Discrete cerebral hypothermia in the management of traumatic brain injury: a randomized controlled trial

2009 ◽  
Vol 110 (6) ◽  
pp. 1256-1264 ◽  
Author(s):  
Odette A. Harris ◽  
Carrie R. Muh ◽  
Monique C. Surles ◽  
Yi Pan ◽  
Grace Rozycki ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Treatment Group ◽  
Temperature Gradient ◽  
Control Group ◽  
Systemic Effects ◽  
Randomized Controlled ◽  
Bladder Temperature ◽  
Significant Difference ◽  
The Mean ◽  
Gcs Score

Object Hypothermia has been extensively evaluated in the management of traumatic brain injury (TBI), but no consensus as to its effectiveness has yet been reached. Explanatory hypotheses include a possible confounding effect of the neuroprotective benefits by adverse systemic effects. To minimize the systemic effects, the authors evaluated a selective cerebral cooling system, the CoolSystem Discrete Cerebral Hypothermia System (a “cooling cap”), in the management of TBI. Methods A prospective randomized controlled clinical trial was conducted at Grady Memorial Hospital, a Level I trauma center. Adults admitted with severe TBI (Glasgow Coma Scale [GCS] score ≤ 8) were eligible. Patients assigned to the treatment group received the cooling cap, while those in the control group did not. Patients in the treatment group were treated with selective cerebral hypothermia for 24 hours, then rewarmed over 24 hours. Their intracranial and bladder temperatures, cranial-bladder temperature gradient, Glasgow Outcome Scale (GOS) and Functional Independence Measure (FIM) scores, and mortality rates were evaluated. The primary outcome was to establish a cranial-bladder temperature gradient in those patients with the cooling cap. The secondary outcomes were mortality and morbidity per GOS and FIM scores. Results The cohort comprised 25 patients (12 in the treatment group, 13 controls). There was no significant intergroup difference in demographic data or median GCS score at enrollment (treatment group 3.0, controls 3.0; p = 0.7). After the third hour of the study, the mean intracranial temperature of the treatment group was significantly lower than that of the controls at all time points except Hours 4 (p = 0.08) and 6 (p = 0.08). However, the target intracranial temperature of 33°C was achieved in only 2 patients in the treatment group. The mean intracranial-bladder temperature gradient was not significant for the treatment group (p = 0.07) or the controls (p = 0.67). Six (50.0%) of 12 patients in the treatment group and 4 (30.8%) of 13 in the control group died (p = 0.43). The medians of the maximum change in GOS and FIM scores during the study period (28 days) for both groups were 0. There was no significant difference in complications between the groups (p value range 0.20–1.0). Conclusions The cooling cap was not effective in establishing a statistically significant cranial-bladder temperature gradient or in reaching the target intracranial temperature in the majority of patients. No significant difference was achieved in mortality or morbidity between the 2 groups. As the technology currently stands, the Discrete Cerebral Hypothermia System cooling cap is not beneficial for the management of TBI. Further refinement of the equipment available for the delivery of selective cranial cooling will be needed before any definite conclusions regarding the efficacy of discrete cerebral hypothermia can be reached.

Therapeutic Effect of Changqiang Acupoint Injection on Children with Functional Fecal Incontinence

2021 ◽  
Author(s):  
Changying Yi ◽  
Jie Zhang ◽  
Meili Fan
Keyword(s):  
Treatment Group ◽  
Fecal Incontinence ◽  
Cleveland Clinic ◽  
Control Group ◽  
Incontinence Score ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Stool Incontinence ◽  
Acupoint Injection ◽  
Significant Difference

<B>Objective:</B> Functional fecal incontinence in children (FFIC), also known as functional fecal disorder in children, is a type of childhood diseases characterized by excretory dysfunction. In the study, we observed the clinical effect of Changqiang acupoint injection on functional fecal incontinence in children (FFIC) by randomized controlled clinical trials. <BR><B>Materials and methods:</B> 140 children with functional fecal incontinence who met the screening criteria were respectively assigned into the treatment group (100 cases) and the control group (40 cases) according to the completely randomized controlled design. In the treatment group, Chuankezhi injection was administrated at the Changqiang acupoint once a week for three weeks (one course of treatment). In contrast, the subjects in the control group was instructed to receive sphincter exercise and defecation training, followed by an assessment on the therapeutic efficacy after one course of treatment. <BR><B>Results:</B> The overall response rate of the two groups was 93.00% (93/100) and 57.50% (23/40), respectively, with a statistically significant difference (P<0.01). The treatment group showed a performance superior to the control group based on the Cleveland Clinic Florida Fecal Incontinence Score System (CCF-FI)—dry stool incontinence, liquid incontinence, gas incontinence, lifestyle change, necessity of using pads or antidiarrheals, the ability to delay defecation, and the total score. The inter-group comparison revealed a statistically significant difference (P<0.01). <BR><B>Conclusion:</B>Changqiang acupoint injection has significant curative effect on FFIC as demonstrated by significant relief in the symptoms associated with fecal incontinence, and thus is considered as a useful approach to be widely applied in clinical practice.

