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NCT ID: NCT03000348 Completed - Cystic Fibrosis Clinical Trials

A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

CARE-CF1
Start date: December 2016
Phase: Phase 2
Study type: Interventional

This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.

NCT ID: NCT02999711 Completed - Asthma Clinical Trials

Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

Start date: February 3, 2017
Phase: Phase 1
Study type: Interventional

Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

NCT ID: NCT02999178 Completed - Clinical trials for Lung Diseases, Interstitial

Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

INBUILD®
Start date: January 17, 2017
Phase: Phase 3
Study type: Interventional

The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.

NCT ID: NCT02998476 Completed - Lymphoma Clinical Trials

A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Start date: March 2, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

NCT ID: NCT02998463 Completed - Breast Feeding Clinical Trials

Facilitating Skin-to-Skin Contact In the Postnatal Period

Start date: March 31, 2017
Phase: N/A
Study type: Interventional

This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.

NCT ID: NCT02998359 Completed - Hip Fractures Clinical Trials

Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures

Start date: August 2013
Phase: N/A
Study type: Interventional

In England each year over 9,000 people fracture their hip. Most of these are elderly females with the fracture occurring after a fall. Approximately half of these fractures are classified as intracapsular fractures because of their close proximity to the hip joint. The majority of these fractures are treated surgically by excising the broken femoral neck and removing the femoral head (ball part of the hip joint) and replacing it with an artificial hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed a 'half hip replacement' in which only the ball part of the hip joint is replaced. An alternative type of hip replacement is the full total hip replacement in which the socket part of the joint is also replaced. This is the operation that is used for replacing arthritic hips. In recent years there have been a number of randomised trials that have compared the outcome for patients with an intracapsular hip fracture treated with either a partial hip replacement (hemiarthroplasty) against those treated with a total hip replacement (THR). Results to date have suggested slightly better long term functional results for those treated with a THR, but it still remains unclear if these benefits are offset by the increased surgical complexity of the procedure and the extra cost involved for a THR. At present the numbers of studies on this topic are too few with limited patient numbers to make any definite conclusions. This study aims to add to the research studies by comparing the two surgical procedures, to enable orthopaedic surgeons to determine the optimum surgical treatment for this common and disabling condition.

NCT ID: NCT02998190 Completed - Healthy Volunteers Clinical Trials

First-in-Human Single and Multiple Dose of EB8018

Start date: November 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.

NCT ID: NCT02998034 Completed - Hip Fractures Clinical Trials

Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty

Start date: August 2013
Phase: N/A
Study type: Interventional

In England each year over 9,000 people fracture their hip. Most of these are elderly females with the fracture occurring after a fall. Approximately half of these fractures are classified as intracapsular fractures because of their close proximity to the hip joint. The majority of these fractures are treated surgically by excising the broken femoral neck and removing the femoral head (ball part of the hip joint) and replacing it with an artificial hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed a 'half hip replacement' in which only the ball part of the hip joint is replaced. There are a number of different designs of hemiarthroplasty that may be used. Some of the implants are fixed in place with bone cement whilst the rest are inserted as a press fit without the bone cement. The early designs of implant were all press fit but these designs have now been shown to be inferior to those implants that are fixed in place with bone cement. There are however a number of newer designs of implant that are coated with a substance (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To date these implants have only been compared to the cement fit implants in only one previous study. This study found no notable difference between the two types of hemiarthroplasty. This study aims to add to the research studies by comparing standard cement fit implant with a hydroxyapatite coated press fit implant to assist in determining the optimum surgical treatment for this common and disabling condition. Both implants to be used in this study are still being used extensively within the United Kingdom and worldwide to treat this fracture. The study is therefore using two different implants within their recommended area of use, but in which there is uncertainty as to which is the best implant.

NCT ID: NCT02997202 Completed - Clinical trials for Acute Myeloid Leukemia

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Start date: June 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

NCT ID: NCT02997046 Completed - Clinical trials for Kidney Transplantation

Ferumoxytol Enhanced Magnetic Resonance Angiography in Chronic Kidney Disease

FeMRA in CKD
Start date: December 12, 2016
Phase:
Study type: Observational

Conventional vascular imaging techniques are often either contra-indicated in chronic kidney disease (CKD) patients due to their relative invasiveness, risks and cost. Computed tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may precipitate significant worsening of renal function and even prompt the need for institution of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging methods also have drawbacks: for example, this frail patient group has a higher risk of complications from conventional invasive catheter-based angiography, non-contrast-enhanced MRA allows visualization of smaller arteries but is less accurate for larger vascular structures, and ultrasound is often not appropriate for evaluation of the deep vessels of the abdomen and pelvis. Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging (MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for the treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI contrast agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in patients with estimated glomerular filtration rates <30mL/min and there are reports in the literature for its safe use and utility in both adult and pediatric patients with CKD. Participants will be selected from those who have been referred for assessment prior to kidney transplant or prior to vascular access creation for haemodialysis and will be divided into three groups. The first group will include patients who will undergo a CTA of abdominal and aortoiliac vasculature as part of their preparation for potential kidney transplantation. The second and third groups will include patients who are having a fistula or a graft created for dialysis, respectively. These patients are routinely having US vascular mapping to visualise the blood vessels before a fistula or a graft is created. Additionally, patients included in the second and third groups are routinely having surveillance scans of their fistula or graft at 6 weeks following creation. Study participants undergoing standard imaging tests as part of their clinical care will also have ferumoxytol-enhanced MRA (FeMRA).