Colorectal cancer (CRC) patients surveyed by 18FDGPET-CT (PET-CT): An open-label multicenter randomized trial (NCT 00624260).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3520-3520 ◽  
Author(s):  
Iradj Sobhani ◽  
Isabelle Baumgaertner ◽  
Emmanuel Itti ◽  
Alain Luciani ◽  
Richard Layese ◽  
...  

3520 Background: Curative surgery is the best therapy of CRC and recurrences. We assessed whether adding semi-annual PET-CT to the usual surveillance would be cost-effective in high risk recurrent CRC patients. Methods: CRC patients (stage II tumor perforated, stages III and IV) in remission after curative surgery were randomly assigned (1:1) to trimester usual surveillance (control) or usual surveillance + semi-annual course PET-CT (intervention) for a 3-yr follow up period. Every 3 months, multidisciplinary committee decided about recurrence by yes/no/doubtful. If yes, curative surgery alone (when relevant), or chemotherapy alone (unresecable recurrence) were conducted; additional exams could be performed if doubtful. Primary composite endpoint (failure) comprised unresectable recurrence & death. The economic assessments according to standards (CHEERS) were performed and costs were compared between groups. Statistical tests for calculation of the relative risk (RR) were used and survival was analyzed using Kaplan-Meier method, Log-Rang test and Cox models. Results: Baseline characteristics of 239 patients (120/119) enrolled in 12 centers were balanced. The failure rate was 29.2% (31 unresectable recurrences & 4 deaths) and 23.5% (27 & 1) in Interventional vs Control, respectively with no significant difference (RR = 1.24, 95% CI: 0.81-1.90; P = .32). Similar results were observed in multivariate analysis (Cox models) adjusted for stage and tumor differentiation (HR = 1.33, 95% CI: 0.8-2.19, P = .27). Period until the unresectable recurrence was significantly shorter in Interventional (median = 7; IQR: 3-20 months) than in Control group (14.3; 7.3-27; P= 0.016). This was consistent with lower elevation (median; IQR) of tumour marker in interventional (3.8; 2.8-19) than in control group (10; 5.2-28.6) at the first recurrence time as compared to the baseline (p = 0.007). Overall (mean; SD) cost (euros)/patient was higher in the PET-Scan (9385; 11658) than in the control group (7027; 7656). Conclusions: Although recurrences were detected earlier in PET-CT group, the strategy was less effective, more expensive. This exam should not be advised routinely. Clinical trial information: NCT 00624260.

2021 ◽  
Vol 9 ◽  
pp. 205031212110202
Author(s):  
Rgda Mohamed Osman ◽  
Mounkaila Noma ◽  
Abdallah Elssir Ahmed ◽  
Hanadi Abdelbagi ◽  
Rihab Ali Omer ◽  
...  

Objectives: Rheumatoid arthritis is a chronic inflammatory autoimmune disease. This study aimed to determine the association of interleukin-17A-197G/A polymorphism with rheumatoid arthritis in Sudanese patients. Methods: A case–control study was conducted between March and December 2018. Clinical and demographic data of the study participants were collected and analyzed. Polymerase chain reaction restriction fragment length polymorphism molecular technique was done to investigate interleukin-17A-197G/A polymorphisms. All statistical tests were considered statistically significant when p < 0.05. Results: The study population included 266 participants aged between 1 and 85 years, with an average of 40 years, classified into 85 (31.2%) cases (mean age 48.5 ± 11.3 years), and 181 (68.8%) controls (mean age 35.3 ± 15.9 years). The interleukin-17A homozygote AA genotype was more frequent among the control group compared to the case group; 95 (52.5%) and 7 (8.2%), respectively. The homozygote GG and the heterozygote AG genotypes were proportionally not different among the cases and control groups; 13 (54.2%) and 11 (45.8%), and 65 (46.4%) and 75 (53.6%), respectively. According to the distribution of interleukin-17A genotypes, a statistically significant difference was observed among cases with the interleukin-17A AA and AG genotypes, p values 0.001 and 0.004, respectively. For the association interleukin-17A genotypes and family history a negatively significant association was reported (95% confidence interval, –0.219, p value = 0.001). There was also a negatively significant association of interleukin-17A genotypes and anti-cyclic citrullinated peptide (95% confidence interval, −0.141, p value = 0.002). Conclusion: This study is the first study in Sudan established the association between interleukin-17A-197G/A (rs2275913) polymorphisms and susceptibly to rheumatoid arthritis. These findings appeal for further research in Sudan to investigate the exact role of IL-17A in immunopathology and disease severity among Sudanese rheumatoid arthritis


