Randomized phase II study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal malignancy patients.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 115-115
Author(s):  
Mariko Kamiya ◽  
Toru Aoyama ◽  
Nobuhiro Sugano ◽  
Tsutomu Sato ◽  
Naoto Yamamoto ◽  
...  
Keyword(s):  
Postoperative Delirium ◽  
Postoperative Mortality ◽  
Signs And Symptoms ◽  
Perioperative Period ◽  
Phase Iii ◽  
Control Group ◽  
Level Of Evidence ◽  
Gastrointestinal Malignancy ◽  
Mortality And Morbidity ◽  
Significant Difference

115 Background: Delirium is one of the common postoperative complications. When postoperative delirium occurred, the patient management becomes much more difficult, leading to functional recovery delay, and is also associated with postoperative mortality and morbidity. Although many attempts to prevent and treat delirium have been developed, a higher level of evidence is needed. In the present study, we evaluated the efficacy and safety of TJ-54 (Yokukansan; one of the traditional Japanese medicines, Kampo) for the prevention and/or treatment of postoperative delirium in a randomized phase III trial for the patients receiving surgery for gastrointestinal malignancy. Methods: Patients 70 years of age or older, who were received surgery for gastrointestinal malignancy were eligible in this study. The 167 eligible patients were randomly assigned on a 1:1 ratio to receive TJ-54 or control during their perioperative care (between day 7 before surgery and day 4 after surgery). The signs and symptoms of delirium were assessed with using Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV by the investigator during perioperative period. Results: We analyzed 167 eligible gastrointestinal malignancy patients (TJ-54; 83, control; 84). There were no disparities between the two PPS randomized groups. The incidence of delirium was 7.2% (6 patients) in the TJ-54 group and 10.7% (9 patients) in the control group with no significant difference (p=0.431), also no significant difference was observed in duration of delirium between the two groups (p=0.477). The ratio of patients who needed some kind of the medication which including treatment of delirium were significantly less in the TJ-54 group than in the control group (p=0.037). Conclusions: In this study, TJ-54 did not demonstrate the contribution to prevention of occurring delirium in the patients receiving surgery for gastrointestinal malignancy. However, TJ-54 might be effective in reducing the medication for treating delirium after surgery for gastrointestinal malignancy. Clinical trial information: 000005423.

scholarly journals Determination of Efficacy of Single and Double 4.7 mg Deslorelin Acetate Implant on the Reproductive Activity of Female Pond Sliders (Trachemys scripta)

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 660
Author(s):  
Edoardo Bardi ◽  
Martina Manfredi ◽  
Raffaella Capitelli ◽  
Emanuele Lubian ◽  
Alessandro Vetere ◽  
...  
Keyword(s):  
Phase Ii ◽  
Egg Production ◽  
Reproductive Activity ◽  
Trachemys Scripta ◽  
Phase Iii ◽  
Control Group ◽  
Sexual Hormones ◽  
Significant Difference ◽  
Group 6 ◽  
Plasmatic Concentration

The use of long-acting gonadotropin-releasing hormone (GnRH) agonists to suppress fertility has been poorly investigated in reptiles, and the few available studies show inconsistent results. The efficacy of single and double intramuscular 4.7 mg deslorelin acetate implants in captive pond sliders (Trachemys scripta) was investigated, with 20 animals divided into three groups: a single-implant group (6 animals), a double-implant group (6 animals), and a control group (no implant). During one reproductive season (March to October), plasmatic concentration of sexual hormones (estradiol, progesterone, and testosterone) and ovarian morphometric activity via computed tomography were monitored about every 30 days. A significative decrease in the number of phase II ovarian follicles was detected in the double-implant group compared with the control group, but no significant difference was noted in the number of phase III and phase IV follicles, egg production, and plasmatic concentration of sexual hormones. Results show that neither a single nor a double deslorelin acetate implant can successfully inhibit reproduction in female pond sliders during the ongoing season, but the lower number of phase II follicles in the double-implant group can possibly be associated with reduced fertility in the following seasons.

