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NCT ID: NCT04955626 Completed - COVID-19 Clinical Trials

To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization. The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19 - At a dose of 30µg (as studied in the Phase 2/3 study C4591001) - In healthy adults 16 years of age and older - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States, Brazil and South Africa Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization. - Blood samples will be collected for troponin testing - The duration of the study for each participant will be up to approximately 2 months. - The study will be conducted in the United States, Germany, Poland and South Africa Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization. - In healthy adults 12 years of age and older - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States, Germany and South Africa Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose - Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment - Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization - Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose. - In healthy adults 18 to 55 years of age - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States and South Africa Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose - In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization - The duration of the study for each participant will be approximately 6 months. - The study will be conducted in the United States Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose. - In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization - The duration of the study for each participant will be approximately 6 months. - The study will be conducted in Israel

NCT ID: NCT04955184 Completed - Clinical trials for Congestive Heart Failure

Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter

Start date: October 10, 2021
Phase:
Study type: Observational

Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is considered the gold standard for cardiac output (CO) monitoring. In this prospective study, we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory CHF patients.

NCT ID: NCT04953234 Completed - COVID-19 Clinical Trials

Effect of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Best Standard of Care for the Treatment of Hospitalized COVID-19 Patients and Continued Treatment Following Discharge

Start date: February 23, 2021
Phase: N/A
Study type: Interventional

The study is a prospective, pilot study aimed to test the safety of Tumor Treating Fields (TTFields) concomitant with best standard of care, for the treatment of hospitalized COVID-19 patients and continued treatment after hospitalization. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the organ to be treated, by means of surface, insulated electrode arrays.

NCT ID: NCT04952909 Completed - Clinical trials for Risk of Coronary Obstruction Following TAVR Procedure

The ShortCut™ Study Protocol

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.

NCT ID: NCT04949048 Completed - Pulmonary Embolism Clinical Trials

Evaluation of the Safety and Performance of Magneto PE Kit

Start date: August 26, 2021
Phase: N/A
Study type: Interventional

This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.

NCT ID: NCT04945109 Completed - Type 2 Diabetes Clinical Trials

Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes

Start date: October 19, 2021
Phase: N/A
Study type: Interventional

The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.

NCT ID: NCT04944992 Completed - Clinical trials for Nonalcoholic Steatohepatitis

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Start date: August 4, 2021
Phase: Phase 2
Study type: Interventional

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

NCT ID: NCT04934735 Completed - Clinical trials for Myocardial Infarction

Case-management Rehabilitation Intervention in Facilitating Return to Work After Myocardial Infarction

CM
Start date: June 1, 2007
Phase: N/A
Study type: Interventional

Abstract Purpose: To study the long-term effectiveness of case-management rehabilitation intervention among patients after myocardial infarction (MI) compared with the current standard of care. Methods: Participants were 151 patients who underwent uncomplicated MI and of which nearly all enrolled in a cardiac rehabilitation program. Patients were randomized into an intervention or control group and provided two years of follow-up data. The intervention, conducted within an occupational medicine clinic, started during hospitalization or immediately thereafter and continued for 2 years. It included: early referral to an occupational physician, charting an occupational intervention program, coordinating between the patient and relevant parties, psychosocial intervention, intensive follow-up sessions during the first 1.5 months, and more spaced interventions during the follow-up period. Outcome variables were: return to work within 6 months of hospitalization and maintenance of employment at one and two years of follow-up.

NCT ID: NCT04933058 Completed - Clinical trials for Women Undergoing Oocyte Retrieval Procedures

Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure

Start date: December 5, 2021
Phase: N/A
Study type: Interventional

It is unclear whether routine addition of opioids for analgesia during minor gynecological procedures is beneficial. In this single-center randomized single-blinded trial, the investigators aim to test the primary hypothesis that opioid-sparing anesthesia regimen including intravenous acetaminophen is non-inferior to a similar anesthesia regimen containing fentanyl in providing postoperative analgesia in women recovering from oocyte retrieval procedures for in vitro fertilization. The investigators also aim to assess the difference in incidence of patient-reported opioid related adverse-effects between the two groups, time to discharge from the post-anesthesia care unit and postoperative rescue analgesia requirements. If we demonstrate no clinically important difference between the two interventions, clinicians may be able to substantially reduce the amount of opioids administered to patients undergoing minor ambulatory procedures, and potentially decrease the associated opioid related adverse effects.

NCT ID: NCT04929366 Completed - Clinical trials for Renal Insufficiency, Chronic

Is Hemodialysis Associated With Cardiac Markers Change?

Start date: December 18, 2017
Phase: N/A
Study type: Interventional

Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis