Multicenter, open-end, randomized controlled study using P53 gene recombinant adenovirus injection (rAd-p53) combined with chemotherapy for orofacial carcinoma (OFC): Phase IV clinical trial—Progress report and conclusion.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6080-6080
Author(s):  
Maolin Yang ◽  
Longjiang Li
Keyword(s):  
Recombinant Adenovirus ◽  
Combined Treatment ◽  
P53 Gene ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Low Grade ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Phase Iv

6080 Background: The gene therapy product (Gendicine, rAd-p53) had pre-market studies done around 1998 indicated its efficacy in the treatment of squamous cell nasopharyngeal carcinoma in multi-modality treatment regimen. Gendicine has been used successfully in treating over 40 cancer types since then. With the advancement in optimization of combined treatment methods over the years, there was a need for a medium term efficacy study. This report summarizes our phase IV study. Methods: Patient selection, intervention and allocation were done according to GCP and supported by statistical analysis. Orofacial cancer (OFC) patients of advanced stages (III/IV) from multiple hospitals (n=30) in China were recruited for this open-end, randomized, controlled study (2009.7--2012.06). The 2 groups were rAd-p53+chemotherapy (GT+CT) (n=743) and CT alone (n=232). Patient exclusion rate were 20.81% (n=128) and 13.9% (n=28) respectively. Virus particles were delivered intra-tumorally at a dose of 109 (tumor cell/cm2 tumor area) x area x100 (virus multiplicity of infection, MOI), every 3d totally 10 times on d 1-28 inclusive. In synchrony with GT, 5-fluorouracil (5-FU, 250 mg/m2/d), on d 7-11 and d 25-29 along with carbocisplatin (KP, 400 mg/m2/d, i.v.), and with methotrexate (MTX, 50mg/m2 /d) on d 7, 14, 25, 32 were administered. The control group received 5-FU, KP and MTX. Results: For advanced OFC treated with GT+CT, the efficacy and QoL were significantly (p<=0.001) improved, the result was in accordance with our phase II/ III studies. Conclusions: This study proved rAd-p53 when used as an adjunct is safe and efficacious. The side-effect was mostly self-limiting low-grade to mild fever. The combined treatment modality had complete remission (CR) improved by 21.38%, relief ratio (RR) by 11.53% and clinical benefit ratio by 20.82% over GT-CT. Long-term follow-up will be continued.

scholarly journals Effect of Tourniquet Use in Ankle Arthroscopic Surgery on Postoperative Recovery: A Prospective Non- Randomized Controlled Study

2020 ◽  
Author(s):  
Tingting Huang ◽  
Haixiao Liu ◽  
Yuezheng Hu ◽  
Xinxian Xu
Keyword(s):  
Functional Outcome ◽  
Ischemia Reperfusion Injury ◽  
Ischemia Reperfusion ◽  
Arthroscopic Surgery ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Complication Rates ◽  
Randomized Controlled ◽  
The Mean

Abstract The aim of this prospective non- randomized controlled study was to explore the effect of tourniquet use on joint swelling, pain, functional outcome, and tourniquet- related ischemia- reperfusion injury (IRI) during ankle arthroscopic surgery.52 patients who received ankle arthroscopy were allocated to had the procedure done with the tourniquet inflated (the Control group, n= 27) or without the tourniquet inflated (the NT group, n= 25). The main outcome measures were: (1) The amount of swelling of the ankle; (2) Pain as measured by a visual analog scale (VAS); (3) The levels of MDA, IMA,TOS, TAS and OSI at 10 min before incision (T1)，after the completion of surgery (T2), and 30 min after tourniquet deflation (T3); (4) The functional outcome as measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot score; (5) The rate of complication. All patients were reviewed at a mean follow- up of 14.2 months (range, 12- 19 months). The mean circumferences of the ankle in the NT group were significantly lower than those in the Control group on postoperative day 2 and 5 (p<0.05). The mean level of VAS in the Control group was significantly higher on postoperative day 2 (p<0.05). The outcomes of AOFAS ankle hindfoot score were comparable between groups postoperatively (p>0.05). The levels of MDA, IMA, TOS and OSI were all significantly lower in the NT group compared at T2 and T3 (p<0.05), and the level of TAS was significantly lower in the NT group at T3 (p<0.05). The complication rates of two groups were comparable (p>0.05).With the use of tourniquet during ankle arthroscopic surgery, there was increased joint swelling and pain postoperatively, and a trend toward increased levels of MDA, IMA, TOS, TAS and OSI intraoperatively. Thus, we do not recommend using a tourniquet in this type of procedure.

