• Title/Summary/Keyword: Prospective clinical evaluation

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Research Design for the Verification of Constitutional Prescription Determinants (체질처방 결정요인 확인을 위한 연구설계)

  • Jin, Hee-Jeong;Kim, Sang-Hyuk;Baek, Young-Hwa;Jang, Eun-Su;Ryu, Jong-Hyang;Lee, Si-Woo
    • Journal of Sasang Constitutional Medicine
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    • v.27 no.2
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    • pp.222-230
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    • 2015
  • Objectives The purpose of this study is to design a research to find clinical factors involved in the decision-making process for determining the constitutional prescription based on prospective clinical data. Methods We have created a draft of the case report form. Therefore, seven constitutional experts was interviewed for additional items to be important used to determine the constitutional prescription in clinic. Interviews were done from December 2012 to March 2014, experts per person 2-3 times, took time of about 120 minutes per interview. Since then, we developed the final case report form through the expert meeting. At the same time, the developing the electronic case report form (eCRF) and the protocol to collect constitutional treatment cases was also discussed. Results & Conclusions The items of the case report form were subject general, lifestyle, health measurement, record of expert, prescription and evaluation after medication. The part of the clinical symptoms of the record of expert allowed to be recorded in the 5-point scale for the collection of quantitative data as much as possible. Assuming a re-visit of the patient, if necessary, twice the recording were to be possible. At the same time, the eCRF and the protocol to collect constitutional treatment cases were also developed. In this study, it will be able to more objectively standardize the medical decision making process that the experts of constitutional prescription decision. As a result, it will be possible to provide the standardized constitutional medical services.

Scolopendra Pharmacopuncture Combined with Electroacupuncture for the Treatment of Ganglion Cysts: A Retrospective Study

  • Choe, Seon;Jerng, Ui Min;Park, Jeong Hwan;Kim, Sungha;Kim, Sungchul;Lee, Jinbok;Lee, Jun-Hwan;Shin, Minseop
    • Journal of Pharmacopuncture
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    • v.23 no.4
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    • pp.247-251
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    • 2020
  • Objectives: Ganglion cysts require a sustainable treatment that suppresses their frequent recurrence. This study aimed to explore the clinical effects of Scolopendra pharmacopuncture (SP) and electroacupuncture on ganglion cysts. Methods: We retrospectively reviewed the patient records and follow-up reports for 20 patients with wrist ganglion cysts who received SP and electroacupuncture from April 2016 to March 2017. The cyst diameter, recurrence, visual analog scale (VAS) scores for pain, the Korean version of the disabilities of arm, shoulder, and hand (K-DASH) score, and the Korean version of the patient-rated wrist evaluation (K-PRWE) score before and after treatment were noted. Results: After treatment, the cyst diameter decreased significantly from 13.61 ± 6.41 mm to 5.15 ± 6.18 mm (p < 0.001), and VAS score for pain decreased from 1.31 ± 1.77 to 0.41 ± 0.33 (p = 0.021). Further, the K-DASH score decreased significantly from 8.97 ± 12.66 to 2.21 ± 7.39 (p = 0.016), and score for the function subscale of K-PRWE decreased from 11.37 ± 4.48 to 9.1 ± 3.67 (p = 0.046). No recurrences were reported from the followed-up patients. Any complication related to SP or electroacupuncture was not observed, except mild rash, itching, and swelling at the injection site in four patients. Conclusion: Combination of SP and electroacupuncture may be effective in treating ganglion cysts; further prospective studies with large population are needed to clarify the effect of SP and electroacupuncture.

