Parallel Group Research Articles

Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson’s disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial

ObjectivesTo assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease.DesignPragmatic, UK based, multicentre, three arm,...

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study

Retrograde intrarenal surgery (RIRS) is the main treatments for upper urinary tract stones. The Ureteral Access Sheath (UAS) serves as a supplementary tool, facilitating direct kidney access during RIRS. High quality of evidence comparing tip bendable suction ureteral access sheath (S-UAS) with traditional UAS in RIRS for the treatment of renal and ureteral stones is lacking. The purpose of the study is to compare the efficacy and safety of S-UAS with traditional UAS in RIRS for the treatment of renal or ureteral stones ≤30mm. An international, multicenter, and superiority randomized controlled trial included 320 intention-to-treat patients across 8 medical centers in China, the Philippines, Malaysia and Turkey from August 2023 to February 2024. The inclusion criteria were patients ≥18 years old with renal or ureteral stones ≤30mm. RIRS was performed using either S-UAS or traditional UAS. The primary outcome was the immediately stone-free rate (SFR). Secondary outcomes included SFR 3 months after operation, operating time, hospital stay, auxiliary procedures, complications (using the Clavien-Dindo grading system), and improvement in the Quality of Life (QoL) score. Differences between proportions [risk difference (RD)]/means [mean difference (MD)] and 95% confidence intervals (CI) were presented. This study is registered at ClinicalTrials.gov: NCT05952635. The S-UAS group demonstrated a significantly higher immediately SFR (81.3% versus 49.4%; RD 31.9%; 95% CI 22.5%-41.7%; p=0.004) compared to the traditional UAS group, as determined by the one-side superiority test. Additionally, the S-UAS group exhibited a higher SFR at 3 months post-operation (87.5% versus 70.0%; RD 17.5%; 95% CI 8.7%-26.3%; p<0.001), lower postoperative fever rate (RD-11.9%; 95% CI-18.7% to-4.9%; p<0.001), reduced use of stone baskets (RD-70.6%; 95% CI-77.8% to-63.5%; p<0.001), and better QoL improvement (MD 7.25; 95% CI 2.21-12.29; p=0.005). No statistically significant differences were observed in operation time, hospital stay, or the need for second-stage RIRS. In RIRS for upper urinary tract stones ≤30mm, S-UAS exhibited superior performance compared to traditional UAS, demonstrating higher SFR, reduced postoperative fever rate, and improved QoL outcomes. S-UAS emerges as a prudent and advantageous alternative to traditional UAS for RIRS. National Natural Science Foundation of China and Guangdong Province, and Zhejiang Medicine and Health Program.

Prevention of premature birth in female patients with bacterial vaginosis using a complex of natural antimicrobial peptides and cytokines

