scholarly journals A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis

eLife ◽  
2016 ◽  
Vol 5 ◽  
Author(s):  
Ming Chao ◽  
Hao Wu ◽  
Kai Jin ◽  
Bin Li ◽  
Jianjun Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lactic Acidosis ◽  
Survival Data ◽  
Clinical Investigation ◽  
Geometric Mean ◽  
Randomized Study ◽  
Objective Response ◽  
Controlled Study ◽  
Trial Number ◽  
Randomized Controlled

Background:Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study.Methods:The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor.Results:In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit.Conclusions:Bicarbonate markedly enhances the anticancer activity of TACE.Funding:Funded by National Natural Science Foundation of China.Clinical trial number:ChiCTR-IOR-14005319.

scholarly journals Ultrasound-Guided Cannulation of the Great Saphenous Vein in Neonates: A Randomized Study

2021 ◽  
Author(s):  
Zhenzhen Tu ◽  
Yanzhe Tan ◽  
Lifei Liu ◽  
Jia Xie ◽  
Ying Xu ◽  
...  
Keyword(s):  
Great Saphenous Vein ◽  
Randomized Study ◽  
Controlled Study ◽  
Control Group ◽  
Success Rates ◽  
Procedure Time ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Key Points ◽  
Procedural Time

Objective This prospective randomized controlled study aimed to compare the ultrasound-guided (USG) technique with the standard single-wall puncture technique for epicutaneo-caval catheter (ECC) placement in neonates. Study Design A total of 100 neonates were included in this study. All enrolled neonates were randomly divided into two groups (n = 50): the USG group and the control group. The control group underwent standard single-wall puncture for ECC placement procedures, and the USG group underwent USG ECC placement procedures. Results The first attempt success rates (62 vs. 38%; p = 0.016) and the total success rates (92 vs. 74%; p = 0.017) were higher in the USG group than in the control group. The procedure time was shorter in the USG group than in the control group: 351.43 (112.95) versus 739.78 seconds (369.13), p < 0.001. The incidence of adverse events was not significantly different between the two groups. Conclusion Compared with the standard single-wall puncture method, USG cannulation is superior for neonatal ECC placement, with a higher success rate, and decreases the total procedural time. Key Points

Maprotiline (Ludiomil) and Imipramine in Depressed In-Patients: A Controlled Study

1975 ◽  
Vol 3 (6) ◽  
pp. 413-416 ◽  
Author(s):  
W Rieger ◽  
K Rickels ◽  
N Norstad ◽  
J Johnson
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Efficacy ◽  
Hospitalized Patients ◽  
Strong Tendency ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled

In this double-blind, randomized, controlled clinical trial of maprotiline ( Ludiomil) against imipramine involving twenty-five newly admitted hospitalized patients, a strong tendency in favour of maprotiline over imipramine emerged. Improvement occurred faster and also at treatment end-point the trend in favour of maprotiline was still to be seen. The slight superiority in clinical efficacy of maprotiline over imipramine was present in both physician and patient measures. Incidences of side-effects were slightly lower for maprotiline than for imipramine.

scholarly journals A new fat-dissociation method to detect lymph nodes in colorectal cancer: a prospective randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shiki Fujino ◽  
Norikatsu Miyoshi ◽  
Masayuki Ohue ◽  
Aya Ito ◽  
Masayoshi Yasui ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Lymph Nodes ◽  
Randomized Study ◽  
Survival Rates ◽  
Controlled Study ◽  
Open Label ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Randomized Controlled ◽  
Time Required

AbstractHistological examination of the lymph nodes (LNs) is crucial to determine the colorectal cancer (CRC) stage. We previously reported a new fat-dissociation method (FM) to detect LNs from surgically resected mesentery. This study aimed to examine the effectiveness of FM compared with that of conventional palpation method (PM) in CRC. This single-center, open-label, randomized controlled study was performed at Osaka International Cancer Institute in Japan in 2014. Randomization was performed using a computer-generated permuted-block sequence. Patients were stratified by surgical procedures and the LN dissection area. The primary endpoint was the time required for LN identification. The secondary endpoint was the number of LNs and 5-year cancer-specific survival. The 130 enrolled patients were randomly assigned in a 1:1 ratio to the FM and the PM groups. LN identification times were 45 (range 15–80) and 15 (range 7–30) minutes in the PM and the FM groups, respectively (P < 0.001). In the PM group, body mass index and identification time were correlated (P = 0.047). The number of LN which could be examined pathologically was 16 (range 2–48) and 18 (range 4–95) in the PM and FM groups, respectively (P = 0.546). In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031). Relapse-free survival rates and cancer-specific survival rates did not differ between the groups. In conclusion, FM reduced the time required for LN detection without reducing the number of detected LNs, making it is a useful method to detect LNs in surgical specimens.

