title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
Materials and methods
PMC9821721
Participants
A priori power analyses (software package, G* Power 3.1.9.7: University of Dusseldorf, Germany) conducted using the results from studies by Hazime et al. [
PMC9821721
Experimental design
This study utilized a fully randomized, crossover, repeated measures design, with all participants completing four protocols. The four protocols involved the participant receiving: 1) a-tDCS targeting the left M1, with testing of the contralateral (right) leg, 2) a-tDCS targeting the left M1 with testing of the ipsilat...
PMC9821721
Experimental design.
knee extensors
CONTRACTION
Abbreviations: KE: knee extensors, KF: knee flexors, MVC: maximal voluntary isometric contraction, tDCS: transcranial direct current stimulation.
PMC9821721
tDCS intervention
A similar stimulation protocol as the only other study to test ipsilateral tDCS effects [
PMC9821721
MVC and fatigue tests
fatigue
CONTRACTION
Prior to any performance measurements, participants completed a five-minute warm up using a cycle ergometer at 70 revolutions per minute and 1 kilopond.To measure force, a cuff with a non-extensible strap was attached to a strain gauge (Omega Engineering Inc., LCCA 500 pounds; sensitivity = 3 mV/V, OEI, Canada) and pla...
PMC9821721
tDCS blinding questionnaire
itching, tingling, scalp irritation
Before and after receiving tDCS (either a-tDCS or s-tDCS), participants were given a questionnaire, where they were asked to rate perceived sensations (e.g., itching, tingling, scalp irritation) on a scale from 1–10 (Likert scale: 1 = absent, 10 = severe) [
PMC9821721
Statistical analysis
blurred vision, scalp irritation, fatigue, anxiety, itching, burning sensation, headache, acute mood, neck pain
Statistical analyses were calculated using SPSS software (Version 27.0, SPSS, Inc. Chicago, IL). Normality and homogeneity of variances tests were conducted for all dependent variables. If the assumption of sphericity was violated, the Greenhouse-Geiser correction was employed. For absolute MVC force, a three-way repea...
PMC9821721
Results
PMC9821721
Absolute force measures
Coefficient of variations (CV) less than 10% of the mean and excellent reliability described as an ICC: >0.9 were found between pre-test measurements for the contralateral (α = 0.943, a-tDCS CV: 31.6 = 6.5% of mean, s-tDCS CV: 30.5 = 6.3% of mean) and ipsilateral (α = 0.964, a-tDCS: 36.4 = 7.5% of mean, s-tDCS: 36.2 = ...
PMC9821721
Mean participant absolute contralateral and ipsilateral knee extensor force following anodal transcranial direct current stimulation (a-tDCS) or sham tDCS (s-tDCS).
(* denotes statistical significance at
PMC9821721
Relative (normalized) MVC force
A significant interaction effect for condition x leg tested [
PMC9821721
Fatigue test
fatigue
There were no significant main or interaction effects for fatigue index force (
PMC9821721
Participant contralateral and ipsilateral knee extensor force fatigue index following anodal transcranial direct current stimulation (a-tDCS) or sham tDCS (s-tDCS).
(* denotes statistical significance at
PMC9821721
Mean participant contralateral and ipsilateral knee extensor (KE) force for each contraction of the fatigue protocol.
Asterisk highlights a significant (p<0.0001) decrease in force from repetition #1 to #12. Columns and bars represent mean force values and standard deviations in Newtons.
PMC9821721
tDCS blinding questionnaire data
fatigue, scalp irritation, itching, burning sensation, headache
MINOR
Only minor side effects were reported following tDCS, including headache, scalp irritation, tingling, itching, burning sensation, and fatigue. Friedman’s ANOVA revealed no significant differences in these variables between the four protocols (all p values ≥ 0.056) suggesting that participants were sufficiently blinded ...
PMC9821721
Discussion
fatigue, muscle fatiguability
The main objective of this study was to determine if a-tDCS targeting the left M1 could modulate maximal force production or muscle fatiguability in either the right (contralateral to tDCS) or left (ipsilateral to tDCS) quadriceps. This study demonstrated significant force impairments (s-tDCS with testing of contralate...