Introduction. The prevalence of bacterial vaginosis (BV) comprises 23–29 %, which in pregnant women is a known risk factor for premature birth (PB) that rates increases by 2.9-fold. BV treatment with antibiotics has no effect PB incidence, therefore stressing a need to search for alternative remedies.Aim: to evaluate the effectiveness of treatment, including antibacterial therapy and a complex preparation containing natural antimicrobial peptides and cytokines, to reduce the incidence of birth defects in pregnant women with BV.Materials and Methods. Design: a prospective open comparative cohort study in parallel groups was conducted with 101 pregnant women: Group I (n = 69) received the antibiotic Metronidazole, 500 mg tablets orally twice a day for 7 days, and a complex preparation containing exogenous natural antimicrobial peptides and cytokines (Superlymph®) suppositories per 25 IU once a day vaginally in the evening for 20 days; Group II (n = 32) received Metronidazole alone (the same regimen). Patient examination was carried out using approaches included clinical methods, accepted in obstetrics, and laboratory tests – microscopy of vaginal content smears, real-time polymerase chain reaction (PCR).Results. The PB (within 240–366 weeks) incidence in Group I was significantly lower than in Group II and comprised 2.9 % vs. 21.9 %, respectively (p = 0.004), with an 8-fold decline in developing PB risk (relative risk (RR) = 0.13; 95 % confidence interval (CI) = 0.03–0.60), whereas inter-group percentage of pregnant women with high risk (PB history) was comparable (p = 0.39) so that PB incidence did not differ from pregnant women without former PB. Microbiological recovery after treatment for BV was achieved in 85.5 % of patients from Group I vs. 56.3 % in Group II (RR = 1.52; 95 % CI = 1.10–2.10; p = 0.002) based on real-time PCR data. The persistence of anaerobic flora after treatment was significantly lower in Group I vs. Group II reaching 7.2 and 34.4 % (p &lt; 0.001), respectively, with a 5-fold lower PB risk (RR = 0.21; 95 % CI = 0.08–0.56). Cessation of viral shedding compared to the number of patients with initial viral shedding was achieved in 94.6 % vs. 8.3 % of patients, respectively, with a 50-fold decline in risk (RR = 0.02; 95 % CI = 0.005–0.08; p &lt; 0.001). The number of newborns weighing less than 2500 g was significantly lower from paired mothers who received Superlymph® + Metronidazole comprising 2.9 % vs. 15.6 % treated with Metronidazole alone (p = 0.03), whereas a risk of low birth weight neonates was decreased by 6-fold (RR = 0.16; 95 % CI = 0.03–0.88). The condition of the neonates assessed by birth Apgar score was comparable.Conclusion. The use of a complex preparation Superlymph® (suppositories per 25 IU once an day vaginally, for 20 days) along with oral antibiotic Мetronidazole in pregnant women with BV facilitates a decline in PB incidence down to 2.9 % at gestational age of 240–366 weeks lowering a risk of PB exceeding that of antibacterial therapy by 8-fold, including patients with former PB.

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial

BackgroundCleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment.MethodThe NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site.DiscussionWe expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe.Trial registrationClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up.How to search: (https://ctri.nic.in/Clinicaltrials/advsearch.php—use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial

Study design This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design. Objective To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin. Setting The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital. Methods Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests. Results Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline. Conclusion Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry. Trial registration: Clinical Trials Registry India identifier: CTRI/2018/05/013735.

O-202 Novel use of hyaluronan enriched media for improving implantation in intrauterine insemination: a prospective randomised controlled trial (HEMI Trial)

Abstract Study question Does the intrauterine instillation of hyaluronan-enriched media influence the implantation rate and reproductive outcomes in patients undergoing controlled ovarian stimulation and intrauterine insemination? Summary answer The intrauterine instillation of Hyaluronan-enriched media significantly improved the implantation rates and ongoing pregnancy rate in women undergoing controlled ovarian stimulation and intrauterine insemination treatment What is known already Hyaluronan is a macromolecule belonging to the glycosaminoglycans family, secreted by cumulus granulosa cells, and is naturally present in the female reproductive tract. Various mechanisms have been proposed to explain the implantation-enhancing properties of Hyaluronan including increased cell-cell and cell-matrix adhesion, by producing a viscous environment for the integration of embryo in intrauterine fluid and its autocrine and paracrine functions via CD44 receptors. This is probably the first trial studying the effect of hyaluronan-enriched media in intrauterine insemination treatment. The proposed novel intervention is based on the biological plausibility and proven safety of hyaluronan in IVF studies. Study design, size, duration This parallel group Randomised Controlled trial was conducted over 2 years of duration, from 2021 to 2023. A total of 100 couples diagnosed with unexplained infertility planned for controlled ovarian stimulation and intrauterine insemination (COS-IUI) treatment were randomized into the intervention and control arm of the trial. Before the commencement of the study, the trial was registered with the Clinical Trial Registry-India (CTRI), and institutional ethical approval was obtained. Participants/materials, setting, methods 100 couples diagnosed with unexplained infertility attending tertiary-level university hospital were allocated to the intervention and control group using block randomization in 1:1 allocation. In the intervention group, the participants underwent intrauterine instillation of 0.4 ml of hyaluronan enriched media, 4 days following intrauterine insemination treatment. The statistical package SPSS (version 21) was used for analysis and results were considered to be statistically significant if the P-value was &amp;lt;0.05. Main results and the role of chance The mean female age of the study population was 28.12±3.74 years with an average duration of infertility of 3.95 ±2.17 years. The study participants underwent an average of 1.7 IUI cycles in the control group and 1.6 cycles in the intervention group. A cumulative biochemical pregnancy rate of 36.5% and 16.6% was observed amid the the intervention group and control group respectively and the difference was statistically significant with a p-value of 0.039. Similarly, the cumulative ongoing pregnancy rate beyond 20 weeks of gestation was statistically significantly higher among the intervention arm of the trial as compared to the control group (31.7% vs 11.9%, p = 0.035). There was a trend of improved clinical pregnancy rate among the intervention participants, however, this difference did not reach statistical significance (34.1% vs 16.6%, p = 0.067). The miscarriage rate was comparable among both groups. The number needed to treat was estimated to be 5, which in effect meant that 5 women would have to receive intrauterine instillation of hyaluronan enriched media for 1 additional ongoing pregnancy. Limitations, reasons for caution The longer follow-up period would have allowed the reporting of live-birth rate which is undeniably the most meaningful parameter to appraise an intervention. Larger multicentric studies are required to establish the clinical benefit and generalisability of the proposed intervention. Wider implications of the findings The study proposes a potential novel, simple, minimally invasive, and patient-acceptable intervention to increase the success rates of intrauterine insemination. Being the first study on the topic, the study can provide a basis for future large multicentric studies on the topic. Trial registration number Clinical Trial Registry-India (CTRI) number- CTRI/2021/10/037064.