Effect of Rapid Rehabilitation Concepts on Quality of Life and Pain in Patients Undergoing Radical Breast Cancer Surgery in Perioperative Period

2021 ◽  
Vol 7 (5) ◽  
pp. 1538-1544
Author(s):  
Xin Li ◽  
Hai-yan An ◽  
Yi Zhao ◽  
Mingli Ji ◽  
Jing An ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Perioperative Period ◽  
Nursing Intervention ◽  
Cancer Surgery ◽  
Breast Cancer Surgery ◽  
Control Group ◽  
T Lymphocyte Subsets ◽  
Significant Difference

To study the effect of rapid rehabilitation nursing on patients’ quality of life and pain level during the perioperative period of radical breast cancer surgery. Methods: 126 patients who were hospitalized in our hospital from January 2018 to February 2020 and underwent radical breast cancer surgery were divided into control group and rapid rehabilitation group according to the perioperative period intervention method. Routine nursing intervention and rapid rehabilitation nursing intervention were used respectively. The general conditions of the two groups were recorded, and the differences of T cell subsets before operation and 3 days after operation were detected. Visual analogue pain (VAS) score was used to evaluate the changes of pain degree at 1 day, 3 days and 5 days after operation and on the day of discharge. Postoperative complications and satisfaction were compared between the two groups. Quality of life (QOL) was assessed at 1 month and 3 months after operation using the CARES-SF score. Results: Anesthesia waking time (26.12 ± 5.77) min, off-bed activity time (14.25 ± 2.87) h and hospital stay (7.82 ± 2.15) d in the rapid rehabilitation group were shorter than those in the control group (P < 0.05). The operation time (92.02 ± 14.78) min and intraoperative blood loss (57.96 ± 13.96) mL in the rapid rehabilitation group were not significantly different from those in the control group (P > 0.05). In the control group, 3d after operation, T lymphocyte subsets were decreased gradually than that before operation (P < 0.05), CD3+ was decreased 3d after operation than that before operation in the rapid rehabilitation group (P < 0.05), but CD4+, CD8+, CD4+ / CD8 + 3d after operation had no significant difference than that before operation (P > 0.05). In rapid rehabilitation group, T lymphocyte subsets at 3d after operation were higher than those in the control group (P < 0.05). The postoperative complication rate of the rapid rehabilitation group was lower than that of the control group, and the satisfaction degree was higher than that of the control group, with significant difference (P < 0.05). After follow-up, it was found that the scores of qualities of life, such as physiology, psychosocial, marriage, sexual life and relationship with medical staff in the rapid rehabilitation group were lower than those in the control group at 1 month and 3 months after operation (P < 0.05). Conclusion: The concept of rapid rehabilitation nursing can stabilize the immune function of patients after radical breast cancer surgery, promote the postoperative rehabilitation and improve the quality of life after operation.

scholarly journals The Effect of Probiotics on Bacterial Pneumonia

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Ahmad Najafi ◽  
Alireza Sharif ◽  
Mohammadreza Sharif ◽  
Hamidreza Gilassi
Keyword(s):  
Bacterial Pneumonia ◽  
Treatment Protocol ◽  
Response To Treatment ◽  
Control Group ◽  
Case Group ◽  
Chi Square ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Mortality And Morbidity ◽  
Significant Difference

Background: Pneumonia, as a fairly prevalent illness, is the main cause of hospital mortality. The major cause of mortality and morbidity of pneumonia is due to bacteria. The presence of multi-drug resistant pathogens and no response to treatment have aroused considerable interest in the use of probiotic components to prevent infections. Objectives: Given that few studies have evaluated the efficacy of probiotics in reducing bacterial pneumonia, the current aimed to evaluate the role of probiotics in decreasing pneumonia. Methods: This double-blind, randomized clinical trial study was conducted on 100 patients diagnosed with bacterial pneumonia in Shahid Beheshti Hospital, Kashan, Iran, during 2018. Patients were randomly classified into two groups (n = 50). One group (case) received two sachets of probiotic/daily for five days, and another group (control) received placebo. Moreover, patients in both groups received the same treatment protocol. All data were extracted from medical records. Chi-square test and independent t-test were used for analysis of data. P < 0.05 was considered statistically significant. Results: No significant difference was seen between case and control groups regarding age, gender, and duration of symptoms before hospitalization (P > 0.05), which implies a completely random classification of two groups. The mean duration of hospitalization, dyspnea, tachypnea, cough, fever, and crackles was significantly decreased in the case group compared to the control group (P < 0.05). Conclusion: The use of probiotics can be effective in reducing the duration of dyspnea, tachypnea, cough, fever, and length of hospitalization. Therefore, probiotics may be considered a promising treatment for the development of new anti-infectious therapy. In addition, the usage of probiotics along with antibiotics is suggested for decreasing pneumonia complications and improving the efficacy of therapy.

scholarly journals Perceptions of caregivers on immunization in Ntungamo district, Uganda

