Search results for: randomized clinical trial

Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Sopana Wongtawee

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Purpose: Adequate bowel cleansing is essential for a high quality, effective and safe colonoscopy. The aims of this study were to compare the efficacy of bowel preparation based on a low-residue diet before 8:00 followed by a clear-liquid diet, and a low-residue diet until 16:00 one day before colonoscopy using sodium phosphate solution (Xubil ®), the side effects of the two protocols and the patient satisfaction with them. Method: This was an endoscopist-blinded, prospective, randomized, controlled trial. A total of 224 patients (112 in each group) scheduled for outpatient colonoscopy met the criteria.They were randomized to either a low-residue diet consisting of white rice porridge with either fish, chicken or eggs before 8:00 followed by a clear-liquid diet (Group 1) or a low-residue diet consisting of the same food and drink, until 16:00 the day before colonoscopy(Group 2). All of them received 45 ml of sodium phosphate solution (Xubil ®) and three glasses of water (300 ml/glass) the evening before and the morning of the procedure. The cleansing efficacy of bowel preparation was rated according to the modified Rajawithi hospital bowel preparation score scale, patient satisfaction with bowel preparation was rated using Likert scale, and side effects of the 2 protocols was assessed using a patient questionnaire. Results: The cleansing efficacy between the two groups was significantly different (p=0.02). Satisfaction with bowel preparation and side effects were not different, except for the feeling of hunger in the first group (p=0.001). Conclusion: The low-residue diet consisting of white rice porridge with fish, chicken or eggs until 16:00 one day before colonoscopy achieved a better bowel-cleansing efficacy than the protocol consisting of clear liquid all day and rice porridge only before 8:00 one day before colonoscopy.

Keywords: bowel preparation, colonoscopy, sodium phosphate solution, nursing management

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Authors: Ali Faisal Saleem, Farheen Quadri, Mach Ondrej, Anita Zaidi

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Purpose: Pakistan is the final frontier for a polio-free world. Chronic malnutrition is associated with lack of effective gut immunity, and possibly associated with poliomyelitis in children received multiple OPV. We evaluate IPV dose administered together with OPV results in higher immunogenicity and mucosal immunity compared to OPV alone in chronically malnourished infants. Methods AND Materials: A community-based, unblinded-randomized-trial, conducted in 5 peri-urban, low-middle-income households of Karachi, in infants 9-12 months. Two study groups were non-malnourished (HAZ= -2 or more) and chronic malnourished (HAZ <-2SD), with 2-arms each i) OPV and ii) OPV and IPV. Two blood specimens (2ml) at baseline and at day 28 and two stool specimens (6 gm.) at day 29 and after 7 days. All infants received a bOPV challenge dose after first stool specimen. Calculates sample size was 210 in each arm. Serological (baseline compared to 28 days post-vaccine) and mucosal immunity after one week of bOPV challenge dose were study outcomes. Results: Baseline seroprevalence in malnourished infants were low compared to non-malnourished (P1, P2 and P3 (p=<0.001). There is significant rise in antibody titer and P1 seroprevalence in Mal A and B after receiving study vaccine; much higher in Mal B. Infants randomized to bOPV + IPV study vaccine showed incremental immune response against P1 (Mal B, 92.2%; Nor B, 98.4%), P2 (Mal B, 90.4%; Nor B, 94.7%), and P3 (Mal B, 85.6% and Nor B, 93.5%) was observed. A significant proportion of infants in malnourished (P1, 13%; P2, 24%; P3, 26%) and normally nourished group (P1, 5%; P2, 11%; P3, 14%) were found to be seronegative at baseline. Infants who received BOPV + IPV as their study vaccine showed a very high seroconversion response after vaccine (p=<0.001 for P1, P2 and P3). Majority of the specimens were negative at baseline (Mal A, 2%, Mal B, 1%; Nor A, 2%; Nor B, 1%), and remains negative after bOPV challenge dose (Mal A, 8%, Mal B, 6%; Nor A, 11%; Nor B, 10%). Conclusion: Malnourished-infants have low poliovirus-seroprevalence that increased remarkably after IPV. There is less viral shedding after IPV in infants.

Keywords: chronic malnutrition, infants, IPV, OPV

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Authors: Ahmed Torad

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Background: Knee osteoarthritis (OA) is a prevalent musculoskeletal condition characterized by pain and functional impairment. While various rehabilitation approaches have been employed, the effectiveness of high-intensity interval training (HIIT) compared to traditional rehabilitation exercises remains unclear. Objective: This randomized controlled trial aimed to compare the effects of HIIT and traditional rehabilitation exercises on pain reduction, functional improvement, and quality of life in individuals with knee OA. Methods: A total of 120 participants diagnosed with knee OA were randomly allocated into two groups: the HIIT group (n=60) and the traditional rehabilitation group (n=60). The HIIT group participated in a 12-week supervised program consisting of high-intensity interval exercises, while the traditional rehabilitation group followed a conventional physiotherapy regimen. Outcome measures included visual analog scale (VAS) pain scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) at baseline and after the intervention period. Results: Both groups showed significant improvements in pain scores, functional outcomes (WOMAC), and quality of life (SF-36) after 12 weeks of intervention. However, the HIIT group demonstrated superior pain reduction (p<0.001), functional improvement (p<0.001), and physical health-related quality of life (p=0.002) compared to the traditional rehabilitation group. No significant differences were observed in mental health-related quality of life between the two groups. Conclusion: High-intensity interval training appears to be a more effective rehabilitation approach than traditional exercises for individuals with knee osteoarthritis, resulting in greater pain reduction, improved function, and enhanced physical health-related quality of life. These findings suggest that HIIT may represent a promising intervention strategy for managing knee OA and enhancing the overall well-being of affected individuals.

