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Discussion
This pilot randomised clinical trial demonstrates that two different daily doses of 200 IU and 1000 IU of vitamin D for 4 months increase serum 25(OH)D concentration in a dose-response relationship in healthy young adults. No statistically significant relationship between BMI was found when comparing the intervention g...
PMC9947753
Vitamin D and BMI
The relationship between vitamin D and BMI is mainly due to the participation of vitamin D as a pre-hormone and its ability to go to many specific tissues in the body
PMC9947753
Vitamin D and serum lipids
cardiovascular and metabolic conditionsIn
VITAMIN D DEFICIENCY
Various observational studies across the world indicate an association between vitamin D deficiency and low levels of high-density lipoproteins (HDL) and high triacylglycerols, as well as higher levels of apolipoprotein EOne of the strengths of our study was the quantification of the concentration of vitamin D in the b...
PMC9947753
Acknowledgements
P.
The authors are grateful to all the participants for their willingness to realise the clinical trial.This work was financed by Minciencias (formerly COLCIENCIAS) with contract No. 774-2018. Project ‘Association between vitamin D status, excess weight and altered lipid profile in Colombian adolescents and young adults: ...
PMC9947753
References
PMC9947753
Key Points
PMC10559177
Question
PROSTATE CANCER
What factors are associated with a shorter time interval to prostate-specific antigen (PSA) failure (PSA nadir plus 2 ng/mL or initiation of salvage therapies) in nonmetastatic unfavorable-risk prostate cancer?
PMC10559177
Findings
SECONDARY
In this secondary analysis of a phase 3 clinical trial with 350 participants, significant factors associated with shorter time to PSA failure were younger than 70 years, a PSA of 10 ng/mL or more, and a Gleason score of 8 to 10. A high-risk group, defined by these 3 factors, had 43.8% risk of PSA failure at 3 years.
PMC10559177
Meaning
PSA failure, prostate cancer
SECONDARY, PROSTATE CANCER
These findings suggest that males with unfavorable-risk prostate cancer who are at very high-risk for early PSA failure can be identified and may benefit from study in randomized treatment escalation studies.This secondary analysis of a randomized clinical trial evaluates the factors associated with a short interval to...
PMC10559177
Importance
A shorter time interval to prostate-specific antigen (PSA) failure is associated with worse clinical outcomes; however, specific factors defining this state remain unknown.
PMC10559177
Objective
To evaluate the factors of a short time interval to PSA failure in order to identify patients for treatment escalation randomized clinical trials.
PMC10559177
Design, Setting, and Participants
prostate cancer, Cancer
SECONDARY, PROSTATE CANCER, CANCER
This secondary analysis of a randomized clinical trial was a secondary analysis of the Dana-Farber Cancer Institute 05-043 trial and included 350 patients with nonmetastatic unfavorable risk prostate cancer (PC).
PMC10559177
Interventions
Patients were randomized 1:1 to receive androgen deprivation therapy (ADT) and radiation therapy (RT) plus docetaxel vs ADT and RT.
PMC10559177
Main Outcomes and Measures
REGRESSION
Cumulative incidence rates curves of PSA failure, defined as PSA nadir plus 2 ng/mL or initiation of salvage therapies, and the Fine and Gray competing risks regression was used to assess the prognostic association between these factors and time to PSA failure.
PMC10559177
Results
ONCOLOGY
The study included 350 males who primarily had a good performance status (330 [94.3%] with Eastern Cooperative Oncology Group score of 0), median (range) age of 66 (43-86) years, with 167 (46.6%) having Gleason scores of 8 to 10, and 195 (55.2%) presenting with a baseline PSA of more than 10 ng/mL. After a median (IQR)...
PMC10559177
Conclusions and Relevance
PSA failure
SECONDARY
In this secondary analysis of a randomized clinical trial of males with unfavorable risk PC, young age, PSA of 10 ng/mL or more, and a Gleason score of 8 to 10 estimated a shorter time to PSA failure. A subgroup of males at very high-risk for early PSA failure, as defined by our study, may benefit from treatment escala...
