title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Limitations |
Several limitations of the present study should be mentioned. First, due to the SARS-CoV2 pandemic and the rigorous restrictions for the Austrian population, the period between the last training session and the qualitative interviews varied between 5.0 and 80.4 (MD = 52.9, IQR = 35.4) weeks. Therefore, it might have b... | PMC10625214 | ||
Conclusion | fits, PMLD |
The results of this study suggest that aPM+, a transdiagnostic psychological intervention, is a feasible and well-accepted intervention for Afghan refugees living in Austria. The study highlights the importance of considering subjectively perceived symptom burden to support treatment compliance and effectiveness. aPM ... | PMC10625214 | |
Acknowledgements |
We would like to express our gratitude to all participants of our study for trusting us and sharing their experiences with us. Further, we want to thank the supporting outpatient treatment centres, NGOs, and the Outpatient Unit for Research, Teaching and Practice at the Faculty of Psychology, University of Vienna. We ... | PMC10625214 | ||
Author’s contributions |
VK and DW wrote the main manuscript text and prepared tables to equal parts. Further, they analised all qualitative data. JSJ and MK analised parts of the data (interrater reliability) and reviewed the final code scheme of the first qualitative part (PSYCHLOPS). MK and BLS were regularly consulted during the data anal... | PMC10625214 | ||
Funding |
This study was funded by the Austrian Science Fund (FWF) (grant number: KLI 755-B).Open access funding provided by Austrian Science Fund (FWF). | PMC10625214 | ||
Data Availability |
The datasets used during the current study are available from the corresponding author on reasonable request. | PMC10625214 | ||
Declarations | PMC10625214 | |||
Ethical approval and consent to participate |
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2013.
The study was registered at the Internet Portal of the German Clinical Trials ... | PMC10625214 | ||
Consent for publication | Not applicable. | PMC10625214 | ||
Competing interests | The authors declare no competing interests. | PMC10625214 | ||
References | PMC10625214 | |||
Keywords | Eyebrows | HYPOTRICHOSIS | Eyebrows are an important feature of facial identity and communications in human beings as well as an important eye defense shield from dust and foreign bodies. To compare the efficacy and safety between 0.01%, 0.03% bimatoprost and minoxidil 2% in gel formulations for eyebrow enhancement. Sixty eligible subjects were ... | PMC10514173 |
Introduction | glaucoma, hypotrichosis, Eyebrows | HAIR LOSS, HYPOTRICHOSIS, GLAUCOMA | Eyebrows are an important feature of facial identity and communications in human beings as well as an important eye defense shield from dust and foreign bodies [The eyebrow hair cycle is comprised no differently from other hairs of three phases (anagen, catagen and telogen) however with specific characteristics. Almost... | PMC10514173 |
Patients and methods | atopic dermatitis, trichotillomania, fullness, hypotrichosis, dermatitis | SYSTEMIC DISEASE, EYEBROW LOSS, ALOPECIA AREATA, THYROID DISEASES, HYPOTRICHOSIS | This was a randomized, triple armed single blinded randomized study to compare the efficacy and safety of topical 0.01% and 0.03% bimatoprost versus topical 2% minoxidil. The sample size was calculated based on data from a previous comparative study in a Thai population, with a 5% significance level and 90% power. The ... | PMC10514173 |
Preparation of minoxidil 2% gel (20 mg/g) | The first step was to dissolve 1% carbopol in distilled water (2 g is dissolved in 100 ml of distilled water under stirring conditions), the second step was to activate carbopol gel formation by using seven drops of triethanolamine for every 100 ml of gel, and the third step was to incorporate the gel preparation into ... | PMC10514173 | ||
Preparation of bimatoprost gel | The first step was to dissolve 1% carbopol in distilled water (2 g is dissolved in 100 ml of distilled water under stirring conditions), the second step was to activate carbopol gel formation by using 0.01 gm or 0.03 gm of bimatoprost for every 100 ml of gel, and the third step was to incorporate the gel preparation in... | PMC10514173 | ||
Acknowledgements | Authors would like to express their full gratitude to Dr. Emad Zahran; PhD; MSc for preparation of the bimatoprost formulations used in this study. | PMC10514173 | ||
Author contribution | MZ, OH, SM and ME, designed and performed the research. MZ, OH, SM and ME performed the work. MZ, OH, SM and ME analyzed and wrote the paper. All authors contributed equally in production of this work. | PMC10514173 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). No funding. | PMC10514173 | ||