Keywords: knee osteoarthritis, high-intensity interval training, traditional rehabilitation exercises, randomized controlled trial, pain reduction, functional improvement, quality of life

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Authors: Rama Krishna Supramanian, Marzuki Isahak, Noran Naqiah Hairi

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Noise-induced hearing loss (NIHL) is one of the highest recorded occupational diseases, despite being preventable. Hearing Conservation Program (HCP) is designed to protect workers hearing and prevent them from developing hearing impairment due to occupational noise exposures. However, there is still a lack of evidence regarding the effectiveness of this program. The purpose of this study was to determine the effectiveness of a Hearing Conservation Program (HCP) in preventing or reducing audiometric threshold changes among vector control workers. This study adopts a cluster randomized controlled trial study design, with district health offices as the unit of randomization. Nine district health offices were randomly selected and 183 vector control workers were randomized to intervention or control group. The intervention included a safety and health policy, noise exposure assessment, noise control, distribution of appropriate hearing protection devices, training and education program and audiometric testing. The control group only underwent audiometric testing. Audiometric threshold changes observed in the intervention group showed improvement in the hearing threshold level for all frequencies except 500 Hz and 8000 Hz for the left ear. The hearing threshold changes range from 1.4 dB to 5.2 dB with largest improvement at higher frequencies mainly 4000 Hz and 6000 Hz. Meanwhile for the right ear, the mean hearing threshold level remained similar at 4000 Hz and 6000 Hz after 3 months of intervention. The Hearing Conservation Program (HCP) is effective in preserving the hearing of vector control workers involved in fogging activity as well as increasing their knowledge, attitude and practice towards noise-induced hearing loss (NIHL).

Keywords: adult, hearing conservation program, noise-induced hearing loss, vector control worker

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Authors: Hasan Dalgic, Fikret Akinerdem

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This trial was made to determine effect of different plant density and weed control on yield and quality of winter sowing safflower (Carthamus tinctorius L.) in Selcuk University, Agricultural Faculty trial fields and the effective substance of Trifluran was used as herbicide. Field trial was made during the vegetation period of 2009-2010 with three replications according to 'Split Plots in Randomized Blocks' design. The weed control techniques were made on main plots and row distances was set up on sub-plots. The trial subjects were consisting from three weed control techniques as fallowing: herbicide application (Trifluran), hoeing and control beside the row distances of 15 cm and 30 cm. The results were ranged between 59.0-76.73 cm in plant height, 40.00-47.07 cm in first branch height, 5.00-7.20 in number of branch per plant, 6.00-14.73 number of head per plant, 19.57-21.87 mm in head diameter, 2125.0-3968.3 kg ha-1 in seed yield, 27.10-28.08 % in crude oil rate and 531.7-1070.3 kg ha-1. According to the results, Remzibey safflower cultivar showed the highest seed yield on 30 cm of row distance and herbicide application by means of the direct effects of plant height, first branch height, number of branch per plant, number of head per plant, table diameter, crude oil rate and crude oil yield.

Keywords: safflower, herbicide, row spacing, seed yield, oil ratio, oil yield

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Authors: Onder Aldemir, Ercan Ceyhan

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The research was conducted to determine effects of salt concentrations on emergence and seedling development of chickpea genotypes. Trials were performed during the year of 2013 on the laboratory and greenhouse of Agricultural Faculty, Selcuk University. Emergency trial was set up according to ‘Randomized Plots Design’ by two factors and four replications; greenhouse trial was also set up according to ‘Randomized Plots Design’ by two factors with three replications. The chickpea genotypes; CA119, CA132, CA149, CA150, CA215, CA222, CA235, CA261, Bozkır and Gokce were used as material for both of the trials. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility, length of shoot and root, fresh weight of shoot and root, dry weight of shoot and root, index of salt tolerance were evaluated. Responses of the chickpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the chickpea genotypes showed significant reduction by depending on the increasing salt level. According to the effects of salt application, the chickpea genotypes Gokce, CA215 and CA222 were the most tolerant in respect to plant dry weights while the chickpea genotypes CA149 and CA150 were the most sensitive.

Keywords: chickpea, emergence, salt tolerant, seedling development

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Authors: Dylan Shiting Lu, Samson Okello, Anita Chunyan Wei, Daniel Xiao Li

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Mammotome vacuum-assisted breast biopsy (MVB) introduced in 1995 can be used for the removal of benign breast lesions. Whether or not MVB is a better option compared to conventional open surgery is inconclusive. We aim to compare the clinical and patient-related outcomes between MVB and open surgery to remove benign breast tumors less than 5 cm in women. We searched English and Chinese electronic databases with the keywords of Mammotome, clinical trial (CT), vacuum-assisted breast biopsy for studies comparing MVB and open surgery until May 2021. We performed a systematic review and random-effects meta-analysis to compare incision size, operation time, intraoperative blood loss, healing time, scar length, patient satisfaction, postoperative hematoma rate, wound infection rate, postoperative ecchymosis, and postoperative sunken skin among those who have Mammotome and those who have surgery. Our analysis included nine randomized CTs with 1155 total patients (575 Mammotome, 580 surgery) and mean age 40.32 years (standard deviation 3.69). We found statistically significant favorable outcomes for Mammotome including blood loss (ml) [standardized mean difference SMD -5.03, 95%CI (-7.30, -2.76)], incision size (cm) [SMD -12.22, 95%CI (-17.40, -7.04)], operation time (min) [SMD -6.66, 95%CI (-9.01, -4.31)], scar length (cm) [SMD -7.06, 95%CI (-10.76, -3.36)], healing time (days) [SMD -6.57, 95%CI (-10.18, -2.95)], and patient satisfaction [relative risk RR 0.38, 95%CI (0.13, 1.08)]. In conclusion, Mammotome vacuum-assisted breast biopsy compared to open surgery shows better clinical and patient-related outcomes. Further studies should be done on whether or not MVB is a better option for benign breast tumors excision.

