title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Secondary | infection, febrile illness | INFECTION, FEBRILE ILLNESS |
To estimate the relative and absolute rate reduction (derived from the same model) of symptomatic culture-confirmed S. Typhi infection among participants in vaccine clusters compared to participants in non-vaccine clusters (overall effect)To estimate the relative and absolute rate reduction of symptomatic culture-conf... | PMC10399005 |
Exploratory | infection | INFECTION |
To estimate the relative and absolute rate reduction of symptomatic culture-confirmed S. Typhi infection in TyphiBEV® unvaccinated participants in vaccine clusters compared to unvaccinated participants in non-vaccine clusters (indirect effect)To estimate the relative and absolute rate reduction of the incidence of hos... | PMC10399005 |
Design | Our study is an observer-blinded, cluster-randomised trial set up among the population of 30 wards in Vellore that are part of the Vellore Health and Demographic Surveillance System (VDSS). Data from the VDSS will be updated with a door-to-door survey and individual residents between the ages of 1 and 30 years will be ... | PMC10399005 | ||
Comparator | Hepatitis A | HEPATITIS A, JAPANESE B ENCEPHALITIS | No control vaccine will be used. All those in the no-intervention arm will receive the vaccine after the study ends. Potential comparator vaccines, i.e. Hepatitis A and Japanese B Encephalitis, were considered to have non-compelling risk-to-benefit ratios by the Christian Medical College (CMC) Vellore’s Institutional R... | PMC10399005 |
Methods and analysis | PMC10399005 | |||
Healthcare provider network | fever illness, fever, febrile | We invited the most utilised healthcare providers in the study area (determined by previous surveys) to participate in the fever surveillance based on their ability to follow a standard fever illness management protocol, i.e. to conduct a blood culture prior to the start of antimicrobial treatment in febrile patients. ... | PMC10399005 | |
Eligibility and recruitment | typhoid | RECRUITMENT, TYPHOID | Field Research Assistants (FRAs) will survey all households in the study area to identify individuals listed in the VDSS and those that may have migrated in or out. They will then approach individuals between the ages of 1 and 30 years for informed consent, and those who consent and do not plan to leave the study area ... | PMC10399005 |
Fever surveillance | febrile, illness, fever | EVENTS, ENTERIC FEVER | To capture febrile events, all participants will be asked to call a 24/7 helpline number before they visit a healthcare facility for an illness. In case the illness is febrile, our helpline operators will raise a unique digital token that the fever surveillance team will use (via an online dashboard) to track the patie... | PMC10399005 |
Laboratory methods | acute febrile illness | ENTERIC FEVER | All healthcare facilities partnered with the study will be encouraged to conduct a blood culture in case a patient has an acute febrile illness that lasts more than 2 days, has a temperature of ≥ 38 °C documented at the facility, or if the physician intends to begin antimicrobial therapy. The physician may defer the bl... | PMC10399005 |
Vaccination | allergic, ®, fever, febrile illness, typhoid | ADVERSE EVENTS, RECRUITMENT, FEBRILE ILLNESS, TYPHOID | Once the fever surveillance is operational, eligible participants from selected vaccine clusters will be invited to designated vaccination clinics over a period of 2 months and have a unique vaccination code sent to their phones. This process will be repeated after the mop-up recruitment drive. In case of vaccination w... | PMC10399005 |
Blinding | fever | The study participants will not be blinded to their vaccination statuses as there is no control vaccine. Only the teams conducting fever surveillance and monthly contacts will be blinded to this and be trained to not seek out vaccination details. The coding for the primary analysis will be first conducted in a dataset ... | PMC10399005 | |
Sample size calculation | infectious disease, typhoid fever, typhoid | INFECTIOUS DISEASE, CNS INFECTIONS, TYPHOID FEVER, TYPHOID | The sample size was calculated using a simulation approach as outcome is an infectious disease that affects the probability of further infections in that cluster. The required number of participants was sampled from the VDSS 2021 dataset so that the simulation used the empirical distributions of age and household size ... | PMC10399005 |
