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Abstract Introduction Physicians frequently use point-of-care ultrasound for intravenous access and bloodwork in the ED. Recently, AIUM and ACEP released recommendations on ultrasound-guided peripheral intravenous lines (USPIVs), but there are no agreed upon standardized policies. We sought to determine whether the use of sterile-covered transducers (SCT) decreases the rate of contamination when compared to uncovered transducers (UCT) after standard low-level disinfection (LLD). Methods This is a randomized control trial comparing contamination rates of US transducers between SCT and UCT after their use for USPIV by the vascular access team, also known as the “PICC” team, over a 3-month period. A sample of admitted patient with an USPIV order were included and randomized to SCT (experimental) or UCT (control) arms. Transducers were swabbed and inserted into the SystemSURE Plus Adenosine Triphosphate (ATP) Luminometer to calculate Relative Light Units (RLU). We performed a cost analysis of requiring sterile covers for USPIVs. Results The UCT and SCT arms contained 35 and 38 patients, respectively. The SCT group had a mean of 0.34 compared to the UCT group mean of 2.29. Each sterile cover costs $8.49, and over 3000 USPIVs are placed annually by the “PICC” team. Conclusion Contamination rates were similar among the UCT and SCT groups after LLD. 254 inpatient USPIVs are performed monthly, not including failed attempts or covers used in the ED where USPIV placement is an essential part of ED workflow. This study suggests that the use of SCT does not significantly affect transducer contamination rates. These findings question burdensome regulatory hospital policies that are not evidence-based.

Abstract Purpose This study aimed to assess the impact of the Nursing Spiritual Care Module on the competence of nurses in providing spiritual care in the context of Malaysia. Method This study employed an experimental design and involved a total of 122 nurses, with 59 in the experimental group and 63 in the control group. Participants were selected from palliative care wards associated with Hospital Universiti Sains Malaysia. Nurses in the experimental group underwent a two-week educational module on nursing spiritual care, while nurses in the control group attended a single lecture on spiritual care provided by the hospital. Results The results indicated no significant differences in sociodemographic characteristics between the two groups. A significant difference in spiritual care competence within the intervention group and the control group over time (p-value = 0.001), between the two groups (p-value = 0.038), and in the interaction between time and group (p-value = 0.001). Conclusion The Nursing Spiritual Care Module is crucial in aiding nurses and healthcare professionals in cultivating the appropriate and wholesome attitudes and practices necessary to address the spiritual needs of patients.

Introduction: Physicians frequently use point-of-care ultrasound for intravenous access and bloodwork in the ED. Recently, AIUM and ACEP released recommendations on ultrasound-guided peripheral intravenous lines (USPIVs), but there are no agreed upon standardized policies. We sought to determine whether the use of sterile-covered transducers (SCT) decreases the rate of contamination when compared to uncovered transducers (UCT) after standard low-level disinfection (LLD). Methods: This is a randomized control trial comparing contamination rates of US transducers between SCT and UCT after their use for USPIV by the vascular access team, also known as the "PICC" team, over a 3-month period. A sample of admitted patient with an USPIV order were included and randomized to SCT (experimental) or UCT (control) arms. Transducers were swabbed and inserted into the SystemSURE Plus Adenosine Triphosphate (ATP) Luminometer to calculate Relative Light Units (RLU). We performed a cost analysis of requiring sterile covers for USPIVs. Results: The UCT and SCT arms contained 35 and 38 patients, respectively. The SCT group had a mean of 0.34 compared to the UCT group mean of 2.29. Each sterile cover costs $8.49, and over 3000 USPIVs are placed annually by the "PICC" team. Conclusion: Contamination rates were similar among the UCT and SCT groups after LLD. 254 inpatient USPIVs are performed monthly, not including failed attempts or covers used in the ED where USPIV placement is an essential part of ED workflow. This study suggests that the use of SCT does not significantly affect transducer contamination rates. These findings question burdensome regulatory hospital policies that are not evidence-based. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to assess the impact of the Nursing Spiritual Care Module on the competence of nurses in providing spiritual care in the context of Malaysia. Method: This study employed an experimental design and involved a total of 122 nurses, with 59 in the experimental group and 63 in the control group. Participants were selected from palliative care wards associated with Hospital Universiti Sains Malaysia. Nurses in the experimental group underwent a two-week educational module on nursing spiritual care, while nurses in the control group attended a single lecture on spiritual care provided by the hospital. Results: The results indicated no significant differences in sociodemographic characteristics between the two groups. A significant difference in spiritual care competence within the intervention group and the control group over time (p-value = 0.001), between the two groups (p-value = 0.038), and in the interaction between time and group (p-value = 0.001). Conclusion: The Nursing Spiritual Care Module is crucial in aiding nurses and healthcare professionals in cultivating the appropriate and wholesome attitudes and practices necessary to address the spiritual needs of patients. [ABSTRACT FROM AUTHOR]

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Purpose: This randomized, controlled, blinded study evaluates the efficacy of intense pulsed light (IPL) therapy with low-level light therapy (LLLT) in the treatment of meibomian gland dysfunction (MGD) and evaporative dry eye (EDE) compared to a control group. Methods: Hundred patients with MGD and EDE were randomized into control (50 subjects, 100 eyes) and study group (50 subjects, 100 eyes). The study group underwent three sittings of IPL with LLLT 15 days apart and were followed up 1 month and 2 months after the last treatment sitting. The control group underwent sham treatment and was followed up at the same intervals. The patients were evaluated at baseline and 1 month and 3 months (post 1st treatment) for dry eye. Schirmer's test and tear breakup time (TBUT), OSDI, meibomian gland expression, and meibography. Results: The study group showed significant improvement in OSDI scores (P < 0.0001) compared to the control group and a significant improvement in TBUT (P < 0.005) compared to the control group. There was no change in schirmer's test and an improvement in the meibomian gland expression but not significant. Conclusion: The results show that a combined therapy of IPL with LLT is effective in treating MGD with EDE compared to controls, and repeated treatment sessions have a cumulative effect on the disease outcomes.