Keywords: clinical and patient outcomes, open surgery, Mammotome vacuum-assisted breast biopsy, meta-analysis

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Authors: Vivek Kumar

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The effects of physical activity on the human body have been well understood. It just not only keeps us healthy and away from many diseases but also helpful in delay ageing. Those who exercise every day are physically as well as mentally strong. As the age advance, we often see that there is a loss of memory in the elderly people and their retention power weaken with time. The association between physical health and mental health of elderly people nowadays is an important topic of research. Many people at their old age who all were suffering from Alzheimer or Parkinson disease or were at the stage of dementia have been benefited significantly on exercise at daily basis. We would conduct a randomized control trial, where we will select a number of old age people (65 years old or above). These selected old age people will have some sorts of mental illness and currently receiving treatment for the same. We will divide them into 3 groups. The first group of people will receive their normal treatment i.e. taking medicines. The second group of people will receive medicine as well as will do exercise for 45 minutes every day in the early morning, the 3rd group of people will do exercise everyday for 45 minutes but will be given placebo instead of medicine. All the member of these groups will be monitored carefully for 6 months of time and making this sure that all the members of the group are taking medicines or doing exercise according to the group they belong to. The mental status of all the participants will be measured; the data will be analyzed accordingly. Expected results- This research will be helpful in establishing the effect of exercise on the mental health of the old age people. Also, it will be examined that whether the medicines along with regular exercise for can months can cure the mental illness significantly.

Keywords: mental health, elderly people, physical activity, randomized control trial

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Authors: Deepak Nathiya1, Ramesh Roop Rai, Pratima Singh1, Preeti Raj1, Supriya Suman, Balvir Singh Tomar

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Background: Sarcopenia is a catabolic state in liver cirrhosis (LC), accelerated with a breakdown of skeletal muscle to release amino acids which adversely affects survival, health-related quality of life, and response to any underlying disease. The primary objective of the study was to investigate the long-term effect of branched-chain amino acids (BCAA) supplementations on parameters associated with improved prognosis in sarcopenic patients with LC, as well as to evaluate its impact on cirrhotic-related events. Methods: We carried out a 24 week, single-center, randomized, open-label, controlled, two cohort parallel-group intervention trial comparing the efficacy of BCAA against lactoalbumin (L-ALB) on 106 sarcopenic liver cirrhotics. The BCAA (intervention) group was treated with 7.2 g BCAA per whereas, the lactoalbumin group was also given 6.3 g of L-Albumin. The primary outcome was to assess the impact of BCAA on parameters of sarcopenia: muscle mass, muscle strength, and physical performance. The secondary outcomes were to study combined survival and maintenance of liver function changes in laboratory and clinical markers in the duration of six months. Results: Treatment with BCAA leads to significant improvement in sarcopenic parameters: muscle strength, muscle function, and muscle mass. The total cirrhotic-related complications and cumulative event-free survival occurred fewer in the BCAA group than in the L-ALB group. Prognostic markers also improved significantly in the study. Conclusion: The current clinical trial demonstrated that long-term BCAAs supplementation improved sarcopenia and prognostic markers in patients with advanced liver cirrhosis.

Keywords: sarcopenia, liver cirrhosis, BCAA, quality of life

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Authors: Edo Shonin, William Van Gordon, Mark D. Griffiths

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Due to its potential to concurrently improve Work-Related Wellbeing (WRW) and job performance; occupational stakeholders are becoming increasingly interested in meditation. Despite this, there is a scarcity of methodologically robust research examining the utility of meditation within occupational contexts. This study conducted the first randomized controlled trial to assess the effects of meditation on outcomes relating to both WRW and job performance. Office-based middle-hierarchy managers (n=152) were allocated to either an eight-week meditation intervention (Meditation Awareness Training: MAT) or an active control intervention. MAT participants demonstrated significant improvements (with strong effect-sizes) over control-group participants in levels of work-related stress, job satisfaction, psychological distress, and employer-rated job performance. It is concluded that MAT appears to be effective for improving both WRW and job performance in middle-hierarchy managers. There are a number of novel implications: (i) meditation can effectuate a perceptual shift in how employees experience their work and psychological environment and may thus constitute a cost-effective WRW intervention, (ii) meditation-based (i.e., present-moment-focused) working styles may be more effective than goal-based (i.e., future-orientated) working styles, and (iii) meditation may reduce the separation made by employees between their own interests and those of the organizations they work for.

Keywords: work-related stress, workplace wellbeing, occupational stress, job performance, meditation awareness training, mindfulness

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Authors: Richard Tanaka, Ying Zhu

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This paper studies a few randomized algorithms in application-layer peer-to-peer networks. The significant gain in scalability and resilience that peer-to-peer networks provide has made them widely used and adopted in many real-world distributed systems and applications. The unique properties of peer-to-peer networks make them particularly suitable for randomized algorithms such as random walks and gossip algorithms. Instead of simulations of peer-to-peer networks, we leverage the Docker virtual container technology to develop implementations of the peer-to-peer networks and these distributed randomized algorithms running on top of them. We can thus analyze their behaviour and performance in realistic settings. We further consider the problem of identifying high-risk bottleneck links in the network with the objective of improving the resilience and reliability of peer-to-peer networks. We propose a randomized algorithm to solve this problem and evaluate its performance by simulations.

Keywords: distributed randomized algorithms, peer-to-peer networks, virtual container technology, resilient networks

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Authors: Moon Jung Kim, Guil Rhim

