• 제목/요약/키워드: Clinical Trial Protocol

검색결과 124건 처리시간 0.03초

온침이 만성요통에 미치는 효과에 대한 무작위배정 대조군 예비 임상연구 프로토콜 (Clinical Research of Warm Needle Acupuncture for Chronic Low Back Pain: A Protocol for Randomized, Controlled Pilot Study)

  • 서연호;김태오;조휘성;고준혁;안종현;김수전;이한솔;장호경;김형석;김고운;조재흥;정원석;송미연
    • 한방재활의학과학회지
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    • 제30권4호
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    • pp.155-164
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    • 2020
  • Objectives This study is aimed to evaluate the feasibility of further clinical research of warm needle acupuncture as an effective and safe treatment for chronic low back pain. Methods Thirty participants will be randomly assigned to the Warm needle acupuncture group (n=15) and Dry needle acupuncture group (n=15). All patients will receive acupuncture therapy twice a week for 6 weeks, but only the experimental group will receive thermal stimulation. The primary outcome will be measured using the visual analogue scale for bothersomeness of low back pain, and the secondary outcome will be measured using the VAS for pain intensity, Oswestry disability index, 36-Item Short Form Health Survey, Beck's depression inventory, and amount of analgesics used. Conclusions The results of this study will be used to determine the feasibility of a future large-scale randomized controlled trial that provides clinical evidence for the efficacy and safety of warm needle acupuncture in the treatment of patients with chronic low back pain.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • 제22권2호
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜 (Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol)

  • 김종희;곽은빈;박소정;김동현;김수담;박지혜;유화승
    • 대한한의학방제학회지
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    • 제31권4호
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Importance of an Integrated Assessment of Functional Disability and Work Ability in Workers Affected by Low Back Pain

  • Fabrizio Russo;Cristina Di Tecco;Simone Russo;Giorgia Petrucci;Gianluca Vadala;Vincenzo Denaro;Sergio Iavicoli
    • Safety and Health at Work
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    • 제15권1호
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    • pp.66-72
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    • 2024
  • Background: This study examines the relationship between functional disability and work ability in workers affected by low back pain (LBP) through an analysis of correlations between the Oswestry Disability Index (ODI) and Work Ability Index (WAI). The role of personal and work factors on functional disability/work ability levels has also been studied. LBP is the most common musculoskeletal problem and a major disabling health problem worldwide. Its etiology is multifactorial. Multidisciplinary approaches may help reduce the burden of pain and disability and improve job continuity and reintegration at work. Methods: A cohort of 264 patients affected by LBP from an Italian outpatient clinic were included in a clinical diagnostic/therapeutic trial aiming at rehabilitation and return to work through an integrated investigation protocol. Data were collected during the first medical examination using anamnestic and clinical tools. The final sample is composed of 252 patients, 57.1% man, 44.0 % blue collars, 46.4% with the high school degree, 45.6% married. Results: WAI and ODI reported a negative and fair correlation (r = -0.454; p = .000). Workers with acute LBP symptoms have a higher probability of severe disability than those with chronic LBP symptoms. White collars without depressive symptoms reported higher work ability - even in chronic disability conditions-than those with depressive symptoms. Conclusion: The study found that ODI and WAI have a convergent validity and this suggests that the two tools measure capture distinctive aspects of disability related to personal, environmental, and occupational characteristics. The most important and modifiable prognostic factors found for ODI and WAI were depressive symptoms, workday absence, and intensity of back pain. The study also found a mild association between age and ODI. The study's findings highlight the importance of using a multidisciplinary approach to manage and prevent disability due to LBP.

