title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
Sociodemographic characteristics
We considered gender of child, age and country of birth of child and caregivers, native language (German, other than German) and migration background of child (native, first generation, second generation) in line with PISA [
PMC9668221
Child characteristics
AD symptoms were assessed using the Diagnostic Tool for Affective Dysregulation in Children (DADYS; [
PMC9668221
Caregiver characteristics
Hostility
Caregiver AD symptoms were assessed using the Aggression and Hostility subscale (five items) from the German version of the Brief Symptom Checklist (BSCL); [
PMC9668221
COVID-19-related changes in external conditions
COVID-19-related stress
We analyzed the four items of the caregiver-rated total stress scale (CCSS-P-Stress) focusing on external conditions (childcare, working conditions, family conditions, leisure options) as potential risk factors for COVID-19-related stress.In the current sample, all scales on risk and protective factors demonstrated suf...
PMC9668221
Data analysis
COVID-19-related stress, AD
SECONDARY
All statistical analyses were performed using SPSS 28 [Differences in sample characteristics between the participating and non-participating families and between the AD and No AD group were calculated using In line with our first aim, we compared the caregiver- and child-rated COVID-19-related stress levels of the AD g...
PMC9668221
Results
PMC9668221
Participant characteristics
Characteristics of participating and non-participating families and of the AD and No AD groups are displayed in Tables S3 and S4, respectively.
PMC9668221
Participating and non-participating families
We did not find differences in retention between the AD group and the No AD group (
PMC9668221
AD and No AD groups
There was a slightly higher proportion of boys in the AD group compared to the No AD group (
PMC9668221
Treatment-related effects
On the scale level, only 18.3% of caregivers reported treatment-related deteriorations, while 19.5% reported improvements. For the domains use of therapeutic interventions and satisfaction with therapy, most caregivers reported no changes (62.6–90.5%). Improvements and deteriorations approximately balanced each other o...
PMC9668221
Discussion
COVID-19-related stress, AD
REGRESSION
The present study investigated COVID-19-related stress in a sample of children with and without AD and their families. Only small differences emerged between families of children with and without AD or between children in out-of-home care and in adoptive/biological families: children with AD and children in out-of-home...
PMC9668221
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 74 KB)
PMC9668221
Acknowledgements
Christiane
MARION, BERNHEIM
We thank all other members of the ADOPT Consortium for their contribution to the project: Dorothee Bernheim, Stefanie Bienioschek, Maren Boecker, Maurice Breier, Veronika Dobler, Jörg M. Fegert, Franziska Giller, Claudia Ginsberg, Monja Groh, Stefan Heintz, Martin Hellmich, Sarah Hohmann, Christine Igel, Michaela Jungh...
PMC9668221
Funding
Open Access funding enabled and organized by Projekt DEAL. The ADOPT study is funded by the German Federal Ministry of Education and Research (BMBF) Grant 01GL1741A-F.
PMC9668221
Data availability
The dataset can be obtained from the corresponding author after publication of the main outcome analyses on treatment effects.
PMC9668221
Declarations
PMC9668221
Conflict of interest
TB
AGD receives royalties from publishing companies as an author of books and treatment manuals on child behavioral therapy and assessment manuals, including the treatment manuals evaluated in this trial. TB served in an advisory or consultancy role for ADHS digital, Infectopharm, Lundbeck, Medice, Neurim Pharmaceuticals,...
PMC9668221
Ethical approval
Ethical approval has been obtained for all study centers.
PMC9668221
Informed consent
Verbal and written consent was obtained from children and parents/caregivers.
PMC9668221
References
PMC9668221
Background
blood loss, Primary dysmenorrhea, dysmenorrhea
BLOOD LOSS, PRIMARY DYSMENORRHEA, DYSMENORRHEA
Primary dysmenorrhea is considered as one of the women’s main problems during reproductive age. The present study aimed to investigate the effect of vitamin D on the severity of dysmenorrhea and menstrual blood loss.
