• Title/Summary/Keyword: randomized clinical trial

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Cancer Prevention with Green Tea and Its Principal Constituent, EGCG: from Early Investigations to Current Focus on Human Cancer Stem Cells

  • Fujiki, Hirota;Watanabe, Tatsuro;Sueoka, Eisaburo;Rawangkan, Anchalee;Suganuma, Masami
    • Molecules and Cells
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    • v.41 no.2
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    • pp.73-82
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    • 2018
  • Cancer preventive activities of green tea and its main constituent, (-)-epigallocatechin gallate (EGCG) have been extensively studied by scientists all over the world. Since 1983, we have studied the cancer chemopreventive effects of EGCG as well as green tea extract and underlying molecular mechanisms. The first part of this review summarizes groundbreaking topics with EGCG and green tea extract: 1) Delayed cancer onset as revealed by a 10-year prospective cohort study, 2) Prevention of colorectal adenoma recurrence by a double-blind randomized clinical phase II trial, 3) Inhibition of metastasis of B16 melanoma cells to the lungs of mice, 4) Increase in the average value of Young's moduli, i.e., cell stiffness, for human lung cancer cell lines and inhibition of cell motility and 5) Synergistic enhancement of anticancer activity against human cancer cell lines with the combination of EGCG and anticancer compounds. In the second part, we became interested in cancer stem cells (CSCs). 1) Cancer stem cells in mouse skin carcinogenesis by way of introduction, after which we discuss two subjects from our review on human CSCs reported by other investigators gathered from a search of PubMed, 2) Expression of stemness markers of human CSCs compared with their parental cells, and 3) EGCG decreases or increases the expression of mRNA and protein in human CSCs. On this point, EGCG inhibited self-renewal and expression of pluripotency-maintaining transcription factors in human CSCs. Human CSCs are thus a target for cancer prevention and treatment with EGCG and green tea catechins.

Pylorus-Preserving Gastrectomy for Gastric Cancer

  • Oh, Seung-Young;Lee, Hyuk-Joon;Yang, Han-Kwang
    • Journal of Gastric Cancer
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    • v.16 no.2
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    • pp.63-71
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    • 2016
  • Pylorus-preserving gastrectomy (PPG) is a function-preserving surgery for the treatment of early gastric cancer (EGC), aiming to decrease the complication rate and improve postoperative quality of life. According to the Japanese gastric cancer treatment guidelines, PPG can be performed for cT1N0M0 gastric cancer located in the middle-third of the stomach, at least 4.0 cm away from the pylorus. Although the length of the antral cuff gradually increased, from 1.5 cm during the initial use of the procedure to 3.0 cm currently, its optimal length still remains unclear. Standard procedures for the preservation of pyloric function, infra-pyloric vessels, and hepatic branch of the vagus nerve, make PPG technically more difficult and raise concerns about incomplete lymph node dissection. The short- and long-term oncological and survival outcomes of PPG were comparable to those for distal gastrectomy, but with several advantages such as a lower incidence of dumping syndrome, bile reflux, and gallstone formation, and improved nutritional status. Gastric stasis, a typical complication of PPG, can be effectively treated by balloon dilatation and stent insertion. Robot-assisted pylorus-preserving gastrectomy is feasible for EGC in the middle-third of the stomach in terms of the short-term clinical outcome. However, any benefits over laparoscopy-assisted PPG (LAPPG) from the patient's perspective have not yet been proven. An ongoing Korean multicenter randomized controlled trial (KLASS-04), which compares LAPPG and laparoscopy-assisted distal gastrectomy for EGC in the middle-third of the stomach, may provide more clear evidence about the advantages and oncologic safety of PPG.

Effect of a 5% naproxen patch on reducing pain caused by separators prior to fixed orthodontic treatment

  • Eslamian, Ladan;Rad, Nazila Akbarian;Nobar, Behnam Rahbani;Mortazavi, Seyed Alireza
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.18 no.3
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    • pp.151-159
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    • 2018
  • Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14-19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. Results: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ${\geq}16years$ (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). Conclusion: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the $7^{th}$ day after separator placement.