Author(s):  
Jeyasudha Jambusayee ◽  
Kulur Mukhyaprana Sudha

Background: Alopecia areata is an autoimmune disorder causing patchy hair loss on scalp and other parts of the body and leading to poor self-esteem and anxiety in patients. Treatment with topical or systemic drugs like steroids or other immunosuppressants is associated with adverse effects. Hydroxychloroquine is an antimalarial drug, with T cell modulating function. This study was undertaken to assess the safety, efficacy and tolerability of Hydroxychloroquine in Alopecia areata compared to betamethasone oral mini pulse (OMP) therapy. Methods: 60 patients with alopecia areata were randomized into two groups of 30 each. Control group received tab. betamethasone 5 mg/day on two consecutive days of week for 12 weeks and Study group received tab. hydroxychloroquine 200 mg/day for 12 weeks. They were followed-up for further 12 weeks. Scale of alopecia tool, dermatology life quality index and global assessment at baseline, 12 weeks and 24 weeks were used to assess the outcome.Results: 94 patients were screened and 60 patients were included. All patients completed the study. At the end of 12 weeks, there was a statistically significant reduction in SALT and DLQI scores in both control and study groups. But at the end of 24 weeks, the study group showed an increase in the scores. Relapses were more in the study group. No significant difference in the incidence of adverse events was noted between the two groups.Conclusions: Hydroxychloroquine 200 mg/day is less efficacious in the management of alopecia areata in comparison to betamethasone oral mini pulse therapy.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jan Bednarsch ◽  
Zoltan Czigany ◽  
Sven H. Loosen ◽  
Lara Heij ◽  
Lorenz Ruckgaber ◽  
...  

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Annelise Ayres ◽  
Geraldo Pereira Jotz ◽  
Carlos R. M. Rieder ◽  
Maira Rozenfeld Olchik

Aims. To verify the effectiveness of the maneuver application in swallowing therapy with PD. Materials and Method. We performed an open-label trial, with three groups compounds by PD individuals: the experimental group, control group, and orientation group. The study included PD patients with dysphagia. A cognitive screening, through a questionnaire about depression and quality of life, was conducted. Swallowing assessment was performed through (1) fiberoptic endoscopic evaluation of swallowing (FEES); (2) clinical evaluation and Functional Oral Intake Scale (FOIS); and (3) assessment of the quality life related to swallowing (SWALQOL). A therapeutic program, which consisted of chin-down postural maneuver and orientations on feeding, was applied. Both groups (EG and OG) received on-month therapeutic program. Results. A significant improvement in swallowing, evaluated by clinical assessment, was observed in solid (p<0.001) and liquid (p=0.022) consistencies in EG when compared to OG and CG. Patients in EG presented improvement in QoL, with the significant difference in comparison with the other groups, about domain frequency of symptoms (p=0.029) in SWALQOL questionnaire. Conclusion. The postural maneuver chin-down improved swallowing performance and self-perception, but not the laryngeal signs. This trial is registered with registration number NCT02973698.


2020 ◽  
Vol 10 (9) ◽  
pp. 2236-2241
Author(s):  
Chengyi Zhou ◽  
Junru Wang ◽  
Min Tao ◽  
Zhiqin Zhou ◽  
Wei Yang ◽  
...  

