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Statistics | For the platinum sensitive study, we used the AGO registration study as a historical control with an ORR of 47% and the trial sample size was designed to detect an improvement in ORR from 40% to 60%. | PMC10020803 | ||
Results | PMC10020803 | |||
Accrual and Treatment | DISEASE | The sensitive study enrolled all 41 patients between December 9, 2009 and February 12, 2012. The resistant study enrolled 46 of the planned 48 patients between December 11, 2009 and December 16, 2012, and 1 patient though enrolled, did not receive any study medication. Sixteen patients (39%) with sensitive disease cont... | PMC10020803 | |
Efficacy | BEST | Best overall response is shown in Response data.Inevaluable patients: *5 for withdrawal of consent and 1 with SAE.Objective response in platinum sensitive GCI patients.Objective response in platinum resistant GCI patients.PFS in platinum sensitive GCI patients.PFS in platinum resistant GCI patients.In the platinum resi... | PMC10020803 | |
Toxicity | neutropenia, intestinal obstruction, fatigue, toxicity, anemia, dehydration, vomiting, small, nausea,, Toxicity, deaths, TEAE, hypokalemia | PULMONARY EMBOLISM, NEUTROPENIA, THROMBOCYTOPENIA, ANEMIA, DEHYDRATION, ADVERSE EVENT, URINARY TRACT INFECTION | Safety profiles consistent with those observed in prior clinical studies with GC. There were no deaths on study or within 60 days of the last dose of study drug. In the sensitive study 12 patients (29%) experienced a serious treatment fmergent adverse event (SAEs), and the most common were neutropenia and thrombocytope... | PMC10020803 |
Discussion | toxicities, thrombocytopenia, BRCA mutated tumors, neutropenia | NEUTROPENIA, RECURRENT OVARIAN CANCER, THROMBOCYTOPENIA, RECURRENT DISEASE, ONCOLOGY, CYTOTOXICITY | These phase II clinical trials investigated a promising novel agent, thought to be a PARP inhibitor with potential synergy with gemcitabine and carboplatin in 2 cohorts of patients with recurrent ovarian cancer. Subsequent studies have clarified the lack of even additive benefit, and the mechanism of in vitro cytotoxic... | PMC10020803 |
Acknowledgments | Jennifer A., Cancer | ONCOLOGY, GYNECOLOGIC CANCER, CANCER | We remain indebted to the participating patients, their families, and the clinical trial investigators and research coordinators of the Dana-Farber/Harvard Cancer Center Gynecologic Cancers Program. We want to acknowledge the support of Sanofi in ensuring that these data are peer reviewed and published and Jennifer A. ... | PMC10020803 |
Funding | This study was supported by an investigator-initiated grant from BiPar Sciences, Inc., and Sanofi Aventis US LLC. | PMC10020803 | ||
Conflict of Interest | PMC10020803 | |||
Author Contributions | Conception/design: R.T.P., M.J.B. Provision of study material or patients: R.T.P., C.N.K., P.A.K., U.A.M., M.J.B. Collection and/or assembly of data: All authors. Data analysis and interpretation: All authors. Manuscript writing: All authors. Final approval of manuscript: All authors. | PMC10020803 | ||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10020803 | ||
References | PMC10020803 | |||
1. Introduction | Media, depressed, ’ | EVENTS | Background: Media affects the trajectory of many individuals’ mental health—with media news, individuals experience negative bias more than positive bias. However, there is also evidence of an age-related positivity effect, with negativity bias generally fading with age. With the rise of COVID-19 cases, older adults (a... | PMC10002267 |
2. Methods | PMC10002267 | |||
2.2. Materials | Media | Background Information Survey. The survey consisted of questions that asked the participants about their age, gender, highest level of education, living status, and socioeconomic status (household income) (see Media Exposure. This consisted of two questions about the participants’ media consumption habits. For example,... | PMC10002267 | |
3. Procedure | The 69 participants were given URL links to the | PMC10002267 | ||
Design | This study was conducted as an online survey during the time period of 29 January to 6 February 2022. The participants were invited to take part in the online survey through | PMC10002267 | ||