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

scholarly journals Dentofacial Changes after Orthodontic Intervention with Eruption Guidance Appliance in the Early Mixed Dentition

2008 ◽  
Vol 78 (2) ◽  
pp. 324-331 ◽  
Author(s):  
Katri Keski-Nisula ◽  
Leo Keski-Nisula ◽  
Hannu Salo ◽  
Kati Voipio ◽  
Juha Varrela
Keyword(s):  
Treatment Group ◽  
Mixed Dentition ◽  
Class I ◽  
Control Group ◽  
Significant Shift ◽  
Facial Height ◽  
Significant Difference ◽  
The Mean ◽  
Maxillary Incisors ◽  
Clinically Significant

Abstract Objective: To evaluate skeletal and dentoalveolar changes induced by the eruption guidance appliance in the early mixed dentition. Materials and Methods: Pre- and posttreatment cephalometric radiographs of 115 consecutively treated children, 62 boys and 53 girls, were compared with those obtained from a control group of 104 children, 52 boys and 52 girls. Pretreatment radiographs were taken at the deciduous-mixed dentition interphase (T1) and after full eruption of all permanent incisors and first molars (T2). The mean age of the children in both groups was 5.1 years at T1 and 8.4 years at T2. Results: A significant difference between the groups at T2 was found in the mandibular length, midfacial length, and maxillomandibular differential. The increase in mandibular length was 11.1 mm in the treatment group and 7.2 mm in the control group. No differences were found in measurements of maxillary position or size. There was a significant shift toward a Class I relationship in the treatment group. Labial tipping and linear protrusion of the mandibular incisors was evident in the treatment group at T2. There was no effect on the inclination or position of the maxillary incisors. Conclusions: Occlusal correction was achieved mainly through changes in the dentoalveolar region of the mandible. In addition, the appliance enhanced condylar growth resulting in a clinically significant increase in mandibular length. No effect was observed on maxillary position, maxillary size, inclination or protrusion of the maxillary incisors, or facial height.

scholarly journals Antibacterial Activity of Lumbricus Rubellus Earthworm Extract Against Porphyromonas Gingivalis as the Bacterial Cause of Periodontitis

2019 ◽  
Vol 7 (6) ◽  
pp. 1032-1036 ◽  
Author(s):  
I Gusti Agung Ayu Dharmawati ◽  
Tjokorda Gde Bagus Mahadewa ◽  
I Putu Eka Widyadharma
Keyword(s):  
Antibacterial Activity ◽  
Treatment Group ◽  
Lumbricus Rubellus ◽  
Control Group ◽  
Inhibitory Zone ◽  
Control Group Design ◽  
Zone Diameter ◽  
Significant Difference ◽  
The Mean

AIM: The purpose of this study was to determine the antibacterial activity of Lumbricus rubellus earthworms through inhibitory zone diameter to the growth of the bacterium Phorphyromonas gingivalis as the cause of periodontitis. METHODS: This was an experimental study with randomised posttest-only control group design. The study was conducted at the Microbiology Research Center laboratory at the Faculty of Dentistry, Airlangga University, Indonesia. The study was conducted in vitro, the sample size was calculated using the Federer formula as many as four agar plates containing bacteria Phorphyromonas gingivalis, with each plate given five different treatments: control (ethanol), Lumbricus rubellus earthworm extract (ECT) with concentrations of 50%, 25%, 12.5%, and 6.25% respectively. The data in the form of inhibition zone diameter (measured in millimetres) obtained were tested using One-Way ANOVA. RESULTS: The mean diameter of the inhibitory zone extract of Lumbricus rubellus earthworm on the growth of Phorphyromonas gingivalis bacteria in the treatment group had significant differences (p < 0.05). The mean inhibition zones between controls and the ECT treatment group (ECT 50%, ECT 25%, ECT 12.5%) were statistically different (p < 0.05), in contrast with ECT 6.25% (p > 0.05) which did not show significant difference with the control group (p > 0.05). CONCLUSION: Lumbricus rubellus earthworm extract with a concentration of 50% has the largest diameter of the inhibitory zone on the growth of the Phorphyromonas gingivalis bacteria. The 6.25% earthworm extract showed no antibacterial activity against the growth of Phorphyromonas gingivalis bacteria.