Prospective evaluation of the clinical utility of whole-exome sequencing using buccal swabbing for undiagnosed rare diseases

  • Chong Kun Cheon;Yong Beom Shin;Soo-Yeon Kim;Go Hun Seo;Hane Lee;Changwon Keum;Seung Hwan Oh
    • Journal of Genetic Medicine
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    • v.19 no.2
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    • pp.76-84
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    • 2022
  • Purpose: Whole-exome sequencing (WES) has been a useful tool for novel gene discovery of various disease categories, further increasing the diagnostic yield. This study aimed to investigate the clinical utility of WES prospectively in undiagnosed genetic diseases. Materials and Methods: WES tests were performed on 110 patients (age range, 0-28 years) with suspected rare genetic diseases. WES tests were performed at a single reference laboratory and the variants reported were reviewed by clinical geneticists, pediatricians, neurologists, and laboratory physicians. Results: The patients' symptoms varied with abnormalities in the head or neck, including facial dysmorphism, being the most common, identified in 85.4% of patients, followed by abnormalities in the nervous system (83.6%). The average number of systems manifesting phenotypic abnormalities per patient was 3.9±1.7. The age at presentation was 2.1±2.7 years old (range, 0-15 years), and the age at WES testing was 6.7±5.3 years (range, 0-28 years). In total, WES test reported 100 pathogenic/likely pathogenic variants or variants of uncertain significance for 79 out of 110 probands (71.8%). Of the 79 patients with positive or inconclusive calls, 55 (50.0%) patients were determined to have good genotype-phenotype correlations after careful review. Further clinical reassessment and family member testing determined 45 (40.9%) patients to have been identified with a molecular diagnosis. Conclusion: This study showed a 40.9% diagnostic yield for WES test for a heterogeneous patient cohort with suspected rare genetic diseases. WES could be the feasible genetic test modality to overcome the diversity and complexity of rare disease diagnostics.

Clinical Utility of Chest Sonography in Chronic Obstructive Pulmonary Disease Patients Focusing on Diaphragmatic Measurements

  • Hend M. Esmaeel;Kamal A. Atta;Safiya Khalaf;Doaa Gadallah
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.1
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    • pp.80-90
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    • 2024
  • Background: There are many methods of evaluating diaphragmatic function, including trans-diaphragmatic pressure measurements, which are considered the key rule of diagnosis. We studied the clinical usefulness of chest ultrasonography in evaluating stable chronic obstructive pulmonary disease (COPD) patients and those in exacerbation, focusing on diaphragmatic measurements and their correlation with spirometry and other clinical parameters. Methods: In a prospective case-control study, we enrolled 100 COPD patients divided into 40 stable COPD patients and 60 patients with exacerbation. The analysis included 20 age-matched controls. In addition to the clinical assessment of the study population, radiological evaluation included chest radiographs and chest computed tomography. Transthoracic ultrasonography (TUS) was performed for all included subjects. Results: Multiple A lines (more than 3) were more frequent in COPD exacerbation than in stable patients, as was the case for B-lines. TUS significantly showed high specificity, negative predictive value, positive predictive value, and accuracy in detecting pleural effusion, consolidation, pneumothorax, and lung mass. Diaphragmatic measurements were significantly lower among stable COPD subjects than healthy controls. Diaphragmatic thickness and excursion displayed a significant negative correlation with body mass index and the dyspnea scale, and a positive correlation with spirometry measures. Patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) group D showed lower diaphragmatic measurements (thickness and excursion). Conclusion: The TUS of COPD patients both in stable and exacerbated conditions and the assessment of diaphragm excursion and thickness by TUS in COPD patients and their correlations to disease-related factors proved informative and paved the way for the better management of COPD patients.

Evaluation of prolonged pain in preterm infants with pneumothorax using heart rate variability analysis and EDIN (Échelle Douleur Inconfort Nouveau-Né, neonatal pain and discomfort scale) scores

