• Title/Summary/Keyword: Multicenter Trials

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Analysis on Research Trend of Studies Related with Scutellariae Radix in Korea (황금(黃芩)에 관한 국내 연구 동향에 관한 소고)

  • Kim, Kang-San;Kim, Lae-Hee;Rhee, Yun-Jin;Lee, Su-Hyoun;Choi, Ji-Hye;Ko, Ha-Neul
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.6
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    • pp.1095-1101
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    • 2011
  • Scutellariae Radix has been used as a traditional medicine for anti-oxidant, anti-inflammatory, anti-allergic function. But most study methods were restricted to in vitro and in vivo. Therefore to perform for clinical trials further for a new natural drug development is necessary and this study will be used as a basis for it. The studies selected from domestic academic database included the following key words; '황금', '黃芩', 'skullcap', 'Scutellariae Radix', 'scutellaria baicalensis' and considered were those published from 1990 to July, 2011. All 1080 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts. and 298 studies were finally selected as subjects for this study. 243 studies among 293 studies were published between 2000 to 2011. Classification was proceeded according to study subjects as followed; anti-Inflammatory effect and antiallergic and antihistamin effect(66), antibacterial and antivirus effect(61), antioxidant effect(51), neuronal cell apoptosis and neuronal cell protective effect(22), liver cell protective effect(20). According to method type of study, 194 studies practicing in vitro, 60 studies practicing in vivo, 37 studies practicing in both. and 5 studies on documentary records. Most study methods were restricted in vitro and in vivo. For developmenting of function of anti-inflammatory effect and antiallergic, antihistamin effect & atopic dermatitis effect, antibacterial and antivirus effect, antioxidant effect, case report on various fields and multicenter clinical trials is necessary.

Recruitment for Phase I of the Trials of Hypertension Prevention

  • Satterfield Suzanne;Borhani Nemat O.;Whelton Paul;Goodwin Laretha;Brinkmann Connie;Charleston Jeanne;Corkery Beth Walker;Dolan Lee;Hataway Heidi;Hertert Stephanie;Lakatos Ed;Milas N. Carole;Morris Martha Clare
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.313-319
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    • 1994
  • Phase I of the Trials of Hypertension Prevention was a multicenter, randomized, controlled trial designed to determine the efficacy of seven nonpharmacologic interventions in reducing blood pressure among persons with high-normal diastolic blood pressure. the initial goal for recruitment was to enroll 2,100 participants over a nine-month period. The yield from the first screening visit to randomization was 13% overall, with clinic-specific yields ranging from 4.5% to 31.7%. After five months of recruitment, approximately 60% of the goal for that point in the recruitment timetable had been randomized. Clinical centers falling short of their goals at that time altered their recruitment strategies and intensified their efforts, and centers that had exceeded their goals recruited additional participants. As a result, 2,182 participants, or 104\% of the goal for recruitment, were randomized over a 13-month period. Those clinics using a cohort, or wave, type of enrollment were most successful in achieving their recruitment goals within the prescribed timetable.

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Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.703-714
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    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

A randomized, double-dummy, multicenter non-inferiority clinical trials to evaluate the efficacy and the safety of SKI 306X compared to diclofenac in patients with osteoarthritis of the knee (양측 눈가림, 무작위배정, 다기관공동 제 3상 임상시험 결과 - 퇴행성 관절염에 대한 SKI 306X정과 Diclofenac과의 비열등성 임상시험)

  • Jung Y.B.;Seong S.C.;Lee M.C.;Shin Y.U.;Kim D.H.;Kim J.M.;Jung Y.K.;Ahn J.H.;Seo J.G.;Park Y.S.;Lee C.S.;Roh K.J.;Han C.K.
    • 대한임상약리학회:학술대회논문집
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    • 2001.12a
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    • pp.24-25
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    • 2001
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Philadelphia chromosome-positive acute lympho-blastic leukemia in childhood

  • Koo, Hong-Hoe
    • Clinical and Experimental Pediatrics
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    • v.54 no.3
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    • pp.106-110
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    • 2011
  • In pediatric patients with acute lymphoblastic leukemia (ALL), the Philadelphia chromosome translocation is uncommon, with a frequency of less than 5%. However, it is classified as a high or very high risk, and only 20-30% of Philadelphia chromosome-positive (Ph+) children with ALL are cured with chemotherapy alone. Allogeneic hematopoietic stem cell transplantation from a closely matched donor cures 60% of patients in first complete remission. Recent data suggest that chemotherapy plus tyrosine kinase inhibitors (TKIs) may be the initial treatment of choice for Ph+ ALL in children. However, longer observation is required to determine whether long-term outcome with intensive imatinib and chemotherapy is indeed equivalent to that with allogeneic related or alternative donor hematopoietic stem cell transplantation (HSCT). Reports on the use of second-generation TKIs in children with Ph+ ALL are limited. A few case reports have indicated the feasibility and clinical benefit of using dasatinib as salvage therapy enabling HSCT. However, more extensive data from clinical trials are needed to determine whether the administration of second-generation TKIs in children is comparable to that in adults. Because Ph+ ALL is rare in children, the question of whether HSCT could be a dispensable part of their therapy may not be answered for some time. An international multicenter study is needed to answer the question of whether imatinib plus chemotherapy could replace sibling allogeneic HSCT in children with Ph+ ALL.