Efficacy of Bimodal High-Voltage Monopulsed Current in the Treatment of Pressure Ulcer: A Systematic Review

2020 ◽  
Author(s):  
Zhiwei ZHANG ◽  
Bojun LI ◽  
Zhichao WANG ◽  
Lina WU ◽  
Lili SONG ◽  
...  
Keyword(s):  
Treatment Group ◽  
Pressure Ulcer ◽  
High Voltage ◽  
Meta Analysis ◽  
Descriptive Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Background: We aimed to systematically evaluate the efficacy of high-voltage pulsed current (HVPC) in the treatment of pressure ulcer. Methods: We searched the databases of PubMed, Cochrane Library, Elsevier and EMBASE to identify randomized controlled studies on the application of HVPC in pressure ulcer treatment, up to January 2019. Two authors independently screened the literature according to the inclusion and exclusion criteria, extracted the data and evaluated the quality. RevMan 5.3 software was used for statistical analysis. Four randomized controlled trials involving a total of 176 patients were included in the study. Results: Meta-analysis showed that the percentage of wound area reduction in the HVPC treatment group was higher than that in the control group (95%CI 24.59, 47.76, P<0.001). Descriptive analysis showed that there was no significant difference in wound healing between the HVPC treatment group and the control group. One study reported that there was contact dermatitis, and the rest of the studies reported no adverse events. Conclusion: Compared with the conventional therapy, the combination with HVPC therapy can reduce the area of pressure ulcers more effectively. However, due to the small number of the studies included in this evaluation, the conclusions need to be verified by more high-quality studies.

scholarly journals Randomized controlled trial on the effectiveness of silver diamine fluoride in arresting caries in Lagos, Nigeria

2021 ◽  
Vol 21 ◽  
pp. e226341
Author(s):  
Moses Okechukwu Azouru ◽  
Modupe Olufunmilayo Ashiwaju ◽  
Augustine Edomwonyi ◽  
Afolabi Oyapero ◽  
Bola Obisesan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Phase Iii ◽  
Treatment Modalities ◽  
Control Group ◽  
Chi Square ◽  
Silver Diamine Fluoride ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Chi Square Test ◽  
The Mean

Treatment of dental caries in children still remains challenging due to lack of cooperation with conventional treatment modalities. Recently, the use of Silver Diamine Fluoride (SDF) has proved useful in addressing this challenge. Aim: This clinical trial aimed to evaluate the effectiveness of Silver Diamine Fluoride (SDF) in arresting caries in children in Lagos, Nigeria. Methods: This was a phase III balanced randomized controlled school based interventional study on 240 children. The study group was treated with SDF while GIC was used in the control group. Follow up visits in 2 weeks, 1 month, and 3 months were carried out to assess the treatment outcome. Inferential statistics with the use of Pearson Chi-square test and Independent Student t-test were used at 5% level of significance. Results: There was significant relationship between SDF and caries arrest in 2 weeks, 1 month and 3 months’ assessment period (p = 0.001). The control group showed continuous decline (71.7%, 54.3% and 50.9%) in restorative success from 2 weeks to 3 months respectively. The mean ± SD and Confidence Interval (CI) of arrested caries in the SDF group were 113± 1.24 and 113.1 – 113.5 respectively. In the control group the mean ± SD and CI of restorative success were 69.3±11.8 and 67.2 – 71.4. The effect size was 5.24. Conclusion: The result of the study showed that SDF was effective in arresting caries in children without any harm and there was statistically significant difference in the use of 38% SDF in arresting caries in children.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Teaching English Vocabulary with Greek or Latin Roots to Iranian EFL Students by PLS Sequential Structures

2020 ◽  
Vol 8 (4) ◽  
pp. p73
Author(s):  
Abolfazl Shirban Sasi
Keyword(s):  
Treatment Group ◽  
Teaching Method ◽  
English Word ◽  
Control Group ◽  
Teaching English ◽  
Control Group Design ◽  
Significant Difference ◽  
Efl Students ◽  
The Mean ◽  
And Control