Purpose: This randomized, controlled, blinded study evaluates the efficacy of intense pulsed light (IPL) therapy with low‑level light therapy (LLLT) in the treatment of meibomian gland dysfunction (MGD) and evaporative dry eye (EDE) compared to a control group. Methods: Hundred patients with MGD and EDE were randomized into control (50 subjects, 100 eyes) and study group (50 subjects, 100 eyes). The study group underwent three sittings of IPL with LLLT 15 days apart and were followed up 1 month and 2 months after the last treatment sitting. The control group underwent sham treatment and was followed up at the same intervals. The patients were evaluated at baseline and 1 month and 3 months (post 1st treatment) for dry eye. Schirmer's test and tear breakup time (TBUT), OSDI, meibomian gland expression, and meibography. Results: The study group showed significant improvement in OSDI scores (P < 0.0001) compared to the control group and a significant improvement in TBUT (P < 0.005) compared to the control group. There was no change in schirmer's test and an improvement in the meibomian gland expression but not significant. Conclusion: The results show that a combined therapy of IPL with LLT is effective in treating MGD with EDE compared to controls, and repeated treatment sessions have a cumulative effect on the disease outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Low back pain (LBP) is the most prevalent form of chronic pain in active-duty military personnel worldwide. Electroacupuncture (EA) and neuromuscular electrical stimulation (NMES) are the two most widely used treatment methods in the military, while evidence for their benefits is lacking. The aim of this randomized clinical trial is to investigate the effectiveness of EA vs. NMES in reducing pain intensity among active-duty navy personals with chronic LBP. Methods: The study is designed as a single-center, randomized controlled trial. The primary outcome is a positive categorical response for treatment success in the first-time follow-up, which is predesignated as a two-point or greater decrease in the NRS score and combined with a score > 3 on the treatment satisfaction scale. The secondary outcomes include pain intensity, rate of treatment success, and Oswestry Disability Index (ODI) fear-avoidance beliefs questionnaire (FABQ) score along with muscular performance. The first follow-up starts on the first day after completing the last treatment session, and then the 4-weeks and 12-weeks follow-up are applied via telephone visit. Results: Eighty-five subjects complete the treatment diagram and are included in the analysis. For the primary outcome, no difference has been found between EA and NMES, with 65.1% (28 in 43) individuals reporting a positive response to EA treatment, while 53.5% (23 in 43) in NMES. However, for longer follow-ups, superiority in positive response of EA has been found in 4-weeks (26 in 39, 66.7% vs. 16 in 40, 40%; P = 0.018) and 12-weeks (24 in 36, 66.7% vs. 12 in 36, 33.3%; P = 0.005) follow-up. In the regression analysis, baseline pain intensity and FABQ score are identified to be highly associated with positive treatment outcomes. Finally, the subgroup analysis suggests that EA treatment is associated with better long-term outcomes in patients with LBP with a severe pain score (NRS score >4, Figure 4B) and stronger fear-avoidance beliefs. Conclusion: Both the EA and NMES are associated with a positive response in treating military LBP, and the former offers lasting benefits in the later follow-ups. Thus, electroacupuncture is a more recommended treatment for military LBP. A lot of research is needed to verify an efficient and standardized treatment session, with more information and evidence about indications for these treatments. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting. LBP can arise from various causes, with stiffness in the paraspinal muscles being a notable contributor. The administration of Botulinum toxin type A (BoNT-A) has been found to alleviate back pain by relaxing these stiff muscles. While BoNT-A is approved for use in numerous conditions, a limited number of randomized clinical trials (RCTs) validate its efficacy specifically for treating LBP., Aim: To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP (CLBP)., Methods: In this RCT, adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled. Participants were allocated to either the Drug group, receiving 200 Ipsen Units (2 mL) of BoNT-A, or the Control group, which received a 2 mL placebo. Over a 2-month follow-up period, both groups were assessed using the Visual Analog Scale (VAS) for pain intensity and the Oswestry Disability Index (ODI) for disability at the start and conclusion of the study. A decrease in pain by 50% was deemed clinically significant., Results: The study followed 40 patients for two months, with 20 in each group. A clinically significant reduction in pain was observed in 36 participants. There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months. Nonetheless, when comparing the mean score changes, only the reduction in ODI scores (15 in the placebo group vs 16.5 in the drug group, clinically insignificant) was statistically significant ( P = 0.012), whereas the change in mean VAS scores was not significant ( P = 0.45)., Conclusion: The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Abstract Background Induced hypernatremia and hyperosmolarity is protective in animal models of lung injury. We hypothesized that increasing and maintaining plasma sodium between 145 and 150 mmol/l in patients with moderate-to-severe ARDS would be safe and will reduce lung injury. This was a prospective randomized feasibility study in moderate-to-severe ARDS, comparing standard care with intravenous hypertonic saline to achieve and maintain plasma sodium between 145 and 150 mmol/l for 7 days (HTS group). Both groups of patients were managed with lung protective ventilation and conservative fluid management. The primary outcome was 1-point reduction in lung injury score (LIS) or successful extubation by day 7. Results Forty patients were randomized with 20 in each group. Baseline characteristics of severity of illness were well balanced. Patients in the HTS group had higher plasma sodium levels during the first 7 days after randomization when compared with the control group (p = 0.04). Seventy five percent (15/20) of patients in the HTS group were extubated or had ≥ 1-point reduction in LIS compared with 35% (7/20) in the control group (p = 0.02). There was also a decrease in length of mechanical ventilation and hospital length of stay in the HTS group. Conclusion We have shown clinical improvement in patients with moderate-to-severe ARDS following induced hypernatremia, suggesting that administration of hypertonic saline is a safe and feasible intervention in patients with moderate-to-severe ARDS. This suggests progress to a phase II study. Clinical Trial Registration Australian and New Zealand Clinical Trials Registry (ACTRN12615001282572)

Background. Grape seed extract contains Proanthocyanin, which reduces collagen degradation by inhibiting interstitial and extracellular collagenase, thus having the potential to reduce the progression of periodontitis. Here we compare and evaluate the aerobic and anaerobic microorganism's CFUs (colony forming units) in plaque samples of Group A, Group B, Group C and severity of periodontal disease on day 0 and 7. Methods. Forty-five subjects in age range 18-30 years were selected among undergraduate students and randomly divided into Group A: 15, 2% grape seed extract mouthwash (GSE), Group B: 15, 0.2% chlorhexidine mouthwash (CHX) and Group C: 15, distilled water (control). The supragingival plaque was collected into transport media. Kruskal Wallis test followed by Mann Whitney test was used to compare the mean CFUs (x103) of microorganisms and severity of periodontal disease was compared, by clinical parameters among all groups on day 0 and 7. Results. There was a significant difference concerning mean scores of all clinical parameters (P<0.001) and mean CFUs of microorganisms between 3 study groups (P=0.005) at 7 days post-intervention period. Intragroup comparison, mean scores were significantly reduced on day 7 as compared to day 0 at (P<0.001) in Group A and B, but no significant difference was noted with Group C. Conclusion. Intervention with GSE mouthwash showed a positive effect on reducing CFUs in the plaque when compared with the control group. GSE group also showed similar results in reducing CFUs in plaque when compared to CHX group, thereby demonstrating the agent's antimicrobial efficacy, therapeutic effect and its potential usefulness in controlling plaque and periodontal diseases. [ABSTRACT FROM AUTHOR]

