RESUMEN

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.

RESUMEN

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.

Asunto(s)

RESUMEN

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.

RESUMEN

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.

Asunto(s)

RESUMEN

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.

Le but de cette étude était de déterminer l'effet de l'extraction du placenta de l'utérus extériorisé par rapport à l'extraction du placenta de l'utérus non extériorisé sur la perte de sang lors d'une césarienne (CS). Il s'agissait d'une étude contrôlée randomisée dans laquelle 98 femmes subissant une césarienne ont été réparties au hasard entre l'accouchement placentaire à partir d'un utérus extériorisé ou l'accouchement placentaire à partir d'un utérus non extériorisé. Le principal critère de jugement était la perte de sang peropératoire et une analyse en intention de traiter a été utilisée. Un plus grand nombre de participants dans le groupe de retrait du placenta non extériorisé ont présenté une perte de sang ≥ 500 ml (valeur P <0,001). La régression logistique a montré une probabilité environ 5 fois supérieure d'avoir une perte de sang de 500 ml ou plus dans le groupe non extériorisé (P < 0,001 ; OR : 5,67 ; IC à 95 % : 2,38-13,40). La perte de sang moyenne estimée était inférieure de 54,1 ml dans le groupe d'ablation du placenta extériorisé (476,12 ± 160,86 contre 530,20 ± 145,18 ; valeur P = 0,084). Les changements moyens de la concentration d'hémoglobine dans les groupes extériorisés et non extériorisés étaient de 0,68 ± 0,19 g/dL et de 0,74 ± 0,20 g/dL ; P = 0,131) respectivement. Cette étude a montré une différence statistiquement significative dans la perte de sang de 500 ml ou plus lors de l'expulsion du placenta du groupe non extériorisé par rapport au groupe extériorisé. Cependant, il n'y avait pas de différence significative dans la perte de sang moyenne, la durée de l'intervention chirurgicale et la modification du taux d'hémoglobine entre les deux groupes.

Asunto(s)

RESUMEN

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.

RESUMEN

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.

Asunto(s)

RESUMEN

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.

RESUMEN

[This corrects the article DOI: 10.3389/fneur.2022.945210.].

RESUMEN

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. Trial registration: ChiCTR, (ChiCTR2100043726); registered February 27, 2021.

RESUMEN

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 (×103) 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.

RESUMEN

Background: In 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 Design: This 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. Discussion: Guided 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].

RESUMEN

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.

RESUMEN

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).

RESUMEN

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.

RESUMEN

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.

Asunto(s)

RESUMEN

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. STUDY TYPE: Randomized controlled study, treatment study and cost effectiveness study.

Asunto(s)

RESUMEN

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.

RESUMEN

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.

Asunto(s)

RESUMEN

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.

Asunto(s)