PLS is a newly developed language teaching method which predominantly applies imaginative and random usage of pictures. The present paper explains and reports the application of a PLS technique in teaching English vocabulary with Greek or Latin roots to Iranian EFL learners. A pretest-posttest control-group design was used to investigate the effects of this sequential structures technique. Participants were intermediate level EFL students in two branches of the same language institute in Tehran (N = 94, p ? 0.05). The subjects were randomly assigned into two groups of treatment and control. The experiment lasted for seven one-hour lessons held in successive sessions in three weeks during which 35 Greek and Latin roots were taught with at least three English word examples. For the research instrument, the students were administered a 35-item multiple-choice vocabulary exam for the pre and post tests prior to and immediately after the teaching phase. Consequently, an independent sample T-test was used to examine the outcome of the experiment. At p = .009, the statistical test revealed a significant difference in the gain scores between the two groups. Also, the mean vocabulary gain score of 7.23 for the treatment group as opposed to the mean of 5.35 for the control group illustrated the relative more L2 vocabulary intake for the treatment group.

scholarly journals Spironolactone versus observation in the treatment of acute central serous chorioretinopathy

2017 ◽  
Vol 102 (8) ◽  
pp. 1060-1065 ◽  
Author(s):  
Xinghong Sun ◽  
Yuanlu Shuai ◽  
Wangyi Fang ◽  
Jia Li ◽  
Weizhong Ge ◽  
...  
Keyword(s):  
Treatment Group ◽  
Central Serous Chorioretinopathy ◽  
Complete Resolution ◽  
Subretinal Fluid ◽  
Control Group ◽  
Significant Difference ◽  
Registration Number ◽  
Acute Central Serous Chorioretinopathy ◽  
The Mean ◽  
Randomised Controlled

PurposeTo evaluate the efficacy of oral spironolactone in patients with acute central serous chorioretinopathy (CSC).MethodsThis is a prospective, randomised controlled clinical study. Thirty patients with acute CSC were the participants, including 18 patients who were treated with spironolactone (40 mg orally, twice daily) for 2 months in the experimental group and 12 patients who received observation in the control group. Main outcome measures included the proportion of eyes achieving complete resolution of subretinal fluid (SRF), changes in central macular thickness (CMT), the height of SRF (SRFH), best corrected visual acuity (BCVA) and subfoveal choroidal thickness (SFCT). The follow-up period was 2 months.ResultsComplete resolution of SRF was achieved in 55.6% (10/18) and 8.3% (1/12) of the eyes in the treatment group and the control group, respectively, at 2 months (p=0.018). The mean CMT and SRFH decreased significantly at each visit in both groups (p<0.05), and there was significant difference between the two groups at 2 months (p<0.05 and p<0.05, respectively). BCVA (in logarithm of the minimum angle of resolution; mean) improved in both groups at 2 months (p<0.05). In the treatment group, the mean baseline SFCT significantly decreased from 502.50±87.38 µm to 427.44±74.37 µm at 2 months (p<0.01), while the change from baseline (from 480.33±102.38 µm to 463.75±100.63 µm) was not significant in the control group (p=0.195). But the differences between the two groups in BCVA and SFCT were not significant.ConclusionsOral spironolactone is more effective with a faster absorption of SRF than observations. It is a promising treatment for acute CSC.Trial registration numberChiCTR-IPR-16008428, Results.

scholarly journals Effects of a novel dye containing toothpaste versus regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Avita Rath ◽  
Chong Junning ◽  
Priyadarshini HR ◽  
Brandon Nicholas Teo ◽  
Naik Hsian Zhen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Image Analysis ◽  
Controlled Trial ◽  
Control Group ◽  
Dental Biofilm ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
The Mean

AIM:To compare the effects of a plaque disclosing toothpaste with a regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis.MATERIALS AND METHODS:This study was a randomized controlled trial with a parallel design. Forty patients, both males and females aged 18-25 years with chronic generalized gingivitis (N=40) were randomly allocated to two groups of twenty each (n=20), using lottery method. Participants in the experimental group brushed with a plaque disclosing toothpaste, while participants in the control group brushed with regular fluoridated toothpaste. Clinically, biofilm was measured using Silness & Loe Plaque Index, both at baseline and at follow up visits by two assessors who were blinded to group allocation. Adjunctly, intraoral photographs were taken for Digital Plaque Image Analysis of the remaining dental biofilm in the upper and lower anterior labial tooth surfaces, and calculated based on the area of stained pixels. Data was analyzed using SPSS version 22. Mean plaque scores between the groups were compared using independent sample t-test and p<0.05 was considered significant.RESULTS:Data of all the 40 participants were analyzed as they were no drop outs. No significant differences were found in the mean plaque scores between the two groups (p=0.059) at the end of the study. Similarly, Digital Plaque Image Analysis showed no significant difference in the mean plaque scores between the groups (p= 0.93).CONCLUSION:This study showed that there are no additional benefits of using a plaque disclosing toothpaste, in enhancing the removal of the supragingival dental biofilm during routine oral hygiene maintenance.   

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