4. Results | depressed | Preliminary analyses using a multivariate ANOVA revealed no significant effects of age, education, living status, and household income on GHQ and positive response scores (First, in order to understand how much of an impact media consumption had on the participants’ mental health, we ran two-tailed correlational analys... | PMC10002267 | |
5. Discussion | depressed | EVENTS, DISEASE | In summary, our findings indicate that the more often older adults consumed media and the more closely they followed COVID-19 news, the more they felt unhappy and depressed. This is largely in line with past studies, suggesting the detrimental impact of general media consumption on mental health. Importantly, we found ... | PMC10002267 |
6. Conclusions | In conclusion, our findings suggest that older adults have a positivity bias with respect to information and have the ability to remain hopeful during periods of stress. While there are certain limitations to the results, our findings provide novel and valuable insight into the way older adults view information, especi... | PMC10002267 | ||
Author Contributions | Conceptualization: Z.Z.N., G.L. and W.Q.Y.; Methodology: Z.Z.N., G.L. and W.Q.Y.; Data curation: Z.Z.N. and G.L.; Investigation: Z.Z.N. and G.L.; Project Administration: Z.Z.N. and G.L.; Resources: Z.Z.N. and G.L.; Formal analysis and Visualization: Z.Z.N., G.L. and W.Q.Y.; Supervision: S.F. and W.Q.Y.; Writing (origin... | PMC10002267 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, IRB approved protocol number IRB 21-395, and an exemption from the Institutional Review Board of the Singapore University of Technology and Design (SUTD) for the students collecting the data as they were not SUTD students. | PMC10002267 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10002267 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10002267 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10002267 | ||
Introduction | obesity, weight loss | OBESITY | Across the world there are over a billion individuals living with obesity (13% prevalence of a BMI >30kg/m2) [The UK’s National Institute for Health and Care Excellence recommends that bariatric surgery should be supplemented by psychological support, though it does not specify a particular therapy modality [Analysis o... | PMC10128967 |
Methods | The full protocol for this trial has been published in the International Journal of Clinical Trials [ | PMC10128967 | ||
Design | This was a feasibility study for a single-centre, parallel-group, single-blind, two-arm trial, with randomisation to either a 10 weeks ACT group therapy or Usual Care Support Group control (SGC). Favourable ethical opinion was obtained from London-Westminster REC (18/LO/1256). The trial was registered at Researchregist... | PMC10128967 | ||
Participants | ideation, RA, PIS | RECRUITMENT, RECRUITMENT | All participants were adults (≥18years) post bariatric-surgery (>15 to < 18 months) at a London-based weight management centre. Patients who expressed suicidal ideation (score >0 on Q9 of thePHQ-9 [Initially, potentially eligible patients were given a Participant Information Sheet (PIS) and PHQ-9 at their regular post-... | PMC10128967 |
Randomisation | This was performed by an independent researcher running R program scripts [ | PMC10128967 | ||
Sample size | We aimed to recruit 58 participants. However, due to high attrition, including before the first session, we ran extra groups (i.e. 4 iterations rather than 2) and recruited 80 participants. Loss to follow up and group attrition are presented in a consort diagram ( | PMC10128967 | ||
CONSORT flow diagram. | ACT, acceptance and commitment therapy; SCG, support group control.As this was a feasibility study, we did not carry out a formal sample size calculation when planning the study. However, we provide an estimate of the precision of the primary endpoints ( | PMC10128967 | ||
Data to inform sample size of a future trial. | *The denominator here is the number of patients still in the study at 12 months**The numbers attending the therapy sessions were averaged over all cohorts, both randomisation groups and all 10 sessions, although it has already been noted that the number attending each session decreased as the study progressed. | PMC10128967 | ||