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The clinical sensitivity of the “VEUPLEXTM TBI assay”, a clinical trial medical device, in mild traumatic brain injury was 28.6% (95% CI, 19.7%-37.5%), and the clinical specificity was 94.0% (95% CI, 89.3%). -98.7%). In addition, when the results analyzed by marker were put together, the sensitivity was higher when interpreting the two tests together than the two tests, UCHL1 and GFAP alone. Additionally, when sensitivity and specificity were analyzed based on CT results for the mild traumatic brain injury patient group, the clinical sensitivity for 2 CT-positive cases was 50.0% (95% CI: 1.3%-98.7%), and 19 CT-negative cases. The clinical specificity for cases was 68.4% (95% CI: 43.5% - 87.4%). Since the low clinical sensitivity for the two CT-positive cases was not statistically significant due to the small number of samples analyzed, it was judged necessary to secure and analyze more samples in the future. Regarding the clinical specificity analysis results for 19 CT-negative cases, there were a large number of patients who were actually clinically diagnosed with mild traumatic brain injury but actually received a CT-negative result, and about 31.6% of them showed abnormal results on VEUPLEXTM TBI assay. Although traumatic brain injury could not be detected in 31.6% of the CT scans, the possibility of actually suffering a mild brain injury could not be ruled out, so it was judged that this could be confirmed through follow-up observation of the patient. In addition, among patients with mild traumatic brain injury, CT examinations were not performed in many cases because the symptoms were very mild, but among these patients, about 25% or more showed abnormal results in the VEUPLEXTM TBI assay. In fact, no damage is observed with the naked eye immediately after traumatic brain injury, and traumatic brain injury is not observed even on CT. But in some cases, brain hemorrhage may occur (delayed cerebral hemorrhage) after a certain period of time, so the patients who did show abnormal results on VEUPLEXTM TBI assay should be followed up for the delayed cerebral hemorrhage. In conclusion, it was judged that it was difficult to judge mild traumatic brain injury with the VEUPLEXTM TBI assay only through clinical findings without CT results, that is, based on the GCS value. Even in the case of CT, it does not detect all mild traumatic brain injury, so it is difficult to necessarily judge that there is no traumatic brain injury, even if there is no evidence of traumatic brain injury in CT. And in the long term, more patients should be included to evaluate the usefulness of the VEUPLEXTM TBI assay in the detection of microscopic traumatic brain injuries without using CT.

Keywords: brain injury, traumatic brain injury, GFAP, UCHL1

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Authors: R. Botrugno, S Basyuni, G. Nugent, I. Jenkyn, A. Ferro, H. Bennett, C. Hjalmarsson, J. Chu, V. Santhanam

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This trainee led randomised controlled trial (RCT) aims to assess various outcomes for resorbable versus non-resorbable sutures for traumatic lacerations to the face. Within this trial of resorbable versus non-resorbable sutures for traumatic lacerations of the face (TORNFace), patient recruitment was facilitated by trainees who were employed at an NHS University Teaching Hospital in the United Kingdom. The trainees received appropriate training prior to recruiting patients for the trial. This included the completion of a national research e-learning module and face-to-face training that was provided locally. The locally delivered training provided an understanding of the eligibility criteria for the trial and the consent process. Existing trainee skills were utilised involving clinical photography to record baseline data and delivering the intervention based on the treatment arm selected. Eligible patients who required primary closure of traumatic lacerations of the face were randomised into one of two treatment arms. These comprised of resorbable (vicryl rapide) or non-resorbable sutures (ethilon). Primarily the cosmetic outcome was assessed. Secondary outcomes included: complications rates, health care economics, and patient-reported outcomes. Remote follow-up of recruited patients utilised photographs of the facial laceration which had received the intervention. These took place at 1 week, 3 months and 6 months post-intervention. This study aims to demonstrate an example of trainee-led research within the specialty of oral and maxillofacial surgery. The available data for the randomised controlled trial will also be presented.

Keywords: laceration, suture, trauma, trial

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Authors: Maryam Panahi

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Background: Adjuvants such as ketamine, promethazine, and paracetamol could bring up patient's satisfaction and control the harmful effects of opioids besides lessening their needed doses, as seen by the fentanyl/paracetamol and fentanyl/ketamine combination before. The current study is headed to compare paracetamol and ketamine, in addition to fentanyl, applied by infusion pumps in order to pain relief following major surgery. Materials and Methods: Through a double-blinded, randomized clinical trial, patients between18 and 65 with elective surgery for tight or leg fractures with ASA Class 1 and 2 referred to a university hospital in Arak, a town in the central region of Iran, were recruited and used infusion pump for their postoperative pain control. The participants were divided into cases and controls regarding using ketamine/fentanyl (KF) or paracetamol/fentanyl (PF) infusion pumps. Results: The mean pain score was a total of 3.87, with the highest value in KF (5.06) and the lowest in PF (4.50) immediately after finishing the surgery and getting conscious when started using an infusion pump. There was no statistical difference between the groups in this regard. Concerning the side effects of the applied medications, blood pressure and heart rate had no differences comparing the groups. Conclusion: This study showed that paracetamol used in infusion pumps could be brilliant in pain control after major surgeries like those done in lower extremities and joint replacement while lessening opioid use. Although paracetamol was more effective than ketamine in the current trial, more qualified studies at bigger sizes and in other fields of surgery besides orthopedic ones would be useful to support the effects if applicable

Keywords: infusion pump, Ketamine, Paracetamol, pain

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Authors: Ayon Mukherjee

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Covariate-adjusted response-adaptive (CARA) designs use the available responses to skew the treatment allocation in a clinical trial in towards treatment found at an interim stage to be best for a given patient's covariate profile. Extensive research has been done on various aspects of CARA designs with the patient responses assumed to follow a parametric model. However, ranges of application for such designs are limited in real-life clinical trials where the responses infrequently fit a certain parametric form. On the other hand, robust estimates for the covariate-adjusted treatment effects are obtained from the parametric assumption. To balance these two requirements, designs are developed which are free from distributional assumptions about the survival responses, relying only on the assumption of proportional hazards for the two treatment arms. The proposed designs are developed by deriving two types of optimum allocation designs, and also by using a distribution function to link the past allocation, covariate and response histories to the present allocation. The optimal designs are based on biased coin procedures, with a bias towards the better treatment arm. These are the doubly-adaptive biased coin design (DBCD) and the efficient randomized adaptive design (ERADE). The treatment allocation proportions for these designs converge to the expected target values, which are functions of the Cox regression coefficients that are estimated sequentially. These expected target values are derived based on constrained optimization problems and are updated as information accrues with sequential arrival of patients. The design based on the link function is derived using the distribution function of a probit model whose parameters are adjusted based on the covariate profile of the incoming patient. To apply such designs, the treatment allocation probabilities are sequentially modified based on the treatment allocation history, response history, previous patients’ covariates and also the covariates of the incoming patient. Given these information, an expression is obtained for the conditional probability of a patient allocation to a treatment arm. Based on simulation studies, it is found that the ERADE is preferable to the DBCD when the main aim is to minimize the variance of the observed allocation proportion and to maximize the power of the Wald test for a treatment difference. However, the former procedure being discrete tends to be slower in converging towards the expected target allocation proportion. The link function based design achieves the highest skewness of patient allocation to the best treatment arm and thus ethically is the best design. Other comparative merits of the proposed designs have been highlighted and their preferred areas of application are discussed. It is concluded that the proposed CARA designs can be considered as suitable alternatives to the traditional balanced randomization designs in survival trials in terms of the power of the Wald test, provided that response data are available during the recruitment phase of the trial to enable adaptations to the designs. Moreover, the proposed designs enable more patients to get treated with the better treatment during the trial thus making the designs more ethically attractive to the patients. An existing clinical trial has been redesigned using these methods.