Evaluation of the Use of Negative Pressure Wound Therapy for Securing Split-Thickness Skin Grafts for Coverage of Chronic Wounds

Abstract Background Split-thickness skin grafting (STSG) is a versatile reconstructive option that has passed the test of time. However, many factors can cause poor graft take. Negative pressure wound therapy (NPWT) has transformed the management of complicated wounds and has been used as a means for securing split-thickness skin grafts (STSG). The role of NPWT in the fixation of grafts was compared to conventional Tie over bolster dressing. Aim of the Work To assess whether NPWT would result in a better graft take especially in wounds with large surface area. Patients and Methods This is a parallel group randomized control study. conducted from November 2021 to June 2022 in the Plastic, burns, and maxillofacial Surgery Department, Ain Shams University Hospitals. Block randomization of 52 patients into one of the two groups (NPWT vs. non-NPWT; 26 patients each) was done. Graft take/loss and length of hospital stay post-grafting were assessed. Results Mean graft take in the NPWT group was quantitatively and qualitatively better than that in the non-NPWT group. None of the patients in the NPWT group required a second coverage procedure. No major complication was encountered with the use of NPWT. Conclusion Compared with conventional tie over bolster dressing, NPWT is a simple, yet powerful and effective alternative in the integration of STSG. It significantly increases the rate of graft take especially in large wounds, while reducing rates of complications and hence re-operation.

The effect of telecounseling on depression in primiparous mothers during the postpartum period: A randomized controlled trial.

Postpartum depression is one of the most common mental health disorders in women after giving birth. This study was conducted to examine the effect of telecounseling support on depression in primiparous mothers. This study was conducted as a randomized controlled trial with a parallel group pretest-posttest design. The study comprised 50 participants each in the intervention and control groups. Face-to-face interviews were conducted with all participants, and the Maternal Information Form and the Edinburgh Postpartum Depression Scale (EPDS) were administered. The intervention group received telecounseling for 6 weeks, while the control group received routine postnatal care. After the 6-week period, EPDS was re-administered to both groups. In the intervention group, the EPDS mean score decreased from 7.12 ± 3.96 to 6.34 ± 3.73 after telecounseling (p < 0.001). Conversely, in the control group, the EPDS mean score increased from 6.62 ± 3.55 to 7.90 ± 4.65 without any intervention (p = 0.002). The results indicate that telecounseling is an effective method for reducing the risk of depression among mothers during the postpartum period. It is recommended that healthcare professionals extend their support by providing telecounseling for mothers.

A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants.

