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NCT ID: NCT03920267 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT03907943 Recruiting - Clinical trials for Cognitive Impairment

Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Assessment of cognitive function in patients undergoing elective carotid endarterectomy Classical treatment for ICA stenosis is carotid endarterectomy (CEA), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. However, the influence of CEA on cognition is less defined, it remains unclear whether CEA can improve cognitive function. A change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system. The difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances. The aim of our study is to identify those factors what may have role in the postoperative cognitive decline. The study was approved by the Ethical Committee of the university ( SE RKEB: 17/2019) and written informed consent will be obtained from all patients. The investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( Semmelweis University Heart and Vascular Center). Exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. The investigators would like to register at least 100-150 patients in our study. Most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. Cognitive functions will be assessed one day before, one day and six month after the surgery using MMSE and a questionnaire called Frailty to characterize beside cognitive function the physiological reserve of the patients too. The investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents. During the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ECG, oxygen saturation, EtCO2, MAC) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (Invos Cerebral/Somatic Oximeter) and the activity of the brain using GE Entropy Module. The investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires. Statistical analyses will be performed using Statistical Package for the Social Sciences.

NCT ID: NCT03906799 Recruiting - Atrial Fibrillation Clinical Trials

Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)

PROMISE-AF
Start date: March 19, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF.

NCT ID: NCT03905642 Completed - Cystic Fibrosis Clinical Trials

Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) - Extension Phase

Start date: January 8, 2009
Phase: Phase 2
Study type: Interventional

A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas (Pa.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal amikacin for inhalation (LAI, Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected subjects when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by Pa. aeruginosa.

NCT ID: NCT03901729 Not yet recruiting - Heart Failure (HF) Clinical Trials

A Phase II Trial to Study BAY1753011 in Patients With Congestive Heart Failure

AVANTI
Start date: May 15, 2019
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.

NCT ID: NCT03892824 Not yet recruiting - Stroke Clinical Trials

Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

CAPTURE2
Start date: April 2019
Phase: N/A
Study type: Interventional

This study will assess the safety of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

NCT ID: NCT03891524 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery

Start date: June 14, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE]), or any death during the treatment period.

NCT ID: NCT03891329 Not yet recruiting - Heart Failure Clinical Trials

Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.

NCT ID: NCT03890809 Recruiting - Healthy Volunteers Clinical Trials

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild, Moderate and Severe Liver Damage

Start date: February 25, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

NCT ID: NCT03890770 Recruiting - Healthy Volunteer Clinical Trials

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Participants With Normal Kidney Function and Participants With Mild, Moderate, and Severe Kidney Damage and in Participants With End-Stage Kidney Disease on Dialysis

Start date: February 7, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.