Data availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10514173 | ||
Declarations | PMC10514173 | |||
Conflict of interest | The author declares that they have no competing interest. | PMC10514173 | ||
Ethical approval | The study was approved by an ethics committee of Faculty of Medicine IRB (00012367-21-03-007), AL-Azhar University, Damietta; Egypt. | PMC10514173 | ||
References | PMC10514173 | |||
Study design | GROUP B | A single-blind prospective cohort study was performed. The high-fidelity simulation model was used in a formal NRP training course for trainees caring for neonatal patients. The trainees were divided into a group that conducted the scenario after the lecture (Group A) and a group that attended the lecture after the sce... | PMC9916567 | |
Results | GROUP B | The increase in score after theory training was statistically significant in both groups, but the final score did not differ between the two groups. However, when compared by career, in Group A, trainees under 24 months tended to be more effective, and in Group B, trainees over 24 months tended to be more effective. | PMC9916567 | |
Conclusion | The difference in short-term memory of trainees according to the order of education identified by the test score was not prominent, but it was found that the degree of difference in test scores for the order of education tended to be different according to the career. It is thought that the effectiveness of the trainin... | PMC9916567 | ||
Data Availability | All relevant data are within the manuscript and its | PMC9916567 | ||
Introduction | GROUP B | The Neonatal Resuscitation Program (NRP) is a field of cardiopulmonary resuscitation (CPR) designed and published based on improving the prognosis by providing appropriate early management to newborns [There are many reports that NRP training using high-fidelity simulation provides training effectively [The authors int... | PMC9916567 | |
Materials and methods | PMC9916567 | |||
Study population | HEART | Thirty-three neonatal staff (19 neonatal intensive care unit (NICU) nurses, 4 nursery nurses, 6 delivery room (DR) nurses, 2 physician-assisted (PA) nurses, 2 paediatric residents) without experience in simulation training through scenarios were included. According to hospital regulations, trainees were randomly assign... | PMC9916567 | |
Materials and methods | COVID-19 infection | GROUP B, COVID-19 INFECTION | As a prospective cohort study, this study was conducted in 8 morning and afternoon sessions from March 22, 2021, to March 26, 2021. Each session consisted of 50 minutes of a short, key-summary lecture, 10 minutes of break, and 2 cycles of simulation, each cycle lasting approximately 40 minutes. Simulation scenarios and... | PMC9916567 |
A Schematic diagram of the research. | Newborn PEDI | PMC9916567 | ||
Data analysis | Age, gender, years of career in the relevant department, and 1 | PMC9916567 | ||
Results | GROUP B | There was no epidemiologic difference between Group A and Group B. The prelecture test scores did not differ between the two groups (32.3±28.4 vs. 37.1±20.4), and interim tests conducted after the first turn showed significant differences between the two groups (65.7±24.0 vs. 47.4±18.2 p = 0.021). It was also confirmed... | PMC9916567 | |
Demographic findings and total score differentiation. | GROUP B | Each group (Group A vs. Group B) was divided into 2 subgroups (the <24 months and the ≥24 months subgroups) according to their experience, and the preliminary test results before the lecture were significantly different in Group B, the ≥24 months experience group (Group A 25.6±25.0 vs. 47.0±32.6 | PMC9916567 | |
Subgroup analysis by the order of the training. | GROUP B | To confirm the learning effect according to their experience, a subgroup analysis was performed targeting those with <24 months and ≥24 months of experience. In the <24 months subgroup, after the first turn, not only were the test scores higher in Group A than in Group B (66.18±23.47 vs. 47.0±18.17 | PMC9916567 | |
Subgroup analysis by careers, 24 months from neonatal care parts. | PMC9916567 | |||
Discussion | GROUP B | The lack of NRP clinical experience in neonatal care continues to appear [For the purpose of ongoing efforts to develop more powerful methods for sustaining cognitive abilities and skills, training professionals through simulation is considered safe and effective [In this study, no matter which training method was sele... | PMC9916567 | |
Supporting information | (XLSX)Click here for additional data file.We thank all participants for their generous contributions. | PMC9916567 | ||
References | PMC9916567 | |||