This phase I thorough QTc, double-blind, randomized, placebo- and positive-controlled, parallel group, multiple-dose study evaluated avacopan's effect on cardiac repolarization using concentration-QTc (C-QTc) as the primary analysis. Avacopan 30 mg b.i.d. (therapeutic dose) was administered orally on days 1 through 7 followed by avacopan 100 mg b.i.d. (supratherapeutic dose) on days 8 through 14 in 29 healthy participants. Moxifloxacin 400 mg and placebo were administered on days 1 and 15 in a nested crossover design for assay sensitivity in separate cohorts to 28 participants. Time-matched plasma concentrations and up to 10 replicate ECGs were obtained on prespecified days at baseline and postdose on days 1, 7, 14, and 15. The mean change from baseline on QTcF for avacopan (-5.5 to 3.5 ms) was similar to placebo (-6.9 to 1.4 ms) across days 1, 7, and 14. The mean effect on ΔΔQTcF (90% CI) was estimated as 1.5 ms (-0.17 to 3.09) and 0.8 ms (-2.41 to 4.05) for 30 and 100 mg avacopan b.i.d. treatments, respectively. Based on the C-QTc analysis, avacopan's effect on ΔΔQTcF >10 ms can be excluded within the observed plasma concentration range of up to ~1220 and ~335 ng/mL for avacopan and active major metabolite, M1, respectively. The estimated population slopes showed a shallow relationship, which was not statistically significant. There was no clinically meaningful effect of avacopan on heart rate or cardiac conduction (PR and QRS intervals). Avacopan appeared to be generally well tolerated in this study population.

Investigating the effectiveness of commercially available mouthwash on SARS-CoV-2 in vivo using viable virus titre as the primary outcome. A randomised controlled trial.

This multi-arm, parallel group, single-blinded randomised controlled trial aimed to assess three commercially available mouthwashes effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This manuscript has been written in accordance with the CONSORT statement. Methods. Eligible participants were SARS-CoV-2 positive with a positive test in the last 72 h. All participants had mild to moderate symptoms and could provide five saliva samples over a 60 min period. Participants delivered a baseline saliva sample and then used a mouthwash as per manufacturer's instructions. They provided further saliva samples at minute 1, 10, 30 and 60. Participants were randomised to one of four groups; OraWize+, Total Care Listerine, Cool Mint Listerine and water (control). The lab-based research team were blind to the intervention. The research question was: can SARS-CoV-2 be rendered inactive in saliva by using a mouthwash and how long does this effect last? The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing. Results. In total 100 participants were recruited (25 per group). Eight participants did not receive the allocated intervention and did not have saliva samples collected. There were no adverse events. In total 42 of the 92 participants had viable virus which could be cultured at baseline. Statistical analysis of the primary outcome was not advised due to the reduced level of viable virus at baseline and the positive skewness present in the distribution of log10(titre) data. Observational data of the primary outcome measure is presented. Analysis of the secondary outcome PCR measure showed that there was strong evidence for a decrease in SARS-CoV-2 RNA levels compared to water for all mouthwashes after 1 min, OraWize+ -0.49 (-0.92, -0.05), p-value 0.029, Cool Mint Listerine -0.81 (-1.25, -0.38), p-value<0.001, Total Care Listerine -1.05 (-1.48, -0.62), p-value<0.001. For the remaining timepoints there was generally no evidence of virus level reduction compared to water although there is weak evidence for a decrease at ten minutes using Total Care Listerine -0.44 (-0.88, 0.01), p-value 0.053. Conclusion. The three mouthwashes included in this trial observationally demonstrated a reduction in virus titre level 1 min after use, with virus levels normalising up to 60 min compared to the control. Although an interesting observation, this result could not be statistically analysed. Using the secondary outcome PCR measure all three included mouthwashes reduced virus levels compared to water at 1 min and these results were statistically significant. Clinically this result does not support the use of the included mouthwashes to reduce SARS-CoV-2 levels in saliva.

Short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain: a randomized controlled clinical trial.