PMC9821721
Limitations
RECRUITMENT
It might be suggested that the recruitment of 16 participants in this study involving a more variable intervention might have led to low statistical power even though the power analysis indicated that 8–10 participants should provide sufficient power. This lower power may have diminished the possibility of revealing an...
PMC9821721
Conclusions
fatigue
This study found that 10 minutes of 2 mA of a-tDCS is not an effective or consistent method for increasing maximal force production or reducing fatigue in the KE either contralateral or ipsilateral to the stimulated M1. Furthermore, the decrements with the contralateral s-tDCS also contributed to the inconsistent findi...
PMC9821721
Methods
PMC10616990
Enrollment
thirty-nine, allergy
MAY, TRIGGER FINGER, ALLERGY
Institutional review board approval was obtained prior to initiation of the study. Four hundred and thirty-nine patients, 18 years of age and older, undergoing carpal tunnel release by three certified hand surgeons at a single academic institution were screened for eligibility between May 2019 and October 2021. Partici...
PMC10616990
Technique
Surgeries were performed by three experienced or highly-experienced fellowship-trained hand surgeons (RMS, COB, RHA) in practice for a minimum of 10 years (
PMC10616990
Data collection
itching, itchiness, scars, pain
SCAR
Patients returned for two postoperative follow-up appointments, at 10–12 days and 6 weeks after surgery. Nylon sutures were removed at the first postoperative visit. At each visit, the incisions were evaluated by trained research personnel. The treating surgeon did not perform these evaluations to ensure interobserver ...
PMC10616990
Statistical analysis
Based on previously published data (
PMC10616990
Results
SCAR, REGRESSION, SCAR
A total of 104 patients completed the first postoperative visit at 2 weeks, and 62 patients completed the second postoperative visit at 6 weeks. At 2 weeks, 48 patients in the Monocryl group and 56 patients in the nylon group successfully completed the questionnaires. At 6 weeks, 31 patients in the Monocryl group and 3...
PMC10616990
Discussion
inflammation, scars, pain, tightness, tenderness, carpal tunnel
SCAR, INFLAMMATION, ADVERSE REACTION, PROLIFERATIVE, SCAR, COMPLICATIONS
Although carpal tunnel release is the most performed elective procedure in the hand, debate remains regarding the optimal suture type and method for wound closure. There is emerging evidence that suture material and closure technique can influence the ultimate outcome (Several studies have pointed to the advantages con...
PMC10616990
Supplemental Material
PMC10616990
sj-zip-1-jhs-10.1177_17531934231178383 - Supplemental material for Prospective randomized controlled trial comparing the effect of Monocryl versus nylon sutures on patient- and observer-assessed outcomes following carpal tunnel surgery
Click here for additional data file.Supplemental material, sj-zip-1-jhs-10.1177_17531934231178383 for Prospective randomized controlled trial comparing the effect of Monocryl versus nylon sutures on patient- and observer-assessed outcomes following carpal tunnel surgery by Edward Wu, Robert Allen, Christopher Bayne and...
PMC10616990
References
PMC10616990
Key Points
PMC10116385
Question
depression
Can depression be reduced during pregnancy and before birth using a brief, safe intervention?
PMC10116385
Findings
depressive disorder, depression
In this randomized clinical trial of 234 adult pregnant individuals, elevated symptoms were reported during routine obstetric care depression screening. Compared with enhanced usual care, brief interpersonal psychotherapy significantly improved depression symptoms and major depressive disorder diagnosis rate during pre...
PMC10116385
Meaning
depression
Brief interpersonal psychotherapy may be warranted to relieve depression in pregnant individuals with potential intergenerational benefits.
PMC10116385
Importance
depression
Prenatal depression is prevalent with negative consequences for both the mother and developing fetus. Brief, effective, and safe interventions to reduce depression during pregnancy are needed.
PMC10116385
Objective
depression
To evaluate depression improvement (symptoms and diagnosis) among pregnant individuals from diverse backgrounds randomized to brief interpersonal psychotherapy (IPT) vs enhanced usual care (EUC).