2021 ◽  
Vol 8 (12) ◽  
pp. 5729
Author(s):  
Byamukama Topher ◽  
Keraka M. Margaret ◽  
Gitonga Eliphas
Keyword(s):  
Risk Factor ◽  
Intervention Group ◽  
Cost Effective ◽  
Systematic Sampling ◽  
Control Group ◽  
Post Intervention ◽  
Mortality And Morbidity ◽  
Significant Difference ◽  
Quasi Experimental ◽  
And Control

Background: Immunization is one of the most cost-effective public health interventions to reduce child mortality and morbidity associated with infectious diseases. The objective of this study was to determine the perceptions of caregivers on immunization in Ntungamo district.Methods: Quasi-experimental study was used with health centres assigned to intervention and control groups. Purposive sampling was used to select the two counties where the study was done. Proportional sampling was done to get study samples from each health facility, while systematic sampling was done to get study participants. A total of 787 children from twelve health facilities provided the study sample. A post intervention evaluation was conducted to determine the effect of these interventions. Association of variables was tested using Mann Whitney U-test and Chi-square.Results: On benefits, most caregivers in the intervention group (85.3%) and in the control group (54.3%) regarded immunization as very highly and moderately beneficial to their children respectively. On risks, most caregivers in the intervention group (85.5%) and control group (43.1%) regarded the risk factor associated with immunization as very low and moderate respectively. From hypothesis testing, there was a significant difference on the perceived benefits and risks of immunization between the intervention and control group.Conclusions: Most caregivers in the intervention and control group regarded immunization as very highly beneficial and moderately to their children respectively. Most of the caregivers in the intervention and control group regarded the risk factor associated with immunization as very low and moderate respectively. 

scholarly journals Treatment of Severe Ulnar Instability of the MCP Joint Improves Function in LRTI Arthroplasty for Osteoarthritis of the Thumb CMC Joint

2019 ◽  
Vol 09 (02) ◽  
pp. 105-115
Author(s):  
Johanna Wirth ◽  
Eva-Maria Baur
Keyword(s):  
Patient Satisfaction ◽  
Strength Function ◽  
Ulnar Collateral Ligament ◽  
Metacarpophalangeal Joint ◽  
Metacarpal Bone ◽  
Control Group ◽  
Level Of Evidence ◽  
Pinch Grip ◽  
Significant Difference ◽  
Retrospective Comparative Study

Abstract Background Comorbidity in the metacarpophalangeal joint (MCPj) of the thumb, i.e., hyperextension or ulnar collateral instability, could affect the outcome of arthroplasty in the thumb carpometacarpal joint (CMCj). Objective In a retrospective study, we evaluated the effect of arthrodesis of the MCPj for thumbs with unstable MCPj and simultaneous ligament reconstruction tendon interposition (LRTI) arthroplasty for the CMCj in terms of strength, function, and patient satisfaction. Patients and Methods A total of 69 thumbs treated with a LRTI arthroplasty of the CMCj were included. In 14 of those cases, an arthrodesis of the MCPj was performed as well. In 12 thumbs, both procedures were done simultaneously; in one case MCPj arthrodesis followed LRTI arthroplasty, whereas one patient already had MCPj arthrodesis at time of LRTI arthroplasty. Those 14 thumbs were compared with the control group of 55 thumbs who had only undergone LRTI. At a mean follow-up of 4 to 5 years (mean 54 [10–124] months) postoperative assessments included range of motion (ROM) of the CMC, MCP, and interphalangeal (IP) joint of the thumb, as well as any instability of the MCPj. Pinch and grip strength were examined, also the visual analogue scale (VAS), patient satisfaction, QuickDASH, PRWE-Thumb, and the Kapandji's Opposition Score. Radiologically, proximalization of the first metacarpal bone was measured. Student's t-test was used to determine significance, p < 0.05 was considered significant. Results Additional arthrodesis of the MCPj provided no significant difference of function in thumbs that only had a hyperextension-instability. However, in thumbs with marked ulnar instability, stronger pinch-grip was obtained with arthrodesis, compared with only LRTI. Conclusion In patients with advanced painful thumb CMCj osteoarthritis, we recommend (simultaneous) arthrodesis of the MCPj, to allow a stable thumb grip if there is additional marked ulnar collateral ligament instability. Level of Evidence This is a Level III, retrospective comparative study.