PMC10045437
Methods
blood loss, dysmenorrhea, primary dysmenorrhea
BLOOD LOSS, DYSMENORRHEA, VITAMIN D DEFICIENCY, PRIMARY DYSMENORRHEA
This double-blind, randomized, placebo-controlled trial, was performed on 84 single female college students between 18 and 25 years old who living in dormitories. Students with primary dysmenorrhea and vitamin D deficiency were divided into experimental (n = 42) and control (n = 42) groups. Five days before the putativ...
PMC10045437
Results
In total, 78 of the 84 students completed the study (39 students per group). The intervention resulted in a significant reduction in the mean scores of both the VAS and VMS in the experimental group, in the first and second menstrual cycles (p < 0.001, p < 0.001, respectively), but not in the means score of PBLAC. Mefe...
PMC10045437
Conclusions
blood loss, primary dysmenorrhea
BLOOD LOSS, PRIMARY DYSMENORRHEA
The results indicate that vitamin D supplementation could decrease the severity of primary dysmenorrhea and the need to consume pain-relief medications. Contrariwise vitamin D supplementation had no significant effect on menstrual blood loss.
PMC10045437
Trial registration
This trial was registered in the Iranian Registry of Clinical Trials with code IRCT201305212324N on 18/1/2014. URL of registry:
PMC10045437
Supplementary Information
The online version contains supplementary material available at 10.1186/s12905-023-02284-5.
PMC10045437
Keywords
PMC10045437
Background
Primary dysmenorrhea, pain
VITAMIN D DEFICIENCY, PATHOLOGY, PRIMARY DYSMENORRHEA, COMPLICATIONS
Primary dysmenorrhea is defined as pain occurring with menses in the absence of pelvic pathology [Non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs) are recommended as first-line medication for pain management. However, complications and dissatisfaction with them are prominent [Vitamin D...
PMC10045437
Methods
PMC10045437
Study design
PRIMARY DYSMENORRHEA
This is a double-blind, randomized, placebo-controlled trial with two parallel groups. The study samples were female college students with primary dysmenorrhea, who living in Tehran University of Medical Sciences (TUMS) dormitories in Tehran, Iran.
PMC10045437
Participants
vomiting 2, bleeding, endometriosis, pain, adenomyosis
BLEEDING, ENDOMETRIOSIS, PAINFUL PERIODS, STRESSFUL EVENTS, DISEASE, ADENOMYOSIS, SECONDARY DYSMENORRHEA, VITAMIN D DEFICIENCY
Participants were healthy, Iranian, and single female college students. The inclusion criteria included: age 18 to 25 years old, BMI ≤ 30 (kg/m2), regular menstrual cycles of 21–35 days with menstrual period of 3–7 days, experience at least four consecutive painful periods in the past six months with the pain starting ...
PMC10045437
Sample size
Sample size was obtained as 66 students based on previous studies [
PMC10045437
Randomization
Among the TUMS dormitories, two dormitories were randomly selected. First, a list of students who met the inclusion criteria was prepared, then numbers were assigned to participants. Using a random numbers table, eighty-four single female college students were enrolled in the study. Numbers 1 to 84 were divided into tw...
PMC10045437
Study instruments
pain
MENSTRUATION PAIN, MENSTRUAL PAIN
The VAS was used to measure menstruation pain. It is a horizontal scale with the descriptors 0: no pain and 10: worst possible pain [The VMS was also used to assess students’ perception of menstrual pain severity and its effect on their daily activities. Items were scored, using a four-point Likert scale ranging from n...
PMC10045437
Intervention and outcomes
SEPARATION
The procedure was explained to the participants who met the inclusion criteria. All participants signed informed written consent. Subsequently, 5 ml of venous blood was taken to determine serum levels of 25(OH)D and calcium. These blood samples were then transferred to a laboratory affiliated with TUMS, centrifuged (2,...
PMC10045437
Statistics analysis
The Skewness test was used to assess the normality of quantitative variables. Descriptive statistics, independent sample t-test, and repeated measurements were utilized for to examine continuous quantitative variables. Meanwhile, Fisher’s exact and Chi-square tests were used to examine associations between variables. R...