Intervention | This comprised ACT group therapy delivered weekly (10 x 90-minute sessions) by a psychologist trained in bariatric psychological support and ACT. The intervention was adapted from an existing manual which addressed all six core processes of ACT: acceptance, defusion, contacting the present moment, self as context, comm... | PMC10128967 | ||
Control (usual care) | This comprised the support group control (SCG) (10 x 90-minute meetings), delivered weekly by a psychology graduate with no formal therapy training. The groups were unstructured to allow patients to talk freely. The groups were held at the same time and venue, but on a different day of the week to the ACT groups. | PMC10128967 | ||
Outcomes | obesity, Obesity | OBESITY, RECRUITMENT, OBESITY, RECRUITMENT | Primary outcomes related to the feasibility of the trial. Measures of the success of recruitment, data collection and acceptability of trial procedures included (1) willingness of participants to be randomised, i.e. the number of participants who drop out of the study after they had been randomised, (2) number of eligi... | PMC10128967 |
Data analysis | REGRESSION, SECONDARY, RECRUITMENT | Descriptive statistical analyses were conducted for the feasibility and potential primary and secondary outcomes at baseline and each follow-up time point. Although this feasibility study was not powered to detect differences between groups in questionnaire-based outcomes, multi-level linear regression models were fitt... | PMC10128967 | |
Participant characteristics. | F/T, full time; P/T, part time; BMI, Body Mass index. | PMC10128967 | ||
Data collection | This information is displayed in Questionnaires took an average of 56 mins to complete at baseline when they were completed face to face and an average of 29 mins to complete at 12 months by phone (as at 3 and 6 months). | PMC10128967 | ||
Acceptability of the intervention | There were high levels of drop out from both groups ( | PMC10128967 | ||
Acceptability of the intervention: number of participants who attended each session. | ACT, acceptance and commitment therapy; SCG, support group control. | PMC10128967 | ||
Process evaluation | Only six ACT participants competed the in-session measures of OE, BA, VA more than five times. Weekly changes were analysed over time. Results indicated that scores fluctuated throughout the intervention but there was no clear indication of improvement in any measure across the time points. No linear or non-linear patt... | PMC10128967 | ||
Exploration of primary and secondary outcome measures for a full RCT | REGRESSION | Data from all questionnaires at each time point are included in the S1 Questionnaire data and include the levels of missing data. Changes from baseline and differences between groups: Findings from the multi-level linear regression models for the outcome measures are provided in Health service use and costs: The ACT gr... | PMC10128967 | |
Costs and outcomes for the ACT and usual care groups. | PMC10128967 | |||
Acceptability: Qualitative findings | Eighteen participants were interviewed: nine from each arm (female n = 11). Three interviews were face to face and the subsequent 15 were by telephone; interview duration ranged from 35 to 65 minutes. Three of those interviewed did not attend any session (ACT n = 2, SGC n = 1), this was due to health reasons and being ... | PMC10128967 | ||
Coding results | All acceptability constructs were coded, except ‘self efficacy’ was not coded for the trial or SGC attendance, and though ‘opportunity costs’ was coded in relation to attending sessions it was not coded specifically in relation to participating in either group. Most codes related to ‘perceived effectiveness’ (50 in 7 i... | PMC10128967 | ||
Opportunity costs | Participants reported having to change their weekly schedule so that they could attend sessions and the issue of travel costs was raised as a potential barrier to attendance. No opportunity costs were coded specific to attending either the ACT group or SGC. | PMC10128967 | ||
Discussion | obesity, type-2 diabetes | OBESITY, SECONDARY, SAID, RECRUITMENT | This trial tested the feasibility of delivering an RCT of ACT It appeared that although data collection was hampered by lack of retention, other trial processes (i.e. recruitment, consent, data collection in those retained in the trial) would be feasible for a future trial but that the intervention, as delivered, may n... | PMC10128967 |