Randomisation | Randomisation will be stratified according to four broad areas in the city with different anticipated incidences of | PMC10399005 | ||
Outcomes | Febrile illness | ADVERSE EVENTS, INDURATION, SECONDARY, TYPHOID FEVER, FEBRILE ILLNESS | The primary outcome is blood culture-confirmed typhoid fever.The secondary effectiveness outcomes are:• Febrile illness episodes lasting at least 3 days where healthcare is sought• Hospitalised culture-confirmed The safety outcomes, defined only in vaccine recipients, are:o Local induration at site of vaccinationo Repo... | PMC10399005 |
Estimands | To provide full clarity for our first two objectives, the corresponding estimands are described in Table Structured statement of estimands | PMC10399005 | ||
Statistical analysis | febrile illness | EVENT, RECRUITMENT, FEBRILE ILLNESS, REGRESSION, EVENTS, TYPHOID FEVER | Our primary summary measure of the effect is a rate ratio (RR), from which vaccine effectiveness can be expressed as (1 − RR) × 100%. This will be estimated using an individual-level analysis using Poisson regression that will account for time at risk with censoring at the last known follow-up time. This is expected to... | PMC10399005 |
Data management, confidentiality, and quality assurance (QA) | CRF | RECRUITMENT, CRF | Operational management of the trial will be aided by an externally validated, custom-built database management software. It will link with the VDSS and be used for recruitment, scheduling, and tracking of participant contacts and outcomes. Primary clinical data will be recorded on validated instances of Redcap (Researc... | PMC10399005 |
Trial oversight | EVENTS, EVENT, RECRUITMENT | A Trial Steering Group (TSG), comprised of the lead investigators, the data manager, internal quality manager, and the trial statisticians, will meet at least once a month to discuss trial operations. Interim reports will be prepared for the independent Data Safety and Monitoring Board (DSMB), comprised of an epidemiol... | PMC10399005 | |
Discussion | ®, typhoid | TYPHOID | TCVs are highly efficacious interventions against typhoid that are cost-effective and can be used to protect children from the age of 6 months [Efficacy studies of TCVs in various settings, regions, and age groups are necessary to help with their effective programmatic use. Our trial’s results will also inform the Indi... | PMC10399005 |
Trial status | TYPHOID | This manuscript is based on protocol version 1.1, dated 26/04/2023 and titled ‘Vellore Typhoid Vaccine Impact Trial’. A timeline of the study can be found in Fig. Timeline of study procedures (SPIRIT figure) | PMC10399005 | |
Acknowledgements | We would like to acknowledge the support provided by Peter Smith from the London School of Hygiene and Tropical Medicine, Nicholas Grassly from the Imperial College London, Jason Andrews from Stanford University, Andrew Pollard and Xinxue Liu from the University of Oxford, Supriya Kumar and Thea Norman from the Bill an... | PMC10399005 | ||
Publication policy | A manuscript detailing the results of this study will form the primary publication and be published in a peer-reviewed journal. Authorship will be determined as per ICMJE guidelines and all other contributors will be acknowledged. The authors will also acknowledge that this trial was funded by the Bill and Melinda Gate... | PMC10399005 | ||
Authors’ contributions | JJ, DKA | The study was conceptualised by JJ and GK. JJ, AC, TM, VA, WR, VB, PS, VRM, JAS, PK, DKA, and NS formulated the study design. TM, PS, AC, and JJ developed the analysis plan. The protocol was drafted by NS and DKA, with subsequent edits by JJ, TM, and AC. All authors have approved the submitted protocol manuscript. All ... | PMC10399005 | |
Funding | typhoid | TYPHOID | This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation (grant number INV-036437). Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 Generic License has already been assigned to the Author Accepted Manuscript version that might arise from this submission. Biol... | PMC10399005 |
Availability of data and materials | De-identified, participant-level data will be made available via a public archive within 3 months of the primary publication, along with the statistical analysis plan and analysis code. Genome sequences obtained will be uploaded to a sequence library. Supplementary analyses may be conducted on this data with attributio... | PMC10399005 | ||
Declarations | PMC10399005 | |||