Keywords: censored response, Cox regression, efficiency, ethics, optimal allocation, power, variability

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Authors: Sandip Tambare, Revati Ghadge

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Alcohol withdrawal syndrome continue to be concerning health issue worldwide in alcoholics. Many current option for treating alcohol withdrawal signs are habit forming causing dependency of sedatives. The divine science of Ayurveda recommends Nasya for improvement of alcohol withdrawal signs. As per the latest reports 1/3 of the Indian population is using alcohol in an unhealthy manner, the complication being wide and varied among which, the Alcohol Withdrawal Syndrome is the dominant one. The presentation varies from mild sleep loss or anxiety to delirium. Ayurveda has given utmost in the context of Madatyaya(Alcoholism). Various protocols based on the identification of the status of tridoshas are explained which includes sodhana, samana and satwavachaya chikitsa. Various medications are being used, with appreciated effects in the clinical practice. As per reports, the panchakarma procedure nasya seems highly effective, in managing of the alcohol withdrawal syndrome. Nasya with Ksheerabala Taila is given for 7 days in the condition of Alcohol Withdrawal syndrome and it was the non Randomized trial with 30 subjects satisfying the DSM V criteria for alcohol withdrawl and the assessment was done using the Clinical Institute Withdrawal Assessment for Alcohol Scale revised (CIWA-Ar). Conclusion: Among the symptoms which were studied after the interventions, it was found that there was high significant response in almost all the symptoms in the given subjects. The eternal science of Ayurveda is able to answer the existing problem of alcohol and its abuse in the society.

Keywords: nasya, alcohol withdrawal, madatyaya, ksheerabala taila

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Authors: Neda Jamalimoghadam, Naval Heydari, Maliheh Abootalebi, Maryam Kasraeian, M. Emamghoreishi , Akbarzadeh Marzieh

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Background: The aim was to investigate the effect of aromatherapy using Citrus aurantium blossom essential oil on premenstrual syndrome in university students. Methods: In this double-blind clinical trial was controlled on 62 students from March 2016 to February 2017. The intervention with 0.5% of C. Aurantium blossom essential oil and control was inhalation of odorless sweet almond oil in the luteal phase of the menstrual cycle. The screening questionnaire (PSST) for PMSwas filled out before and also one and two months after the intervention. Results: Mean score of overall symptoms of PMS between the Bitter orange and control groups In the first (p < 0.003) and second months (p < 0.001) of the intervention was significant. Besides, decreased the mean score of psychological symptoms in the intervention group (p < 0.001), but on physical symptoms and social function were not significant (p > 0.05). Conclusion: The aromatherapy with Citrus aurantium blossom improved the symptoms of premenstrual syndrome.

Keywords: aromatherapy, Citrus Aurantium, premenstrual syndrome, oil, students

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Authors: Moustafa Ibrahim Moustafa

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The purpose of this study was to determine the immediate and long term effects of a multimodal program, with the addition of cervical sagittal curve restoration and forward head correction, on severity of dizziness, disability, frequency of dizziness, and severity of cervical pain. 72 patients with cervicogenic dizziness, definite hypolordotic cervical spine, and forward head posture were randomized to experimental or a control group. Both groups received the multimodal program, additionally, the study group received the Denneroll cervical traction. All outcome measures were measured at three intervals. The general linear model indicated a significant group × time effects in favor of experimental group on measures of anterior head translation (F=329.4 P < .0005), cervical lordosis (F=293.7 P < .0005), severity of dizziness (F=262.1 P < .0005), disability (F=248.9 P < .0005), frequency of dizziness (F=53.9 P < .0005), and severity of cervical pain (F=350.1 P < .0005). The addition of Dennroll cervical traction to a multimodal program can positively affect dizziness management outcomes.

Keywords: randomized controlled trial, traction, dizziness, cervical

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Authors: P. Akbartehrani, M. Khaledi Pour, M. Amini, M. Khani, M. Mohajeri Tehrani, E. Ghasemi, P. Charipoor, B. Shokri

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A common problem between diabetic patients is foot ulcers which are chronic and require specialized treatment. Previous studies illustrate that Cold atmospheric plasma (CAP) has beneficial effects on wound healing and infection. Nevertheless, the comparison of different cap exposure protocols in diabetic ulcer wound healing remained to be studied. This study aims to determine the effect of two different exposure protocols on wound healing in diabetic ulcers. A prospective, randomized clinical trial was conducted at two clinics. Diabetic patients with G1 and G2 wanger classification diabetic foot ulcers were divided into two groups of study. One group was treated by the first protocol, which was treating wounds by argon-generated cold atmospheric plasma jet once a week for five weeks in a row. The other group was treated by the second protocol, which was treating wounds every three days for five weeks in a row. The wounds were treated for 40 seconds/cubic centimeter, while the nozzle tip was moved nonlocalized 1 cm above the wounds. A patient with one or more wounds could participate in different groups as wounds were separately randomized, which allow a participant to be treated several times during the study. The study's significant findings were two different reductions rate in wound size, microbial load, and two different healing speeds. This study concludes that CAP therapy by the second protocol yields more effective healing speeds, reduction in wound sizes, and microbial loads of foot ulcers in diabetic patients.