A phase III, randomized, controlled study to compare tivozanib with sorafenib in patients (pts) with advanced renal cell carcinoma (RCC).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 310-310 ◽  
Author(s):  
R. J. Motzer ◽  
P. Bhargava ◽  
B. Esteves ◽  
M. Al-Adhami ◽  
W. Slichenmyer ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Clear Cell ◽  
Objective Response ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Controlled Study ◽  
Vegf Receptor ◽  
Randomized Controlled ◽  
Long Term Treatment ◽  
Clear Cell Rcc

310 Background: Drugs that block vascular endothelial growth factor (VEGF) pathway signaling, such as the tyrosine kinase inhibitor sorafenib, have become standard treatment for pts with RCC. Tivozanib (AV-951) is a potent, selective small-molecule pan-VEGF receptor (VEGFR) inhibitor, with activity against the VEGFR-1, -2, and -3 kinases at subnanomolar concentrations. Preliminary results from a phase II randomized discontinuation trial of tivozanib (1.5 mg/d; 3 wks on, 1 wk off) in pts with RCC demonstrated an objective response rate (ORR) of 27% and a median progression-free survival (PFS) of 11.8 mo by independent radiology review, with a favorable safety profile. Patients with clear cell RCC who had undergone nephrectomy had an ORR of 32% and median PFS of 14.8 mo (Bhargava, et al. ASCO 2010. Abstract 4599). Based on this antitumor activity a phase III, randomized, controlled, global, multicenter trial is currently in progress to compare tivozanib with sorafenib in pts with advanced RCC. Methods: Approximately 500 adults with clear cell RCC who have undergone nephrectomy and received ≤ 1 prior systemic treatment (no prior VEGF-targeted therapy) were randomized 1:1 to treatment with tivozanib or sorafenib. Pts are receiving 1.5 mg/d tivozanib orally in 4-week cycles (3 wks on, 1 wk off) or continuous 400 mg sorafenib orally twice daily. The primary endpoint will be PFS by independent radiology review; secondary endpoints will include overall survival, ORR, and duration of response. Safety is being monitored through adverse event reporting and laboratory analyses; toxicities are graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0. The effect of therapy on health-related quality of life will be compared between arms using kidney cancer-specific (FKSI-DRS), oncology (FACT-G), and general (EQ-5D) assessments. Pharmacokinetics and biomarker analyses will be performed. Results: Pending. Conclusions: Enrollment completed in August 2010. An ongoing extension study will allow access to tivozanib for pts who demonstrate progressive disease on sorafenib, as well as long-term treatment with tivozanib or sorafenib for pts who demonstrate clinical benefit. [Table: see text]

scholarly journals The Effect of Acupuncture and Physiotherapy on Patients with Knee Osteoarthritis: A Randomized Controlled Study

2021 ◽  
pp. E269-E278
Author(s):  
Sevgi Gumus Atalay
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Functional Status ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Tertiary Center ◽  
Significant Difference

Background: Osteoarthritis is the most prevalent form of joint disease, and the most common location is the knee. Objectives: The aim of this study was to determine the effect of acupuncture treatment and physiotherapy on pain, physical function, and quality of life (QOL) in patients with knee osteoarthritis (KOA). Study Design: This study was a prospective, randomized, controlled clinical trial. Settings: The research took place in the interventional pain unit of a tertiary center in a university hospital. Methods: One hundred patients with KOA were randomly divided into the acupuncture group and the physiotherapy group. Both treatments were given in 12 sessions over 6 weeks. Thirteen acupuncture points were selected for the knee. Local points were GB34, SP10, SP9, ST36, ST35, ST34, EX-LE2, EXLE5, EXLE4, and distal (distant) points were defined as KI3, SP6, LI4, and ST41. The Visual Analog Scale (VAS) was used to measure pain intensity. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the 36-Item Short Form Health Survey (SF-36) were used to determine functional status and health-related QOL, respectively. All patients were evaluated at baseline, after the last treatment, and at the 12-week follow-up period. Results: There was no statistically significant difference between the acupuncture group and physiotherapy group in terms of pain, total WOMAC, and SF-36 levels at baseline, after treatment, and at the 12th week after treatment (P > 0.05). Both treatments significantly improved functional status (acupuncture, from 63.8 ± 20.81 to 53.72 ± 19.43; and physiotherapy, from 59.04 ± 21.49 to 52.28 ± 19.54; P < 0.05) and decreased the level of pain assessed by VAS (acupuncture, from 8.32 ± 1.61 to 5.54 ± 2.34; and physiotherapy, from 7.86 ± 1.9 to 5.68 ± 2.42; P < 0.05) at the 12-week follow-up of the study. There was no adverse advent related to therapeutic methods. Limitations: Sham or placebo control groups are lacking in this study. Conclusions: The acupuncture and physiotherapy performed twice weekly for 6 weeks have similar effects with regard to pain, functional status, and QOL. There were no significant differences between the acupuncture and physiotherapy groups in relief of pain, improved functional status, and QOL in the treatment of KOA. Both acupuncture and physiotherapy treatments were found to yield significantly superior results when compared with baseline values. Key words: Knee osteoarthritis, acupuncture, physiotherapy, randomized clinical trial

scholarly journals Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Homoeopathic Arnica C30 for Pain and Infection after Total Abdominal Hysterectomy

1997 ◽  
Vol 90 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Oliver Hart ◽  
Mark A Mullee ◽  
George Lewith ◽  
John Miller
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Total Abdominal Hysterectomy ◽  
Abdominal Hysterectomy ◽  
Postoperative Recovery ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Significant Difference

Homoeopathic potencies of arnica have been used for many years to aid postoperative recovery. The effects of arnica C30 on pain and postoperative recovery after total abdominal hysterectomy were evaluated in a double-blind, randomized, controlled study. Of 93 women entered into the study, 20 did not complete protocol treatment: nine were excluded because they failed to comply with the protocol, nine had their operations cancelled or changed within 24 h and two had to be withdrawn because of the recurrence of previously chronic painful conditions. Those who did not complete protocol treatment were equally divided between the arnica (nine patients) and placebo groups (11 patients). 73 patients completed the study, of whom 35 received placebo and 38 received arnica C30. The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated. We conclude that arnica in homoeopathic potency had no effect on postoperative recovery in the context of our study.

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