Effect of pre-operative medication with paracetamol and ketorolac on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a double-blind randomized clinical trial

  • Kumar, Umesh;Rajput, Akhil;Rani, Nidhi;Parmar, Pragnesh;Kaur, Amandeep;Aggarwal, Vivek
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.441-449
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    • 2021
  • Background: The efficacy of local anesthesia decreases in patients with symptomatic irreversible pulpitis. Therefore, it was proposed that the use of premedication with an anti-inflammatory drug might increase the success rate of pulpal anesthesia in mandibular posterior teeth with vital inflamed pulp. Methods: One hundred thirty-four patients who were actively experiencing pain willingly participated in this study. The Heft Parker (HP) visual analog scale (VAS) was used to record the initial pain intensity. Patients were randomly allocated to receive a placebo, 10 mg of ketorolac, and 650 mg of paracetamol. The standard inferior alveolar nerve block (IANB) was administered to all patients using 2% lidocaine with 1:200,000 adrenaline after one hour of medication. After 15 min, the patient was instructed to rate the discomfort during each step of the treatment procedure, such as access to remaining dentin, access to the pulp chamber, and during canal instrumentation on the HP VAS. IANB was considered successful if the patient reported no or mild pain during access preparation and instrumentation. Moderate or severe pain was classified as a failure of IANB and another method of anesthesia was used before continuing the treatment. Results: The rate of successful anesthesia in the placebo, paracetamol, and ketorolac groups was 29%, 33%, and 43%, respectively, and no statistically significant difference was found between the groups. Conclusion: Preoperative administration of paracetamol or ketorolac did not significantly affect the success rate of IANB in patients with irreversible pulpitis. No significant difference was observed between the paracetamol and ketorolac groups.

Effects of dynamic myofascial release on trunk mobility and standing balance in persons with chronic nonspecific low back pain

  • Lee, Dong-Woo;Shin, Hwa-Kyung;Kim, Kwang-Su
    • Physical Therapy Rehabilitation Science
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    • v.8 no.2
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    • pp.74-78
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    • 2019
  • Objective: Myofascial release (MFR) is used to restore tissue extensibility of the fascia tissue and is considered to be useful in a number of clinical settings, such as low back pain (LBP). Dynamic myofascial release (DMFR) is the manual therapy, which combined the conventional MFR with the joint mobilization. The purpose of this study was to investigate the effects of the DMFR on trunk mobility, and furthermore, whether the increase of trunk mobility can carry over the improvement of dynamic standing balance in persons with chronic nonspecific LBP. Design: Randomized controlled trial. Methods: Thirty persons with chronic non-specific LBP participated in the study and were randomly assigned to the DMFR group (n=15) or the control group (n=15). DMFR was performed for two sessions (15 minutes/session) per week for four weeks for the treatment group. Both the DMFR and control groups were allowed to perform low-intensity physical activities during the treatment period. The Modified-modified $Sch{\ddot{o}}ber$ test (MMST) for trunk mobility and the Functional Reach Test (FRT) for dynamic standing balance were measured before and after the treatment period in both the DMFR group and the control group. Results: The MMST value of DMFR group increased significantly in all trunk range of motion (flexion, extension, lateral flexion, and rotation) after treatment, compared with the control group (p<0.05). Additionally, the FRT value of the DMFR group improved significantly after treatment, compared with the control group (p<0.05). Conclusions: We suggest that DMFR have a positive effect on trunk mobility and standing balance in persons with chronic LBP.