PMC10116385
Design, Setting, and Participants
depression
A prospective, evaluator-blinded, randomized clinical trial, the Care Project, was conducted among adult pregnant individuals who reported elevated symptoms during routine obstetric care depression screening in general practice in obstetrics and gynecology (OB/GYN) clinics. Participants were recruited between July 2017...
PMC10116385
Interventions
Treatment comprised an engagement session and 8 active sessions of brief IPT (MOMCare) during pregnancy. EUC included engagement and maternity support services.
PMC10116385
Main Outcomes and Measures
depression, Depression
Two depression symptom scales, the 20-item Symptom Checklist and the Edinburgh Postnatal Depression Scale, were assessed at baseline and repeatedly across pregnancy. Structured Clinical Interview for
PMC10116385
Results
MDD
Of 234 participants, 115 were allocated to IPT (mean [SD] age, 29.7 [5.9] years; 57 [49.6%] enrolled in Medicaid; 42 [36.5%] had current MDD; 106 [92.2%] received intervention) and 119 to EUC (mean [SD] age, 30.1 [5.9] years; 62 [52.1%] enrolled in Medicaid; 44 [37%] had MDD). The 20-item Symptom Checklist scores impro...
PMC10116385
Conclusions and Relevance
MDD, depression, ’ mental health
In this study, brief IPT significantly reduced prenatal depression symptoms and MDD compared with EUC among pregnant individuals from diverse racial, ethnic, and socioeconomic backgrounds recruited from primary OB/GYN clinics. As a safe, effective intervention to relieve depression during pregnancy, brief IPT may posit...
PMC10116385
Trial Registration
ClinicalTrials.gov Identifier:
PMC10116385
Introduction
depression, Depression, disability
DISEASE
Depression is common and contributes to disability and disease burden.The US Preventive Services Task Force (USPSTF) showed that current interventions exhibit significant but small effects to prevent perinatal depression (defined broadly including pregnancy through 12 months post partum).The present study follows the U...
PMC10116385
Methods
PMC10116385
Participants
mania, psychosis, blood transfusions, depression, Depression
RECRUITMENT
We randomized 234 pregnant individuals recruited primarily from obstetrics clinics at 2 major medical centers in the Denver, Colorado, metropolitan area. Recruitment began July 2017 and ended August 2021 with a pause from mid-April through mid-June 2020 due to the COVID-19 pandemic. Initial screening was performed base...
PMC10116385
CONSORT Flow Diagram
Participants allocated to interpersonal psychotherapy and designated as “did not receive intervention” did not attend any prenatal intervention sessions.
PMC10116385
Procedures
MDD
Participants completed a baseline evaluation, including interview and questionnaire assessments. Eligible individuals were then randomly assigned to IPT or EUC using a computer-generated random numbers sequence. Participants were randomized in blocks of 2 and stratified on current MDD (assessed via the Structured Clini...
PMC10116385
Intervention Conditions
depression, psychiatric
MomCare is a culturally relevant, collaborative care intervention that provides brief IPT.All IPT therapists and collaborative care team members completed a 3-day training and were certified by Nancy Grote, PhD, a leading brief IPT expert for antenatal depression. IPT therapists were doctoral-level clinicians who follo...
PMC10116385
Measures and Outcomes
depression
The 20-item Symptom Checklist (SCL-20) measures depression symptoms from the full Symptom Checklist-90-R.EPDS is used to screen maternal depression across the peripartum period. Research shows reliability and validity in pregnancy.Prior to randomization, trained independent evaluators administered the SCID-5 at baselin...
PMC10116385
Sociodemographic and Obstetric Characteristics
Research staff blinded to condition collected sociodemographic and obstetric characteristics. Birth date, socioeconomic status, cohabitation with partner, marital status, educational attainment, race (categories: American Indian/Alaska Native, Asian, Black or African American, European, Middle Eastern, Native Hawaiian ...
PMC10116385
Data Analytic Strategy
reduced depression, depression
All models were fit using SAS statistical software version 9.4 (SAS Institute). All analyses were conducted with the full intention-to-treat sample. We compared differences by condition on baseline demographic and clinical characteristics using To test hypotheses that participants assigned to IPT would experience reduc...
