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NCT ID: NCT05175105 Recruiting - Clinical trials for Pediatric Pyruvate Kinase Deficiency

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

ACTIVATE-Kids
Start date: June 6, 2022
Phase: Phase 3
Study type: Interventional

Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to < 6 years, 6 to < 12 years, 12 to < 18 years). Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 12-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

NCT ID: NCT05174663 Completed - Clinical trials for Hypercholesterolemia

Investigating the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia

Start date: January 10, 2022
Phase: N/A
Study type: Interventional

This study will determine the quantity of almonds (1.5 oz or 2.5 oz) consumed as a snack that will provide optimal increases in HDL-C levels.

NCT ID: NCT05174338 Enrolling by invitation - Clinical trials for Amyloidosis, Immunoglobulin Light-chain

Cardiac Amyloidosis Registry Study

CARS
Start date: January 8, 2020
Phase:
Study type: Observational

This registry is a observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025.

NCT ID: NCT05174273 Recruiting - Clinical trials for Major Depressive Disorder

Neurocognitive Effects of FMT in MDD Patients With and Without IBS

Start date: April 6, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a phase 2/3 open-label controlled trial (CT) in which adults with Major Depressive Disorder (MDD) and adults who have MDD plus comorbid Inflammatory Bowel Syndrome (IBS) will be assigned to either receive oral Fecal Microbiota Transplantation (FMT) or to continue with the treatment they are currently receiving in a Treatment As Usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group. The primary goals of this study are to determine effectiveness, safety and tolerability of oral FMT in adults with MDD and in MDD who have comorbid IBS. Additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with MDD and with MDD + IBS and to determine if they improve with FMT. It is known that both, individuals with MDD and those with MDD and IBS show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to FMT."

NCT ID: NCT05174169 Recruiting - Clinical trials for Stage III Colon Cancer

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

CIRCULATE-US
Start date: March 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

NCT ID: NCT05173987 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Start date: February 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

NCT ID: NCT05173155 Recruiting - Hip Fractures Clinical Trials

Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.

NCT ID: NCT05172973 Recruiting - Clinical trials for Aortic Valve Stenosis

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

NCT ID: NCT05172960 Recruiting - Clinical trials for Aortic Stenosis, Severe

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

NCT ID: NCT05172726 Recruiting - Plaque Psoriasis Clinical Trials

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.