Ethics approval and consent to participate | The study proposal was reviewed and approved by India’s Health Ministry Screening Committee (proposal ID 2022–16229, dated 16 March 2022). The protocol was approved by the IRB of CMC Vellore (IRB minutes number 14247, dated 29/09/2021). Any changes or amendments made to the protocol will be submitted to the IRB for app... | PMC10399005 | ||
Consent for publication | Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. | PMC10399005 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10399005 | ||
References | PMC10399005 | |||
Objective: | To establish whether the use of a WaterPik | PMC10693741 | ||
Design: | A single-centre, two-arm, parallel-group, single-blind, randomised controlled clinical trial with a 1:1 allocation ratio. | PMC10693741 | ||
Setting: | Orthodontic department at York Hospital, York Teaching Hospitals NHS Foundation Trust, UK. | PMC10693741 | ||
Participants: | A total of 40 fit and well participants, aged 10–20 years, being treated with upper and lower fixed orthodontic appliances. | PMC10693741 | ||
Methods: | Participants were randomly allocated, using stratified block randomisation, to the control group (MTB) or intervention group ‘(Waterpik | PMC10693741 | ||
Results: | PLAQUE | An interim analysis of results was performed with 40 patients recruited and 85% of data collected. The overall mean differences between the groups were as follows: plaque index = 0.199 ( | PMC10693741 | |
Conclusions: | In terms of oral hygiene, our study did not find evidence to support the claim of benefit of using a Waterpik | PMC10693741 | ||
Introduction | orthodontic | PLAQUE, DECALCIFICATION, PLAQUE | It is widely accepted that it is more difficult to maintain good oral hygiene when wearing orthodontic appliances (As well as the effect on the periodontium, stagnating plaque around orthodontic appliances predisposes to decalcification. This can leave permanent, unsightly white or brown marks on the teeth that can pro... | PMC10693741 |
Specific objectives and null hypotheses | The aim of the present study was to establish whether the use of a WaterPikNull hypotheses: the use of a WaterPik | PMC10693741 | ||
Methods | PMC10693741 | |||
Trial design and any changes after trial commencement | bleeding, coin toss | BLEEDING, RECRUITMENT | This study was a single-centre, single-operator, two-arm, parallel-group, stratified, single-blind RCT trial with a 1:1 allocation ratio, conducted in the Department of Orthodontics at York Hospital, UK.Changes after the commencement of the trial were as follows:Due to the COVID-19 pandemic, there was a reduced pool of... | PMC10693741 |
Participants, eligibility criteria and setting | Potential participants for the trial were consecutive patients treated by a single Specialty Registrar in Orthodontics at York Hospital, UK. Patients treated were non–fee-paying patients who were treated under the UK National Health Service (NHS). The eligibility criteria are shown in Eligibility criteria for participa... | PMC10693741 | ||
Interventions | The interventions provided for each group are shown in The interventions provided to both groups.DN, dental nurse; OHE, oral health education. | PMC10693741 | ||
Outcomes | trauma | PLAQUE, PLAQUE | Participants were seen at baseline (T0), 8 weeks (T1), 32 weeks (T2) and 56 weeks (T3). At these time points, clinical indices to assess oral hygiene and gingival health were completed. The trial indices were performed by the same clinician.The primary outcome was plaque level, measured using the Orthodontic Modificati... | PMC10693741 |
Sample size calculation | To establish sample size, a power calculation was performed by the trial statistician (JK) based on the primary outcome OMPI. The significance level of the study was set at 5% (α = 0.05). The clinically significant effect size was set as 0.5 based on previous studies (The Power Analysis and Sample Size software (PASS, | PMC10693741 | ||
Randomisation: Sequence generation, allocation concealment and implementation | PMC10693741 | |||
Sequence generation | orthodontic | Participants were allocated using stratified block randomisation. The participants were stratified based on three prognostic characteristics: gender, age and IBI at baseline. It has been shown that female orthodontic patients report cleaning their teeth more often than male patients (Using three prognostic characterist... | PMC10693741 | |