Clinical Study on Child's Height Growth of Mixtures of Cynanchum wilfordii and Phlomis umbrosa Extract (백수오-한속단 추출 복합물의 어린이 키 성장에 관한 임상 연구)

  • Ha, Ki Chan;Baek, Hyang Im;Kim, Hye Mi;Kim, Young Mi;Jeong, Da Young;Hong, Seong Je;Hong, Sang Keun;Choi, Chang Min
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.1
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    • pp.75-83
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    • 2019
  • Objectives Previous animal studies have shown that mixtures of Cynanchum wilfordii and Phlomis umbrosa extract (IPLUS-CWPU) increases femur length and insulin like growth factor-1 (IGF-1) secretion. IPLUS-CWPU may thus be a promising ingredient in functional foods aimed at growing child's height. The purpose of the study is to investigate the effect of IPLUS-CWPU on height growth in children with short stature. Methods For this purpose, we recruited 90 children aged 4 to 12 years who had heights ranging from the 5th to 25th percentiles of Korean children's growth curve and randomized to either the IPLUS-CWPU or the placebo group. Results The IPLUS-CWPU group showed a significant increase in the change of the height growth compared to the placebo group after 20 weeks of administration (p=0.02). The height growth velosity also showed a statistically significant difference in the test group compared to the placebo group at 10 weeks (p=0.04). The IGF-1 levels showed a tendency to increase in the IPLUS-CWPU group (p=0.08). Moreover, the IPLUS-CWPU significantly increased IGF-1/IGFBP-3 ratio (p=0.02). However, there were no significant differences in blood biochemical parameters including growth hormone, bone age, thyroid stimulating hormone, and osteocalcin levels. Conclusions In conclusion, the data of this trial indicate that IPLUS-CWPU is effective and safe, generally well-tolerated without severe adverse events, in the treatment of children with short stature over a 20 weeks period.

Inferior alveolar nerve block by intraosseous injection with Quicksleeper at the retromolar area in mandibular third molar surgery

  • Sovatdy, Sam;Vorakulpipat, Chakorn;Kiattavorncharoen, Sirichai;Saengsirinavin, Chavengkiat;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.18 no.6
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    • pp.339-347
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    • 2018
  • Background: There are many techniques of inferior alveolar nerve block injection (IANBI); one among them is the computer-assisted intraosseous injection (CAIOI). Here we aim to evaluate the effectiveness of CAIOI with $Quicksleeper^{(R)}$ in mandibular third molar surgery. Methods: This study is a clinical, single-blind, randomized, split-mouth, controlled trial including 25 patients (10 males and 15 females, mean age 21 years). The patients underwent surgical removal of bilateral mandibular third molars with two different IANBI techniques. One side was injected using $Quicksleeper^{(R)}$, and the other side was injected using a conventional IANBI. Both techniques used one cartridge (1.7 ml) of 1:100,000 epinephrine 4% articaine. A supplementary injection was used if necessary. All volumes of anesthetic agent used were recorded. Statistical analysis was performed using paired t-test and Wilcoxon test. Results: This research showed that CAIOI has faster onset and shorter duration of action than IANBI (P < 0.05). The pain was similar in both techniques. In the CAIOI group, one-third of the cases could be completed without additional anesthesia. The remaining two-thirds required minimal supplementary volume of anesthesia. The success rates were 68% for CAIOI and 72% for IANBI, respectively. Conclusion: CAIOI is an advantageous anesthetic technique. It can be used as an alternative to conventional IANBI for mandibular third molar surgery.

Comparison of postoperative pain intensity after using reciprocating and continuous rotary glide path systems: a randomized clinical trial

  • Adiguzel, Mehmet;Yilmaz, Koray;Tufenkci, Pelin
    • Restorative Dentistry and Endodontics
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    • v.44 no.1
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    • pp.9.1-9.9
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    • 2019
  • Objectives: The aim of this study was to compare postoperative pain intensity after root canal treatment with One G (OG) vs. R-Pilot (RP) files used for glide path preparation. Materials and Methods: Ninety-three single-canaled mandibular premolar teeth with asymptomatic non-vital pulp were randomly assigned into 3 groups (n = 31): OG, RP, or without glide path (WGP). After creating the glide path, the root canals were prepared using sequential Mtwo rotary files to size 30/0.05. One endodontic specialist carried out single-visit endodontic treatment. The patients were asked to rate the severity of postoperative pain on a visual analogue scale at 24, 48, and 72 hours after the visit. They were also asked to record their intake of prescribed analgesics taken. The data were analyzed using the ${\chi}^2$, Friedman, Kruskal-Wallis, and Mann-Whitney U tests. Results: In all 3 groups, postoperative pain decreased significantly at each time interval (p < 0.05). At 24 hours, the OG group had less postoperative pain than the WGP group (p < 0.05). However, no significant difference was found between the RP group and the others. No statistically significant difference was found among the WGP, OG, and RP groups in postoperative pain intensity at 48 or 72 hours or in analgesic tablet intake at the 3 assessed time intervals. Conclusions: The OG group had less postoperative pain than the WGP group in the first 24 hours. The OG and RP systems were similar regarding postoperative pain intensity and analgesic intake.