scholarly journals Effectiveness of ultrasound guided ethanol motor points block in reduction of spasticity and improvement of upper limb function in hemiplegic patients: a randomized controlled study

2020 ◽  
Vol 7 (9) ◽  
pp. 1409
Author(s):  
Sreejith C. ◽  
Akoijam Joy Singh ◽  
Longjam Nilachandra Singh ◽  
Kanti Rajkumari ◽  
Margaret Chabungbam ◽  
...  
Keyword(s):  
Upper Limb ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Ultrasound Guided ◽  
Limb Function ◽  
Ethanol Injection ◽  
Randomized Controlled ◽  
Upper Limb Function ◽  
Group A

Background: Stroke is the third leading cause of disability in general population commonly causing upper motor neuron syndrome complications like spasticity, which is more common in upper limb. Ethanol injection into spastic muscle is an emerging effective treatment in the spasticity management. Ethanol causes selective destruction of nerve fibers through denaturation of protein.Methods: A randomized controlled study was conducted for a period of 2 years from March 2018 on sixty-eight hemiplegic patients to assess the effectiveness of ethanol muscle block in reduction of spasticity and improvement in functional ability. The patients were allocated into two groups (Group A and B). Group A received ultrasound guided intramuscular ethanol injection along with range of motion (ROM) exercises and wrist hand orthosis (WHO) and Group B received ROM exercises and WHO. The outcomes were measured by modified ashworth scale (MAS) for spasticity and modified version of motor assessment scale for functional improvement.Results: Intervention group showed significant improvement in spasticity shown by reduction of MAS of elbow flexors from 3 at baseline to 1.15±0.3 at 12 weeks as compared to control group with 3 at baseline to 1.76±0.5 at 12 weeks (p<0.05). Upper limb function scale of study group improved from 1.5±0.8 to 3.0±0.6 at 12 weeks compared to control group 1.3±0.8 to 2.8±0.6 (p<0.05).Conclusions: It can thus be concluded that intramuscular injection of ethanol accompanied by wrist hand orthosis have beneficial effect on improvement of spasticity and upper limb function.

scholarly journals Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized–controlled study

2019 ◽  
Vol 8 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Stephanie L Hansel ◽  
Joseph A Murray ◽  
Jeffrey A Alexander ◽  
David H Bruining ◽  
Mark V Larson ◽  
...  
Keyword(s):  
Small Bowel ◽  
Capsule Endoscopy ◽  
Bowel Preparation ◽  
Diagnostic Yield ◽  
Completion Rate ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE. Methods Single-blind, prospective randomized–controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment. Results Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P &gt; 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01). Conclusions Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).

Percutaneous versus surgical tracheostomy: A randomized controlled study with long-term follow-up*

2006 ◽  
Vol 34 (8) ◽  
pp. 2145-2152 ◽  
Author(s):  
William Silvester ◽  
Donna Goldsmith ◽  
Shige Uchino ◽  
Rinaldo Bellomo ◽  
Simon Knight ◽  
...  
Keyword(s):  
Randomized Controlled Study ◽  
Controlled Study ◽  
Surgical Tracheostomy ◽  
Randomized Controlled ◽  
Long Term Follow Up

scholarly journals Effects of a randomized controlled study on the behaviors of overweight schoolchildren

2021 ◽  
Vol 26 ◽  
Author(s):  
Anastácio Neco de Souza Filho ◽  
Thaynã Alves Bezerra ◽  
Paulo Felipe Ribeiro Bandeira ◽  
Luciana Gatto Azevedo Cabral ◽  
José Fernando Vila Nova de Moraes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Behavioral Therapy ◽  
Vigorous Physical Activity ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Daily Routine ◽  
Randomized Controlled ◽  
School Based ◽  
Significant Difference

