• Title/Summary/Keyword: Non-clinical outcomes

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Presentation of potential genes and deleterious variants associated with non-syndromic hearing loss: a computational approach

  • Ray, Manisha;Rath, Surya Narayan;Sarkar, Saurav;Sable, Mukund Namdev
    • Genomics & Informatics
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    • v.20 no.1
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    • pp.5.1-5.10
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    • 2022
  • Non-syndromic hearing loss (NSHL) is a common hereditary disorder. Both clinical and genetic heterogeneity has created many obstacles to understanding the causes of NSHL. The present study has attempted to ravel the genetic aetiology in NSHL progression and to screen out potential target genes using computational approaches. The reported NSHL target genes (2009-2020) have been studied by analyzing different biochemical and signaling pathways, interpretation of their functional association network, and discovery of important regulatory interactions with three previously established miRNAs in the human inner ear as well as in NSHL such as miR-183, miR-182, and miR-96. This study has identified SMAD4 and SNAI2 as the most putative target genes of NSHL. But pathogenic and deleterious non-synonymous single nucleotide polymorphisms discovered within SMAD4 is anticipated to have an impact on NSHL progression. Additionally, the identified deleterious variants in the functional domains of SMAD4 added a supportive clue for further study. Thus, the identified deleterious variant i.e., rs377767367 (G491V) in SMAD4 needs further clinical validation. The present outcomes would provide insights into the genetics of NSHL progression.

Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method (퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석)

  • Lim, Hoi-Jeong;Kim, Yoon-I;Jung, Young-Bok;Seong, Sang-Cheol;Ahn, Jin-Hwan;Roh, Kwon-Jae;Kim, Jung-Man;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.37 no.4
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    • pp.381-389
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    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial

  • Jovanovski, Elena;Smircic-Duvnjak, Lea;Komishon, Allison;Au-Yeung, Fei (Rodney);Sievenpiper, John L.;Zurbau, Andreea;Jenkins, Alexandra L.;Sung, Mi-Kyung;Josse, Robert;Li, Dandan;Vuksan, Vladimir
    • Journal of Ginseng Research
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    • v.45 no.5
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    • pp.546-554
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    • 2021
  • Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

Comparison of Treatment Compliance and Nutritional Outcomes among Patients with Nasopharyngeal Carcinoma with and without Percutaneous Endoscopic Gastrostomy during Chemoradiation

  • Peerawong, Thanarpan;Phungrassami, Temsak;Pruegsanusak, Kovit;Sangthong, Rassamee
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.11
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    • pp.5805-5809
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    • 2012
  • Aims: The study aimed to compare treatment compliance and nutritional outcomes in nasopharyngeal carcinoma (NPC) patients during chemoradiation. Methods: Clinical information of patients with NPC that underwent chemoradiation during 2004-2009 were retrieved from the hospital database and retrospectively reviewed. Patients were categorised into a prophylactic percutaneous endoscopic gastrostomy (PPEG) group and a non-PPEG group. Clinical information including treatment compliance, weight, haematological and renal toxicity was compared. Results: A total of 219 patients were reviewed and categorised into PPEG (n=77) and non-PPEG (n=142). Significant differences in absolute percentage weight loss between groups were found from the $3^{rd}$ cycle of chemotherapy. There were 24.2, 20.3 and 24.8% in the third, the fourth and the fifth cycles of chemotherapy, respectively. Migration of grade 2 to grade 3 weight loss was obviously seen in the $3^{rd}$ cycle as well. A significant difference of grade 3 or more hypokalemia was found with values of 14.3% and 50% in the PPEG and non-PPEG groups, respectively. Other toxicity parameters and treatment compliance were not different between the groups. Conclusions: Use of PPEG resulted in decreased severe weight loss, reduced migration from grade 2 to grade 3 weight loss and reduced hypokalaemia. However, benefits in treatment compliance could not be detected. So consideration of PPEG in NPC patients requires care.

Comparison of concurrent chemoradiotherapy versus sequential radiochemotherapy in patients with completely resected non-small cell lung cancer