BackgroundIn hospital settings, malnutrition affects 30–50% of aged inpatients and is related to a higher risk of hospital complications and death. This study aims to demonstrate the effectiveness of a tailored optimum nutritional therapy in malnourished, elderly inpatients based on multidisciplinary team recommendations in hopes of decreasing the incidence of deleterious clinical outcomes.Methods and DesignThis trial will be a multicenter, open-label, randomized control trial conducted in the geriatric wards of at least five hospitals in five different regions. We aim to include 500 inpatients over the age of 60 with or at risk of malnutrition based on a Mini Nutritional Assessment Short-Form (MNA-SF) score of ≤ 11 points and the Global Leadership Initiative on Malnutrition with an expected length of stay of ≥ 7 days. Eligible inpatients will be randomized into a 1:1 ratio, with one receiving a multidisciplinary team intervention and the other receiving standard medical treatment or care alone. A structured comprehensive assessment of anthropometry, nutritional status, cognition, mood, functional performance, and quality of life will be conducted twice. These assessments will take place on the day of group allocation and 1 year after discharge, and a structured screening assessment for elderly malnutrition will be conducted at 3 and 6 months after discharge using the MNA-SF. The primary outcome will be nutritional status based on changes in MNA-SF scores at 3, 6 months, and 1 year. The secondary outcome will be changes in cognition, mood, functional status, length of hospital stay, and all-cause mortality 1 year after discharge.DiscussionGuided by the concept of interdisciplinary cooperation, this study will establish a multidisciplinary nutrition support team that will develop an innovative intervention strategy that integrates nutritional screenings, evaluations, education, consultation, support, and monitoring. Moreover, nutritional intervention and dietary fortification will be provided to hospitalized elderly patients with or at risk of malnutrition. The nutrition support team will formulate a clinical map for malnutrition in elderly patients with standardized diagnosis and treatment for malnutrition in this population.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [ChiCTR2200055331].

Introduction: Altered dopaminergic neurotransmission, especially in the functioning of dopamine D2-type receptors, is considered central to the etiology of a variety of neuropsychiatric disorders. In particular, individuals with substance use disorders have been consistently observed to exhibit lower D2-type receptor availability (quantified as binding potential; BPND) using positron emission tomography (PET). Upregulation of D2-type receptor density thus may therefore provide a therapeutic effect for substance use disorders. Importantly, in vitro studies reveal that D2 receptors coexist with adenosine 2A (A2A) receptors to form the highest density of heteromers in the whole striatum, and there is a functional interaction between these two receptors. As such, blockade of A2A receptor's function may prevent D2 receptor downregulation, yet no study has currently examined this hypothesis in humans. Methods and Analysis: This double-blind, randomized controlled trial aims to evaluate the effect of the A2A receptor antagonist istradefylline (compared to placebo) on both dopamine D2-type receptor availability in the human brain and on neuropsychological measurements of impulsivity. It is hypothesized that istradefylline will both increase striatal D2-type BPND and improve control of impulsivity more than placebo. Forty healthy participants, aged 20–65 with no history of psychiatric or neurological disorders, will be recruited and randomized into two groups and will undergo [11C]raclopride PET, once before and once after administration of either 40 mg/day istradefylline or placebo for 2 weeks. Neuropsychological measurements will be administered on the same days of the PET scans. Ethics and Dissemination: The study protocol was approved by the Certified Review Boards (CRB) of National Center of Neurology and Psychiatry (CR18-011) and prospectively registered with the Japan Registry of Clinical Trials (jRCTs031180131; https://jrct.niph.go.jp/latest-detail/jRCTs031180131). The findings of this study will be disseminated through peer reviewed scientific journals and conferences. Clinical Trial Registration: www.ClinicalTrials.gov, identifier jRCTs031180131. [ABSTRACT FROM AUTHOR]

Introduction: Altered dopaminergic neurotransmission, especially in the functioning of dopamine D2-type receptors, is considered central to the etiology of a variety of neuropsychiatric disorders. In particular, individuals with substance use disorders have been consistently observed to exhibit lower D2-type receptor availability (quantified as binding potential; BPND) using positron emission tomography (PET). Upregulation of D2-type receptor density thus may therefore provide a therapeutic effect for substance use disorders. Importantly, in vitro studies reveal that D2 receptors coexist with adenosine 2A (A2A) receptors to form the highest density of heteromers in the whole striatum, and there is a functional interaction between these two receptors. As such, blockade of A2A receptor’s function may prevent D2 receptor downregulation, yet no study has currently examined this hypothesis in humans.Methods and Analysis: This double-blind, randomized controlled trial aims to evaluate the effect of the A2A receptor antagonist istradefylline (compared to placebo) on both dopamine D2-type receptor availability in the human brain and on neuropsychological measurements of impulsivity. It is hypothesized that istradefylline will both increase striatal D2-type BPND and improve control of impulsivity more than placebo. Forty healthy participants, aged 20–65 with no history of psychiatric or neurological disorders, will be recruited and randomized into two groups and will undergo [11C]raclopride PET, once before and once after administration of either 40 mg/day istradefylline or placebo for 2 weeks. Neuropsychological measurements will be administered on the same days of the PET scans.Ethics and Dissemination: The study protocol was approved by the Certified Review Boards (CRB) of National Center of Neurology and Psychiatry (CR18-011) and prospectively registered with the Japan Registry of Clinical Trials (jRCTs031180131; https://jrct.niph.go.jp/latest-detail/jRCTs031180131). The findings of this study will be disseminated through peer reviewed scientific journals and conferences.Clinical Trial Registration:www.ClinicalTrials.gov, identifier jRCTs031180131.