Supporting information | PMC10128967 | |||
CONSORT checklist. | (PDF)Click here for additional data file. | PMC10128967 | ||
Individual weight changes. | (PDF)Click here for additional data file. | PMC10128967 | ||
Results from mixed models–unadjusted. | (PDF)Click here for additional data file. | PMC10128967 | ||
FAB_fulldata_26SEP2022. | (CSV)Click here for additional data file. | PMC10128967 | ||
Questionnaire data. | (PDF)Click here for additional data file. | PMC10128967 | ||
Questionnaire results. | (PDF)Click here for additional data file. | PMC10128967 | ||
Results from multi-level linear regression models. | (PDF)Click here for additional data file. | PMC10128967 | ||
Service use and costs. | (PDF)Click here for additional data file. | PMC10128967 | ||
Feasibility of acceptance and commitment therapy for post-bariatric surgery patients: the FAB study protocol. | (PDF)Click here for additional data file.The authors would like to thank the study’s PPI representatives, Georgina Hayman and Roy Ebbs, for bringing a service user perspective to every aspect of the study, including during regular Project Advisory Group meetings. We thank Ms Hayman for chairing this group. | PMC10128967 | ||
Background | There is a long latent period for the sciatic nerve block before a satisfactory block is attained. Changes in the temperature of local anesthetics may influence the characters of the peripheral nerve block. This study was designed to evaluate the effect of warming ropivacaine on the ultrasound-guided subgluteal sciatic... | PMC10641952 | ||
Methods | Fifty-four patients for distal lower limbs surgery were randomly allocated into warming group (group W, | PMC10641952 | ||
Results | The onset time of sensory blockade was shorter in group W than in group R (16 (16,18) min vs 22 (20,23) min, | PMC10641952 | ||
Conclusions | Warming ropivacaine 0.5% to 30℃ accelerates the onset time of sensory and motor blockade in the ultrasound-guided subgluteal sciatic nerve block and it has no influence on the duration of sensory and motor blockade. | PMC10641952 | ||
Trial registration | The trial was registered on October 3, 2022 in the Chinese Clinical Trial Registry ( | PMC10641952 | ||
Keywords | PMC10641952 | |||
Background | nerve block, sciatic nerve block | The sciatic nerve block is frequently applied alone or in combination with other peripheral nerve blocks for orthopedic procedures involving the foot and lower limb [In the literature, few studies focused on the effect of warming local anesthetics on peripheral nerve block [ | PMC10641952 | |
Methods | obesity, loss of pinprick sensation, muscle weakness, mellitus diabetes, swelling, neurological disorder, paralysis, pain, sensory disability, coagulopathy | OBESITY, MUSCLE WEAKNESS, NEUROLOGICAL DISORDER, BLIND, COAGULOPATHY, COMPLICATIONS | The protocol utilized in this study was granted approval by the ethics committee at Cixi People’s Hospital on July 24, 2022, and subsequently reviewed and registered at the Chinese Clinical Trials Registry (ChiCTR-TRC-0000054) on October 3, 2022. This study was conducted from October 2022 to February 2023 at Cixi Peopl... | PMC10641952 |
Sample size calculation | In advance, we conducted a preliminary experimental study with 10 patients in each group. The results indicated that the mean onset time of sensory block was 19.8 ± 2.27 min in warming group and 17.8 ± 1.89 min in room temperature group. Drawing on these statistics, a minimum of 24 patients were included in each group ... | PMC10641952 | ||
Statistical analysis | SD | Data analysis was conducted using SPSS software version 27 (IBM Corporation, Armonk, NY). Normal distribution was evaluated using the Shapiro–Wilk test. Continuous variables for normality were expressed as mean ± SD and were analyzed with the Student t-test. Nonnormally distributed data was expressed as medians (interq... | PMC10641952 | |
Discussion | peripheral nerve block, sciatic nerve tract, connective and adipose | CYTOTOXICITY | In the present study, we demonstrated that warming ropivacaine 0.5% to 30℃ shortened the onset time of sensory and motor blockade in the ultrasound-guided subgluteal sciatic nerve block. The duration of sensory and motor blockade showed no significant difference between the studied groups. No evident clinical neural sy... | PMC10641952 |
