Search results for “Adverse Events

About 8 results in articles

Open Access Pub publishes peer-reviewed, free-to-read open-access articles. Showing articles matching Adverse Events — open any to read the full text, or download the PDF or XML.

8 articles

Efficacy and Safety of Pulsed Magnetic Therapy in Sleep related Disorders: A Remote, Randomized, Double-Blind, Placebo-Controlled Trial

Mar 2026 DOI 10.14302/issn.2574-4518.jsdr-26-6010

Background/Aim Sleep disturbances are common and are associated with impaired daytime functioning, reduced quality of life, and increased health risks. Non-pharmacological neuromodulatory interventions have gained interest as alternatives to hypnotic medication. Pulsed electromagnetic field (PEMF) therapy has been proposed as a non-invasive approach to improve sleep quality and recovery, but evidence from large, well-controlled trials remains limited. The objective of this study was to evaluate the efficacy and safety of pulsed magnetic field therapy (PMT) on sleep quality, sleep-related symptoms, daytime functioning, and well-being in adults with heterogeneous sleep complaints.  Materials and Methods In this remote, randomized, double-blind, placebo-controlled trial, 217 adults reporting non-restorative sleep, difficulties initiating sleep, or frequent nocturnal awakenings were assigned to active PMT using a PEMF device (Night Harmony Female/Male protocol) or a sham application for three weeks. Primary outcomes were changes in the Pittsburgh Sleep Quality Index (PSQI) global score and self-rated sleep satisfaction, restfulness, and sleep initiation difficulties. Secondary outcomes included sleep diary measures, daytime functioning, well-being (WHO-5), symptom burden (MYMOP), and daytime sleepiness (Epworth Sleepiness Scale). Analyses followed the intention-to-treat principle using ANCOVA with baseline values of the respective parameter as covariate.  Results Both groups showed significant improvements over time in global sleep quality and most secondary outcomes (p < 0.001). Between-group differences in PSQI global score were not significant (p = 0.314). However, active PMT resulted in significantly greater improvements in subjective sleep satisfaction (p = 0.02) and restfulness (p = 0.02), particularly among participants with moderate to severe baseline sleep disturbances (p < 0.001 for both). Sleep continuity measures improved similarly in both groups. No serious adverse events were reported.  Conclusions PMT produced modest but significant improvements in subjective restorative aspects of sleep beyond placebo effects and was well tolerated. Further studies using objective sleep measures and longer follow-up are warranted.

Efficacy and Safety of Lercanidipine Combination in Hypertensive Patients

Dec 2025 DOI 10.14302/issn.2329-9487.jhc-25-5778

Calcium channel blockers (CCBs) are widely used for the treatment of arterial hypertension, but they differ in terms of pharmacology, tolerability, and pleiotropic actions. Lercanidipine, a highly lipophilic third generation dihydropyridine, reduces blood pressure (BP) effectively as monotherapy and in combination without inferiority to other major antihypertensive classes. We systematically searched PubMed and the Cochrane Library (last update: September 1, 2025) and screened reference lists for additional studies. Evidence from dose finding trials, randomized controlled studies, large observational cohorts, and meta analyses shows clinically meaningful reductions in office, home, and ambulatory BP with lercanidipine, including in patients with diabetes, obesity, chronic kidney disease, or high cardiovascular (CV) risk. Fixed- dose combinations with renin angiotensin system blockers (e.g., enalapril) provide greater BP reductions than monotherapy and are associated with favorable neurometabolic profiles. Beyond BP control, lercanidipine improves central hemodynamics and arterial stiffness, favors endothelial biology, and contributes to left ventricular hypertrophy regression. Across comparative trials, lercanidipine is generally better tolerated than older dihydropyridines. Presents lower rates of vasodilatory adverse events, less sympathetic activation, while discontinuations due to adverse events are uncommon. Overall, lercanidipine particularly within single pill combinations offers effective, durable BP lowering across diverse patient profiles with a favorable safety and tolerability profile and pleiotropic benefits that extend beyond BP reduction. Figure 1. Graphical Abstract: Pleiotropic effects of Lercanidipine

The Potential Usefulness of Peripheral Somatosensory Stimulation in Improving Sleep Quality in Patients with Insomnia