PMC10116385
Results
PMC10116385
Preliminary Analyses
Of 234 individuals, 119 were allocated to EUC and 115 assigned to IPT (106 of whom received intervention, and 9 participated in no intervention sessions). Participants reported their race and ethnicity as 10 (4.3%) Asian, 21 (9%) Black, 43 (18.4%) Latine, 1 (0.4%) Native Hawaiian or Pacific Islander, 101 (43.2%) non-Hi...
PMC10116385
Descriptive Information for the Study Sample
MDD, depressive disorder
Abbreviations: EUC, enhanced usual care; IPT, interpersonal psychotherapy; MDD, major depressive disorder (diagnosis per Structured Clinical Interview using Effect sizes for continuous measures are Cohen Retention rates through prenatal assessments were 88% (101 of 115) in IPT and 87% (104 of 119) in EUC (χ
PMC10116385
Intervention Effects
PMC10116385
SCL-20
depression
There was a differential rate of change in depression symptoms assessed via SCL-20 between IPT and EUC from randomization through the end of gestation (
PMC10116385
Model-Based Estimated Depression Symptoms Over Time for IPT and EUC
depressive disorder, Depression
Abbreviations: EPDS, Edinburgh Postnatal Depression Scale; EUC, enhanced usual care; IPT, interpersonal psychotherapy; SCL-20, 20-item Symptom Checklist.Mean estimates and standard error derived from the fitted hierarchical linear modeling adjusted for covariates and the variance-covariance structure. Test of significa...
PMC10116385
Effect of Intervention on Depression Symptom Trajectories Over Pregnancy
Depressive
The color shaded regions represent 95% CIs. Hierarchical linear modeling (HLM) results with full sample for intent-to-treat analyses included 115 individuals in the interpersonal psychotherapy (IPT) group and 119 in the enhanced usual care (EUC) group. A, Depressive symptoms were measured by the 20-item Symptom Checkli...
PMC10116385
EPDS
A differential rate of change over time between IPT and EUC groups was observed for EPDS (
PMC10116385
Effect of Intervention on Major Depressive Disorder (MDD)
With full sample for intent-to-treat analyses (interpersonal psychotherapy [IPT]: n = 115; enhanced usual care [EUC]: n = 119), between-groups analysis showed significant difference (χ
PMC10116385
Moderator Analyses
MDD, SCL-20
We evaluated baseline MDD and GA at randomization as potential a priori moderators of treatment effects on primary study outcomes. Neither baseline MDD (SCL-20:
PMC10116385
Discussion
MDD, depression, elevated depression
There is critical need to reduce depression during pregnancy given consequences for both mother and developing fetus. We initiated the Care Project to tackle this unaddressed challenge of decreasing depression for pregnant individuals with elevated depression (MDD and symptoms). Study findings demonstrated that a safe,...
PMC10116385
Strengths and Limitations
MDD, depression
Strengths of the present work enhance confidence in the findings. The USPSTFRegarding limitations, inclusion of only English-speaking participants limits generalizability. Our intentional focus on the prenatal period precludes evaluating persistence of depression improvement after pregnancy. Further, depression symptom...
PMC10116385
Conclusions
MDD, depression, neurodevelopmental delays
Prenatal maternal depression is one of the strongest contributors to intergenerational transmission of depression, other forms of psychopathology, and neurodevelopmental delays.From an implementation perspective, it is encouraging that IPT reduced depression relatively quickly after starting treatment and that recipien...
PMC10116385
References
psychiatric
SENSITIVITY
Trial protocolClick here for additional data file.eMethods 1. Additional details on CONSORT diagram for exclusionseMethods 2. Adherence and fidelity ratingseFigure. Depiction of general Care Project RCT timeline, with the time points and study elements occurring when they tended to happen on average for modal participa...
PMC10116385
Methods
This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6–8, 10–12 and 14–16 weeks of age...
PMC10426953
Results
HEPATITIS B, PERTUSSIS, HIB
The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune respo...
