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NCT ID: NCT04056780 Active, not recruiting - Clinical trials for Prosthetic Joint Infection

Integrated Microfluidic Systems for Diagnosis of Periprosthetic Joint Infection

Start date: April 1, 2020
Phase:
Study type: Observational

Diagnosing periprosthetic joint infection (PJI) remains a major clinical challenge. The diagnosis of PJI is based on a composition of clinical judgment, serologic test from peripheral blood, synovial fluid cytology and biomarkers, radiography, microbiology, histopathologic evaluation of periprosthetic tissue, and intraoperative findings. The importance of PJI diagnosis give the subsequent treatment options, like the removal of prosthesis, debridement and prosthesis retention and the time of reimplantation. Currently, The Second International Consensus Meeting (ICM) has announced its criteria for the diagnosis of PJI. The preoperative diagnosis includes serologic tests (C-reactive protein, D-dimer, and erythrocyte sedimentation rate) and synovial fluid biomarkers (white blood cell and differential, leukocyte esterase and ⍺-defensin). The intraoperative diagnosis includes a single positive culture, positive histology, and positive intraoperative purulence. However, some of the markers used in the 2018 ICM criteria, such as ⍺-defensin, leukocyte esterase, and synovial fluid C-reactive protein, are not available in every hospital and cannot be immediately available to clinicians in decision making. The microfluidic technologies have made a notable impact on the evolution of diagnostic tools by providing a rapid and cost-effective platform for the application of immunoassay techniques. The microfluidic system integrates the complex processing steps of the laboratory protocols into a single chip through logical integration and optimization of processes. Chang Gung Memorial Hospital and National Tsing Hua University have conducted preliminary research to confirm the feasibility of their microfluidic systems. Therefore, the project will develop a "microfluidic biomarker detection chip" to detect the concentrations three important biomarkers for PJI, including ⍺-defensin, leukocyte esterase and C-reactive protein in synovial fluids. This will be a three-year project. In the 1st year, 50 patients who will be scheduled to undergo unilateral revision total joint arthroplasty (RTJA) will be collected with the synovial fluid and tested on a laboratory platform. In the 2nd year, based on laboratory results, 50 patients undergoing RTJAs will be recruited to develop a microfluidic chip system, and their on-chip performance will be fine-tuned and optimized. In the 3rd year, 50 patients undergoing RTJA will be collected, and the verification of the microfluidic system will be realized. This system will be validated in PJIs cohorts in the first stage of debridement and implant removal, in the interim period, and the second stage of reimplantation. It is expected that biomarker detection chip will improve medical distress and bring important information to clinical decision-making.

NCT ID: NCT04105036 Active, not recruiting - Geriatrics Clinical Trials

Social Deprivation Assessment in Older Adults

Start date: April 1, 2020
Phase:
Study type: Observational

Social deprivation is a state to which older adults may be exposed, leading to adverse social, psychological, and health outcomes. Social deprivation may be more sensitive than socioeconomic status for predicting adversity while using only a few items for evaluation. However, there is no practical assessment for social deprivation in older Canadian adults. Two indices that capture a broad picture of social vulnerability have previously been developed for older Canadians. Using participants in the Canadian Longitudinal Study on Aging (CLSA), the overall objective is to examine and compare the associations of the COAD score and index, as well as the Keefe et al. and Andrew et al. indices with prevalent and incident adverse social, psychological, and health outcomes in participants at baseline assessment.

NCT ID: NCT04115423 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

Start date: April 1, 2020
Phase:
Study type: Observational

The purpose of this study is to evaluate whether the risk of serious infections in rheumatoid arthritis patients with tocilizumab is higher than in those with tumor necrosis factor inhibitors using the nationwide real-world data.

NCT ID: NCT04167540 Active, not recruiting - Parkinson's Disease Clinical Trials

GDNF Gene Therapy for Parkinson's Disease

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.

NCT ID: NCT04288089 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.

NCT ID: NCT04288570 Active, not recruiting - Rotator Cuff Tears Clinical Trials

Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

Punch/Drill
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.

NCT ID: NCT04293276 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

DAP-Her-01
Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

NCT ID: NCT04306367 Active, not recruiting - Cholangiocarcinoma Clinical Trials

Study of Pembrolizumab and Olaparib in Bile Duct Cancer

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The investigators propose an open label, one-arm study to assess the safety and efficacy of olaparib and pembrolizumab in patients with cholangiocarcinoma who have progressed on or cannot tolerate gemcitabine-based therapy.

NCT ID: NCT04307381 Active, not recruiting - Clinical trials for Hereditary Angioedema

An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).

NCT ID: NCT04329780 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

Start date: April 1, 2020
Phase:
Study type: Observational

A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)