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NCT ID: NCT05680337 Recruiting - Clinical trials for Heart Rate Variability

Auricular Vagus Stimulation and Heart Rate Variability

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Transcutaneous electrical stimulation of the auricular vagus nerve (TENS) is a promising method of neuromodulation of the autonomic nervous system in patients with various pathologies. The use of this method requires the determination of a reliable biomarker of successful activation of the vagus nerve using TENS. Currently, most studies focus on the assessment of heart rate variability (HRV) as a marker of the functioning of the autonomic nervous system. Despite the physiological justification of HRV as a biomarker for TENS, the data on the effects of TENS on HRV are ambiguous. In some studies, a significant decrease in the ratio of spectral characteristics (LF/HF) in active TENS was found in comparison with fictitious stimulation (sham), which indicated an increase in the parasympathetic component of HRV. However, other studies have not revealed an increase in HRV.

NCT ID: NCT05679336 Recruiting - Clinical trials for Membranous Nephropathy - PLA2R Induced

Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This exploratory study aims to assess the efficacy, safety of the experimental treatment based on a combination of rituximab (RTX), intravenous (IV) cyclophosphamide (CYC), and corticosteroids (S) administrated at lower cumulative doses (RCP) for the induction of early remission in subjects with anti-PLA2R antibody-positive primary membranous nephropathy (PMN) having nephrotic syndrome (NS).

NCT ID: NCT05669989 Recruiting - Plasma Cell Myeloma Clinical Trials

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Start date: April 5, 2023
Phase: Phase 2
Study type: Interventional

- This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. - This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. - The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

NCT ID: NCT05660993 Recruiting - Hodgkin Lymphoma Clinical Trials

Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Start date: August 19, 2019
Phase: Phase 2
Study type: Interventional

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.

NCT ID: NCT05654454 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer

Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

BEV-III/2022 is a double-blind randomized multicenter clinical trial comparing efficacy of bevacizumab (manufactured by Mabscale, LLC) and paclitaxel plus carboplatin to Avastin® and paclitaxel plus carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC. The purpose of the study is to demonstrate equivalence of efficacy and safety of bevacizumab (manufactured by Mabscale, LLC) to Avastin®. Study includes pharmacokinetics assessment.

NCT ID: NCT05652595 Recruiting - Pharmacokinetics Clinical Trials

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Start date: June 3, 2022
Phase: Phase 1
Study type: Interventional

Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.

NCT ID: NCT05643989 Recruiting - Clinical trials for Neoplasms,Colorectal

Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy

PATENCY
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.

NCT ID: NCT05639569 Recruiting - Clinical trials for Dissection of Thoracic Aorta

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

Start date: May 3, 2023
Phase:
Study type: Observational

The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).

NCT ID: NCT05637398 Recruiting - Colchicine Clinical Trials

Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Start date: December 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.

NCT ID: NCT05624658 Recruiting - Dyslipidemias Clinical Trials

Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS

Combi-LLT ACS
Start date: September 2, 2022
Phase: N/A
Study type: Interventional

The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( > 1.4 mmol/l) despite statin therapy at the highest dosage. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.