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NCT ID: NCT05081518 Terminated - Focal Epilepsy Clinical Trials

A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy

Start date: September 29, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to investigate effects of Lu AG06466 on seizure activity after increasing daily doses during 4 weeks in participants with an implanted responsive neurostimulation system.

NCT ID: NCT05081388 Terminated - SARS-CoV-2 Clinical Trials

COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease

Start date: November 8, 2021
Phase: Phase 1
Study type: Interventional

Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) - Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy - Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy - Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy

NCT ID: NCT05081375 Terminated - Surgical Blood Loss Clinical Trials

Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures

Start date: December 16, 2019
Phase: Phase 4
Study type: Interventional

All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.

NCT ID: NCT05081271 Terminated - Multiple Sclerosis Clinical Trials

COVID-19 Booster Vaccination in Persons With Multiple Sclerosis

Start date: October 15, 2021
Phase: Early Phase 1
Study type: Interventional

The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is unclear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is a way to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.

NCT ID: NCT05080842 Terminated - Breast Cancer Clinical Trials

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer

Start date: November 12, 2021
Phase: Phase 1
Study type: Interventional

This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: - Identify the recommended dose of AC682 that can be given safely to participants - To evaluate the side effects of AC682 - To evaluate pharmacokinetics of AC682 - To evaluate the effectiveness of AC682

NCT ID: NCT05079230 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

ENHANCE-3
Start date: July 7, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

NCT ID: NCT05079126 Terminated - Clinical trials for Interstitial Lung Disease

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

ILD-DLCO
Start date: December 2, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.

NCT ID: NCT05078437 Terminated - Dementia Clinical Trials

Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia

AMOR-KY
Start date: October 14, 2021
Phase: N/A
Study type: Interventional

The AMOR-Kentucky study will examine the impact of a pharmacist-physician patient-centered medication therapy management deprescribing intervention to address inappropriate medication use in patients with cognitive impairment in underserved, lower socioeconomic populations in rural Appalachian Kentucky. The results of this study will provide valuable insights on how to expand and implement deprescribing interventions using telemedicine to reduce the prevalence and the associated healthcare costs of medication-related problems in patients with mild cognitive impairment, Alzheimer's disease and other dementias in rural areas throughout the US. The investigators will assess the potential use of telemedicine in this population by performing an initial single arm, unblinded study of the medication therapy management (MTM) describing intervention in rural/underserved Kentucky Appalachian populations with cognitive impairment and/or dementia using potentially inappropriate medications (n=50). Following initial recruitment and clinical evaluation, engaged participants will have their medication list reviewed by a pharmacist-clinician team to identify targets for deprescribing intervention. The intervention will be engaged remotely with the participant and their caregiver, and the MTM team at 4 weeks post initial evaluation, and then reinforced at a 3-month timepoint. This approach will be carried forward through a telemedicine practice at University of Kentucky that is comprised of approximately 500 patient-caregiver dyads throughout rural areas of Appalachian Kentucky.

NCT ID: NCT05077969 Terminated - COVID-19 Clinical Trials

Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

Start date: December 29, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

NCT ID: NCT05077423 Terminated - AML, Childhood Clinical Trials

A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: May 25, 2022
Phase: Phase 1
Study type: Interventional

Pediatric patients (<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.