Concealment | For allocation of the participants, sealed envelopes containing either intervention or control were used. | PMC10693741 | ||
Implementation | Patients were enrolled into the trial at the start of their visit by DT. At the end of the appointment to place the fixed appliances, DT then allocated the participant into one of the eight blocks and informed the dental nurse of which block they were in. DT then left the clinic and the dental nurse took out the releva... | PMC10693741 | ||
Blinding | BLIND | This was a single blind trial. The operator carrying out the indices (DT) was blinded to the patient allocation. The participants could not be blinded to their allocation. The participants were told that they must not tell DT whether they had a WaterPik | PMC10693741 | |
Statistical analysis | gingiva, trauma, bleed | SECONDARY, BLEED | Statistical analysis was performed using IBM SPSS version 27 software (IBM Corp., Armonk, NY, USA). Summary descriptive statistics were produced to report demographic features and for each oral health variable.A generalised linear mixed model was used to assess whether there was a difference between the intervention an... | PMC10693741 |
Ethical considerations | Ethical approval was sought for the trial through the Integrated Research Application System (IRAS). This was approved by the Health Research Authority and Health and Care Research Wales (HRA & HCRW) on 23 August 2019. The IRAS project ID was 266235. The trial was registered with York Teaching Hospital NHS Foundation T... | PMC10693741 | ||
Results | PMC10693741 | |||
Participant flow | RECRUITMENT | A flow chart of participants through the trial is shown in CONSORT participant flow chart.Adapted from A single patient in the intervention group withdrew from the study after the 32-week indices, as he wished to start using an electric toothbrush.Recruitment for the trial began on 15 November 2019. The first patient t... | PMC10693741 | |
Baseline data | Baseline data are shown in Baseline data.The groups were similar at baseline in terms of age. There were more female patients in the control group. The PI and GI were very similar at baseline between the two groups. The mean IBI was slightly higher in the control group. | PMC10693741 | ||
Numbers analysed for each outcome | Bleeding, trauma | BLEEDING, PLAQUE | The analysis was performed on an intention-to-treat basis. This means that all patients who were randomised to receive an intervention were included in the analysis, regardless of whether they completed the trial (The results for PI, GI and IBI are shown in Difference of each outcome between control and treatment group... | PMC10693741 |
Adherence with oral hygiene regime | In terms of adherence with an oral hygiene regime, <25% of the oral hygiene diaries were returned, so it was not appropriate to analyse the data and draw any conclusions on adherence with prescribed oral hygiene regime. As a research group, it was thought that the data from those participants who did return the diaries... | PMC10693741 | ||
Satisfaction with oral hygiene regime | Questionnaire responses regarding satisfaction with an oral hygiene regime are shown in | PMC10693741 | ||
Harms | No harms were reported or detected for any participant. | PMC10693741 | ||
Discussion | PMC10693741 | |||
Interpretation | orthodontic | PLAQUE | Based on the results of this trial, there is no benefit, in terms of plaque control or gingival health, in using a WaterPikThere is only one other published trial assessing orthodontic patients with a WaterPikPatients were recruited for the trial by | PMC10693741 |
Limitations | orthodontic | PLAQUE | There was a higher proportion of female participants in the control group (65%) compared to the intervention group (50%). As previously stated, female patients have been shown to have lower levels of plaque and have a greater level of knowledge of oral health (In terms of outcome measures, although the descriptors for ... | PMC10693741 |
Generalisability | The trial was carried out in a single NHS district general hospital and treatment was carried out by a single clinician. Patients in this setting do not pay for their treatment because it is funded by the NHS. It has been demonstrated that patients who self-fund orthodontic treatment have higher levels of compliance th... | PMC10693741 | ||
Conclusions | In the population studied, there was no benefit in terms of oral hygiene in the use of a WaterPik | PMC10693741 | ||
Supplemental Material | PMC10693741 | |||
References | PMC10693741 | |||
