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1.
J Palliat Med ; 2024 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-39304187

RESUMEN

Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.

2.
Artículo en Inglés | MEDLINE | ID: mdl-39309545

RESUMEN

Both imagery and acupuncture are the oldest medical practices. Recently, we have developed a new treatment modality, video-guided acupuncture imagery treatment (VGAIT), which combines acupuncture and imagery. In this crossover study, we investigated the modulation effects of video-guided acupuncture imagery treatment compared with placebo acupuncture using no-touch double-blind placebo acupuncture needles and a no-treatment resting control. Pressure pain threshold and electroencephalogram (EEG) data were collected before and after each intervention. 12 healthy participants completed the study. Results showed that pressure pain thresholds were significantly increased after VGAIT compared to the resting control condition. In addition, we found that VGAIT, but not the no-touch placebo acupuncture or the resting control, significantly increased alpha and beta band power. Our findings demonstrate the potential of VGAIT as a remote therapeutic method (e-health treatment option) for pain and the value of no-touch double-blind placebo acupuncture in acupuncture research.

3.
Conserv Biol ; : e14369, 2024 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-39225268

RESUMEN

Conservation literature addresses a broad spectrum of interdisciplinary questions and benefits. Conservation science benefits most when a diverse range of authors are represented, particularly those from countries where much conservation work is focused. In other disciplines, it is well known that barriers and biases exist in the academic publishing sphere, which can affect research dissemination and an author's career development. We used a discrete choice experiment to determine how 7 journal attributes affect authors' choices of where to publish in conservation. We targeted authors directly by contacting authors published in 18 target journals and indirectly via communication channels for conservation organizations. We only included respondents who had previously published in a conservation-related journal. We used a multinomial logit model and a latent class model to investigate preferences for all respondents and distinct subpopulations. We identified 3 demographic groups across 1038 respondents (older authors from predominantly middle-income countries, younger authors from predominantly middle-income countries, and younger authors from high-income countries) who had published in conservation journals. Each group exhibited different publishing preferences. Only 2 attributes showed a consistent response across groups: cost to publish negatively affected journal choice, including authors in high-income countries, and authors had a consistent preference for double-blind review. Authors from middle-income countries were willing to pay more for society-owned journals, unlike authors from high-income countries. Journals with a broad geographical scope that were open access and that had relatively high impact factors were preferred by 2 of the 3 demographic groups. However, journal scope and open access were more important in dictating journal choice than impact factor. Overall, different demographics had different preferences for journals and were limited in their selection based on attributes such as open access policy. However, the scarcity of respondents from low-income countries (2% of respondents) highlights the pervasive barriers to representation in conservation research. We recommend journals offer double-blind review, reduce or remove open access fees, investigate options for free editorial support, and better acknowledge the value of local-scale single-species studies. Academic societies in particular must reflect on how their journals support conservation and conservation professionals.


Comprensión de las elecciones de los autores en el entorno actual de publicaciones sobre la conservación Resumen La bibliografía sobre conservación aborda un amplio espectro de preguntas y beneficios interdisciplinarios. La mayor parte de ella representa una gama diversa de autores, sobre todo de países en los que se centra gran parte del trabajo de conservación. Es bien sabido que en otras disciplinas existen barreras y sesgos en el ámbito de la publicación académica que pueden afectar a la difusión de la investigación y al desarrollo de la carrera de un autor. Usamos un experimento de elección discreta para determinar cómo afectan siete atributos de las revistas sobre conservación en la elección de los autores sobre en cuál publicar. Nos dirigimos directamente a los autores y nos pusimos en contacto con quienes publicaban en 18 revistas objetivo e indirectamente a través de los canales de comunicación de las organizaciones de conservación. Sólo incluimos a los encuestados que habían publicado anteriormente en una revista relacionada con la conservación. Usamos un modelo logit multinominal y un modelo de clases latentes para investigar las preferencias de todos los encuestados y de las distintas subpoblaciones. Identificamos tres grupos demográficos entre los 1038 encuestados (autores de más edad de países con predominancia de ingresos medios, autores más jóvenes de países con predominancia de ingresos medios y autores más jóvenes de países con ingresos altos) que habían publicado en revistas de conservación. Cada grupo mostraba preferencias editoriales diferentes. Sólo dos atributos mostraron una respuesta coherente en todos los grupos: el costo de la publicación afectaba negativamente a la elección de la revista, incluidos los autores de países con ingresos altos, y los autores tenían una preferencia coherente por la revisión doble ciego. Los autores de países con ingresos medios están dispuestos a pagar más por las revistas pertenecientes a la sociedad, a diferencia de los autores de países de ingresos altos. Dos de los tres grupos demográficos prefieren las revistas de ámbito geográfico amplio, de acceso abierto y con un factor de impacto relativamente alto. Sin embargo, el alcance de la revista y el acceso abierto fueron más importantes que el factor de impacto. En general, los distintos grupos demográficos tenían preferencias diferentes en cuanto a las revistas y su selección se veía limitada por atributos como la política de acceso abierto. No obstante, la falta de encuestados procedentes de países con bajos ingresos (2% de los encuestados) destaca las barreras generalizadas para la representación en la investigación sobre conservación. Recomendamos que las revistas ofrezcan revisiones doble ciego, reduzcan o eliminen las tarifas de acceso abierto, investiguen opciones de apoyo editorial gratuito y reconozcan mejor el valor de los estudios de una sola especie a escala local. Las sociedades académicas, en particular, deben reflexionar sobre la forma en que sus revistas apoyan la conservación y a los profesionales de la conservación.