Background: Induced hypernatremia and hyperosmolarity is protective in animal models of lung injury. We hypothesized that increasing and maintaining plasma sodium between 145 and 150 mmol/l in patients with moderate-to-severe ARDS would be safe and will reduce lung injury. This was a prospective randomized feasibility study in moderate-to-severe ARDS, comparing standard care with intravenous hypertonic saline to achieve and maintain plasma sodium between 145 and 150 mmol/l for 7 days (HTS group). Both groups of patients were managed with lung protective ventilation and conservative fluid management. The primary outcome was 1-point reduction in lung injury score (LIS) or successful extubation by day 7. Results: Forty patients were randomized with 20 in each group. Baseline characteristics of severity of illness were well balanced. Patients in the HTS group had higher plasma sodium levels during the first 7 days after randomization when compared with the control group (p = 0.04). Seventy five percent (15/20) of patients in the HTS group were extubated or had ≥ 1-point reduction in LIS compared with 35% (7/20) in the control group (p = 0.02). There was also a decrease in length of mechanical ventilation and hospital length of stay in the HTS group. Conclusion: We have shown clinical improvement in patients with moderate-to-severe ARDS following induced hypernatremia, suggesting that administration of hypertonic saline is a safe and feasible intervention in patients with moderate-to-severe ARDS. This suggests progress to a phase II study. Clinical Trial Registration Australian and New Zealand Clinical Trials Registry (ACTRN12615001282572) [ABSTRACT FROM AUTHOR]

Objective: No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid- induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA. Methods: This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints. Results: Increase in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92-5.05] vs Placebo: 0.12% [95% CI: -2.07 to 2.30], p<.0001). No significant difference was found in the femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients. Conclusion: Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to assess the marginal bone level changes at dental implants after 1 year in function. Methods: Detailed searches from PubMed databases were made. A MEDLINE search (PubMed) published in the English language from 1980 to December 2018 was included in this study. Results: The electronic database research (MEDLINE) produced 166 corresponding articles. One hundred and twenty studies were excluded on the basis of abstract while the 46 researches were used chosen for full-text examination after the title and abstract testing, and 41 studies were excluded that did not meet the requirements of our inclusion and exclusion criteria. A total of 5 studies for a quantitative analysis were taken into account. Conclusion: Within the limits of the study, the mean marginal bone loss (MBL) was found to be 0.56 mm. A statistically significant difference in the MBL was found between the various studies. [ABSTRACT FROM AUTHOR]

Study Design: A multicenter, randomized, open-label, parallel-group trial.Objective: To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.Summary Of Background Data: Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.Methods: During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 years) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography (CT) and assessed by modified intention-to-treat (mITT) analysis in 149 cases and per-protocol (PP) analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and the Oswestry Disability Index (ODI).Results: The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; p = 0.03) was independently associated with bone fusion at 6 months after surgery. JOABPEQ and ODI results improved postoperatively in both groups.Conclusions: Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.Level Of Evidence: 1. [ABSTRACT FROM AUTHOR]

Despite the available consensus, intrapleural fibrinolytic therapy (IFT) in pediatric empyema is grossly underutilized in the Indian subcontinent where the disease burden is huge. Possible reasons may be epidemiological differences and physician bias. There is a paucity of literature from developing countries on the use of IFT in pediatric empyema thoracis. Hence, this study was undertaken to determine if fibrinolytic therapy is equivalent to video-assisted thoracoscopic surgery (VATS) in treating stage II empyema in children even in developing countries. Consecutive cases of stage II empyema were randomized to receive either IFT or VATS. The outcomes measured were the duration of hospital stay, efficacy of therapy, complications, and cost differences. 41 children were randomized to either VATS (n = 20) or IFT (n = 21) group. Overall successful clearance of empyema was achieved in 18 out of 20 (90%) children undergoing VATS and 20 out of 21(95.2%) children in fibrinolytic arm. The median length of the hospital stay was 7 and 8 days for VATS and IFT groups respectively (p =.24). Need for CT scan and blood transfusion was significantly higher in the VATS group than IFT group (p =.02 and.000). Fibrinolytic therapy is noninferior to VATS in the treatment of stage II empyema in children in the Indian subcontinent. A multicenter trial with larger sample size and uniform, detailed protocols on indications for CT scan, blood transfusions, nutrition status and costs involved will be needed to eliminate institutional bias and to increase the strength of the study. Randomized controlled study, treatment study and cost effectiveness study. [ABSTRACT FROM AUTHOR]

Background: Good oral health is an integral part of overall child health. However, immune-deficient states like the presence of Human Immunodeficiency Virus (HIV) will compromise oral health and salivary bacterial composition, leading to adverse oral conditions. Nigeria has 1.9 million HIV-positive residents, and 0.2% of incident HIV infections occur among children below 15 years., Aim: This study aims to determine through a randomized control study, the effect of an educational intervention on the oral health status and oral health-related quality of life (OHRQoL) of HIV-positive children presenting to five pediatric HIV clinics in Kano, Nigeria., Methods/design: This 2-arm randomized control study will be conducted in five pediatric HIV outpatient clinics in Kano State, Nigeria over a period of 6 months. Eligible participants will include 172 HIV-infected frequency matched children aged 8-16 years (they can self-implement the oral health intervention with minimal supervision from the caregivers) who will be randomized and allocated into control and intervention groups. The evaluation and oral health assessment will be carried out by five examiners who will be trained and calibrated., Discussion: Our findings will help inform policies to improve the oral health and OHRQoL of HIV-positive Nigerian children and inform the need to integrate oral health care services into HIV programs in similar settings., Trial Registration: ClinicalTrails.gov ID: National Clinical Trial (NCT) NCT05540171. Registered on 12 th September 2022., Competing Interests: Declaration of Interests The authors have no interests including financial interests to declare. Declaration of interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Introduction: Laparoscopic adrenalectomy has become the gold standard of surgical treatment for benign adrenal masses. Two alternative surgical approaches are currently advocated: the lateral transperitoneal approach (LTA) and the posterior retroperitoneal approach (PRA). Several randomized trials have compared LTA to PRA, but most of them included small numbers of patients or had stringent inclusion criteria. Aim: To compare clinical results of LTA and PRA endoscopic adrenalectomies for tumors < 8 cm with wide inclusion criteria. Material and methods: We randomized 77 patients to either LTA (n = 33) or PRA (n = 44). The groups were comparable in terms of age, gender proportions, body mass index, tumor size, clinical and pathological diagnosis. We analyzed duration of surgery, intraoperative blood loss, postoperative pain, length of hospital stay and postoperative morbidity. Results: The follow-up concerned 98.8% of patients and was on average 28 (8-47) months long. There were no conversions. We identified significantly lower intensity of pain assessed 24 h after surgery in the PRA group (3.4 ±1), as compared to LTA (4.2 ±1), with lower prevalence of shoulder pain (2.3% vs. 30.3%, respectively). Postoperative hospital stay was shorter in the PRA (1.14 ±0.4) than in the LTA (1.36 ±0.5) group. Perioperative morbidity concerned 4 patients in each group with pain requiring oral analgesia > 7 days. Conclusions: To our knowledge this is the largest prospective randomized study comparing LTA to PRA. We demonstrated safety, efficacy and very low morbidity of both techniques. The PRA proved superior to LTA in terms of lower intensity of postoperative pain and shorter hospital stay. [ABSTRACT FROM AUTHOR]