In today's industrialized world, between sixty and ninety percent of the working-age population experiences low back discomfort. Chronic mechanical low back pain (CMLBP), the most common ailment among working-age people in contemporary industrial society, causes a major economic burden due to the widespread use of medical services and the absence of work. For those suffering from persistent mechanical low back pain, this experiment aimed to assess the efficacy of using acupuncture dry needles in the short term. Our research included 30 individuals with nonspecific low back pain; their ages varied from 20 to 45. The participants were divided into two parallel groups using a random process: 15 individuals in group A had acupuncture treatment with a dry needle placed to specified locations on their backs, whereas 15 individuals in group B participated in muscle strengthening and stretching exercises. Both before and after therapy, researchers examined the lumbar range of motion (ROM) in four directions: flexion, extension, bilateral side bending, as well as pain intensity and functional impairment. We examined the data for normality and covariance homogeneity using the Shapiro-Wilk and Box's tests, respectively. The variables of interest that were investigated were compared across various test groups and measurement periods using a 2x2 mixed design-multivariate analysis of variance (MANOVA). We used a significance threshold of 0.05. When comparing the two groups after treatment, it was found that the flexion and extension range of motion increased significantly (p<0.05), while the pain intensity, bending to the right and left, and functional impairment decreased significantly (p<0.05). The results of multiple pairwise comparisons showed a noteworthy difference in pain severity, functional debility, and back ROM between the two groups before and after treatment (p<0.05), with group A showing an advantage over group B after treatment. Based on the study results, dry needle acupuncture may be a beneficial modality in treating chronic mechanical low back pain by relieving pain intensity, improving functional debility, and improving ROM.

Effect of hydrogen peroxide and hyaluronic acid in mouth rinse after third molar extraction: a triple-blind parallel randomized controlled clinical trial.

The study aimed to investigate the potential beneficial role of hydrogen peroxide (H2O2) and hyaluronic acid (HA) combination formulation in socket healing after third molar surgery. Biomaterials, including mouthwash formulations, were hypothesized to contribute to improved socket healing and reduced post-operative complications. A triple-blinded parallel randomized controlled clinical trial was conducted at a single-center dental hospital in Milan, Italy. The trial included 114 patients who underwent extraction of impacted, partially erupted, and completely erupted third molars. Patients were randomly assigned to three parallel groups: Group 1 (H2O2 and HA), Group 2 (placebo), and Group 3 (0.2% chlorhexidine). The trial was registered at ClinicalTrial.gov (registration number NCT04438434). The main outcome measures included various parameters related to socket healing, such as pain, inflammation, swelling, plaque index, bleeding index, granulation tissue, suppuration, re-epithelialization, bleeding upon palpation, odor, and taste alteration. Patients were followed up for 7 days. All 114 enrolled patients completed the study, with no dropouts or loss to follow-up. The mean age of patients in the three groups differed (H2O2 and HA: 30.9±14.9; placebo: 27.6±13.1; 0.2% chlorhexidine: 23.05±10.16). Significant reductions (p<0.001) in visual analog scale (VAS) pain levels and other outcome measures were observed in the H2O2 and HA group compared to the placebo group. These findings suggest a positive effect of the H2O2 and HA combination on socket healing after the third molar surgery. The study concludes that the combination of hydrogen peroxide and hyaluronic acid can be considered a potential mouthwash with beneficial effects on socket healing following third molar surgery. However, additional clinical trials are recommended to validate its effectiveness further and provide additional evidence supporting its use in clinical settings. gov: NCT04438434.

Launching! to Adulthood: A Group Counseling Initiative for Young Adults With Neurodevelopmental Differences Transitioning to Adulthood and Their Family members.