4.
Eur Psychiatry ; 67(1): e53, 2024 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-39301594

RESUMEN

BACKGROUND: The change in symptoms necessary to be clinically relevant in obsessive-compulsive disorder (OCD) is currently unknown. In this study, we aimed to create an empirically validated threshold for clinical significance or minimal important difference (MID). METHODS: We analyzed individual participant data from short-term, double-blind, placebo-controlled registration trials of selective serotonin reuptake inhibitors in adult OCD patients. Data were collected from baseline to week 12. We used equipercentile linking to equate changes in the Clinical Global Impression (CGI) scale to changes in the Yale-Brown Obsessive-Compulsive Scale (YBOCS). We defined the MID as the YBOCS change linked to a CGI improvement of 3 (defined as "minimal improvement"). RESULTS: We included 7 trials with a total of 1216 patients. The CGI-scores and YBOCS were moderately to highly correlated. The MID corresponded to 4.9 YBOCS points (95% CI 4.4-5.4) for the full sample, or a 24% YBOCS-decrease compared to baseline. The MID varied with baseline severity, being lower in the group with mild symptoms and higher in the group with severe symptoms. CONCLUSIONS: By linking the YBOCS to the CGI-I, this is the first study to propose an MID in OCD trials. Having a clearly defined MID can guide future clinical research and help interpretation of efficacy of existing interventions. Our results are clinician-based; however, there is further need for patient-reported outcomes as anchor to the YBOCS.


Asunto(s)
Trastorno Obsesivo Compulsivo , Inhibidores Selectivos de la Recaptación de Serotonina , Humanos , Trastorno Obsesivo Compulsivo/tratamiento farmacológico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Método Doble Ciego , Adulto , Masculino , Femenino , Diferencia Mínima Clínicamente Importante , Escalas de Valoración Psiquiátrica , Persona de Mediana Edad , Resultado del Tratamiento
5.
Chin J Integr Med ; 2024 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-39251465

RESUMEN

OBJECTIVE: To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care. METHODS: A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded. RESULTS: A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events. CONCLUSION: The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).

6.
J Food Allergy ; 6(1): 21-25, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39257602

RESUMEN

Current food allergy management universally treats all patients with food allergy as being at risk for anaphylaxis (with the exception perhaps of pollen food allergy syndrome). Thus, patients are told to avoid the allergenic food in all potentially allergic forms and amounts. However, research over the past 2 decades has shown that many patients will tolerate small amounts of the allergen without any allergic reaction. Thus, if one were able to identify the threshold of reactivity, this could change management. At the population level, establishing levels at which the vast majority of patients (e.g., 95%) do not react could have public health ramifications, such as altering labeling laws. At the individual patient level, personal threshold levels could determine avoidance strategies, affect quality of life, and alter treatment decisions, e.g., oral immunotherapy starting doses. In this review, threshold data for various allergens and their potential effect on the management of the patient with food allergy are examined.

