scholarly journals Safety Analysis of Apatinib Combined with Chemotherapy in the Treatment of Advanced Gastric Carcinoma: A Randomised Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Min Yuan ◽  
Zhaohui Wang ◽  
Yibo Zhang ◽  
Liying Chen ◽  
Yuting Liu ◽  
...  
Keyword(s):  
Gastric Carcinoma ◽  
Immune Cell ◽  
Reference Group ◽  
Controlled Trial ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
Clinical Indicators ◽  
Advanced Gastric Carcinoma ◽  
Before And After ◽  
Randomised Controlled

Objective. To study the safety of apatinib combined with chemotherapy in the treatment of advanced gastric carcinoma (GCA). Methods. 74 patients with advanced GCA treated in the oncology department of Weifang People’s Hospital (January 2019–January 2020) were enrolled in this study and equally split into study group (SG) and reference group (RG) according to the odd and even admission numbers. RG underwent chemotherapy alone, while SG received apatinib combined with chemotherapy. The clinical indicators of serum matrix metalloproteinase 9 (MMP-9), serum interleukin-2 receptor (SIL-2R), and immune cell level were detected in the two groups before and after treatment to analyze the therapeutic effect of different treatment methods on patients with advanced gastric carcinoma. Results. No obvious differences in gender ratio, average age, average BMI, pathological staging, pathological types, organ metastasis types, and residence were observed between the two groups ( P > 0.05 ). The short-term follow-up results showed that the disease control rate (DCR) in SG was markedly higher compared with RG ( P < 0.05 ). The MMP-9 and SIL-2R levels in both groups after treatment decreased ( P < 0.05 ), and the levels in SG after treatment were notably lower compared with RG ( P < 0.001 ). Compared with RG, CD3+, CD4+, and CD4+/CD8+ levels in SG after treatment were notably higher ( P < 0.001 ), while the CD8+ level was notably lower ( P < 0.001 ). The median progression-free survival (MPFS) and overall survival (OS) in SG were markedly higher compared with RG ( P < 0.001 ). The GQOLI-74 scores in both groups after treatment increased ( P < 0.001 ), and the GQOLI-74 score in SG after treatment was markedly higher compared with RG ( P < 0.001 ). The total incidence of adverse reactions was lower in SG than in RG ( P < 0.05 ). Conclusion. Apatinib combined with chemotherapy is superior to chemotherapy alone in effectively improving treatment outcomes in patients with advanced GCA.

Administration of bortezomib before and after autologous stem cell transplantation improves outcome in multiple myeloma patients with deletion 17p

Blood ◽  
2012 ◽  
Vol 119 (4) ◽  
pp. 940-948 ◽  
Author(s):  
Kai Neben ◽  
Henk M. Lokhorst ◽  
Anna Jauch ◽  
Uta Bertsch ◽  
Thomas Hielscher ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Chromosomal Abnormalities ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Before And After ◽  
Randomised Controlled

Abstract In patients with multiple myeloma (MM), risk stratification by chromosomal abnormalities may enable a more rational selection of therapeutic approaches. In the present study, we analyzed the prognostic value of 12 chromosomal abnormalities in a series of 354 MM patients treated within the HOVON-65/GMMG-HD4 trial. Because of the 2-arm design of the study, we were able to analyze the effect of a bortezomib-based treatment before and after autologous stem cell transplantation (arm B) compared with standard treatment without bortezomib (arm A). For allanalyzed chromosomal aberrations, progression-free survival (PFS) and overall survival (OS) were at least equal or superior in the bortezomib arm compared with the standard arm. Strikingly, patients with del(17p13) benefited the most from the bortezomib-containing treatment: the median PFS in arm A was 12.0 months and in arm B it was 26.2 months (P = .024); the 3 year-OS for arm A was 17% and for arm B it was 69% (P = .028). After multivariate analysis, del(17p13) was an independent predictor for PFS (P < .0001) and OS (P < .0001) in arm A, whereas no statistically significant effect on PFS (P = .28) or OS (P = .12) was seen in arm B. In conclusion, the adverse impact of del(17p13) on PFS and OS could be significantly reduced by bortezomib-based treatment, suggesting that long-term administration of bortezomib should be recommended for patients carrying del(17p13). This trial is registered at the International Standard Randomised Controlled Trial Number Register as ISRCTN64455289.

scholarly journals Immune-Related Circulating miR-125b-5p and miR-99a-5p Reveal a High Recurrence Risk Group of Pancreatic Cancer Patients after Tumor Resection