Objective: The objective is to study the effect of continuous nursing on the vomiting of patients with expectant vomiting of lung cancer, and to establish a three-dimensional segmentation model of PET-CT image, so as to provide an effective nursing intervention for patients with expectant vomiting of lung cancer. Methods: In this study, the sampling method is adopted. We collected 68 patients (over 18 years old) diagnosed with lung cancer from May 2016 to June 2018 as the study subjects. Patients are divided into experimental group and control group. Before discharge, the patients in the control group are given general discharge guidance and health knowledge guidance. The patients in the experimental group are treated with continuous nursing until the next admission, except for general discharge guidance and health knowledge guidance. The cycle is a period of intermittent chemotherapy. According to the general data questionnaire designed by the researchers themselves, the criteria of acute and subacute toxicity of anticancer drugs developed by the World Health Organization (WHO), and the simple coping style questionnaire, the data are collected. SPSS 22.0 is used for analysis. The rank sum test is used in the grading of expected nausea and vomiting. The score of self coping ability is compared within the group by paired sample t-test, and P < 0.05 is statistically significant. Results: First, before continuous nursing, there is no significant difference in the expected nausea and vomiting between the two groups (P = 0.299). After continuous nursing, in the experimental group, nausea and vomiting is significantly improved (P < 0.001). Second, the positive and negative coping scores of the two groups are 15.98±1.11 and 16.99±1.23, respectively. There is no significant difference between the two groups (P > 0.05). After continuous nursing, the experimental group is compared with the control group. There is a significant difference between positive coping score (19.21±2.12) and negative coping score (16.27±1.53) (P < 0.01). Thirdly, the pixels with the standard uptake value (SUV) > 1/4 of the maximum standard uptake value (SUVmax) are selected as the basic tumor range, which can accurately predict the tumor size and range. Conclusion: PET-CT image analysis and continuous nursing can reduce the degree of nausea and vomiting in patients with lung cancer expectant vomiting, predict the size of lung cancer tumor, improve the patients’ self-response ability and the cure rate of tumor, which is worth promoting in patients with lung cancer expectant vomiting.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24021-e24021
Author(s):  
Manupol Maikami ◽  
Napa Parinyanitikul ◽  
Nattaya Poovorawan

e24021 Background: The Geriatric 8 (G8) is a simplified screening tool to select the appropriate elderly patients for chemotherapy. Vulnerable patients with impaired G8 score might need additional comprehensive geriatric assessment (CGA) with intervention for individual problem. However, the impact of CGA and therapeutic intervention on rate of complete chemotherapy among these patients is rarely addressed. This study aims to evaluate the benefit of CGA guided intervention. Methods: A single center, randomized, open-label study which included newly diagnosed elderly cancer patients (age ≥ 65) with impaired G8 score (≤ 14) who were designated for chemotherapy. After the enrollment, patients were randomized to 1:1 ratio to receive CGA guided intervention (intervention group) or usual care (control group). The primary end point was the rate of complete chemotherapy at 90-day. Associated factors for complete chemotherapy were evaluated. Results: Between June 2019 and December 2019, 52 patients were randomized (26 patients for intervention group and 26 patients for control group). Mean age was 72 years, 59.6% was female, 40.4% had breast cancer and 51.9% had early stage cancer. With G8 assessment, 55.8% had intermediate (score 11-14) and 44.2% had low (score < 11) impaired G8 score. All baseline characteristics were balanced. Using per protocol analysis, there was no significant difference in rate of complete chemotherapy between groups (61.9% vs 50%, OR 1.63; 95%Cl 0.51-5.23; p = 0.42). Considering subgroup analysis in the intermediate G8 score patients, the intervention group had a significant higher rate of complete chemotherapy than control group (81.8% vs 66.7%, OR 2.71; p = 0.02), but no significant difference in low G8 score group (40% vs 27.3%, OR 1.78; p = 0.58). In univariate analysis, age below 75 years, BMI > 20 kg/m2 and intermediate G8 score showed significant factors for improving rate of complete chemotherapy. Conclusions: This is the first study in south-east Asia using CGA and intervention to improve rate of completion in chemotherapy. Although the CGA and intervention had no significant difference but had tendency to be better in completion rate of chemotherapy than usual care. The intermediate-impaired G8 score subgroup is more likely to benefit from CGA guided intervention for complete chemotherapy as planned.


