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NCT ID: NCT03151993 Completed - Ischemic Stroke Clinical Trials

Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS

Start date: March 18, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.

NCT ID: NCT03150589 Completed - Clinical trials for Age-Related Macular Degeneration

A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Start date: March 14, 2018
Phase: Phase 3
Study type: Interventional

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

NCT ID: NCT03144024 Completed - Clinical trials for Tricuspid Regurgitation

Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

BvsRR
Start date: September 14, 2016
Phase: N/A
Study type: Interventional

randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

NCT ID: NCT03144011 Completed - Clinical trials for Cardiopulmonary Bypass

Acute Kidney Injury in Children After Cardiopulmonary Bypass

Start date: February 8, 2017
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%. The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors. Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage. Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage. It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost. Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.

NCT ID: NCT03138733 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Start date: August 26, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

NCT ID: NCT03138512 Completed - Clinical trials for Carcinoma, Renal Cell

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

CheckMate 914
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

NCT ID: NCT03137927 Completed - Whooping Cough Clinical Trials

A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine

Start date: June 13, 2017
Phase: Phase 1
Study type: Interventional

The study contains three periods: screening, inpatient hospitalization and follow-up. And should be leaded as a randomized placebo-controlled study with in chain order enrolled volunteers and dose escalating.

NCT ID: NCT03136861 Completed - Spondyloarthritis Clinical Trials

SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis

SKIPPAIN
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.

NCT ID: NCT03130959 Completed - Clinical trials for Various Advanced Cancer

A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

CheckMate 908
Start date: June 12, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

NCT ID: NCT03130179 Completed - Tobacco Dependence Clinical Trials

A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.

Start date: March 20, 2017
Phase: Phase 1
Study type: Interventional

This is a research study to verify the same effectiveness and safety profile for the test product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint lozenge (reference product), in a standardized mode. This verification is done in a so-called bioequivalence study, which means that the same amount of the same active substance (nicotine), in the same dosage form, for the same route of administration, and meeting the same or comparable standards is performed. During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two products are comparable. Tolerability of the treatments will be evaluated based on reported and observed adverse events.