2019 ◽  
Vol 9 (22) ◽  
pp. 4784
Author(s):  
Vietsch ◽  
Peran ◽  
Suker ◽  
van den Bosch ◽  
Sijde ◽  
...  
Keyword(s):  
Cancer Progression ◽  
B Lymphocyte ◽  
Immune Cell ◽  
Tumor Resection ◽  
Progression Free Survival ◽  
Tumor Stroma ◽  
Recurrence Risk ◽  
High Serum ◽  
Ductal Adenocarcinoma ◽  
Before And After

Clinical follow-up aided by changes in the expression of circulating microRNAs (miRs) may improve prognostication of pancreatic ductal adenocarcinoma (PDAC) patients. Changes in 179 circulating miRs due to cancer progression in the transgenic KrasG12D/+; Trp53R172H/+; P48-Cre (KPC) animal model of PDAC were analyzed for serum miRs that are altered in metastatic disease. In addition, expression levels of 250 miRs were profiled before and after pancreaticoduodenectomy in the serum of two patients with resectable PDAC with different progression free survival (PFS) and analyzed for changes indicative of PDAC recurrence after resection. Three miRs that were upregulated ≥3-fold in progressive PDAC in both mice and patients were selected for validation in 26 additional PDAC patients before and after resection. We found that high serum miR-125b-5p and miR-99a-5p levels after resection are significantly associated with shorter PFS (HR 1.34 and HR 1.73 respectively). In situ hybridization for miR detection in the paired resected human PDAC tissues showed that miR-125b-5p and miR-99a-5p are highly expressed in inflammatory cells in the tumor stroma, located in clusters of CD79A expressing cells of the B-lymphocyte lineage. In conclusion, we found that circulating miR-125b-5p and miR-99a-5p are potential immune-cell related prognostic biomarkers in PDAC patients after surgery.

Auricular Acupuncture for Pre-Exam Anxiety in Medical Students: A Prospective Observational Pilot Investigation

2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko
Keyword(s):  
Medical Students ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Final Analysis ◽  
Auricular Acupuncture ◽  
Before And After ◽  
Pilot Investigation ◽  
Exam Anxiety ◽  
Randomised Controlled ◽  
To Receive

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

scholarly journals Analysis of the components of cancer risk perception and links with intention and behaviour: A UK-based study

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith
Keyword(s):  
Factor Analysis ◽  
Risk Perception ◽  
Cancer Risk ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Distinct Component ◽  
Cancer Risk Perception ◽  
Before And After ◽  
Randomised Controlled ◽  
The Uk

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

Use and impact of selective internal radiation therapy (SIRT) in routine care patients with metastatic colorectal cancer (mCRC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 742-742
Author(s):  
Belinda Lee ◽  
Hui-Li Wong ◽  
Kathryn Maree Field ◽  
Louise M. Nott ◽  
Jeremy David Shapiro ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Progression Free Survival ◽  
Routine Care ◽  
Routine Practice ◽  
Internal Radiation ◽  
Free Survival ◽  
Palliative Intent ◽  
Line Setting ◽  
Randomised Controlled ◽  
The Impact

742 Background: The liver is the dominant site of metastasis in patients (pts) with mCRC. Radioembolisation is a potential option in the multidisciplinary management of these patients. Recently initial analysis of a randomised controlled trial (RCT) in the 1st line setting demonstrated no overall progression free survival (PFS) benefit from adding SIRT, but prolongation of liver PFS (HR 0.69, p=0.002) was seen. Methods: Consecutive pts with mCRC enrolled from January 2009 were identified from a prospective multi-site Australian registry. Characteristics and outcomes for pts selected for treatment with SIRT were analysed. Results: Of 1,694 pts with mCRC, 580 (34.2%) had liver only disease at diagnosis, 409/580 (70.5%) with synchronous vs 166/580 (28.6%) with metachronous disease. Of pts with liver only disease, 187 (32.2%) were considered resectable at diagnosis, 100 (17%) as potentially resectable and 293 (51%) were treated with palliative intent. Overall 47 pts received SIRT with 1stline chemotherapy (CT). SIRT treated pts were more likely to have a synchronous presentation (85% vs 68%, p=0.01), liver only disease (83.0% vs 27.3%, p=<0.01), to be ECOG 0 (51.1% vs 34.6%, p=0.01), to be younger (60.8 years vs. 65.9 years, p=0.008) and to be enrolled on a RCT (38.3% vs 7.3%, p=<0.01). In the liver only population treated with palliative intent, SIRT treated pts (n=30) vs CT only pts (n=188) had a median PFS of 10.6 months vs 9.9 months (HR 0.87, p = 0.18) and a median OS of 24.3 months vs 19.3 months (HR 0.73, p = 0.04). Conclusions: SIRT is rarely used in the 1st line treatment of mCRC in routine practice. The available data suggests that OS gains can be seen in the absence of differences in PFS. However, this observed differential effect on survival maybe due to selection biases. SIRT treated patients were significantly younger and fitter than the CT alone group. Future analyses will include a multivariate analysis and examine the impact of the recently presented SIRFLOX trial data on the use of SIRT in clinical practice.