Keywords: wound healing, diabetic ulcers, cold atmospheric plasma, cold argon jet

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Authors: Simin Shahvazi, Sepideh Soltani, Seyed Mehdi Ahmadi, Russell J. De Souza, Amin Salehi-Abargouei

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Background and Objectives: Vitamin D has received attention for its potential to disrupt cancer processes such as attenuating cell proliferation and exacerbating differentiation and apoptosis. However, whether there exists a role for vitamin D in the treatment of prostate cancer specifically remains controversial. We systematically review the literature to assess whether supplementation with vitamin D influences PSA response and overall survival in patients with prostate cancer. Methods: We searched PubMed, Scopus, ISI Web of Science and Google scholar from inception through up to 10 September 2017 for both before-and-after and randomized trials that evaluated the effect of vitamin D supplementation on the prostate specific antigen (PSA) response rate in participants with prostate cancer. The DerSimonian and Laird, inverse-weighted random-effects model was used to pool effect estimates from the studies. Heterogeneity and potential publication bias were evaluated. Subgroup analyses were also performed. Results: Twenty-two studies (16 before-after and 6 randomized controlled trials) were found and included in meta-analysis. The analysis on controlled clinical trials revealed that PSA change from baseline [weighted mean difference (WMD) = -1.66 ng/ml, 95%CI: -0.69, 0.36, P= 0.543)], PSA response (RR=1.18, 95%CI: 0.97, 1.45, P=0.104) and mortality rate (risk ratio (RR) = 1.05, 95% CI: 0.81-1.36; P=0.713) was not significantly different between vitamin D supplementation and placebo groups. Single arm trials revealed that vitamin D supplementation had had a modest effect on PSA response rate: 19% of those enrolled had at least a 50% reduction in PSA by the end of treatment (95% CI: 7% to 31%; p=0.002). Conclusion: We found that vitamin D modestly increases the PSA response rate in single arm studies. No effect on serum PSA levels, PSA response and mortality was seen in randomized controlled clinical trials. It does not seem patients with prostate cancer benefit from vitamin D supplementation.

Keywords: mortality, prostatic neoplasms, PSA response, vitamin D

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Authors: Faezeh Jahanpour, Shahin Dezhdar, Saeedeh Firouz Bakht, Afshin Ostovar

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Objective: The hospitalized premature babies often undergo various painful procedures such as venous sampling. The Kangaroo mother care (KMC) method is one of the pain reduction methods, but as mother’s presence is not always possible, this research was done to compare the effect of swaddling and KMC method on venous sampling pain on premature neonates. Methods: In this randomized clinical trial 90 premature infants selected and randomly alocated into three groups; Group A (swaddling), Group B (the kangaroo care), and group C (the control). From 10 minutes before blood sampling to 2 minutes after that in group A, the infant was wrapped in a thin sheet, and in group B, the infant was under Kangaroo care. In all three groups, the heart rate and arterial oxygen saturation in time intervals of 30 seconds before, during, 30-60-90, and 120 seconds after sampling were measured and recorded. The infant’s face was video recorded since sampling till 2 minutes and the videos were checked by a researcher who was unaware of the kind of intervention and the pain assessment tools for infants (PIPP) for time intervals of 30 seconds were completed. Data analyzed by t-test, Q square, Repeated Measure ANOVA, Kruskal-Wallis, Post-hoc and Bonferroni test. Results: Findings revealed that the pain was reduced to a great extent in swaddling and kangaroo method compared to that in control group. But there was not a significant difference between kangaroo and swaddling care method (P ≥ 0.05). In addition, the findings showed that the heart rate and arterial oxygen saturation was low and stable in swaddling and Kangaroo care method and returned to base status faster, whereas, the changes were severe in control group and did not return to base status even after 120 seconds. Discussion: The results of this study showed that there was not a meaningful difference between swaddling and kangaroo care method on physiological indexes and pain in infants. Therefore, swaddling method can be a good substitute for kangaroo care method in this regard.

Keywords: Kangaroo mother care, neonate, pain, premature, swaddling, venipuncture,

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Authors: Masoumeh Khailghi Sikaroudi, Mohsen Masoodi, Fazad Shidfar, Meghdad Sedaghat

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Background: The hypertonicity of internal anal sphincter resting pressure is one of the main reasons for chronic anal fissures. The aim of this study is to assess the effect of oral administration of L-arginine on anal fissure symptom improvement by relaxation of the internal anal sphincter. Method: Seventy-six chronic anal fissure patients (age: 18-65 years) took part in this randomized, double-blind, placebo-controlled trial study from February 2019 to October 2020 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were allocated into treatment (L-arginine) or placebo groups. They took a 1000 mg capsule three times a day for one month and were followed up at the end of the first and third months after receiving the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. Result: The analysis of data was shown significant improvement in bleeding, fissure size, and pain within each group; however, this effect was more seen in the arginine group compared to the control group at the end of the study (P-values<0.001). Following that, a significant increase in QoL was seen just in patients who were treated with arginine (P-value=0.006). Also, the comparison of anal pressures to baseline and between groups at the end of the study showed a significant reduction in sphincter pressure in treated patients (P-value<0.001, =0.049; respectively). Conclusion: Oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing anal internal sphincter pressure with fewer side effects. However, a long-term study with more follow-up is recommended.

