Clinical Trials Logo

Filter by:
NCT ID: NCT04998201 Completed - Mixed Dyslipidemia Clinical Trials

Study of ARO-APOC3 in Adults With Mixed Dyslipidemia

MUIR
Start date: September 28, 2021
Phase: Phase 2
Study type: Interventional

Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluted for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standard of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.

NCT ID: NCT04969965 Completed - Healthy Volunteers Clinical Trials

To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations

Start date: June 21, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label and uncontrolled study to evaluate the comparative PK of EQ143 following oral single dose administration in adult healthy volunteers different racial and ethnic populations. A total of one (1) single dose cohort is planned at 110 mg of EQ143. EQ143 is an approved therapy in China at the 110 mg dose for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) T790Mmutation-positive, metastatic non-small cell lung cancer (NSCLC), who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy. A total of 45 (15 Caucasian, 8 Black/African American and 7 Hispanic/Latino, and 15 ethnic Chinese)

NCT ID: NCT04965324 Completed - Clinical trials for Surgery--Complications

Depth of Anaesthesia and Long-term Survival: The Balanced Anaesthesia Follow-up Study

BALANCEDLT
Start date: December 19, 2012
Phase:
Study type: Observational

Anaesthetic depth and complications after major surgery: an international, randomised controlled trial - The BALANCED trial. In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival. The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35. The two secondary hypotheses are that BIS titration to BIS 50 will 1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival 2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of ~80% translating to an absolute survival difference of ~2% potentially (if the ~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights. Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.

NCT ID: NCT04958876 Completed - Healthy Volunteers Clinical Trials

Study to Evaluate the Safety of SP-104

Start date: October 4, 2021
Phase: Phase 1
Study type: Interventional

Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.

NCT ID: NCT04956224 Completed - Clinical trials for SARS-CoV-2 Virus Infection

Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

Start date: August 9, 2021
Phase: Phase 3
Study type: Interventional

This is a A Phase III, Open label, Multicenter, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001 in volunteers aged ≥ 56 years. Approximately 300 participants are enrolled in a non-randomized manner.

NCT ID: NCT04947852 Completed - COPD Clinical Trials

Efficacy of NIV Masks in COPD

Start date: July 28, 2021
Phase: N/A
Study type: Interventional

A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.

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: NCT04940559 Completed - Healthy Clinical Trials

Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

Start date: August 2, 2016
Phase: Phase 1
Study type: Interventional

This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.

NCT ID: NCT04926376 Completed - Liver Cancer Clinical Trials

Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.

NCT ID: NCT04908683 Completed - Clinical trials for Respiratory Syncytial Viruses

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

EVERGREEN
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.