Subject terms | human immunodeficiency virus type 1 (HIV-1) cure. | Inducing antiretroviral therapy (ART)-free virological control is a critical step toward a human immunodeficiency virus type 1 (HIV-1) cure. In this phase 2a, placebo-controlled, double-blinded trial, 43 people (85% males) with HIV-1 on ART were randomized to (1) placebo/placebo, (2) lefitolimod (TLR9 agonist)/placebo,... | PMC10579101 | |
Main | PWH | Human immunodeficiency virus type 1 (HIV-1) infection persists mainly in CD4Many HIV-1 curative strategies aim to enhance HIV-1-specific immunity as a means to achieve ART-free HIV-1 virologic control. Until recently, HIV-1 cure trials have typically involved people with HIV-1 (PWH) on long-term suppressive ART, which ... | PMC10579101 | |
TITAN trial design (a) and abbreviated CONSORT flow diagram (b). | Solid green arrows indicate lefitolimod injections. Solid red and blue triangles indicate 3BNC117 and 10-1074 infusions, respectively. Empty green arrows as well as red and blue triangles indicate placebo injections or infusions, respectively. Gray shaded areas indicate time on ART, and white shaded areas indicate stil... | PMC10579101 | ||
Results | PMC10579101 | |||
Plasma HIV-1 RNA kinetics after ART interruption | To determine the impact of the interventions on ART-free virologic control, all participants underwent a closely monitored 25-week ATI. The study’s primary endpoint was time from stopping ART to the date of meeting the criteria for loss of virologic control (defined as 4 weeks with sustained plasma HIV-1 RNA ≥1,000 cop... | PMC10579101 | ||
bNAb sensitivity and serum concentrations | The proviral reservoir’s sensitivity to neutralization by 3BNC117 and 10-1074 was assessed for each potential study participant as part of the inclusion criteria before randomization (see | PMC10579101 | ||
bNAb sensitivity at screening and viral rebound. | bNAb sensitivity was primarily analyzed using the PhenoSense Monoclonal Antibody Assay with predefined IC | PMC10579101 | ||
Quantification of intact HIV proviruses | We used a digital droplet PCR (ddPCR) assay (Intact Proviral DNA Assay (IPDA)) to estimate the proportion of intact proviruses in CD4 | PMC10579101 | ||
HIV-1-specific T cell immunity | The median frequency of HIV-1-specific CD8 | PMC10579101 | ||
Safety | ADVERSE EVENTS | Both lefitolimod and bNAbs were overall safe. A total of 253 adverse events (AEs) were registered, of which 94 were determined to be unrelated to any investigational drug, including placebo (Extended Data Tables | PMC10579101 | |
Discussion | PWH, viral suppression | In this randomized, placebo-controlled HIV-1 cure trial among PWH on long-term ART who screened sensitive to the study bNAbs, we found that two doses of 3BNC117 and 10-1074 in the setting of ATI led to a significant delay in viral rebound compared to placebo. We also observed that 36% of individuals in the placebo/bNAb... | PMC10579101 | |
Methods | PMC10579101 | |||
Study design | This was a phase 2a, investigator-initiated, randomized, placebo-controlled, double-blinded international multicenter trial enrolling at six sites in Denmark (Aalborg, Aarhus, Gødstrup, Hvidovre, Odense and Rigshospitalet); one site in Oslo, Norway; and one site in Melbourne, Australia (EudraCT: | PMC10579101 | ||
Participants | PWH | PWH were aged 18–65 years and on ART for at least 18 months, with plasma HIV-1 RNA <50 copies per milliliter for at least 15 months and a CD4 T cell count >500 cells per mmThe sample size calculation was based on the primary endpoint: time to viral rebound during ATI. Time from stopping ART to loss of virological contr... | PMC10579101 | |
Randomization | The Clinical Trial Unit at Aarhus University generated the randomization sequence using permuted blocks of four or eight by computer-generated random numbers without stratification to sex and age. Randomization assignment was provided to each site using REDCap. | PMC10579101 | ||
Blinding | STERILE | Participants, study physicians and nurses handling administrations of the study drugs, as well as those individuals doing the analyses, were blinded to interventions. Only the pharmacy and study personnel preparing the study drugs were unblinded to interventions.The placebo for lefitolimod, 3BNC117 and 10-1074 was ster... | PMC10579101 | |
Procedures | Lefitolimod or placebo was administered s.c. at a dose of 120 mg once weekly for the first 8 weeks from week −2 to week 5. Lefitolimod dosing was based on previously observed effects in clinical trials | PMC10579101 | ||
25-week analytical treatment interruption | At week 0, participants were instructed to discontinue ART the following day and continue off ART for 25 weeks unless one of four criteria was met. Details can be found in the study protocol. | PMC10579101 | ||
Plasma HIV-1 RNA measurements | Plasma HIV-1 RNA levels were measured with standardized clinical assays at every visit. After resumption of ART, we monitored plasma HIV-1 RNA every fourth week until levels were undetectable (<50 copies per milliliter). | PMC10579101 | ||