Measurement of Glenohumeral Internal Rotation in Asymptomatic Tennis Players and Swimmers

2009 ◽  
Vol 37 (5) ◽  
pp. 1017-1023 ◽  
Author(s):  
Renato Rangel Torres ◽  
João Luiz Ellera Gomes
Keyword(s):  
Internal Rotation ◽  
External Rotation ◽  
Control Group ◽  
Level Of Evidence ◽  
Cross Sectional ◽  
Tennis Players ◽  
Glenohumeral Internal Rotation Deficit ◽  
Significant Difference ◽  
Overhead Sports ◽  
The Difference

Background Glenohumeral internal rotation deficit, often diagnosed in players of overhead sports, has been associated with the development of secondary shoulder lesions. Hypothesis Asymptomatic players of different overhead sports will exhibit variable degrees of glenohumeral internal rotation deficit. Study Design Cross-sectional study; Level of evidence, 3. Methods Fifty-four asymptomatic male volunteers (108 shoulders) divided into 3 groups (tennis players, swimmers, control group) underwent measurements of glenohumeral internal and external rotation using clinical examination with scapular stabilization. Measurements of dominant and nondominant shoulders were compared within and between groups. Glenohumeral internal rotation deficit (GIRD) was defined as the difference in internal rotation between the nondominant and dominant shoulders. Results In tennis players, mean GIRD was 23.9° ± 8.4° (P < .001); in swimmers, 12° ± 6.8° (P < .001); and in the control group, 4.9° ± 7.4° (P = .035). Dominant shoulders showed significant difference between all groups, and the difference in internal rotation of the dominant shoulder between the group of tennis players in comparison with the control group (27.6°, P < .001) was greater than the difference in internal rotation of the dominant shoulder found in the group of swimmers compared with the control group (17.9°, P < .001). Between tennis players and swimmers, the difference in internal rotation of the dominant shoulder was 9.7° (P = .002). Conclusion Dominant limbs showed less glenohumeral internal rotation than the nondominant limbs in all groups, with the deficit in the group of tennis players about twice the deficit found for swimmers. Mean difference between limbs in the control group was less than 5°, which is within normal parameters according to most studies. There were statistically significant differences between all groups when dominant shoulders were compared with each other, differences that were not compensated by external rotation gain. Tennis players had the least range of motion, followed by swimmers.

Neoadjuvant therapy for localized gastrointestinal stromal tumors (GISTs): A propensity score weighted analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e23516-e23516
Author(s):  
Kathryn E. Marqueen ◽  
Erin Moshier ◽  
Michael Buckstein ◽  
Celina Ang
Keyword(s):  
Overall Survival ◽  
Logistic Regression ◽  
Propensity Score ◽  
Survival Benefit ◽  
Postoperative Mortality ◽  
Phase Iii ◽  
R0 Resection ◽  
Treatment Groups ◽  
Significant Difference ◽  
The Impact

e23516 Background: Retrospective and single-arm prospective studies have reported clinical benefit associated with receipt of neoadjuvant imatinib for GISTs. In the absence of randomized phase III data, the impact of neoadjuvant systemic therapy (NAT) on survival, in comparison to upfront resection, remains unknown. Methods: We identified N = 14,402 patients with complete clinical, demographic, treatment and pathologic data within the National Cancer Database (2004-2016) who underwent resection of localized GIST of the stomach, esophagus, small bowel, and colorectum, with or without ≥3 months of NAT. Inverse probability of treatment weighting (IPTW) was used to adjust for covariable imbalance among treatment groups, with the propensity score estimated by logistic regression. The effect of NAT on overall survival was estimated with a weighted time-dependent Cox proportional hazards model. A weighted logistic regression was used to estimate the effect of NAT on 90-day postoperative mortality and R0 resection. Results: 759 (5.3%) patients received NAT followed by resection, compared to 13,643 (94.7%) who underwent upfront resection. Median length of NAT was 6.3 months. 53% of NAT patients were male vs. 49% of UR patients, 68% vs. 66% had primary gastric GIST, and 73% vs 49% were high risk. Patients receiving NAT had larger tumors (p < 0.001) and higher mitotic index (p = 0.003). There was a significant survival benefit associated with receipt of NAT (table). 90-day postoperative mortality rate was 3/759 (0.4%) among NAT patients vs. 307/13,643 (2.3%) UR patients. Receipt of NAT was significantly associated with lower odds of 90-day postoperative mortality (table). Of the 13,562 patients with information on margin status, the R0 resection rate was 635/716 (88.7%) for the neoadjuvant group vs. 11,823/12,846 (92%), with no significant difference between treatment groups (table). Conclusions: After adjustment for imbalance in prognostic and demographic factors, this analysis demonstrates that receipt of NAT for localized GIST is associated with a modest overall survival benefit. Although NAT patients had higher risk features, NAT was associated with a lower risk of 90-day postoperative mortality, with no difference in likelihood of achieving an R0 resection. [Table: see text]

scholarly journals Fast-track Cardiac Surgery in Children: Feasibility in Bangladeshi Setting