Feb 2024 DOI 10.14302/issn.2574-4518.jsdr-24-4949

Background Insomnia and other sleep disorders represent a major cause of disability and impaired productivity. We evaluated the impact of peripheral somatosensory stimulation (PSS) on sleep quality in 12 patients with varying degrees of insomnia. Methods Twelve adult patients underwent daily PSS therapy for a 4-week period and were evaluated using the Insomnia Severity Index at baseline (prior to initiation of therapy) and then at the conclusion of the treatments. All data were obtained through a self-reported 7-question survey evaluating overall severity of insomnia symptoms and the impact of sleep patterns on satisfaction with sleep, daily functioning, and overall quality of life. Changes from baseline insomnia scores were analyzed using cumulative link mixed models (CLMMs). Results Seven men and five women completed one month of PSS therapy. Mean age was 55.1 (range 29 to 80 years). No adverse events were described by the patients. The average total change from baseline score was -10.3 points (baseline: 16.5 vs. week 4: 6.2). Patients had statistically significant improvements for every individual survey question by week 4. The median composite score was improved from baseline, with an overall median score of 2 (IQR: 1.25 – 2.75, min-max: 1-4) at baseline compared to 0.5 (IQR: 0 – 0.25, min-max: 0-2) by week 4 (MD = -1 95% CI: , p < 0.001), signaling typically moderate insomnia at baseline vs. typically minimal to no symptoms by week 4. The predicted probability of obtaining the best outcome (score=0) was 9% at baseline vs. 53% by week 4. The overall cumulative odds ratio was 11.9 (p < 0.001), suggesting that on average, the odds of moving from one score to a lower (improved) score at week 4 compared to the baseline are approximately 12 times higher than moving to a neutral or worse score. Conclusions PSS stimulation appeared to have a significantly favorable effect on sleep quality in this group of patients. Symptoms related to ability to fall asleep, remain asleep, and overall quality of sleep were all improved with PSS therapy. We suggest that further investigation into the potential usefulness of PSS therapy in patients with sleep disorders is warranted.

Human Health Research Open Access

A Note from the Field “Potlatch” Advancing a Health Survey: The Pen is Truly Mighty

Dec 2022 DOI 10.14302/issn.2576-9383.jhhr-22-4397

Despite vast improvements in chemo-therapeutic interventions extensively extending the life span of patients with chronic and terminal diseases, there also is the unhappy extension of side- effects and adverse events. Thus, Health-Related Quality of Life (HR-QoL) becomes equally as important as length of life. Accurately, reliably, validly, and representatively measuring the on-going pulse beat of HR-QoL means ensuring optimal responses and response rates, which in turn means fostering and maximizing Survey Participants’ continued rapport, enlistment, engagement, and participation regarding HR-QoL research survey studies. This is generally true regarding all human subjects’ research. HR-QoL survey work at a nationally renowned Cancer Center recently identified an example of Potlatch or gift-giving (i.e., gifting), and its surrounding nuances, that were calculated and appear to evoke enhanced reciprocal engagement in a HR-QoL survey. This work involves continuous, iterative marketing study. The intent of this field note is to describe the methodological phenomenon that may have epistemological and theoretical relevance for ubiquitously advancing the interest of health survey research. Specifically, the contention will be that considered, and tactically deployed Potlatch can serve as a mechanism for facilitating and enhancing health survey research as well as enhancing stronger social engagement in research and treatment for patients undergoing medical care for long-term, chronic illness. First, it can rejuvenate and refocus Survey Participants’ involvement. Second, it can serve as an entrée and springboard to further forge a social connection in the interest of research. Lessons Learned and implications are reported.

Transformative Psychopharmacology: the Case of 5-Methoxy-N,N-Dimethyltryptamine

Jan 2019 DOI 10.14302/issn.2574-612X.ijpr-18-2503

Since the 2nd part of last century neo-shamanic rituals using mind-altering extracts from plants or animals have become increasingly popular in Europe and the USA. The first rituals coming to the west were based on drinking a special Amazonian tea, Ayahuasca, based on 2 different plants, with active compounds belonging to the class of the beta-carbolines (harmala alkaloids) and tryptamines. The use of such compounds will be described from the perspective of the transformative psychopharmacology: that part of psychopharmacology studying the use of psychoactive compounds to achieve a new balance, a transformation or healing and sometimes even leading to a cure. Examples of curing are meanwhile well documented, for instance the positive influence on drug abuse and addiction, alcoholism. The importance of the healing aspects of these rituals however are often neglected or overlooked. For users, these are key however. As medicine becomes more and more personalized and postmodern, it will be relevant to understand why patients and healthy people decide to participate in healing rituals based on psycho-active compounds. We will present the pharmacology, the transformative psychopharmacology, the effects and adverse events of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) and its place in postmodern medicine.

Blockade of Programmed Cell Death Protein-1 Pathway for the Treatment of Melanoma

Nov 2017 DOI 10.14302/issn.2471-2175.jdrt-17-1760

Metastatic melanoma is a very deadly type of skin cancer with poor prognosis and low 5-year survival rates. Until recently, patients with metastatic melanoma had very few treatment options, which only included dacarbazine and aldesleukin. In 2011, the first checkpoint blocker, ipilimumab was approved for the treatment of unresectable metastatic melanoma but its success was eclipsed by low response rates and high incidence of adverse events. Later in 2014, anti-PD-1 antibodies, nivolumab and pembrolizumab were approved for the treatment of metastatic melanoma. With comparatively high response rates and manageable safety profile, PD-1 blockers were remarkably successful in the treatment of melanoma and also other cancer subtypes such as non-small cell lung cancer and metastatic urothelial carcinoma. This article highlights the success of anti-PD-1 antibodies, discusses the mechanism of PD-1:PD-L1/2 pathway, responses of melanoma patients to PD-1 blockers and the research on improving response rates to PD-1 blockers.