Doubling time of plasma HIV-1 RNA | REGRESSION | The initial increase in plasma HIV-1 RNA was calculated based on the first two consecutive plasma HIV-1 RNA measurements that increased, and the second measurement had to increase by 1,000 copies per milliliter compared to the previous measurement. The slope of this increase was calculated using a linear regression mod... | PMC10579101 | |
bNAb sensitivity | bNAb sensitivity prediction was performed at screening for all participants primarily using the LabCorp–Monogram Biosciences PhenoSense HIV Monoclonal Antibody Assay on proviral HIV-1 DNA. bNAb sensitivity was a pre-specified inclusion criterion. For the PhenoSense assay, sensitivity was determined based on the concent... | PMC10579101 | ||
Proviral HIV-1 | For screening of participants who failed the PhenoSense assay and post hoc for all participants receiving the bNAb combination, SGA, sequencing and genotypic analysis were performed on proviral HIV-1 For participants in whom these primers did not amplify All primer sequences, an overview of which primer set was used fo... | PMC10579101 | ||
Rebound plasma HIV-1 | VIRUS | Plasma rebound virus was sequenced for participants who received bNAbs and rebounded within the study period or were viremic at the end of the 25-week ATI. Extraction of RNA, cDNA synthesis and SGA of plasma HIV | PMC10579101 | |
HIV-1 sequence assembly and annotation | Assembly and annotation of HIV-1 sequences was performed by The Rockefeller University pipeline (Defective and Intact HIV Genome Assembler) | PMC10579101 | ||
Sequence-based assessment of bNAb sensitivity | The HIV-1 | PMC10579101 | ||
Plasma antiretroviral drug concentrations | Antiretroviral drug concentrations in plasma were determined at BioXpedia using liquid chromatography with tandem mass spectrometry (LC–MS/MS) assay for individuals not fulfilling the criteria for viral rebound at week 13. Two timepoints were analyzed: (1) week 0 and (2) end of study, defined as the timepoint for reach... | PMC10579101 | ||
Serum bNAb concentrations | Each bNAb concentration in human serum was quantitatively measured using a sandwich immunoassay on Meso Scale Discovery Electrochemiluminescence (MSD-ECL) platform at PPD Bioanalytical Lab. In this assay, the bNAb was captured by biotinylated anti-idiotypic anti-bNAb antibody coated onto an MSD streptavidin plate, whic... | PMC10579101 | ||
Intact HIV-1 proviruses | IPDA | The IPDA is used to measure intact and defective HIV-1 proviruses by targeting the Ψ and RRE, which are frequently deleted or mutated in defective provirusesRegardless of the downstream assay applied—IPDA, IPDA with alternative RRE primer/probe or IPDA-like 3dPCR—CD4 | PMC10579101 | |
HIV-1-specific T cell immunity | HIV-1-specific T cell immunity was assessed using the AIM assay by flow cytometry at weeks 0, 6, 13 and 25 after ATI. Aliquots of cryopreserved PBMCs were thawed, washed and rested at 37 °C for 3 h. Cells were then plated into wells of a 96-well plate at a total of 1 × 10 | PMC10579101 | ||
Cytokine detection | Cytokine detection of IFN-γ and GzmB were measured in supernatants from Gag and non-stimulated AIM assay using MSD U-PLEX Custom Immuno-Oncology (K151AEM-2) according to the manufacturer’s instructions. The concentration of IFN-γ (pg ml | PMC10579101 | ||
HLA class I typing | HLA class I (HLA-A, HLA-B and HLA-C) alleles were genotyped at the American Safety and Health Institute-accredited laboratory HistoGenetics using sequence-based typing. | PMC10579101 | ||
Outcomes | The primary endpoint was time to loss of virological control during ATI (sustained plasma HIV-1 RNA ≥1,000 copies per milliliter for 4 weeks or confirmed plasma HIV-1 RNA >100,000 copies per milliliter). Secondary endpoints were (1) safety, including CD4 | PMC10579101 | ||
Statistical methods | SECONDARY | The analyses performed on primary, secondary and exploratory endpoints were pre-specified in the protocol. Paired two-tailed Wilcoxon tests and two-tailed Mann–Whitney tests were used to analyze non-parametric outcomes within and between groups, respectively. When more than two groups were compared, the Kruskal–Wallis ... | PMC10579101 | |
Reporting summary | Further information on research design is available in the | PMC10579101 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02547-6. | PMC10579101 | ||
Supplementary information |
Supplementary Tables 1–7, Supplementary Fig. 1 and CONSORT 2010 checklist and study protocol: TITAN-001, version 3.0, 2 July 2021.Reporting Summary | PMC10579101 | ||
Extended data | PMC10579101 | |||
A comprehensive CONSORT Flow Diagram. | ADVERSE EVENT | ART, antiretroviral therapy; ATI, ART interruption; bNAb, broadly neutralizing antibody, SAE, severe adverse event.