7.
Pharm Nanotechnol ; 2024 Aug 30.
Artículo en Inglés | MEDLINE | ID: mdl-39219425

RESUMEN

BACKGROUND: The assessment of the hard and soft tissue conditions is part of the overall dental treatments. AIM: In this study, we investigated nano curcumin-containing membranes to improve the quality of the hard and soft tissues in the extracted tooth area as a clinical trial study. METHODS: After the patient was selected following the inclusion and exclusion criteria, the patients who had teeth extracted from both sides of the mouth (split mouth) on the side of the intervention received a membrane containing nanocurcumin, and on the control side, no material was placed in the socket. For data analysis, SPSS software version 24 was used. A significance threshold was deemed to be less than 0.05 in terms of probability. RESULTS: Two months after tooth extraction, during implant placement, the average gingival thickness on the "intervention side," was 3.1±0.34 mm, while the average gingival thickness on the "control side" was 2.6±0.42 mm. Then, the membrane could improve the quality of soft tissue (P< 0.0001). As another outcome, the application of this membrane did not significantly affect bone repair in these patients compared to the control group (P = 0.72). However, the histology data revealed that the newly generated bone of the intervention group was seen close to the membrane, demonstrating the osteoconductive ability of the membrane. CONCLUSION: Based on the obtained results, the newly developed membrane can be used to improve the quality of hard and soft tissues in the extracted tooth area. Nonetheless, more efforts in nanocurcumin dosage adjustment are needed for hard tissue regeneration in future studies.

8.
J Pers Med ; 14(8)2024 Jul 27.
Artículo en Inglés | MEDLINE | ID: mdl-39201987

RESUMEN

Cognitive frailty (CF) is a heterogeneous syndrome that is becoming one of the most serious health problems as the world's population age is increasing. Elucidating its biological mechanisms as well as prevention and treatments is becoming increasingly significant, particularly in view of the associated health costs. We presented the study protocol of a research project funded by the Italian Ministry of Health (grant number RF-2016-02363298) aiming to investigate the cognitive and neuropsychological effects of a 5-week treatment with therapy based on the regenerative properties of ozone (O3) in a cohort of subjects stratified according to CF scores. We also studied the potential effects of O3 on blood-based biomarkers indicative of specific biological systems that may be altered in CF. Seventy-five older persons were recruited and randomly assigned to receive the active treatment (150 cc of oxygen-O2-O3 mixture at the concentration of 30 µg of O3 per cc of O2), O2, or the placebo (air) for 5 weeks. The main endpoints were the change in the scores of clinical scales from baseline (T0) to weeks 3 (T3), 9 (T9), and 15 (T15) after treatment and the change in biomarker levels resulting from transcriptomics, proteomics, and metabolomic patterns at the same times. The positive results from this study could have important clinical implications.

9.
J Autism Dev Disord ; 2024 Aug 17.
Artículo en Inglés | MEDLINE | ID: mdl-39153149

RESUMEN

Scarce clinical trials involving autistic people with intellectual disability (ID) and minimally speaking (MS) status have been a substantial unmet research need in the field. Although earlier studies have demonstrated the feasibility and beneficial potentials of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) in intellectually able autistic people, the feasibility and tolerability of applying rTMS in autistic people with ID/MS has never been studied. We conducted the world-first 4-week randomized, double-blind, sham-controlled pilot trial to investigate the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS) over the left DLPFC in autistic youth with ID/MS. 25 autistic youth with ID/MS (aged 8-30 years) were randomized to a 20-session 4-week daily iTBS (n = 13) vs. sham stimulation (n = 12) with follow-up 4 and 8 weeks, respectively, after the last stimulation. A retention rate was 100% in our study. Adverse events of local pain (38%) and dizziness (8%) were only noted in the active group. All adverse events were mild and transient. There were no seizures, new behavioral problems, or other severe/serious adverse events noted. No participants dropped out due to adverse events. With a small sample size, we did not find any beneficial signal of DLPFC iTBS. Our pilot data suggest regular daily TBS treatment for four weeks is feasible, well tolerated and safe in autistic youth with ID/MS. Future randomized controlled trials with sufficiently powered samples are needed to investigate the beneficial potential of rTMS/TBS for autistic people with ID/MS.

