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NCT ID: NCT04848896 Not yet recruiting - Arthroplasty Clinical Trials

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

CORI RCT TKA
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.

NCT ID: NCT04845321 Not yet recruiting - Healthy Volunteers Clinical Trials

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

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

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

NCT ID: NCT04840316 Not yet recruiting - Clinical trials for Complication,Postoperative

INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

INPOD-NZ
Start date: April 19, 2021
Phase:
Study type: Observational

As the population of older adults increases, so too with the number of older adult patients that present for anesthesia and surgery. The development of delirium following surgery has some significant potential effects on patient outcomes; however, POD is often under diagnosed. Some studies reported that more than 50% of patients with delirium were undiagnosed by clinical teams. POD is associated with cognitive decline, increased hospital length of stay, discharge to institutional care, mortality and higher healthcare costs. POD contributes significantly to healthcare inefficiency; a diagnosis of POD is estimated by the Australian Commission on Quality and Safety in Healthcare to cost an additional $27,791 AUD. The incidence of POD reported in clinical trials depends on the risk profile of the study population, the frequency and duration of delirium assessments as well as the surgical procedure. Reported incidence may also vary due to the presence of high-risk pathways involving multi-specialty management and intervention. POD may present as either hyperactive or hypoactive subtypes, the latter being more difficult to detect. There are few reports on the incidence of POD in New Zealand national level datasets, with single centre studies primarily looking at in-hospital delirium and demonstrating an incidence of 11.2 to 29% on mixed and/or medical wards. A review of elderly patients with neck-of-femur fractures found the incidences of POD to be as high as 39%. The current data suggests a significant level of morbidity due to POD in New Zealand hospitals, however there is lack of national level data in the surgical population; which is crucial for establishing demographic and regional need for effective intervention.

NCT ID: NCT04838353 Not yet recruiting - Heart Failure Clinical Trials

Alleviate-HF-2 Study

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data

NCT ID: NCT04824092 Not yet recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

frontMIND
Start date: April 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

NCT ID: NCT04818801 Not yet recruiting - Covid19 Clinical Trials

Safety, Reactogenicity and Immunogenicity Study of ReCOV

Start date: April 2021
Phase: Early Phase 1
Study type: Interventional

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. In this phase I first-in-human clinical trial, healthy volunteers in two different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV. The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.

NCT ID: NCT04810078 Not yet recruiting - Clinical trials for Clear Cell Renal Cell Carcinoma

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

CheckMate-67T
Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.

NCT ID: NCT04797897 Not yet recruiting - Avascular Necrosis Clinical Trials

Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

CORI RCT UKA
Start date: March 31, 2021
Phase: N/A
Study type: Interventional

This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.

NCT ID: NCT04782323 Recruiting - Influenza Clinical Trials

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years to determine the appropriate age population for this vaccine. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

NCT ID: NCT04775797 Not yet recruiting - Chronic Hepatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

Start date: March 2021
Phase: Phase 1
Study type: Interventional

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.