PMC10045437
Discussion
bleeding, reduced primary dysmenorrhea, menstrual pain, blood loss, pain, primary dysmenorrhea, dysmenorrhea
BLEEDING, STILL, MENSTRUAL PAIN, BLOOD LOSS, PRIMARY DYSMENORRHEA, DYSMENORRHEA, VITAMIN D DEFICIENCY, UTERUS
The present study aimed to investigate the effect of 300,000 IU single-dose vitamin D supplement (50,000 IU, two tablets every 8 h) on the severity of primary dysmenorrhea and menstrual blood loss in Iranian university students. The results revealed that one and two months after the prescription of vitamin D, the mean ...
PMC10045437
Conclusions
blood loss, primary dysmenorrhea, pain
BLOOD LOSS, DYSMENORRHEA, PRIMARY DYSMENORRHEA, VITAMIN D DEFICIENCY, VITAMIN D DEFICIENCY
Based on the study findings, over two follow-up periods, a high dose of vitamin D could improve pain intensity and decrease the need for using NSAIDs in women with primary dysmenorrhea and vitamin D deficiency. Vitamin D deficiency is common among those living in Iran. As such, by using supplementation, the amount of v...
PMC10045437
Acknowledgements
We greatly appreciate students for participating in the current study. This study was submitted as fulfillment of the MSc thesis of midwifery which TUMS supported.
PMC10045437
Authors’ contributions
AA and MK participated in the study’s design, acquisition, and analysis of the data. EG participated in the study’s conceptualization and sampling. SP participated in reviewing and editing the manuscript. FS participated in the analysis of data. All authors read and approved the final version of the submitted manuscrip...
PMC10045437
Funding
The study was supported by the Tehran University of Medical Sciences.
PMC10045437
Data availability
The datasets generated in the current study are available from the corresponding author.
PMC10045437
Declarations
PMC10045437
Ethics approval and consent to participate
The study protocol was in accordance with the declaration of Helsinki and was approved by the Research Ethics Committee of the TUMS, Tehran, Iran (ethics code: 2478/130). It was recorded in the Iranian Registry of Clinical Trials Center with code IRCT201305212324N9 on 18/1/2014. The first sampling was on 20/03/2014. In...
PMC10045437
Consent for publication
Not applicable.
PMC10045437
Competing interests
The authors declare that they have no competing interests.
PMC10045437
Abbreviations
Body mass indexCresolphthalein complexoneEnzyme-linked immunosorbent assay.International unitsNon-steroidal anti-inflammatory drugsOral contraceptive pillsPictorial blood assessment chartVisual analog scaleVitamin D receptorsVerbal multidimensional scoring system
PMC10045437
References
PMC10045437
Background
multiple sclerosis
MULTIPLE SCLEROSIS
A study was undertaken to evaluate remote monitoring via smartphone sensor-based tests in people with multiple sclerosis (PwMS). This analysis aimed to explore regional neural correlates of digital measures derived from these tests.
PMC9970954
Methods
In a 24-week, non-randomized, interventional, feasibility study (NCT02952911), sensor-based tests on the Floodlight Proof-of-Concept app were used to assess cognition (smartphone-based electronic Symbol Digit Modalities Test), upper extremity function (Draw a Shape Test, Pinching Test), and gait and balance (Static Bal...
PMC9970954
Results
CORTEX
Worse performance on digital and clinical measures was associated with smaller regional brain volumes and larger ventricular volumes. Whereas digital and clinical measures had many neural correlates in common (e.g., putamen, globus pallidus, caudate nucleus, lateral occipital cortex), some were observed only for digita...
PMC9970954
Conclusions
Multiple neural correlates were identified for the digital measures in a cohort of people with early MS. Digital measures showed associations with brain regions that clinical measures were unable to demonstrate, thus providing potential novel information on functional ability compared with standard clinical assessments...
PMC9970954
Supplementary Information
The online version contains supplementary material available at 10.1007/s00415-022-11494-0.
PMC9970954
Keywords
PMC9970954
Introduction
atrophy, disability, chronic disease of the central nervous system [
ATROPHY, MULTIPLE SCLEROSIS (MS), CORTEX
Multiple sclerosis (MS) is a chronic disease of the central nervous system [MRI-measured atrophy occurs in distinct, non-random patterns and involves many different regions, including the cerebral cortex, deep gray matter, brainstem, cerebellum, and spinal cord [Although there have been efforts to link clinical disabil...
