• Title/Summary/Keyword: preliminary clinical trial

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Preliminary Study to Develop the Instrument of Oriental Medical Evaluation for Lung Cancer (폐암 한의 평가도구 개발 기초 연구)

  • Park, So Jung;Kim, Seon Young;Cho, Chong Kwan;Jung, In Chul;Yoo, Hwa Seong
    • The Journal of Korean Medicine
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    • v.36 no.3
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    • pp.53-64
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    • 2015
  • Objectives: The aim of study was to develop a standard instrument of oriental medical evaluation lung cancer. Methods: For this study, the committee advisor was organized by 10 Korean Medicine professors of the Korean Association of Traditional Oncology. The items and structure of the instrument were quoted from the instrument of pattern identification for lung cancer. We had a consultation with the committee twice and took additional advice from it via E-mail. Results: According to the research, we determined the Korean oriental medical assessment tool for lung cancer comprised of the 6 types of patterns of syndrome differentiation. The advisor committee gave the answers about discrimination between bian-zheng and su-zheng, mean weight of each symptom and sign. The final weight was calculated from the combination of the ratio of bian-zheng and mean weight. Conclusions: The instrument of oriental medical evaluation for lung cancer was developed through experts' discussion. If the validity and the reliability of this instrument are validated through additional clinical trial, the instrument of oriental medical evaluation for lung cancer is expected to be applied to the later research.

Surgical Outcomes of Single-port Laparoscopic Appendectomy versus Conventional Laparoscopic Appendectomy in Children: Preliminary Report of a Prospective Randomized Trial (소아에서 단일공과 삼공 복강경 충수절제술의 수술 후 결과 비교: 전향적 무작위 연구 예비 결과)

  • Cho, Jung Rae;Kang, Won Me;Ahn, Soo Min
    • Advances in pediatric surgery
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    • v.20 no.2
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    • pp.48-52
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    • 2014
  • Purpose: Currently the substantial clinical benefits of single-port laparoscopic appendectomy (SLA) over conventional three-port laparoscopic appendectomy (CLA) are equivocal. The aim of this study was to compare surgical outcomes between SLA and CLA in children with acute appendicitis. Methods: A single blind prospective randomized single center study was performed to compare the surgical outcomes of SLA and CLA. A total of 105 patients were randomized and various parameters were analyzed, 52 patients with SLA and 53 patients with CLA between July 2013 and March 2014. Patients with sonographically confirmed acute appendicitis were randomly assigned to receive either SLA or CLA. The outcome measurements were operating time, wound complication, and intraperitoneal morbidities, postoperative pain score and cosmetic result score. Results: Operating time is significantly longer in SLA ($70.4{\pm}26.7$ minutes vs. $58.0{\pm}23.4$ minutes; p=0.016). There were no significant differences in the postoperative wound complication rate and intraperitoneal morbidities between two groups. There were no significant differences in postoperative resting pain score ($6.6{\pm}2.5$ vs. $6.3{\pm}2.5$; p=0.317) and activity pain score ($6.9{\pm}2.4$ vs. $6.3{\pm}2.5$; p=0.189), and the cosmetic result score ($9.2{\pm}1.1$ vs. $9.1{\pm}1.4$; p=0.853). Conclusion: Although SLA would be a safe and feasible procedure in children, SLA could not demonstrate the clear benefit over CLA.

Utilization and Isolation of new active substances from Sericulture Related MaterialsII. Development of an oral antihyperglycemic agent from silkworm powder

  • Ryu, Kang-Sun;Lee, Heui-Sam;Choue, Ryo-Won;Chung, Sung-Hyun
    • Proceedings of the Korean Society of Sericultural Science Conference
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    • 1997.06a
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    • pp.133-158
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    • 1997
  • Since 1992, Sericulture & Entomology Research Institute(NSERI) and Kyung Hee University group screened an activity of lowering blood-glucose levels with silkworm related materials such as silkworm larvae powder, dried feces, pupae and silkworm moth in other to guide laymans to rational and educated utilization of silkworm-related materials for the treatment of diabetes mellitus. In experiments examining several silkworms in different stages and prepared in different conditions, a freeze dried silkworm powder of 5th instar 3rd day showed a higher glucose lowering activity about 20% than heat dried matured silkworm powder. Among the three dosage of 500mg, 830mg and 1,160mg in ate preliminary clinical trial, the 830mg exhibited a significant effect on postprandial blood glucose level and did and did not cause any hypoglycemic side effect. In the blood glucose lowering activity of mulberry and silkworm varieties, the Yongcheonppong and Samkwangjam showed the highest activity for lowering blood glucose levels. In experiments to see the difference in blood-glucose lowering activity between either male and female or larvae and pupae, activity of larvae was higher than that of pupae and the male was higher than female. The heating dry and artificial diet showed lower than mulberry diet and normal freeze dry of the 5th instar 3rd day. Among the sericultural products, larvae showed the highest activity. We find out the fact that effect of silkworm powder attributed to the inhibition of ${\alpha}$-glucohydrolase catalyzed reaction in the small intestine.

