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The management of pressure ulcers (PUs) poses challenges due to their chronic nature and the lack of established conservative treatment methods. In this clinical trial, our objective was to examine the validity and safety of using a light-emitting diode device contained four wavelengths in the treatment of grade 2 sacral PUs. A total of 38 patients were randomly assigned to two groups: sham device (Sham) and experimental device (LED) group. The treatment sessions were conducted over a period of four weeks, with a frequency of three times per week. The study was conducted in a double-blinded manner. The study assessed the primary validity by measuring wound size and re-epithelialization after 0 and 4 weeks. Secondary evaluations included epidermal regeneration, collagen density, and immunological markers. Safety was evaluated by monitoring adverse reactions throughout the trial. The presence of eschar was found to have a significant impact on wound healing. Sham consisted of 15 wounds without eschar, while LED had nine. After treatment in without eschar situation, the post-treatment size of wounds in Sham was 13.80 ± 20.29%, while it was 3.52 ± 6.68% in LED. However, there was no significant difference (p = 0.070). And analysis of epidermal thickness showed a significant increase in LED (495.62 ± 327.09 μm) compared to Sham (195.36 ± 263.04 μm) (p < 0.0001). While LED treatment had a potential for wound reduction in PUs without eschar, we could not uncover evidence to support the efficacy of LED treatment in grade 2 PUs.

Background Around 2–6% of term or late preterm neonates receive phototherapy for hyperbilirubinemia. Standard treatment today is overhead phototherapy. A new device has been developed, the BiliCocoon, where the neonates are “wrapped” presumably making them more comfortable. The aim was to compare the efficacy and performance of the BiliCocoon with overhead LED phototherapy. Methods A randomized open-label multicenter trial in three Danish neonatal units. Healthy hyperbilirubinemic neonates, gestational age ≥33 weeks and postnatal age 24 h to 14 days were randomized to 24 hours’ of treatment with BiliCocoon or overhead blue LED phototherapy with an equal level of irradiance. A mixed effect model with random effect by center was used to compare the percentage decrease in total serum bilirubin (TSB) between the treatments. Results Totally 83 neonates were included. Mean TSB reduction in the BiliCocoon group ( N  = 42), adjusted for baseline TSB, was significantly lower than in the overhead LED group ( N  = 41), 29% vs. 38% ( p -value < 0.01). Overall difference in temperature by treatment (BiliCocoon vs overhead) was 0.70 [0.37; 1.02] °C, p -value < 0.01. Conclusion Bilirubin reducing efficacy of BiliCocoon was lower than that of overhead phototherapy, but it was sufficient for nearly all neonates during 24 hours of treatment. Impact The BiliCocoon has a bilirubin reducing efficacy, sufficient for almost all neonates during 24 hours of phototherapy. The BiliCocoon does not have an equal bilirubin reducing efficacy as overhead phototherapy. The duration of light exposure was longer for the neonates treated in the BiliCocoon. A few neonates can be exclusively breastfed in the BiliCocoon throughout the treatment. The reason for stopping breastfeeding in the BiliCocoon was most often, that the neonates developed hyperthermia.

Phototherapy (PT) is a widely used treatment for neonatal jaundice, yet the ideal model of application remains controversial. In this study, the effects of continuous phototherapy (CPT) and intermittent phototherapy (IPT) models were compared in the treatment of neonatal indirect hyperbilirubinemia (IHB) and whether IPT is a superior modality is investigated. Single-centre parallel randomized controlled open label trial. A computer-based table of random numbers was used to allocate treatments. Newborns ≥ 34 weeks’ gestation who received phototherapy in our neonatal intensive care unit (NICU) between July 2022 and April 2023 were included. CPT was applied continuously for 6 h, and IPT was applied as 2 cycles of 1 h on and 2 h off in a 6-h session. Rebound TSB was measured 8 h after phototherapy was stopped in both groups. Phototherapy duration, TSB reduction rate and rebound bilirubin rate were compared between intervention groups. One hundered and four neonates met the inclusion criteria during the study period. CPT and IPT were each used in 52 newborns. Demographic characteristics of the study groups, including sex, mode of delivery, birth weight, admission weight, age at postnatal presentation, diet, discharge weight, and history of PT in siblings, were similar ( p  > 0.05). The most common cause of IHB in both groups was ABO incompatibility. The median phototherapy time was 12 h (6–15) in the CPT group and 4 h (2–4) in the IPT group ( p  < 0.001). The mean rate of bilirubin decrease was 1.12 ± 0.73 mg/dl/h in those who underwent IPT and 0.51 ± 0.33 mg/dl/h in those who underwent CPT ( p  < 0.001). The mean rebound bilirubin rate 8 h after phototherapy was 0.08 ± 0.28 mg/dl/h in the CPT group, and −0.01 ± 0.17 mg/dl/h in the IPT group ( p  = 0.039). The length of hospital stay was longer in the CPT group ( p  = 0.032). Skin rash, diarrhoea and increased body temperature were less frequent in the IPT group ( p  < 0.001). Conclusions : In this study, IPT was found to be at least as effective as CPT in reducing total serum bilirubin. Even though the duration of PT is shorter in IPT, the slower rate of rebound bilirubin, shorter hospital stays and lower incidence of side effects indicated that intermittent phototherapy is superior to continuous phototherapy. Choosing IPT over CPT is a more rational approach in neonatal jaundice. ClinicalTrials.gov Identifier : NCT 06386731 (registered retrospectively on 23/04/2024) What is Known: • PT is common used in the treatment of neonatal jaundice. • There is no standard model of application for PT. What is New: • The IPT model is as effective as CPT. • Newborns are discharged faster with IPT.