Background | extensive-stage small-cell lung cancer | Anlotinib plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) achieves good efficacy, but there is still room for improvement. This clinical study examined the effectiveness of anlotinib plus etoposide for maintenance therapy in ES-SCLC. | PMC10663256 | |
Methods | Cancer | DISEASE PROGRESSION, ADVERSE EVENTS, DISEASE, REMISSION, CANCER | The current single-arm, prospective phase II study was performed at Jiangsu Cancer Hospital (March 2019 to March 2022). After successful primary etoposide-based therapy, anlotinib was administered at 12 mg/day on days 1 to 14 of 21-day cycles until disease progression or consent withdrawal. All patients also received e... | PMC10663256 |
Results | fatigue, proteinuria, hypertension, hemoptysis, all-grade, hand and foot syndrome | ORAL MUCOSITIS, DISEASE, GINGIVAL BLEEDING, LOSS OF APPETITE, HYPERTENSION | Twenty-eight patients were treated. Median PFS and OS were 8.02 (95%CI 5.36–10.67) and 11.04 (95%CI 10.37–11.68) months, respectively. Totally 9 and 18 participants showed a partial response and stable disease, respectively; ORR and DCR were 32.14% and 96.43%, respectively. The commonest all-grade AEs were fatigue (n =... | PMC10663256 |
Conclusion | Maintenance anlotinib plus etoposide achieves promising PFS and OS in clinical ES-SCLC. | PMC10663256 | ||
Registration number | ChiCTR1800019421. | PMC10663256 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s10637-023-01398-9. | PMC10663256 | ||
Keywords | PMC10663256 | |||
Introduction | SCLC, Small-cell lung cancer | PEARLY DISEASE, METASTASES, SCLC | Small-cell lung cancer (SCLC) SCLC features fast doubling time, elevated growth fraction, and extensive metastases in early disease phases, generally showing widespread hematogenous metastases [The best SCLC management is based on surgery, chemotherapy, targeted therapy, and radiotherapy [The vascular endothelial growt... | PMC10663256 |
Materials and methods | PMC10663256 | |||
Study design | Cancer | ONCOLOGY, CANCER | The current single-arm, prospective phase II trial was performed at the Oncology Department of Jiangsu Cancer Hospital between March 2019 and March 2022. The study followed the Declaration of Helsinki (2000), and had approval from the Ethics Committee of Jiangsu Cancer Hospital. Each patient provided signed informed co... | PMC10663256 |
Participants | SCLC, tumor, pleural effusion, allergic, ascites, allergy, respiratory syndrome | PLEURAL EFFUSION, TUMOR, ASCITES, SCLC, ALLERGY, ONCOLOGY | Inclusion criteria were: (1) 18 to 75 years old; (2) proven with ES-SCLC by histopathological examination; (3) treatment with standard first-line Etoposide-platinum solely chemotherapy, without progression; (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; (5) one or more computed tomography (CT)... | PMC10663256 |
Intervention | toxicity, PD, death, SD | DISEASE PROGRESSION, DISEASE, REMISSION, ADVERSE EFFECTS | All patients underwent baseline imaging assessment after enrollment. The participants started treatment within 3 weeks (21 calendar days) from screening. All participants were administered anlotinib plus etoposide. Specifically, all participants were treated with oral anlotinib 12 mg q.d. on days 1–14 of 21-day cycles.... | PMC10663256 |
Endpoints | PD, death | DISEASE PROGRESSION, ADVERSE EVENT, ADVERSE EVENTS, DISEASE, DISEASE | The primary endpoint was PFS, which was the time elapsed from the start of therapy to first disease progression as judged by the investigators or per imaging findings or death. Secondary endpoints encompassed OS, ORR, disease control rate (DCR), and safety. OS represented the time elapsed from the start of therapy to d... | PMC10663256 |
Sample size | Previous data revealed a PFS of 2 months in ES-SCLC without maintenance therapy following standard first-line etoposide chemotherapy [ | PMC10663256 | ||
Statistical analysis | The intent-to-treat (ITT) set encompassed all participants administered the treatment. The per-protocol analysis (PP) set included all participants with high compliance with the study protocol and strictly completed the trial processes per the study protocol. All participants in the PP set completed the drug therapy th... | PMC10663256 | ||
Results | PMC10663256 | |||
Characteristics of participants | SCLC | ONCOLOGY, SMALL CELL LUNG CANCER, SCLC | From March 2019 to March 2022, eligibility screening was conducted for 32 advanced SCLC cases with no progression through first-line therapy (Fig.