PMC10559177
Trial Registration
PMC10559177
Introduction
hormone-sensitive M0 prostate cancer
SECONDARY
Androgen-deprivation therapy (ADT) using a luteinizing hormone-releasing hormone agonist or antagonist is a component of treatment for advanced hormone-sensitive M0 prostate cancer (PC) as several prospective randomized clinical trials have demonstrated that the addition of ADT to radiation therapy (RT) prolongs PC-spe...
PMC10559177
Methods
Cancer
CANCER
This randomized clinical trial was approved by the institutional review board of the Dana-Farber/Harvard Cancer Center and registered with ClinicalTrials.gov.
PMC10559177
Patient Population and Treatment
T2c, adenocarcinoma of the prostate, Cancer
SEMINAL VESICLES, ONCOLOGY, ADENOCARCINOMA OF THE PROSTATE, CANCER
Between September 21, 2005, and January 13, 2015, 350 patients from both academic and community-based health centers in the United States, Australia, and New Zealand who has been diagnosed with the 2002 American Joint Commission on Cancer Clinical Stage T1b-T4N0M0 adenocarcinoma of the prostate with at least 1 unfavora...
PMC10559177
CONSORT Diagram
ADT indicates androgen deprivation therapy; RT, radiation therapy.
PMC10559177
Follow-Up
death
After the end of treatment, males were followed up with every 6 months for the first 5 years and annually thereafter. A serum PSA was obtained at each follow-up. In addition to routine follow-up assessment, restating with a bone scan and pelvis magnetic resonance imaging or computed tomography were performed at the tim...
PMC10559177
Statistical Analysis
PSA failure, Deaths
REGRESSION, EVENTS, DISEASE, SECONDARY
The baseline characteristics of the study cohort at the time of randomization were presented using descriptive statistics in a tabular format. The primary end point was time to PSA failure, defined as time from randomization to earliest date of PSA nadir plus 2 ng/mL or the initiation of salvage therapies, such as ADT,...
PMC10559177
Results
PMC10559177
Patient Characteristics
The study population included 350 males with a median (range) age of 66 (43-86) years and included 4 Asian males (1.1%), 9 Black males (2.6%), 271 White males (77.4%), and 66 males (18.9%) who selected other as their race. In total, 167 males (46.6%) had a Gleason score of 8 to 10 and 195 (55.2%) with baseline PSA of m...
PMC10559177
Baseline Clinical Characteristic of 350 Study Patients
ONCOLOGY
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen.SI conversion factor: To convert PSA to μg/L, multiply by 1.0.
PMC10559177
Factors of Time to PSA Failure
The CIRs of PSA failure at 3 and 5 years by clinical factors are shown in eTable 2 and illustrated in eFigure in
PMC10559177
Multivariable Competing Risk Regression Estimate of sHR for Biochemical Progression in Fine and Gray’s Model
ONCOLOGY
Abbreviations: ECOG, Eastern Cooperative Oncology Group; RT, PSA, prostate-specific antigen; radiation therapy; sHR, subdistribution hazard ratio.SI conversion factor: To convert ng/mL to μg/L, multiply by 1.0.The multivariable model is also stratified by regions (US-Northeast, US-West, US-Other, Australia, New Zealand...
PMC10559177
Cumulative Incidence Curves of PSA Failure by Risk Categories
High risk category is defined as age younger than 70 years, PSA 10 ng/mL or more, and a Gleason score of 8 to 10.
PMC10559177
Multivariable Competing Risk Regression Estimate of sHR for Biochemical Progression in Fine and Gray Model
ONCOLOGY
Abbreviations: ECOG, Eastern Cooperative Oncology Group; RT, radiation therapy; sHR, subdistribution hazard ratio.The multivariable model is also stratified by regions (US-Northeast, US-West, US-Other, Australia, New Zealand) and randomization arm.The high-risk category was defined as being younger than age 70 years, a...
PMC10559177
Discussion
SECONDARY
In this study, we examined a cohort of males who experienced PSA failure after ADT and RT with or without docetaxel for nonmetastatic unfavorable-risk PC in the context of a randomized clinical trial. We found 3 significant factors that were associated with a shorter time to PSA failure were being younger than 70 years...