| PMC10579101 | |
Time to plasma HIV-1 RNA above 50 and 1,000 copies/mL during 25 weeks of ATI. | (
| PMC10579101 | ||
Plasma HIV-1 RNA kinetics for participants with partial and ongoing complete ART-free virologic control during the 25 weeks of ATI. | (
| PMC10579101 | ||
bNAb sensitivity at screening for the placebo/placebo and lefitolimod/placebo groups. | bNAb sensitivity was primarily analyzed using the PhenoSense Monoclonal Antibody Assay with predefined IC90 thresholds for 3BNC117 ( < 1.5 µg/mL) and 10-1074 ( < 2.0 µg/mL) and maximum percentage inhibition (MPI) ≥ 98%. In seven participants, the PhenoSense Assay failed, and we secondarily used proviral HIV-1 envelope ... | PMC10579101 | ||
Fraction and size of the defective HIV-1 proviruses. | Mean fraction of intact, 3′ and 5′ defective HIV-1 proviruses per 10
| PMC10579101 | ||
HIV-1-specific CD8+ and CD4+ immune responses during ATI. | (
| PMC10579101 | ||
Extended data | is available for this paper at 10.1038/s41591-023-02547-6. | PMC10579101 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02547-6. | PMC10579101 | ||
Acknowledgements | Neurological Disorders, Digestive, Stroke, Diabetes | INFECTIOUS DISEASES, LUNG, ALLERGY, STROKE, KIDNEY DISEASES, ABUSE, DIABETES, BLOOD, HEART, NEUROLOGICAL DISORDERS | We thank all study participants who devoted time to our research as well as every clinical research unit involved in the study. We acknowledge The Rockefeller University for providing 3BNC117 and 10-1074 and Mologen AG (now part of Gilead Sciences, Inc.) for providing lefitolimod. The funders were not involved in the s... | PMC10579101 |
Author contributions | H.N. | O.S.S. developed the trial design. J.F.H., M.H.P., P.W.D., M.T., M.C.N., M.C. and O.S.S. wrote the protocol. J.D.G., J.F.H., B.S., J.M., H.N., I.S.J., T.B., S.L., J.G., L.Ø., L.V., N.W., A.M.D.R., K.B.H.P., J.L., S.R.L., T.A.R., D.H.R. and O.S.S. did the clinical visits. J.D.G., M.H.P., M.R.U., M.H.S., R.O., D.C.C.J., ... | PMC10579101 | |
Peer review | PMC10579101 | |||
Data availability | Data are not available for download due to privacy/ethical restrictions under the European Union General Data Protection Regulation. Specific requests for access to the trial data may be sent to olesoega@rm.dk, and access may be provided to a named individual in agreement with the rules and regulations (All viral seque... | PMC10579101 | ||
Competing interests | M.C.N. is listed as an inventor on patents for the antibodies 3BNC117 and 10-1074. All other authors declare no competing interests. | PMC10579101 | ||
References | PMC10579101 | |||
Purpose | BREAST CANCER | To report the planning benchmark case results of the POTENTIAL trial—a multicenter, randomized, phase 3 trial—to evaluate the value of internal mammary nodal (IMN) irradiation for patients with high-risk breast cancer. | PMC10685528 | |
Methods | All participating institutions were provided the outlines of one benchmark case, and they generated radiation therapy plans per protocol. The plans were evaluated by a quality assurance team, after which the institutions resubmitted their revised plans. The information on beams arrangement, skin flash, inhomogeneity co... | PMC10685528 | ||
Results | heart D | The plans from 26 institutions were analyzed. Some major deviations were found in the first submission. The protocol compliance rates of dose coverage for the planning target volume of chest wall, supraclavicular fossa plus axilla, and IMN region (PTVim) were all significantly improved in the final submission, which we... | PMC10685528 | |
Conclusion | The major deviations were corrected and protocol compliance was significantly improved after revision, which highlighted the importance of planning benchmark case to guarantee the planning quality for multicenter trials. | PMC10685528 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13014-023-02379-1. | PMC10685528 | ||
Keywords | PMC10685528 | |||
Background | breast cancer | BREAST CANCER | Regional nodal irradiation has been proven to benefit breast cancer patients with positive axillary nodes, and with negative axillary nodes and high-risk features [Pretrial quality assurance (QA) is very important in multicenter RT trials to guarantee uniform planning quality and enhance the reliability of outcomes [ | PMC10685528 |
Methods and materials | PMC10685528 |
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