제2형 당뇨병환자에서 임상영앙치료의 임상적 효과와 비용효과 연구 (The Clinical and Cost Effectiveness of Medical Nutrition Therapy for Patients with Type 2 Diabetes Mellitus)

  • 조영연;이문규;장학철;라미용;김지영;박영미;손정민
    • Journal of Nutrition and Health
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    • 제41권2호
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    • pp.147-155
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    • 2008
  • 우리나라의 경제적 발달과 문화 수준의 향상으로 질병 양상과 사망 원인에 많은 변화가 있는데, 그 중에서도 최근 당뇨병의 유병률의 상승 현상이 두드러지게 나타나고 있으며, 사망 원인의 수위를 차지하고 있다. 그러므로 이를 예방하고 당뇨병 합병증을 예방하기 위한 구체적이고 근거중심인 영양치료 방법의 제시가 절실한 실정이다. 미국영양사협회에서는 지속적으로 증가하는 당뇨병 유병율을 낮추기 위하여 생활습관의 개선을 목표로 임상영양치료의 표준화 지침을 제시하고 이에 따른 치료 효과 연구가 활발히 진행되고 있으나, 아직 국내에서는 많은 연구가 진행되고 있지 않은 현실이다. 따라서 본 연구에서는 이미 국외에서 사용되고 있는 지침에 근거하여 심층영양교육 방법을 실시하여 그 효과를 1회 교육만으로 시행되는 기본교육 방법과 비교하여 다음과 같으나 결과를 얻었다. 심층 및 기본영양교육 즉, 두 가지 교육 방법을 비교하였을 때 심층영양치료 방법을 실시한 경우 기본영양교육을 실시한 경우보다 혈당, 혈압 및 체중 강하 효과 면에서 유의적으로 개선효과가 있는 것으로 나타났다. 비용효과 면에서 장기간의 혈당변화 상태를 알 수 있는 당화혈색소의 경우 1%를 낮추기 위하여 소요되는 비용은 심층영양교육군에서 더 적었으며, 교육의 잠재 효과를 고려하였을 경우, 모든 혈당 검사 지표의 영양치료 비용 대비 효과 면에서 심층영양교육 방법이 기본영양교육 방법보다 앞서는 것으로 나타났다. 저비용 고치료 효과를 보여주고 있는 임상영양치료는 당노병과 같은 만성질환의 중요한 기본치료로 주목되고 있는 현 시점에서 영양치료행위의 의료 보험 급여화는 국민의 건강을 증진시키고, 국가적으로는 의료비 지출을 감소시키며 국민의 건강을 증진시키는데 큰 기여를 하는 합리적인 방안이라 생각된다. 따라서 현 비급여 수가로 되어 있는 교육수가를 급여화하여 많은 환자들에게 의료 혜택을 주는 일이 필요하리라 사료된다.

경항통에 관한 침구임상 진료지침 개발을 위한 전자우편 설문조사 (The E-mail Survey on the Neck Pain for Acupuncture and Moxibustion Clinical Guideline)