Conclusions | peripheral nerve block | ADVERSE EFFECTS | In conclusion, our study shows that warming the ropivacaine 0.5% to 30℃ can accelerate the onset time of the ultrasound-guided subgluteal sciatic nerve block whithout obvious adverse effects. Therefore, warming the local anesthetics is a simlpe, safe and effective method to reduce the latency of peripheral nerve block,... | PMC10641952 |
Acknowledgements | Not applicable. | PMC10641952 | ||
Authors’ contributions | J.L.H.wrote the main manuscript text. N.N.Z. and J.P.X. conducted statistical analyses. Y.J.M. conducted the block procedure. J.J.J. collected data. J.L.H.and F.J.Z. designed study and conducted the analysis and interpretation of results. F.J.Z. and W.D.W. reviewed the manuscript. All authors reviewed the manuscript. | PMC10641952 | ||
Funding | This research was funded by the Zhejiang Provincial Natural Science Foundation of China 2023 (No.LY23H090015). | PMC10641952 | ||
Availability of data and materials | The data associated with the paper are not publicly available but are available from the corresponding author (YG) on reasonable request. | PMC10641952 | ||
Declarations | PMC10641952 | |||
Ethics approval and consent to participate | The study has been conducted in accordance with the principles set forth in the Helsinki Declaration, and all patients provided written informed consent for participation in the research study. Ethical approval for this study (2022-LP-KY020) was provided by the Institutional Review Board of Cixi People’s Hospital, Hush... | PMC10641952 | ||
Consent for publication | Not applicable. | PMC10641952 | ||
Competing interests | The authors declare no competing interests. | PMC10641952 | ||
References | PMC10641952 | |||
Patients and methods | SECONDARY | This randomized, controlled, prospective study evaluates the functional results and costs of the 2 casting positions in patients 65 and older with DRF. Primary end point in this study was Patient-Reported Wrist Evaluation (PRWE) at 24 months, and secondary end points were cost-effectiveness of treatment, health-related... | PMC10079055 | |
Results | We enrolled 105 patients, of which 81 (77%) continued until 24-month follow-up. 8 patients (18%) were operated in the VFUDC group and 4 (11%) in the FC group. Patients in the VFUDC group also received more frequent physical therapy. The difference in PRWE score between the VFUDC and FC groups at 24 months was -4.31. Th... | PMC10079055 | ||
Interpretation | Colles’ type DRF | We found a slight, but consistent difference in the functional results between groups. These results suggest that VFUDC is not superior to FC when treating Colles’ type DRF. Cost analysis revealed overall costs in the VFUDC group are nearly double those in the FC group, mostly due to more physical therapy, additional v... | PMC10079055 | |
Data Availability | Data cannot be shared publicly due to the legislation in Finland and EU area (Finnish Data Protection Act). Data are available from the Institutional Data Access for researchers who meet the criteria for access to confidential data. Contact information: Tampere University Hospital. Research Services. Elämänaukio 1. 332... | PMC10079055 | ||
Introduction | fracture, disability | Distal radius fracture (DRF) is the most common fracture among adults. Individuals 65 years and older are at the highest risk of sustaining DRF, Court-Brown & Caesar [The volar-flexion and ulnar deviation cast (VFUDC) is still widely used as the primary immobilization method for DRF. It has been suggested, that in the ... | PMC10079055 | |
Patients and methods | PMC10079055 | |||
Study design | fracture | This pragmatic, randomized controlled, multicenter trial compared two commonly used below elbow cast positions (VFUDC and FC) in patients 65 years and older who had sustained a dorsally angulated distal radius fracture. The patients for this study were enrolled at three large emergency hospitals in Finland: Tampere Uni... | PMC10079055 | |