Study Objectives: We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD). Methods: This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior. Results: The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: −5.51 ± 1.03 for the active intervention, −1.50 ± 1.24 for the control intervention). Conclusions: A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments. Clinical Trial Registration: Registry: ClinicalTrials.gov , title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152 , identifier: NCT01816152. Citation: Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a tailored lighting intervention on sleep quality, rest–activity, mood, and behavior in older adults with Alzheimer disease and related dementias: a randomized clinical trial. J Clin Sleep Med . 2019;15(12):1757–1767.

Filtered-sunlight phototherapy (FSPT) that blocks ultraviolet light and reduces infrared radiation is safe and non-inferior to intensive electric phototherapy (IEPT) for treating mild-to-severe neonatal hyperbilirubinemia. In this randomized non-inferiority trial, the safety, efficacy, exchange transfusion (ET), and mortality rates of FSPT versus IEPT among Nigerian neonates with severe-to-hazardous hyperbilirubinemia were investigated. Safety was defined as the absence of hyperthermia, hypothermia, dehydration, or sunburn; efficacy by the proportion of assessable treatment days during which total serum or plasma bilirubin (TSB) increased by < 0.2 mg/dL/hr for newborns aged ≤ 72 h-old or decreased for newborns > 72 h-old. A treatment day was deemed assessable if a neonate received phototherapy for ≥ 4 h, and non-inferiority was inferred for differences within a 10% margin. We enrolled 192 newborns (admission TSB ≤ 62 mg/dL), assigned to FSPT (n = 98) or IEPT (n = 94). FSPT was effective on 94.2% of the assessable treatment days compared with 97.1% for IEPT. The mean difference in efficacy between FSPT and IEPT was -2.9%, 95% CI: -7.6, 1.9). 2.6% of newborns who received FSPT developed controlled hyperthermia, and no baby met the criteria for withdrawal for safety reasons. Overall, 50.6% (39/77) of newborns who received FSPT and 53.7% (51/95) of newborns who received IEPT had ET (p = 0.89) and 7 in each group (9.1% vs 7.4%; p = 0.86) died. In conclusion, FSPT is safe and non-inferior to IEPT for treating neonates with severe-to-hazardous hyperbilirubinemia, it is not associated with significantly higher rates of ET and mortality and should be considered where practicable when IEPT cannot be assured. Clinical Trials.gov Number: NCT02612727 (24/11/2015).

To evaluate the effectiveness of syntonic phototherapy and compare it with partial time occlusion to improve visual acuity in cases of refractive amblyopia. This study is a prospective, comparative, and randomized study. It included 40 patients. Their mean age  ±  SD was 14.45 ± 10.03 years (Range: 6–45 years). Twenty patients were subjected to partial time occlusion of the sound eye, and 20 received syntonic phototherapy treatment.The study revealed that there was statistically significant improvement in visual functions, UCVA, BCVA, AOP, and functional visual field in patients who were subjected to syntonic phototherapy, whereas the improvement of UCVA and BCVA in patients who were subjected to conventional treatment was satisfactory but less than that reported by syntonic therapy. Visual acuity increased significantly in patients with amblyopia after syntonic phototherapy as compared to partial occlusion therapy.

Background Owing to high genetic diversities of tumor cells and low response rate of standard chemotherapy, patients with triple negative breast cancer (TNBC) have short progression-free survivals and poor outcomes, which need to explore an effective approach to improve therapeutic efficacy. Methods Novel gadolinium doped carbon dots (Gd@CDs) have been designed and prepared through hydrothermal method with 3,4-dihydroxyhydrocinnamic acid, 2,2′-(ethylenedioxy)bis(ethylamine) and gadolinium chloride. The synthesized nanostructures were characterized. Taking advantage of good biocompatibility of Gd@CDs, a nanoplatform based on Gd@CDs has been developed to co-deliver chemotherapy drug doxorubicin hydrochloride (Dox) and a near-infrared (NIR) photothermal agent, IR825 for magnetic resonance imaging (MRI) guided photothermal chemotherapy for TNBC. Results The as-synthesized Dox@IR825@Gd@CDs displayed favorable MRI ability in vivo . Upon NIR laser irradiation, Dox@IR825@Gd@CDs could convert the NIR light to heat and efficiently inhibit tumor growth through photothermal chemotherapy in vitro and in vivo. Additionally, the impact of photothermal chemotherapy on the murine motor coordination was assessed by rotarod test. Dox@IR825@Gd@CDs presented low toxicity and high photothermal chemotherapy efficiency. Conclusion A noble theranostic nanoplatform (Dox@IR825@Gd@CDs) was developed that could be tailored to achieve loading of Dox and IR825, intracellular delivery, favorable MRI, excellent combination therapy with photothermal therapy and chemotherapy to enhance therapeutic effect against TNBC cells. This study will provide a promising strategy for the development of Gd-based nanomaterials for MRI and combinational therapy for TNBC. Graphic abstract

When patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS). This assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive-behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks. Assessments took place at 0, 2, 4 and 12 weeks. Feasibility outcomes assessed recruitment, retention of participants and uptake of the therapy. Primary efficacy outcomes were the Insomnia Severity Index and Warwick-Edinburgh Mental Wellbeing Scale at week 2. Analyses were intention-to-treat, estimating treatment effect with 95% confidence intervals. Between October 2015 and July 2016, 40 participants were recruited (from 43 assessed eligible). All participants offered STAC completed treatment (mean sessions received = 8.6, s.d. = 1.5). All participants completed the primary end point. Compared with SC, STAC led to large effect size (ES) reductions in insomnia at week 2 (adjusted mean difference -4.6, 95% CI -7.7 to -1.4, ES -0.9), a small improvement in psychological wellbeing (adjusted mean difference 3.7, 95% CI -2.8 to 10.1, ES 0.3) and patients were discharged 8.5 days earlier. One patient in the STAC group had an adverse event, unrelated to participation. In this challenging environment for research, the trial was feasible. Therapy uptake was high. STAC may be a highly effective treatment for sleep disturbance on wards with potential wider benefits on wellbeing and admission length.

This study aimed to establish the cost-effectiveness of home phototherapy versus hospital phototherapy treating hyperbilirubinemia in neonates more than 36 weeks. Based on clinical results from a randomised controlled trial showing that home phototherapy for hyperbilirubinemia in term neonates is as effective as hospital phototherapy, we performed a cost-minimisation analysis to identify the most cost-effective alternative. We included costs for health care resource use as well as costs for transportation in connection with re-visits. The cost per patient was €337 for home phototherapy compared with €1156 for the hospital alternative indicating average cost savings of €819 (95% confidence interval €613–1025) or 71% per patient. Transportation and outpatient costs were higher in the home treatment group and hospital care costs were higher in the hospital group. Sensitivity analysis shows that results are robust also when allowing for uncertainty. Home phototherapy for neonates more than 36 weeks costs less than in-hospital phototherapy while being equally effective, meaning that home phototherapy is a cost-effective alternative to hospital treatment for infants with neonatal hyperbilirubinemia. Trial registration NCT03536078 . Date of registration: 24/05/2018.

Background The clinical part of this randomized controlled trial concerning phototherapy of neonates with hyperbilirubinemia showed that the recommended blue–green LED light (≈478 nm) was 31% more efficient than standard blue LED light (≈459 nm) measured by the decline in total serum bilirubin. Lumirubin has biologic effects. The aim was to compare the serum bilirubin isomers, efficacy, and biologic effects between the two phototherapy groups. Methods Inclusion criteria: neonates healthy except for hyperbilirubinemia, gestational age ≥33 weeks, birth weight ≥1800 g, and postnatal age >24 h. Forty-two neonates were randomized to receive overhead blue–green light and 44 blue light. Treatment 24 h. The light irradiance was equal. Results The percentage decrease of combined bilirubin isomers was 47.8% for blue–green light vs 33.4% for blue light, the ratio being 1.43. Corresponding values for Z,Z-bilirubin were 55.6% vs 44.2%, the ratio being 1.26. The increase in the absolute serum concentrations of the photoisomer Z,E-bilirubin and thereby combined photoisomers were greater using blue light. Conclusion Blue–green light was essentially more efficient determined by the decline of combined bilirubin isomers and Z,Z-bilirubin itself. Regarding biological effects neonates receiving blue–green light might be more affected than neonates receiving blue light. Impact Phototherapy of hyperbilirubinemic neonates using blue–green LED light with a peak emission of 478 nm was 43% more efficient than standard blue LED light with a peak emission of 459 nm was measured by the decline of serum combined bilirubin isomers, and the decline of toxic Z,Z-bilirubin was 26% greater. Apparently, there was a discrepancy between the huge drop in total serum bilirubin and the low serum concentrations of E,Z-bilirubin and E,Z-lumirubin. This was caused by the rapid excretion of E,Z-lumirubin. Lumirubin has biologic effects. Due to greater lumirubin production neonates exposed to blue–green light might be more affected than those exposed to blue light.