  • Kim, Hwan-Ik;Noh, O Kyu;Oh, Young-Taek;Chun, Mison;Kim, Sang-Won;Cho, Oyeon;Heo, Jaesung
    • Radiation Oncology Journal
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    • v.34 no.3
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    • pp.202-208
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    • 2016
  • Purpose: Our institution has implemented two different adjuvant protocols in treating patients with non-small cell lung cancer (NSCLC): chemotherapy followed by concurrent chemoradiotherapy (CT-CCRT) and sequential postoperative radiotherapy (PORT) followed by postoperative chemotherapy (POCT). We aimed to compare the clinical outcomes between the two adjuvant protocols. Materials and Methods: From March 1997 to October 2012, 68 patients were treated with CT-CCRT (n = 25) and sequential PORT followed by POCT (RT-CT; n = 43). The CT-CCRT protocol consisted of 2 cycles of cisplatin-based POCT followed by PORT concurrently with 2 cycles of POCT. The RT-CT protocol consisted of PORT followed by 4 cycles of cisplatin-based POCT. PORT was administered using conventional fractionation with a dose of 50.4-60 Gy. We compared the outcomes between the two adjuvant protocols and analyzed the clinical factors affecting survivals. Results: Median follow-up time was 43.9 months (range, 3.2 to 74.0 months), and the 5-year overall survival (OS), locoregional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were 53.9%, 68.2%, and 51.0%, respectively. There were no significant differences in OS (p = 0.074), LRFS (p = 0.094), and DMFS (p = 0.490) between the two protocols. In multivariable analyses, adjuvant protocol remained as a significant prognostic factor for LRFS, favouring CT-CCRT (hazard ratio [HR] = 3.506, p = 0.046) over RT-CT, not for OS (HR = 0.647, p = 0.229). Conclusion: CT-CCRT protocol increased LRFS more than RT-CT protocol in patients with completely resected NSCLC, but not in OS. Further studies are warranted to evaluate the benefit of CCRT strategy compared with sequential strategy.

Effect of Nutrition Support Team Management - Focusing on Medical Intensive Care Unit Patients - (영양집중지원에 따른 결과 비교 - 내과계 중환자실 대상으로 -)

  • Im, Waon Sun;Lee, Yun Mi
    • Journal of Korean Critical Care Nursing
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    • v.11 no.3
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    • pp.108-119
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    • 2018
  • Purpose : This study evaluated the nutritional status and effect of nutritional support team (NST) management in critically ill patients. Methods : From January 2015 to August 2017, the study retrospectively investigated 128 patients aged above 19 years admitted to a medical intensive care unit (MICU). The patients were divided into two groups: NST (n=65) and non-NST (n=63) groups. Nutritional status, classification of bedsore risks, incidence rate of bedsore and clinical outcomes were compared. Results : The study found a higher rate of the use of enteral nutrition in the NST group (${\chi}^2=45.60$, p < .001). The prescription rate of parenteral nutrition (PN) was found to be lower in the NST group (4.6%) compared to the non-NST group (60.3%). There was a higher PN of total delivered/required caloric ratio in the NST, compared to the non-NST, group (${\chi}^2=3.33$, p=.025). There were significant differences for higher albumin levels (t=2.50, p=.014), higher total protein levels (t=2.94, p=.004), and higher proportion of discharge with survival rates (${\chi}^2=18.26$, p < .001) in the NST group. Conclusions : Providing NST management to critically ill patients showed an increase in the nutrition support. Further, to achieve effective clinical outcomes, measures such as nutrition education and continuous monitoring and management for the provision of nutritional support by the systemic administration of a nutritional support team should be considered.

Clinical Effectiveness of Acupuncture in the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review (비알코올성 지방간 질환에 대한 침치료의 효과 : 체계적 고찰)

  • Hyun, Joon;Lee, Joo-bok;Kim, So-yeon;Han, Chang-woo
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1206-1224
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    • 2018
  • Purpose: This systematic review was planned and performed in order to determine the clinical effectiveness of acupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: We searched related randomized controlled trials in several medical online databases, including China National Knowledge Infrastructure (CNKI), Excerpta Medica dataBASE (EMBASE), Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), National Digital Science Library (NDSL), and Research Information Sharing Service (RISS). NAFLD related outcomes were extracted from the included trials and meta-analyzed. Results: From the 8 included trials, the values of the following examinations were extracted: liver ultrasonography, liver CT, body fat CT, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, fasting blood sugar (FBS), hosmeostatic model assessment for insulin resistance (HOMA-IR), weight, body mass index (BMI), waist hip ratio (WHR), obesity degree, body fat mass, body fat rate, leptin, malondialdehyde (MDA), and super oxide dismutase (SOD). In the 4 outcomes, cure rate in liver ultrasonography (RR=1.56; 95%CI=1.05~2.31; P=0.03), cure rate in liver CT (RR=2.23; 95%CI=1.33~3.72; P=0.002), TC (MD=-0.78; 95%CI=-1.41~-0.15; P=0.02), and TG (MD=-2.05; 95%CI=-3.88~-0.21; P=0.03), acupuncture was more effective than the control intervention. Conclusions: In this meta-analysis, acupuncture relieved hepatic steatosis, and reduced TC, and TG in NAFLD patients. more well-planned studies are still needed due to the heterogeneity and the considerable methodological flaws in the analyzed trials.