Keywords: L-arginine, anal fissure, sphincter pressure, clinical symptoms, quality of life

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Authors: Davit Khachatryan, Shuo Xiang

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Numerous published studies on the use of prazosin in the treatment of PTSD-related sleep disturbances in adult population have resulted in updates to the recommendation for prazosin for nightmares that showed its strength of evidence elevated from C to B in the US Department of Veterans Affairs clinical practice guideline. In addition, the American Academy of Sleep Medicine clinical practice guideline gave prazosin a level-A recommendation for the treatment of PTSD-associated nightmares. The aim of this review is to summarize the available literature for prazosin use for nightmares and other sleep disturbances in children and adolescents with PTSD. Method: A comprehensive search for studies on prazosin use for sleep disturbances in child and adolescent population with PTSD has been performed. We looked at MEDLINE, EMBASE, PsycINFO, CINAHL, AMED, Scopus, Web of Science, and Cochrane CENTRAL databases. Results: Compared to adult population with similar psychopathology, the available literature in child and adolescent population is scarce. Despite increased interest in prazosin in the management of PTSD, only six studies investigating this medication in children and adolescents have been published. Conclusion: A large randomized control trial on this topic is needed for more definite evidence on the efficacy and safety of prazosin in the treatment of nightmares in children and adolescents with PTSD.

Keywords: guidelines, prazosin, PTSD, sleep disturbance

Procedia PDF Downloads 362

Authors: Kristin Lewis, Howard Steele, Anne Murphy, Miriam Steele, Karen Bonuck, Paul Meissner

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The present study examines data collected during the randomized control trial (RCT) of the Group Attachment-Based Intervention (GABI©), a trauma-informed, attachment-based intervention aimed at promoting healthy parent-child relationships that support child development. Families received treatment at Treatment Center and were randomly assigned to either the GABI condition or the treatment as usual condition, a parenting class called Systematic Training for Effective Parenting (STEP). Significant improvements in the parent-child relationship have been reported for families participating in GABI, but not in the STEP control group relying on Coding Interactive Behavior (CIB) as applied to 5-minute video-films of mothers and their toddlers in a free play context. This report considers five additional attachment-relevant 'clinical codes' that were also applied to the 5-minute free play sessions. Seventy-two parent-child dyads (38 in GABI and 34 in STEP) were compared to one another at intake and end-of-treatment, on these five-point dimensions: two-parent codes—the dissociation and ignoring; two child codes—simultaneous display of contradictory behavior and fear; and one parent-child code, i.e., role reversal. Overall, scores were low for these clinical codes; thus, a binary measure was computed contrasting no evidence with some evidence of each clinical code. Crosstab analyses indicate that child fear at end-of-treatment was significantly lower among children who participated in GABI (7% or 3 children) as compared to those whose mothers participated in STEP (29% or 10 children) Chi Sq= 6.57 (1), p < .01. Discussion focuses on the potential for GABI to reduce childhood fearfulness and so enhance the child's health.

Keywords: coding interactive behavior, clinical codes, group attachment based intervention, GABI, attachment, fear

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Authors: Andreas Aceranti, Stefano Costa

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The aim of this study was to demonstrate that manipulative treatment combined with therapeutic exercisetherapywas more effective than isolated therapeutic exercise in the short-term treatment of eye convergence disorders in boxers. A randomized controlled trial (RCT) pilot trial was performed at our physiotherapy practices. 30 adult subjects who practice the discipline of boxing were selected after an initial skimming defined by the Convergence Insufficiency Symptom Survey (CISS) test (results greater than or equal to 10) starting from the initial sample of 50 subjects; The 30 recruits were evaluated by an orthoptist using prisms to know the diopters of each eye and were divided into 2 groups (experimental group and control group). The members of the experimental group were subjected to manipulation of the lateral strain of sphenoid from the side contralateral to the eye that had fewer diopters and were subjected to a sequence of 3 ocular motor exercises immediately after manipulation. The control group, on the other hand, received only ocular motor treatment. A secondary outcome was also drawn up that demonstrated how changes in ocular motricity also affected cervical rotation. Analysis of the data showed that the experimental treatment was in the short term superior to the control group to astatistically significant extent both in terms of the prismatic delta of the right eye (0 OT median without manipulation and 10 OT median with manipulation) and that of the left eye (0 OT median without manipulation and 5 OT median with manipulation). Cervical rotation values also showed better values in the experimental group with a median of 4° in the right rotation without manipulation and 6° with thrust; the left rotation presented a median of 2° without manipulation and 7° with thrust. From the results that emerged, the treatment was effective. It would be desirable to increase the sample number and set up a timeline to see if the net improvements obtained in the short term will also be maintained in the medium to long term.

Keywords: boxing, basilar spheno synchondrosis, ocular convergence deficit, osteopathic treatment

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Authors: Jeewantha Ranawaka, Gunawardane Kapila, Wijethunaga Mudiyanselage B. G. Jayathilake

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Introduction: Sweeping of the membranes is a fairly simple technique that may positively influence the shift from maintenance of pregnancy to the beginning of labor. Objective: To assess the effectiveness and acceptability of twice versus once-only membrane sweeping in uncomplicated primi gravid at 40 weeks of gestational age in a tertiary care hospital in Sri Lanka. Methods: A randomized controlled clinical trial was done in Ward 05 of Teaching Hospital, Kandy. The participants were primi-gravida with a singleton live fetus who was at 40 weeks of gestation with intact fetal membranes and with a Modified Bishop’s score <5. After randomization both groups received membrane sweeping at 40 weeks of gestation and the experimental group received membrane sweeping after 48 hours (40+2 days). The modified Bishop Score was assessed at 40+5 days. In two groups who did not go into natural labor at 40+5 days were managed according to the ward policy of cervical ripening and with labor induction at 40+5 days. Two different methods were used to assess discomfort and pain. Patient acceptability was assessed using recommendation to another patient and acceptance during next pregnancy. Perinatal, maternal and labour outcomes were assessed. Results: A change of the Bishops score was 67.3% (n= 31 of 46) in experimental group whereas in control group it was 57.5% (n= 38 of 66). (p = 0.21, OR-1.52, CI = 0.6 -3.34). Mean (SD) of Modified Bishop score was 6.36 (1.94) in experimental group and 6.03 (.84) in control group (p = 0.354). The probability of having the spontaneous onset of labour in experimental group was 61.6% (n=74 of 120) whereas in control group it was 45% (n= 54 of 120) (p=0.01, OR-1.966, CI = 1.17 – 3.28 NNT = 5.99). Recommending the method to another among experimental group was 75% (n= 90 of 120) whereas in control group it was 79.2% (n= 95 of 120) (p= 0.443). Accepting membrane Sweeping for subsequent pregnancy among experimental was 72.5% (n=87 of 120) whereas in control group was 72.5% (n=87 of 120) (p= 1.00) Need of formal induction of labour at 40+ 5 days in experimental group was 38.4% (n=46 of 120) whereas in control group was 61.6% (n=66 of 120) (p=0.01, OR=0.5, CI= 0.3 – 0.8, NNT=6). Neonatal outcome, labour outcome such as Cesarean -section rate, need for augmentation and maternal complications such as fever, Premature rupture of membrane, bleeding were comparable in two groups. Conclusions and Recommendations: It can be concluded that twice sweeping of membrane was effective to reduce the need of formal induction of labour and increase the chances of having spontaneous onset of labour (SOL) at 40+5 days without increasing maternal or fetal morbidity. Acceptability of twice sweeping is not different from sweeping once. Hence we recommend consideration of multiple membranes sweeping as first line for women at 40 weeks of gestation.

