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NCT ID: NCT03922282 Completed - Thyroidectomy Clinical Trials

BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .

NCT ID: NCT03920917 Not yet recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)

Start date: May 2019
Phase: N/A
Study type: Interventional

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation, and it can reduce the procedure time compared to conventional radiofrequency (RF) catheter ablation. Recently, high-power short-duration RF ablation has been known to reduce procedure time remarkably, and it can eliminate extra-pulmonary vein foci, which cannot be treated by Cryoballoon ablation. The aim of this study is to compare Cryoballoon ablation and high-power short-duration RF ablation in patients with paroxysmal atrial fibrillation in terms of the efficacy and the safety in a prospective randomized trial.

NCT ID: NCT03920891 Not yet recruiting - Clinical trials for Valvular Atrial Fibrillation

Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)

Start date: May 2019
Phase: N/A
Study type: Interventional

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.

NCT ID: NCT03920579 Recruiting - Hypertension Clinical Trials

A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

NCT ID: NCT03920540 Recruiting - Hunter Syndrome Clinical Trials

A Study of GC1111 in Hunter Syndrom Patients

Start date: March 9, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

NCT ID: NCT03920436 Recruiting - Metabolic Problems Clinical Trials

Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks.

NCT ID: NCT03919487 Recruiting - Colon Adenoma Clinical Trials

Surrogate Quality Indicators for Adenoma Detection Rate (ADR)

Start date: January 1, 2017
Phase:
Study type: Observational

This study is to evaluate the correlation of adenoma missing rate and quality indicators of colonoscopy including adenoma detection ratee (ADR), polyp detection rate (PDR), adenoma per colonoscopy rate (APC), adenoma per positive participant (APP), ADR-Plus, and to find out the surrogate indicators of ADR. This study is a prospective observational multi-center study. Correlation between AMR and quality indicators of colonoscopy based on the previous studies, 8 endoscopists participated in this study and will enroll 50 screening colonoscopies respectively. Recruit research participants who want to participate in research in outpatient clinics. Perform colonoscopy in the morning after colon cleansing with split method. Colonoscopy is performed by back-to-back two consecutive colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. After retracting to the anus of the first colonoscopy, the second colonoscopy is performed immediately. In case of newly detected colon polyps except for the small polyps and S-colon and rectal polyps which were left as photographs during the first colonoscopy with the second colonoscopy, we regard them as an overlooked lesion during the first colonoscopy. After the procedure, the histologic examination is confirmed and classified as benign lesions (all adenomas, advanced adenomas, dysplasia, and colorectal cancer) and non-lesion lesions. Using the back-to-back colonoscopy results of the participants during the study period, calculate the quality indicators including ADR, PDR, APC, ADR-plus, APP and AMR for each endoscopist. And then, evaluate the correlation between AMR and other quality indicators.

NCT ID: NCT03918967 Recruiting - Healthy Clinical Trials

To Demonstrate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-11 in Human Participants

Start date: April 8, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 in human participants. This is a double-blinded, sequential group, single and multiple ascending (oral) dose study in healthy volunteers aged 19-55 years.

NCT ID: NCT03914404 Completed - Diabetic Neuropathy Clinical Trials

Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy

Start date: January 26, 2016
Phase: Phase 4
Study type: Interventional

This study was a 12-week, multi-center, randomized, double-blind, double dummy, parallel clinical trial to compare the efficacy of γ-linolenic acid and Thioctic acid in patients with diabetic neuropathy.

NCT ID: NCT03913234 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

Start date: May 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Survival benefit and quality of life are two key elements that should be kept in mind in the treatment of metastatic breast cancer. In this regards, endocrine therapy (ET) is strongly recommended in hormone receptor (HR) positive patients unless there is visceral crisis even though there is no concrete evidence that it is better than chemotherapy in terms of survival. HER2 positive breast cancer is a subtype of breast cancer that showed the greatest improvement in terms of survival during the last decade due to trastuzumab based therapy. Recently, taxane and HER2 directed doublet including trastuzumab and pertuzumab (THP) is considered as standard of therapy based upon randomized phase 3 clinical trial (CLEOTATRA). HER2 positive breast cancer can be divided into HER2 enriched subgroup (HR-HER2+) and luminal B subgroup (HR+HER2+) in biologic viewpoint because they are distinctly different subgroups in gene expression analysis. Accordingly, we are currently treating biologically different subtypes in a same way, which is CTx and anti-HER2 combination therapy (THP). Luminal HER2+ subgroup has actually been tested with endocrine therapy (ET) and anti-HER2 therapy showed better PFS than ET alone (TAnDEM trial and trial comparing lapatinib plus letrozole versus letrozole alone) [2],[3] confirming existence of cross talk between ER and HER2 pathways in clinical setting. However, the combination regimen between ET and anti-HER2 therapy is not widely used in current practice in ER+HER2+ MBC patients because PFS seemed to be relatively shorter compared with chemotherapy based combination with anti-HER2 therapy even though several guidelines recommend it to be used as an initial treatment unless there is visceral crisis as they recommended ET alone first in ER+HER2- MBC (NCCN 2018). Recently, various CDK4/6 inhibitors including palbociclib, abemaciclib, and ribociclib were approved by FDA based on the clinical trial results demonstrating prolonged PFS over ET alone when it was combined with ET in ER+ advanced breast cancer [4]. In PALOMA 2 biomarker study, it was beneficial regardless of ER and Ki67 expression status. Reflecting quite durable PFS prolongation (10 month in PALOMA2) shown in ER+ disease (luminal A and luminal B subtype except HR+HER2+ patients) with CDK4/6 inhibitor on top of ET, the hypothesis of this trial is whether CDK4/6 inhibitor could prolong survival in luminal HER2 breast cancer as it did in ER+HER2-patients. In preclinical study, palbociclib showed activity in not only ER+ cell lines but also HER2 positive cell lines [5]. Also, in phase Ib trial, a CDK4/6 inhibitor from Lilly, abemaciclib showed acceptable toxicity with endocrine therapy or trastuzumab with response rate of around 20%. Hence, as of today, it could be justified and warranted to conduct a prospective trial of ribocicib+letrozole+trastuzumab in order to take a look at its efficacy and toxicity in HR+HER2 + advanced breast cancer.