Clinical Feasibility of Vascular Navigation System During Laparoscopic Gastrectomy for Gastric Cancer: A Retrospective Comparison With Propensity-Score Matching

  • Ji Eun Jung;Jeong Ho Song;Seyeol Oh;Sang-Yong Son;Hoon Hur;In Gyu Kwon;Sang-Uk Han
    • Journal of Gastric Cancer
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    • v.24 no.4
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    • pp.356-366
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    • 2024
  • Purpose: The usability of a new surgical navigation system that provides patient-specific vascular information for robotic gastrectomy in gastric cancer remains unexplored for laparoscopic gastrectomy owing to differences in surgical environments. This study aimed to evaluate the applicability and safety of this navigation system in laparoscopic gastrectomy and to compare the post-operative outcomes between procedures with and without its use. Materials and Methods: Between June 2022 and July 2023, 38 patients across 2 institutions underwent laparoscopic gastrectomy using a navigation system (navigation group). The technical feasibility, safety, and accuracy of detecting variations in vascular anatomy were measured. The perioperative outcomes were compared with 114 patients who underwent laparoscopic gastrectomy without a navigation system (non-navigation group) using 1:3 propensity score matching during the same study period. Results: In all patients in the navigation group, no adverse events associated with the navigation system occurred during surgery in any patient in the navigation group. No accidental vessel injuries necessitate auxiliary procedures. All vessels encountered during the gastrectomy were successfully reconstructed and visualized. Patient demographics and operative data were comparable between the 2 groups. The navigation group exhibited a significantly lower overall complication rate (10.5%) than the non-navigation group (26.3%, P=0.043). Notably, pancreas-related complications were absent in the navigation group but occurred in eight cases in the non-navigation group (7.0%, P=0.093), although the difference was not statistically significant. Conclusions: The patient-specific surgical navigation system demonstrated clinical feasibility and safety for laparoscopic gastrectomy for gastric cancer, potentially reducing complication rates compared with laparoscopic gastrectomy without its use.

Comparison of Posterior Fixation Alone and Supplementation with Posterolateral Fusion in Thoracolumbar Burst Fractures

  • Hwang, Jong-Uk;Hur, Jin-Woo;Lee, Jong-Won;Kwon, Ki-Young;Lee, Hyun-Koo
    • Journal of Korean Neurosurgical Society
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    • v.52 no.4
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    • pp.346-352
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    • 2012
  • Objective : We compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures. In addition, we also evaluated the necessity of posterolateral fusion for patients treated with posterior pedicle screw fixation. Methods : From January 2007 to December 2009, 46 consecutive patients with thoracolumbar burst fracture were included in this study. On the basis of posterolateral fusion, we divided our patients into the non-fusion group and the fusion group. The radiological assessment was performed according to the Cobb's method, and results were obtained at immediately, 3, 6, 12 months after surgery. The clinical outcomes were evaluated using the modified Mcnab criteria at the final follow-up. Results : The demographic data and the mean follow-up period were similar between the two groups. Patients of both groups achieved satisfactory clinical outcomes. The mean loss of kyphosis correction showed that patients of both groups experienced loss of correction with no respect to whether they underwent the posterolateral fusion. There was no significant difference in the degree of loss of correction at any time points of the follow-up between the two groups. In addition, we also compared the effect of fixed levels (i.e., short versus long segment) on loss of correction between the two groups and there was no significant difference. There were no major complications postoperatively and during follow-up period. Conclusion : We suggest that posterolateral fusion may be unnecessary for patients with thoracolumbar burst fractures who underwent posterior pedicle screw fixation.

Effects of Preoperative Autologous Blood Donation in Patients Undergoing Minimally Invasive Cardiac Surgery

  • Lim, Mi Hee;Je, Hyung Gon;Ju, Min Ho;Lee, Ji Hye;Oh, Hye Rim;Kim, Ye Ri
    • Journal of Chest Surgery
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    • v.52 no.6
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    • pp.385-391
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    • 2019
  • Background: Preoperative autologous blood donation (PABD) is a conservation strategy for reducing allogenic blood transfusion (ABT) during minimally invasive cardiac surgery (MICS). We aimed to evaluate the effects of PABD on the frequency of ABT and clinical outcomes in patients undergoing MICS. Methods: We enrolled 113 patients (47.8±13.1 years, 50 men) undergoing MICS without preoperative anemia (hemoglobin >11 g/dL) between 2014 and 2017. Of these patients, 69 (the PABD group) donated autologous blood preoperatively and were compared to the non-PABD group (n=44). We analyzed the frequency of perioperative ABT and clinical outcomes. Results: Baseline characteristics did not significantly differ between groups, although preoperative hemoglobin levels were lower in the PABD group. All operations were performed using a minimally invasive approach. Patients' surgical profiles were similar. There were no cases of mortality or significant differences in early postoperative outcomes. During the early postoperative period, hemoglobin levels were higher in the PABD group. No significant difference was found in the frequency of ABT. Conclusion: Although the PABD group had higher postoperative hemoglobin levels, there was no clear clinical benefit in the early postoperative period, despite a great deal of effort and additional cost. Additional PABD in the setting of strict policies for blood conservation was ineffective in reducing ABT for young and relatively healthy patients who underwent MICS.