10.
Compr Psychiatry ; 135: 152520, 2024 Jul 23.
Artículo en Inglés | MEDLINE | ID: mdl-39126759

RESUMEN

OBJECTIVE: Characterized by its disabling nature, obsessive compulsive disorder (OCD) affects individuals profoundly, with nearly 40% of patients showing resistance to initial treatment methods. Despite being safe and easily accessible, transcranial direct current stimulation (tDCS) lacks extensive substantiation supporting its efficacy in treating OCD. The objective of this study was to evaluate how cathodal high-definition transcranial direct current stimulation (HD-tDCS) applied to the right orbitofrontal cortex affected patients with OCD in terms of efficacy. METHOD: 47 patients with OCD were enrolled. They were randomly allocated to active or sham stimulation groups, and underwent HD-tDCS stimulation treatment for 2 weeks. The central electrode located in the right orbitofrontal cortex region was cathodic. The severity of the patients' obsessive-compulsive symptoms, depression and anxiety were assessed before and after treatment. RESULT: Out of the total, 44 patients concluded the treatment, comprising 23 participants from the active stimulation group and 21 from the sham stimulation group. Notably, substantial reductions in symptoms related to OCD, depression, and anxiety were exhibited in both groups. With a response rate of 26.1% in the active stimulation group and 23.8% in the sham stimulation group, there was no significant difference in efficacy observed. Furthermore, the reduction in depression and anxiety symptoms at the conclusion of the treatment was not notably superior in the active stimulation group. CONCLUSION: This study provided evidence for the acceptability and safety of HD-tDCS. Nevertheless, the study did not reveal notable clinical effectiveness of tDCS in addressing moderate to severe OCD in comparison to the sham stimulation group.

11.
Br J Biomed Sci ; 81: 12054, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38952614

RESUMEN

The peer review process is a fundamental aspect of modern scientific paper publishing, underpinning essential quality control. First conceptualised in the 1700s, it is an iterative process that aims to elevate scientific literature to the highest standards whilst preventing publication of scientifically unsound, potentially misleading, and even plagiarised information. It is widely accepted that the peer review of scientific papers is an irreplaceable and fundamental aspect of the research process. However, the rapid growth of research and technology has led to a huge increase in the number of publications. This has led to increased pressure on the peer review system. There are several established peer review methodologies, ranging from single and double blind to open and transparent review, but their implementation across journals and research fields varies greatly. Some journals are testing entirely novel approaches (such as collaborative reviews), whilst others are piloting changes to established methods. Given the unprecedented growth in publication numbers, and the ensuing burden on journals, editors, and reviewers, it is imperative to improve the quality and efficiency of the peer review process. Herein we evaluate the peer review process, from its historical origins to current practice and future directions.


Asunto(s)
Revisión de la Investigación por Pares , Humanos , Investigación Biomédica/tendencias , Investigación Biomédica/normas , Historia del Siglo XXI , Revisión de la Investigación por Pares/tendencias , Revisión de la Investigación por Pares/normas , Publicaciones Periódicas como Asunto , Edición/normas , Edición/tendencias , Control de Calidad
13.
BMC Infect Dis ; 24(1): 719, 2024 Jul 22.
Artículo en Inglés | MEDLINE | ID: mdl-39039459

RESUMEN

BACKGROUND: Evidence on ivermectin as a treatment for Covid-19 is controversial. A Cochrane review concluded that the efficacy and safety of ivermectin is uncertain (evidence up to April 2022) and WHO recommended its use only in the setting of clinical trials. This study aimed to assess the efficacy and safety of oral ivermectin in hospitalized patients with mild to moderate Covid-19. TRIAL DESIGN AND METHODS: A double-blind, randomized placebo-controlled clinical trial was conducted among RT-PCR-confirmed, adults, hospitalised within the first four days of symptoms. Patients received oral ivermectin 24 mg or placebo daily for five days. RT-PCR was repeated on days five and ten. Clinical progression was monitored using the World Health Organization Clinical Progression Scale. Serum ivermectin levels were measured on days three, five, and seven. The primary outcome was the difference in the viral load between day zero and ten in the two groups. RESULTS: Out of 1699 patients screened, 249 underwent randomization and 127 received ivermectin, and 122 placebo. D10 median viral load for E gene (IQR) was 2,000 copies/mL (100 - 20,500) with ivermectin (n = 80) and 4,100 copies/mL (1,000-65,600) with placebo (n = 81, p = 0.028), per protocol analysis. The difference in Log viral load between day zero and ten between ivermectin and placebo was 3.72 and 2.97 respectively (p = 0.022). There was no significant difference in the WHO clinical progression scale or the adverse effects. Ivermectin blood levels taken before or with meals were not significantly different. Only 7 and 17 patients achieved blood levels above 160ng/ML and 100ng/ML respectively and they did not achieve a significantly lower viral load. CONCLUSION: Although ivermectin resulted in statistically significant lower viral load in patients with mild to moderate Covid-19, it had no significant effect on clinical symptoms. TRIAL REGISTRATION NUMBER: SLCTR/2021/020, Sri Lanka Clinical Trials Registry. 19/07/2021.


