An open-label, randomized, controlled clinical trial to explore the curative effects between the treatment of capecitabine and andrographolide and the single capecitabine in the patients with pathological and/or histologic diagnosed unresectable, advanced, recurrent, and metastatic colorectal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS819-TPS819 ◽  
Author(s):  
Yongqian Shu ◽  
Jing Sun ◽  
Peifen Cai ◽  
Weicheng Wang ◽  
Xiao Han ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Target Therapy ◽  
The Elderly ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Randomized Controlled Clinical Trial ◽  
Open Label ◽  
Randomized Controlled

TPS819 Background: Colorectal cancer (CRC) is one of the most commonly diagnosed solid tumors worldwide. Current therapies for the treatment of CRC mainly comprise fluoropyromidine-based chemotherapies that are used individually or in combination with oxaliplatin or/with target therapy. Andrographolide, a natural diterpenoid from Andrographispaniculata, has been reported to exert antibacterial, antiviral, anti-inflammation and neuroprotectiveactivities. Our previous studies have proved that Andrographolide can inhibit tumor growth in mice at a relatively high dose(about 200 mg/kg).The aim of the study is to make a comparison of PFS, RR, and OS of the elderly CRC between the treatment of xeloda and andrographolide and the signal xeloda.We look forward to these findings highlight the potential possibility of using this natural, safe and relatively inexpensivecompound as potential adjunctive treatments in improving the overall treatment response of patients with CRC in future. Methods: This is an open-label, randomized, controlled clinical trial. Patients older than or equal to 65, by pathological and/or histologic diagnosed unresectable, advanced, recurrent andmetastatic CRC, will be enrolled. These patients’ tumors must be clearly measured by radiographic technology. All cases of chemotherapy patients randomly divided into two groups, experimental group (xeloda with andrographolide): xeloda: 1250mg/m2 , po bid, d1–14, q3w; andrographolide: 500mg, ivd qd, d1–14, q3w; control group (xeloda): 1250mg/m2, po bid, d1–14, q3w, 21d/cycle. After each 2 cycles, patients will be examined by imageological tests (CT and/or MRI) or tumour biomarkers (CEA and CA199) to estimate the curative effects. Until the tumor progression or after 6 cycles, patients will be removed from this study. PFS is set as the primary endpoint while secondary endpoints include overall survival (OS), overall response rate (ORR), and health-related quality of life (HRQoL). Recruitment has begun in Jan 2014 and about 52 patients has joined this study. Clinical trial information: NCT01993472.

scholarly journals Effects of HIIT and MIIT Suspension Training Programs on Sleep Quality and Fatigue in Older Adults: Randomized Controlled Clinical Trial

2021 ◽  
Vol 18 (3) ◽  
pp. 1211
Author(s):  
José Daniel Jiménez-García ◽  
Fidel Hita-Contreras ◽  
Manuel Jesús de la Torre-Cruz ◽  
Agustín Aibar-Almazán ◽  
Alexander Achalandabaso-Ochoa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Programs ◽  
The Elderly ◽  
Moderate Intensity ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Post Intervention ◽  
Randomized Controlled

Poor sleep quality lessens general health quality and is related to physical and mental problems. Moreover, fatigue is one of the foremost common complaints in medical care and plays a role in the decreasing quality of life of the older population. For these reasons, the objective of this study was to examine the effect of high- and moderate-intensity interval training programs (HIIT vs. MIIT)—both consisting of twelve weeks of TRX training—on the sleep quality and fatigue levels of the elderly. A randomized controlled clinical trial (NCT03404830) was conducted. A total of 82 subjects were randomized to either a HIIT group (n = 28) that performed a main squat activity with a suspension system, comprising four four-minute intervals between 90–95% of the maximum heart rate (HR), an MIIT group (n = 27) with an intensity of 70% of the maximum HR, and a control group (CG) (n = 27) that continued their daily lifestyle. The two exercise groups trained twice a week for 12 weeks, with each session lasting 45 min. Sleep quality was measured using the Pittsburgh sleep quality index (PSQI), and fatigue was assessed using the fatigue severity scale (FSS). Outcomes were measured before the intervention and after the intervention period. Post-intervention sleep quality measurements revealed a statistically significant interaction regarding group × time (p < 0.005) and fatigue (p = 0.002). Specifically, fatigue decreased in the HIIT group between both measurement moments (p = 0.003). In addition, differences were obtained in the post-intervention measure between the HIIT and MIIT groups (p = 0.013) and HIIT and control (p = 0.029). Our analysis indicates that a population of the elderly showed improvements in sleep quality and fatigue after performing a high-intensity intervention using suspension training (TRX), with markedly better results in the HIIT group.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals High-dose intravenous versus oral iron in blood donors with iron deficiency: The IronWoMan randomized, controlled clinical trial

2020 ◽  
Vol 39 (3) ◽  
pp. 737-745 ◽  
Author(s):  
Camilla Drexler ◽  
Susanne Macher ◽  
Ines Lindenau ◽  
Magdalena Holter ◽  
Martina Moritz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Iron Deficiency ◽  
Blood Donors ◽  
Oral Iron ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled
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