PMC9970954
Methods
PMC9970954
Study design and participants
This 24-week, non-randomized, interventional, feasibility study (clinicaltrials.gov: NCT02952911) aimed to assess the feasibility of remotely monitoring PwMS with the Floodlight PoC app, through sensor-based assessment via a provisioned smartphone device [
PMC9970954
Smartphone sensor-based tests
Key neurologic functions underlying cognitive information processing speed were assessed by the e-SDMT. It instructed participants to correctly match as many symbols as possible to their paired digits within 90 s, according to a symbol–digit key also displayed on the smartphone screen.The Draw a Shape Test assessed fin...
PMC9970954
Digital data processing
Since the active tests were unsupervised, quality control flags as defined in Montalban et al. [
PMC9970954
MRI acquisition and processing
PMC9970954
Image acquisition
BRAIN
Brain MRI scans were collected from PwMS at baseline and at week 24 with Siemens 3-Tesla scanners (Siemens Healthcare GmbH, Erlangen, Germany) following optimized clinical practice protocols in place at the two investigating centers: (1) Hospital Universitari Vall d'Hebron, three-dimensional (3D) T1-weighted (repetitio...
PMC9970954
Image processing
MR images were analyzed with icobrain ms v.5.0 (icometrix, Leuven, Belgium), a CE- and Food and Drugs Administration-certified software as medical device for automatic labeling, visualization, and volumetric quantification of segmentable brain structures [
PMC9970954
Standard clinical measures
During three clinical visits (baseline, week 12, and week 24) PwMS underwent clinical evaluation. These included the oral Symbol Digital Modalities Test (SDMT), Nine-Hole Peg Test (9HPT), Berg Balance Scale, Timed 25-Foot Walk (T25FW), and EDSS.
PMC9970954
Statistical analysis
REGRESSION
Due to the exploratory nature of this analysis, an unbiased approach with no pre-specified hypotheses was adopted to investigate associations between the brain/spinal cord regions and the digital measures obtained with the Floodlight PoC app (Table In the second analysis, the variance in the digital measures that can b...
PMC9970954
Discussion
cognitive decline
DISEASE PROGRESSION, DISEASE, PATHOLOGY
Digital measures captured by the Floodlight PoC app demonstrated robust correlations with volumetric measurements of specific brain regions. While many neural correlates were shared between clinical and digital measures, the latter showed associations with brain regions that clinical measures were unable to demonstrate...
PMC9970954
Conclusions
different neurologic domains
In this exploratory post-hoc analysis, digital measures obtained with the Floodlight PoC app correlated with normalized volumes of distinct anatomical regions. While many of the correlations were also observed with standard clinical measures, some were only observed with the digital measures. In addition, the explained...
PMC9970954
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (PDF 9479 KB)
PMC9970954
Acknowledgements
We would like to thank all patients, their families, and the investigators who participated in this trial. We would like to thank the following colleagues at F. Hoffmann-La Roche Ltd for their contributions and support to the study: Jan Beckmann, Sandro Fritz, Nicholas Pierce Heinemeier, Timothy Kilchenmann, Lito Kriar...
PMC9970954
Author contributions
Design or conceptualization of the study: CB, ML. Analysis or interpretation of the data: MG, JSG, SPH, FD, LG, LC. Drafting and revising the manuscript for intellectual content: MG, JSG, SPH, FD, LM, LG, LC, FL, CB, XM, SLH, ML.
PMC9970954
Funding
This research was funded by F. Hoffmann-La Roche Ltd, Basel, Switzerland.
PMC9970954
Data availability
For up-to-date details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here:
PMC9970954
Declarations
PMC9970954
Conflicts of interest
TG
EMD
MG is a contractor for F. Hoffmann-La Roche Ltd. JSG over the past year has received grant/contract research support from the National MS Society, Biogen, and Octave Biosciences. She serves on a steering committee for a trial supported by Novartis. She has received honoraria for a non-promotional, educational activity ...
PMC9970954
Ethics approval
ICH
The study was registered on clinicaltrials.gov (NCT02952911). The study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. All participants provided informed consent and ethical approval was obtained from the ethics committee of the ...