The role of Lactobacillus reuteri DSM 17938 for the absorption of iron preparations in children with iron deficiency anemia

  • Manoppo, Jeanette;Tasiringan, Hilda;Wahani, Audrey;Umboh, Adrian;Mantik, Max
    • Clinical and Experimental Pediatrics
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    • v.62 no.5
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    • pp.173-178
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    • 2019
  • Purpose: To determine whether Lactobacillus reuteri DSM 17938 plays a role in absorption of iron preparations given to children with iron deficiency anemia (IDA). Methods: We performed a quasi-experimental study involving pre- and postintervention tests using a control group in North Sulawesi province, Indonesia, between July and September 2017. We conducted a single-blind controlled trial that included primary school children who were diagnosed with IDA based on reticulocyte hemoglobin equivalent (Ret-He) levels <27.8 pg/L. Results: A total of 66 children were randomized into 2 groups. Thirty-four children received iron preparations with the addition of L. reuteri DSM 17938 (group 1), whereas the other 32 received iron preparations alone (group 2). The baseline Ret-He levels before intervention were similar in both groups. After 14 days of intervention, mean Ret-He level in group 1 changed from $24.43{\pm}1.64$ to $28.21{\pm}1.72pg/L$ (P=0.000). Mean Ret-He level in group 2 changed from $24.31{\pm}1.42$ to $27.03{\pm}2.14pg/L$ (P=0.000). Statistical analysis showed a significant increase in Ret-He levels in both groups; Ret-He levels were significantly higher in the experimental group than in the control group (P<0.05). Conclusion: Children with IDA receiving iron preparations with L. reuteri DSM 17938 for 14 days show higher Ret-He levels than those receiving iron preparations alone.

Effect of Proprioceptive Neuromuscular Facilitation Chopping Pattern on Neglect, Balance, and Activity of Daily Living of Stroke Patients with Hemi-Spatial Neglect: A randomized clinical trial (고유수용성신경근촉진법 내려치기 패턴 훈련이 편측무시가 있는 뇌졸중 환자의 편측무시, 균형능력 및 일상생활수행능력에 미치는 영향: 무작위 임상 시험)

  • Kang, Tae-Woo;Kim, Beom-Ryong
    • Journal of the Korean Society of Physical Medicine
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    • v.14 no.2
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    • pp.107-115
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    • 2019
  • PURPOSE: This study examined the effects of the chopping pattern of proprioceptive neuromuscular facilitation (PNF) on the neglect, balance ability, and activities of daily living in stroke patients with hemi-spatial neglect. METHODS: Twenty stroke patients with neglect volunteered for this study. The subjects were assigned randomly to either the experimental group (EG, n=10) or control group (CG, n=10). The chopping pattern of PNF and exercise therapy were applied in the EG and CG, respectively, for four weeks. Neglect, balance, and activities of daily living were evaluated at the pre-and post-intervention. The assessment tools included a line-bisection test, balance test using Space balance 3D, and modified Barthel index. The pre-and post-intervention values were compared in each group using a paired t-test and the between-group differences were assessed using an independent t-test. Statistical significance was set to ${\alpha}=.05$ for all variables. RESULTS: Significant differences were observed between the EG and CG in terms of neglect, balance, and activities of daily living (p<.05). Both groups showed significant improvement in neglect, balance, and activities of daily living (p<.05). CONCLUSION: These results suggest that the chopping pattern of PNF is effective in improving the hemi-spatial neglect, balance, and activities of daily living in stroke patients with neglect.