  • 김현욱;김성수;남동우;김은정;홍권의;김성철;김선웅;이재동;김갑성;이건목
    • Journal of Acupuncture Research
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    • 제26권3호
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    • pp.67-80
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    • 2009
  • Objectives : The purpose of this survey is the development on the neck pain for acupuncture and moxibustion clinical guideline. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results and Conclusions : 1. The first selected pattern identification on the neck pain This study shows that the meridian pattern identification was selected 35 times(61.4%), the pattern identification based on cause of disease was selected 8 times(14.0%), the visceral pattern identification was selected 7 times(12.3%), the other pattern identification was selected 4 times(7.0%), Qi blood yin yang pattern identification was selected 2 times(3.5%), according to symptoms was selected 1 time(2.4%). 2. Meridian pattern identification Small intestine meridian of hand Taeyang was used 39 times(18.1%), Large intestine meridian of hand Yangmyeong and Bladder meridian of foot Taeyang was used 34 times(15.7%), Gall-bladder meridian of foot Soyang was 32 times(14.8%), Tripple energizer meridian of hand Soyang was used 31 times(14.4%), Governor meridian was used 30 times(13.9%), Lung meridian of hand Taeeum was used 8 times(3.7%), Heart meridian of hand Soeum and Pericarduim meridian of hand Gworeum was used 4 times(1.9%). 3. Pattern identification based on cause of disease Wind-Cold-Dampness was used 31 times(17.5%), Accumulation of the collateral by Phelgm-Dampness was used 16 times(14.0%), affection by exopathogen Wind-Cold(stiff neck, sprain of cervical) was used 13 times (11.4%), Defecient-Cold was used 10 times(8.8%), affection by exopathogen Wind-Dampness was used 9 times(7.9%), Deep Invasion by Wind-Cold was used 8 times(7.0%), Wind-Cold was used 7 times (6.1%), Wind-Cold was used 6 times(5.3%), Accumulation in the Center by Phelgm-Dampness, Imparement of bou fluid by Pathogenic Heat, Wind-Heat with Dampness was used 5 times(4.4%), affection by exopathogen Wind-Dampness and Accumulation of the collateral by Wind-Cold was used 4 times(3.5%), Invasion of Dampness-Heat was used 2 times(1.8%). 4. Visceral pattern identification Rising of the Liver yang was used 16 times(41%), Yin deficiency of Liver and Kidney+pathogens was used 15 times(38.5%), Yin deficiency of Liver and Kidney was used 8 times(20.5%) on this survey.

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Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • 제36권1호
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon;Yun, Hyunjong;Choi, Jong Woo;Suh, Joong Min;Jeong, Woo Shik;Park, Hojin;Kang, Min Kyu;Shin, Yongho;Kim, Kuylhee;Chung, Chul Hoon
    • 대한두개안면성형외과학회지
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    • 제23권4호
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    • pp.152-162
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    • 2022
  • Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

Anesthetic efficacy of primary and supplemental buccal/lingual infiltration in patients with irreversible pulpitis in human mandibular molars: a systematic review and meta-analysis

  • Gupta, Alpa;Sahai, Aarushi;Aggarwal, Vivek;Mehta, Namrata;Abraham, Dax;Jala, Sucheta;Singh, Arundeep
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권4호
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    • pp.283-309
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    • 2021
  • Achieving profound anesthesia in mandibular molars with irreversible pulpitis is a tedious task. This review aimed at evaluating the success of buccal/lingual infiltrations administered with a primary inferior alveolar nerve block (IANB) injection or as a supplemental injection after the failure of the primary injection in symptomatic and asymptomatic patients with irreversible pulpitis in human mandibular molars. The review question was "What will be the success of primary and supplemental infiltration injection in the endodontic treatment of patients with irreversible pulpitis in human mandibular molars?" We searched electronic databases, including Pubmed, Scopus, and Ebsco host and we did a comprehensive manual search. The review protocol was framed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist. We included clinical studies that evaluated and compared the anesthetic outcomes of primary IANB with primary and/or supplementary infiltration injections. Standard evaluation of the included studies was performed and suitable data and inferences were assessed. Twenty-six studies were included, of which 13 were selected for the meta-analysis. In the forest plot representation of the studies evaluating infiltrations, the combined risk ratio (RR) was 1.88 (95% CI: 1.49, 2.37), in favor of the secondary infiltrations with a statistical heterogeneity of 77%. The forest plot analysis for studies comparing primary IANB + infiltration versus primary IANB alone showed a low heterogeneity (0%). The included studies had similar RRs and the combined RR was 1.84 (95% CI: 1.44, 2.34). These findings suggest that supplemental infiltrations given along with a primary IANB provide a better success rate. L'Abbe plots were generated to measure the statistical heterogeneity among the studies. Trial sequential analysis suggested that the number of patients included in the analysis was adequate. Based on the qualitative and quantitative analyses, we concluded that the infiltration technique, either as a primary injection or as a supplementary injection, given after the failure of primary IANB, increases the overall anesthetic efficacy.

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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    • 제27권2호
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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)