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NCT ID: NCT03867227 Completed - Atrial Fibrillation Clinical Trials

Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Start date: December 1, 2018
Phase:
Study type: Observational

Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation. However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy. Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated. The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected. TEE will be performed at three and six months to check for device leak, displacement and thrombosis.

NCT ID: NCT03863496 Completed - Clinical trials for Neuromuscular Diseases

Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation. The study will take place at this center. It is expected to enroll 70 patients aged 6-25 years with NMD, all of whom will be subjected to thoracic and lumbar spinal deformity surgery. Patients will be divided into two groups depending on skeletal maturity. The degree of skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic bones. The type of surgical correction will depend on the group.

NCT ID: NCT03861416 Completed - Clinical trials for Peripheral Arterial Disease

"Unifuzol®" in Patients With Peripheral Arterial Disease

Start date: March 16, 2018
Phase: Phase 2
Study type: Interventional

The present study is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of the drug Unifuzol® (L-arginine) in patients with obliterating atherosclerosis of the lower extremities. The study recruits patients 40-79 years old with a confirmed diagnosis of chronic ischemia of the lower limb and a stable symptom of intermittent claudication that occurs when walking a distance of 100-299 meters. L-arginine improves microcirculation due to activation of nitrogen monoxide production and stimulates capillary blood flow, thus can probably improve the quality of life of patients with intermittent claudication. The criterion for treatment efficacy will be an increase in the maximum walking distance measures before and on the next day after the end of treatment course.

NCT ID: NCT03859427 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

ARROW2
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

NCT ID: NCT03857230 Completed - Pharmacokinetics Clinical Trials

The Safety and Pharmacokinetics of Primapur and Gonal-f

Start date: October 29, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa preparation (Gonal-F) in healthy young female volunteers.

NCT ID: NCT03855891 Completed - Atherosclerosis Clinical Trials

Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA

CT-CA-miRNA
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT).

NCT ID: NCT03855137 Completed - Chronic Migraine Clinical Trials

Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Start date: March 11, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

NCT ID: NCT03854305 Completed - Crohn's Disease Clinical Trials

Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease

PRINCE
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease

NCT ID: NCT03854253 Completed - Clinical trials for Coronary Artery Disease

Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

IntroLength
Start date: February 26, 2019
Phase: N/A
Study type: Interventional

This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.

NCT ID: NCT03852433 Completed - Clinical trials for Chronic Hepatitis Delta

Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of bulevirtide combination with pegylated interferon in participants with chronic hepatitis delta (CHD).