PMC10426953
Conclusions
The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants.
PMC10426953
Clinical trial registration
Clinical Trials Registry India number:
PMC10426953
Data Availability
Qualified researchers may request access to patient-level data and related study documents, including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized, and study documents will be redacted ...
PMC10426953
Methods
PMC10426953
Study design and participants
ICH, tetanus
TETANUS, HIB
This was a phase 3, randomized, observer-blind study conducted in 8 centers across India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator DTwP-HepB-Hib formulations at 6–8, 10–12 and 14–16 weeks of age. ...
PMC10426953
Immunogenicity assessment
FHA
SECONDARY, PERTUSSIS
All subjects provided a pre-vaccination (baseline) blood sample at day 0 and a post-vaccination sample 28 days after administration of the third dose (day 84). The serological primary endpoints were assessed 28 days after the third dose of the primary series for the non-inferiority analyses. HepB seroprotection status ...
PMC10426953
Safety assessment
vomiting, abnormal crying, convulsions, drowsiness, loss of appetite, fever, erythema, pain, irritability
ADVERSE EVENTS, FEBRILE CONVULSION, ERYTHEMA, ENCEPHALOPATHY, HAND SWELLING, HYPOTONIC
Subjects were observed for 30 min after vaccination to assess the occurrence of any immediate adverse events (AEs). Participants were provided with diary cards, digital thermometers, and flexible rulers to record daily body temperature as well as solicited injection site (pain, erythema, and swelling) and systemic reac...
PMC10426953
Statistical analysis
HEPATITIS B, PERTUSSIS, PERTUSSIS, SECONDARY, HEP B, HEPATITIS B
For HepB, non-inferiority testing was based on the use of the two-sided 95% confidence interval (CI) of the difference of proportions of subjects with an anti-HBs Ab concentration ≥ 10 mIU/mL at day 84. The 95% CI of the difference was calculated using Wilson score method without continuity correction. Hepatitis B non-...
PMC10426953
Results
A total of 460 subjects were enrolled between December 22, 2018, and April 08, 2019, and randomized into 2 groups, group 1 (Investigational DTwP-HepB-Hib vaccine formulation, primary series, n = 232) and group 2 (Comparator (licensed) DTwP-HepB-Hib vaccine formulation, primary series, n = 228). A total of 447 subjects ...
PMC10426953
Subject disposition.
PMC10426953
Baseline demography of randomized group (FAS).
SD, standard deviation
PMC10426953
Immunogenicity
PMC10426953
Hepatitis B seroprotection rate (primary objective)
The investigational DTwP-HepB-Hib vaccine formulation (group 1) was non-inferior to the comparator DTwP-HepB-Hib vaccine formulation (group 2) for anti HBsAg in terms of post-dose 3 seroprotection rates in the PPAS population. Seroprotection against HepB at post-dose 3 was observed in 99.1% (95% CI, 96.6–99.9) and 99.0...
PMC10426953
Pertussis immune responses (primary objective)
hepatitis B
HEPATITIS B, PERTUSSIS
The investigational DTwP-HepB-Hib vaccine formulation (group 1) was non-inferior to the comparator DTwP-HepB-Hib vaccine formulation (group 2) for anti-pertussis responses in terms of post-dose 3 aGMCs in the PPAS population. The aGMC for anti-PT at day 84 were 76.7 EU/mL (95% CI, 62.1–94.7) and 63.3 EU/mL (95% CI, 50....
PMC10426953
Secondary objectives
HIB
The immune responses to the antigens of the five valences (D, T, P, HepB and Hib) in the investigational and comparator vaccine groups were also similar (Tables
PMC10426953
Summary of seroprotection and seronconversion rates—Pre-dose 1 and post-dose 3 (PPAS).
PERTUSSIS
n refers to the number of subjects experiencing the endpoint listed in the first three columns; M refers to the number of subjects with available data for the relevant endpoint; *Vaccine response is defined as: If the pre-primary vaccination concentration is < 4 x LLOQ, then the post-primary vaccination concentration i...