1970 ◽  
Vol 3 (1) ◽  
pp. 50-54 ◽  
Author(s):  
SA Quader ◽  
R Sarker ◽  
F Ahmed ◽  
MK Hasan ◽  
AK Beg ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Hospital Stay ◽  
Fast Track ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Postoperative Mortality ◽  
Control Group ◽  
Mortality And Morbidity ◽  
Surgical Closure ◽  
Fast Tracking

Background: Fast-track recovery protocols in cardiac surgery is gaining worldwide popularity and have contributed to significant reductions in the postoperative hospital stay and cost without any increase in postoperative mortality and morbidity. The aim of this study was to find out the feasibility of fast track paediatric cardiac surgery in Bangladeshi setting. Method: It was a prospective study conducted in National Institute of Cardio-vascular Diseases, Dhaka, from July 2009 to June 2010. All patients, between 3 to 18 years, underwent surgical closure of atrial or ventricular septal defect under cardio-pulmonary bypass. 20 patients from our unit served as fast track group and 30 patients from other units of the same hospital served as conventional group. Fast track patients were extubated in less than 6 hours after surgery, shifted from ICU in less than 24 hours and geared up to discharge home within 3 days of surgery. Result: 18 (90%) of the 20 patient of the fast track group were discharged within 3 days of surgery, 2 patients cannot be discharged within this time frame. Mean post operative hospital stay for study group was 3.1 days, whereas the mean hospital stay in the control group was 7.5 days. Follow-up was 100% complete at 30 days. There was no major in-hospital or out-of-hospital complications in either group. No patient was readmitted at our centre or elsewhere for any complication arising from this process. Conclusion: Fast tracking is feasible and safe in low-risk paediatric open-heart surgery in Bangladeshi scenario. A multidisciplinary approach with a set protocol is required to achieve this goal in a safe and reproducible manner. Keywords: Cardiac surgery; Congenital heart disease; Fast track; Hospital discharge. DOI: 10.3329/cardio.v3i1.6427Cardiovasc. j. 2010; 3(1): 50-54

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

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

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

scholarly journals THE INFLUENCE OF ACE I/D GENE POLYMORPHISM IN AMATEUR AMERICAN FOOTBALL ATHLETES IN BRAZIL

2019 ◽  
Vol 25 (6) ◽  
pp. 460-463
Author(s):  
Gino Fellipe Santoro ◽  
Katlyn Duarte de Mello ◽  
Zair Cândido de Oliveira Netto ◽  
Gabrielle Pfutzenreuter ◽  
Julio Cesar Bassan ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
American Football ◽  
Control Group ◽  
P Value ◽  
Genetic Profile ◽  
Chi Square ◽  
Level Of Evidence ◽  
Genotypic Distribution ◽  
Significant Difference ◽  
Chi Square Test

ABSTRACT Introduction Physical performance depends on a variety of biological and mechanical properties. These different phenotypes are related through the complex interaction between the environment and the individual genetic profile. The hypothesis is that there is a hereditary component that interferes in physical fitness. ACE stands out among the genes that may influence this response. Objectives The objective of this study is to analyze the polymorphism of the ACE gene in American football athletes. Methods: At the end of the study, the sample was composed of 45 male athletes and 72 non-athletes. DNA was extracted from the jugal mucosa. ACE polymorphisms were genotyped through polymerase chain reaction and analyzed using the electrophoresis process. To compare the frequency of genotypes between athletes and the control group, we used the Chi-square test. The association between the frequencies of alleles was verified through the 2X2 contingency tables analyzed using the Chi-square test with Yates correction. The type of study was diagnostic - Investigation of a diagnostic test, level of evidence II. A p-value of ≤0.05 was considered statistically significant for all the analyses. Results The results showed a greater frequency of the D allele in American football athletes when compared with non-athletes, and a significant difference in the genotypic distribution of the athletes being composed of a higher number of the DD genotype as compared to the control group. Conclusion The study provides evidence of the allelic and genotypic influence of ACE polymorphism in amateur American football players in Brazil. Level of evidence II; Investigation of a diagnostic test.

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