PMC10559177
Limitations
comorbidity
SECONDARY
This study has limitations. First, it is a secondary subgroup analysis, and therefore these results are hypothesis-generating and should be evaluated in a new cohort study. Second, our observation of the significant factors associated with the shorter time to PSA failure may not be applicable in treatment settings outs...
PMC10559177
Conclusions
PSA failure
SECONDARY
In this secondary analysis of a randomized clinical trial of nonmetastatic unfavorable-risk PC, we found that being younger than 70 years, having a PSA of 10 ng/mL or more, and having a Gleason score of 8 to 10 could be used to estimate the shorter time to PSA failure following initial treatment with ADT and RT with or...
PMC10559177
Introduction
In 2021, there were 38.4 million people living with HIV (PLHIV) globally, of which 20.6 million (54%) were living in Eastern and Southern Africa. Longitudinal studies, inclusive of community randomized trials (CRTs), provide critical evidence to guide a broad range of health care interventions including HIV prevention....
PMC10294466
Methods
REGRESSION
HPTN 071 (PopART) was a community randomized trial (CRT) conducted from 2013 to 2018, in 21 communities. The primary outcome was measured in a randomly selected population cohort (PC), followed up over 3 to 4 years at annual rounds. PC retention was defined as completion of an annual follow-up questionnaire. Baseline c...
PMC10294466
Results
Of the 38,474 participants enrolled during the first round of the trial (PC0), most were women (27,139, 71%) and 73% completed at least one follow-up visit. Retention was lower in men (adj RR: 0.90; 95% CI: 0.88, 0.91) and higher among older participants (adj RR: 1.23; 95% CI 1.20, 1.26) when comparing ages 35–44 to 18...
PMC10294466
Conclusion
Despite challenges, satisfactory retention outcomes were achieved in PopART with limited variability across study arms. In keeping with other studies, younger age, male sex, and lower SES were associated with lower levels of retention. Relocation outside of catchment area was the most common reason for non-retention in...
PMC10294466
Keywords
PMC10294466
Introduction
HIV infections
HIV INFECTIONS
In 2021, there were 38.4 million people living with HIV (PLHIV) globally, most of whom (20.6 million, 54%) were in Eastern and Southern Africa with 1.5 million new HIV infections globally [Participant retention outcomes vary across different types of longitudinal studies. Very high rates of loss to follow-up are routin...
PMC10294466
Methods
disability, primary retention
DISORDER, REGRESSION, SECONDARY, TUBERCULOSIS
HPTN 071 (PopART) was a three-arm CRT conducted from 2013 through 2018, in 21 urban or peri-urban communities in Zambia and South Africa [PC participants were recruited according to the following steps: (i) household census data were collected prior to PC0 to create a sampling frame; (ii) households in trial communitie...
PMC10294466
Discussion
primary retention
Of participants enrolled at PC0, 73% had at least one follow-up visit completed (Table Retention in PopART was lower than that achieved in the Botswana Combination Prevention Project (BCPP). BCPP was a smaller CRT, conducted in a more rural setting (15 villages in Botswana) between 2013 and 2018 that evaluated the effe...
PMC10294466
Acknowledgements
AIDS
INFECTIOUS DISEASES, ALLERGY, AIDS, ABUSE, EMERGENCY
HPTN 071 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements UM1-AI068619, UM1-AI068617, and UM1-AI068613, with funding from the US President’s Emergency Plan for AIDS Relief (PEPFAR). Additional funding is provided through NIAID, the National Institute of Ment...
PMC10294466
Authors’ contributions
NM and PB conceptualized the paper, EW and DS completed the analysis, and all authors participated in HPTN 071 and in the development of the manuscript. All authors have approved this final draft.
PMC10294466
Availability of data and materials
Hutchinson Cancer
Data used in this study will be available on request immediately after publication, with no end date. This includes de-identified participant data with a data dictionary. A data archive will be held at Fred Hutchinson Cancer Center, Seattle, WA, USA. Requests can be sent to HPTN-Data-Access@scharp.org.
PMC10294466
Declarations
PMC10294466
Competing interests
The authors declare that they have no competing interests.