  • Buyuktiryaki, Mehmet;Uras, Nurdan;Okur, Nilufer;Oncel, Mehmet Yekta;Simsek, Gulsum Kadioglu;Isik, Sehribanu Ozluer;Oguz, Serife Suna
    • Clinical and Experimental Pediatrics
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    • v.61 no.10
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    • pp.322-326
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    • 2018
  • Purpose: The EDIN scale (${\acute{E}}chelle$ Douleur Inconfort Nouveau-$N{\acute{e}}$, neonatal pain and discomfort scale) and heart rate variability has been used for the evaluation of prolonged pain. The aim of our study was to assess the value of the newborn infant parasympathetic evaluation (NIPE) index and EDIN scale for the evaluation of prolonged pain in preterm infants with chest tube placement due to pneumothorax. Methods: This prospective observational study assessed prolonged pain in preterm infants with a gestational age between 33 and 35 weeks undergoing installation of chest tubes. Prolonged pain was assessed using the EDIN scale and NIPE index. Results: There was a significant correlation between the EDIN scale and NIPE index (r=-0.590, P=0.003). Prolonged pain is significantly more severe in the first 6 hours following chest tube installation (NIPE index: 60 [50-86] vs. 68 [45-89], P<0.002; EDIN score: 8 [7-11] vs. 6 [4-8], P<0.001). Conclusion: Prolonged pain can be accurately assessed with the EDIN scale and NIPE index. However, evaluation with the EDIN scale is time-consuming. The NIPE index can provide instantaneous assessment of prolonged and continuous pain.

Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children

  • Nunna, Mahesh;Dasaraju, Rupak Kumar;Kamatham, Rekhalakshmi;Mallineni, Sreekanth Kumar;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.19 no.5
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    • pp.277-288
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    • 2019
  • Background: This study evaluated the efficacy of virtual reality (VR) distraction and counter-stimulation (CS) on dental anxiety and pain perception to local anesthesia in children. Methods: A prospective, randomized, single-blinded interventional clinical trial with a parallel design was used. Seventy children 7-11 years old who required local anesthesia (LA) for pulp therapy or tooth extraction were recruited and allocated to two groups with equal distribution based on the intervention. Group CS (n = 35) received CS and Group VR (n = 35) received VR distraction with ANTVR glasses. Anxiety levels (using pulse rate) were evaluated before, during, and after administration of local anesthesia, while pain perception was assessed immediately after the injection. Wong-Baker faces pain-rating scale (WBFPS), visual analog scale (VAS), and Venham's clinical anxiety rating scale (VCARS) were used for pain evaluation. Student's t-test was used to test the mean difference between groups, and repeated measures ANOVA was used to test the mean difference of pulse rates. Results: Significant differences in mean pulse rates were observed in both groups, while children in the VR group had a higher reduction (P < 0.05), and the mean VCARS scores were significant in the VR group (P < 0.05). Mean WBFPS scores showed less pain perception to LA needle prick in the CS group while the same change was observed in the VR group with VAS scores. Conclusions: VR distraction is better than CS for reducing anxiety to injection in children undergoing extraction and pulpectomy.

Are steroids required in the treatment of ganglion impar blockade in chronic coccydynia? a prospective double-blinded clinical trial

  • Sencan, Savas;Edipoglu, Ipek Saadet;Demir, Fatma Gul Ulku;Yolcu, Gunay;Gunduz, Osman Hakan
    • The Korean Journal of Pain
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    • v.32 no.4
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    • pp.301-306
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    • 2019
  • Background: Ganglion impar blockade is a reliable and effective treatment option used in patients with coccydynia. Our primary objective was to specify the role of corticosteroids in impar blockade. We compared applications of local anesthetic with the local anesthetic + corticosteroid combination in terms of treatment efficiency in patients with chronic coccydynia. Methods: Our study was a prospective randomize double-blind study. The patients were divided into 2 groups after randomization. The first group (group SL) was made up of patients where a corticosteroid + local anesthetic were used during ganglion impar blockade. In the second group (group L) we used only local anesthetic. We evaluated numeric rating scale (NRS) and Beck depression scale, which were employed before the procedure and in 1st and 3rd months after the procedure. Results: Seventy-three patients were included in the final analysis. We detected a significantly greater decrease in NRS values in the 1st month in group SL than in group L (P = 0.001). In the same way, NRS values in the 3rd month were significantly lower in the group with steroids (P = 0.0001). During the evaluation of the Beck test, we detected significantly greater decreases in the 1st month (P = 0.017) and 3rd month (P = 0.021) in the SL group than in the L group. Conclusions: Ganglion impar blockade decreases pain in the treatment of chronic coccydynia and improve depression. Addition of steroids in a ganglion impar blockade is required for treatment response that should accumulate over a long period of time.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool;Yoon, Hong Man;Min, Jae Seok;Cho, In;Park, Ji-Ho;Jung, Mi Ran;Hur, Hoon;Kim, Young-Woo;Park, Young Kyu;Nam, Byung-Ho;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.157-164
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    • 2019
  • Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Influence of the root canal filling technique on the success rate of primary endodontic treatments: a systematic review