PMC9970954
References
PMC9970954
Introduction
Multiple myeloma, bone marrow malignancy, haematologic cancers, MM
MULTIPLE MYELOMA, SOLID TUMOUR
Multiple myeloma (MM) is a bone marrow malignancy accounting for almost 10% of all haematologic cancers [Assessment of patient response to therapy is an important element when determining appropriate treatments for MM [The use of real-world data (RWD) is key to understanding the treatment course of patients with MM in ...
PMC10174483
Materials and methods
PMC10174483
Description of the dR algorithm
Flexible IMWG criteria, with exclusion of bone marrow biopsy data and imaging results, and reduction in either serum or urine M protein levels (but not both), were used to define the following dR categories: partial response (PR), very good PR (VGPR), complete response (CR) and stringent CR (sCR) (
PMC10174483
Criteria for a derived real-world response algorithm based on IMWG criteria.
MYELOMA
CR, complete response; FLC, free light chain; h, hours; IMWG, International Myeloma Working Group; M, monoclonal; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.To generalize the algorithm, we required at least two laboratory measurements per patient; one at baseline and one fo...
PMC10174483
Validation of the dR algorithm using BELLINI clinical trial data
BELLINI was a randomized 2:1, double-blind, multicentre, phase III trial that evaluated venetoclax or placebo in combination with bortezomib and dexamethasone in patients with RRMM [Serum and urine M protein and FLC levels were assessed at baseline and at various time points during the trial (S2 Table in Response asses...
PMC10174483
RWD—Evaluating the association between dR and overall survival
The nationwide Flatiron Health EHR-derived de-identified database is a longitudinal database, comprising de-identified patient-level structured and unstructured data, curated via technology-enabled abstraction and subject to obligations to prevent re-identification and protect patient confidentiality [Treatment regimen...
PMC10174483
Study design.
PD, MM
MULTIPLE MYELOMA, DISEASE
A) Landmark analysis for assessing individual-level associations and B) building cohorts for the assessment of treatment-level association between derived ORR and OS for a RWD cohort from the Flatiron Health MM database. MM, multiple myeloma; ORR, overall response rate; OS, overall survival; PD, progressive disease; RW...
PMC10174483
Results
PMC10174483
The dR algorithm response assessment is in concordance with that of the IRC
Data from all 291 patients enrolled in BELLINI were included in the current study. Concordance was high between the IRC’s and the dR algorithm’s assignments of responders classified as ≥PR (275/291 assignments in agreement, Cohen’s Kappa 0.83;
PMC10174483
Number of responders (≥PR) and non-responders (<PR) in the BELLINI trial as assessed by IRC and the dR algorithm.
dR, derived response; IRC, independent review committee; PR, partial response.In total there were 16 discrepant cases for which different responses were assigned by the IRC and the dR algorithm. In the only case assigned as a non-responder by the dR algorithm but as a PR by the IRC, there were not enough consecutive la...
PMC10174483
The dR algorithm reliably evaluates overall response rate and VGPR+ endpoints
The OR between the overall response rate (≥PR) of the intervention and placebo arms derived from the IRC response assessment in the BELLINI trial was 2.10 (overall response rate 82% [159/194] vs. 68% [66/97]), indicating the benefits of the treatment. The OR resulting from the dR algorithm assignment of overall respons...
PMC10174483
Analysis of the differences in overall response rate, ≥VGPR and ≥CR in the intervention and placebo arms of the BELLINI trial by IRC and the dR algorithm.
*Nominal p-values without multiple hypotheses correction are shown for completeness and serve to compare the estimated treatment effect between dR and IRC.CI, confidence interval; CMH, Cochran-Mantel-Haenszel; CR, complete response; dR, derived response; IRC, independent review committee; ORR, overall response rate; VG...
PMC10174483
Sensitivity analysis
MINOR
The summary of the laboratory assessment frequency upon simulation of missing data can be seen in S4 Table in The original laboratory data contained two consecutive measurements of the same type for 283/291 patients (data missing for eight patients who discontinued the trial early) and thus confirmed response criteria ...