PMC10294466
References
PMC10294466
Background
metabolic syndrome, MetS
METABOLIC SYNDROME, SYNDROME
Despite the prior evidence of the impacts of sumac on glycemic indices, lipid profile and visceral fat, there is a lack of evidence regarding the efficacy of sumac in cases with metabolic syndrome (MetS). Therefore, we aimed to assess the effect of sumac supplementation on MetS markers among adults with this syndrome.
PMC10183306
Methods
MetS
In this triple-blinded randomized placebo-controlled cross-over clinical trial 47 adults with MetS were randomly assigned to receive 500 mg sumac or placebo (lactose) capsule, twice a day. Each phase took 6 weeks and there was a 2-week washout between phases. All clinical evaluations and laboratory tests were conducted...
PMC10183306
Results
At the baseline of the study, mean (± SD) age, weight, and waist circumference of participants were respectively 58.7 (± 5.8) yr, 79.9 (± 14.3) kg, and 107.6 (± 10.8) cm. Intention to treat analysis (ITT) analyses revealed that sumac supplementation decreased systolic blood pressure by 5 mmHg (128.8 ± 21.4 at the basel...
PMC10183306
Conclusions
This cross-over trial revealed that sumac supplementation could reduce systolic blood pressure in men and women with MetS. Daily intake of 1000 mg sumac, as an adjuvant therapy, may be beneficial in management of MetS in adults.
PMC10183306
Keywords
PMC10183306
Methods
PMC10183306
Participants
MetS
A single-center triple-blind randomized placebo-controlled cross-over clinical trial was performed in Isfahan Endocrine and Metabolic Research Center (IEMRC) between November 2020 and June 2021. Individuals with MetS with the age range of 20 to 70 years who were willing to participate in the trial were included in the ...
PMC10183306
Study design
Since the components of available sumac powder in the market might be non-standard, At the initial of study, participants were randomly assigned to one of 2 groups. In order to have appropriate randomization and blinding, an unaware person, who was not involved in the study, performed randomization through the website ...
PMC10183306
Measurements
fasting blood glucose
CREST
All clinical evaluations and laboratory tests were conducted before and after each phase. A trained nutritionist gathered the information about socio-demographic and medical history of participants through the face-to-face interview. Half way between the lower rib margin and the iliac crest was measured as waist circum...
PMC10183306
Statistical analysis
The normality of each variable distribution was examined by the use of Kolmogorov–Smirnov test. Descriptive statistics (means, SDs or SEs and range) were used to describe general characteristics of the study participants. For comparison of baseline characteristics between study groups, a paired t-test was applied. Chan...
PMC10183306
Discussion
MetS, hypertension, steatohepatitis, MetS.Previous
NONALCOHOLIC FATTY LIVER, HYPERTENSION, STEATOHEPATITIS, OXIDATIVE STRESS
The current cross-over RCT revealed that sumac supplementation has significantly decreased systolic blood pressure among adults with MetS. Sumac supplementation might also prevent a significant rise in serum triglyceride among study subjects. This was the first cross-over trial that examined the effect of sumac supplem...
PMC10183306
Conclusion
METABOLIC SYNDROME
This cross-over randomized controlled trial revealed that sumac supplementation could decrease systolic blood pressure and might prevent a rise in triglyceride concentration in men and women with metabolic syndrome. Daily intake of 1000 mg sumac, as an adjuvant therapy, could be beneficial in management of MetS in adul...
PMC10183306
Acknowledgements
This study was extracted from an MS dissertation which was approved by Isfahan University of Medical Sciences.
PMC10183306
Authors’ contributions
FSM, ZH, MS and PS contributed in conception, design, data collection, data interpretation, manuscript drafting, approval of the final version of the manuscript, and agreed for all aspects of the work. The author(s) read and approved the final manuscript.
PMC10183306
Funding
The financial support for conception, design, data analysis and manuscript drafting comes from Isfahan University of Medical Sciences, Isfahan, Iran (no. 398797).
PMC10183306
Availability of data and materials
The data that support the findings of this study are available from the corresponding author (PS) upon reasonable request.