Asunto(s)
Tratamiento Farmacológico de COVID-19 , Ivermectina , SARS-CoV-2 , Carga Viral , Humanos , Ivermectina/administración & dosificación , Ivermectina/efectos adversos , Ivermectina/uso terapéutico , Método Doble Ciego , Masculino , Femenino , Persona de Mediana Edad , Administración Oral , Carga Viral/efectos de los fármacos , Adulto , SARS-CoV-2/genética , SARS-CoV-2/efectos de los fármacos , Resultado del Tratamiento , COVID-19/virología , Anciano , Antivirales/administración & dosificación , Antivirales/uso terapéutico , Antivirales/efectos adversos
14.
Front Aging Neurosci ; 16: 1375841, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38915348

RESUMEN

Objective: To evaluate the efficacy and safety of intranasal insulin on postoperative cognitive dysfunction (POCD) in elderly patients after laparoscopic radical resection of colorectal cancer. Methods: Older patients scheduled for laparoscopic radical resection of colorectal cancer at Beijing Luhe Hospital, Capital Medical University, between August 2023 and November 2023, were enrolled in this double-blind pilot study. Patients were randomized to the control and insulin groups at a 1:1 ratio. The primary outcome was the rate of POCD at postoperative 7 days. Results: A total of 61 patients (30 in the insulin group) were analyzed. The insulin group had a significantly lower POCD rate compared with the control group at postoperative day 7 [4(13.3%) vs. 12 (38.7%), p = 0.024]. The serum levels of IL-6, TNF-α and S100ß at T2-5 in the insulin group were significantly lower than those of the control group (IL-6: mean difference at T2, -4.14, p = 0.036; T3, -3.84, p = 0.039; T4, -3.37, p = 0.013; T5, -2.57, p = 0.042; TNF-α: mean difference at T2, -3.19, p = 0.002; T3, -2.35, p = 0.028; T4, -2.30, p = 0.019; T5, -1.96, p = 0.0181; S100ß: mean difference at T2, -8.30, p = 0.019; T3, -23.95, p = 0.020; T4, -20.01, p = 0.023; T5, -17.67, p = 0.010). No insulin allergic reactions, nasal irritation, or hypoglycemic reactions were observed in either of the groups. Conclusion: Intranasal insulin may decrease the risk of POCD and inhibit the elevated serum IL-6, TNF-α, and S100ß levels in elderly patients after laparoscopic radical resection of colorectal cancer, which proves that intranasal insulin may be a promising therapeutic option for POCD. Clinical trial registration: Identifier, ChiCTR2300074423.