Effect of Acupuncture on Perception Threshold: A Randomised Controlled Trial

2012 ◽  
Vol 30 (1) ◽  
pp. 32-36
Author(s):  
Shuang Wu ◽  
Hidenori Yamaguchi ◽  
Koh Shibutani
Keyword(s):  
Controlled Trial ◽  
Mental Foramen ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Control Group ◽  
Perception Threshold ◽  
Left Hand ◽  
Before And After ◽  
Sham Acupuncture Group ◽  
Randomised Controlled

Objective To determine the current perception thresholds (CPTs) for arm and mental foramen areas to enable a quantitative evaluation of the effectiveness of acupuncture treatment. Methods Ninety-eight volunteers enrolled as participants and were randomly assigned to one of three groups: an acupuncture group (34 subjects); a sham acupuncture group (32 subjects) and a waiting group (32 subjects). CPTs for the arm and mental foramen areas were determined before and after acupuncture at LI4 Hegu of the left hand. A Neurometer CPT was used to evaluate the perception threshold at the homolateral mental foramen and arm. For further exploration, thresholds of homolateral and contralateral mental foramina were determined before and after acupuncture in a subgroup of 13 participants in the acupuncture group. Results Acupuncture at LI4 increased the perception thresholds of the left mental foramen in the acupuncture group significantly (p<0.01). The increases were significantly greater than in the control group for all frequencies, and significantly greater than sham acupuncture for 250 Hz and 5 Hz. In the subgroup, only the CPTs at 5 Hz increased significantly for the contralateral mental foramen. Conclusions Acupuncture at LI4 increases the perception threshold in the mandibular area, but not in the arm. This finding is probably related to the analgesic effect of acupuncture.

scholarly journals Eating frequency in relation to BMI in very young children: a longitudinal analysis

2017 ◽  
Vol 20 (8) ◽  
pp. 1372-1379 ◽  
Author(s):  
Rachael W Taylor ◽  
Ella Iosua ◽  
Anne-Louise M Heath ◽  
Andrew R Gray ◽  
Barry J Taylor ◽  
...  
Keyword(s):  
Young Children ◽  
Controlled Trial ◽  
Cohort Analysis ◽  
Age Difference ◽  
Older Children ◽  
Eating Frequency ◽  
Confounding Variables ◽  
Before And After ◽  
Eating Occasions ◽  
Randomised Controlled

AbstractObjectiveEating less frequently is associated with increased obesity risk in older children but data are potentially confounded by reverse causation, where bigger children eat less often in an effort to control their weight. Longitudinal data, particularly in younger children, are scarce. We aimed to determine whether eating frequency (meals and snacks) at 2 years of age is associated with past, current or subsequent BMI.DesignCohort analysis of a randomised controlled trial. Eating frequency at 2 years of age was estimated using 48 h diaries that recorded when each child ate meals and snacks (parent-defined) in five-minute blocks. Body length/height and weight were measured at 1, 2 and 3·5 years of age. Linear regression assessed associations between the number of eating occasions and BMI Z-score, before and after adjustment for potential confounding variables.SettingPrevention of Overweight in Infancy (POI) study, Dunedin, New Zealand.SubjectsChildren (n 371) aged 1–3·5 years.ResultsOn average, children ate 5·5 (sd 1·2) times/d at 2 years of age, with most children (88–89 %) eating 4–7 times/d. Eating frequency at 2 years was not associated with current (difference in BMI Z-score per additional eating occasion; 95 % CI: −0·02; −0·10, 0·05) or subsequent change (0·02; −0·03, 0·06) in BMI. Similarly, BMI at age 1 year did not predict eating frequency at 2 years of age (difference in eating frequency per additional BMI Z-score unit; 95 % CI: −0·03; −0·19, 0·13).ConclusionsNumber of eating occasions per day was not associated with BMI in young children in the present study.

scholarly journals Evaluation of muscle activity, bite force and salivary cortisol in children with bruxism before and after low level laser applied to acupoints: study protocol for a randomised controlled trial

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Mônica da Consolação Canuto Salgueiro ◽  
Carolina Carvalho Bortoletto ◽  
Anna Carolina RattoTempestini Horliana ◽  
Ana Carolina Costa Mota ◽  
Lara Jansiski Motta ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Salivary Cortisol ◽  
Muscle Activity ◽  
Controlled Trial ◽  
Low Level ◽  
Low Level Laser ◽  
Level Laser ◽  
Before And After ◽  
Randomised Controlled
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