2018 ◽  
Vol 42 (6) ◽  
pp. 636-643 ◽  
Author(s):  
Sang Jun Kim ◽  
Sung Jae Kim ◽  
Yong Ho Cha ◽  
Keun Ho Lee ◽  
Jeong-Yi Kwon

Background: Three-dimensional printer technology can produce the personalized orthosis in various forms. Objective: To develop a personalized wrist orthosis using a three-dimensional scanner and three-dimensional printer for patients with wrist pain. Study design: A preliminary, prospective, randomized, open-label study. Methods: A total of 22 patients with wrist pain were randomly assigned to the control and experimental groups. The control group wore a cock-up orthosis and the experimental group wore a three-dimensional-printed wrist orthosis for 1 week. The Patient-Rated Wrist Evaluation, Jebsen Hand Function Test, and Orthotics and Prosthetics Users’ Survey were checked before and 1 week after the application. Results: The Patient-Rated Wrist Evaluation showed significant pain relief in both groups. Two items of the 28 Orthotics and Prosthetics Users’ Survey questions, “Put toothpaste on brush and brush teeth” and “Dial a touch tone phone,” showed high satisfaction scores, with statistically significant difference in the experimental group ( p = 0.036 and 0.004). Conclusion: The three-dimensional-printed wrist orthosis was superior to the cock-up orthosis for two items of the Orthotics and Prosthetics Users’ Survey. Wrist pain was reduced in the group wearing the three-dimensional-printed wrist orthosis as well as the group wearing the cock-up orthosis, so the three-dimensional-printed wrist orthosis could possibly play the same role as the cock-up orthosis. Clinical relevance A three-dimensional-printed wrist orthosis can be a substitute for a conventional ready-made wrist orthosis for patients with wrist pain with more satisfaction.


Author(s):  
Brooke E. Wilson ◽  
Michelle B. Nadler ◽  
Alexandra Desnoyers ◽  
Eitan Amir

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.


2015 ◽  
Vol 1 (2) ◽  
pp. 84 ◽  
Author(s):  
Akhmad Muntaha ◽  
Haitami Haitami ◽  
Nurul Hayati

Tofu is a food with high protein content and the moisture content reaches 85%, so that it knows can not last long. Manufacturers know still use formaldehyde as a preservative. Handling to reduce formaldehyde levels in the know are soaked in hot water and boiled in boiling water. The purpose of this study was to determine the ratio decreased levels of formaldehyde in the know are boiled and soaked in hot water out. This type of research is True Experiment with posttest study design Only Control Group Design. The population in this study is tofu containing formalin. Then examined by spectrophotometry of formaldehyde levels in most groups as a pretest sample, others are given treatment and formalin levels checked by spectrophotometry. Data were analyzed using the Mann-Whitney test. Results of this study the average levels of formaldehyde in the know before the treatment is 68.668 ppm. Decreased levels of formaldehyde in formalin know after boiling for 10 minutes was 64.77%. Decreased levels of formaldehyde in formalin know with the treatment of immersion in hot water for 10 minutes is 33.1%. Based on statistical tests that have been conducted, it was found a significant difference between the reduced levels of formaldehyde in formalin boiled out and the know formalin soaked in hot water with sig. 0,000. Boiling know formalin reduce levels of formaldehyde greater than soaking out in hot water.