PMC10174483
Number of responders (≥PR) and non-responders (<PR) in the BELLINI trial as assessed by IRC and the dR algorithm using 50% of all laboratory measurements.
dR, derived response; IRC, independent review committee; PR, partial response.Differences in overall response rate between the intervention and placebo arms in the trial based on IRC assessment could still be replicated by the algorithm after excluding 50% of all laboratory measurements (overall response rate in interv...
PMC10174483
Analysis of the differences in overall response rate, ≥VGPR and ≥CR in the intervention and placebo arms of the BELLINI trial by IRC and the dR algorithm using 50% of all available laboratory measurements.
MINOR
*Nominal p-values without multiple hypotheses correction are shown for completeness and serve to compare the estimated treatment effect between dR and IRC.CI, confidence interval; CMH, Cochran-Mantel-Haenszel; CR, complete response; dR, derived response; IRC, independent review committee; ORR, overall response rate; VG...
PMC10174483
Number of responders (≥PR) and non-responders (<PR) in the BELLINI trial as assessed by IRC and the dR algorithm using 50% of all laboratory measurements and 25% of all urine M protein measurements.
dR, derived response; IRC, independent review committee; M, monoclonal; PR, partial response.
PMC10174483
Efficacy analysis assessing differences in overall response rate, ≥VGPR and ≥CR in the intervention and placebo arms of the BELLINI trial by IRC and the dR algorithm using 50% of all available laboratory measurements and 25% of all urine M protein measurements.
MINOR
*Nominal p-values without multiple hypotheses correction are shown for completeness and serve to compare the estimated treatment effect between dR and IRC.CI, confidence interval; CMH, Cochran-Mantel-Haenszel; CR, complete response; dR, derived response; IRC, independent review committee; M, monoclonal; ORR, overall re...
PMC10174483
Validation using RWD—Association between dR and OS
DISEASE CHARACTERISTIC
Of the 6,806 patients in the Flatiron Health MM database, 4,727 had valid laboratory test results for dR assessment during first-line treatment and were included in the study cohort. Baseline patient and disease characteristics are shown in S5 Table in
PMC10174483
Treatment-level association between OR for derived overall response rate and HR for overall survival for a RWD cohort from the Flatiron Health MM database.
MULTIPLE MYELOMA
Each dot in the plot represents one comparison in one cohort. For the treatment-level association analysis, only the significant ORs and HRs from the comparative analyses were used. PI+steroid was used as the comparator treatment group for all analyses. Error bars show the 95% CI of the estimated ORs and HRs. chemo, ch...
PMC10174483
Discussion
MM
MINOR
Automated algorithms are increasingly used in clinical decision management due to their reliability and reproducibility, timely assessment of a large sample of patients, and adherence to recommended clinical practice [In this exploratory pilot study, we developed a dR algorithm to determine whether response assessment ...
PMC10174483
Supporting information
PMC10174483
Kaplan-Meier curve comparing responders (PR+; blue) and non-responders (<PR; red) at different landmark times.
death
Time presented in months from the landmark to the patient’s death or censoring. PR, partial response.(TIF)Click here for additional data file.(DOCX)Click here for additional data file.Third-party medical writing assistance, under the direction of all authors, was provided by Helen Cathro, PhD, of Ashfield MedComms, an ...
PMC10174483
Abbreviations
ONCOLOGY, MYELOMA
confidence intervalCochran-Mantel-Haenszelcomplete responsederived responseEastern Cooperative Oncology Groupelectronic health recordFood and Drug Administrationfree light chainhourshazard ratioimmunofixationimmunomodulatory drugsInternational Myeloma Working Groupindependent review committeemonoclonalmaximumminimummul...
PMC10174483
References
PMC10174483
Background
Infection, Cancer
INFECTIOUS DISEASES, ALLERGY, INFECTION, CANCER
Edited by: Javeed Ahmad, National Institute of Allergy and Infectious Diseases (NIH), United StatesReviewed by: Sonam Raj, National Cancer Institute (NIH), United States; Abir Kumar Panda, National Institute of Allergy and Infectious Diseases (NIH), United States†These authors share senior authorshipThis article was su...
PMC9905247