Group therapy may help young adults with neurodevelopmental differences (NDDs; such as autism spectrum disorder [ASD] or attention deficit hyperactivity disorder [ADHD]) socialize and manage mental health difficulties such as anxiety and depression during the transition to adulthood (18-25 years old). Family members may also benefit from group therapy during this transition period. Despite this need, few group therapy programs in a virtual/telehealth format have been developed to help young adults with NDDs and their families during the transition to adulthood. The present study sought to provide initial feasibility and acceptability data for a parallel young adult and family member group treatment program for young adults with NDDs transitioning to adulthood. Launching! to adulthood is an 8-week program utilizing evidence-based interventions to reduce distress and support the transition to independence for young adults with NDDs and their family members. Measures of well-being were collected pre- and post-intervention. Brief qualitative interviews were conducted post-intervention. From our pilot study, we found that the Launching! program was acceptable and feasible for both family members and young adults, with high ratings of satisfaction. Three themes were shared by young adults and family members, including gaining group connection and support from others in a similar life circumstance, learning the importance of self-care, and gaining new skills. Barriers to attendance included work conflicts and internet difficulties. This pilot trial of the Launching! program is novel in that few existing therapies have addressed challenges of the transition to adulthood for individuals with NDDs. Launching! has the potential to help young adults with NDDs prepare for postsecondary goals and may be utilized by businesses to support employees with NDDs.

The Impact of the New Families Home Visiting Program on Depressive Symptoms Among Norwegian Fathers Postpartum: A Nonrandomized Controlled Study.

Becoming a parent is a vulnerable life transition and may affect parents' mental health. Depressive symptoms may occur in fathers, as well as mothers, during pregnancy and the postpartum period. The health service is expected to have a family perspective, aiming to support both parents. Despite this goal, mothers traditionally receive more support than fathers. Home visiting programs may provide enhanced guidance for new fathers and increased mental health support. The aim of this study was therefore to assess possible differences in level of depressive symptom in fathers receiving the New Families home visiting program compared with those receiving standard care from the Norwegian Child Health Service. A prospective nonrandomized controlled study with a parallel group design was performed. The Edinburg Postnatal Depression Scale (EPDS) was used to measure depressive symptoms in fathers (N = 197) at 28 weeks of their partners' pregnancy (T1), at 6 weeks (T2), and 3 months postpartum (T3), in the intervention and the control group. The results indicate a prevalence of depressive symptoms (EPDS score ≥ 10) in Norwegian fathers of 3.1% at T1, 3.9% at T2, and 2.2% at T3 for the full sample. No significant EPDS score differences were found between the intervention and the control group at six weeks and three months postpartum. This suggests that the intervention had no clear impact on depressive symptoms during this time-period.

Right ventricular remodeling induced by prolonged excessive endurance exercise is mediated by upregulating Wnt/β-catenin signaling in rats

BackgroundThe aim of this study was to develop an animal model to investigate whether prolonged intensive endurance exercise induces RV remodeling, taking into account the involvement of Wnt/β-catenin signaling. MethodsFour-week-old male Wistar rats (100 to 125 g) were assigned to four groups (n = 8/group): 1) sixteen weeks of intensive (36 m/min) exercise (INT), 2) twelve weeks of the intensive exercise followed by four weeks of moderate intensity (18 m/min) exercise (INT + MOD), 3) twelve weeks of the intensive exercise followed by four weeks of detraining (INT + DT), and 4) sedentary rats (SED). The exercise protocols were performed five days a week for one h/day. Echocardiography, real-time PCR, western blotting, and histological staining were performed at the end of week sixteen. ResultsINT rats developed concentric hypertrophy without diastolic dysfunction compared to SED (p = 0.006) and INT + DT (p = 0.035). Wnt1, β-catenin and CyclinD1 proteins in the training groups were significantly higher than SED rats (p < 0.001). Interestingly, INT rats had higher protein levels than INT + DT and INT + MOD (p < 0.001), with higher gene expression compared to SED rats (p < 0.05). There was also a significant increase in collagen deposition in INT rats compared to SED (p = 0.046) and INT + DT (p = 0.034). Furthermore, INT + MOD and INT + DT rats did not show any adverse structural, functional, or histological changes. ConclusionsLong-term intensive endurance training seems to be associated with increased collagen deposition and wall thickness in the RV through Wnt/β-catenin signaling (which is concentration dependent), without changes in diastolic function. Clinical perspectiveOver the past decades, there has been an ongoing debate about whether the structural and functional adaptations of the cardiovascular system in trained endurance athletes are benign physiological responses to training or potentially pathological changes related to disease. While the adaptations of the left heart are well-documented, the remodeling of the right heart remains a subject of discussion. To gain insights into the ability of sustained high-intensity exercise to cause adverse right ventricular (RV) remodeling, we conducted an experimental study in which male rats were trained to run vigorously for 1 h daily over a 16-week period and compared them to a parallel group of sedentary control rats. Our findings revealed that intense long-term exercise induced morphological changes along with fibrosis affecting the RV. These fibrotic changes were a result of the 16-week vigorous exercise training regimen. If these results are confirmed in humans, they suggest that prolonged high-intensity endurance exercise training may lead to adverse cardiac remodeling. Our findings have important potential implications for the assessment of cardiac remodeling in individuals engaged in high-level exercise training.