Objective: To compare outcomes and postoperative quality of life (QoL) among patients with kidney stone who received mini-percutaneous nephrolithotomy (mPCNL), partial tubeless mPCNL or mPCNL with ureter catheter in a prospective randomized clinical trial. Methods: From May 2017 to December 2017, 60 patients with kidney stone who underwent mPCNL were randomized into 3 groups: Group I (mPCNL), Group II (partial tubeless mPCNL), Group III (mPCNL with ureter catheter). We evaluated perioperative characteristics, stone clearance, analgesic requirements and QoL by using the Wisconsin Stone QOL questionnaire. Results: The age, gender, stone diameter, body mass index, length of operation, drop in hemoglobin and stone-free rates for the 3 groups were similar among these groups. However, the postoperative visual analog scale and the analgesic requirement in Group II were significantly the lowest (p < 0.05). According to Wisconsin Stone QOL questionnaire, compared to Group I, statistical significant difference in the QoL was seen in Group II and III, indicating a meaningful and immediate improvement in the postoperative QoL following mPCNL. Conclusion: Compared with standard and partial tubeless mPCNL, mPCNL with ureter catheter is a safe and useful form of mPCNL, which can offer better QoL and is more cost effective. [ABSTRACT FROM AUTHOR]

Background: Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease, characterized by progressive loss of spinal and cortical motor neurons, leading to muscular atrophy, respiratory failure, and ultimately death. There is no known cure, and the clinical benefit of the two drugs approved to treat ALS remains unclear. Novel disease-modifying therapeutics that are able to modulate the disease course are desperately needed. Our objective was to evaluate the efficacy and tolerability of Elysium Health's candidate drug EH301 in people with ALS (PALS). Methods: This was a single-center, prospective, double-blind, randomized, placebo-controlled pilot study. Thirty-two PALS were recruited thanks to the collaboration of the Spanish Foundation for ALS Research (FUNDELA). Study participants were randomized to receive either EH301 or placebo and underwent evaluation for 4 months. Differences between EH301 and placebo-treated participants were evaluated based on standard clinical endpoints, including the revised ALS functional rating scale (ALSFRS-R), forced vital capacity (FVC), and the Medical Research Council (MRC) grading scale. Results: Compared to placebo, participants treated with EH301 demonstrated significant improvements in the ALSFRS-R score, pulmonary function, muscular strength, and in skeletal muscle/fat weight ratio. EH301 was shown to significantly slow the progression of ALS relative to placebo, and even showed improvements in several key outcome measures compared with baseline. Conclusions: This study provides evidence in support of the disease-modifying effects of EH301 for the treatment of ALS. [ABSTRACT FROM AUTHOR]

Aim. Anemia is the most common adverse event in patients with chronic hepatitis C virus (HCV) treated with telaprevir (TVR) combined triple therapy. We examined the effects of drug dose adjustment on anemia and a sustained viral response (sVR) during combination therapy.Material and methods. This study enrolled 62 patients treated with TVR (2,250 mg) for 12 weeks plus pegylated interferon-alpha-2b and ribavirin for 24 weeks. The patients were assigned randomly to the TVR-standard or -reduced groups before treatment. At the occurrence of anemia (hemoglobin < 12 g/dL), the TVR-reduced group received 1500 mg TVR plus the standard dose of ribavirin, whereas the TVR-standard group received the standard TVR dose (2,250 mg) and a reduced dose of ribavirin (200 mg lower than prescribed originally). The safety and SVR at 24 weeks were compared between the TVR-standard (n = 28) and TVR-reduced (n = 25) groups.Results. No differences in the proportion of patients who became HCV RNA-negative were detected between the TVR-standard and -reduced groups (72 and 72% at week 4, 79 and 84% at the end of treatment, and 76 and 80% at SVR24, respectively). Two groups had comparable numbers of adverse events, which led to the discontinuation of TVR in 14 patients of TVR-standard group and in 14 of TVR-reduced group. A lower incidence of renal impairment was observed in the TVR-reduced group (6%) than the TVR-standard group (11%, not statistically significant).Conclusions. TVR dose adjustment could prevent anemia progression without weakening the anti-viral effect during triple therapy in HCV-patients.

Background: Good oral health is an integral part of overall child health. However, immune-deficient states like the presence of Human Immunodeficiency Virus (HIV) will compromise oral health and salivary bacterial composition, leading to adverse oral conditions. Nigeria has 1.9 million HIV-positive residents, and 0.2% of incident HIV infections occur among children below 15 years., Aim: This study aims to determine through a randomized control study, the effect of an educational intervention on the oral health status and oral health-related quality of life (OHRQoL) of HIV-positive children presenting to five pediatric HIV clinics in Kano, Nigeria., Methods/design: This 2-arm randomized control study will be conducted in five pediatric HIV outpatient clinics in Kano State, Nigeria over a period of 6 months. Eligible participants will include 172 HIV-infected frequency matched children aged 8-16 years (they can self-implement the oral health intervention with minimal supervision from the caregivers) who will be randomized and allocated into control and intervention groups. The evaluation and oral health assessment will be carried out by five examiners who will be trained and calibrated., Discussion: Our findings will help inform policies to improve the oral health and OHRQoL of HIV-positive Nigerian children and inform the need to integrate oral health care services into HIV programs in similar settings., Trial Registration: ClinicalTrails.gov ID: National Clinical Trial (NCT) NCT05540171. Registered on 12th September 2022., (Copyright © 2023. Published by Elsevier Inc.)

