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NCT ID: NCT04903717 Active, not recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists

PROMPT-MRA
Start date: November 3, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this guideline-recommended therapy. The system will also inform providers about FDA-approved potassium binders for the treatment of hyperkalemia if elevated potassium is a barrier for MRA use and will provide educational information on the evidence for MRA therapy in these patients.

NCT ID: NCT04903626 Active, not recruiting - Clinical trials for Hepatitis C Virus (HCV)

Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Start date: August 24, 2021
Phase: Phase 3
Study type: Interventional

Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. 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, monitoring for side effects and completing questionnaires.

NCT ID: NCT04903288 Active, not recruiting - AADC Deficiency Clinical Trials

A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants

Start date: May 12, 2021
Phase: Phase 2
Study type: Interventional

This study will have a trial phase, extension phase, and a long-term extension phase. The primary objectives of the trial phase are to assess the pharmacodynamics (PD) of eladocagene exuparvovec treatment by evaluation of homovanillic acid (HVA) levels and to assess the safety of the SmartFlow® magnetic resonance (MR) Compatible Ventricular Cannula for administering eladocagene exuparvovec to pediatric participants with aromatic L-amino acid decarboxylase (AADC) deficiency. The extension phase is designed to capture additional clinical information for eladocagene exuparvovec through study evaluations, changes in motor development, AADC-specific symptoms, and other PD measures. The long-term extension phase is designed to capture long-term safety and efficacy data from participants treated with eladocagene exuparvovec.

NCT ID: NCT04903106 Active, not recruiting - Meniscus Tear Clinical Trials

Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

FAST-FIX FLEX
Start date: January 20, 2022
Phase:
Study type: Observational

This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.

NCT ID: NCT04902872 Active, not recruiting - Breast Cancer Clinical Trials

Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

Start date: May 3, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.

NCT ID: NCT04902781 Active, not recruiting - Clinical trials for Classic Galactosemia

Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia

Start date: March 20, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to assess the clinical benefit as well as the safety, pharmacokinetics (PK), and pharmacodynamics (PD) (reduction of galactitol levels) of AT-007 in pediatric subjects with Classic Galactosemia (CG).

NCT ID: NCT04901702 Active, not recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Start date: June 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm. In Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of the DNA once the cancer cell is damaged. By damaging the tumor DNA and blocking the repair, the cancer cells may die. In Arm B, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and temozolomide. Both of these medications work by damaging the DNA of the cancer call which may cause the tumor(s) to die. Once the highest doses are reached in Arm A and Arm B, then "expansion Arms" will open. An expansion arm treats more children and AYAs with recurrent or refractory solid tumors at the highest doses achieved in the phase I study. The goal of the expansion arms is to see if the tumors go away in children and AYAs with recurrent or refractory solid tumors. There will be 3 "expansion Arms". In Arm A1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and talazoparib. In Arm A2, children and AYAs with recurrent or refractory solid tumors, whose tumors have a problem with repairing DNA (identified by their doctor), will receive Onivyde and talazoparib. In Arm B1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and temozolomide. Once the highest doses of medications used in Arm A and Arm B are determined, then a phase II study will open for children or young adults with Ewing sarcoma that has recurred or is refractory following treatment received after the initial diagnosis. The trial will test the same 2 combinations of therapy in Arm A and Arm B. In the phase II, a participant with Ewing sarcoma will be randomly assigned to receive the treatment given on either Arm A or Arm B.

NCT ID: NCT04901195 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

BE HEARD EXT
Start date: May 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

NCT ID: NCT04900896 Active, not recruiting - Stroke Clinical Trials

Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis

Start date: May 11, 2021
Phase:
Study type: Observational

The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.

NCT ID: NCT04900792 Active, not recruiting - Glioblastoma Clinical Trials

A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma

XACT-Fe-GBM-01
Start date: February 28, 2023
Phase: Phase 1
Study type: Interventional

This clinical trial evaluates adding ferumoxytol and pharamcologic ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive ferumoxytol and pharmacologic ascorbate in addition to the standard treatment.