The Effect of Voice Therapy for the Treatment of Functional Aphonia: A Preliminary Study (기능적 실성증에 대한 음성치료의 효과 분석: 기초 연구)

  • Kim, No Eul;Kim, Jun Seok;Oh, Jae Hwan;Kim, Dong Young;Woo, Joo Hyun
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.32 no.2
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    • pp.75-80
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    • 2021
  • Background and Objectives Functional aphonia refers to in which by presenting whispering voice and almost producing very high-pitched tensed voices are produced. Voice therapy is the most effective treatment, but there is a lack of consensus for application of voice therapy. The purpose of this study was to examine the vocal characteristics of functional aphonia and the effect of voice therapy applied accordingly. Materials and Method From October 2019 to December 2020, 11 patients with functional aphonia were treated using voice therapy which was processing three stages such as vocal hygiene, trial therapy, and behavioral therapy. Of these, 7 patients who completed the voice evaluation before and after voice therapy was enrolled in this study. By retrospective chart review, clinical information such as sex, age, symptoms, duration, social and medical history, process of voice therapy, subjective and objective findings were analyzed. Voice parameters before and after voice therapy were compared. Results In GRBAS study, grade, rough, and asthenic, and in Consensus Auditory-Perceptual Evaluation of Voice, overall severity, roughness, pitch, and loudness were significantly improved after voice therapy. In Voice handicap index, all of the scores of total and sub-categories were significantly decreased. In objective voice analysis, jitter, cepstral peak prominence, and maximum phonation time were significantly improved. Conclusion The voice therapy was effective for the treatment of functional aphonia by restoring patient's vocalization and improving voice quality, pitch and loudness.

Prospective Randomized Trial for Postoperative Adjuvant Chemotherapy in Gastric Cancer Patients without Serosal Invasion -Preliminary Report- (장막 침윤이 없는 위암 환자에서 수술 후 보조적 화학 요법에 대한 전향적 연구 -중간 보고-)

  • Kim Yong-Ho;Kim Byung-Sik;Lee Chang-Hwan;Kim Wan Su;Yook Jung-Whan;Oh Sung-Tae;Park Kun-Choon
    • Journal of Gastric Cancer
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    • v.1 no.4
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    • pp.221-227
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    • 2001
  • Purpose: We have carried out prospective randomized clinical trial to compare survival benefit and side effect among three postoperative adjuvant chemotherapeutic regimens in serosa-negative gastric cancer patients. Materials and Methods: Total 317 cases were recognized as serosa negative and randomized into three groups at operating room. Out of them, 172 cases were excluded because of various reasons and 135 cases were analyzed finally; Group A 36 cases, Group B 49 cases, Group C 50 cases. Group A were treated with intravenous FP combination therapy, group B with MF combination therapy and group C with oral $UFT^{(R)}$ (mixture of Tegafur and Uracil) for one year. The median follow-up period was 30 months. Results: $88.9\%$ of Group A, $83.7\%$ of Group B and $90.4\%$ of Group C received adequate chemotherapy. The complication rates of Group A ($44.4\%$) was significantly higher than group B ($20.4\%$) and group C ($24.0\%$)(P<0.05). Most frequent complications were nausea and vomiting. The 3-year survival rates and disease-free survival rates were $92.2\%$ and $89.9\%$ respectively (Group A: $96.6\%,\;87.8\%$, B: $90.3\%,\;87.7\%$, C: $95.7\%,\;93.8\%$). There were no significant differences in survival rate and disease-free survival rate among the three groups (P>0.05). Conclusion: This study might suggest that the survival benefit of postoperative adjuvant chemotherapy for gastric Pseudomonas aeruginosa, and therefore it may be a useful adjunct tool for detection of Pseudomonas aeruginosa infection in combination with other conventional techniques.

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A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5957-5961
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    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

An Analysis of Emotional and Cognitive Factors on Acupuncture (침에 대한 정서와 인지요소 분석)

  • Chae, Youn-Byoung;Park, Hi-Joon;Kang, O-Seok;Lee, Jeong-Chan;Park, Kyung-Mo;Lee, Hye-Jung
    • Journal of Acupuncture Research
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    • v.24 no.3
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    • pp.215-229
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    • 2007
  • Objectives : Placebo phenomena have been considered as a confounding factor of clinical trial. Expectancy and belief of acupuncture have not been evaluated quantitatively. The present study was performed to analyze the emotional and cognitive factor .of acupuncture and investigate whether the expectancy of acupuncture treatment is associated with the cognition of acupuncture. Methods : The expectancy and the perception of bodily sensation (PBS) of 22 participants were assessed using self-reported questionnaire. The subjects used the self assessment manikin (SAM) to rate each of the standard affective image of the international affective picture system (lAPS) and other acupuncture-related image. Based on the degree of expectancy, the high expectant (HE) and the low expectant (LE) group were classified. The thermal and pressure pain threshold was objectively evaluated using radiant-heat device and algometer. The degree of expected pain of acupuncture and the actual pain of painful stimulation was subjectively evaluated using facial pain scales (FPS). Results : Using SAlVI analysis, we identified the negative correlation between hedonic valence and arousal dimension on acupuncture-related visual cue. The degree of the PBS and general pain threshold did not show any significant difference between the HE and the LE group. The HE group rated the acupuncture images as more pleasant, more arousing, than the LE group. In addition, we also found that the higher expectancy marked the lower FPS of the expected pain of acupuncture, but not of the actual pain of painful stimulation. Conclusions : Our preliminary study identified the psychological dimensions of acupuncture-related visual cue. These findings indicate that the expectancy of acupuncture could affect the cognition of acupuncture.

