could reduce the time clinicians have to utilise the blood in the syringe. Also any alteration in clotting could affect the therapeutic value of the epidural blood patch. The primary objective of this research was to determine if phlebotomy using this new 21G needle altered blood clotting, determined by thromboelastograph analysis, compared to a standard 21G hypodermic needle.

NCT ID: NCT03420092 Completed - Clinical trials for Coronary Artery Disease

A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers

Start date: February 5, 2018
Phase: Phase 1
Study type: Interventional

In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. This study consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participant in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Each participant will be involved in the study for approximately 5 to 6 weeks. Fourteen participants will be randomized to ensure at least 10 evaluable participants at the end of the last treatment period.

NCT ID: NCT03419897 Completed - Clinical trials for Hepatocellular Carcinoma (HCC)

Study of BGB-A317 in Participants With Previously Treated Unresectable HCC

Start date: April 9, 2018
Phase: Phase 2
Study type: Interventional

This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.

NCT ID: NCT03419845 Completed - Falls Injury Clinical Trials

Frequent Fallers' Experiences of an Adapted Walking Frame, Designed to Reduce the Walking Aid's Associated Falls Risk

Walker
Start date: May 18, 2017
Phase: N/A
Study type: Interventional

For some patients with mobility issues, a walking frame (commonly known as a zimmer frame - trademark of Zimmer Holdings), is provided to keep them on their feet and help them remain more independent in their home and when out and about. When patients are given the walking frame, they are given information on how to use it safely to protect them from hurting themselves. For a small group of patients, using the walking frame is difficult, and they will have a fall because they are unable to use the frame safely. For these patients, a fear of falling can then develop and they can then have more falls. It is thought that these falls with the walking frame happen because the patient steps too far into the frame, making them unstable. We have made an attachment for a standard walking frame, which we are calling the Step Right Buddy, that we think will help improve the stability of patients who step too far into the frame. We have attached a detachable elasticated band across the back legs of the frame to make patients aware that they have stepped far enough into the frame, to stop them stepping any further. In order to develop this further, we need to understand how people feel using this adapted frame and whether there are any new risks to the user. The investigators propose to ask patients who are considered to be at risk of falling because of the way they use their walking frame if they would like to use the adapted walking frame in their home, instead of their standard frame, for a week. At the end of this week, investigators will spend up to an hour with this patient, talking with them about their experience of the adapted walking frame, in order to understand things such as how they felt using the frame, were they more or less fearful of using it than their usual frame, did they think they were going to fall over more or less often, do they think they fall more or less often. In addition to this, patients will keep a written record of when they thought they nearly fell, or when they had an injury whilst using the adapted walking frame. This information will be used to explore whether or not the adaption to the frame introduces new risks to patients.

NCT ID: NCT03419598 Completed - Clinical trials for Osteoarthritis, Knee

Personalised HTO Versus Generic HTO Virtual Clinical Trial

Start date: January 3, 2017
Phase:
Study type: Observational

High Tibial Osteotomy (HTO) is an alternative to knee replacement in suitable patients with early knee osteoarthritis (OA), it is particularly suited to patients with single compart disease who otherwise would be suitable for unicompartmental knee replacement (UKR). OA of the knee is very common and increasing driven by the ageing of the population. The current limitations of HTO are related to the difficulty of achieving the desired correction due to a challenging surgical technique and soft tissue irritation due to the use of generic stabilisation plates. This study will examine the safety equivalence of a new patient specific HTO process which has patient specific 3D printed plates, i.e. personalised HTO plates, with the existing most commonly used HTO procedure using the Tomofix generic HTO plate. Importantly this study will be undertaken as a Virtual Trial, existing anonymised 3D imaging data will be used to create the virtual patient cohort. This cohort will receive both procedures, which for this type of procedure is only possible in a virtual scenario. The main question to be addressed is: "Is the personalised HTO procedure as safe as the most commonly used existing generic HTO procedure?". In this context safety concerns the mechanical loads placed upon the tibia and the support plate. The interventions will all be made on computer models, the 3D imaging data will be used to create the intact (un-operated) models of the subject tibias. Each model will then be virtually operated upon, with both the personalised and generic HTO procedures. The models will then be loaded with physiological loads experienced during function and the mechanical states compared.

NCT ID: NCT03419572 Completed - Clinical trials for Renal Cell Carcinoma

Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma

CASSIOPE
Start date: April 24, 2018
Phase:
Study type: Observational

The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.

NCT ID: NCT03418480 Completed - Clinical trials for Head and Neck Neoplasm

HARE-40: HPV Anti-CD40 RNA vaccinE

HARE-40
Start date: April 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine. Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.