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NCT ID: NCT05529316 Suspended - Advanced Melanoma Clinical Trials

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

Start date: December 12, 2022
Phase: Phase 2
Study type: Interventional

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

NCT ID: NCT05259631 Suspended - Clinical trials for Acute Respiratory Distress Syndrome

Inhalational (Sevoflurane) Versus Intravenous (Propofol) Sedation in Adults With a Moderate Form of ARDS

Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The American European Consensus Conference (AECC) 1994 defined acute respiratory distress syndrome (ARDS) as an acute inflammatory syndrome manifesting as diffuse pulmonary edema and respiratory failure that cannot be explained by, but may co-exist with, left-sided heart failure. During the sequel Conference of the European Society of Intensive Care Medicine, in 2012 minor changes were made, and since that so-called Berlin definition of ARDS is used worldwide for the description of this severe disease. Three grades of severity were proposed to distinguish ARDS according to the level of hypoxemia with a mortality of 24% in patients with mild ARDS, rising to 48% in those with severe ones. Systemic inflammation is considered to be the main reason of ARDS. Activated neutrophils interact with the alveolar-capillary membrane causing the increasing permeability with the sequence lung edema's development. Inflammatory exudate inactivates surfactant leading to collapse and consolidation of distal airspaces with progressive loss of the lung's gas exchange surface area. Unfortunately, systemic inflammatory response syndrome (SIRS) simultaneously inhibits the mechanism of active pulmonary vasoconstriction and allows deoxygenated blood to pass through unventilated areas of the lung boosting the right-to-left shunt. Both mechanisms lead to hypoxemia, which is the main and obligatory feature of ARDS. Actually, endothelial dysfunction and transcapillary leakage seem to be one of the main steps in the development of respiratory failure during ARDS. Last decades it was found out that glycocalyx is also participating in this process too. Thus, it became clear that substances preserving endothelium and glycocalyx from SIRS-causing damage may have a beneficial effect in ARDS treatment. It seems to be crucially important so as the majority of drugs failed to demonstrate any positive effects in terms of ARDS treatment. To the moment we have some evidence, which came from experimental studies, that halogenated anesthetics can preserve glycocalyx against ischemia-reperfusion injury. The primary objective for the multicentral INVERSE Trial will be to determine the effects of inhalational (sevoflurane) versus intravenous (propofol) sedation on P/F ratio on the second day, hospital mortality and ICU (intensive care unit), and in-hospital length of stay in adults with a moderate form of ARDS.

NCT ID: NCT04862026 Suspended - Clinical trials for Acute Coronary Syndrome

Telemonitoring of Patients With Acute Coronary Syndrome

TeleCor
Start date: April 29, 2021
Phase:
Study type: Observational

It is planned to enroll 950 patients in an open, prospective, randomized study to assess the impact of telemonitoring on the development of clinical events and improve the quality of life of patients with acute coronary syndrome. The duration of the study is 365 days, of which 180 days are enrollment of patients, 180 days are observation. The study of patients will include the collection of anamnesis, assessment of the clinical status of patients using special questionnaires, data of objective, laboratory and instrumental examinations. The instrumental complex of the examination will include: electrocardiography (ECG), 6-minute walk test (6MWT), Holter ECG monitoring (HMECG), echocardiography, veloergometry (VEM), assessment of the actual nutrition Nutrilogic, autogeneration of an individual diet (Nutrilogic), weekly telemonitoring. Laboratory examination includes: biochemical blood test. The main objectives of the study are to study the effect of telemonitoring on mortality from cardiovascular diseases (CVD), as well as the number of readmissions for cardiovascular pathology in patients with ACS. The secondary endpoints of the study include quality of life as measured by the HeartQol questionnaire and adherence to ambulatory monitoring.

NCT ID: NCT04250311 Suspended - Influenza Clinical Trials

Clinical Trial of Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults

Start date: December 12, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is: • to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults.

NCT ID: NCT04023058 Suspended - Clinical trials for Ischemic Mitral Regurgitation

Stress Echo for Ischemic Mitral Valve Surgery

SURVIVE
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Comparison patients with CABG alone vs. CABG+mitral surgery with non-massive ischaemic mitral regurgitation (IMR) depending on stress echo data.

NCT ID: NCT03953755 Suspended - Clinical trials for Tricuspid Regurgitation

Surgery in Secondary Tricuspid Regurgitation

STRONG
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary tricuspid regurgitationare unclear. AIM: To compare right ventricle structural and functional changes after operation in patients with secondary tricuspid regurgitation with severe mitral /aortic valve pathology, requiring surgical intervention; define the factors influencing major adverse cardiac events depending on the operation/non-operation due to moderate tricuspid regurgitation. This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up.

NCT ID: NCT02361996 Suspended - Coronary Disease Clinical Trials

Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients

CCT/MPERF
Start date: February 2015
Phase:
Study type: Observational

It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion. In order to increase (normalize) the reduced perfusion, when a conventional approach failed, coronary bypass surgery, coronary vessel dilatation or stenting are performed. The similar situation with reduced myocardial perfusion may be found in patients with stenosis of the aortic valve, where aortic valve replacement may increase myocardial perfusion by left-ventricular remodelling. However, there is presently no method established to measure myocardial perfusion quantitatively and noninvasively before and after a therapeutic intervention. Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in ml/100g/min would strengthen the indication for specific therapeutic approach and enable an objective control of effectiveness of the applied therapy. Hypothesis: There is a measureable difference in quantitative myocardial perfusion values before (lower) and after (higher) interventional or surgical procedure. The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients: 1. Before and after coronary bypass surgery 2. Before and after coronary vessel dilatation/stenting 3. Before and after aortic valve replacement. The investigators will not assign specific interventions to the subjects of these three groups. Therefore, the research is strictly observational. Design: Prospective study to measure quantitatively myocardial perfusion in the above mentioned three groups of patients with simultaneous control and registration of all essential, physiological determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial perfusion measurements will be performed directly after the indication for intervention or surgery and on the last day before discharge from hospital. All the collected data (determinants) inclusively the CT-studies will be anonymised and archived on a local server. The investigators of the University of Medical Computed Sciences and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion measurements and all statistical analysis independently of the CT-studies performing physicians.

NCT ID: NCT00865488 Suspended - Endometriosis Clinical Trials

Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.