2015 ◽  
Vol 4 (3) ◽  
Author(s):  
Desi Sarli ◽  
Masrul Masrul ◽  
Meilinda Agus

Abstrak Upaya penanganan perdarahan postpartum adalah dengan pemberian oksitosin yang mempunyai peranan penting dalam merangsang kontraksi otot polos uterus sehingga perdarahan dapat teratasi.Hormon oksitosin dapat dihasilkan melalui rangsangan pemijatan oksitosin yang akan mempercepat kerja saraf parasimpatis untuk menyampaikan perintah ke hipotalamus untuk menghasilkan oksitosin. Tujuan penelitian ini adalah untuk mengetahui pengaruh perbedaan kadar oksitosin melalui pemijatan oksitosin terhadap jumlah perdarahan pada ibu 2 jam postpartum. Penelitian menggunakan desain eksperimen. Penelitian ini dilaksanakan ± 6 bulan dengan jumlah sampel 64 orang. Pengolahan data dilakukan dengan komputerisasi. Data disajikan dalam bentuk distribusi frekuensi dan selanjutnya dilakukan uji independen t-test, uji korelasi dan regresi untuk mengetahui pengaruh hubungan kedua variabel. Hasil penelitian perbedaan kadar oksitosin pada ibu 2 jam postpartum pada kelompok intervensi mempunyai rata-rata kadar oksitosin 47.16 pg/ml dengan standar deviasi 17.583 pg/ml,sedangkan kadar oksitosin  pada kelompokkontrol 29.86 pg/ml dengan standar deviasi 17.532 pg/ml dengan nilai p<0,05.Rata-rata jumlah perdarahan pada kelompok intervensi 175.00 ml dengan standar deviasi 48.894 ml,sedangkan jumlah perdarahan  pada kelompok kontrol 247.06 ml dengan standar deviasi 72.093 ml dengan nilai p<0,05. Hasil uji korelasi didapatkan hubungan kadaroksitosin terhadap jumlah perdarahan menunjukkan hubungan sedang (r=0,482). Hasil uji statistik didapatkan ada perbedaan kadar oksitosin terhadap jumlah perdarahan (p<0,05). Terdapat perbedaan yang bermakna antara kadar oksitosin ibu 2 jam postpartum pada kelompok intervensi dan kelompok kontrol.Terdapat perbedaan yang bermaknaantara jumlah perdarahan ibu 2 jam postpartum pada kelompok intervensi dan kelompok kontrol. Semakin tinggi kadar oksitosin maka jumlah perdarahan semakin sedikit.Kata kunci: Pemijatan oksitosin, oksitosin, jumlah perdarahan 2 jam postpartumAbstract Efforts to handling postpartum hemorrhage is to give oxytocin,which it is an important role in oxytocin stimulates uterine smooth muscle contraction, so that bleeding can be resolved.The hormone oxytocin can be generated through the stimulation of oxytocin massage that will accelerate parasympathetic nerves to deliver commands to the hipotalamus to produce oxytocin. The objective of this study was to determine effect of different levels of oxytocin trough massage of oxytocin on the amount of bleeding at 2 hours postpartum. This research use experimental designthat was conducted ± 6 months to 64 people. Data processing was done by computerized. The data presented in the form of a frequency distribution and performed an independen t-test and correlation test and regression to determine the effect ofthe relationship between the two variables. There is differences the levels of oxytocin at 2 hours postpartum in the intervention group had higher median levels of oxytocin 47.16pg/ml with a standard deviation of 17.583pg/ml, whereas the levels ofoxytocin at 2 hours post partum control group 29.86 pg/ml with a standard deviation of 17.532 pg/ml with p<0.05. The average of bleeding in the intervention group was 175.00 ml with a standard deviation of 48.894 ml, while the amount of bleeding at 2 hours postpartum control group 247.06 ml with a standard deviation of 72.093 ml with p<0.05. The results obtained correlation levels of oxytocin relation to 2 hours postpartum hemorrhage showed moderate relationship (r =0.482). The results of statistical tests found differences in the levels of oxytocin on the amount of bleeding at 2 hours postpartum (p<0.05). There is differences between the levels of oxytocin 2 hours pos partum in the intervention group and the group control. There are significant difference between the hemorrhage 2 hours post partum in the intervention group and the group of high levels of oxytocin control. Keywords: massage of oxytocin, oxytocin, amount of bleeding at 2 hours postpartum


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