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NCT ID: NCT03378648 Completed - Asthma Clinical Trials

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366

Start date: December 28, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal bronchodilation after inhalation dosing via two validated mechanisms in one molecule. The study will consist of three parts: Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366 Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366 Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single dose of CHF6366 in an active and placebo controlled design

NCT ID: NCT03378531 Completed - Hyperargininemia Clinical Trials

A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency

AEB1102
Start date: December 7, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

NCT ID: NCT03378258 Completed - Sepsis Clinical Trials

Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.

PIC
Start date: November 9, 2017
Phase:
Study type: Observational

A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children. In particular the investigators are interested in researching how quick bedside tests can be used to do this.

NCT ID: NCT03377699 Completed - Diabetes Clinical Trials

Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes

EXPECT
Start date: November 22, 2017
Phase: Phase 3
Study type: Interventional

The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.

NCT ID: NCT03377296 Completed - Malaria, Vivax Clinical Trials

Study of Controlled Human Plasmodium Vivax Infection

VAC068
Start date: March 3, 2018
Phase: N/A
Study type: Interventional

This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.

NCT ID: NCT03376529 Completed - Healthy Volunteers Clinical Trials

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

Start date: November 10, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.

NCT ID: NCT03376009 Completed - Clinical trials for Liver Transplantation

A Study of Novel Biomarkers of Kidney Dysfunction at Liver Transplant

Start date: January 15, 2018
Phase:
Study type: Observational

Kidney dysfunction before and immediately after liver transplantation is common and leads to poorer outcomes, including prolonged need for post-operative intensive care, diminished graft survival, and greater risk of permanent kidney dysfunction and death. Blood creatinine level - the standard measure of kidney function - is suboptimal in people with advanced liver disease, overestimating kidney function by >20%. There is significant concern that liver transplant recipients are at higher risk of acute kidney injury (AKI) than we can currently predict. This study aims to identify superior tests (blood/urine or imaging) for kidney dysfunction, to enable improved treatment and patient outcomes. This study aims to recruit 80-100 consecutive patients admitted to the Scottish Liver Transplant Unit (SLTU), Royal Infirmary of Edinburgh (RIE) for liver transplant assessment over a 6 month period. Permission will be sought to record the results of routine tests performed by the NHS during this assessment week. These tests include: electrocardiograph (ECG), Computed Tomography (CT) liver and abdomen, cardio-pulmonary exercise testing (CPEX), pulmonary function tests (PFTS), routine haematology and biochemistry blood tests, 24 hour urine collection and body composition analysis. In addition, we will invite participants to attend the RIE clinical research facility (CRF) for a single visit (~2 hours) to perform extra research assessments. Blood and urine will be collected for biomarker analysis. Non-invasive assessment of cardiovascular function will be completed using cardiac bio-impedance and aortic pulse wave velocity. Examination of the blood vessels at the back of the eye will be performed using optical coherence tomography. A subgroup of 10 participants will undergo magnetic resonance imaging (MRI) of the kidneys using arterial spin labelling to identify dysregulated renal perfusion. Patients who are transplanted during the study timeframe will be asked to re-attend the CRF for repeat assessments at 6 weeks post transplantation. Funded by Scottish Liver Transplant Unit Endowment Fund

NCT ID: NCT03375450 Completed - Clinical trials for Comparative Effectiveness Study

Treatment and Exacerbation in COPD Subjects

Start date: June 9, 2017
Phase:
Study type: Observational

This is a study comparing the effects of ICS containing treatments in patients with chronic obstructive pulmonary disease (COPD) in a real world setting, using the UK Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES). The main outcome to be assessed is exacerbation rates.

NCT ID: NCT03374800 Completed - Clinical trials for Gastrointestinal Hemorrhage (Clinically Important, Upper)

Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

REVISE
Start date: July 9, 2018
Phase: Phase 3
Study type: Interventional

Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to decades ago, critically ill patients rarely develop upper gastrointestinal bleeding. This decrease is likely due to modern medicine, better resuscitation and earlier feeding. There may also be harms associated with pantoprazole and other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and bowel infections (Clostridioides difficile). Studies in this area are old and of modest quality. Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems. The goal of this international study is to determine if, in critically ill patients using breathing machines, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia) and bowel infection (Clostridioides difficile), or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.

NCT ID: NCT03374488 Completed - Clinical trials for UC (Urothelial Cancer)

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Start date: December 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.