The purpose of this study was to determine the effect of placenta extraction from exteriorized uterus versus placenta extraction from non- exteriorized uterus on blood loss during caesarean section (CS). It was a randomized control study in which 98 women undergoing caesarean section were allocated randomly to either the placental delivery from exteriorized uterus or placental delivery from non-exteriorized uterus. The main outcome measure was intraoperative blood loss, and Intention to treat analysis was used. More participants in the non-exteriorized placenta removal group had blood loss ≥500mls (P-value <0.001). Logistic regression showed about 5times likelihood of having blood loss of 500mls or more in the non-exteriorized group (P< 0.001; OR: 5.67; 95%CI: 2.38-13.40). The mean estimated blood loss was 54.1mL less in exteriorized placenta removal group (476.12±160.86 versus 530.20±145.18; P-value = 0.084). The mean changes in haemoglobin concentration in exteriorized and non-exteriorized groups were 0.68±0.19g/dL and 0.74±0.20g/dL; P = 0.131) respectively. This study showed statistically significant difference in blood loss of 500mls or more in the placenta delivery from non-exteriorized compared to the exteriorized group. However, there was no significant difference in the mean blood loss, duration of surgery, and change in haemoglobin between the two groups., Competing Interests: The authors declared no conflict of interest, (African Journal of Reproductive Health © 2023.)

The purpose of this study was to assess the effectiveness of a specific exercise intervention of mechanisms to control dynamic postural stability under unstable conditions in old adults. Forty‐seven old adults (65‐80 years) were assigned to 2 experimental groups (muscle strength group, n = 15; perturbation‐based group, n = 16) and a control group (n = 16). The strength group performed resistance exercises for leg and trunk muscles, while the perturbation‐based group exercised mechanisms of dynamic stability under unstable conditions. The training duration was 14 weeks, with training sessions twice a week for 1.5 hours. Muscle strength, balance ability, and balance recovery performance were investigated before and after the interventions using maximal isometric plantar flexion and knee extension contractions, the approach of the center of pressure to the anterior limits of stability and simulated forward falls. Both interventions increased balance recovery performance in simulated forward falls (81%, d = 1.50 and 80%, d = 1.08 in the muscle strength and perturbation‐based group, respectively), while the control group did not show any changes. Plantar flexor strength increased 20% (d = 0.72) in the muscle strength and 23% (d = 1.03) in the perturbation‐based group, while muscle strength of the knee extensors increased only in the muscle strength group (8%, d = 0.76). On the other hand, only the perturbation‐based group showed a significant improvement of standing balance ability (38%, d = 1.61). We conclude that a perturbation‐based training program focusing on exercising mechanisms of dynamic stability in unstable conditions has the potential to enhance muscle strength as well as sensory information processing within the motor system during sudden and static balance tasks and, as a consequence, reduce the risk of falls in old adults. [ABSTRACT FROM AUTHOR]

Introduction: Despite the increasing use of carotid angioplasty and stenting (CAS), carotid endarterectomy (CEA) nonetheless remains a more medically beneficial method of treatment for carotid artery stenosis. Therefore, one possibility for progress within this procedure may be to use minimally invasive carotid surgery, especially when the scar is in plain sight: the use of the natural wrinkles (skin crease) as a camouflage of the skin incision provides significant cosmetic improvements. Aim: To compare the cosmetic effects of classic and trans-wrinkle CEA. To assess the distance between the carotid artery bifurcation (CAB) and the skin-crease incision whilst attempting CEA. Material and methods: It was a randomized prospective study with two groups: patients undergoing classic surgery (control group; n = 100) and skin-crease trans-wrinkle camouflaged CEA (study group; n = 100). Follow-up was at 2 months and 1 year. Results: The medical results of the treatment were similar in both groups. The cumulative count of strokes and myocardial infarctions was 0.5% within 30 days, and after one year 3.5% (and 5.5% including cases of death). The superiority of the transverse crease being hidden compared to the conventional longitudinal technique was proven in the Patient and Observer Scar Assessment Scale (POSAS) score, respectively 11.4 ±1.0 vs. 14.1 ±3.4 (p = 0.0001) after 2 months and 13.5 ±2.8 vs. 14.1 ±3.4 (p = 0.039) after a year. Conclusions: Trans-wrinkle incision gives better cosmetic results, can be safely performed in most cases, and offers a comfortable approach during CEA. [ABSTRACT FROM AUTHOR]

Purpose: This randomized, controlled, blinded study evaluates the efficacy of intense pulsed light (IPL) therapy with low-level light therapy (LLLT) in the treatment of meibomian gland dysfunction (MGD) and evaporative dry eye (EDE) compared to a control group., Methods: Hundred patients with MGD and EDE were randomized into control (50 subjects, 100 eyes) and study group (50 subjects, 100 eyes). The study group underwent three sittings of IPL with LLLT 15 days apart and were followed up 1 month and 2 months after the last treatment sitting. The control group underwent sham treatment and was followed up at the same intervals. The patients were evaluated at baseline and 1 month and 3 months (post 1 st treatment) for dry eye. Schirmer's test and tear breakup time (TBUT), OSDI, meibomian gland expression, and meibography., Results: The study group showed significant improvement in OSDI scores (P < 0.0001) compared to the control group and a significant improvement in TBUT (P < 0.005) compared to the control group. There was no change in schirmer's test and an improvement in the meibomian gland expression but not significant., Conclusion: The results show that a combined therapy of IPL with LLT is effective in treating MGD with EDE compared to controls, and repeated treatment sessions have a cumulative effect on the disease outcomes., Competing Interests: None