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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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    • v.36 no.1
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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.

Whole pelvic intensity-modulated radiotherapy for high-risk prostate cancer: a preliminary report

  • Joo, Ji Hyeon;Kim, Yeon Joo;Kim, Young Seok;Choi, Eun Kyung;Kim, Jong Hoon;Lee, Sang-Wook;Song, Si Yeol;Yoon, Sang Min;Kim, Su Ssan;Park, Jin-Hong;Jeong, Yuri;Ahn, Hanjong;Kim, Choung-Soo;Lee, Jae-Lyun;Ahn, Seung Do
    • Radiation Oncology Journal
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    • v.31 no.4
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    • pp.199-205
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    • 2013
  • Purpose: To assess the clinical efficacy and toxicity of whole pelvic intensity-modulated radiotherapy (WP-IMRT) for high-risk prostate cancer. Materials and Methods: Patients with high-risk prostate cancer treated between 2008 and 2013 were reviewed. The study included patients who had undergone WP-IMRT with image guidance using electronic portal imaging devices and/or cone-beam computed tomography. The endorectal balloon was used in 93% of patients. Patients received either 46 Gy to the whole pelvis plus a boost of up to 76 Gy to the prostate in 2 Gy daily fractions, or 44 Gy to the whole pelvis plus a boost of up to 72.6 Gy to the prostate in 2.2 Gy fractions. Results: The study cohort included 70 patients, of whom 55 (78%) had a Gleason score of 8 to 10 and 50 (71%) had a prostate-specific antigen level > 20 ng/mL. The androgen deprivation therapy was combined in 62 patients. The biochemical failure-free survival rate was 86.7% at 2 years. Acute any grade gastrointestinal (GI) and genitourinary (GU) toxicity rates were 47% and 73%, respectively. The actuarial rate of late grade 2 or worse toxicity at 2 years was 12.9% for GI, and 5.7% for GU with no late grade 4 toxicity. Conclusion: WP-IMRT was well tolerated with no severe acute or late toxicities, resulting in at least similar biochemical control to that of the historic control group with a small field. The long-term efficacy and toxicity will be assessed in the future, and a prospective randomized trial is needed to verify these findings.

What is the effect of initial implant position on the crestal bone level in flap and flapless technique during healing period?

  • Al-Juboori, Mohammed Jasim;Ab Rahman, Shaifulizan;Hassan, Akram;Ismail, Ikmal Hisham Bin;Tawfiq, Omar Farouq
    • Journal of Periodontal and Implant Science
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    • v.43 no.4
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    • pp.153-159
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    • 2013
  • Purpose: The level of the implant above the marginal bone and flap design have an effect on the bone resorption during the healing period. The aim of this study is to detect the relationship between the level of the implant at the implant placement and the bone level at the healing period in the mesial and distal side of implants placed with flapless (FL) and full-thickness flap (FT) methods. Methods: Twenty-two nonsubmerged implants were placed with the FL and FT technique. Periapical radiographs were taken of the patient at implant placement, and at 6 and 12 weeks. By using computer software, bone level measurements were taken from the shoulder of the healing cap to the first bone implant contact in the mesial and distal side of the implant surface. Results: At 6 weeks, the correlation between the crestal bone level at the implant placement and crestal bone level of the FT mesially was significant (Pearson correlation coefficient=0.675, P<0.023). At 12 weeks, in the FT mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.297, P<0.346). At 6 weeks in the FT distally, the correlation was nonsignificant (Pearson correlation coefficient=0.512, P<0.107). At 12 weeks in the FT distally, the correlation was significant (Spearman correlation coefficient=0.730, P<0.011). At 6 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.083, P<0.809). At 12 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient= 0.062, P<0.856). At 6 weeks in the FL distally, the correlation was nonsignificant (Spearman correlation coefficient=0.197, P<0.562). At 12 weeks in the FL distally, the correlation was significant (Pearson correlation coefficient=0.692, P<0.018). Conclusions: A larger sample size is recommended to verify the conclusions in this preliminary study. The bone level during the healing period in the FT was more positively correlated with the implant level at implant placement than in the FL.