  • Daniel Feijolo Marconi ;Giovana Siocheta da Silva ;Theodoro Weissheimer;Isadora Ames Silva ;Gabriel Barcelos So;Leonardo Thomasi Jahnke ;Jovito Adiel Skupien ; Marcus Vinicius Reis So ; Ricardo Abreu da Rosa
    • Restorative Dentistry and Endodontics
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    • v.47 no.4
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    • pp.40.1-40.18
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    • 2022
  • Objectives: This study aimed to investigate the influence of different obturation techniques compared to cold lateral compaction on the success rate of primary non-surgical endodontic treatments. Materials and Methods: Systematic searches were performed for studies published up to May 17th, 2022 in MEDLINE/PubMed, Cochrane Library, Web of Science, Scopus, EMBASE, and Grey Literature Reports. Randomized clinical trials and nonrandomized (nonrandomized clinical trials, prospective or retrospective) studies that evaluated the success rate of primary non-surgical endodontic treatments obturated with the cold lateral compaction (control) and other obturation techniques were included. The revised Cochrane risk of bias tools for randomized trials (RoB 2) and nonrandomized studies of interventions (ROBINS-I) were used to evaluate the risk of bias. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool was used to evaluate the certainty of evidence. Results: Eleven studies (4 randomized clinical trials (RCTs), 4 prospective, and 3 retrospectives) were included. Two RCTs were classified as having some concerns risk of bias and 2 as a low risk of bias. Two nonrandomized studies were classified as having a critical risk of bias and 5 as having a moderate risk of bias. The GRADE analysis demonstrated a very low to moderate certainty of evidence. Conclusions: This systematic review generally evidenced no differences in the success rate of primary non-surgical endodontic treatments when the cold lateral compaction technique and other obturation techniques are performed. Further well-designed studies are still necessary.

Effect and Safety of a Commercial diet-food(Pulmuone $Diet^{(R)}$) in normal health obese females (건강 비만성인에 있어서의 시판 다이어트 제품의 다이어트효과와 안전성에 대한 연구)

  • Shin, Hyun-Taek;Kweon, Hyuk-Myung;Kim, Soo-Bin;Kwang, Sin-Uk;Yu, Ik-Hyun
    • Korean Journal of Clinical Pharmacy
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    • v.5 no.2
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    • pp.51-60
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    • 1995
  • Obesity is defined as excessive storage of energy in the form of fat resulting in adverse effect on healthy and longevity. Some data have shown increased incidence of hypertension, diabetes, hypercholesterolemia in overweight individuals and other disorders such as joint disease, cancer have been also associated with obesity. Recently, various commercial diet programs have been introduced for weight reduction without scientific evaluation for clinical effect and safety. The diet program must be based on a sound and scientific rationale and also be safe and nutritionally adequate. Pulmuone $diet^{(R)}$ is a calorie-restricted commercial diet-food, which contains adequate nutritients. The efficacy and safety of Pulmuone diet were evaluated in 28 normal healthy obese females in a prospective study. Each volunteer was placed in 3-week diet program. To observe weight reduction effect, body weight, TSF and AMC were measured every week. To account for safety of this program, blood chemistry test, blood pressure and side effects were monitored every week. Mean body weight was reduced by 3.24kg following diet program, which is statistically significant(P < 0.05) and this weight reduction was related to reduction in fat weight and not muscle weight as shown by the results of TSF and AMC Blood chemistry was not influenced by this program, but blood pressure was significantly reduced following this program. Thought diet program was generally well tolerated in most volunteers, the most frequent side effects are constipation, dizzness and headache. In conclusion, Pulmuone $diet^{(R)}$ program seems to be safe and effective for weight reduction in normal healthy obese females.

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