Keywords: acceptability, induction, labour, membrane sweeping

Procedia PDF Downloads 279

Authors: Fasanmi Samuel Sunday

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This study investigated the influence of gender and personality traits on emotional distress among awaiting trial inmates in Nigeria. Participants were three hundred and twenty (320) awaiting trial inmates, drawn from three main correctional centres in Northeast Nigeria, namely: Gashua Correctional Centre, Postiskum Correctional Centre, and Bauchi Correctional Centre. Expo facto research design was adopted. Questionnaires such as the Big Five Inventory and the Perceived Emotional Distress Inventory (PEDI) were used to measure the variables of the study. Three hypotheses were tested. Logistic regression was used for data analysis. Results of the analysis indicated that conscientiousness significantly predicted emotional distress among awaiting trial inmates. However, most of the identified personality traits did not significantly predict emotional distress among awaiting trial inmates. There was no significant gender difference in emotional distress among awaiting-trial inmates. The implications of the study were discussed.

Keywords: personality traits, emotional distress, awaiting-trial inmates, gender

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Authors: Amin Davoudi

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Aim: New approaches have been introduced to improve soft tissue indices of the dental implants. This systematic review aimed to investigate the effect of computer-aided design and computer-assisted manufacture (CAD/CAM) zirconia (Zr) implant abutments on periodontal aspects. Materials and Methods: Five electronic databases were searched thoroughly based on prior defined MeSH and non-MeSH keywords. Clinical studies were collected via hand searches in English language journals up to September 2020. Interproximal papilla stability, papilla recession, pink and white esthetic score (PES, WES), bone and gingival margin levels, color, and contour of soft tissue were reviewed. Results: The initial literature search yielded 412 articles. After the evaluation of abstracts and full texts, six studies were eligible to be screened. The study design of the included studies was a prospective cohort (n=3) and randomized clinical trial (n=3). The outcome was found to be significantly better for Zr than titanium abutments, however, the studies did not show significant differences between stock and CAD/CAM abutments. Conclusion: Papilla fill, WES, PES, and the distance from the contact point to dental crest bone of adjacent tooth and inter-tooth–implant distance were not significantly different between Zr CAD/CAM and Zr stock abutments. However, soft tissue stability and recession index were better in Zr CAD/CAM abutments.

Keywords: zirconia, CADCAM, periodental, implant

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Authors: Ifeoma C. Afiaenyi, Elizabeth K. Ngwu, Rufina N. B. Ayogu

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Diabetes has crept into the rural areas of Nigeria, causing devastating effects on its sufferers; most of them could not afford diabetic medications. Moringa oleifera has been used extensively in animal models to demonstrate its antilipidaemic and haematinic qualities; however, there is a scarcity of data on the effect of graded levels of Moringa oleifera leaves on the lipid profile and hematological parameters in human diabetic subjects. The study determined the effect of Moringa oleifera leaves on the lipid profile and hematological parameters of type 2 diabetic subjects in Ukehe, a rural Nigerian community. Twenty-four adult male and female diabetic subjects were purposively selected for the study. These subjects were shared into four groups of six subjects each. The diets used in the study were isocaloric. A control group (diabetics, group 1) was fed diets without Moringa oleifera leaves. Experimental groups 2, 3 and 4 received 20g, 40g and 60g of Moringa oleifera leaves daily, respectively, in addition to the diets. The subjects' lipid profile and hematological parameters were measured prior to the feeding trial and at the end of the feeding trial. The feeding trial lasted for fourteen days. The data obtained were analyzed using the computer program Statistical Product for Service Solution (SPSS) for windows version 21. A Paired-samples t-test was used to compare the means of values collected before and after the feeding trial within the groups and significance was accepted at p < 0.05. There was a non-significant (p > 0.05) decrease in the mean total cholesterol of the subjects in groups 1, 2 and 3 after the feeding trial. There was a non-significant (p > 0.05) decrease in the mean triglyceride levels of the subjects in group 1 after the feeding trial. Groups 1 and 3 subjects had a non-significant (p > 0.05) decrease in their mean low-density lipoprotein (LDL) cholesterol after the feeding trial. Groups 1, 2 and 4 had a significant (p < 0.05) increase in their mean high-density lipoprotein (HDL) cholesterol after the feeding trial. A significant (p < 0.05) decrease in the mean hemoglobin level was observed only in group 4 subjects. Similarly, there was a significant (p < 0.05) decrease in the mean packed cell volume of group 4 subjects. It was only in group 4 that a significant (p < 0.05) decrease in the mean white blood cells of the subjects was also observed. The changes observed in the parameters assessed were not dose-dependent. Therefore, a similar study of longer duration and more samples is imperative to authenticate these results.

Keywords: anemia, diabetic subjects, lipid profile, moringa oleifera

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