Study on the efficiency of virtual reality in the treatment of alcohol use disorder: study protocol for a randomized controlled trial

ContextAccording to the World Health Organization, alcohol is a major global public health problem, leading to a significant increase in illness and death. To treat alcohol use disorders, new therapeutic tools are being promoted, among which virtual reality (VR) shows promise. Previous research has demonstrated the efficacy of VR in reducing alcohol cravings in patients, but there is a lack of data on its effectiveness in maintaining abstinence or reducing consumption in recently abstinent individuals.The E-Reva study aims to compare the efficacy of a treatment strategy combining virtual reality cue exposure therapy (VR-CET) and cognitive behavioral therapy (CBT) with conventional CBT in reducing alcohol consumption and craving in patients with alcohol use disorder (AUD). In addition to this primary objective, the study will compare the effects of VR-CET combined with CBT on anxiety, depression, rumination, and feelings of self-efficacy versus conventional CBT.MethodsThis prospective randomized controlled trial will be conducted over 8 months in four addiction departments in France. It includes two parallel groups: i) the VR-CET + CBT group, and ii) the CBT-only group, which serves as a control group.Participants will be recruited by the investigating doctor in the addiction centers. The sample will consist of 156 patients diagnosed with AUD and abstinent for at least 15 days.Both treatment groups will participate in four group CBT sessions followed by four individual sessions: i) the VR-CET group will be exposed to virtual environments associated with alcohol-related stimuli, ii) the CBT-only group will receive traditional CBT sessions. After completion of the 8 sessions, patients will be followed up for 6 months. The primary outcome is the cumulative number of standard drinks consumed at 8 months, assessed using the TLFB method.DiscussionDespite the promise of VR-CET to reduce the desire to drink, the effect on alcohol consumption remains uncertain in the existing literature. Our protocol aims to address the limitations of previous research by increasing sample size, targeting consumption reduction, and incorporating neutral environments. E-Reva aims to enrich the literature on the use of VR in the treatment of AUD and open new perspectives for future interventions.Trial registrationClinicalTrials.gov ID NCT06104176, Registered 2023/11/13 (https://clinicaltrials.gov/study/NCT06104176?id=NCT06104176&rank=1).N° IDRCB: 2022-A02797-36.Protocol version 1.0, 12/05/2023.

Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE).

Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE). A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61). The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated. Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP. EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment.

Northwestern University's Center for Scalable Telehealth Cancer Care (STELLAR) is 1 of 4 Cancer Moonshot Telehealth Research Centers of Excellence programs funded by the National Cancer Institute to establish an evidence base for telehealth in cancer care. STELLAR is grounded in the Institute of Medicine's vision that quality cancer care includes not only disease treatment but also promotion of long-term health and quality of life (QOL). Cigarette smoking, insufficient physical activity, and overweight and obesity often co-occur and are associated with poorer treatment response, heightened recurrence risk, decreased longevity, diminished QOL, and increased treatment cost for many cancers. These risk behaviors are prevalent in cancer survivors, but their treatment is not routinely integrated into oncology care. STELLAR aims to foster patients' long-term health and QOL by designing, implementing, and sustaining a novel telehealth treatment program for multiple risk behaviors to be integrated into standard cancer care. Telehealth delivery is evidence-based for health behavior change treatment and is well suited to overcome access and workflow barriers that can otherwise impede treatment receipt. This paper describes STELLAR's 2-arm randomized parallel group pragmatic clinical trial comparing telehealth-delivered, coach-facilitated multiple risk behavior treatment vs self-guided usual care for the outcomes of reach, effectiveness, and cost among 3000 cancer survivors who have completed curative intent treatment. This paper also discusses several challenges encountered by the STELLAR investigative team and the adaptations developed to move the research forward.