Study flowchart
Baseline characteristics of the participantsITT: intent-to-treat; PP: per-protocol; ECOG PS: Eastern Cooperative Oncology Group Performance Status; ES-SCLC:... | PMC10663256 |
Efficacy | DISEASE | Median PFS was 8.02 (95%CI 5.36–10.67) months (Table
Clinical outcomesITT: intent-to-treat; PP: per-protocol; mPFS: median progression-free survival; mOS: median overall survival; CR: complete response; PR: partial response; SD: stable disease; ORR: objective response rate; DCR: disease control rate
(
( | PMC10663256 | |
Safety | any-grade, TEAEs, TRAEs | Almost all participants (96.43%) experienced any-grade TEAEs. Any-grade TEAEs leading to anlotinib dose modification were observed in 35.71% of patients. TEAEs leading to anlotinib dose interruption were observed in 14.29% of cases. TEAEs leading to etoposide dose modification were observed in 7.14% of participants (Ta... | PMC10663256 | |
Discussion | any-grade, SCLC, TEAEs | BRAIN METASTASIS, SCLC | This work examined the effectiveness of anlotinib combined with etoposide for maintenance treatment of ES-SCLC cases. The above findings suggest that maintenance treatment with anlotinib and etoposide after primary treatment with etoposide + platinum was effective and safe in clinical ES-SCLC.Patient survival in ES-SCL... | PMC10663256 |
Acknowledgements | We are grateful to all participants involved in the present trial as well as to the clinicians who supported this research. | PMC10663256 | ||
Authors’ contributions | Conceptualization: BS and YW. Data curation: YW, XFZ, WQZ, QW, ZXH, LFW, and WJZ. Formal analysis: YW, TZ, HZS, KHY, LS, BZP, and RHG. Funding acquisition: BS and YW. Investigation: YW, XFZ, and BS. Methodology: YW, XFZ, FJF, and BS. Project administration: GRZ, FJF, and BS. Resources: all authors. Software: BS. Superv... | PMC10663256 | ||
Funding | Cancer | CANCER | The current project was funded by the National Natural Science Foundation of China (Grant No. 82272863), the Beijing Medical and Health Foundation Project (Grant No. YWJKJJHKYJJ-F2030E), and the Huilan Public Interest Project (Grant No. HL-HS-2020102) (to Bo Shen) and the China International Medical Foundation Project ... | PMC10663256 |
Data Availability | The data generated or analyzed during this study are included in this published article. | PMC10663256 | ||
Declarations | PMC10663256 | |||
Competing interests | The authors declare no competing interests. | PMC10663256 | ||
Ethics approval | Cancer | CANCER | This trial complied with the Declaration of Helsinki (2000) of the World Medical Association. It had approval from the Ethics Committee of the Jiangsu Cancer Hospital. Signed informed consent was provided by each patient. The study was registered at the Chinese clinical trial registry ( | PMC10663256 |
Consent to participate | Signed informed consent was provided by each patient. | PMC10663256 | ||
Consent to publish | N/A. | PMC10663256 | ||
Animal Studies | N/A. | PMC10663256 | ||
References | PMC10663256 | |||
Background | lung injury | Inhaling aerosolized nicotine and cannabis (colloquially called “vaping”) is prevalent among young adults. Instagram influencers often promote both nicotine and cannabis vaporizer products. However, Instagram posts discouraging the use of both products received national media attention during the 2019 outbreak of e-cig... | PMC10540020 | |
Objective | This experiment tested the impact of viewing Instagram posts about EVALI, varying in image and text valence, on young adults’ perceived harmfulness of nicotine and cannabis products, perceived risk of nicotine and cannabis vaporizer use, and intentions to use nicotine and cannabis vaporizers in the future. | PMC10540020 | ||
Methods | REGRESSION, POSITIVE | Participants (N=1229) aged 18-25 (mean 21.40, SD 2.22) years were recruited through Qualtrics Research Services, oversampling for ever-use of nicotine or cannabis vaporizers (618/1229, 50.3%). Participants were randomly assigned to view Instagram posts from young people portraying their experiences of EVALI in a 2 (ima... | PMC10540020 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.