15.
Neuropsychiatr Dis Treat ; 20: 1097-1106, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38774254

RESUMEN

Objective: The purpose of this study was to evaluate the positive impact of mobile neurofeedback (MNF) in neurotypical children compared to sham mobile neurofeedback. Methods: Neurotypical children aged 10-15 participated in the study. All subjects were assessed using the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version Korean Version (K-SADS-PL-K) and confirmed to have no psychiatric symptoms. The participants were randomly assigned to the MNF active (N=31) or sham control (N=30) groups. The MNF program was administered using a mobile app for 30 min/day, 3 days/week, for 3 months. All participants and their parents completed self-report scales and participants complete neurocognitive function assessments including the continuous performance test, Stroop, children's color trails test-1 and 2, and intelligence test at baseline and after the 3-month MNF program. Results: This study involved 61 participants (mean [SD] age, 11.24 [1.84] years; 30 male participants [49.2%]). To verify the difference between the MNF group and the sham group, 2(MNF-Sham) X 2(Pre-Post) repeated measures ANOVA was performed. The main effect of the K-scale (Korea Internet addiction scale) between-group factor (MNF vs Sham) was not significant, but the main effect of the within-group factor (Pre vs Post) was significant (F=7.595, p=0.008). The interaction effect of between-group factors and within-group factors was also significant (F=5.979, p=0.017). In other self-reported scales of children and parents and neurocognitive function assessments, there was no significant difference between the two groups. Conclusion: Active mobile neurofeedback significantly improved children's K-scale score compared to the sham group. Therefore, mobile neurofeedback could be an easy-to-access therapeutic option for children at risk of Internet addiction. On the other hand, there was no significant difference in other scales and neurocognitive function. A 3-month intervention may not have been long enough to cause change, so longer interventions are needed for confirmation.

16.
Front Nutr ; 11: 1389374, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38757130

RESUMEN

Pycnogenol® French maritime pine bark extract is a well-known and thoroughly studied patented extract from the bark of Pinus pinaster Ait. ssp. Atlantica. In 39 randomized double-blind, placebo-controlled (RDP) human clinical trials including 2,009 subjects, Pycnogenol® French maritime pine bark extract supplementation for two weeks to six months has been shown to beneficially affect cardiovascular health, chronic venous insufficiency, cognition, joint health, skin health, eye health, women's health, respiratory health and allergies, oral health and sports performance. The mechanisms of action that can explain the respective effects on different conditions in the human body are discussed as well. As investigated in several in vitro, in vivo and in clinical studies, Pycnogenol® French maritime pine bark extract showed antioxidative effects, anti-inflammatory abilities, beneficial effects on endothelial function and reinforcing effects on the extracellular matrix. The present review aims to give a comprehensive overview of currently available "gold standard" RDP trials of Pycnogenol®'s benefits across various health domains compared to placebo. In addition, some of the processes on which the presented effects of Pycnogenol® French maritime pine bark extract are based will be elucidated and discussed. This broad overview of RDP studies on Pycnogenol® in different health domains can be used as a basis for further research on applications and mechanisms of this unique French maritime pine bark extract.

17.
Pilot Feasibility Stud ; 10(1): 70, 2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38698433

RESUMEN

INTRODUCTION: Blinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors. METHODS AND ANALYSIS: Two-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol-both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes-included to blind the study objective from participants-are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery. ETHICS AND DISSEMINATION: The independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023-00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain-the SALuBRITY trial. TRIAL REGISTRATION: NCT05778396.

18.
J Psychiatr Res ; 175: 280-286, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38759495

RESUMEN

Infra-low frequency neurofeedback training (ILF-NFT) has shown promise in addressing cognitive and affective distress symptoms across a range of psychiatric disorders. This study tested ILF-NFT's effects in a double-blinded, placebo-controlled longitudinal context in healthy psychology students. Across five weeks, forty-two healthy psychology students (aged 18-35) were randomly allocated into two groups, receiving ten sessions of 30 minutes of active and sham ILF-NFT. Dependent variables were measured before, following, and two months after the intervention and were comprised of: heartrate variability assessments as a measure of stress resilience; digit span, n-back, trail making and go-no-go task measures of executive functioning performance; and SCL-90-R, WHOQOL-Bref, and peak performance measures of subjective self-report. Statistical analysis was performed using an ANCOVA and compared across groups correcting for baseline differences and multiple comparisons. ANCOVA analyses revealed no significant differences across active and placebo groups in any dependent variables, when correcting for multiple comparisons. Thus, the remaining analyses focused on questionnaire correlations. Here, significant correlations were observed between the novel peak performance questionnaire with the SCL-90-R and WHOQOL-Bref, confirming its construct and retest validity. Despite several methodological limitations, including a potential type-2 error, this study highlights limited effects of ILF-NFT in healthy volunteers. Future research should thus focus on clinically driven experimental designs to explore ILF-NFT's potential in psychiatric contexts. Further research utilization of the novel peak performance questionnaire is recommended for measures of peak performance.