The use of laser photobiomodulation as pre-anesthetic tissue management technique in reducing injection pain in children

BackgroundOne of the main goals for pediatric dentists is to offer a painless anesthesia experience. Laser photobiomodulation is among the suggested strategies to decrease injection pain. So, this study aimed to assess the impact of laser photobiomodulation on local anesthesia (LA) injection pain in children and its effect on the efficacy of LA during pulpotomy and SSC procedures.MethodsThe research was carried out as a randomized controlled clinical trial with two parallel group design. It involved 64 cooperative healthy children, age range from 5 to 7 years, each having at least one maxillary molar indicated for pulpotomy. Children were randomly allocated to one of the two groups based on the pre-anesthetic tissue management technique used: test group received laser photobiomodulation, while control group received topical anesthetic gel. Pain during injection, pulpotomy, and SSC procedures was assessed using physiological measures (Heart Rate (HR)), subjective evaluation (modified Face-Pain‐Scale (FPS), and objective analysis (Sound‐Eye‐Motor scale (SEM)).ResultsA total of 64 children with mean age 6.23 ± 0.78 participated in this research. The mean HR scores were significantly lower in the laser PBM group during buccal and palatal infiltration injections. The SEM mean scores were significantly lower in the laser PBM group during both injections. For the FPS scale, the number of children who recorded satisfaction during injection was significantly higher in laser PBM group. There was no statistically significant difference in mean HR as well as in SEM and FPS scores between the two groups during pulpotomy and SSC procedures. Comparisons between the two study groups were performed using independent samples t- and Mann-Whitney U tests. Significance was set at p value < 0.05.ConclusionLaser photobiomodulation is a promising non-pharmacological pre-anesthetic tissue management technique in children that offered less painful injection compared to topical anesthetic gel without compromising the effectiveness of LA.Trial RegistrationClinicalTrials.gov Identifier: NCT05861154. Registered on 16/5/2023.Graphical

A new look at the myopia control efficacy of orthokeratology

PurposeTo evaluate the efficacy of orthokeratology contact lens wear in slowing the axial elongation of the eye in myopic children. MethodsData from three prospective studies, which evaluated the use of orthokeratology for slowing myopia progression in children in comparison to a parallel control group of distance, single-vision spectacle lens wearers over a 2-year period, were pooled together for analysis. ResultsCollectively, data from 125 orthokeratology and 118 control subjects were analyzed in this study. Of these, 101 (81 %) and 88 (75 %) orthokeratology and control subjects completed the 2-year follow-up period, respectively. Statistically significant differences in the change in axial length from baseline were found over time, between groups and for the time*group interaction (all p < 0.001), indicating that the rate of increase in axial length over time was significantly lower in the orthokeratology versus the control group. The lower axial elongation of the orthokeratology versus the control group was statistically significant at all time points (all p < 0.001), with significant differences being also present between each of the different pairs of time points (all p < 0.001). The interactions of group with age, gender, mean spherical refractive error and ethnicity at baseline were not significant (p > 0.05). The change in axial length at the 2-year visit in comparison to baseline for the orthokeratology and control groups were 0.41 ± 0.25 and 0.65 ± 0.30 mm, respectively, thus providing a treatment effect following 2-years of lens wear of 0.24 mm (95 % confidence intervals: 0.15 to 0.34 mm). About 40 % and 25 % of the orthokeratology subjects experienced remarkably low and high levels of myopia progression, respectively (2-years axial elongation: ≤0.30 mm and >0.59 mm, respectively). ConclusionsOrthokeratology lens wear slows the axial elongation of the eye in comparison to spectacle lens wear in myopic children. The use of these lenses for slowing myopia progression appears to be very effective and not effective at all in 40% and 25% of orthokeratology lens wearers, respectively.