PMC10183306
Declarations
PMC10183306
Ethics approval and consent to participate
All participants provided an informed written consent. The study procedure was performed according to CONSORT 2010 checklist. The study protocol was ethically approved by the local Ethics Committee of Isfahan University of Medical Sciences.
PMC10183306
Consent for publication
All authors approved the final version of the manuscript, and agreed for all aspects of the work to be published.
PMC10183306
Competing interests
None of the authors had any personal or financial conflicts of interest.
PMC10183306
References
PMC10183306
Background
THYROID
Edited by: Andrea Frasoldati, Endocrine Unit ASMN, ItalyReviewed by: Adnan Işgör, Memorial Sisli Hospital, Türkiye; Demet Sengul, Giresun University, TürkiyeThis article was submitted to Thyroid Endocrinology, a section of the journal Frontiers in EndocrinologyThere is a cost advantage in using a needle without stylet ...
PMC10076701
Methods
MAY, THYROID NODULES
In this study, patients with thyroid nodules undergoing FNA were consecutively enrolled between May 2022 and July 2022. One experienced operator performed two punctures of each nodule with a stylet and without a stylet. Specimen adequacy was the primary outcome. Wald test was used for statistical analysis of the primar...
PMC10076701
Results
malignancy
A total of 149 patients (195 nodules) were enrolled in the study. A total of 167 of 195 nodules (85.64%) and 169 of 195 nodules (86.67%) were obtained adequate specimens using the S+ and S- methods, respectively. The difference in specimen adequacy (S- minus S+) between the two methods was 1.03% (95% CI, -5.83% to 7.88...
PMC10076701
Conclusion
THYROID
Thyroid FNA without a stylet is non-inferior to thyroid FNA with a stylet on specimen sampling.
PMC10076701
Introduction
DISEASES
Fine needle aspiration (FNA) is a simple, minimally invasive, and highly accurate method widely used in the diagnosis of many organ diseases, including thyroid (Furthermore, the value of the stylet has not been systematically evaluated in the FNA of the thyroid. Only one study evaluated the role of stylet using a few s...
PMC10076701
Materials and methods
PMC10076701
Study design
A single-center, prospective, randomized, controlled, non-inferiority trial was conducted at Fuyang People’s Hospital, a tertiary referral medical center. Written informed consent was obtained from all patients, and the study was approved by the Ethics Committee of Fuyang People’s Hospital (NO: 2022-80).
PMC10076701
Patients
cough
MAY, THYROID NODULES, THYROID NODULE
Patients with thyroid nodules who underwent FNA between May 2022 and July 2022 were prospectively enrolled in the study. The inclusion criteria were: (1) patients aged 18 years and above; (2) patients who provided written informed consent; and (3) patients who underwent ultrasound suggesting the presence of a thyroid n...
PMC10076701
Randomization
bleeding
BLEEDING
Each nodule was sampled for four passes (twice with a stylet (S+) and twice without a stylet (S-)). The nodules were randomly divided (1:1) into S+ (order of the four passes; S+→S-→S+→S-) and S- (order of the passes; S-→S+→S-→S+) to avoid the effect of bleeding from the previous pass on the later pass specimen. The ord...
PMC10076701
FNA procedure
THYROID, -20
FNAs were performed under ultrasound (US) guidance by the same experienced operator. For patients with multiple nodules, FNA was performed on suspicious nodules, otherwise, the largest nodule was selected for sampling. For patients with mixed cystic-solid nodules, FNA was performed from the solid component. An US scann...
PMC10076701
Cytological evaluation
THYROID
Five pathologists blinded to the stylet status of the passes evaluated cytology specimens. The same pathologist evaluated all specimens of one patient. Every thyroid FNA was first evaluated for specimen adequacy. Each specimen was classified as adequate or inadequate based on the Bethesda System for Reporting Thyroid C...
PMC10076701
Outcome variables
malignancy
SECONDARY
Specimen adequacy was the primary outcome, while the yield for malignancy was the secondary outcome. Specimen adequacy was defined as the rate at which adequate specimens were obtained (proportion of non-TBSRTC category I specimens). The yield for malignancy was defined as a percentage of TBSRTC category VI specimens.