Enrollment and randomization | fracture, Colles’ type DRF | All patients aged 65 years or older with a Colles’ type DRF and a sufficient reduction result were eligible for randomization (criteria presented in The patients were randomized to either the VFUDC or FC group using a random number matrix in block allocation fashion with a 1 to 1 ratio. The blocks were stratified by ag... | PMC10079055 | |
Procedure | fracture, plaster | Following enrollment, closed reduction of the fracture was performed under local anesthesia and the wrist was placed in a volar-flexion and ulnar deviation cast or a functional position cast according to the randomization. No fluoroscopy was used but x-rays were taken following reduction. All casts were non-circumferen... | PMC10079055 | |
Follow-up | fracture, loss of reduction | Initially, the aim was that the casting period would last for 5 weeks. The cast was only changed if there were problems with the cast or patient has symptoms related to the cast or if the patient was operated. Follow-up appointments were arranged at 1, 2, and 5 weeks after sustaining the fracture. For some patients, th... | PMC10079055 | |
Outcome measures | disability, pain | COMPLICATIONS | The primary outcome was the Patient-Reported Wrist Evaluation (PRWE) score between the study groups at 24 months. Secondary outcomes were differences in means in the short version of Disabilities of arm, shoulder and hand, Quick-DASH score (qDASH, gives a scale from 0 to 100), visual analogue scale of pain (VAS, scale ... | PMC10079055 |
Cost analysis | We evaluated the costs between the two treatment groups by recording the number of cost-inducing contacts patients had with healthcare professionals. We recorded the number of visits to the hospital due to symptoms in the fractured wrist, surgery when needed, the number of physical therapy guidance visits, and possible... | PMC10079055 | ||
Statistical analysis | fracture | REGRESSION, REGRESSION | The analysis included all patients who completed the questionnaires at 24-month follow-up. Differences between the two casting groups in PRWE score, qDASH score, VAS, 15D, and the effect of fracture in the dominant hand on PRWE were analyzed using t-test. Linear regression was used to estimate adjusted group difference... | PMC10079055 |
Results | PMC10079055 | |||
Participants | MAY | From July 2016 to May 2017, a total of 105 patients from three Finnish hospitals were recruited into the trial and randomized to 2 groups. In total, 55 patients were assigned to the VFUDC group and 50 to the FC group The patients were then observed for 24 months until May 2019. The baseline characteristics of the recru... | PMC10079055 | |
The baseline characteristics of patients in the Volar Flexion Ulnar Deviation Cast (VFUDC) and Functional Cast (FC) groups. | RECRUITMENT | At 12-months, 19 patients had been lost to follow-up and a total of 24 patients did not return the questionnaires at 24-months following recruitment. Thus, 81 patients were included in the analysis ( | PMC10079055 | |
Randomization of patients and inclusion in the final analysis. | PMC10079055 | |||
Outcomes at 24 months | PMC10079055 | |||
PROMs and health-related quality of life | fracture | The outcome measures, PRWE, VAS, Quick-DASH, and 15D were recorded at 3, 12, and 24 months after fracture. These results are presented in | PMC10079055 | |
Analysis of the outcome measures for DRF at 3, 12, and 24 months in the VFUDC and FC treatment groups. | fracture, hand dominancy | REGRESSION | VFUDC = Volar Flexion Ulnar Deviation Cast, FC = Functional Cast, PRWE = Patient-Reported Wrist Evaluation, Quick-DASH = short version of Disabilities of Arm, Shoulder and Hand, 15D = self-administrated questionnaire for measuring health-related quality of life, VAS = Visual Analogue Scale of painThere was a slight dif... | PMC10079055 |
Predicted outcomes from the cumulative probability model for PRWE at 24 months for each combination of baseline variables. | FC = Functional Cast group, VFUDC = Volar-Flexion Ulnar Deviation Cast group.The number of cast changes was recorded per patient’s report. The number of cast changes was higher in the VFUDC group (25 cast changes) than in the FC group (15). The number of casts per patient was 1.57 in the VFUDC group and 1.41 in the FC ... | PMC10079055 |
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