Background: With this rising popularization of enhanced recovery after surgery (ERAS) protocols, it is important to ask if the current and developing pathways are fully comprehensive for the patient's perioperative experience. Many current pathways discuss aspects of care including fluid management, pain management, and anti-emetic medication regiments, but few delineate recommendations for lung protective strategies. The hypothesis was that intraoperative lung protective strategies would results in improved postoperative lung function., Methods: One hundred patients at the Medical University of South Carolina undergoing hepatobiliary and colorectal surgeries were randomized to receive intraoperative lung protective techniques or a standard intraoperative ventilation management. Three maximum vital capacity breaths were recorded preoperatively, and postoperatively 30 min, 1 h, and 2 h after anesthesia stop time. Average maximum capacity breaths from all four data collection interactions were analyzed between both study and control cohorts., Results: There was no significant difference in the preoperative inspiratory capacity between the control and the ERAS group (2,043.3 ± 628.4 mL vs. 2,012.2 ± 895.2 mL; P = 0.84). Additional data analysis showed no statistically significant difference between ERAS and control groups: total average of the inspiratory capacity volumes (1,253.5 ± 593.7 mL vs. 1,390.4 ± 964.9 mL; P = 0.47), preoperative oxygen saturation (97.76±2.3% vs. 98.04±1.7%; P = 0.50), the postoperative oxygen saturation (98.51±1.4% vs. 96.83±14.2%; P = 0.40), and change in inspiratory capacity (95% confidence interval (CI) (-211.2 - 366.6); P = 0.60)., Conclusions: No statistically significant difference in postoperative inspiratory capacities were seen after the implementation of intraoperative lung protective strategies. The addition of other indicators of postoperative lung function like pneumonia incidence or length of inpatient stay while receiving oxygen treatment could provide a fuller picture in future studies, but a higher power will be needed., Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this clinical research project., (Copyright 2023, Gutman et al.)

Objective: The study was undertaken to evaluate maternal and Perinatal outcomes following transcervical intrapartum amnioin- fusion in women with meconium stained amniotic fluid. Methods: A randomized control study was conducted on 200 women with moderate to thick meconium stained amniotic fluid during labor. Group A (study group) of 100 cases received amnio- infusion. Group B (control group) of 100 cases received standard obstetric care. Fetal heart rate monitoring was done using cardioto- cography. Results: 66% of women were in the age group of 21-25 years. Av- erage cervical dilatation at detection of meconium and detection of meconium to delivery interval was similar in both groups. In the study group, 68% women had normal vaginal delivery as com- pared to 49% in the control group (p

Background: The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis.Methods/design: The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months.Discussion: The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases.Trial Registration: NCT02369757. [ABSTRACT FROM AUTHOR]

Aims: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI. Methods and results: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns). Conclusion: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials. [ABSTRACT FROM AUTHOR]

Background and Objective: The survival benefit of induction therapy for non-small cell lung cancer (NSCLC) remains controversial. Recently, the outcomes of systemic therapy for NSCLC have dramatically changed with the advent of molecular target drugs and immune checkpoint inhibitors (ICIs). The present review was conducted to investigate the outcomes of induction therapy with reference to randomized control trials (RCTs)., Methods: We reviewed RCTs and ongoing clinical trials between 1990 and 2022 using relevant databases: PubMed, Web of Science, and EMBASE database. We investigated the outcomes of induction therapy., Key Content and Findings: Induction therapy was associated with longer overall survival in comparison to surgery alone in several RCTs for stage III disease. However, its benefit in early-stage (I-II) disease was unclear. Regarding induction chemotherapy and chemoradiotherapy, the safety and survival outcomes did not differ between the two arms. Epidermoid growth factor receptor (EGFR) tyrosine kinase inhibitors as induction therapy in patients with proven EGFR mutations may be a sufficient choice for the improvement of overall survival. In ongoing single arm clinical trials and a randomized control study, the administration of ICIs as induction therapy was associated with a good pathological response and satisfactory safety, which will lead to a better survival outcome. Long-term observation is needed to evaluate the toxicity and survival impact of induction therapy with ICIs., Conclusions: Induction chemotherapy and EGFR-TKIs for stage IIIA NSCLC may contribute to the improvement of survival outcomes although the effect of systemic therapy on stage I-II remains controversial. ICIs may be considered as a valuable treatment option because of their feasibility and safety for induction therapy., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-22-957/coif). The authors have no conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)

Simulation is a recognized method of teaching in academic medicine. Despite its long availability, only a paucity of information exists regarding its efficacy and utility on patient care and subsequently on patient outcomes. In this meta-analysis, we attempt to systematically study the effect of simulation-based clinical teaching in critical care medicine. A review of literature was conducted, looking across several databases, for any available studies that compare simulation to standard methods of teaching in the setting of critical care medicine on three surrogate outcomes: enhancement of knowledge, improvement in skills, and patient outcomes. In this study, 508 articles were found at the initial screening, however only 14 articles were eligible after applying our inclusion and exclusion criteria. Of these 14 articles only 5 were found to be randomized control trials and their outcomes were either knowledge or skill enhancement, no study on patient outcome was identified. Despite the significant heterogeneity between studies (χ2 (4) = 120.73) p < 0.001), the random effect was significant on both surrogate markers (p < 0.001). as a conclusion, albeit only a few randomized trials, simulation has a positive impact on knowledge and skill acquisition in the field of critical care medicine. [ABSTRACT FROM AUTHOR]

Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR. [ABSTRACT FROM AUTHOR]

A well-designed and executed clinical trial is the gold standard of evidence-based medicine. It is important for readers to understand the rationale for the study design, identify common pitfalls, and scrutinize limitations. Herein, we present a brief overview of types of designs used for clinical trials and discuss the use of appropriate end points, the selection of study participants, randomization, sample size calculation, blinding, and analysis of data. Finally, we emphasize the importance of accurate and transparent reporting. Our goal is to provide a primer for practicing urologists to enhance their understanding of the clinical trial literature. [ABSTRACT FROM AUTHOR]

Context: Laryngoscopy and endotracheal intubation activates the sympathetic nervous system, causing tachycardia and hypertension. Dexmedetomidine has an affinity for alpha2 receptors 8 times greater than that of clonidine. It diminishes norepinephrine release and inhibits sympathetic activity leading to decreased heart rate (HR) and blood pressure. Aims: The aim was to compare the effect of intravenous (IV) infusion of dexmedetomidine and clonidine on the pressor response among patients undergoing tracheal intubation in elective surgeries under general anesthesia. Settings and Design: A prospective, randomized control study. Subjects and Methods: Seventy-five adult patients of age 18-55 years in American Society of Anesthesiologists physical status I and II were included in this study. Patients were allocated randomly into Group P, Group D and Group C of 25 patients each. In the operation theatre, clonidine (3 µg/kg) or dexmedetomidine (0.5 µg/kg) or placebo (0.9% normal saline) diluted in 100 ml NaCl 0.9% were infused over a period of 10 min. Statistical Analysis Used: Statistical analysis was done using Statistical Package for Social Sciences version 15.0. Chi-square test, ANOVA, Student's t-test, and Paired t-test were used. Results: As compared to Group P, the mean systolic blood pressure in Group D and Group C were significantly lower (<0.01) after intubation and all the subsequent intervals. After infusion and after the induction interval, the maximum value was observed in Group D while minimum mean value was observed in Group C. As compared to Group P, the mean arterial pressure in Group D was significantly higher at after infusion and after induction intervals but significantly lower after intubation and subsequent intervals. However, in Group C, the mean value was significantly lower as compared to Group P at all-time intervals except after infusion and after induction intervals. As compared to Group P, the mean HR in Group D was significantly higher at after infusion and after induction intervals. However at all the subsequent intervals, Group D was significantly lower as compared to Group P. Conclusion: It was found that attenuating response to hemodynamic changes were observed with dexmedetomidine and clonidine IV infusion. The early onset of dexmedetomidine makes it a promising choice. Hence premedication with IV infusion of dexmedetomidine can safely be recommended for attenuation of hemodynamic response to endotracheal intubation. [ABSTRACT FROM AUTHOR]