As how artificial intelligence is revolutionizing endoscopy

  • Jean-Francois Rey
    • Clinical Endoscopy
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    • v.57 no.3
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    • pp.302-308
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    • 2024
  • With incessant advances in information technology and its implications in all domains of our lives, artificial intelligence (AI) has emerged as a requirement for improved machine performance. This brings forth the query of how this can benefit endoscopists and improve both diagnostic and therapeutic endoscopy in each part of the gastrointestinal tract. Additionally, it also raises the question of the recent benefits and clinical usefulness of this new technology in daily endoscopic practice. There are two main categories of AI systems: computer-assisted detection (CADe) for lesion detection and computer-assisted diagnosis (CADx) for optical biopsy and lesion characterization. Quality assurance is the next step in the complete monitoring of high-quality colonoscopies. In all cases, computer-aided endoscopy is used, as the overall results rely on the physician. Video capsule endoscopy is a unique example in which a computer operates a device, stores multiple images, and performs an accurate diagnosis. While there are many expectations, we need to standardize and assess various software packages. It is important for healthcare providers to support this new development and make its use an obligation in daily clinical practice. In summary, AI represents a breakthrough in digestive endoscopy. Screening for gastric and colonic cancer detection should be improved, particularly outside expert centers. Prospective and multicenter trials are mandatory before introducing new software into clinical practice.

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • v.27 no.2
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

Treatment of refractory IgA vasculitis with dapsone: a systematic review

  • Lee, Keum Hwa;Hong, Sung Hwi;Jun, Jinhae;Jo, Youngheun;Jo, Woogyeong;Choi, Dayeon;Joo, Jeongho;Jung, Guhyun;Ahn, Sunghee;Kronbichler, Andreas;Eisenhut, Michael;Shin, Jae Il
    • Clinical and Experimental Pediatrics
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    • v.63 no.5
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    • pp.158-163
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    • 2020
  • IgA vasculitis, formerly known as Henoch-Schönlein purpura, is a systemic IgA-mediated vasculitis of the small vessels commonly seen in children. The natural history of IgA vasculitis is generally self-limiting; however, one-third of patients experience symptom recurrence and a refractory course. This systematic review examined the use of dapsone in refractory IgA vasculitis cases. A literature search of PubMed databases retrieved 13 articles published until June 14, 2018. The most common clinical feature was a palpable rash (100% of patients), followed by joint pain (69.2%). Treatment response within 1-2 days was observed in 6 of 26 patients (23.1%) versus within 3-7 days in 17 patients (65.4%). Relapse after treatment discontinuation was reported in 17 patients (65.4%) but not in 3 patients (11.5 %). Four of the 26 patients (15.4%) reported adverse effects of dapsone including arthralgia (7.7%), rash (7.7%), and dapsone hypersensitivity syndrome (3.8%). Our findings suggest that dapsone may affect refractory IgA vasculitis. Multicenter randomized placebo-controlled trials are necessary to determine the standard dosage of dapsone at initial or tapering of treatment in IgA vasculitis patients and evaluate whether dapsone has a significant benefit versus steroids or other medications.

Preliminary Experience of Neuroform Atlas Stenting as a Rescue Treatment after Failure of Mechanical Thrombectomy Caused by Residual Intracranial Atherosclerotic Stenosis

  • Yi, Ho Jun;Sung, Jae Hoon;Lee, Dong Hoon
    • Journal of Korean Neurosurgical Society
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    • v.64 no.2
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    • pp.198-206
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    • 2021
  • Objective : The low-profile Neuroform Atlas stent can be deployed directly without an exchange maneuver by navigating into the Gateway balloon. This retrospective study assessed the safety and efficacy of Neuroform Atlas stenting as a rescue treatment after failure of mechanical thrombetomy (MT) for large artery occlusion. Methods : Between June 2018 and December 2019, a total of 31 patients underwent Neuroform Atlas stenting with prior Gateway balloon angioplasty after failure of conventional MT caused by residual intracranial atherosclerotic stenosis (ICAS). Primary outcomes were successful recanalization and patency of the vessel 24 hours after intervention. Secondary outcomes were vessel patency after 14 days and 3-month modified Rankin Scale. Peri-procedural complications, intracerebral hemorrhage (ICH), and 3-month mortality were reviewed. Results : With a 100% of successful recanalization, median value of stenosis was reduced from 79.0% to 23.5%. Twenty-eight patients (90.3%) showed tolerable vessel patency after 14 days. New infarctions occurred in three patients (9.7%) over a period of 14 days; two patient (6.5%) underwent stent occlusion at 24 hours, and the other patient (3.2%) with delayed stent occlusion had a non-symptomatic dot infarct. There were no peri-procedural complications. Two patients (6.5%) developed an ICH immediately after the procedure with one of them is symptomatic. Conclusion : Neuroform Atlas stenting seems to be an effective and safe rescue treatment modality for failed MT with residual ICAS, by its high successful recanalization rate with tolerable patency, and low peri-procedural complication rate. Further multicenter and randomized controlled trials are needed to confirm our findings.

Diffusion-Weighted Imaging as a Stand-Alone Breast Imaging Modality (독립적 검사 방법으로서의 확산강조 자기공명영상검사)

  • Hee Jung Shin;Su Hyun Lee;Woo Kyung Moon
    • Journal of the Korean Society of Radiology
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    • v.82 no.1
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    • pp.29-48
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    • 2021
  • Diffusion-weighted magnetic resonance imaging (DW MRI) is a fast unenhanced technique that shows promise as a stand-alone modality for cancer screening and characterization. Currently, DW MRI may have lower sensitivity than that of dynamic contrast-enhanced MRI as a standalone modality for breast cancer detection but superior to that of mammography, which may provide a useful alternative for supplemental screening. Standardized acquisition and interpretation of DW MRI can improve the image quality and reduce the variability of the results. Furthermore, high-resolution DW MRI, with advanced techniques and postprocessing, will facilitate better detection and characterization of subcentimeter cancers and reduce false-negatives and false-positives. Future results from ongoing prospective multicenter clinical trials using standardized and optimized protocols will facilitate the use of DW MRI as a stand-alone modality.