PMC10426953
Summary of geometric means—Pre-dose 1 and post-dose 3 (PPAS).
M refers to the number of subjects with available data for the relevant endpoint.
PMC10426953
Safety
There were no AEs leading to study discontinuation, no SAEs and no AESI reported in the study. No immediate AEs were reported after any vaccination in both investigational and comparator vaccine groups. Solicited reactions (injection site reactions and systemic reactions) within 7 days after any vaccination were report...
PMC10426953
Subjects reporting solicited injection site reactions after all and each vaccination.
PMC10426953
Subjects reporting solicited systemic reactions after all and each vaccine injection.
Unsolicited AEs within 28 days after any vaccine injection were reported in 4.7% (11/233) and 4.0% (9/227) of subjects of investigational and comparator vaccine groups respectively (
PMC10426953
Unsolicited AEs within 28 days after any vaccine injections, by system organ class and preferred term (safety analysis set).
n refers number of subjects experiencing the endpoint listed in the first column.
PMC10426953
Discussion
diphtheria, tetanus
DIPHTHERIA, PERTUSSIS, PERTUSSIS, HEP B, HIB, TETANUS
This phase 3 study conducted in India evaluated the safety and immunogenicity in 460 infants followed up for 28 days after administration of three doses of either investigational or existing vaccine formulations of the SHIPL DTwP-HepB-Hib pentavalent vaccine at 6–8 weeks, 10–12 weeks and 14–16 weeks of age when adminis...
PMC10426953
Conclusions
PERTUSSIS, HIB
The study demonstrated that the investigational DTwP-HepB-Hib vaccine formulation was non-inferior to the licensed comparator DTwP-HepB-Hib vaccine formulation both in terms of HepB seroprotection rate and in terms of pertussis immune responses. The immune responses to all the antigens (D, T, P, HepB and Hib) in both t...
PMC10426953
Supporting information
PMC10426953
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
SBKS
(DOC)Click here for additional data file.(PDF)Click here for additional data file.The authors would like to thank the parents of all study subjects for consenting to participate in this research study; all the investigators and their site staff of the Departments of Paediatrics, Mysore Medical College, Mysore, KLES Dr ...
PMC10426953
Abbreviations
HEPATITIS B, PERTUSSIS
antibody; AE, adverse eventAEs of special interestadjusted geometric mean concentrationsconfidence intervaldiphtheriaDrugs Controller General of IndiaDTP immunoassay by multiplexed Electro Chemiluminescent methodfull analyses set; FHA, filamentous hemagglutininfimbriaegeometric mean concentrationsgeometric mean concent...
PMC10426953
References
PMC10426953
Background
hand dexterity, early-phase motor learning
CORTEX
The left dorsolateral prefrontal cortex (DLPFC) is involved in early-phase manual dexterity skill acquisition when cognitive control processes, such as integration and complexity demands, are required. However, the effectiveness of left DLPFC transcranial direct current stimulation (tDCS) on early-phase motor learning ...
PMC9951449
Methods
In this randomized, double-blind, sham-controlled trial, 70 healthy, right-handed, young adult participants were recruited. They were randomly allocated to the active tDCS (2 mA for 20 min) or sham groups and repeatedly performed the Purdue Pegboard Test (PPT) left-handed peg task and left-handed assembly task three ti...
PMC9951449
Results
The final sample comprised 66 healthy young adults (mean age, 22.73 ± 1.57 years). There were significant interactions between group and time in both PPT tasks, indicating significantly higher performance of those in the active tDCS group than those in the sham group post tDCS (p < 0.001). Moreover, a greater benefit w...
PMC9951449
Supplementary Information
The online version contains supplementary material available at 10.1186/s12967-023-03989-9.
PMC9951449
Keywords
PMC9951449
Background
upper-limb motor learning, human behavior
Motor skill learning is crucial for optimizing human behavior and essential in a variety of daily life situations. The motor learning theory of Fitts and Posner [Moreover, the DLPFC is highly activated during the performance of unfamiliar or complex fine motor skill tasks with bimanual and unimanual non-dominant hands ...
PMC9951449
Methods
PMC9951449