Pregnancy Outcome in Gestational Diabetes Mellitus under Treatment-Bangladesh Perspective

Feb 2017 DOI 10.14302/issn.2374-9431.jbd-17-1429

Objectives: To observe pregnancy outcomes in gestational diabetes mellitus (GDM) under treatment. Methods: Pregnant mothers (N=191) diagnosed with GDM (n=91, age: 27.44±4.91yr; body mass index, BMI: 26.88±4.16 kg/m2; mean±SD) on the basis of WHO 2013 criteria were compared with non-GDM (n=100, age: 26.01±4.81yr, BMI: 25.53±3.77 kg/m2, mean±SD) for pregnancy outcome irrespective of gestational age. HbA1c was also measured in all mothers. Gestational hypertension, preeclampsia, premature rupture of membrane (PROM), hydramnios, recurrent urinary tract infection (UTI), recurrent moniliasis, intrauterine growth retardation (IUGR), intra uterine death (IUD), mode of delivery, birth weight, birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome (RDS), congenital anomaly were recorded at every trimester. 160 mothers (GDM=75, non-GDM=85) could be followed for outcomes to the end of pregnancy. All the GDM mothers were offered standard treatment throughout pregnancy period. Results: HbA1c was significantly higher in GDM than that in non-GDM (5.42±0.61 vs. 4.98±0.44%, mean±SD; p<0.001).Outcome events in GDM and non-GDM were: gestational hypertension- 3.6% vs. 2.3% (p=0.621), preeclampsia- 2.4% vs. 0% (p=0.150), PROM- 4.9% vs. 0% (p=0.037), hydramnios- none in any group, recurrent UTI- 12.3% vs. 4.7% (p=0.073), recurrent moniliasis- 0.0% vs. 2.3% (p=0.165), caesarian section- 85.3% vs. 72.9% (p=0.056), small for gestational age (SGA)- 26.4% vs. 36.7% (p=0.246), large for gestational age (LGA)- 1.4% vs. 0%, p=0.246, IUGR- 2.3 vs. 2.5% (p=0.952), neonatal hypoglycemia- 2.7% vs. 0.0% (p=0.130), hyperbilirubinemia- 12.0% vs. 11.8% (p=0.963), RDS- 0.0% vs. 2.4% (p=0.181) and birth injury- 0.0% vs. 1.2% (p=0.346), congenital anomaly- 4.0% vs. 1.2% (p=0.254) and abortion- 1.3% vs. 0.0% (p=0.286). Preterm delivery (12.0% vs. 7.1%, p=0.285) and caesarean section (85.3% vs. 72.9%, p=0.056) were more in GDM. Conclusions: Despite treatment, adverse events were relatively higher but non-significant in GDM.

Predictors of Averse Events After Total Laryngectomy: An Analysis of the 2005-2011 NSQIP Datasets

Nov 2014 DOI 10.14302/issn.2379-8572.joa-14-429

Background: We reviewed the 2005-2011 ACS-NSQIP database to evaluate factors associated with adverse events (AE) after total laryngectomy (TL). Methods: All total laryngectomies performed from 2006 to 2011 were identified for analysis. The cohort was characterized with respect to preoperative and demographic characteristics, complications, reoperation, and mortality. Results: 493 cases were identified. Complications of any category occurred in 189 cases (38.3%). Factors that were found to confer significant risk for medical complications were increased age (dds Ratio (OR) 1.03), prior PCI (OR 2.84), disseminated cancer (OR 2.47), chronic steroid/immunosuppresion use (OR 2.87), unintended weight loss > 10% over 6 months prior to surgery (OR 2.02), increasing work RVU total (OR 1.02), and increased anesthesia Z-score (OR 1.31). Only increased anesthesia Z-score (OR 1.27) was found to be a statistically significant risk factor for surgical complications. Chronic steroid/immunosuppression use (OR 3.16) and increased anesthesia Z-score (OR 1.29) were both found to be statistically significant risk factors of reoperation within 30 days. Conclusions: NSQIP is the only dataset that correctly discerns between minimally invasive and wide excision in laryngectomy. The use of the NSQIP dataset may be imperfect, as pertinent details of chemotherapy and radiation, and procedure-specific complications, including fistula formation, are not tracked. In spite of this, our findings suggest avenues for improvement in the care of TL patients, and suggest directions for a laryngectomy-specific outcomes database.

Frequently asked questions

Are these articles peer-reviewed?
Yes. Articles published at Open Access Pub go through single-blind peer review (double-blind on request) under an editorial board before publication.
Are the articles free to read?
Yes. Every article is open access — read the full text online for free and download the PDF or XML, with no paywall or subscription.
How do I cite an article?
Use the DOI shown on each result and on the article page; it is the permanent, citable link to the article.
How do I read or download an article?
Click "Read full text" to open the article HTML, or use the PDF / XML buttons on each card to download it.