This study aimed to determine the effects of a school-based multi-component intervention on accelerometer- measured physical activity (PA) and sedentary behavior (SB) in schoolchildren overweight. This is a randomized controlled study with overweight schoolchildren, allocated to experimental group (EG; n = 13; 7.6 ± 0.8 years; 42.9% boys) and control group (CG; n = 17; 8.2 ± 0.9 years; 26.7% boys). The EG was submitted to a 10-week school-based intervention, comprised of PA and psychological sessions (behavioral therapy), and nutritional guidance. The CG followed the daily routine of life. The time of PA and SB were measured using accelerometers used for seven days. To compare mean SB, moderate to vigorous physical activity (MVPA) and total physical activity (TPA), generalized estimation equations (GEE) were used. It was observed that the average time in MVPA and TPA increased significantly in EG at the weekend (+ 40.9 min / day, p < 0.001; and + 51.6 min/day, p = 0.035, respectively) and at full week (+ 62.9 min/day, p < 0.001; and + 225.0 9 min/day, p = 0.038, respectively). There was no significant difference in time spent in SB after the intervention in both groups. Thus, it was concluded that the proposed school-based multicomponent intervention was effective in increasing levels of MVPA and TPA in overweight schoolchildren. This finding can optimize future interventions to promote a healthy lifestyle for schoolchildren in the school environment.

scholarly journals Effect of the Use of WeChat to Disseminate Preoperative Health Education to Parents of Children with Restrictive Ventricular Septal Defects: A Prospective Randomized Controlled Study

2020 ◽  
Vol 23 (6) ◽  
pp. E897-E901
Author(s):  
Qiliang Zhang ◽  
Ning Xu ◽  
Shuting Huang ◽  
Qiang Chen ◽  
Hua Cao
Keyword(s):  
Health Education ◽  
Ventricular Septal Defect ◽  
Septal Defect ◽  
Preoperative Care ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Loss To Follow Up ◽  
Randomized Controlled

Background: This study explored the clinical effect of implementing WeChat-based preoperative health education for parents of children with restrictive ventricular septal defect. Methods: A prospective randomized controlled study was conducted in a provincial hospital on the southeast coast of China. Participants were randomly divided into an intervention (WeChat) group (n = 35) and a control group (leaflet) group (n = 35). The study explored the parents’ knowledge of preoperative care, the follow-up rate, and complications of children with restrictive ventricular septal defect. Results: The score of preoperative care knowledge of the WeChat group (66.9 ± 3.5) was significantly higher than that of the leaflet group (47.3 ± 6.3) (P = .006). Compared with the score of care knowledge at the first visit, the score of the WeChat group at the preoperation was significantly higher (P < .05), whereas the increase in the score of the leaflet group was not significant. The rate of lost follow-up in the WeChat group (0%) was significantly lower than in the leaflet group (16.7%) (P = .02). The complications in the leaflet group were significantly higher than in the WeChat group. Conclusions: Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents’ knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.

Comparison of Autogenous Block Bone Graft and Screw Tent-Pole Techniques for Vertical Bone Augmentation in the Posterior Mandible: A Split-Mouth Randomized Controlled Study

2020 ◽  
pp. 232020682097601
Author(s):  
Gözde Işık ◽  
Tayfun Günbay ◽  
Yig˘it Uyanıkgil ◽  
Hüseyin Kısaog˘lu ◽  
Meltem Özden Yüce
Keyword(s):  
Bone Graft ◽  
Test Group ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Bone Augmentation ◽  
Implant Survival ◽  
Platelet Rich Fibrin ◽  
Randomized Controlled ◽  
Block Bone Graft

Aim: To evaluate the effect on vertical bone augmentation of the screw tent-pole technique using particulate allograft in combination with injectable platelet-rich fibrin, and to compare this with autogenous block bone graft. Materials and Methods: This split-mouth randomized controlled study involved patients with bilateral partial edentulism and vertical bone loss in the posterior mandible. In each patient, the control side was treated with autogenous block bone graft harvested from the mandibular ramus and, on the test side, the screw tent-pole technique was employed, using particulate allograft in combination with injectable platelet-rich fibrin. All augmented sites were covered by leukocyte and platelet-rich fibrin membrane. The primary outcome variable of this study was the radiographic changes to bone height 6 months after augmentation. The secondary outcome variables were the percentage of newly formed bone and the implant survival rate. The data were analyzed with a significance level of α = 0.05. Results: Of the 13 patients included, a total of 11 patients (7 females, 4 males; mean age 50.92) completed the study. The mean values of vertical bone gain were 1.72 ± 0.78 mm for the test group and 2.83 ± 0.89 mm for the control group, which constitutes a significant difference ( P = .008). The percentage of newly formed bone was 18.08% ± 2.17% for the test group and 14.26% ± 1.76% for the control group. The difference between the groups was statistically significant ( P < .001). The implant survival rates were 100% for both study groups. Conclusions: Based on the study results, screw tent-pole can be considered a feasible technique for bone augmentation. Further randomized studies will be necessary to fully evaluate vertical bone augmentation using the screw tent-pole technique, with different graft materials and with larger samples.

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