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NCT ID: NCT05610280 Active, not recruiting - Clinical trials for Cardiovascular Diseases

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

NCT ID: NCT05605899 Recruiting - Clinical trials for High-risk Large B-cell Lymphoma (LBCL)

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

ZUMA-23
Start date: February 10, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.

NCT ID: NCT05603143 Terminated - COVID-19 Clinical Trials

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

BIRCH
Start date: November 5, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to test how well the study drug, obeldesivir (formerly GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

NCT ID: NCT05601882 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Level Up
Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05601453 Recruiting - Clinical trials for Aortic Valve Stenosis

The ReTAVI Prospective Observational Registry

Start date: September 5, 2023
Phase:
Study type: Observational [Patient Registry]

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.

NCT ID: NCT05600439 Completed - Professional Role Clinical Trials

Efficacy of an Attachment-based Intervention in Residential Care (CareME)

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

CareME is a group attachment-based intervention program developed for improving relational abilities in professional caregivers working in Youth Residential Care (YRC) settings. The intervention program was planned to integrate 12 group session (90 minutes each), implemented fortnightly during a 6-month period, and facilitated by two psychologists and expertise researchers on attachment framework. The project aims to produce effects on professional caregivers' behaviors and, as an indirect effect, to produce changes on adolescents' outcomes (age 12 to 18 years old). Regarding professional caregivers' behaviors the project aims to improve reflective functioning, perspective taking, emotion regulation, group intervention practices and quality of relationships in RC (primary outcomes). Additionally, it's expected to reduce levels of professional exhaustion and improve mental health (secondary outcomes). Attachment was considered a moderator. As a result of professional's caregivers behavior change, it is expected to observe subsequent effects on adolescents' psychosocial adaptation indicators, such as improvements on the quality of relationship with professional caregivers, hope, self-efficacy and in emotional regulations processes and a decrease on antisocial behavior, anger control problems and emotional suffering (secondary outcomes). Attachment was considered also a moderator. Program efficacy was evaluated using a randomized control trial (RCT). Institutions were assigned to the experimental (n = 10) and to the control (n = 11) group using a covariate adaptative randomization method. Data was assessed using a 4-wave longitudinal design (baseline, interim, post, 6-month follow-up) with professional caregivers and adolescents' self-reports.

NCT ID: NCT05599295 Recruiting - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

NCT ID: NCT05589545 Enrolling by invitation - Prosthesis Survival Clinical Trials

PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.

PEEKPilotZyg
Start date: July 19, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 Hybrid concept (standard and zygomatic implants) after one year of follow-up. The main question it aims to answer is: - What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

NCT ID: NCT05589532 Enrolling by invitation - Prosthesis Survival Clinical Trials

Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

PEEKPilotST
Start date: August 6, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is: - What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.

NCT ID: NCT05589519 Enrolling by invitation - Prosthesis Survival Clinical Trials

Partial Implant-supported Rehabilitation Using PEEK

PEEKPilotSB
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is: - What is the survival outcome of partial implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with dental implants will receive a definitive 3 unit prosthesis incorporating Poly-ether-ehter-ketone.