Asunto(s)
Neurorretroalimentación , Humanos , Neurorretroalimentación/métodos , Adulto , Masculino , Femenino , Adulto Joven , Método Doble Ciego , Adolescente , Estudios Longitudinales , Función Ejecutiva/fisiología
19.
J Matern Fetal Neonatal Med ; 37(1): 2333929, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38570191

RESUMEN

OBJECTIVE: To determine the effectiveness of oral dydrogesterone in preventing miscarriage in threatened miscarriage. METHODS: A randomized, controlled trial study was conducted among pregnant Thai women at the gestational age of six to less than 20 weeks who visited King Chulalongkorn Memorial Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand with threatened miscarriage from August 2021 to August 2022. These pregnant women were randomized to receive oral dydrogesterone 20 mg per day or placebo twice a day until one week after vaginal bleeding stopped or otherwise for a maximum of six weeks. RESULTS: A total of 100 pregnancies were recruited. Fifty of them were assigned to receive oral dydrogesterone and 50 were assigned to receive placebo. The rate of continuing pregnancy beyond 20 weeks of gestational age was 90.0% (45 out of 50 women) in the dydrogesterone group and 86.0% (43 out of 50 women) in the placebo group (p = 0.538). The incidence of adverse events did not differ significantly between the groups. CONCLUSION: Oral dydrogesterone 20 mg/day could not prevent miscarriages in women with threatened miscarriage.


Asunto(s)
Aborto Espontáneo , Amenaza de Aborto , Femenino , Humanos , Embarazo , Aborto Espontáneo/prevención & control , Amenaza de Aborto/tratamiento farmacológico , Amenaza de Aborto/prevención & control , Método Doble Ciego , Didrogesterona/uso terapéutico , Progestinas , Tailandia
20.
Front Vet Sci ; 11: 1352314, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38645644

RESUMEN

Introduction: Cannabinoids show great therapeutic potential, but their effect on anesthesia still remains unclear. Use of chronic recreational Cannabis in humans undergoing anesthetic procedures tends to require a higher dose when compared to non-users. On the other hand, studies on rodents and dogs have shown that cannabinoid agonists may potentiate certain anesthetics. This contrast of effects possibly occurs due to different time lengths of administration of different phytocannabinoids at different doses, and their distinct effects on the Endocannabinoid System, which is also affected by anesthetics such as propofol and isoflurane. Methods: Twenty-seven healthy male dogs, client-owned, ranging from 1 to 7 years, and from 5 to 35 kg were selected, mean weight 15.03±7.39 kg, with owners volunteering their animals to participate in the research performed in the Federal University of Santa Catarina (UFSC). Dogs were randomized into 3 groups. The Control Group (CON, n = 9), receiving only Extra Virgin Olive Oil, the same oil-base used in the treatment groups. Group 2 (G2, n = 9) received 2 mg/kg of total phytocannabinoids, and Group 3 (G3, n = 9) received 6 mg/kg of total phytocannabinoids. All groups received their treatments transmucosally, 75 min before their induction with propofol. Heart and respiratory rate, blood pressure, temperature and sedation were evaluated prior to, and at 30, 60, and 75 min after administration of the fsCBD-rich extract or Placebo extract. Preanesthetic medication protocol was also included across all treatment groups, 15 min before induction. Parametric data was analyzed with one-way ANOVA, followed by Student-Newman-Keuls (SNK) if significant statistical differences were found. Non-parametric data was analyzed using Friedman's test, followed by Dunn test for comparisons between all timepoints in the same group. Kruskal-Wallis followed by Dunn was utilized for between groups comparisons. Propofol dose necessary for induction was analyzed through One-way ANOVA followed by Tukey's Multiple Comparisons Test, using Instat by Graphpad, and differences were considered statistically significant when p < 0.05. Our analysis assessed if statistical significance was present between time points in the same group, and between groups in the same time points. Results: In our study, 6 mg/kg of total phytocannabinoids were able to reduce the dose of propofol necessary for induction by 23% when compared to the control group. The fsCBD-rich extract did not produce significant sedation within or between groups, although statistically significant differences in heart rate and systolic blood pressure were found. Discussion: Our findings indicate that phytocannabinoids could be an adjunct option in anesthesia, although further research is necessary to better confirm this data. Additionally, further research is needed to determine the best dosage, delivery method, time for administration, ideal molecular profile for desired effects, safety, drug-drug interactions, and transurgical effects.

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