PMC10076701
Sample size estimation and statistical analysis
SECONDARY
Power Analysis and Sample Size (PASS) version 11 was used for sample size estimation. The sample size was determined based on data from a meta-analysis involving 25,000 patients, which claimed an overall specimen adequacy rate of 87.1% for thyroid FNA (For a patient with more than one nodule undergoing FNA, the nodules...
PMC10076701
Results
PMC10076701
Patients and nodules
MAY, THYROID NODULES
A total of 154 patients were enrolled from May 2022 to July 2022 (Flow diagram for 154 consecutive patients referred for thyroid nodules fine needle aspiration (FNA).
PMC10076701
Cytological results
malignancy, follicular neoplasm
ATYPIA OF UNDETERMINED SIGNIFICANCE, FOLLICULAR NEOPLASM
The final cytological diagnosis was malignant (TBSRTC category VI) in 23 nodules (11.79%), suspicious for malignancy (TBSRTC category V) in 33 nodules (16.92%), follicular neoplasm or suspicious for a follicular neoplasm (TBSRTC category IV) in 5 nodules (2.56%), atypia of undetermined significance or follicular lesion...
PMC10076701
Specimen adequacy
The rates of obtaining adequate specimens were 167 of 195 nodes (85.64%) and 169 of 195 nodes (86.67%) for S+ and S- methods, respectively. The difference in specimen adequacy (S- minus S+) between the two methods was 1.03% (95% CI, -5.83% to 7.88%). The lower bound 95% CI of the difference in specimen adequacy (-5.83%...
PMC10076701
Yield for malignancy
malignancy
The yields for malignancy were 21 of 195 nodules (10.77%) and 20 of 195 nodules (10.26%) for S+ method and S- method, respectively (
PMC10076701
Adverse events
COMPLICATIONS
No complications or needle blockage were reported in this study.
PMC10076701
Discussion
bleeding
BLEEDING, THYROID NODULES
Puncture needles with a stylet is widely used by many puncturers during thyroid FNA (Besides, there are limited data comparing thyroid FNA with and without a stylet. A published trial comparing the two techniques compared only a subset of selected thyroid nodules (hypoechoic vascular type II nodules) (However, a previo...
PMC10076701
Conclusions
In conclusion, this non-inferiority study demonstrated that the absence of a stylet during thyroid FNA is non-inferiority to using a stylet on specimen sampling. If other studies confirm these results, using a low-cost needle without a stylet during thyroid FNA is justified. This would make the whole process easier, as...
PMC10076701
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC10076701
Ethics statement
This study was approved by the Ethics Committee of Fuyang People’s Hospital (NO: 2022-80). The patients/participants provided their written informed consent to participate in this study.
PMC10076701
Author contributions
All authors contributed to the study conception and design. PL, XM, and WM performed material preparation, data collection and analysis. PL wrote the first draft of the manuscript and all authors approved previous versions of the manuscript. All authors contributed to the article and approved the submitted version.
PMC10076701
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10076701
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10076701
References
PMC10076701
Abstract
PMC10075296
Background
DLBCL
LYMPHOMA, REMISSION
Diffuse large B‐cell lymphoma (DLBCL) is the most common (30%–35%) type of B‐cell lymphoma. Only about 60% of all newly diagnosed advanced‐stage DLBCL can be completely treated with x6 R‐CHOP. High‐dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation in the first remission (upfront au...
PMC10075296
Aims
DLBCL
This trial aimed to improve prognosis in DLBCL by upfront auto‐HSCT.
PMC10075296
Methods and Results
DLBCL
ONCOLOGY
A group of 105 patients: DLBCL NOS, age 18–65, stage IV, IPI ≥2, CR/PR after x6 R‐CHOP/DA‐EPOCH‐R from 2010 to 2019 at NMRC of Oncology named after N.N.Petrov of MoH of Russia was retrospectively analyzed. The HSCT group included patients with upfront HDCT followed by auto‐HSCT (
PMC10075296
Conclusion
DLBCL
Upfront HDCT followed by auto‐HSCT can increase 3‐year OS and PFS and improve prognosis in DLBCL NOS, age 18–65, stage IV, IPI ≥2 patients.
PMC10075296