Background: In surgical treatment of elderly patients, securing the safety of surgery and radical cure must be balanced. Our purpose was to verify the safety and validity of laparoscopic surgery for the treatment of colorectal cancer in elderly patients. Methods: Patients with cTis-T4a colorectal cancer who were 75 years or older were randomized to receive open or laparoscopic surgery. Exclusion criteria were patients who had a bulky tumor, rectal cancer that required pelvic side wall lymphadenectomy, and history of colon resection. Patients were divided according to tumor location (right colon, left colon, and rectum). The short-term outcomes were compared between the two groups. Results: One hundred patients (right 43, left 28, and rectum 29) were registered in each group from August 2008 to August 2012. There were no differences in patient characteristics between the two groups. Three patients were converted from laparoscopic to open, because of bleeding, excision of peritoneum metastasis, and patient's desire, respectively. In the short-term results (open:laparoscopic), there were significant differences in the rates of complications (36:23 %) and ileus (12:4 %), amount of blood loss (157:63 mL), and duration of surgery (150:172 min). There were no significant differences in the pathological margins, and the number of dissected lymph nodes. In the subgroup analysis according to the tumor location, there were significant differences in the rate of complications (39.4:22.5 %), amount of blood loss (135:42 mL), duration of surgery (139:160 min), and length of postoperative stay (13.0:10.0 days) in the colon cancer. There were no significant differences in short-term results in the rectal cancer. Conclusions: Laparoscopic surgery in elderly colorectal cancer patients did not result in a difference in radical cure compared with open surgery, and the short-term results except the duration of surgery were excellent. It is an effective procedure for elderly patients with colorectal cancer, especially colon cancer. [ABSTRACT FROM AUTHOR]

Aim. To investigate the efficacy and safety of brotizolam in outpatients with insomnia. Methods. This randomized, double-blind, double-dummy, multicenter, controlled trial recruited 253 outpatients randomized to receive either brotizolam (n = 126) or estazolam (n = 127) for 14 days followed by 1 week of follow-up for rebound detection. Sleep Dysfunction Rating Scale (SDRS) and Clinical General Impression Scale were applied for efficacy evaluation. Safety evaluation was based on data regarding vital signs, physical examination, lab tests, ECG and collection of adverse events. Results. Full Analyses Set (FAS) and Safety Set (SS) included data of 251 subjects, with 126 from brotizolam group and 125 from estazolam group. Per Protocol Set (PPS) analysis included data of 235 subjects, with 121 and 114 from each group. After 14 days of treatment, there was no difference with statistical significance between the two groups regarding SDRS total score change from baseline. FAS and PPS analysis showed that the brotizolam is non-inferior to estazolam in efficacy evaluation. There was also no difference with statistical significance regarding rebound rate between brotizolam and estazolam group in FAS. The rate of adverse event in two groups was with no statistically significant difference in SS. Conclusion. Brotizolam is effective and safe in relieving the symptoms of insomnia. [ABSTRACT FROM AUTHOR]

Purpose: In order to confirm the impact of adding S-1 to gemcitabine, we conducted a randomized phase II study to compare the combination therapy of gemcitabine plus S-1 to gemcitabine monotherapy in patients with advanced biliary tract cancer. Methods: Sixty-two patients with advanced cholangiocarcinoma or gallbladder cancer were randomized to either the combination therapy of gemcitabine and S-1 (gemcitabine 1,000 mg/m on days 1 and 15 and S-1 40 mg/m b.i.d. on days 1-14, repeated every 4 weeks) or gemcitabine monotherapy (gemcitabine 1,000 mg/m on days 1, 8, and 15, repeated every 4 weeks). The primary endpoint of this study was response rate, and the regimen which showed the better response rate was selected as a candidate of phase III study. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria version 1.0. Results: The response rates of the combination therapy and the monotherapy were 20.0 and 9.4 %, respectively. The median time-to-progressions and overall survivals of these two treatments were nearly the same (5.6 vs. 4.3 months; 8.9 vs. 9.2 months). Adverse events occurred more frequently in the combination arm. Conclusions: The combination therapy of gemcitabine and S-1 showed the better response rate, but the superiority of this combination therapy was not clear in total. Because the standard of care changed to the combination therapy with gemcitabine and cisplatin during this study, it is difficult to select this combination therapy with a 4-week regimen as a candidate of phase III study. [ABSTRACT FROM AUTHOR]

Although some previous studies have compared the 2 medicines, ziprasidone and olanzapine most selected chronic patients as subjects. Therefore, the present study was designed to compare the efficacy and safety of ziprasidone vs. olanzapine in naive first-episode schizophrenia.80 patients were randomly assigned to a 6-week treatment either with 80-160 mg/day of ziprasidone or 10-20 mg/day of olanzapine. The primary efficacy measurements were the Positive and Negative Syndrome Scale and Clinical Global Impression-severity scale scores. The second efficacy measurement was the response rate of treatment. Tolerability assessments were also performed.79 patients completed the trial. The average dose was 127.5 mg/day with ziprasidone and 19.1 mg/day with olanzapine. No significant differences were found between the 2 groups in primary or secondary efficacy measurements at each visit point (all p>0.05). Body weight significantly increased with olanzapine, and more extrapyramidal symptoms were observed with ziprasidone (all p<0.05). Both medicines were well tolerated, and no serious adverse events were observed.Ziprasidone was as effective as olanzapine in short-term treatment for first-episode schizophrenia, and both medicines were well tolerated. [ABSTRACT FROM AUTHOR]